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Precision BioSciences, Inc. (DTIL): Business Model Canvas [Dec-2025 Updated] |
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Precision BioSciences, Inc. (DTIL) Bundle
You're digging into Precision BioSciences, Inc. (DTIL)'s strategy, trying to see past the biotech noise to where the real value is hiding. Honestly, the story here isn't just about gene editing; it's about a high-stakes pivot. They are betting their remaining cash-about $71.2 million as of late Q3 2025-on turning their proprietary ARCUS platform into a functional cure for Hepatitis B and a treatment for Duchenne Muscular Dystrophy, moving aggressively away from their older CAR T focus. This canvas breaks down exactly how Precision BioSciences, Inc. (DTIL) is structuring its operations, from their $13.4 million quarterly R&D burn to the key partnerships driving their pipeline forward; see below for the full, precise breakdown.
Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Key Partnerships
You're looking at how Precision BioSciences, Inc. structures its external relationships to drive its ARCUS platform forward, especially as it pivots more toward in vivo gene editing. These partnerships are crucial for funding development and getting assets like azer-cel across the finish line.
iECURE for the ECUR-506 Program Targeting OTC Deficiency
The collaboration with iECURE centers on ECUR-506, an ARCUS-mediated in vivo targeted gene insertion program for neonatal onset ornithine transcarbamylase (OTC) deficiency. This is being evaluated in a first-in-human Phase 1/2 trial called OTC-HOPE. Precision BioSciences reported that iECURE announced clinical efficacy and safety data in January 2025 for the first patient dosed, showing a complete clinical response from three months post-exposure through the end of the study at six months. The patient is now over one year old and eating age-appropriate levels of protein. iECURE expects to complete enrollment in 2025 across the U.K., the U.S., Australia, and Spain, with complete trial data anticipated in the first half of 2026. Precision BioSciences expects an IND filing for its PBGENE-DMD program by the end of 2025, which is a separate program but shows the company's focus on in vivo editing advancement.
Imugene for the Development and Commercialization of the azer-cel Allogeneic CAR T Therapy
The deal with Imugene Limited for the global rights to azer-cel, an allogeneic CAR T therapy, has been a significant source of non-dilutive funding and operational relief for Precision BioSciences. This partnership supports Precision's pivot to in vivo editing by offloading the cell therapy execution. The financial structure has already delivered several payments to Precision BioSciences as of late 2025.
Here's a look at the financial flow from this key alliance:
| Event/Metric | Value/Data Point | Date Context |
|---|---|---|
| Initial Upfront Economics (Cash & Equity) | $21 million | August 2023 |
| Near-Term Payment (Phase 1b Dosing Completion) | $8 million (Cash & Equity) | Original Term |
| Milestone Payment Received (FDA Pivotal Trial Discussion) | $8 million (Cash & Stock) | October 31, 2025 |
| Additional Milestone Payment Received (FDA Pivotal Trial Discussion) | US$3 million (Cash) + 19,491,635 shares | November 2, 2025 |
| Total Potential Milestones for azer-cel (Cancer) | Up to $198 million | Original Term |
| Potential Milestones per Additional Cancer Program Option | Up to $145 million each | Original Term |
| Best Overall Response Rate (DLBCL, July 2025 Data) | 75% | July 2025 |
| Complete Response Rate (DLBCL, July 2025 Data) | 55% | July 2025 |
| Overall Response Rate (CAR T-Naïve Arm, Nov 2025 Data) | 83% (5 out of 6 patients) | November 2025 |
Imugene is actively enrolling patients in the Phase 1b azer-cel trial at ten U.S. sites and five sites in Australia. Precision BioSciences is also eligible for double-digit royalties on net sales if the therapy is commercialized.
Academic Institutions for Preclinical Research and Clinical Trial Execution
While specific financial arrangements with academic partners aren't always public, the clinical execution relies heavily on these relationships. For instance, the azer-cel trial involves multiple centers, and Precision BioSciences has expanded the advisory role of Mark Sulkowski, M.D., Professor of Medicine at Johns Hopkins University School of Medicine, to support clinical strategy across its pipeline, including the PBGENE-HBV trial. The OTC-HOPE trial is running in the U.S., U.K., Australia, and Spain, indicating a broad international academic/clinical site network.
