Developing innovative therapies in

NASH

Corporate Presentation

April 2024

DISCLAIMER

This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements.

These statements include, but are not limited to, forecasts and estimates with respect to Inventiva's cash resources and potential financing or strategic options and potential counterparties, forecasts and estimates with respect to Inventiva's pre-clinical programs and clinical trials, including design, duration, timing, recruitment costs, screening and enrollment for those trials, including the ongoing NATiV3 Phase III clinical trial with lanifibranor in MASH/NASH, and the results and timing thereof and regulatory matters with respect thereto, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of Inventiva's product candidates, including lanifibranor alone and in combination with empagliflozin in patients with MASH/NASH and T2D, the potential of lanifibranor to address patient needs, the estimated market size and patient population, potential regulatory submissions, approvals and commercialization, Inventiva's pipeline and preclinical and clinical development plans, the expected benefit of having received Breakthrough Therapy Designation from the FDA and NMPA, including its impact on the development and review timeline of Inventiva's product candidates, the potential development of and regulatory pathway for odiparcil, future activities, expectations, plans, growth and prospects of Inventiva and its partners, the expected benefit of Inventiva's partnerships and Inventiva's ability to achieve milestones and receive potential milestones under its partnership agreements. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "would", "could", "might", "should", "designed", "hopefully", "target", "potential", "opportunity", "possible", "aim", and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that Inventiva cannot provide assurance on the impacts of the SUSAR on enrollment or the ultimate impact on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva's ability to obtain financing and to enter into potential transactions, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' product candidate claims, Inventiva's expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require holds and/or amendments to Inventiva's clinical trials, Inventiva's expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH/NASH may not be realized and may not support the approval of a New Drug Application, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's and its partners' control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's and its partners' business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, impacts and potential impacts on the initiation, enrollment and completion of Inventiva's and its partners' clinical trials on anticipated timelines and the state of war between Israel and Hamas and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including global inflation, rising interest rates, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the Universal Registration Document for the year ended December 31, 2023, filed with the Autorité des Marchés Financiers on April 3, 2024, and the Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission on April 3, 2024. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

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Key take-aways

A Phase III asset in NASH

Lanifibranor: only pan-PPAR agonist in

clinical development for NASH

Positive Phase IIb results with statistically significant efficacy on histological NASH resolution andone stage fibrosis reduction

Positive Phase II, Proof-of-Concept, results of LEGEND with lanifibranor/empagliflozin announced in Q1 2024

Mechanism of action addressing all key features of NASH

Breakthrough Therapy Designation granted by FDA and Chinese NMPA

Pivotal Phase III initiated in Q3 2021 with topline results expected H1 2026

Licensing and commercialization agreements in Greater China, Japan and South Korea

(1) MPS: mucopolysaccharidosis ; (2) Trials conducted by GSK prior to Inventiva's founding

A Phase III ready program in

MPS(1)

Odiparcil: a GAG reduction therapy to potentially treat several forms of MPS

Reduces GAG accumulation in multiple organs in MPS VI models. Well-tolerated in MPS VI patients and in 1000s of patients previously tested(2)

Functional improvements to mobility and respiratory function and clinical efficacy signals in both ERT treated patients and ERT-naïve MPS VI patients

MPS VI Orphan Drug Designation granted in the U.S. and in the EU. Rare Pediatric Disease Designation in MPS VI granted in the U.S.

Guidance on path to regulatory submission from FDA with a single Phase II/III trial

Inventiva continues to review potential options to further develop odiparcil which may include pursuing a partnership

R&D Capabilities and Cash

Position

R&D capabilities including wholly- owned 'pharma scale' discovery facilities with a discovery engine focused on nuclear receptors, transcription factors and epigenetic targets

Clinical Ops team in place in Europe and the United States

Strong U.S. and European shareholder base and experienced senior management team

Cash position allowing a runway until the beginning of Q3 2024

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Management team with extensive global experience across all stages of drug development and commercialization

Frédéric Cren, MA/MBA, CEO and Co- Founder

  • Wide expertise within the areas of R&D, marketing, strategy and commercial operations
  • Held senior positions at Abbott, Fournier, Solvay Pharma and The Boston Consulting Group
  • Former member of both Fournier and Solvay Pharma Executive Committees

Pierre Broqua, Ph.D., CSO and Co-Founder

  • Successfully managed numerous research programs leading to the discovery, development and commercialization of innovative compounds, including lanifibranor and Degarelix/ Firmagon®
  • Held several senior research positions at Fournier, Solvay Pharma and Abbott

Jean Volatier, MA, CFO

  • Former Head of controlling at URGO & Financial Director International Operations of Fournier
  • Held various positions as CFO
  • Started his career with PwC in Paris and Philadelphia

Alice Roudot-Ketelers, PharmD, COO

  • Previously in charge of all drug development programs and cross-functional teams in Chemistry, CMC, non-clinical and clinical development up to Phase III at one of the major biotech companies in the NASH field

Michael Cooreman, MD, CMO

  • Gastroenterologist-hepatologist
  • Held global roles in several companies including Takeda Pharmaceuticals, Merck, Mitsubishi Tanabe, ImmusanT and Novartis

David Nikodem, Ph.D., VP U.S. Operations

  • Former buyside portfolio manager and analyst for +15 years in public equities and VC

Pascaline Clerc, Ph.D., EVP Strategy and Corporate Affairs

  • Held global roles in academia, non-profit organization, government and biotech companies

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Oral small molecule-focused discovery engine targeting nuclear receptors, transcription factors and epigenetic modulation

