On November 10, 2021 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended September 30, 2021 and provided a business update (Press release, Phio Pharmaceuticals, NOV 10, 2021, View Source [SID1234595110]).

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"Our development programs continue to generate positive in vivo data showing how INTASYL technology can be utilized in various applications to treat cancer. These data have generated broad interest in our programs as we prepare to enter the clinic with the initiation of two trials expected in the next couple of quarters," said Dr. Gerrit Dispersyn, President and CEO of Phio. "We expect to initiate our first-in-human clinical study of our lead program, PH-762, in the first quarter of 2022, which will be followed by the first study with PH-762-empowered tumor infiltrating lymphocyte therapy to start in Q2. In addition, we’ve generated a lot of exciting in vivo data in support of the development of our PH-894 compound, showing it provides enhanced immunotherapeutic activity by reprograming T cells and other cells in the TME, and supporting our plans to file for a clinical trial application with the FDA in the second half of 2022."

Quarter in Review and Recent Corporate Updates

Presented positive data from several in vivo preclinical studies demonstrating the flexibility and application of INTASYL in the field of immuno-oncology at leading scientific conferences held during the third quarter of 2021:
Announced new data showing that local treatment in vivo with INTASYL has the potential to cure locally treated and distal untreated tumors and generate systemic tumor immunity that is both durable and tumor specific, further highlighting the technology’s potential in direct therapeutic applications. Data from this study, presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, showed a complete response in up to 83% of the animals treated with a low dose formulation of dual-targeting INTASYL PH-3861 (targeting PD-1 and BRD4).
Introduced new in vitro and in vivo data that showed silencing BRD4 with INTASYL compound PH-894 had a significant impact on T cell function and phenotype promoting T cell activation and immunosuppression in the tumor microenvironment as presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). These new data build upon a growing body of evidence that BRD4 plays a role in tumor cells and can also regulate T cell function, and that PH-894 can reprogram T cells to provide enhanced immunotherapeutic activity.
Completed additional in vivo and in vitro preclinical studies with PH-894, an INTASYL product candidate for direct drug therapy, which showed the potential of INTASYL compounds to modulate the expression of intracellular and/or commonly considered "undruggable" targets, such as epigenetic targets. These data will support our regulatory filings and the Company expects to file a clinical trial application for PH-894 in the second half of 2022.
Upcoming Pipeline Milestones

Expect to initiate a first-in-human clinical study on the direct therapeutic use of PH-762 in patients with advanced melanoma in the first quarter of 2022.
Expect to initiate a first-in-human clinical study on the use of PH-762 and tumor infiltrating lymphocytes (TILs) in adoptive cell therapy (ACT) in patients with advanced melanoma in the second quarter of 2022.
Expect to file a clinical trial application for PH-894 in the second half of 2022.
Additional data publications on the Company’s pipeline programs.
Financial Results

Cash Position

At September 30, 2021, the Company had cash of $26.5 million as compared with $14.2 million at December 31, 2020. The Company expects its current cash will be sufficient to fund currently planned operations to the second quarter of 2023.

Research and Development Expenses

Research and development expenses were approximately $2.8 million for the quarter ended September 30, 2021, compared to approximately $1.3 million for the quarter ended September 30, 2020. The increase in research and development expenses was primarily due to manufacturing costs for the Company’s PH-762 and PH-894 INTASYL compounds and fees for the required preclinical studies in support of the Company’s clinical trials for PH-762 as compared to the same period in the prior year.

General and Administrative Expenses

General and administrative expenses were approximately $0.9 million for the quarter ended September 30, 2021, compared to approximately $1.1 million for the quarter ended September 30, 2020. The decrease is primarily due to a decrease in legal fees partially offset by increased stock-based compensation expense as the Company did not grant equity awards in the same period in the prior year.

Net Loss

Net loss was $3.7 million, or $0.28 per share, for the quarter ended September 30, 2021, compared with $2.3 million, or $0.40 per share, for the quarter ended September 30, 2020. The increase in net loss was primarily attributable to the increase in research and development expenses related to the Company’s preclinical activities in preparation for the start of its clinical trials with PH-762, as described above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of the Company’s capital raise activities as compared to the prior year period.

