On March 12, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of the PREDICT-DNA study in the Journal of Clinical Oncology. The article, "The Pathologic Response Evaluation and Detection In Circulating Tumor-DNA (PREDICT-DNA) study: Ultrasensitive ctDNA Assessment of Breast Cancer Minimal Residual Disease," showed that ultrasensitive molecular residual disease (MRD) testing with NeXT Personal can perform better than current standard approaches in predicting patient outcomes following neoadjuvant therapy (NAT).

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The prospective study followed 227 patients with Triple-Negative (TNBC) and HER2+ breast cancer across more than 24 leading US cancer centers. The results demonstrate the ability of NeXT Personal to provide a more precise risk-stratification for patients who have received NAT.

A key finding of the study was the necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Of note, 55% of all ctDNA detections following NAT occurred at levels below 100 parts per million, detections that could be missed with less sensitive tests.

"Many breast cancer patients receive neoadjuvant therapy as standard of care, prior to surgery. The results of this study suggest that an ultrasensitive ctDNA assay like NeXT Personal could help patients better understand their response to neoadjuvant therapy, with the potential to help inform the need for additional therapy," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "The publication of this data is important as we look to expand reimbursement and improve the tools used in neoadjuvant monitoring."

Key study highlights include:

High Prognostic Power: Detectable ctDNA post-NAT was associated with a 4 to 9 times higher likelihood of relapse.
Superior to Traditional Metrics: In multivariate analyses, ctDNA status was the most significant independent prognostic signal, performing better than nodal status, tumor grade, and pathologic complete response (pCR) status. In addition, ctDNA detection post-NAT was a stronger predictor of recurrence than pCR status.
Identification of Low Risk: Patients who were ctDNA-negative post-NAT showed excellent outcomes, regardless of pCR status.
Post-Surgical Relapse Prediction: Patients with detectable ctDNA up to 12 months post-surgery were more than 100 times more likely to experience disease recurrence.
"We partnered with Personalis because their technology offers a level of sensitivity down to 1 to 3 parts per million that allows for a higher cancer detection rate," said Dr. Ben Park, MD, PhD, Director of the Vanderbilt-Ingram Cancer Center. "The PREDICT-DNA results show that if a patient clears their ctDNA, their outcomes are excellent even if residual disease is found at surgery. Conversely, detectable ctDNA signals a very high risk. These insights allow us to more precisely risk-stratify breast cancer patients in future trials and clinical practice."

The findings reinforce the NeXT Personal test’s ability to detect ctDNA at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.

(Press release, Personalis, MAR 12, 2026, View Source [SID1234663521])

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 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2025.

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"Adicet closed the year with solid momentum, driven by strong enrollment progress and the positive data from the prula-cel Phase 1 autoimmune study reported during the fourth quarter. Enrollment in our Phase 1 prula‑cel autoimmune study continues advancing ahead of expectations, supported by significant physician and patient interest in the study and FDA alignment that enables outpatient dosing for LN and SLE patients. We look forward to providing a clinical update in LN, SLE and SSc in the first half of this year," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "Beyond prula-cel, we expect to submit a regulatory filing for ADI-212 for the treatment of mCPRC in the third quarter of 2026 with enrollment expected to begin in the fourth quarter of 2026. Adicet is well positioned for continued execution and poised to deliver meaningful, value‑driving milestones in the year ahead."

Fourth Quarter 2025 and Recent Operational Highlights:

Autoimmune diseases

Phase 1 trial of prula‑cel demonstrating strong enrollment momentum across multiple autoimmune indications, with next clinical update expected in the first half of 2026. Adicet continues to advance its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune diseases. Prula-cel has received Fast Track Designation from the FDA for the potential treatment of relapsed/refractory Class III or Class IV LN, refractory SLE with extrarenal involvement, and systemic sclerosis (SSc). The next clinical update is expected in the first half of 2026, with plans to provide an additional clinical update from the study in the second half of 2026. Adicet plans to meet with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate a pivotal study in LN or LN and SLE patients in the second half of 2026.
Alignment with FDA allows outpatient dosing for LN and SLE patients. In November 2025, the Company reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials.
Phase 1 study underway in treatment-refractory rheumatoid arthritis (RA) patients to evaluate the potential to reduce conditioning requirements. In October 2025, Adicet dosed the first patient in a Phase 1 study of prula-cel in treatment refractory RA. The study is evaluating two lymphodepletion regimens: cyclophosphamide alone and cyclophosphamide in combination with fludarabine. The primary objective of the study is to assess the safety and tolerability of prula-cel, with secondary objectives including evaluation of cellular kinetics, pharmacodynamics, and disease activity scores. The next clinical update on this trial is expected in the second half of 2026.
Solid tumor indications

