Inventiva S.A. (IVA): Business Model Canvas [Dec-2025 Updated]

You're digging into the nuts and bolts of Inventiva S.A.'s (IVA) business, and frankly, the whole structure is laser-focused on getting lanifibranor across the finish line in MASH, which is a huge, unmet medical need. As an analyst who's seen countless biotech models, I can tell you this one is a classic high-stakes play, balancing massive R&D expenses-like the €64.6 million spent over the first nine months of 2025-against crucial partnerships, such as the one with Chia Tai Tianqing Pharmaceutical Group, and recent lifeline funding, like the €115.6 million gross proceeds from their May 2025 equity tranche. This canvas distills exactly where their value lies-in that oral pan-PPAR agonist-and how they are funding the critical Phase 3 trial until potential revenue kicks in post-2026, so dive in below to see the full strategic map.

Inventiva S.A. (IVA) - Canvas Business Model: Key Partnerships

You're looking at the alliances Inventiva S.A. (IVA) relies on to push lanifibranor through late-stage development and toward commercialization, which is the core of their current strategy. These partnerships are critical for funding and market access, so the numbers here tell a big part of the story.

The company's strategic collaborations are segmented geographically and financially. For instance, the deal with Chia Tai Tianqing Pharmaceutical Group (CTTQ) covers the Greater China region, while Hepalys Pharma, Inc. handles Japan and South Korea. These regional partners take on local development and commercialization costs, which is a smart way to manage capital.

The financial backing from Structured Financing Investors was essential to keep the NATiV3 pivotal Phase 3 trial moving forward. Here's a look at the key components of the financing and the CTTQ deal that were active in 2025.

The collaboration with Hepalys Pharma, Inc. for Japan and South Korea is structured to offload development expenses in those territories. Inventiva S.A. (IVA) retains a stake in this venture, which is a nice way to keep some upside.

• Inventiva S.A. (IVA) holds a 30% ownership stake in Hepalys Pharma, Inc.
• The upfront payment received from Hepalys Pharma was $10 million.
• Inventiva S.A. (IVA) is eligible for up to $231 million in milestone payments from Hepalys Pharma.
• The Phase 1 trial in Japan began with the dosing of the first participant on February 20, 2025.
• Up to 2.7% of the Japanese population suffers from MASH.

The clinical trial network supporting the NATiV3 study is quite extensive, which is necessary for a global Phase 3 trial in MASH. The completion of enrollment in April 2025 was a major trigger for unlocking financing tranches.

The NATiV3 pivotal Phase 3 clinical trial involves a broad network:

• The trial takes place in approximately 25 countries.
• The network includes more than 350 clinical sites.
• Enrollment for the main cohort was completed on April 1, 2025, with 1009 patients randomized, exceeding the target of 969.
• The exploratory cohort randomized 410 patients, exceeding the target of 350.

Inventiva S.A. (IVA) - Canvas Business Model: Key Activities

You're focused on the execution phase right now, which means every activity needs to be tied directly to delivering the NATiV3 data and securing the next financing milestone. Here's the breakdown of what Inventiva S.A. is actively driving as of late 2025.

Executing the pivotal Phase 3 NATiV3 clinical trial for lanifibranor in MASH

The primary activity is pushing the pivotal Phase 3 NATiV3 trial to its data readout. Enrollment is complete, which was a major trigger for financial events. The focus now shifts entirely to trial maintenance and data collection.

• Enrollment completion for the main cohort was achieved on April 1, 2025.
• The main cohort randomized 1009 patients, exceeding the target of 969.
• The exploratory cohort randomized 410 patients, exceeding the target of 350.
• Top-line results from NATiV3 are anticipated in the second half of 2026.

This trial execution is directly linked to the financial structure. The completion of enrollment supported the unlocking of the second tranche of structured financing.

Preparing regulatory filings (NDA/MAA) for lanifibranor approval post-2026

With enrollment done, the Key Activity shifts to preparing the necessary documentation for submission to regulatory bodies. This requires an expansion of the team focused on this specific task, even as overall headcount is reduced.

• The potential New Drug Application (NDA) submission is targeted for the first half of 2027.
• The pipeline prioritization plan specifically included expanding the program team to prepare for potential filings for marketing approval.

Managing the pipeline prioritization plan and workforce reduction

This activity involves the difficult but necessary restructuring to extend the cash runway. The plan was to focus exclusively on lanifibranor and terminate other research tracks.

The pipeline prioritization involved stopping all preclinical research activities, specifically terminating the YAP-TEAD and NR4A1 programs. The workforce reduction, planned at approximately 50%, began implementation in the second quarter of 2025, with the reduction taking effect on May 23, 2025. This strategic move is designed to fund operations as currently planned until the end of the third quarter of 2026.

