On March 12, 2026 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported financial results for the fourth quarter and fiscal year ended December 31, 2025, and provided a business update.

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"2025 was an exceptional year for Precision BioSciences marked by meaningful clinical and financial progress. We delivered on what we committed to achieve and more in 2025 positioning Precision BioSciences for success in 2026 and beyond," said Michael Amoroso, Chief Executive Officer. "The evidence supporting the clinical utility of ARCUS for in vivo gene editing continues to mount in diseases with high unmet need led by advancement of PBGENE-HBV through multiple cohorts in our ELIMINATE-B study for chronic hepatitis B. At The Liver Meeting 2025, we presented late-breaking clinical data showing safety and cumulative, dose-dependent antiviral activity along with paired biopsy findings that provide the first molecular evidence consistent with viral DNA gene editing in patients. In another first, our partner iECURE achieved a complete response in the first infant with neonatal onset OTC deficiency following treatment with ECUR-506 which utilizes an ARCUS nuclease developed by Precision for in vivo gene insertion."

"Additionally, our team completed all Investigational New Drug (IND) enabling activities for PBGENE-DMD and filed an IND application by the end of 2025 after announcing prioritization of the program in May 2025. This paved the way for the IND clearance in early 2026 and allowed us to begin the IRB process to activate clinical trial sites," continued Mr. Amoroso. "Finally, we strengthened our financial position by extending our expected cash runway through 2028 and entered 2026 focused on achieving multiple potential clinical value-inflection points for PBGENE-HBV and PBGENE-DMD this year."

Wholly Owned Portfolio:

PBGENE-HBV (Hepatitis B Viral Elimination Program)

PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. In patients with chronic hepatitis B, cccDNA acts as the template to make new infectious viral particles. PBGENE-HBV is the only clinical stage program that targets the elimination of cccDNA, the sole source of viral replication, leading to sustained loss of HBV DNA and other downstream viral transcripts.

On November 10, 2025, the Company reported late-breaking Phase 1 data at AASLD The Liver Meeting 2025 from the first three ELIMINATE-B cohorts, including nine patients across 22 total doses, demonstrating safety and tolerability across repeat administrations (at doses of 0.2 mg/kg, 0.4 mg/kg, and 0.8 mg/kg at eight week intervals) with no dose-limiting toxicities reported, and evidence of cumulative, dose-dependent antiviral activity and HBsAg declines. The presentation featured substantial viral marker reductions and paired biopsy data providing first evidence consistent with direct viral DNA gene editing.

As part of the ongoing assessment of the safety and efficacy profile of PBGENE-HBV after repeat doses in Part 1 dose finding, Precision has administered additional doses in Cohort 3 and in parallel commenced pre-planned additional cohorts to investigate a shorter dosing interval. Cohort 4 is investigating dosing at 0.4 mg/kg every 4 weeks and Cohort 5 is investigating dosing at 0.65 mg/kg every 4 weeks to evaluate the potential for an optimized therapeutic index. In addition, to mitigate acute infusion reactions common to lipid nanoparticle (LNP) delivered therapies, such as transient hypotension and transient elevated liver enzymes, Precision continues to investigate prophylactic measures per protocol. These measures include intravenous (IV) fluids, steroids, antihistamines, and infusion duration across dose levels and administrations. The goal during Part 1 of the study is to select the dose and schedule that achieves the desired therapeutic index to move to the expansion phase of the ELIMINATE-B trial.

PBGENE-HBV is the first in vivo gene editing approach to prospectively employ repeat administrations of LNP. To date, 13 participants have completed more than 30 administrations of PBGENE-HBV across five cohorts. Looking ahead, Precision expects additional clinical biomarker and biopsy data in the first half of 2026 and expects to have completed dosing in Cohorts 3, 4, and 5. This will inform selection of an optimal dosing regimen intended to support discontinuation of nucleos(t)ide analog treatment and progression into the Part 2 expansion phase of ELIMINATE-B. Precision expects to share further clinical data from the PBGENE-HBV program at hepatitis-focused medical conferences throughout 2026.

PBGENE-DMD (Muscle Targeted Gene Excision Program)

PBGENE-DMD is Precision’s development program for the treatment of Duchenne muscular dystrophy (DMD). In February 2026, Precision announced that it had received IND clearance from the U.S. Food and Drug Administration (FDA) to advance PBGENE-DMD. IND clearance enables Precision to initiate Institutional Review Board (IRB) activities and clinical trial site activation for the FUNCTION-DMD Phase 1/2 clinical trial for PBGENE-DMD. The FUNCTION-DMD trial will include ambulatory DMD patients at highly specialized U.S clinical trial sites. Initial data from multiple patients is expected by year-end 2026, including safety and early efficacy assessment based on near full-length dystrophin protein expression from muscle biopsies.

