#DTIL

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3 days ago

Precision BioSciences Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides Business Update Precision BioSciences (Nasdaq: DTIL) reported Q4 and FY2025 results and provided clinical and corporate updates. Key highlights include PBGENE-HBV Phase 1 late-breaker data showing safety and dose-dependent antiviral activity, IND clearance for PBGENE-DMD in Feb 2026, and a $75M financing in Nov 2025.The company ended 2025 with $137.2M cash, expects runway through 2028, reported Q4 revenue of $34.2M and full-year revenue of $34.3M, and received two patent Notices of Allowance extending PBGENE-HBV protection to Nov 2044.

#DTIL #TGTX Precision BioSciences Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides Business Update

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4 days ago

Precision BioSciences Receives U.S. Patent Allowances Covering the PBGENE-HBV Program Precision BioSciences (Nasdaq: DTIL) received two U.S. Notices of Allowance for patent applications covering its PBGENE-HBV program, including composition-of-matter claims for the PBGENE-HBV ARCUS nuclease and a novel shortened polypeptide linker.When issued, each patent is expected to expire in November 2044, extending intellectual property protection for PBGENE-HBV and future ARCUS nucleases that use the linker.

#DTIL Precision BioSciences Receives U.S. Patent Allowances Covering the PBGENE-HBV Program

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6 days ago

Precision BioSciences Receives FDA Fast Track Designation for PBGENE-DMD and Announces Duchenne Muscular Dystrophy Investor Event Precision BioSciences, Inc., a clinical stage gene editing company utilizing its novel proprietary ARCUS ® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that the U.S. Food and Drug Administration has granted Fast Track designation to PBGENE-DMD for the treatment of Duchenne muscular dystrophy.

#DTIL Precision BioSciences Receives FDA Fast Track Designation for PBGENE-DMD and Announces Duchenne Muscular Dystrophy Investor Event

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StockTitan

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1 week ago

Precision BioSciences Receives $7.5M in Proceeds from TG Therapeutics for Azer-cel Clinical Milestone in Multiple Sclerosis Precision BioSciences (Nasdaq: DTIL) will receive $7.5 million from TG Therapeutics after a clinical milestone tied to a Phase 1 trial of azer-cel in progressive multiple sclerosis.The proceeds consist of $5.25 million cash plus $2.25 million via purchase of 201,504 Precision shares at $11.17 per share. Precision said these funds, existing cash, and its ATM access are expected to provide runway through 2028.

#DTIL #TGTX Precision BioSciences Receives $7.5M in Proceeds from TG Therapeutics for Azer-cel Clinical Milestone in Multiple Sclerosis

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3 months ago

Precision BioSciences Announces Presentation of Clinical Data from the ELIMINATE-B Trial at HEP-DART 2025 Precision BioSciences (Nasdaq: DTIL) will present clinical data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV at Hep-DART 2025 in Honolulu, December 7–11, 2025.The oral presentation titled “PBGENE-HBV, a first-in-class gene editing therapy for chronic hepatitis B, demonstrates safety and antiviral activity across three cohorts” is scheduled for Tuesday, December 9, 4:45pm HST and will be presented by Man-Fung Yuen, MBBS, MD, PhD, DSc, with authorship including Cassandra L. Gorsuch and others.The announcement emphasizes Phase 1 clinical results on safety and antiviral activity for an in vivo ARCUS® gene editing candidate targeting viral templates that drive chronic hepatitis B.

#DTIL Precision BioSciences Announces Presentation of Clinical Data from the ELIMINATE-B Trial at HEP-DART 2025

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StockTitan

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4 months ago

Precision BioSciences Announces $75 Million Offering of Common Stock, Pre-Funded Warrants and Warrants Precision BioSciences (Nasdaq: DTIL) announced an underwritten offering expected to raise approximately $75 million in gross proceeds by selling 10,815,000 common shares, pre-funded warrants to purchase 1,400,000 shares and accompanying warrants.The per-unit price is $6.14 (pre-funded at $6.139995); each whole warrant has a $7.25 exercise price, is exercisable immediately and expires five years after issuance. The offering is expected to close on or about November 12, 2025, and proceeds will fund R&D, working capital and general corporate purposes.