Here's a quick look at the financial position supporting this runway:

Protecting and expanding core intellectual property (IP) for pan-PPAR agonists

The core IP protection is managed through ongoing partnership obligations and the general corporate structure, which is reflected in the company's market valuation. The company has devoted substantial efforts to building this portfolio since its inception in 2011.

• The company has an exclusive licensing agreement with Chia Tai Tianqing Pharmaceutical Group (CTTQ) for lanifibranor in China.
• Hepalys Pharma, Inc. holds the exclusive license for Japan and South Korea, financing its own development, including a Phase 1 trial initiated in February 2025.

The market capitalization, a proxy for the perceived value of the IP and pipeline, stood at $0.61B as of December 03, 2025. Finance: draft 13-week cash view by Friday.

Inventiva S.A. (IVA) - Canvas Business Model: Key Resources

You're looking at the core assets Inventiva S.A. (IVA) relies on to drive its value proposition forward, especially as they approach the critical readout from their Phase 3 trial. These aren't just line items; they represent years of specialized work and significant capital deployment.

• Lanifibranor, the proprietary oral pan-PPAR agonist drug candidate: This is the crown jewel. Lanifibranor is the only pan-PPAR agonist in clinical development for Metabolic Dysfunction-associated Steatohepatitis (MASH). The pivotal NATiV3 Phase 3 clinical trial is fully enrolled, having randomized 1009 patients in the main cohort and 410 in the exploratory cohort, exceeding initial targets. Topline results from NATiV3 are anticipated in the second half of 2026. The intellectual property protection for this asset is secured through 2040.
• Cash and cash equivalents of €97.6 million as of September 30, 2025: While the specific September 30, 2025, figure isn't in the latest reports, the most recent reported liquidity position as of June 30, 2025, shows cash and cash equivalents of €146.7 million, which included €24.6 million held in short-term deposits. This financing, bolstered by the €115.6 million gross proceeds from the second tranche of structured financing received in May 2025, currently provides a cash runway planned until the end of the third quarter of 2026.
• FDA Breakthrough Therapy and Fast Track designations for lanifibranor: These regulatory advantages are crucial for expediting development and review. The FDA previously granted Breakthrough Therapy designation in October 2020 and Fast Track designation in September 2019 (later expanded to include MASH with compensated cirrhosis) for lanifibranor in MASH.
• Extensive library of proprietary small molecules and R&D facility: Inventiva S.A. possesses a wholly-owned research and development facility. This facility supports a deep pipeline backed by an extensive library containing approximately 240,000 pharmacologically relevant molecules, of which about 60% are proprietary. However, following a pipeline prioritization plan implemented in Q2 2025, all work on the YAP-TEAD and NR4A1 preclinical programs was terminated to focus exclusively on lanifibranor.

Here's a quick look at the financial foundation supporting these resources as of mid-2025:

The focus is clearly on maximizing the value of lanifibranor. The termination of other preclinical programs shows a sharp prioritization, meaning the R&D facility and the remaining proprietary library are now almost entirely dedicated to supporting the Phase 3 trial and potential future regulatory filings. That runway extending to Q3 2026 gives you a decent window, but you know that clinical trial readouts always carry inherent uncertainty.

Finance: draft 13-week cash view by Friday.

Inventiva S.A. (IVA) - Canvas Business Model: Value Propositions

You're looking at the core value Inventiva S.A. (IVA) is bringing to the table with lanifibranor, especially as we look toward late 2025. It's all about hitting the right targets in Metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis.

• - Potential first-in-class oral pan-PPAR agonist for MASH with advanced fibrosis
• - Unique mechanism addressing all MASH components: fat, inflammation, and fibrosis
• - Addressing a significant unmet medical need in a large global market
• - Oral, small-molecule therapy offering patient convenience over injectables

The drug candidate, lanifibranor, is designed as an orally available small molecule. It's the only pan-PPAR agonist in clinical development for MASH, meaning it activates all three peroxisome proliferator-activated receptor ($\text{PPAR}$) isoforms ($\text{PPAR}\alpha$, $\text{PPAR}\delta$, and partial $\text{PPAR}\gamma$). This mechanism is intended to induce anti-fibrotic, anti-inflammatory, and beneficial vascular and metabolic changes.