Preclinical development ongoing for ADI‑212, with a regulatory filing expected in the third quarter of 2026, which is expected to enable Phase 1 enrollment beginning in the fourth quarter of 2026. Adicet continues to advance preclinical development of ADI‑212, a next‑generation gene‑edited and armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). ADI‑212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor‑specific recognition. It integrates membrane‑tethered IL‑12 armoring, and CRISPR/Cas9‑mediated disruption of subunit 12 (MED12) to enhance potency in solid tumors and deliver multiple anti‑tumor mechanisms of action within the tumor microenvironment. Adicet plans to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with Phase 1 enrollment expected to begin in the fourth quarter of 2026, subject to regulatory clearance.
ADI‑212 preclinical data presented at scientific meeting. In October 2025, Adicet presented preclinical data from its ADI‑212 program at the 32nd Annual Prostate Cancer Foundation Scientific Retreat. The data supported the rationale for the program’s design features and demonstrated functional enhancements across multiple preclinical models of disease.
Financial Results for Fourth Quarter and Full Year 2025:

Three months ended December 31, 2025

Research and Development (R&D) Expenses: R&D expenses were $25.0 million for the three months ended December 31, 2025, compared to $23.3 million during the same period in 2024. The increase in R&D expenses was primarily due to a $6.1 million increase in expenses related to contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), partially offset by a $2.7 million decrease in payroll and personnel expenses due to lower headcount and a $1.0 million decrease in facilities related expenses.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the three months ended December 31, 2025, compared to $7.5 million during the same period in 2024. The decrease in G&A expenses was primarily due to a $1.3 million decrease in rent and office related expenses and a $0.7 million decrease in professional services and consultants, partially offset by a $1.6 million increase in payroll and personnel expenses primarily related to stock-based compensation.
Net Loss: Net loss for the three months ended December 31, 2025 was $30.5 million, or a net loss of $2.94 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million, as compared to a net loss of $28.7 million, or a net loss of $5.06 per basic and diluted share, including non-cash stock-based compensation expense of $3.8 million during the same period in 2024.
Twelve months ended December 31, 2025

Research and Development (R&D) Expenses: R&D expenses were $99.1 million for the year ended December 31, 2025, compared to $99.3 million for the year ended December 31, 2024. The decrease in R&D expenses was primarily due to a $5.1 million decrease in payroll and personnel expenses related to lower headcount and a $0.7 million decrease in lab supplies and materials. The decrease was partially offset by a $5.6 million increase in CRO costs primarily for autoimmune studies.
General and Administrative (G&A) Expenses: G&A expenses were $23.0 million for the year ended December 31, 2025, compared to $28.3 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due to a decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation of $3.6 million, a $1.6 million decrease in office related expenses, and a $0.3 million decrease in rent expense.
Net Loss: Net loss for the year ended December 31, 2025 was $116.8 million, or a net loss of $16.95 per basic and diluted share, including non-cash stock-based compensation expense of $14.3 million, as compared to a net loss of $117.1 million, or a net loss of $21.33 per basic and diluted share, including non-cash stock-based compensation expense of $22.2 million during the same period in 2024.
Cash Position: Cash, cash equivalents and short-term investments were $158.5 million as of December 31, 2025, compared to $176.3 million as of December 31, 2024. In October 2025, Adicet successfully raised $74.8 million in net proceeds through an underwritten registered direct offering of equity securities. The Company expects that current cash, cash equivalents and short-term investments as of December 31, 2025, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, MAR 12, 2026, View Source [SID1234663522])

On March 11, 2026 CRISPR Therapeutics AG (Nasdaq: CRSP) (the "Company") reported the pricing of $550 million aggregate principal amount of its convertible senior notes due 2031 (the "notes") in a private offering (the "offering") to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The Company also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $50 million aggregate principal amount of the notes. The sale of the notes is expected to close on March 16, 2026, subject to the satisfaction of customary closing conditions. The offering was upsized from the previously announced offering of $350 million aggregate principal amount of notes.