#DTIL Precision BioSciences Announces $75 Million Offering of Common Stock, Pre-Funded Warrants and Warrants

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StockTitan

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4 months ago

Precision BioSciences Reports Third Quarter 2025 Financial Results and Provides Business Update On October 7th, Precision announced that the first clinical trial sites in the U.S. for the ELIMINATE-B trial had officially been activated. The site at Massachusetts General Hospital in Boston, Massachusetts, is now actively recruiting chronic hepatitis B patients along with multiple global clinical trial sites. On September 12th, the Company presented...

#DTIL Precision BioSciences Reports Third Quarter 2025 Financial Results and Provides Business Update

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Small Cap Strategist

@smcapstrategist.bsky.social

4 months ago

Small-cap stocks with strong volume gains, Thu Oct 16th - #WHWK #WATT #SOND #REE #PRAX #KCHV #DTIL #CBIO #BMRA #ANY - More: crystalequityresearch.com/trade-alerts... - #smallcap

StockTitan

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5 months ago

Precision BioSciences Announces Late-Breaking Oral Presentation for PBGENE-HBV at AASLD The Liver Meeting® 2025 Precision BioSciences, Inc., a clinical stage gene editing company utilizing its novel proprietary ARCUS ® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that it has been selected to deliver a late-breaking oral presentation at the Liver Meeting ® 2025. The oral presentation will feature new PBGENE-HBV...

#DTIL Precision BioSciences Announces Late-Breaking Oral Presentation for PBGENE-HBV at AASLD The Liver Meeting® 2025

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StockTitan

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5 months ago

Precision BioSciences Announces Opening of First Clinical Trial Site in U.S. for ELIMINATE-B Trial Precision BioSciences (Nasdaq: DTIL) announced activation of its first U.S. clinical trial site for the Phase 1 ELIMINATE-B study of PBGENE-HBV at Massachusetts General Hospital in Boston, now actively recruiting chronic hepatitis B patients.The open-label, multi-part study is evaluating safety, tolerability, dose level and dosing regimen. Precision BioSciences said Cohort 3 is underway and the company remains on track to report additional higher-dose cohort data in 2025. Trial identifier: NCT06680232.

#DTIL Precision BioSciences Announces Opening of First Clinical Trial Site in U.S. for ELIMINATE-B Trial

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5 months ago

85% Muscle Cell Response: Precision BioSciences' Revolutionary DMD Gene Therapy Shows Lasting Results PBGENE-DMD therapy demonstrates sustained muscle function improvement with up to 85% dystrophin-positive cells. Clinical trials planned for 2026. Treatment could benefit 60% of DMD patients.

#DTIL Precision BioSciences Announces Late-Breaking Poster Presentation at the 30th Annual International Congress of the World Muscle Society

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StockTitan

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6 months ago

First Evidence: Novel Gene Therapy PBGENE-HBV Shows Substantial Hepatitis B Antigen Reduction in Trial Precision BioSciences presents Phase 1 ELIMINATE-B trial data showing PBGENE-HBV's efficacy in targeting cccDNA and integrated HBV DNA. Well-tolerated across two dose cohorts, Cohort 3 now initiated.

#DTIL Precision BioSciences Presents Data from the Phase 1 ELIMINATE-B Trial of PBGENE-HBV at the 6th International Coalition to Eliminate HBV Cure Symposium

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6 months ago

Major Patent Win: Precision BioSciences' Revolutionary HBV Gene Therapy Protected Until 2042, Trial Progressing Biotech firm receives USPTO patent for PBGENE-HBV ARCUS nuclease technology targeting chronic hepatitis B, with protection until 2042. Phase 1 ELIMINATE-B trial advances to Cohort 3 dosing.