The Phase 3 NATiV3 trial is evaluating lanifibranor at dosages of $\mathbf{800mg/daily}$ and $\mathbf{1200mg/daily}$ in patients with biopsy-proven non-cirrhotic MASH and $\text{F2/F3}$ stage of liver fibrosis. The trial has $\mathbf{1009}$ patients enrolled in the main cohort. The goal is to assess MASH resolution and improvement of fibrosis of at least one stage after $\mathbf{72}$ weeks of treatment. This is building on earlier data from the Phase 2b NATIVE trial, which showed NASH resolution and fibrosis improvement after just $\mathbf{6}$ months of treatment.

The market need is defintely large. A 2025 analysis shows the diagnosed MASH population in the US is greater than $\sim \mathbf{1.5M}$ people, with $\sim \mathbf{315K}$ of those patients currently under treater care. US healthcare professionals have stated the greatest unmet need is for oral therapies that improve fibrosis stage without worsening Steatohepatitis. The global non-alcoholic steatohepatitis market is projected to reach $\mathbf{\$48.3}$ billion by the end of 2035.

Here's a quick look at some of the numbers underpinning the development and potential impact:

The convenience factor is key here. Lanifibranor is a novel, once-daily, small molecule. This oral dosing offers a clear advantage over therapies that require injections, which is something patients and physicians value in managing chronic conditions like MASH. Topline results from the pivotal Phase 3 NATiV3 study are anticipated in the second half of $\mathbf{2026}$.

Inventiva S.A. (IVA) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage environment, where every interaction with capital markets, experts, and partners is critical for advancing lanifibranor toward potential commercialization. Here's how Inventiva S.A. (IVA) structures those key external connections as of late 2025.

Dedicated Investor Relations and Analyst Events for Capital Markets

Inventiva S.A. actively engages the capital markets through scheduled events to update on clinical and financial progress. The company hosted a dedicated Analyst and Investor Event on October 8, 2025, in New York City, providing a strategic corporate update ahead of anticipated Phase 3 NATiV3 topline results in the second half of 2026. This event featured presentations from senior management and key opinion leaders.

The company's investor engagement calendar for September 2025 included participation in several key conferences:

• H.C. Wainwright 27th Annual Global Investment Conference (September 9, 2025)
• 8th Edition of the Lyon Pôle Bourse Forum (September 23, 2025)
• KBC Life Sciences Conference (September 25, 2025)
• Stifel 2025 Virtual Cardiometabolic Forum (September 30, 2025)

Financially, the company reinforced its position by announcing a public offering of approximately $125 million (representing approximately €108 million) on November 12, 2025. As of September 30, 2025, Inventiva S.A. reported cash and cash equivalents of €97.61 million and short-term deposits of €24.71 million. This follows a significant capital raise about a year prior, a $400-plus million PIPE, which supported the enrollment of the global Phase 3 NATiV3 trial.

Close Collaboration with Key Opinion Leaders (KOLs) and Clinical Experts

Collaboration with leading clinical experts is central to validating lanifibranor's profile. The October 8, 2025, investor event specifically featured insights from three distinguished key opinion leaders in the MASH field: Nezam Afdhal, MD, William Alazawi, MD, and Henry E. Chang.

Inventiva S.A. has also supported the publication of investigator-initiated and collaborative research throughout 2025, demonstrating ongoing scientific engagement:

The company's focus on data dissemination helps build credibility with the clinical community.

Strategic, Long-Term Relationships with Regional Licensing Partners (CTTQ, Hepalys)

Inventiva S.A. maintains strategic, long-term relationships through exclusive licensing agreements for territories outside its primary focus. The relationship with Chia Tai Tianqing Pharmaceutical Group (CTTQ) for China continues to generate revenue milestones.

Financial contributions from the CTTQ agreement include:

• $10 million milestone payment received in 2024
• $10 million milestone payment invoiced in the first half of 2025
• $5 million (€4.3 million) in credit notes recognized under the agreement in the first half of 2025

For Japan and South Korea, the relationship with Hepalys Pharma, Inc. is structured for shared development and commercialization. Inventiva S.A. holds a 30% ownership stake in Hepalys Pharma. The agreement outlines potential future value:

Operationally, Inventiva S.A. and Hepalys initiated the clinical development program of lanifibranor in Japan on February 20, 2025, with the dosing of the first participant in a Phase 1 trial. Hepalys is responsible for funding all necessary studies for regulatory filing in Japan and South Korea.

Finance: draft 13-week cash view by Friday.

Inventiva S.A. (IVA) - Canvas Business Model: Channels

You're looking at how Inventiva S.A. (IVA) gets its drug development data and moves toward commercialization, which is heavily reliant on partnerships and clinical execution right now.

The primary channel for data generation is the global clinical trial network, which, as of late 2025, has successfully completed a major enrollment milestone for its lead asset.