PBGENE-DMD received Fast Track designation from the FDA on February 26, 2026. Fast Track designation is designed to facilitate development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and address an unmet medical need. A drug that has received Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval. A drug receiving Fast Track designation may also be eligible for Priority Review if relevant criteria are met. In July 2025, PBGENE-DMD was granted Orphan Drug Designation from the FDA for the treatment of Duchenne muscular dystrophy.

New preclinical study data supporting the potential long-term efficacy of PBGENE-DMD was presented in a poster session at the Muscular Dystrophy Association Clinical & Scientific Conference 2026 on March 9, 2026.

On March 17th, the Company will host a KOL event featuring Aravindhan Veerapandiyan, MD (Pediatric Neurologist and Associate Professor of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children’s Hospital), and Pat Furlong (Founding President, Parent Project Muscular Dystrophy), who will join company management to discuss the unmet need and current treatment landscape for DMD. The event will provide an overview of PBGENE-DMD and FUNCTION-DMD Phase 1/2 clinical trial.

Partnered In Vivo Gene Editing Programs:

iECURE-OTC (Gene Insertion Program)

Led by iECURE, ECUR-506 is an ARCUS-mediated in vivo gene editing program currently in a first-in-human Phase 1/2 trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency. Recently announced alignment with the FDA on key study elements could support a potential Biologics License Application (BLA). In addition, ECUR-506 was granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation. The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain. In January 2025, iECURE reported clinical results demonstrating complete clinical response in the first participant at the lowest dose level (1.3×1013 GC/kg) of ECUR-506, as defined by the study protocol. iECURE expects to release additional data from the ongoing OTC-HOPE clinical trial in the first half of 2026.

PBGENE-NVS (Gene Insertion Program)

As previously reported in October 2025, Novartis and Precision have concluded their work in the area of hemoglobinopathies. Precision and Novartis are continuing their research collaboration in other areas of undisclosed therapeutic focus.

Non-Core Ex Vivo Programs:

Azer-Cel (Azercabtagene Zapreleucel Allogeneic CAR T Treatment or Cancer)

Imugene Limited continues development of Azer-Cel in diffuse large B-cell lymphoma and has received written guidance from the FDA regarding the registrational pathway for azer-cel. The guidance provided clear alignment with the FDA across key elements required to support advancement into a pivotal study, including dosing regimen, patient population, endpoints, and manufacturing readiness. In October 2025, Precision received an $8 million milestone payment consisting of $3 million in cash and $5 million in Imugene ordinary shares related to Imugene’s clinical and regulatory progress.

Azer-Cel (Azercabtagene Zapreleucel Allogeneic CAR T Treatment for Multiple Sclerosis)

Separately, Azer-Cel is being evaluated by TG Therapeutics, Inc. (Nasdaq: TGTX) in a Phase 1 trial in progressive multiple sclerosis. In March 2026, Precision announced the achievement of a clinical milestone under its license agreement with TG Therapeutics. As a result, Precision has earned a cash payment of $7.5 million in proceeds, inclusive of $5.25 million cash and $2.25 million for the purchase of 201,504 shares of Precision common stock by TG Therapeutics at $11.17 per share. Anticipated 2026 events include presentation of preliminary Phase 1 azer-cel data in progressive multiple sclerosis in the second half of 2026 and commencement of additional exploratory studies in autoimmune diseases outside of multiple sclerosis.

Corporate Updates:

$75 Million Financing

In November 2025, the Company announced a $75 million underwritten offering of 10,815,000 shares of its common stock with accompanying warrants, and, for certain investors, pre-funded warrants with accompanying warrants. The financing included participation from new and existing investors including Aberdeen Investments, Bleichroeder LP, Driehaus Capital Management, Empery Asset Management LP, Lynx1 Capital Management, Octagon Capital, Readout Capital, Sphera Funds Management, Stonepine Capital Management, as well as other leading life science investors.

New Intellectual Property Notices

In March 2026, Precision reported that it received two Notices of Allowance from the U.S. Patent and Trademark Office relating to the Company’s PBGENE-HBV program which extend the patent expiration date to November 2044 once issued. The first Notice of Allowance was for U.S. Patent Application No. 19/347,136, titled "Engineered meganucleases having specificity for a recognition sequence in the Hepatitis B virus genome." The second Notice of Allowance was for U.S. Patent Application No. 19/273,982, titled "Polypeptide linkers for use in engineered meganucleases."

Quarter Ended December 31, 2025 Financial Results:

Cash, Cash Equivalents, and Restricted Cash: As of December 31, 2025, Precision had approximately $137.2 million in cash, cash equivalents, and restricted cash. The Company expects that existing cash and cash equivalents, inclusive of the expected azer-cel milestone proceeds, continued fiscal and operating discipline, and availability of the Company’s at-the-market facility will fund the Company’s cash runway through 2028. Based on its expected cash runway, Precision believes it is sufficiently capitalized to achieve PBGENE-HBV and PBGENE-DMD data milestones through 2028.