#DTIL Precision BioSciences Announces U.S. Patent Covering PBGENE-HBV for Chronic Hepatitis B and Updates Program Status

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7 months ago

FDA Orphan Drug Designation Gives Precision BioSciences 7-Year Market Exclusivity for DMD Treatment Precision BioSciences secures FDA Orphan Drug status for PBGENE-DMD, advancing novel gene therapy for Duchenne muscular dystrophy. See clinical timeline.

#DTIL Precision BioSciences Receives FDA Orphan Drug Designation for PBGENE-DMD for the Treatment of Duchenne Muscular Dystrophy

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StockTitan

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8 months ago

Precision BioSciences Receives FDA Rare Pediatric Disease Designation for PBGENE-DMD for the Treatment of Duchenne Muscular Dystrophy Precision BioSciences (Nasdaq: DTIL) has received FDA Rare Pediatric Disease Designation for PBGENE-DMD, its treatment for Duchenne muscular dystrophy (DMD). The company's ARCUS® gene editing platform aims to excise exons 45-55 of the dystrophin gene, potentially benefiting up to 60% of DMD patients.The therapy targets a rare disease affecting fewer than 200,000 people in the U.S., with approximately 15,000 Americans living with DMD. Upon FDA approval, Precision may receive a Priority Review Voucher, which can be used for priority review of another product or sold to generate non-dilutive capital. Initial clinical data is expected in 2026.

#DTIL Precision BioSciences Receives FDA Rare Pediatric Disease Designation for PBGENE-DMD for the Treatment of Duchenne Muscular Dystrophy

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StockTitan

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10 months ago

Precision BioSciences Reports First Quarter 2025 Financial Results and Provides Business Update <p>Precision BioSciences (DTIL) reported Q1 2025 financial results and significant progress in its gene editing programs. The company's lead program <b>PBGENE-HBV</b> for chronic Hepatitis B received FDA Fast Track Designation and regulatory clearance to expand trials globally. Initial safety data was presented at EASL, showing positive results after repeat dosing.</p> <p>The company is accelerating <b>PBGENE-DMD</b>, its Duchenne Muscular Dystrophy program, targeting IND/CTA filing in 2025 with clinical data expected in 2026. Preclinical data showed significant functional improvements and protein expression across multiple muscle types.</p> <p>Financially, Precision reported <b>$100 million</b> in cash and equivalents, with runway extended into H2 2026. Q1 2025 resulted in a net loss of <b>$20.6 million</b> ($2.21 per share), compared to net income of $8.6 million in Q1 2024. The company paused development of PBGENE-3243 to focus resources on its lead programs.</p>

#DTIL Precision BioSciences Reports First Quarter 2025 Financial Results and Provides Business Update

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10 months ago

Precision BioSciences Announces Multiple Presentations for In Vivo Gene Editing Programs at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting Precision BioSciences (NASDAQ: DTIL) announced five abstract presentations at the upcoming ASGCT Annual Meeting (May 13-17, 2025) in New Orleans. The presentations showcase their ARCUS® gene editing platform across multiple programs. Key highlights include: Initial safety data from ELIMINATE-B trial for chronic hepatitis B (PBGENE-HBV), their first-in-human study. Updates on ECUR-506, a partnered program with iECURE for OTC deficiency. Preclinical results from two muscle programs: PBGENE-3243 for mitochondrial disease and PBGENE-DMD for Duchenne Muscular Dystrophy. The presentations demonstrate ARCUS platform's versatility in gene elimination, insertion, and excision across complex genetic diseases. The company aims to develop durable, curative treatments through various gene editing approaches.

