Precision BioSciences Q2 2024 Financial Results and Business Update

Precision BioSciences, Inc., a gene editing company listed on Nasdaq (DTIL), has revealed its financial results for the second quarter that ended on June 30, 2024, along with a business update. The company, based in Durham, N.C., leverages its proprietary ARCUS® platform for advanced gene editing therapies.

During the first half of 2024, Precision BioSciences made significant headway in their key initiatives. A major milestone was the advancement of PBGENE-HBV toward an investigational new drug (IND) submission and/or clinical trial application (CTA) planned for later this year. PBGENE-HBV is positioned to be the first gene editing program entering clinical trials aimed at providing a functional cure for chronic Hepatitis B by eliminating the root cause of viral replication. The company's efforts included completing final toxicology studies, producing clinical trial materials, and setting up global clinical study sites for the Phase 1 trial. Additionally, leading clinicians were added to the Hepatitis Scientific Advisory Board.

While focusing on PBGENE-HBV, the company also progressed its second wholly-owned program, PBGENE-PMM, which targets mitochondrial diseases caused by the 3243 mutation. This program is expected to file for IND and/or CTA in 2025.

Financially, the company is in a robust position, supported by multiple business development deals and a $40 million equity raise. These funds are expected to support the development of their programs through Phase 1 data readouts in 2025 and 2026.

Precision BioSciences’ portfolio includes several significant projects:

1. PBGENE-HBV: Aimed at curing chronic Hepatitis B, it targets the elimination of cccDNA and integrated HBV DNA. Recent preclinical safety data presented at the European Association for the Study of the Liver supported its ability to safely target HBV DNA. The planned Phase 1 clinical trial material has been manufactured and the IND and/or CTA submissions are expected this year.

2. PBGENE-PMM: Targets mitochondrial diseases by eliminating mutant mitochondrial DNA without harming normal DNA. Data presented at the United Mitochondrial Disease Foundation Conference showed promising results, highlighting the program's specificity and effectiveness. An IND and/or CTA filing is anticipated in 2025.

Besides these, Precision also regained control of three programs initially developed with Prevail Therapeutics Inc., and is currently assessing these for internal development or new partnerships. These include:
- PBGENE-DMD: A novel gene excision approach for Duchenne Muscular Dystrophy.
- PBGENE-LIVER: A gene insertion program targeting liver cells.
- PBGENE-CNS: A program for in vivo editing of neurons to address central nervous system diseases.

In partnership updates, iECURE is leading the gene insertion program for OTC deficiency, which has entered a Phase 1/2 trial and received Fast Track designation from the FDA. Additionally, Precision is collaborating with Novartis on a gene editing program for hemoglobinopathies like sickle cell anemia and beta thalassemia, aiming to develop a transformative one-time treatment.

The company also announced several corporate updates:
- Expansion of the Hepatitis Scientific Advisory Board with world-class investigators.
- Inclusion in the Russell Microcap® Index.
- A stock purchase by management totaling $300,000.
- An amended loan agreement with Banc of California, securing a $22.5 million term loan.

Financially, Precision BioSciences reported solid results:
- As of June 30, 2024, the company had $123.6 million in cash and cash equivalents.
- Revenues for the quarter were $49.9 million, a significant increase from $19.8 million in the same period in 2023.
- Research and development expenses rose to $17.2 million, reflecting progress in their key programs.
- General and administrative expenses decreased to $8.5 million.
- Net income from continuing operations was $32.7 million, compared to a net loss of $11.9 million in the same period in 2023.
- The company had 7.12 million shares of common stock outstanding as of the end of the quarter.

Precision BioSciences continues to leverage its ARCUS® platform to develop novel in vivo gene editing therapies aimed at providing lasting cures for genetic and infectious diseases.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!