Revelation Biosciences, Inc. (REVB): Business Model Canvas [Dec-2025 Updated]

You're digging into Revelation Biosciences, Inc.'s (REVB) playbook right now, trying to figure out how this clinical-stage company plans to turn its Gemini platform-aimed at reprogramming the innate immune system for conditions like CKD and AKI-into shareholder value. Honestly, the model is classic biotech: heavy R&D costs, with net cash used for operations hitting $6.3 million through Q3 2025, which they recently supplemented by pulling in $9.6 million in warrant inducement proceeds to keep the PRIME study moving. We've mapped out exactly how they partner, what they spend their cash on, and where the eventual revenue is supposed to come from, so let's break down the nine blocks of their current strategy, which is propped up by about $12.7 million in cash as of September 30, 2025.

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Key Partnerships

You're looking at how Revelation Biosciences, Inc. (REVB) structures its external relationships to drive its clinical pipeline forward, especially as they move toward later-stage trials. Honestly, for a clinical-stage biotech, these partnerships are the engine room.

Academic institutions for preclinical and clinical research (e.g., Vanderbilt University)

Revelation Biosciences, Inc. maintains active collaborations with academic centers to support its research and clinical development. The company specifically highlighted the continuation of its work with Vanderbilt University and Dr. Bohannon regarding the application of Gemini in severe burn patients, as noted in their May 8, 2025 financial results release. This type of academic tie-in is crucial for accessing specialized expertise and patient populations for novel indications.

The company's primary clinical focus, the Gemini program, has involved external clinical sites. The Phase 1b PRIME study in chronic kidney disease (CKD) patients utilized external infrastructure.

Contract Research Organizations (CROs) for managing clinical trials

While specific CRO names aren't always public, the execution of the PRIME study implies the use of CROs to manage the trial logistics. The PRIME study involved a defined structure which requires external management expertise. The operational scale suggests a formal relationship with a third-party organization to handle site monitoring and data management.

Here's a look at the structure of the recently completed Phase 1b PRIME study, which would have heavily relied on CRO/Investigator partnerships:

Contract Manufacturing Organizations (CMOs) for drug substance (PHAD®) production

The production of the active drug substance, phosphorylated hexaacyl disaccharide (PHAD®), which is the basis for Gemini, requires specialized CMO partners. Revelation Biosciences, Inc. relies on these organizations for GMP (Good Manufacturing Practice) compliant manufacturing to support clinical trials and future commercialization. The company has not publicly detailed the specific CMOs engaged for PHAD® production as of late 2025.

Future strategic pharmaceutical partners for co-development and commercialization

The drive toward later-stage development, particularly for the Acute Kidney Injury (AKI) indication following the planned end-of-Phase 1 meeting with the FDA in late 2025, sets the stage for seeking strategic pharmaceutical partners. These partnerships would be essential for funding and executing larger, more expensive Phase 3 trials and eventual global commercialization. The company's cash position as of September 30, 2025, was $12.7 million, which provides runway but makes external funding or partnership critical for late-stage costs.

The financing activities in 2025 suggest preparation for this next phase:

• Gross proceeds of $4 million from a public offering in May 2025.
• Gross proceeds of $9.6 million from warrant inducement in September 2025.

These capital raises support the groundwork needed to attract a co-development partner.

Key Opinion Leaders (KOLs) and clinical investigators for trial design and execution

Key Opinion Leaders (KOLs) are integral for validating trial design and interpreting complex biomarker data. The PRIME study readout focused on activity biomarkers, which requires KOL input for context. The study measured changes in biomarkers such as IL-10, IL-1RA, and TGF-b, demonstrating attenuated immune cell response to second stress.

The clinical investigators at the 3 US-based clinics who managed the 40 patients in the PRIME study serve as the immediate network of clinical investigators. The company's CEO, James Rolke, noted the focus on advancing the clinical development path for Gemini as a treatment for AKI, which will necessitate expanding this network of investigators for a larger 2026 study.

The cash used for operating activities for the nine months ended September 30, 2025 was $6.3 million, a significant portion of which supports the costs associated with engaging these clinical experts and sites.

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Key Activities

You're looking at the core engine driving Revelation Biosciences, Inc. (REVB) right now-the things they absolutely must do well to move Gemini forward. It's all about execution in the lab and the clinic, plus keeping the lights on.

Conducting and managing clinical trials (e.g., PRIME Phase 1b study)

The management of the PRIME Phase 1b clinical study in chronic kidney disease (CKD) patients was a major activity, concluding dosing in July 2025. This study was designed to test escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 CKD. The activity observed was significant in specific patient subgroups.