- Clinical data from the first patient in the OTC-HOPE trial was presented at the 2025 ACMG Annual Clinical Genetics Meeting in March 2025.
- Additional data from the PBGENE-HBV ELIMINATE-B trial was accepted for presentation at the 75th American Association for the Study of Liver Diseases (AASLD) Liver Meeting 2025.
- The company plans to present data at the Hep-DART 2025 meeting in December 2025.
Contract Manufacturing Organizations (CMOs) for Drug Substance and Product Manufacturing
Precision BioSciences has strategically managed its manufacturing footprint. As part of the Imugene transaction, Imugene assumed control of Precision's cell therapy infrastructure, which implies a transfer of certain manufacturing oversight or relationships related to azer-cel. For its in vivo programs, Precision BioSciences is manufacturing clinical supplies for PBGENE-DMD, with an anticipated IND filing by the end of 2025. As of June 30, 2025, the company was managing operating costs, having paused development on PBGENE-3243 to prioritize its lead programs.
Strategic Alliances for Non-Therapeutic Applications of the ARCUS Platform (e.g., Food Segment)
Precision BioSciences continues to advance its gene editing program with Novartis (PBGENE-NVS) to develop a custom ARCUS nuclease for patients with hemoglobinopathies, such as sickle cell disease and beta thalassemia. This is a gene insertion program intended to deliver a one-time transformative treatment directly to the patient. While the search results don't specify a 'Food segment' partnership, the Novartis collaboration represents a key strategic alliance utilizing the ARCUS platform for a specific therapeutic application outside the immediate focus areas of OTC and HBV.
The company's overall financial discipline, including reducing annual operating expenses through efficiency programs initiated in July 2025, is designed to extend its expected cash runway to the second half of 2027, supported by cash on hand of approximately $71.2 million as of September 30, 2025.
Finance: review the Q3 2025 cash burn rate against the projected runway by end of next week.Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Key Activities
You're managing a clinical-stage biotech, so the key activities revolve around translating platform science into approved medicines. For Precision BioSciences, Inc., this means heavy investment in the lab and the clinic to prove out the ARCUS platform. Honestly, the numbers tell you where the focus is right now.
Research and Development (R&D) of proprietary ARCUS nucleases.
The engine room for Precision BioSciences, Inc. is the R&D function. This activity covers the continuous engineering and refinement of the ARCUS genome editing platform itself, which is the core intellectual property. Looking at the third quarter of 2025, the financial commitment to this work was substantial, reflecting the ongoing need to optimize the technology for different therapeutic modalities like insertion, elimination, and excision. The $\text{R\&D}$ Expenses for the quarter ended September 30, 2025, totaled $\text{\$13.4 million}$. This is balanced against the G&A Expenses for the same period, which were $\text{\$7.3 million}$.
Advancing wholly-owned clinical programs like PBGENE-HBV and PBGENE-DMD.
This is where the R&D spend translates into potential revenue. Precision BioSciences, Inc. is driving two lead, wholly-owned in vivo gene editing programs. The focus is on generating the data needed to support regulatory filings and eventual commercialization. The company has clearly prioritized these two programs, pausing development on others like $\text{PBGENE-3243}$ to concentrate capital and effort.
The status of these key programs as of late 2025 looks like this:
| Program | Indication | Key Activity Status (Late 2025) | Key Data Point |
| PBGENE-HBV | Chronic Hepatitis B | Phase 1 ELIMINATE-B trial dosing of Cohort 3 initiated in Q3 2025 | Best $\text{HBsAg}$ reduction in Cohort 1 was $\text{47-69\%}$ |
| PBGENE-DMD | Duchenne Muscular Dystrophy | On track for $\text{IND/CTA}$ filing by the end of 2025 | Preclinical data showed up to $\text{85\%}$ dystrophin-positive cells in gastrocnemius |
Managing and executing Phase 1 clinical trials across multiple geographies.