• Completion of enrollment in the NATiV3 Phase 3 clinical trial occurred on April 1, 2025.
• The NATiV3 main cohort randomized 1009 patients; the exploratory cohort randomized 410 patients.
• Topline data readout from NATiV3 is projected for the second half of 2026.
• A Phase 1 clinical trial in Japan, in partnership with Hepalys Pharma, was initiated with the first dosing in February 2025.
• The internal scientific team has approximately 90 people.
• The company possesses an extensive molecule library of approximately 240,000 compounds, with about 60% being proprietary.

Commercialization channels are currently channeled through exclusive licensing agreements, which provide upfront cash and future milestone potential, defintely shaping the near-term financial runway.

Direct regulatory filings for core markets (US/EU) are the final step in this channel, contingent on the clinical data success.

• The 2024 Universal Registration Document was filed with the AMF on April 15, 2025.
• The 2024 Annual Report on Form 20-F was filed with the SEC on April 15, 2025.
• Positive NATiV3 topline results (expected 2H 2026) are expected to be the basis for submission for regulatory approval.

Inventiva S.A. (IVA) - Canvas Business Model: Customer Segments

You're looking at the core groups that Inventiva S.A. (IVA) must satisfy to bring lanifibranor to market and secure its financial future. This isn't just about the sick; it's about the entire ecosystem that funds and partners with late-stage biotech.

Adult patients with Metabolic Dysfunction-associated Steatohepatitis (MASH) and F2/F3 fibrosis

This is the ultimate end-user, the patient population whose lives Inventiva S.A. aims to improve with its oral small molecule therapy, lanifibranor. The target is specific: adults with MASH who have moderate to advanced liver scarring, which includes the F2 and F3 fibrosis stages. You need to appreciate the sheer scale of this unmet need, especially as approved treatments are just starting to emerge.

Here's a look at the patient burden that defines this segment:

• - MASH affects more than 250 million people worldwide.
• - In the US, the number of patients with MASH and clinically significant fibrosis (stage F≥2) was estimated to increase from 6.7 million in 2020 to 11.7 million by 2050.
• - In Inventiva S.A.'s Phase 2b NATIVE trial, the higher 1200 mg dose of lanifibranor achieved improvement of fibrosis by at least one stage with no worsening of MASH in 42% of patients.

The market size reflects this patient pool. While the global MASH market was valued at US$7.9 billion in 2024, it is forecast to grow at a compound annual growth rate of 17.7% from 2025 to 2033, reaching US$31.8 billion by 2033.

To give you a clearer picture of the target population size relevant to Inventiva S.A.'s focus:

Global pharmaceutical companies seeking regional licensing rights for MASH treatments

For a clinical-stage company like Inventiva S.A., these large pharma entities are crucial partners for global commercialization, especially outside of core territories or for funding late-stage trials like NATiV3. The MASH space is seeing massive capital deployment, which signals high interest from these potential partners.

The competitive landscape shows that big pharma is actively acquiring or partnering for MASH assets:

• - MASH-focused M&A activity reached approximately $70 billion in upfront consideration through October 10, 2025.
• - Three major acquisitions for FGF21 analogs alone totaled $8.3 billion upfront in a short period.
• - Novo Nordisk's acquisition of Akero Therapeutics was valued up to $5.2 billion, including $4.7 billion upfront.
• - Roche committed $2.4 billion for 89bio.
• - GSK paid $1.2 billion for Boston Pharmaceuticals' asset.

This activity suggests that a successful readout from Inventiva S.A.'s NATiV3 trial, with lanifibranor being the only pan-PPAR agonist in development, could command significant regional or global deal terms. The company is advancing two clinical candidates in three indications, backed by a discovery engine with an extensive library of proprietary molecules.

Here's a summary of recent deal values in the MASH space:

Institutional and private investors funding high-risk, high-reward biotech development

These are the financial backers who provide the necessary capital to bridge the gap between promising science and regulatory approval. For Inventiva S.A., this segment has been critical for financing the NATiV3 study.

Financially, Inventiva S.A. has actively managed its cash position to support its development plan:

• - The company reinforced its position with the closing of the €116 million second tranche of structured financing in H1 2025.
• - Net cash generated from financing activities for the first nine months of 2025 was €103.4 million.
• - As of September 30, 2025, cash and cash equivalents stood at €97.6 million.
• - In November 2025, a US public offering brought in aggregate gross proceeds of approximately €149 million.
• - The company estimates this cash position will finance operations until the end of the first quarter of 2027.

Investor sentiment, while acknowledging the R&D burn (Free cash flow was -$77.39 million), remains highly optimistic based on pipeline progress. The company reported revenues of €4.5 million for the first half of 2025.