Revenues: Total revenues for the quarter ended December 31, 2025, were $34.2 million, as compared to $0.6 million for the quarter ended December 31, 2024. The increase of $33.6 million in revenue during the quarter ended December 31, 2025 was primarily the result of recognizing $26.2 million in revenue under the Novartis agreement following conclusion of the hemoglobinopathy collaboration in October 2025 and recognition of $8.0 million in revenue under the Imugene license agreement.

Research and Development Expenses: Research and development expenses were $14.5 million for the quarter ended December 31, 2025, as compared to $15.9 million for the quarter ended December 31, 2024. The decrease of $1.4 million was primarily due to decreases in the PBGENE-HBV program preclinical costs as the program entered the clinic in the fourth quarter of 2024 and decreases in PBGENE-3243 program costs as Precision pivoted to PBGENE-DMD in the first half of 2025. These decreases were partially offset by increases in the PBGENE-DMD program as it prepared to enter the clinic in 2026.

General and Administrative Expenses: General and administrative expenses were $7.2 million for the quarter ended December 31, 2025, as compared to $9.6 million for the quarter ended December 31, 2024. The decrease of $2.4 million was primarily a result of operational discipline and lower employee-related costs.

Other Income (Expense): Total other income for the quarter ended December 31, 2025 was $6.7 million, as compared to $7.1 million for the quarter ended December 31, 2024.

Net Income (Loss) from Continuing Operations: Net income from continuing operations was $19.2 million for the quarter ended December 31, 2025, as compared to a net loss of ($17.8) million for the quarter ended December 31, 2024.

Net Income (Loss): Net income was $20.1 million, or $1.06 per share basic and $1.05 per share diluted for the quarter ended December 31, 2025. Net loss was $17.8 million, or $(2.22) per share (basic and diluted) for the quarter ended December 31, 2024.

Fiscal Year 2025 Financial Results:

Revenues: Total revenues for the year ended December 31, 2025 were $34.3 million, as compared to $68.7 million for the year ended December 31, 2024. The decrease of $34.4 million in revenue during the year ended December 31, 2025 was primarily the result of revenue recognized in the year ended December 31, 2024 related to the conclusion of our agreement with Prevail Therapeutics and revenue recognized under the TG License Agreement.

Research and Development Expenses: Research and development expenses were $54.2 million for the year ended December 31, 2025, as compared to $59.6 million for the year ended December 31, 2024. The decrease of $5.4 million was primarily due to decreases in the PBGENE-HBV and PBGENE-3243 programs and platform development and early-stage research expenses, partially offset by increases in our PBGENE-DMD program.

General and Administrative Expenses: General and administrative expenses were $32.2 million for the year ended December 31, 2025, as compared to $35.3 million for the year ended December 31, 2024. The decrease of $3.1 million was primarily a result of operational discipline and lower employee-related costs.

Other Income (Expense): Total other income was $5.5 million for the year ended December 31, 2025, as compared to $33.3 million for the year ended December 31, 2024. The decrease of $27.8 million was primarily due to a decrease in gain in fair value of the warrant liability, losses from equity method investment and other fair value adjustments which did not impact cash, and a decrease in interest income.

Net (Loss) Income from Continuing Operations: Net loss from continuing operations was ($46.6) million for the year ended December 31, 2025, as compared to a net income from continuing operations of $7.2 million for the year ended December 31, 2024 primarily driven by the final year of revenue recognition from Prevail.

Net (Loss) Income: Net loss was ($45.7) million, or ($3.56) per share (basic and diluted) for the year ended December 31, 2025. Net income was $7.2 million, or $1.05 per share basic and $1.04 share diluted for the year ended December 31, 2024 primarily driven by the final year of revenue recognition from Prevail.

Shares: Basic and diluted weighted-average common shares outstanding for the year ended December 31, 2025 were 12,826,078, compared to 6,832,982 basic shares and 6,883,911 diluted shares for the year ended December 31, 2024. Precision BioSciences had 24,088,425 shares outstanding as of December 31, 2025.

About Chronic Hepatitis B

Chronic hepatitis B virus causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis. There is no cure for chronic hepatitis B, and current treatments rarely result in a functional cure, primarily due to persistence of viral DNA in the liver. In patients with chronic hepatitis B, genetic material of the virus is converted within infected liver cells into cccDNA that acts as the only template to make new infectious viral particles. Hepatitis B virus also inserts fragments of its DNA into the human genome of infected liver cells. These integrated fragments are viral replication incompetent and cannot produce new infectious virus. Both cccDNA and integrated HBV DNA produce the viral protein, hepatitis B surface antigen ("HBsAg"), which is secreted in the blood.