Here are the hard numbers from that key trial activity:

The primary endpoint to evaluate safety and tolerability was met. Also, Revelation Biosciences announced a new indication for Gemini in severe burn patients as of May 8, 2025.

Research and Development (R&D) of the Gemini platform and new indications

R&D centers on Gemini, the proprietary formulation of phosphorylated hexaacyl disaccharide (PHAD®), which is an established TLR4 agonist. This work supports multiple programs beyond the CKD trial.

• Gemini-CKD program for treatment of chronic kidney disease.
• Gemini-SSI for prevention of surgical site infection.
• Gemini-AKI for prevention of acute kidney injury.
• Preclinical testing to expand potential uses of Gemini.

The company reported a net loss for the nine months ended September 30, 2025, of $6.4 million. Analyst consensus forecast for 2025 earnings was -$55,289,971.

Regulatory strategy and submissions (e.g., FDA End-of-Phase 1 meeting package)

A critical recent activity was advancing the regulatory pathway for Gemini, specifically for acute kidney injury (AKI). You need to know the status of these interactions with the FDA.

Revelation Biosciences announced the successful submission and acceptance of the end-of-phase 1 meeting package to the FDA on November 20, 2025. The primary purpose of this meeting, scheduled for later in 2025, is to get agency feedback on the clinical development and regulatory approval pathway for Gemini as an AKI treatment. The near-term focus is initiating a later-stage clinical study during 2026 for AKI.

Capital raising and investor relations to fund operations

Keeping the cash flowing is definitely a top activity, given the clinical stage of the business. You've seen two distinct financing events in 2025 so far.

As of September 30, 2025, the cash position stood at $12.7 million, up from $6.5 million at the end of 2024. This cash, combined with current plans, is projected to fund operations through the third quarter of 2026. Net cash used for operating activities for the nine months ended September 30, 2025 was $6.3 million. The market capitalization as of December 1, 2025 was approximately $5.66 million.

Intellectual Property (IP) management and patent portfolio expansion

This involves securing the foundation for Gemini's technology. While specific patent filing numbers aren't public in the latest reports, the core asset is the proprietary formulation itself, Gemini (PHAD®).

The company operates with 13 total employees as of late 2025. The P/B ratio was reported at 0.31, suggesting the stock traded below its book value around December 1, 2025. Finance: draft 13-week cash view by Friday.

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Key Resources

You're looking at the core assets Revelation Biosciences, Inc. (REVB) is counting on right now to drive its programs forward. Honestly, for a clinical-stage company, these resources are the engine, the fuel, and the map all rolled into one.

Proprietary Gemini Formulation (PHAD®) and Related Intellectual Property

The central resource is the science itself. Gemini is the company's proprietary formulation of phosphorylated hexaacyl disaccharide, which they refer to as PHAD®. This molecule acts as a toll-like receptor 4 (TLR4) agonist, designed to precondition the innate immune system-this concept is called trained immunity. The IP around Gemini is critical, especially since key development programs are tied to licensed patents.

The intellectual property foundation includes a patent family licensed from Vanderbilt University, covering the use of Gemini for preventing post-surgical infection (GEMINI-PSI program) and infection in severe burn patients (GEM-PBI program). This proprietary platform is being evaluated across several indications:

• Prevention for acute kidney injury (GEMINI-AKI program).
• Prevention for post-surgical infection (GEMINI-PSI program).
• Prevention for post-severe burn infection (GEM-PBI program).
• Treatment to slow the progression of chronic kidney disease (GEMINI-CKD program).

Cash and Cash Equivalents

Financial runway is a non-negotiable key resource. As of September 30, 2025, Revelation Biosciences held $12.7 million in cash and cash equivalents. This position is a significant improvement from the $6.5 million held at the end of 2024, largely due to a May 2025 public offering and a September 2025 warrant inducement that brought in gross proceeds of $9.6 million. This capital position is projected to fund operations through the third quarter of 2026. Here's a quick look at the recent cash burn:

The net cash used for operations over the first nine months of 2025 was $6.3 million, which is substantially less than the $14.6 million used in the same period of 2024. That's smart capital management, frankly.