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The notes will be senior, unsecured obligations of the Company. The investors in the notes agreed to an effective coupon of 1.125%. Because of anticipated 35% withholding on interest payments on the notes under Swiss tax law, the Company agreed to increase the coupon by 0.6058% to 1.7308% to effectively eliminate the impact of such anticipated withholding on any noteholders who are not eligible to receive a refund. Interest will be payable semiannually in arrears on March 1 and September 1 of each year, beginning on September 1, 2026. The notes will mature on March 1, 2031, unless earlier converted, redeemed or repurchased.

Holders may convert all or any portion of their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date, other than during a "conversion freeze period" (as defined in the indenture that will govern the notes). Upon conversion, the Company will deliver for each $1,000 principal amount of converted notes a number of its common shares, nominal value CHF 0.03 per share ("common shares"), equal to the conversion rate.

The conversion rate will initially be 13.0617 common shares per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $76.56 per common share). The initial conversion price represents a premium of approximately 45% above the last reported sale price of $52.80 per common share on the Nasdaq Global Market on March 10, 2026. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, if certain corporate events occur or are anticipated to occur prior to the maturity date or if the Company delivers a notice of optional redemption, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption in connection with such notice of optional redemption, as the case may be.

The Company may not redeem the notes prior to March 6, 2029. The Company may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on an optional redemption date occurring on or after March 6, 2029 if the last reported sale price of the common shares has been at least 130% of the conversion price for the notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of optional redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date. No sinking fund is provided for the notes.

If the Company undergoes a "fundamental change" (as defined in the indenture that will govern the notes), then, subject to certain conditions and limited exceptions, holders may require the Company to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The Company estimates that the net proceeds from the offering will be approximately $536.3 million (or approximately $585.2 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for general corporate purposes.

The offer and sale of the notes and the common shares deliverable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or the common shares deliverable upon conversion of the notes, nor will there be any sale of the notes or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

(Press release, CRISPR Therapeutics, MAR 11, 2026, View Source [SID1234663454])

On March 11, 2026 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported a financial and corporate update in conjunction with the Company’s 10-K filing for the year ending December 31, 2025. With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"We are building meaningful momentum as we further advance our first-in-class portfolio of potential medicines targeting cancers with significant unmet needs," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "Our lead candidate FHD-909 continues to progress as planned through dose escalation in collaboration with Lilly. The trial is enriching for NSCLC patients with SMARCA4 mutations, where outcomes remain especially poor and deteriorate with later lines of therapy. In parallel, our wholly owned programs are moving toward the clinic. Our Selective CBP degrader program and our Selective EP300 degrader are on track for IND-enabling studies in 2026. Our recent cash infusion strengthens our balance sheet and enables us to focus on continued execution beyond our near-term milestones."

Recent Corporate Updates

Bolstered Balance Sheet. Announced the successful closing of a $50 million registered direct financing at $6.71 (issue price), a 30% premium to the closing price on January 9, 2026. The offering also included series warrants representing 50% coverage at $13.42 per share (two times the issue price) and another 50% coverage at $20.13 per share (three times the issue price). The transaction, supported by BVF Partners, Deerfield Management, founding investor Flagship Pioneering and a leading biotech mutual fund, strengthens the Company’s balance sheet and extends the anticipated cash runway into the first half of 2028.

Strengthened Executive Leadership. In February 2026, Foghorn appointed Ryan Maynard as Chief Financial Officer. Mr. Maynard joins Foghorn with over 25 years of executive experience driving financial strategy, capital markets execution, and operational performance across public and private biopharmaceutical companies.