Historically, the focus for drug development and regulatory approval of drugs for chronic hepatitis B has relied on the temporary suppression of HBsAg. Achieving undetectable HBsAg may lead to a functional cure if there is no rebound in HBV DNA or HBsAg after drug treatment has been discontinued for at least six months, but this is achieved in less than three out of 100 patients treated with the current standard of care. Since cccDNA is the only source of infectious particles (HBV DNA), elimination of cccDNA results in a cure of chronic hepatitis B. Sustained loss of HBV DNA alone as a result of cccDNA elimination is an approvable endpoint for the FDA and highly relevant for PBGENE-HBV.

About PBGENE-HBV, A Viral Elimination Program

PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic Hepatitis B, cccDNA, while inactivating integrated HBV DNA. Elimination of cccDNA results in HBV cure as cccDNA is the only source of infectious replication (HBV DNA). The ELIMINATE-B trial is investigating PBGENE-HBV at multiple dose levels across a number of administrations per dose level in patients with chronic Hepatitis B. PBGENE-HBV has been granted Fast Track designation by the FDA.

PBGENE-HBV is the only clinical stage program targeting the elimination of cccDNA leading to sustained loss of HBV DNA. The FDA has previously provided guidance that sustained loss of HBV DNA is an approvable endpoint for chronic hepatitis B.

Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT06680232.

About PBGENE-DMD, A Muscle-Targeted Excision Program

PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for approximately 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. The aim of this approach is to restore a near full-length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated microdystrophin approaches with minimal functional benefit. The Phase 1/2 FUNCTION-DMD study is expected to enroll ambulatory DMD patients with mutations between exons 45 and 55 impacting up to 60% of boys with DMD. The clinical trial will employ an appropriate immune modulation regimen and safety monitoring program to treat ambulatory patients at world class specialized DMD clinical sites.

PBGENE-DMD was granted Orphan Drug Designation by the FDA in July, 2025. The PBGENE-DMD program is eligible for a Priority Review Voucher (PRV) via the Rare Pediatric Disease Priority Review Voucher (PRV) program, which was signed into law on February 3, 2026, as part of the Consolidated Appropriations Act of 2026. PBGENE-DMD received Fast Track designation from the FDA in February 2026.

Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT07429240.

(Press release, Precision Biosciences, MAR 12, 2026, View Source [SID1234663503])

On March 12, 2026 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter ended December 31, 2025.

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Cash and investments in marketable securities on December 31, 2025 were $245.8 million as compared to $269.1 million on December 31, 2024. Cash and investments at December 31, 2025 excludes net proceeds of approximately $432 million from the $460 million secondary offering completed by the Company in February 2026, and also excludes net proceeds of $44 million from sales of shares in February and March 2026 under the Company’s existing $110 million at-the-market offering facility that was established in November 2025.

"2025 was a pivotal year for Nektar as we saw successful and transformative Phase 2 data readouts for rezpegaldesleukin," said Howard W. Robin, President and CEO of Nektar. "The data highlighted the promise and differentiation of our novel Treg mechanism in two inflammatory dermatological disease settings of atopic dermatitis and alopecia areata. In early 2026, we reported the 52-week treatment data for rezpegaldesleukin. These data provide hope that complete clearance of disease could be possible for patients with monthly and quarterly maintenance dosing of rezpegaldesleukin. With our strengthened financial position following the recent financing, we look forward to initiating our Phase 3 program in atopic dermatitis in June of this year, while we continue to advance our earlier TNFR2 agonist antibody and bispecific program toward the clinic."

Summary of Financial Results

Revenue in the fourth quarter of 2025 was $21.8 million as compared to $29.2 million in the fourth quarter of 2024. Revenue for the full year of 2025 was $55.2 million compared to $98.4 million in 2024. Revenue primarily decreased year over year because we no longer recognize product sales due to the December 2024 sale of the Huntsville manufacturing facility, as well as a decrease in non-cash royalty revenue.

Total operating costs and expenses in the fourth quarter of 2025 were $49.5 million as compared to $14.8 million in the fourth quarter of 2024. Total operating costs and expenses for 2025 were $195.3 million compared to $203.6 million in 2024. In the fourth quarter of 2024, we recorded a one-time $40.4 million gain from the sale of the Huntsville manufacturing facility. Excluding this gain, operating expenses for the fourth quarter and full year of 2025 decreased due to the elimination of cost of goods sold following the sale of the Huntsville manufacturing facility.

R&D expense in the fourth quarter of 2025 was $29.7 million as compared to $28.7 million for the fourth quarter of 2024. For the full year of 2025, R&D expense was $117.3 million compared to $120.9 million in 2024. R&D expense decreased for full year of 2025 primarily due to a decrease in expense for the development of NKTR-255, partially offset by an increase in expense for the development of rezpegaldesleukin.