Scientific and Clinical Management Team Expertise in Innate Immunity

The team's specialized knowledge in innate immunity and trained immunity is a core intangible asset. This expertise is what allows Revelation Biosciences to develop and advance a complex mechanism like TLR4 stimulation via Gemini. The focus on rebalancing inflammation to optimize health is a direct reflection of this specialized human capital. The management team, led by CEO James Rolke, is clearly focused on translating this expertise into regulatory milestones, such as the recent FDA submission.

Clinical Data from Completed Studies (e.g., Positive PRIME Top-Line Results)

Tangible clinical proof points are essential resources for attracting future investment and regulatory support. Revelation Biosciences announced groundbreaking top-line results from the PRIME Clinical Study (PReconditioning IMmunostimulatory Evaluation), a Phase 1b trial in patients with Stage 3 and 4 Chronic Kidney Disease (CKD). The study successfully met its primary endpoint for safety and tolerability with escalating doses of Gemini. Furthermore, the data demonstrated statistically significant pharmacodynamic activity, including the upregulation of IL-10. The PRIME study involved 40 patients across 5 cohorts at 3 US-based clinics.

Regulatory Filings and Clinical Trial Infrastructure

The established infrastructure for running clinical trials and interacting with regulatory bodies is a necessary resource. Revelation Biosciences successfully submitted and received acceptance of its end-of-phase 1 meeting package to the FDA on November 20, 2025. The purpose of this meeting is to gain agency input on the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury (AKI). The company is planning to initiate and run a later-stage clinical study during 2026. This capability to manage complex regulatory submissions and trial execution is a key operational resource.

Finance: draft 13-week cash view by Friday.

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Value Propositions

You're looking at the core value Revelation Biosciences, Inc. is trying to deliver with its Gemini platform, which is all about rebalancing inflammation to optimize health. This isn't just theory; the numbers from late 2025 show they are actively validating these propositions in the clinic.

Reprogramming the innate immune system to reduce inflammation damage

The central value is reprogramming the innate immune system to respond to stress in an attenuated manner, which is key to reducing damage from inflammation. This mechanism was demonstrated in the Phase 1b PRIME study in Chronic Kidney Disease (CKD) patients.

• The study enrolled 40 patients across 5 cohorts at 3 US-based clinics.
• Gemini met its primary safety and tolerability endpoint.
• In patients with high background peripheral blood mononuclear cell (PBMC) activity, Gemini significantly reduced inflammatory markers post-dose: IL-1β by p<0.01, TNF-α by p=0.05, IL-6 by p<0.01, IL-10 by p<0.01, and IL-1RA by p<0.001.
• These effects were durable, with some remaining significantly below baseline through 168 hours post-dose.
• Background inflammation was reduced to levels comparable to PBMCs isolated from healthy subjects.

Potential treatment for Chronic Kidney Disease (CKD) with Gemini-CKD

The PRIME study specifically targeted Stage 3 and 4 CKD patients, showing Gemini's potential to address the underlying immune dysregulation in this chronic condition.

The company reported holding $12.7 million in cash and cash equivalents as of September 30, 2025, with projections to fund operations through Q3 2026, supporting the advancement of this program.

Prevention and treatment of Acute Kidney Injury (AKI) (GEM-AKI program)

Revelation Biosciences sees the GEM-AKI program as providing the shortest pathway to marketing approval by addressing an acute condition with no current therapies.

• Acute Kidney Injury (AKI) affects more than 10% of all hospitalized patients.
• AKI affects over 50% of patients in intensive care units.
• Dialysis remains the only therapeutic option for severe AKI cases.
• Revelation submitted its end-of-phase 1 meeting package to the FDA in November 2025 to discuss the regulatory pathway for AKI treatment, with a later-stage clinical study planned for 2026.

Novel therapeutic approach for severe burn patients

The company announced a new indication for Gemini in severe burn patients in May 2025, targeting infection post-severe burn (GEMINI-PBI).

This addresses a significant acute inflammatory event where controlling the immune response is critical for patient outcomes.

Addressing high unmet medical needs in inflammation-driven diseases

The broader value proposition targets the significant burden of chronic inflammation across the healthcare landscape.

For the nine months ended September 30, 2025, Revelation Biosciences reported net cash used for operating activities of $6.3 million, down from $14.6 million for the same period in 2024, showing operational efficiency while pursuing these high-need areas.

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Customer Relationships

You're looking at how Revelation Biosciences, Inc. (REVB) manages its critical external relationships as of late 2025. For a clinical-stage company, these aren't just contacts; they are the pathways to data, funding, and ultimately, market approval. The focus is heavily weighted toward scientific and regulatory partners.