Analyst expectations reflect this high-reward potential:

Finance: draft 13-week cash view by Friday.

Inventiva S.A. (IVA) - Canvas Business Model: Cost Structure

You're looking at the expenses that keep Inventiva S.A. (IVA) running as they push lanifibranor through its final clinical stages. The cost structure is heavily weighted toward research, which is typical for a clinical-stage biopharma, but you're seeing shifts as they manage their pipeline and workforce.

The biggest line item is definitely Research and Development (R&D), which is the engine for their primary asset. For the first nine months of 2025, R&D expenses totaled €64.6 million. This figure is slightly lower by 11% compared to the same period in 2024, reflecting the pipeline prioritization plan initiated earlier in 2025, which stopped all preclinical research activities.

The bulk of that R&D spend is tied up in the Phase 3 NATiV3 clinical trial evaluating lanifibranor in patients with MASH. You know this trial is critical; enrollment was completed in April 2025, and topline results are now targeted for the second half of 2026. The costs associated with this pivotal study are significant, representing the major ongoing clinical development expenditure for Inventiva S.A. (IVA).

General and administrative (G&A) expenses have seen an increase, which you'd expect when managing dual listings on Nasdaq and Euronext, plus the general overhead of a late-stage company. For the first half of 2025, G&A expenses were €14.7 million, up from €7.7 million in the first half of 2024. This jump was mainly driven by personnel costs.

Speaking of personnel, you should note the workforce management strategy. Inventiva S.A. (IVA) implemented a pipeline prioritization plan that included a planned 50% workforce reduction in non-core areas. Even with this reduction taking effect in May 2025, personnel costs still drove the G&A increase in the first half of 2025, with an increase of €5.7 million, largely related to non-cash share-based compensation expenses of €4.7 million for that same period. It's a balancing act, managing the costs of the core program while streamlining the rest of the organization.

Here's a quick look at the key expense components we have data for:

The overall cash burn reflects these outlays. Net cash used in operating activities for the first nine months of 2025 was €76.3 million, up 20% compared to the same period in 2024. This increase is due to working capital evolution and the net cash impact of that pipeline prioritization plan.

The cost structure is clearly focused on:

• - Completing the NATiV3 Phase 3 trial, which is the primary driver of R&D spend.
• - Managing overhead, including costs associated with the dual listing on Euronext and Nasdaq.
• - Executing the workforce reduction plan to manage personnel costs going forward.

Finance: draft 13-week cash view by Friday.

Inventiva S.A. (IVA) - Canvas Business Model: Revenue Streams

You're looking at the core ways Inventiva S.A. is currently funding its operations as of late 2025, which is heavily weighted toward financing events and prior licensing deals, since the company has no product sales yet. Honestly, this is typical for a clinical-stage biopharma; the revenue isn't from selling pills, it's from hitting specific targets in development.

The immediate, realized revenue streams for the first nine months of 2025 were dominated by cash infusions from financing and milestone achievements related to the CTTQ agreement for lanifibranor in China. For the first half of 2025, Inventiva S.A. recorded revenues of €4.5 million.

Here is a breakdown of the key financial inflows that constitute the current revenue streams:

• - Milestone payments from licensing agreements, such as the $10 million CTTQ payment received in July 2025.
• - Proceeds from structured equity financing, including €115.6 million gross from the second tranche settled in May 2025.
• - Future royalties and product sales (post-2026) if lanifibranor is approved.
• - Research tax credits and grants (Other Income).

The most recent concrete revenue components for the first half of 2025 are detailed below. Note that this revenue figure is distinct from the larger financing proceeds, which are classified under cash flow from financing activities.

The structured financing itself provided a massive boost to the balance sheet, which is a critical, albeit non-recurring, revenue-like event for a company at this stage. The second tranche settlement in May 2025 brought in €115.6 million in gross proceeds, translating to net proceeds of approximately €108.5 million.

Looking ahead, the long-term potential revenue stream hinges entirely on lanifibranor's success. Under the CTTQ License Agreement, Inventiva S.A. is eligible for significant future payments:

• Up to an additional $265 million in clinical, regulatory, and commercial milestone payments.
• Royalties on annual net sales of lanifibranor in licensed territories, structured in the low single digits percentage range, should the drug gain approval post-2026.

For the category of Research Tax Credits and Grants, which typically falls under Other Income, the latest full-year figure available is from 2024, where Other Income amounted to €5.5 million. You'll want to track the 2025 year-end filing to see the updated figure for this non-dilutive funding source.

Finance: draft 13-week cash view by Friday.