G&A expense was $11.2 million in the fourth quarter of 2025 as compared to $17.1 million in the fourth quarter of 2024. G&A expense was $68.7 million for 2025 compared to $76.8 million in 2024. G&A expense decreased for both the fourth quarter and the full year of 2025 due to decreases in facilities and stock-based compensation expenses.

Non-cash restructuring and impairment charges were $8.6 million in the fourth quarter of 2025 and $9.3 million for the full year of 2025, as compared to $1.4 million in the fourth quarter of 2024 and $15.7 million in the full year of 2024. These non-cash charges are related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar.

In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem’s equity each quarter. This resulted in non-cash losses from the equity method investment of $1.3 million in the fourth quarter of 2025 and $8.7 million for the full year of 2025.

Net loss for the fourth quarter of 2025 was $36.1 million or $1.78 basic and diluted net loss per share as compared to net income of $7.3 million or $0.521 basic and diluted earnings per share in the fourth quarter of 2024. Net loss for 2025 was $164.1 million or $9.73 basic and diluted loss per share compared to a net loss of $119.0 million or $8.681 basic and diluted net loss per share in 2024. Excluding the $8.7 million non-cash loss from our equity method investment in Gannet BioChem, and the $9.3 million restructuring and impairment charges, net loss, on a non-GAAP basis, for the full year of 2025 was $146.0 million or $8.66 basic and diluted net loss per share.

Recent Business Highlights

● In February 2026, Nektar established a Research Collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165, a tumor necrosis factor receptor 2 (TNFR2) antibody, in multiple sclerosis.

● In February 2026, Nektar announced the successful closing of a public offering of its common stock, including the full exercise of underwriters’ option to purchase additional shares, raising $460 million in gross proceeds.

● In February 2026, Nektar presented new maintenance data from the REZOLVE-AD Phase 2b Study in atopic dermatitis, demonstrating durable and new responses with rezpegaldesleukin across key disease measurements with both monthly and quarterly dosing.

● In December 2025, Nektar announced topline results from the 36-week induction treatment period of the REZOLVE-AA Phase 2b Study, establishing proof-of-concept of rezpegaldesleukin in patients with severe-to-very-severe alopecia areata.

● In November 2025, Nektar presented a late-breaking oral abstract titled "Rezpegaldesleukin, Novel Treg-Inducing Therapy, Demonstrates Efficacy in Atopic Dermatitis and Asthma in Phase 2b Trial" at the American College of Allergy, Asthma and Immunology’s 2025 Annual Scientific Meeting (ACAAI), highlighting statistically significant improvements across key efficacy endpoints in atopic dermatitis and supportive findings in patients with comorbid asthma.

Upcoming Milestones

● Data from the 36-week treatment period of the REZOLVE-AA study in patients with alopecia areata were accepted for a presentation in a late-breaking oral session at the American Academy of Dermatology (AAD) 2026 Annual Meeting to be held March 27-31, 2026, in Denver, CO.

● Topline data to be reported from the blinded 16-week treatment extension period in the Phase 2b REZOLVE-AA study of rezpegaldesleukin in alopecia areata in April 2026. (The Company will enter a quiet period beginning April 1, 2026 and continuing until the public announcement of these data.)

● Commencement of the Phase 3 studies for rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis in Q2 2026.

● Presentation of 36-week maintenance data from the Phase 2b REZOLVE-AD study of rezpegaldesleukin in moderate-to-severe atopic dermatitis at a medical conference in second half of 2026.

● Topline data to be reported from the 24-week off-treatment period in REZOLVE-AA in Q4 2026.

● Topline data to be reported from the 52-week off-treatment period in REZOLVE-AD in Q1 2027.

● Initial data from TrialNet-sponsored Phase 2 study of rezpegaldesleukin in Stage 3 New Onset Type 1 Diabetes to be reported in 2027.

● Preclinical data presentation from the NKTR-0165 (TNFR2 agonist antibody) program to be presented at a scientific conference in second half of 2026.

Conference Call to Discuss Fourth Quarter 2025 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on March 12, 2026.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 12, 2026.

To access the conference call by phone, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

(Press release, Nektar Therapeutics, MAR 12, 2026, View Source [SID1234663502])

On March 12, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported financial results and business highlights for the fourth quarter and year ended December 31, 2025. Lyell has since commenced patient dosing in the first-of-its-kind Phase 3 head-to-head CAR T-cell randomized controlled clinical trial of rondecabtagene autoleucel (ronde-cel) versus investigator’s choice of axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) with disease progression on at least one prior line of therapy (PiNACLE-H2H). Lyell has dosed seven new patients with metastatic colorectal cancer (mCRC) with LYL273, an enhanced guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate, since its November 2025 acquisition, without dose-limiting toxicity and including dose escalation to Dose Level 3.