On November 10, 2021 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the third quarter ended September 30, 2021 (Press release, In8bio, NOV 10, 2021, View Source [SID1234595109]). In addition, the Company provided an overview of recent corporate developments.

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"Our IPO has provided the capital to enable us to advance our clinical programs for INB-100 in leukemia and INB-200 in newly diagnosed glioblastoma (GBM) and other solid tumors as well as progress our preclinical-stage assets," said William Ho, Chief Executive Officer and co-founder of IN8bio. "Both of our clinical programs continue to progress and we took the opportunity during the required safety observation period for the allogeneic INB-100 trial to improve our manufacturing processes and overall gamma-delta T cell yield. We look forward to the continued advancement of our clinical and preclinical programs and to providing updates on them in the future."

Third Quarter Business Highlights & Corporate Updates

In July 2021, IN8bio appointed Emily Fairbairn and Luba Greenwood as two independent members of the Company’s Board of Directors. Ms. Fairbairn is currently a principal of Transcend Partners and was co-founder and CEO of Ascend Capital. Ms. Greenwood serves as Managing Partner of Binney Street Capital LLC, a venture capital fund established by the Dana Farber Cancer Institute, and as CEO of LUCA Biologics.

In August 2021, IN8bio closed its initial public offering, in which it issued and sold 4,000,000 shares of common stock at a public offering price of $10.00 per share. The net proceeds to the Company were approximately $32.3 million, after deducting underwriting discounts, commissions and offering expenses.

In August 2021, IN8bio completed dosing of the first cohort of INB-100, a Phase 1 clinical trial of donor-derived allogeneic gamma-delta T cells in leukemia patients undergoing haploidentical hematopoietic stem cell transplant (HSCT). No severe adverse infusion reactions, cytokine release syndrome, neurotoxicity (or ICANS) or dose-limiting toxicities were observed. Episodes of mild-to-moderate acute skin graft-versus-host-disease (GvHD) responsive to standard therapy have been observed. Additional patients will be enrolled at the first dose-level to further assess these events and any potential relationship to the ongoing positive clinical responses observed in the INB-100 treated patients. Skin biopsies were consistent with the expected pathology in post-HSCT GvHD and the vast majority of immune cell infiltration were alpha-beta T cells. All three patients treated with INB-100 continue in remission with the first two patients beyond 18- and 16-months post-transplant, respectively. The Company continues to expect to report initial results from the first cohort in this Phase 1 trial in 2022, with topline results for all cohorts in 2023.

In September 2021, IN8bio announced the peer-reviewed publication of preclinical results that it believes provides foundational support for the use of its DeltEx Drug Resistant Immunotherapy (DRI) in newly diagnosed GBM. This work, published in Scientific Reports, a Nature Portfolio journal, focused on the use of gamma-delta T cells genetically engineered to be chemotherapy resistant through the addition of an O6-Methylguanine-DNA Methyltransferase (MGMT). Concurrent dosing of DRI cells with temozolomide (TMZ) resulted in a significant improvement in survival outcomes in mice over either monotherapy alone in both classical and mesenchymal primary high-grade gliomas.

In October and November 2021, the Company presented updates on its programs at the 2021 Advanced Therapies Congress and at the 13th Annual Protein and Antibody Engineering Summit (PEGS) Europe.
Upcoming Scientific Presentations

36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), November 10 – 14, 2021.

26th Annual Meeting of the Society of Neuro-Oncology (SNO), November 18 – 21, 2021.
Third Quarter 2021 Financial Highlights

Cash position: As of September 30, 2021, the Company had cash of $40.7 million, compared to $18.0 million as of December 31, 2020. The increase in cash was primarily due to the IPO proceeds, net of cash used by the Company in operations to advance its programs and research and development.