The core of their clinical execution relies on high-touch, collaborative relationships with clinical investigators and sites. This is where the rubber meets the road for their lead candidate, Gemini. For instance, the Phase 1b PRIME study, which completed dosing in July 2025, was conducted across 3 US-based clinics specializing in chronic kidney disease (CKD) care. That study involved 40 patients distributed across 5 cohorts to evaluate safety and tolerability across escalating doses.

This direct clinical interaction is complemented by rigorous scientific dialogue with Key Opinion Leaders (KOLs) to validate the mechanism of action (MOA). The data from the PRIME study showed a clear cellular effect, with peripheral blood mononuclear cells (PBMCs) isolated from patients showing significantly reduced inflammatory activity at 2, 24, and 168 hours post-dose. Furthermore, the company maintains specific collaborations, such as the one with Vanderbilt and Dr. Bohannon concerning the severe burn indication.

Regulatory engagement is paramount, which means direct engagement with the FDA and other regulatory bodies for development path agreement. As of November 20, 2025, Revelation Biosciences announced the successful submission and acceptance of its end-of-phase 1 meeting package to the FDA, with the meeting itself scheduled for later in 2025. The goal here is to secure agency input for the clinical development and regulatory approval pathway for Gemini in acute kidney injury (AKI), with plans to initiate a later-stage study in 2026.

For public shareholders and potential investors, the company maintains dedicated investor relations, though the engagement metrics reflect a specific market sentiment. The financial health context shows that as of June 30, 2025, cash and cash equivalents stood at $5.2 million. However, the company secured gross proceeds of $9.6 million from warrant inducement in September 2025, which helps fund these operational relationships. Still, the trailing twelve months Earnings Per Share (EPS) was -44.07, and institutional interest remains low, with ownership at 1.21%.

Here's a quick look at the quantitative aspects of these relationships as of late 2025:

The operational cadence requires tight coordination, which you can see in the planned next steps following regulatory milestones. You're managing a lean operation where every interaction counts:

• Finalize activities for initiating later-stage study in 2026.
• Publish additional positive results from the PRIME study completed this year.
• Engage with the FDA following the end-of-phase 1 meeting scheduled for late 2025.
• Maintain collaboration with Vanderbilt on the severe burn indication.
• Manage shareholder communications following the Special Meeting on December 3, 2025.

Finance: draft 13-week cash view by Friday.

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Channels

You're looking at how Revelation Biosciences, Inc. gets its science and its financial needs out into the world. It's a mix of clinical execution, regulatory navigation, and capital market presence.

Clinical trial sites and hospitals for drug administration during studies

The PRIME Phase 1b clinical study, evaluating escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD), was executed across a defined set of sites. Dosing completion for this study was announced in July 2025.

• Total number of clinics enrolled in PRIME Phase 1b: 3.
• Total number of cohorts planned: 5.
• Maximum planned subjects per cohort: 8.

Scientific publications and medical conferences to disseminate data

Data dissemination channels include scientific publications and medical conferences, though specific 2025 publication counts aren't detailed here. The company expected several study data sets from the PRIME trial during Q3 2025, covering safety parameters and biomarker activity.

Direct regulatory communication channel with the U.S. FDA

The direct line to the U.S. Food and Drug Administration (FDA) is critical for advancing Gemini. Revelation Biosciences, Inc. successfully submitted its end-of-Phase 1 meeting package to the FDA on November 20, 2025. The company stated it was on track to hold this meeting later in 2025 to discuss the clinical development and regulatory approval pathway for Gemini as a treatment for acute kidney injury (AKI).

Investor relations platforms (NASDAQ, press releases) for capital market access

Access to capital markets is channeled through the NASDAQ listing and regular financial disclosures. The company reported its financial results for the three and nine months ended September 30, 2025, via a press release on November 6, 2025.

Here's a quick look at some key financial and operational data points from the reporting periods leading up to late 2025:

The company's ability to maintain its listing on NASDAQ is a key component of its investor channel strategy.

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Customer Segments

You're looking at the core groups Revelation Biosciences, Inc. (REVB) is targeting with its Gemini program as of late 2025. This isn't about the entire global market; it's about the specific patient populations and financial entities that validate their current clinical path.

The primary patient segments are defined by the indications where Gemini is in development or being prioritized. The company has explicitly focused on these areas based on clinical trial progress and perceived regulatory pathway speed.

• Patients suffering from Chronic Kidney Disease (CKD) and Acute Kidney Injury (AKI).
• Patients at risk of post-surgical infection (SSI) (e.g., colorectal surgery).