#DTIL Precision BioSciences Announces Multiple Presentations for In Vivo Gene Editing Programs at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting

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StockTitan

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11 months ago

Precision BioSciences Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Update Precision BioSciences (NASDAQ: DTIL) reported significant clinical progress in Q4 and FY2024, highlighting two successful in vivo gene editing programs. The company's lead program PBGENE-HBV, targeting Hepatitis B, demonstrated safety and substantial antiviral activity in initial trials. The first patient cohort showed HBsAg reduction in two of three patients at the lowest dose level.Their partner iECURE reported a complete clinical response in the first infant treated for Ornithine Transcarbamylase Deficiency. The company received IND and CTA approvals for ELIMINATE-B trials across multiple countries, including the US.Financial highlights include $108.5M in cash and equivalents as of December 31, 2024, with runway extended into H2 2026. Q4 revenues were $0.6M compared to $7.0M in Q4 2023. Net loss increased to $17.8M from $13.4M year-over-year.

#DTIL Precision BioSciences Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Update

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StockTitan

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11 months ago

Breakthrough: First Infant Successfully Treated in iECURE's OTC Deficiency Gene Therapy Trial First patient achieves complete clinical response in OTC deficiency gene therapy trial, successfully discontinuing medication with normalized protein intake and ammonia levels.

#DTIL iECURE Announces Presentation of Full Data for the First Infant Dosed with ECUR-506 in OTC-HOPE Phase 1/2 Clinical Trial at the 2025 ACMG Annual Clinical Genetics Meeting

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StockTitan

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1 year ago

Can This New Gene Editing Approach Transform Duchenne Muscular Dystrophy Treatment? Revolutionary ARCUS platform shows promise in DMD treatment through targeted exon excision, potentially restoring skeletal muscle function in preclinical studies.

#DTIL Precision BioSciences Announces Oral Presentation at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

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StockTitan

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1 year ago

Precision BioSciences Announces Initial Safety and Antiviral Activity of PBGENE-HBV in the ELIMINATE-B Clinical Trial Precision BioSciences (NASDAQ: DTIL) announced initial results from the ELIMINATE-B Phase 1 trial of PBGENE-HBV, their novel gene editing therapy for chronic Hepatitis B. The first cohort of three patients received the lowest dose level (0.2 mg/kg) of PBGENE-HBV, which uses ARCUS-encoding mRNA in lipid nanoparticles.Key findings include:The treatment was safe and well-tolerated with no Grade ≥2 treatment-related adverse eventsTwo of three participants showed substantial reduction in Hepatitis B surface antigen (HBsAg)The trial is designed for three dose administrations per dose levelThe study is currently enrolling HBeAg-negative chronic Hepatitis B patients in Moldova, Hong Kong, and New Zealand, with plans to expand to the U.S. and U.K. Precision plans to share detailed clinical data throughout 2025.

#DTIL Precision BioSciences Announces Initial Safety and Antiviral Activity of PBGENE-HBV in the ELIMINATE-B Clinical Trial

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1 year ago

Precision BioSciences Breaks Ground: First In-Vivo Gene Editing Trial for Hepatitis B Approved in Hong Kong Pioneering ARCUS® gene editing therapy targets chronic hepatitis B virus across all genotypes. Phase 1 ELIMINATE-B trial expands with second regulatory approval of 2024.

#DTIL Precision BioSciences Receives Approval in Hong Kong to Expand PBGENE-HBV Phase 1 ELIMINATE-B Trial for the Treatment of Chronic Hepatitis B

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1 year ago

#DTIL Precision BioSciences to Participate in Upcoming November Investor Conferences

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1 year ago

#DTIL Precision BioSciences Highlights Preclinical Data and Outlines Design of First-in-Human Clinical Trial for PBGENE-HBV for Treatment of Chronic Hepatitis B

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1 year ago

Breaking News: ( NASDAQ: #DTIL ) Precision BioSciences to Present at the Upcoming H.C. Wainwright 5th Annual Viral Hepatitis Virtual Conference

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