Executing the ELIMINATE-B trial for $\text{PBGENE-HBV}$ involves managing sites across several regulatory jurisdictions. Precision BioSciences, Inc. announced that $\text{PBGENE-HBV}$ is cleared for trials in 5 countries. This global execution is critical for gathering robust safety and efficacy data. For instance, the U.S. $\text{FDA}$ cleared the trial to commence in March 2025, and the $\text{U.K.}$ $\text{MHRA}$ cleared an expansion $\text{CTA}$ in April 2025. The company is using ascending dose levels, with Cohort 1 receiving a $\text{0.2 mg/kg}$ dose. The safety profile allowed the Data Monitoring Committee to recommend proceeding to Cohort 3 dosing in the third quarter of 2025.
The near-term clinical milestones Precision BioSciences, Inc. is working toward include:
- Presenting new data from multiple cohorts of the $\text{PBGENE-HBV}$ trial at The Liver Meeting 2025.
- Anticipating initial clinical data for $\text{PBGENE-DMD}$ in the second half of 2026.
- Planning Phase 1 initiation for $\text{PBGENE-DMD}$ in the first half of 2026.
- Expecting cash runway to last into the second half of 2027 to fund these readouts.
Securing and maintaining a global intellectual property portfolio.
Protecting the ARCUS platform and its specific applications is a core activity that underpins future revenue streams. The company has successfully secured patent protection for its lead program. Specifically, Precision BioSciences, Inc. strengthened its intellectual property for $\text{PBGENE-HBV}$ with U.S. patent protection extending into the year 2042. Furthermore, $\text{PBGENE-DMD}$ has received both FDA Rare Pediatric Disease Designation and Orphan Drug Designation, which are regulatory forms of market exclusivity that support the IP strategy.
Engineering and optimizing viral and non-viral delivery systems (e.g., LNP).
The success of in vivo gene editing hinges on the delivery vehicle. Precision BioSciences, Inc. employs different systems depending on the target. For the $\text{PBGENE-HBV}$ program, the company is using Lipid Nanoparticle ($\text{LNP}$) delivery for the ARCUS mRNA. In contrast, the $\text{PBGENE-DMD}$ program utilizes an AAV vector to deliver the two ARCUS nucleases needed for the excision edit. The preclinical data for $\text{PBGENE-HBV}$ showed similar $\text{HBsAg}$ reduction levels in mouse models following $\text{LNP}$ administration as those seen in earlier studies.
The financial health supporting these complex engineering activities is anchored by the current cash position. As of September 30, 2025, Precision BioSciences, Inc. reported $\text{\$71.2 million}$ in cash, cash equivalents, and restricted cash. This, combined with operational efficiencies and non-dilutive funding like an $\text{\$8 million}$ milestone payment from a partner, supports the projected cash runway into the second half of 2027.
Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Key Resources
You're looking at the core assets that power Precision BioSciences, Inc.'s strategy as of late 2025. These aren't just line items; they are the foundation for their in vivo gene editing ambitions.
The most fundamental resource is the proprietary ARCUS® genome editing platform technology. This is the engine, distinct from other tools because of how it cuts, its smaller size, and its simpler structure, making it suitable for both gene insertion and excision approaches. This platform underpins the entire pipeline.
Financially, you need to know the burn rate versus the reserves. As of September 30, 2025, Precision BioSciences, Inc. held approximately $71.2 million in cash, cash equivalents, and restricted cash. This figure reflects the operating efficiencies implemented in July 2025 to manage expenses. The company projects this capital, along with potential near-term cash from CAR T transactions and use of their at-the-market facility, extends their cash runway into the second half of 2027. That runway is designed to fund key milestones for their lead programs.