Program Overview and Upcoming Milestones

FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC alone and implicated in a significant number of solid tumors. Across lines of therapy, significant unmet needs remain for patients with SMARCA4 (BRG1)-mutant cancers, with both poor response rates and short progression-free survival.
•Phase 1 trial on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well. The trial is on track, following the dosing of the first patient in October 2024.
•Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Preclinical data support enhanced anti-tumor activity of FHD-909 in combination with standard-of-care (SoC) chemotherapies, anti-PD-1 pembrolizumab and several novel KRAS inhibitors in NSCLC animal models.
◦Pending successful Phase 1 dose escalation results, Foghorn and Lilly anticipate evaluating FHD-909 in combination studies in the front-line setting of NSCLC.

Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control platform.

Selective CBP degrader program. Foghorn’s Selective CBP degrader selectively targets CBP, an acetyltransferase closely related to EP300. CBP lineage dependencies are established in several cancers, including breast cancer, and there is also a synthetic relationship in EP300-mutated cancers, which include endometrial, cervical, ovarian, bladder, and colorectal cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities.

•Preclinical data for the Selective CBP degrader program identified CBPd-171 as a highly potent and selective lead candidate, which is currently advancing through dose-range finding toxicology studies.
•CBPd-171 demonstrates promising efficacy in ER+ breast cancer, while showing no impact on platelet counts and sparing megakaryocytes. Additionally, it demonstrates robust anti-tumor activity in EP300-mutant solid tumors and broader CBP-dependent cancers.
•A long-acting injectable (LAI) formulation has been optimized for subcutaneous administration on a weekly or every-other-week schedule, supporting convenient and patient-friendly dosing.
•Investigational New Drug (IND)-enabling studies anticipated in 2026.
Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities. EP300 lineage dependencies are established in several hematologic malignancies, which include diffuse large b-cell lymphoma (DLBCL) and multiple myeloma (MM).
•Preclinical efficacy and safety data for selective EP300 degraders in models of hematological malignancies demonstrate broad anti-tumor activity across more than 70% of hematologic sub-lineages tested, highlighting the program’s wide therapeutic potential.
•A VHL-based selective degrader has shown impressive efficacy in MM without hematologic toxicities, including thrombocytopenia, and EP300 degraders have retained full efficacy in IMiD-resistant multiple myeloma cell lines. Together, these findings support a favorable tolerability profile and suggest broad applicability in combination regimens across hematologic cancers.
•IND-enabling studies anticipated in 2026.
Selective ARID1B degrader program. Foghorn’s first-in-class Selective ARID1B degrader selectively targets and degrades ARID1B in ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including endometrial, gastric, gastroesophageal junction, bladder and NSCLC. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors.
•The preclinical program has made meaningful progress with the development of both VHL- and cereblon-based bifunctional degraders designed with potential for oral delivery. Both have achieved selective degradation of ARID1B, confirming effective target engagement, and have demonstrated modulation of downstream target genes consistent with ARID1B pathway disruption.
•Advancing towards in vivo proof of concept in 2026.

Chromatin Biology and Degrader Platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in induced proximity, long-acting injectables, novel ligases, and oral delivery.

Full Year 2025 Financial Highlights

•Collaboration Revenues. Collaboration revenues were $30.9 million for the year ended December 31, 2025, compared to $22.6 million for the year ended December 31, 2024. The increase year-over-year was primarily driven by continued advancement of programs under the Lilly Collaboration Agreement.

•Research and Development Expenses. Research and development expenses were $85.5 million for the year ended December 31, 2025, compared to $94.5 million for the year ended December 31, 2024. This decrease was primarily due to a decrease in FHD-286 costs, decreases in personnel-related costs, early development and other research external costs and facilities and IT-related expenses, partially offset by an increase in Lilly-partnered programs.

•General and Administrative Expenses. General and administrative expenses were $27.6 million for the year ended December 31, 2025, compared to $28.4 million for the year ended December 31, 2024. This decrease was primarily due to lower facilities and IT related expenses.

•Net Loss. Net loss was $74.3 million for the year ended December 31, 2025, compared to a net loss of $86.6 million for the year ended December 31, 2024.

•Cash, Cash Equivalents and Marketable Securities. As of December 31, 2025, the Company had $158.9 million in cash, cash equivalents and marketable securities, providing cash runway into the first half of 2028.

About FHD-909
FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models.

(Press release, Foghorn Therapeutics, MAR 11, 2026, View Source [SID1234663455])