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Lyell also recently announced it has closed the sale of an additional $50 million of shares of its common stock to investors from its July 2025 equity private placement of up to $100 million, following achievement of a clinical milestone within its PiNACLE pivotal trial evaluating ronde-cel in patients with R/R LBCL in the third- or later-line setting (3L+), and the appointment of Smital Shah as its Chief Financial and Business Officer.

"Lyell is on track to achieve multiple clinical milestones in the next 12 to 18 months. We have now advanced ronde-cel into two pivotal clinical trials, with the pivotal data supporting BLA submission from the PiNACLE trial expected to be reported mid-next year," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "With the encouraging emerging safety profile and clinical activity observed with LYL273 in patients with metastatic colorectal cancer, we believe Lyell is well-positioned with two next-generation CAR T‑cell product candidates."

Fourth Quarter Updates and Recent Business Highlights

Ronde-cel: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL

Ronde-cel is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. Ronde-cel has received from the U.S. Food and Drug Administration (FDA) Regenerative Medicine Advanced Therapy (RMAT) designation as well as Fast Track designation for the treatment of adults with R/R LBCL.

•The pivotal PiNACLE single-arm trial is a seamless expansion of the 3L+ cohort in the Phase 1/2 multi-cohort trial and is evaluating ronde-cel at a dose of 100 x 106 CAR T cells in patients with R/R LBCL. The trial is expected to enroll approximately 120 patients in the inpatient or outpatient setting, and there is no upper age limit for eligibility. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response.

•Patient dosing commenced in February 2026 in PiNACLE-H2H, the Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axi-cel or liso-cel in patients with R/R LBCL in the 2L setting. The trial is expected to enroll approximately 400 patients (200 per arm) at sites in the US, Canada and Australia. Patients may be treated in either the inpatient or outpatient setting. The trial’s primary endpoint is event-free survival.
•Updated data from the ongoing Phase 1/2 clinical trial were presented at the December 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2025):
◦A best overall response rate of 93% and a complete response rate of 76% in 29 efficacy-evaluable patients with R/R LBCL in the 3L+ setting. The median progression-free survival was 18 months as of the data cutoff date of September 5, 2025.
◦Data were also presented from the 2L cohort in the Phase 1/2 multi-cohort clinical trial, including an efficacy-evaluable population of 18 patients (94% with high-risk primary refractory disease) and demonstrated an 83% best overall response rate and a 61% complete response rate.
◦The safety profile was appropriate for outpatient administration. Data from 25 patients treated with ronde-cel who received dexamethasone prophylaxis in the 3L+ and 2L settings revealed no events of ≥ Grade 3 cytokine release syndrome and a 4% rate of ≥ Grade 3 immune cell-associated neurotoxicity syndrome.
LYL273 (formerly known as GCC19CART): A next-generation GCC-targeted CAR T-cell product candidate for the treatment of mCRC and other GCC-expressing cancers
LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile tumor microenvironment. In November 2025, we acquired global rights (excluding mainland China, Hong Kong, Macau and Taiwan) to LYL273, which has shown promising dose-dependent clinical activity in patients with advanced mCRC in a Phase 1 trial conducted in the U.S. LYL273 received from the FDA Fast Track designation for the treatment of mCRC.
•The U.S. Phase 1 clinical trial is continuing to enroll patients to determine the recommended Phase 2 dose. Seven additional patients with mCRC have been treated with LYL273 since the November 2025 acquisition without dose-limiting toxicity and including dose escalation to Dose Level 3.

•A 67% best overall response rate, an 83% disease control rate and an 8-month median progression-free survival with a manageable safety profile have been reported at the highest dose level tested as of the data cutoff date of October 28, 2025 (Dose Level 2) in patients with refractory mCRC in the U.S. Phase 1 clinical trial.

Fourth Quarter and Full Year 2025 Financial Results

Lyell reported a net loss of $140.7 million and $274.4 million for the fourth quarter and year ended December 31, 2025, respectively, compared to a net loss of $191.9 million and $343.0 million for the same periods in 2024. Net loss for the fourth quarter and year ended December 31, 2025 included $66.3 million in acquired in-process research and development (IPR&D) expense as part of the acquisition of our rights to LYL273, and $19.7 million in stock-based compensation expense for an equity milestone deemed probable related to the LYL273 license acquisition. Net loss for the fourth quarter and year ended December 31, 2024 included $87.2 million in acquired IPR&D expense as part of our acquisition of ImmPACT Bio and $51.3 million of long‑lived asset impairment expense. Non‑GAAP net loss, which excludes stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and securities purchase agreement put/call liability, long‑lived asset impairment expense and certain non-cash investment gains and charges, was $33.1 million and $144.8 million for the fourth quarter and year ended December 31, 2025, respectively, compared to $45.9 million and $159.5 million for the same periods in 2024.