| Financial/Pipeline Metric | Specific Value/Status | As of/Target Date |
| Cash, Cash Equivalents, and Restricted Cash | $71.2 million | September 30, 2025 |
| Expected Cash Runway | Into the second half of 2027 | |
| PBGENE-HBV Trial Status (ELIMINATE-B) | Dosing of Cohort 3 initiated | Third Quarter of 2025 |
| PBGENE-DMD IND Filing Target | Anticipated IND filing | End of 2025 |
| PBGENE-HBV Key Patent Expiration | March 2042 (U.S. Patent No. 12,410,418) |
Intellectual property is critical here. The extensive patent portfolio provides a defensive moat around the core technology. Specifically, Precision BioSciences, Inc. was issued U.S. Patent No. 12,410,418 on September 9, 2025, which covers the PBGENE-HBV ARCUS nuclease. This composition of matter patent has an expiration date extending into March 2042. Also reinforcing the portfolio are granted patents covering similar claims in Europe and Hong Kong.
You can't run a gene editing company without the right people, so the highly specialized scientific and clinical development personnel are a non-negotiable resource. These teams are responsible for advancing the complex in vivo programs from the bench through clinical trials.
The pipeline itself represents tangible, near-term value. The clinical-stage assets are the immediate focus for resource deployment:
- PBGENE-HBV for chronic hepatitis B is in Phase 1 of the ELIMINATE-B trial, with dosing for Cohort 3 started in the third quarter of 2025.
- PBGENE-DMD for Duchenne Muscular Dystrophy is in the IND-enabling stage, with the company targeting an IND filing by the end of 2025.
- Phase 1 initiation for PBGENE-DMD is anticipated in the first half of 2026, with initial data expected in the second half of 2026.
The company also paused development of PBGENE-3243 for mitochondrial diseases to focus resources on these two lead programs. Finance: draft 13-week cash view by Friday.
Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Value Propositions
The value propositions for Precision BioSciences, Inc. center on the differentiated capabilities of its proprietary ARCUS genome editing platform to deliver potentially curative, single-step genetic modifications across multiple high-unmet-need diseases.
Potential for a functional cure for chronic Hepatitis B (HBV) via cccDNA elimination.
PBGENE-HBV is the first and only clinical-stage gene editing therapy targeting direct viral elimination as the curative mechanism for chronic Hepatitis B infection, which currently afflicts an estimated 300 million people worldwide.
The Phase 1 ELIMINATE-B trial has progressed through multiple dose levels:
| Metric | Data Point |
| Dosing Cohorts as of Oct 31, 2025 | 3 ascending cohorts |
| Doses Administered (Total as of Oct 31, 2025) | 22 administered doses |
| Dose Levels Tested (mg/kg) | 0.2, 0.4, and 0.8 |
| Best HBsAg Reduction (Cohort 1) | 47-69% |
| Durable HBsAg Reduction (Patient 1, 7 Months Post-Dose) | Approximately 50% from baseline |
The goal of the study is to define the optimal dose and number of dose administrations for safely eliminating cccDNA and inactivating integrated HBV DNA.
ARCUS platform's small size allows for efficient delivery via AAV and LNP vectors.
The ARCUS platform is designed for sophisticated edits, and its components facilitate delivery:
- PBGENE-HBV utilizes an ARCUS-encoding mRNA encapsulated in a Lipid Nanoparticle (LNP) vector.
- PBGENE-DMD uses ARCUS nucleases delivered by AAV9.
- Research publications demonstrate ARCUS nucleases can achieve transgene insertion rates exceeding 85% in T lymphocytes.
- The platform can achieve up to 40% insertion efficiency in non-dividing primary human hepatocytes.
Single-step, sophisticated gene edits (insertion, elimination, excision) with high specificity.
The ARCUS platform supports multiple edit types, including gene insertion, single base editing, specific deletions, and replacement of large stretches of genomic DNA.
Potential to restore near full-length dystrophin for Duchenne Muscular Dystrophy (DMD).
PBGENE-DMD targets the genetic root cause for up to 60% of DMD patients with defects between exons 45 and 55. Preclinical data in a humanized DMD mouse model showed significant functional improvements:
- Treated mice showed a 66% improvement in resistance to eccentric injury compared to untreated mice.
- In the gastrocnemius muscle, up to 85% of cells were dystrophin-positive in one long-term durability study.