Research & Development (R&D) expense: R&D expense was $1.4 million for the three months ended September 30, 2021, compared to $1.1 million for the comparable prior year period. The increase in R&D expense was primarily due to increased third-party clinical trial related activities and contract manufacturing costs for the ongoing clinical trials and increased personnel-related costs, including salaries, benefits and stock-based compensation.

General and administrative expense: General and administrative expense was $2.0 million for the three months ended September 30, 2021, compared to $0.6 million for the comparable prior year period. The increase was primarily due to increased personnel costs, including salaries, benefits and stock-based compensation and increased legal expenses in anticipation of operating as a public company.

Net loss: The Company reported a net loss of $3.4 million, or $0.25 per basic and diluted common share, for the three months ended September 30, 2021, compared to a net loss of $1.7 million and a net loss attributable to common stockholders of $2.2 million, or $0.60 per basic and diluted common share, for the comparable prior year period.

On November 10, 2021 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the third quarter ended September 30, 2021 (Press release, TapImmune, NOV 10, 2021, View Source [SID1234595108]).

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"This quarter, we continued our momentum in advancing Marker’s Phase 2 trial of MT-401, Marker’s lead MultiTAA-specific T cell therapy, for the treatment of post-transplant acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "We are pleased to announce that the first patients in Marker’s Phase 2 AML trial have been dosed with study drug. Further, we are on track to enroll the first 20 patients of the trial in the fourth quarter, with the first data readout expected in the first quarter of 2022. We look forward to providing year-end updates in a conference call and webcast early next year."

PROGRAM UPDATES

The Company continues to enroll patients and activate clinical sites across the U.S. in Marker’s Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant AML. The trial is expected to enroll approximately 120 patients in the adjuvant setting and 40 patients with active disease at approximately 20 clinical sites.
BUSINESS UPDATES

The Company’s new cGMP manufacturing facility in Houston, Texas is fully operational and is supporting ongoing operations. The facility will also manufacture Marker’s MultiTAA-specific T cell products for future hematological and solid tumor trials, in addition to producing the potential commercial supply of any products, if approved.
In August, the Company announced that it received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Company’s Phase 2 AML trial.
ANTICIPATED PROGRAM MILESTONES

AML Trial Milestones

Enrollment of first 20 patients of the Phase 2 AML trial expected in Q4 2021
Topline readout of Group 2 active disease anticipated in Q1 2022
THIRD QUARTER 2021 FINANCIAL RESULTS

Cash Position and Guidance: At September 30, 2021, Marker had cash and cash equivalents of $48.7 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.
R&D Expenses: Research and development expenses were $6.8 million for the quarter ended September 30, 2021 compared to $4.8 million for the quarter ended September 30, 2020. The increase was primarily attributable to increases in clinical trial and sponsored research expenses and headcount-related expenses due to growth of research and development operations.
G&A Expenses: General and administrative expenses were $3.2 million for the quarter ended September 30, 2021 compared to $2.6 million for the quarter ended September 30, 2020.
Net Loss: Marker reported a net loss of $12.4 million for the quarter ended September 30, 2021, compared to a net loss of $7.4 million for the quarter ended September 30, 2020.

On November 10, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the third quarter and year-to-date for the period ended September 30, 2021 (Press release, Navidea Biopharmaceuticals, NOV 10, 2021, View Source [SID1234595107]).

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Alexander L. Cappello, Chair of Navidea’s Board of Directors, said, "During this time of transition in our leadership, we remain focused on our mission of developing precision immunodiagnostic agents and immunotherapeutics to enhance patient care. We are confident that our strong management team, supported by our experienced and active Board of Directors, can execute on our business plan and fulfill the vision we have for Navidea."