GAAP and Non-GAAP Operating Expenses

•Research and development (R&D) expenses were $52.2 million for the fourth quarter ended December 31, 2025, compared to $48.7 million for the same period in 2024. The increase in fourth quarter 2025 R&D expenses of $3.5 million was primarily due to $19.7 million in stock-based compensation expense for an equity milestone deemed probable related to the LYL273 license acquisition. The increase in fourth quarter 2025 R&D expenses was partially offset by an $8.9 million reduction in personnel costs and a $4.7 million reduction in additional facilities and technology costs primarily due to reduced headcount following the successful technology transfer of ronde-cel to our LyFE Manufacturing CenterTM (LyFE) and associated workforce reduction in the first half of 2025. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the fourth quarter ended December 31, 2025, were $30.1 million compared to $45.4 million for the same period in 2024 due to the workforce reduction related to the successful technology transfer of ronde-cel.
•General and administrative (G&A) expenses were $10.6 million for the fourth quarter ended December 31, 2025, compared to $14.5 million for the same period in 2024. The decrease in fourth quarter 2025 G&A expenses of $3.9 million was primarily due to a $4.1 million decrease in personnel costs associated with the workforce reduction related to the successful ronde-cel technology transfer, partially offset by a $0.8 million increase in collaborations and licenses expenses.
A discussion of non-GAAP financial measures, including reconciliations of the most comparable U.S. generally accepted accounting principles (GAAP) measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of December 31, 2025 were approximately $247.2 million (excluding the $50 million tranche received in March 2026), compared to approximately $383.5 million as of December 31, 2024. Lyell believes that its current cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into the second quarter of 2027.

(Press release, Lyell Immunopharma, MAR 12, 2026, View Source [SID1234663501])

On March 12, 2026 Enodia Therapeutics, a biotechnology company developing novel small-molecule therapies for targeted protein degradation at the point of synthesis, and Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, reported that Enodia has acquired Kezar’s assets from its Sec61-based discovery and development program. The acquisition enables Enodia to advance its understanding of Sec61 selectivity mechanisms, expanding biological and translational insights for faster progression toward key clinical milestones.

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Under the terms of the purchase agreement between Enodia and Kezar, Kezar will receive an initial upfront payment totaling $1 million, and will receive future payments upon achievement of certain development, regulatory and commercialization milestones, for a potential total of up to $127 million. Enodia has also agreed to pay tiered royalties on net sales.

"Kezar has made significant early advances in the Sec61 field with the discovery of small molecule inhibitors," said Yves Ribeill, Chief Executive Officer of Enodia Therapeutics. "By integrating Kezar’s extensive preclinical datasets into our selective targeted protein degradation platform, this acquisition enhances our ability to make accelerated, yet informed development decisions across our candidate programs."

Enodia’s proprietary platform enables selective Sec61 Translocon modulation, a novel approach to inhibit disease-relevant proteins at the point of their synthesis before pathological effects occur, while preserving essential physiological functions. Enodia has built a broad and well-characterized chemical space spanning multiple Sec61 inhibitor families, supported by extensive biological datasets, including proteomics, Cryo-EM and tailored cell line libraries to enable rational small-molecule drug design powered by machine learning. Insights from Kezar’s Sec61-based programs will further strengthen Enodia’s core focus on Sec61-driven selectivity for targeting protein degradation.

"Kezar has spent nearly ten years pioneering research and drug discovery efforts around the Sec61 translocon and continues to have strong conviction in this novel target," said Chris Kirk, PhD, CEO of Kezar Life Sciences. "The team at Enodia is poised to make great progress in this space, and we are excited to see our efforts being carried on and expanded upon."

(Press release, Enodia Therapeutics, MAR 12, 2026, View Source [SID1234663500])

On March 12, 2026 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the fourth quarter and full year ended December 31, 2025 and provided an update on recent company developments.

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"With our first BLA now under review by the FDA, we are focused on delivering INO-3107 to RRP patients who are desperate for treatment options that reduce reliance on surgery to control this rare and devastating disease," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "Our top priority is advancing INO-3107, and to do so, optimizing and extending our financial resources towards our target PDUFA date of October 30, 2026. We are excited about the opportunities ahead as we prepare to become a commercial-stage company and work to leverage the power of partnerships to advance other promising candidates in our pipeline. I look forward to providing more updates on our progress with these efforts in the coming months."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
In December 2025, the FDA accepted INOVIO’s BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP. As part of the submission, INOVIO requested a priority review, which is typically 6 months. Instead, the FDA granted a standard 10-month review with a PDUFA target date set for October 30, 2026.

While the BLA was accepted under the accelerated approval program, in the file acceptance letter the FDA noted as a potential review issue its preliminary conclusion that the company had not provided adequate information to justify eligibility for the accelerated approval pathway. INOVIO continues to strongly believe that INO-3107 fulfills the criteria for accelerated approval, meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. The FDA has agreed to a yet-to-be-scheduled meeting to discuss eligibility for review under the accelerated approval program.