- Dystrophin-positive muscle cells increased up to a three-fold amount between three and nine months post-treatment in key skeletal muscles, heart, and diaphragm.
Precision BioSciences anticipates filing an Investigational New Drug (IND) application by the end of 2025.
Allogeneic (off-the-shelf) cell therapy technology for broader patient access.
The ex vivo azer-cel program, developed with partner Imugene Limited, has shown compelling efficacy data in Phase 1b trials for relapsed/refractory diffuse large B-cell lymphoma:
- The overall response rate was 81% in patients treated with azer-cel and IL-2.
- This included seven complete responses and six partial responses.
- In a specific relapsed cohort (n=11), 55% achieved ongoing durable responses for $\ge$ 6-months.
This progress is tied to near-term financials, with Precision BioSciences expecting an $8 million milestone payment in cash and stock from Imugene in the fourth quarter of 2025. As of September 30, 2025, the company held approximately $71.2 million in cash, cash equivalents, and restricted cash, extending the expected cash runway into the second half of 2027.
Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Customer Relationships
You're looking at how Precision BioSciences, Inc. (DTIL) manages its external relationships, which is critical for a clinical-stage company where data milestones are the primary currency. This isn't about selling widgets; it's about deep, scientific collaboration and regulatory navigation.
High-touch, collaborative R&D with large pharmaceutical and biotech partners
The relationship with partners is a key driver of near-term financing and validation, though it can be lumpy. You see this dynamic playing out right now with their existing agreements. For instance, the revenue recognition from the Novartis Agreement has tapered off, resulting in Q3 2025 total revenues of less than $0.1 million (or approximately $10,000). This relationship is winding down, as Precision announced Novartis issued a termination notice effective January 30, 2026. Still, new partner engagement provides immediate cash boosts. On October 31, 2025, Precision received an $8 million milestone payment from Imugene. Earlier in 2025, in January 2025, they received a $2.5 million deferred payment from TG Therapeutics. These milestones are essential for bridging the cash gap between financing rounds and clinical readouts.
Here's a quick look at the recent financial interactions with key collaborators:
| Partner/Agreement | Financial Event/Status | Date/Period | Amount/Impact |
| Novartis Agreement | Reduced Billable Effort/Revenue Impact | Q3 2025 | Revenue less than $0.1 million |
| Novartis Agreement | Termination Notice Issued (Effective Date) | October/November 2025 (Effective Jan 30, 2026) | Raises future collaboration revenue uncertainty |
| Imugene | Milestone Payment Received | October 31, 2025 | $8 million |
| TG Therapeutics | Deferred Payment Received | January 2025 | $2.5 million |
The narrative is definitely pivoting from quarterly collaboration revenue to clinical proof points, which is typical when a platform is maturing.
Direct engagement with clinical investigators and key opinion leaders (KOLs)
The relationship with the clinical community is centered on generating and presenting compelling data from their wholly owned programs, PBGENE-HBV and PBGENE-DMD. This engagement is how they build credibility with the physicians who will ultimately prescribe their therapies.
- PBGENE-HBV data presented at AASLD on November 10, 2025, covered the first three cohorts.
- The lowest dose cohort (Cohort 1) involved three participants receiving a 0.2 mg/kg dose.
- Data was also presented at the Hep-DART 2025 meeting on November 19, 2025.
- PBGENE-DMD preclinical data was presented at the 2025 Muscular Dystrophy Association (MDA) Conference in March 2025.
- PBGENE-DMD data was also presented at the 30th Annual International Congress of the World Muscle Society.
These presentations are the direct output of the high-touch interaction with the investigators running the trials.
Regulatory relationship management with agencies like the FDA (e.g., Fast Track designation)
Managing the relationship with the U.S. Food and Drug Administration (FDA) is paramount, as regulatory designations can significantly speed up development and enhance future commercial value. Precision BioSciences has secured key designations for its lead programs.
- PBGENE-HBV received Fast Track designation from the U.S. FDA in April 2025.
- PBGENE-DMD has received both Orphan Drug Designation and Rare Pediatric Disease (RPD) designation from the FDA.