Third Quarter 2021 Highlights and Subsequent Events

Submitted draft Clinical Study Report to the U.S. Food and Drug Administration ("FDA") for the Company’s completed NAV3-31 Phase 2b study in Rheumatoid Arthritis ("RA") as part of the briefing package for an End-of-Phase 2 Type B meeting.
Held an End-of-Phase 2 Type B meeting with the FDA to discuss the Company’s ongoing program in RA and advancement to the pivotal Phase 3 trial September 1, 2021 via conference call.
Opened a third site for enrollment in the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Enrollment is ongoing and biopsy specimens are in the process of analysis.
Nearly completed enrollment in the Company’s NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Arm 1 is 4 subjects from completion and Arm 2 is fully enrolled.
Completed enrollment and imaging data analysis in the investigator-initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Converted the provisional patent application "Synthesis of Uniformly Defined Molecular Weight Mannosylated Dextrans and Derivatives Thereof" to an A1 application on July 9, 2021.
Appointed Alexander L. Cappello and John K. Scott, Jr. to the Board of Directors. Mr. Scott is the Company’s largest shareholder and Mr. Cappello brings over 30 years of banking and public board experience to the Company.
Appointed Thomas F. Farb and Agnieszka Winkler to the Board of Directors. Mr. Farb has over three decades of experience as an investor in and senior executive of numerous life science and information technology companies both in the U.S. and internationally, and Ms. Winkler has extensive professional and board experience with start-up, mid-cap and Fortune 500 companies.
Appointed Michel Mikhail, Ph.D. as Chief Regulatory Officer of Navidea. Dr. Mikhail brings more than 30 years of experience in the pharmaceutical industry and a track record of achievement in research and development ("R&D") and international regulatory affairs at large multinational research-based pharmaceutical companies.
Jed A. Latkin resigned as Chief Executive Officer, Chief Financial Officer and Chief Operating Officer of the Company and as a member of the Company’s Board of Directors. The Company’s Board of Directors has established an Executive Leadership Committee to lead the Company on an interim basis while its next CEO is identified. The Executive Leadership Committee includes Michael Rosol, Ph.D., the Company’s Senior Vice President and Chief Medical Officer; Erika Eves, the Company’s Vice President of Finance and Administration; and Jeffrey Smith, the Company’s Vice President of Operations. The Executive Leadership Committee will work with a newly established Board Oversight Committee, consisting of independent directors Alexander Cappello, Thomas Farb and John K. Scott, Jr.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. We have had a constructive dialogue with the FDA over the results of the completed NAV3-31 Phase 2b trial as well as our proposed plan for the NAV3-33 Phase 3 study, and we continue to prepare for initiation of this trial. We also have active enrollment in the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients, and have near full enrollment in the NAV3-35 normative database study. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."

Financial Results

Total net revenues for the third quarter of 2021 were $96,000, compared to $268,000 for the same period in 2020. Total net revenues for the first nine months of 2021 were $481,000, compared to $695,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by receipt of reimbursement from Cardinal Health 414, LLC of certain R&D costs and the partial recovery of debts previously written off in 2015.
R&D expenses for the third quarter of 2021 were $1.0 million, compared to $1.4 million in the same period in 2020. R&D expenses for the first nine months of 2021 were $3.8 million, compared to $3.7 million in the same period in 2020. The net increase during the year to date was primarily due to net increases in drug project expenses, including increased Manocept therapeutic and Tc99m tilmanocept development costs, offset by decreased Manocept diagnostic development costs. The net increase in research and development expenses also included increased regulatory consulting and general office expenses offset by decreased employee compensation including incentive-based awards.
Selling, general and administrative ("SG&A") expenses for the third quarter of 2021 were $1.5 million, compared to $1.8 million in the same period in 2020. SG&A expenses for the first nine months of 2021 were $5.1 million, compared to $4.9 million in the same period in 2020. The net increase during the year to date was primarily due to increased consulting services related to preparation for European distribution of Tc99m tilmanocept, increased employee compensation including incentive-based awards, increased insurance cost, increased director fees related to additional board members, increased travel costs, increased European license fees, increased general office expenses, and a loss on the third quarter 2021 abandonment of certain intellectual property, offset by decreased legal and professional services, decreased investor relations costs, decreased facilities costs and decreased franchise taxes.
Navidea’s net loss attributable to common stockholders for the third quarter of 2021 was $2.4 million, or $0.08 per share, compared to $3.3 million, or $0.13 per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the first nine months of 2021 was $8.1 million, or $0.28 per share, compared to $8.4 million, or $0.37 per share, for the same period in 2020.
Navidea ended the third quarter of 2021 with $7.2 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. As noted in the Company’s press release dated November 3, 2021, questions will not be taken during the conference call. Previously-submitted questions will be read aloud and answered during the Q&A portion of the conference call, and we may also respond to questions on an individual basis or by posting answers on our website after the call.