Library of ~240,000 compounds of which

60% proprietary

Wholly-owned 129,000 square foot pharma-like

Expertise: nuclear receptors, transcription factors, epigenetic targets

R&D facilities

Highly experienced R&D team of ~80 people

Clinical and Medical team based in Europe and in the US

Power of discovery engine underpins deep pipeline of clinical and discovery stage assets

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Deep pipeline

Program

Indication

Discovery IND Enabling

Phase I

Phase II

Phase III

Lanifibranor NASH

pan-PPAR

Odiparcil

MPS VI

GAG clearance

Yap-TeadOncology

TGF-βFibrosis

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Key financials and shareholder base

Key financials

ISIN code

FR0013233012 / US46124U1079

Market

Euronext Paris / Nasdaq GM

Shares outstanding

52,477,188

Market cap

Euronext Paris: €173 m

(April 4, 2024)

Nasdaq Global Market: $191m

€35.9m (vs €88.4m as of December

Cash position

31, 2022)(1)

Current expected cash runway until early Q3

(as of December 31, 2023)

2024, including the EIB second €25m tranche

drawn Jan. 18, 2024

Revenues

€17.5m compared to €12.2m for 2022

(as of December 31, 2023)

R&D expenditures

€110m compared to €60.5m in 2022

(as of December 31, 2023)

Shareholder base

Free Float

Founders

25.2%

18.4%

Employees & Others

BVF

2.3%

16.2%

Yiheng

7.4%

Sofinnova

NEA

9.8% Qatar Holding LLC10.8%

9.9%

Analyst coverage

Jefferies

L. Codrington / M. J. Yee

Guggenheim

S. Fernandez

Stifel

A. Samimy

HC Wainwright

E. Arce

Canaccord Genuity

E. Nash

KBC

J. Mekhael

Portzamparc

M. Kaabouni

Gilbert Dupont

P.A. Desir

  1. Cash position also includes: i. short-term deposits recorded in the category "other current assets" in the IFRS consolidated statement of financial position and are considered by the Company as liquid and easily available, ii. the long-term deposit has a two-year term accessible prior to the expiration of the term with a notice period of 31 days and is considered as liquid by the Company.

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Lanifibranor: licensing and commercialization agreement in Greater China, Japan and South Korea

Licensing agreement in Greater China

  • Agreement with CTTQ an affiliate of Sino Biopharm one of the largest Chinese pharmaceutical groups listed in Hong Kong Exchange (HSI composite) with a market cap of c.US$10bn(1) and c.US$4bn of revenue(2) and ranked top 40th pharma globally(3)
  • $17 million of non-dilutive payments received
  • Up to $290 million of clinical, regulatory and commercial milestone payments
  • Tiered royalties from high single-digit to mid-teen double digits on net sales made during the first three years of commercialization and from low to mid-teen double digits starting from year four.
  • CTTQ will bear all costs associated with the trials conducted in Greater China
  • CTTQ to randomize patients into the NATiV3 Phase III clinical trial in mainland China

Licensing agreement in Japan / South Korea

  • Licensing agreement with Hepalys Pharma, Inc. backed by Catalys Pacific, Mitsubishi UFJ Capital, DBJ Capital, and MEDIPAL Innovation Fund
  • $10M upfront payment
  • Up to $231M of clinical, regulatory and commercial milestone payments
  • Tiered royalties from mid double digits to low twenties on net sales
  • Inventiva owns a stake of Hepalys Pharma, Inc. and has an option to acquire all outstanding shares at a pre-agreed multiple of post-money valuation
  • Right of first refusal in the event Hepalys receives an offer to sell the license or rights related to lanifibranor.
  • Hepalys will bear all costs associated with the trials conducted in Japan and South Korea
  • Development includes PK/PD Phase I studies and following phase I and NATiV3 results an independent pivotal Phase III study in Japan and South Korea

Inventiva eligible to more than 500M$ of milestones plus sales royalties

  1. Information about Sino Biopharm, its business, operations and finances are based on third-party information and disclosures. Inventiva makes no representations regarding the accuracy of such information presented herein; (2) Market data as of Sept 2022 ; (3) Converted from RMB to USD

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Lanifibranor in Nonalcoholic Steatohepatitis (NASH)

Lanifibranor: a pan-PPAR agonist in phase III development in NASH

Moderate and balanced pan-PPAR agonist activity

PPARα

PPARβ/δ PPARγ

LANIFIBRANOR

  • Small molecule that activates all three PPAR isoforms in humans
  • Differentiated chemical structure: not a fibrate or a TZD
  • Once daily oral administration
  • Positive Phase IIb trial topline results in NASH
  • FAST Track (including in NASH patients with compensated cirrhosis) and Breakthrough Therapy designations granted by FDA
  • IP: 19 families with last expiry in 2044
    • Composition of matter patent: LOE(1) August 2026 (5-year extension excluded)
    • Method of use patent: LOE(1) June 2035 (5-year extension excluded)

Pan-PPAR activity expected to ensure improved efficacy in MASH/NASH

METABOLISM

STEATOSIS

INFLAMMATION AND

FIBROSIS

VASCULAR

BALLOONING

PPARα PPARδ PPARγ

PPARγ

PPARα PPARδ PPARγ

PPARδ PPARγ

PPARα PPARγ

Insulin sensitivity

FA uptake

NFkB-dependent

Stellate cell

Portal pressure

gene activation

proliferation and

LSEC capillarization

HDLc

FA catabolism

Inflammasome

activation

Triglycerides

Lipogenesis

Collagen and

Intrahepatic vascular

Ballooning

fibronectin production

resistance

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Inventiva SA published this content on 30 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 April 2024 17:44:07 UTC.