- The RPD designation makes Precision eligible for a Priority Review Voucher upon approval, which is a major non-dilutive asset; one such voucher recently sold for more than $150 million.
- The company is targeting an IND filing for PBGENE-DMD by the end of 2025.
The Fast Track status for PBGENE-HBV allows for more frequent communication and meetings with the FDA, which is a direct benefit of that relationship management.
Investor relations focused on communicating pipeline progress and cash runway
Investor relations is about managing expectations around the burn rate versus the time until the next data inflection point. You need to know where the cash stands relative to the milestones.
As of September 30, 2025, Precision BioSciences reported cash, cash equivalents, and restricted cash of $71.2 million. This is down from the unaudited estimate of approximately $108.5 million as of December 31, 2024. The company projects this current cash position extends the operational runway into the second half of 2027. This runway is intended to cover the clinical milestones for both PBGENE-HBV and PBGENE-DMD, including the anticipated Phase 1 start for DMD in the first half of 2026 and initial data in the second half of 2026. To bolster this position, the company announced a $75 million offering of common stock, pre-funded warrants, and warrants on November 10, 2025. For the third quarter ended September 30, 2025, the net loss was $21.8 million, or ($1.84) per share, with Research and Development Expenses at $13.4 million for that quarter. Finance: draft 13-week cash view by Friday.
Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Channels
Direct licensing and collaboration agreements with biopharma companies.
| Agreement Type/Metric | Financial/Statistical Data (2025) | Related Program/Partner |
|---|---|---|
| Secured License Agreement Amount | $2.5 million | CAR T therapy (with TGTherapeutics) |
| Cash, Cash Equivalents, and Restricted Cash (as of March 31, 2025) | Approximately $100 million | Company Balance Sheet |
| Analyst Consensus Rating (as of Dec 4, 2025) | Buy (based on 2 analysts) | Stock Coverage |
| Analyst Rating Breakdown | 50% Strong Buy, 50% Buy, 0% Hold, 0% Sell, 0% Strong Sell | Stock Coverage |
| Consensus Revenue Forecast (2025Q4) | $9.075M | Financial Projection |
| Consensus EPS Forecast (2025Q4) | -0.595 | Financial Projection |
Revenue stream is noted as slowing due to the conclusion of the Prevail/Lilly partnership.
Clinical trial sites for patient enrollment and data generation.
- Phase 1 ELIMINATE-B trial for PBGENE-HBV is designed to initially enroll up to 45 patients.
- Trial sites include locations in Moldova, Hong Kong, New Zealand, and the U.S.
- First U.S. clinical trial site activated at Massachusetts General Hospital in Boston, Massachusetts, on October 7, 2025.
- Precision BioSciences expects to expand the study to clinical trial sites in the U.K.
- Data from the first three cohorts showed the greatest reduction in hepatitis B surface antigen (HBsAg) ranged from 47 percent to 69 percent in one patient.
Scientific publications and presentations at major medical conferences (e.g., AASLD).
Precision BioSciences, Inc. presented data at multiple forums in 2025:
- Presented late-breaking Phase 1 PBGENE-HBV data at AASLD The Liver Meeting® in November 2025.
- Scheduled to present data from the ELIMINATE-B Trial at HEP-DART 2025 (December 7-11, 2025).
- Presented data at the 6th International Coalition to Eliminate HBV Cure Symposium in Berlin, Germany, on September 12, 2025.
- Published a paper in Nucleic Acids Research in October 2025.
- Presented at the Chardan\'s 9th Annual Genetic Medicines Conference on October 21, 2025.
- Presented at the H.C. Wainwright Liver Diseases Virtual Conference on October 21, 2025.
Investor and analyst briefings for capital market communication.
Capital market activities in late 2025 included:
- Announced a $75 Million Offering of Common Stock, Pre-Funded Warrants and Warrants on November 10, 2025.
- Reported Third Quarter 2025 Financial Results on November 3, 2025.
- Filed an 8-K reporting a material event on November 12, 2025.
- Filed a 424B5 Prospectus Supplement (Debt Securities) on November 12, 2025.
Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Customer Segments
You're looking at the customer base for Precision BioSciences, Inc. as of late 2025. The model clearly splits between direct patient focus for their wholly-owned assets and strategic alliances for platform monetization and co-development.
Large pharmaceutical and biotechnology companies represent a key segment, primarily through licensing and collaboration agreements that validate the ARCUS platform and provide non-dilutive funding. These partners gain access to Precision BioSciences, Inc.'s gene editing technology for specific targets.
Here's a look at the financial structure associated with one such major partnership:
| Partner/Program Type | Upfront/Near-term Payments (Total) | Potential Milestone Payments (Total) | Royalty Structure |
| Ex Vivo CAR T (Imugene for azer-cel) | Up to $47 million | Over $900 million | High-Single-Digit to Low-Double-Digit on Net Sales |
The company also has active collaborations with partners like Novartis for hemoglobinopathies and iECURE for the OTC deficiency program (ECUR-506), plus an option agreement with Acuitas Therapeutic Inc. for LNP delivery technology. Precision BioSciences, Inc. is expecting an $8 million milestone payment from Imugene in the fourth quarter of 2025 due to progress with azer-cel.
For the segment focused on patients with high unmet medical needs, Precision BioSciences, Inc. targets specific diseases with their wholly-owned pipeline assets:
- Patients with chronic Hepatitis B (HBV) receiving PBGENE-HBV, currently in the Phase 1 ELIMINATE-B Trial, with Cohort 3 dosing commenced in the third quarter of 2025.
- Patients with Duchenne Muscular Dystrophy (DMD) targeted by PBGENE-DMD. The estimated US patient population is approximately 15,000 patients.
The company is prioritizing these two programs, with an expected cash runway extending into the second half of 2027 to fund their achievement.
Clinical investigators and academic research institutions form a necessary segment for clinical validation and data dissemination. This interaction is evidenced by:
- Late-breaking oral presentation of PBGENE-HBV data at AASLD The Liver Meeting® 2025 on November 10, 2025.
- Presentation of PBGENE-DMD preclinical data at the 30th Annual International Congress of the World Muscle Society in October 2025.
While the focus is heavily therapeutic, the platform itself serves strategic partners for technology utilization. The ARCUS HDR Gene Insertion and Gene Excision capabilities have been validated by Big Pharma and Biotech Partners, which is a form of customer segment that pays for platform access and co-development rights, as seen in the Novartis agreement.
Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Cost Structure
You're looking at the cost structure for Precision BioSciences, Inc. as of late 2025. For a clinical-stage gene editing company, the costs are heavily weighted toward the science and getting those therapies into patients. Honestly, the numbers reflect a high-burn, high-potential environment.
The primary drivers of operating expense in the third quarter of 2025 centered on advancing the ARCUS platform pipeline, particularly the wholly-owned programs like PBGENE-HBV and PBGENE-DMD. The company noted implementing operating efficiencies in July 2025 to reduce annual operating expenses and extend its cash runway, which was expected to reach into the second half of 2027.
Here is a breakdown of the key reported costs for the quarter ended September 30, 2025:
| Cost Category | Q3 2025 Amount (USD) | Context/Driver |
| Research and Development (R&D) Expenses | $13.4 million | Driven primarily by the advancement of the PBGENE-DMD program. |
| General and Administrative (G&A) Costs | $7.3 million | Decreased from $8.8 million in Q3 2024, primarily due to reduced employee-related costs. |
| Net Loss | $21.8 million | The total operating cost less revenue for the period. |
| Cash, Cash Equivalents, and Restricted Cash | $71.2 million | Balance as of September 30, 2025, before a received milestone payment. |
The R&D spend is where the bulk of the investment in future value creation sits. While the specific line items aren't broken out in the top-line report, you can infer where that $13.4 million is going based on their stated activities.
- High Research and Development (R&D) expenses, which were $13.4 million in Q3 2025.
- General and Administrative (G&A) costs, totaling $7.3 million in Q3 2025.