A live audio webcast of the conference call will be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On November 10, 2021 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, reported its cash position as of September 30, 2021 and its revenues for the first nine months of 2021 (Press release, Inventiva Pharma, NOV 10, 2021, View Source [SID1234595106]).

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Cash Position

As of September 30, 2021, Inventiva’s cash and cash equivalents stood at €105.7 million, compared to €93.6 million as of June 30, 2021 and €105.72 million as of December 31, 2020.

Net cash used in operating activities amounted to €31.6 million for the first nine months of 2021 compared to (€19.4) million for the same period in 2020. R&D expenses for the first nine months of 2021 were up by 88% compared to the same period in 2020, mainly driven by the costs associated with the preparation and initiation of the NATiV3 Phase III clinical trial with lanifibranor in NASH, and to a lesser extent, by the increase of general and administrative expenses (G&A) expenses (+ 51%) resulting from Inventiva’s dual listing status.

Net cash generated from financing activities for the first nine months of 2021 amounted to €23.9 million, mainly due to the sale of $30 million in gross proceeds of the Company’s ordinary shares in the form American Depositary Shares ("ADS") on September 23, 2021. The sale was made through the Company’s At-The-Market (ATM) program established on August 2, 2021, to existing and new specialized institutional investors. For the same period in 2020, net cash generated from financing activities amounted to €111.6 million, driven by: the issuance of €15 million (gross proceeds) of ordinary shares to certain existing investors in the Company, the entry into €10 million in French state-guaranteed credit agreements with a syndicate of French banks, and the receipt of €94.9 million3 (gross proceeds) following the successful IPO on the Nasdaq Global Market in July 2020.

Over the third quarter of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.0 million.

Considering its current R&D and clinical development programs and excluding additional financial resources that may originate from funding activities, Inventiva’s cash runway will allow the Company to fund its operations through the first quarter of 2023.

Revenues

The Company’s revenues for the first nine months of 2021 amounted to €0.2 million, as compared to €0.3 million for the same period in 2020. As part of its collaboration with AbbVie in auto-immune diseases, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant planned before the end of 2021.

Update on the Phase II clinical trial with lanifibranor in patients with NAFLD and T2D

The Phase II investigator-initiated clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2D) is progressing and Professor Cusi is recruiting the last patients of the trial. However, given the current status of recruitment, the publication of the results is now expected for the second half of 2022, rather than the first half of 2022 as previously communicated.

Next key milestones expected

Webcast with Key Opinion Leaders from the AASLD The Liver Meeting 2021 hosted by Inventiva – scheduled on November 19, 2021
Initiation by AbbVie of the Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis – planned for November 2021
Activation of first clinical sites for Phase IIa combination trial with lanifibranor and SGLT2 inhibitor empagliflozin in patients with NASH and T2D – planned for the first half of 2022
Last Patient First Visit of the NATIV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the second half of 2022
Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of NAFLD in patients with T2D – planned for the second half of 2022
Strategy update on the development of odiparcil – planned for 2022
Upcoming investor conference participation

Stifel Healthcare Conference 2021 – November 16-17, 2021
Jefferies 2021 London Healthcare Conference – November 16-18, 2021
J.P. Morgan Healthcare Conference 2022 – January 10-13, 2021
Upcoming scientific conference presentations

AASLD The Liver Meeting, November 12-15, 2021
Next financial results publication

Full-Year 2021 Revenues and cash position: Monday, February 14, 2022 (after U.S. market close)