During 2025, INOVIO published clinical and immunological results from its Phase 1/2 trial (RRP-001) in Nature Communications showing that INO-3107 induced new populations of T cells in the blood that traveled to airway tissue and were associated with significant clinical benefit as measured by reduced need for surgery. INOVIO also published data from a retrospective study (RRP-002) investigating the long-term safety and clinical response of patients treated with INO-3107 in The Laryngoscope. Data demonstrated that the majority of patients experienced continued improvement beyond the initial 12-month study period of the previously published Phase 1/2 trial (RRP-001), as measured by a reduction in the number of surgical procedures needed after treatment with INO-3107.

INOVIO also continued to advance commercial readiness plans, including conducting critical market research supporting a positively differentiated product profile, developing a pricing strategy, finalizing our go-to-market model, and advancing the build-out of our commercial organization. We’ve also selected key commercial partners including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB.

INO-5412/INO-5401
INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 (INO-5401 plus INO-9012 in a single vial) in combination with cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of GBM. The combination therapy will be studied as a part of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), the innovative Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care Inc. that is designed to quickly and efficiently find new treatments for GBM. The novel combination of INO-5412 with cadonilimab builds on INOVIO’s previous promising research in GBM and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding.

INOVIO also continues to dose patients in the GBM-001 Phase 1/2 trial in newly diagnosed glioblastoma that combines INO-5401 plus INO-9012 with Regeneron’s PD-1 checkpoint inhibitor Libtayo.

INOVIO’s partners at the Basser Center at the University of Pennsylvania continue to evaluate the tolerability and immunogenicity of INO-5401 plus INO-9012 in a Phase 1 study exploring the potential to prevent cancer in people with BRCA1 or BRCA2 mutations.

Next Generation DNA Medicine Candidates
Results from a Phase 1 proof-of-concept trial evaluating next generation DMAbs for COVID-19 were published online in Nature Medicine, demonstrating the technology’s potential as a long-acting, scalable and tolerable alternative to traditional monoclonal antibody therapies. The study is being led by The Wistar Institute in collaboration with INOVIO, AstraZeneca, and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania. This was the first demonstration that DNA plasmid encoded monoclonal antibodies, which are complex proteins, can be durably and tolerably expressed in humans.

INOVIO also presented promising Factor VIII preclinical data from its DPROT program at the World Federation of Hemophilia Global Forum in November 2025. This technology aims to address some of the shortcomings of conventional therapeutic protein replacement treatments, including gene therapy approaches. INOVIO is developing additional DPROT indications and is actively seeking partners to accelerate development of this promising program.

General Corporate
INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program towards commercialization and a potential approval date in October 2026, and extending the cash runway. To achieve this goal, INOVIO has further prioritized programs, spending, and resource needs, and has eliminated roles that don’t directly support our primary goal of advancing INO-3107 toward US approval.

2025 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the quarter and year ended December 31, 2025 were $10.3 million and $54.2 million, respectively, compared to $12.9 million and $75.6 million for the same periods in 2024. The decrease was due primarily to the result of lower drug manufacturing, clinical study and other expenses related to INO-3107, lower contract labor and lower expensed inventory, among other variances.

General and Administrative (G&A) Expenses: G&A expenses were $7.2 million and $32.7 million, respectively, for the quarter and year ended December 31, 2025, versus $7.6 million and $37.0 million, respectively, for the same periods in 2024. The decrease in G&A expenses was primarily related to a decrease in employee and consultant compensation, including stock-based compensation, among other variances.

Total Operating Expenses: Total operating expenses were $17.5 million and $86.9 million for the quarter and year ended December 31, 2025, respectively, compared to $20.5 million and $112.6 million for the same periods in 2024.

Net Loss: INOVIO’s net income (loss) for the quarter and year ended December 31, 2025 was $3.8 million, or $0.06 per basic and ($0.26) per diluted share, and ($84.9) million, or ($1.81) per basic and diluted share, respectively, compared to net loss of $19.4 million, or $0.65 per basic and diluted share, and $107.3 million, or $3.95 per basic and diluted share, for the quarter and year ended December 31, 2024, respectively. The net income for the fourth quarter 2025 was primarily driven by a $21.2 million non-cash gain on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net income (loss).

Shares Outstanding: As of December 31, 2025, INOVIO had 69.0 million common shares outstanding and 109.7 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, stock options, restricted stock units and convertible preferred stock.

Cash, Cash Equivalents and Short-term Investments: As of December 31, 2025, cash, cash equivalents and short-term investments were $58.5 million compared to $94.1 million as of December 31, 2024.
INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s annual report on Form 10-K for the year ended December 31, 2025, which can be accessed at: View Source

Cash Guidance
INOVIO estimates its current cash, cash equivalents and short-term investments balances to support the company’s operations into the fourth quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the first quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

(Press release, Inovio, MAR 12, 2026, View Source [SID1234663499])