- Costs associated with manufacturing clinical-grade gene editing therapies, which are embedded within R&D as the PBGENE-HBV program is in a Phase 1 dose escalation study.
- Intellectual property maintenance and litigation expenses, which are typically captured within G&A or R&D overhead.
- Clinical trial execution and regulatory submission costs, as the company was focused on dose escalation for PBGENE-HBV and targeting an Investigational New Drug (IND) filing for PBGENE-DMD by the end of 2025.
To be fair, the costs related to clinical execution and manufacturing for a gene editing therapy are significant, even if they are not explicitly itemized outside of the main buckets. For instance, the progress on PBGENE-DMD, targeting an IND filing by the end of 2025, necessitates substantial spending on process development and cGMP (current Good Manufacturing Practice) material production, which falls under R&D. Also, the company received an $8 million milestone payment in October 2025 from Imugene, which helps offset these ongoing costs.
The cost structure is clearly weighted toward the development pipeline, as shown by the R&D spend being nearly double the G&A spend for the quarter. Finance: draft 13-week cash view by Friday.
Precision BioSciences, Inc. (DTIL) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Precision BioSciences, Inc. (DTIL) as of late 2025, and honestly, it's heavily weighted toward non-recurring events like milestones and upfront payments right now, which is typical for a clinical-stage platform company. The core revenue streams are built around monetizing the proprietary ARCUS® genome editing platform through external partnerships.
Collaboration and licensing revenue forms the backbone, encompassing both upfront fees and those crucial milestone payments tied to partner progress. For instance, revenue recognized under the Novartis Agreement saw a decrease as Precision neared completion of its pre-clinical workplan, showing how these streams fluctuate based on the stage of collaboration work.
You definitely saw a significant cash event recently. Precision BioSciences received an $8 million milestone payment in cash and stock from Imugene on October 31, 2025. This payment was tied to the successful completion of phase 1b dosing in the CAR T relapsed LBCL patient population for azer-cel.
Looking at the top line for the period ending September 30, 2025, the Trailing Twelve Months (TTM) revenue was reported at $698.00 thousand. To give you some context on the recent quarter, the reported revenue for the third quarter ended September 30, 2025, was approximately $10,000, which was a stark drop from the $0.6 million reported in the same quarter last year, largely due to that lower billable effort under the Novartis collaboration.
The long-term upside is definitely in potential future royalties from commercialized partnered products. Precision is eligible for double-digit royalties on net sales for the azer-cel program with Imugene. Also, the non-exclusive license granted to Caribou Biosciences entitles Precision to royalties on net sales of licensed products, plus tiered milestone payments for certain strategic transactions involving Caribou.
Upfront payments from new strategic alliances or technology licenses provide immediate capital to fund operations. You can see this in the strategic transaction with Imugene, which provided upfront economics valued at $21 million, consisting of cash and equity. Similarly, the license agreement with Caribou Biosciences included an upfront payment.
Here's a quick look at the economics tied to some of those key deals:
| Revenue Source/Event | Type of Payment | Value/Terms | Partner |
| Azer-cel Milestone | Milestone Payment (Received Q4 2025) | $8 million (cash and stock) | Imugene |
| Azer-cel Potential | Additional Milestones | Up to $198 million | Imugene |
| Imugene Additional Programs | Milestone Payments | Up to $145 million per program | Imugene |
| Azer-cel Commercialization | Royalties | Double-digit royalties on net sales | Imugene |
| Caribou License | Upfront Payment | Undisclosed (plus royalties) | Caribou Biosciences |
| Imugene Strategic Transaction | Upfront Economics | Valued at $21 million (cash and equity) | Imugene |
The revenue recognition model is clearly dependent on hitting specific targets across its portfolio. The key components that drive these non-recurring revenue events include:
- Milestone payments from the Novartis collaboration for hemoglobinopathies.
- Upfront fees and potential royalties from the Caribou Biosciences license.
- Equity stake and milestone/royalty payments from the iECURE agreement.
- The expected tiered milestone payments for each additional research program selected by Imugene.
Finance: draft 13-week cash view by Friday.
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