For the CKD segment, Revelation Biosciences, Inc. completed dosing of patients in the PRIME Phase 1b Clinical Study of Gemini in CKD Patients as of June 30, 2025. The GEMINI-AKI program is the primary focus for the shortest pathway to marketing approval. Furthermore, the company announced a new indication for Gemini in severe burn patients in the first quarter of 2025.

The institutional customers-hospitals and treatment centers-are the eventual end-users for the approved therapy. Revelation Biosciences, Inc. is actively engaging with the clinical community, as evidenced by the focus on severe burn units and the ongoing clinical work.

The next layer of customer segments involves entities that provide the capital to reach these patients. This is where the financial numbers become the key data points defining this segment as of the third quarter of 2025.

Future pharmaceutical companies represent a potential licensing or acquisition customer segment. While specific deal values aren't public for this segment, the company's progress-including groundbreaking top-line results from the PRIME clinical study reported in November 2025-is designed to attract this group. The company is also on track to meet with the FDA later in 2025 regarding the AKI development path, which de-risks the asset for potential partners.

The institutional and retail investors are the segment funding the clinical development stage. Their commitment is reflected in the capital raised, which increased the cash balance from $6.5 million at the end of 2024 to $12.7 million by September 30, 2025. The net loss for the nine months ended September 30, 2025, was $6.4 million.

You can see the direct financial impact of investor confidence:

• Cash on hand increased by $6.2 million between December 31, 2024, and September 30, 2025.
• Net cash used for operating activities for the nine months ended September 30, 2025, was $6.3 million.
• The net loss for the three months ended September 30, 2025, was $1.9 million.

Finance: draft 13-week cash view by Friday.

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Cost Structure

You're looking at the cash burn for a clinical-stage company, and the cost structure is almost entirely driven by advancing the science.

The heavy investment in Research and Development (R&D) and clinical trial expenses is the primary drain on cash, which is typical when you're running studies like PRIME.

• Net cash used for operating activities was $6.3 million for the nine months ended September 30, 2025.
• The net loss for the same nine-month period was $6.4 million.

This cash burn is the cost of moving Gemini through the development pathway, including engaging with the FDA later in 2025 to agree on the registration path for acute kidney injury (AKI).

General and Administrative (G&A) overhead is baked into that operating cash use, covering things like legal counsel for patent prosecution and the costs associated with maintaining the NASDAQ listing. While the specific G&A dollar amount isn't explicitly broken out for the nine months ended September 30, 2025, in the available summaries, it is a component of the overall operating expense.

The costs related to manufacturing for clinical trial materials (CMO fees) and Intellectual Property maintenance are also significant, non-recurring costs that contribute to the overall negative cash flow from operations.

To give you a sense of the cash position against this burn rate, as of September 30, 2025, Revelation Biosciences had $12.7 million in cash and cash equivalents. That cash position, bolstered by the $9.6 million in gross proceeds received from warrant inducement in September 2025, is projected to fund operations through the third quarter of 2026.

Finance: draft 13-week cash view by Friday

Revelation Biosciences, Inc. (REVB) - Canvas Business Model: Revenue Streams

You're looking at the current financial lifeblood of Revelation Biosciences, Inc. (REVB) as of late 2025. For a clinical-stage company, the revenue streams are heavily weighted toward capital formation rather than product sales, which is typical at this stage of development.

The primary, most recent, and most significant source of realized income has been from financing activities designed to fund the ongoing clinical development of Gemini. This is the cash that keeps the lights on and the trials running.

As of September 30, 2025, Revelation Biosciences, Inc. reported cash and cash equivalents totaling $12.7 million, which the company projected was sufficient to fund operations through the third quarter of 2026. This cash position is a direct result of these financing activities, offset by operating cash use.

Beyond the immediate equity financing, the Business Model Canvas points toward several critical, but currently unrealized, future revenue streams contingent on clinical and regulatory success:

• Potential future milestone payments from existing or future licensing agreements with pharma partners.
• Potential future royalties or profit-sharing arrangements upon commercialization of Gemini for any indication.
• Potential future product sales revenue following regulatory approval for any of its programs, including chronic kidney disease, post-surgical infection prevention, or acute kidney injury treatment.

Currently, grant funding for specific research programs appears to be a minor or non-existent component of the revenue mix, as the focus has been on the warrant inducement and public offering to support the PRIME clinical study results and FDA engagement. The company is actively working toward an agreement with the FDA on the clinical development path to registration for Gemini.