On February 14, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported its financial results for the fiscal quarter ended December 31, 2021 and provides a corporate update (Press release, iBioPharma, FEB 14, 2022, View Source [SID1234608065]).

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"We are pleased to report that we have now added six new immuno-oncology assets to our pipeline in the six months since we announced our new drug discovery capabilities," said Tom Isett, Chairman & CEO of iBio. "Our most recent addition progressed the fastest, already advancing into late-discovery stage thanks to our deployment of artificial intelligence design capabilities. We are also leveraging our research on a novel peptide with anti-fibrotic effects into oncology by exploring its possible use in treating solid tumors with a strong fibrotic matrix. Meanwhile, we are in position to move our second-generation COVID-19 vaccine candidate towards the clinic and potentially address many of the unmet needs that remain in the fight against COVID-19 as it transitions to an endemic disease. Overall, we are elated to see in this quarter multiple new pipeline additions and advancements as a result of our recent investments in drug discovery R&D."

Second Quarter and Recent Business Developments:

BIOPHARMACEUTICALS

Vaccines

In light of the waning periods of SARS-CoV-2 immunity provided by commercially available first-generation vaccines that are all based upon the virus’ frequently changing spike protein, the Company is moving forward with IND-Enabling studies of IBIO-202 in an attempt to bring a more durable COVID-19 vaccine to market. Pending the outcome of those studies, iBio plans to file an IND application for its nucleocapsid-based, intramuscularly delivered vaccine candidate with the U.S. Food and Drug Administration before the end of calendar 2022.
iBio is continuing to work with a leading innovator of microarray patch systems to evaluate the feasibility of intradermal delivery of its vaccine candidates.
The Company continues to advance IBIO-400, which has the potential to be the first fully approved vaccine for Classical Swine Fever, an agricultural biothreat that poses a significant risk to domestic food security and the multi-billion dollar U.S. pork export market. The life-phase of the oral immunogenicity study of IBIO-400 has been completed. Next steps will be determined following data analysis.
Therapeutics

To better assist investors in tracking iBio’s progress with its biopharmaceutical candidates, it will now classify its discovery programs into four stages: (1) Early Discovery; (2) Late Discovery; (3) Lead Optimization; and (4), Investigational New Drug ("IND")-Enabling. In that regard, the Company announced today that ‘immuno-oncology Target 3’ and ‘AI-driven immuno-oncology Target 6’ successfully advanced into the Late Discovery stage.
iBio continues to develop its IL-2 sparing anti-CD25 antibody, IBIO-101, on the FastPharming Platform. The Company anticipates the program will advance from Lead Optimization to IND-Enabling before the middle of calendar 2022.
The Company’s endostatin E4 molecule for fibrotic diseases, IBIO-100, is subject to an exclusive, worldwide license to certain patents and related intellectual property granted to it by the University of Pittsburgh. Last week, the parties signed an amended license agreement that extends several milestone-related deadlines. Given the additional flexibility provided by the amended agreement and the effort to balance positive developments with IBIO-202 and its oncology portfolio with cash management objectives, the Company has decided to appropriately pace the progression of IBIO-100 through the Lead Optimization stage.
In November 2021, iBio announced a research collaboration with the University of Texas Southwestern Medical Center to evaluate the potential effects the endostatin E4 molecule may have upon fibrotic tumors in combination with other cancer treatments. Initial data from the collaboration is expected in the second half of calendar 2022.
BIOPROCESS

In November 2021, iBio purchased three assets for approximately $28.7 million from two affiliates of Eastern Capital Limited (the "Eastern Affiliates"). One asset is the Bryan, Texas, FastPharming Manufacturing Facility, which it previously operated under a lease from the Eastern Affiliates. Another is the rights to develop the adjacent land using the ground lease from Texas A&M University. The third asset was the iBio CMO Preferred Tracking Stock held by the Eastern Affiliates, which represented their approximately 30% equity interest in the jointly-owned subsidiary, iBio CDMO LLC, iBio continues to evaluate options with respect to the acquired assets, including a potential sale-leaseback transaction for the facility.
Second Quarter and Recent Corporate Developments:

On January 31, 2022, the Company reconvened its 2021 Annual Meeting to allow more of its stockholders to consider and vote on Proposal 4 (Reverse Stock Split) and Proposal 5 (Change in Authorized Shares). Although approximately 65% and 68% of the votes received were in favor of Proposal 4 and Proposal 5, respectively, the total number of shares voting were insufficient for them to pass.
"We were pleased by the support we received for each of these proposals," said Mr. Isett. "Stockholders who chose to vote their shares did so in favor of Proposals 4 and 5 by a large margin of approximately 2-to-1. We will continue to work on solutions to overcome structural impediments to implementing the will of our voting stockholders and, more broadly, to ensure iBio is in position to continue to grow. In the meantime, we have made a number of adjustments to our operating and development plans in order to achieve our cash management objectives. These changes include deferring a number of planned new hires as well as less aggressively advancing the IBIO-100 program, to name a few. The adjustments will allow us to extend our cash runway by two quarters while still advancing IBIO-202 and other key Biopharmaceutical and Bioprocess initiatives."

Financial Results:

Revenues for the second quarter ended December 31, 2021, were approximately $0.2 million, which was not a significant change from the prior quarter and a decrease of 76% from approximately $0.7 million in the same period of 2020. As is commonplace for early-stage Pharma Services companies, iBio has experienced significant quarter-to-quarter revenue variability, driven by factors such as the number and size of customer contracts, as well as the timing of revenue recognition. As previously communicated, the Company expects revenue growth to return in the second half of fiscal 2022.

R&D and G&A expenses for the second quarter of fiscal 2022 increased 40% and 48%, respectively, over the comparable period in fiscal 2020. This reflects the Company’s growing investments in its pipeline, platform technologies, employees, and related infrastructure. iBio anticipates this trend continuing, however, the rate of growth is expected to moderate over time.

The Company’s consolidated net loss for the second quarter ended December 31, 2021, was approximately $11.9 million, or $0.05 per share, compared to a net loss of approximately $8.2 million, or $0.04 per share, in the same period of 2020.

As of December 31, 2021, iBio had cash and cash equivalents plus debt securities of approximately $57.4 million, excluding $5.9 million of restricted cash. The Company now believes that it has adequate cash to support its activities through September 30, 2023.

Webcast and Conference Call

iBio management will host a webcast and conference call at 4:30 p.m. Eastern Time today, February 14, 2022, to discuss these results and provide a corporate update.

The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 3527478.

On February 14, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported its financial results for the third fiscal quarter ended December 31, 2021 and provided an update on the Company’s operations (Press release, Roivant Sciences, FEB 14, 2022, View Source [SID1234608081]).

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Roivant’s Chief Executive Officer, Matt Gline, noted: "We are looking forward to the upcoming launch of tapinarof this year and to the impact we believe it can have for psoriasis patients. We are also pleased with the continued enrollment in Dermavant’s registrational studies in atopic dermatitis. We remain on track this year to initiate multiple Phase 2 and Phase 3 clinical trials, including at Immunovant and Kinevant, and to expand the ongoing Phase 1/2 trial in MDS patients at newly launched Hemavant. RVT-2001, the lead product candidate at Hemavant, is a great example of our plans for pipeline expansion, which will come from both in-licensing and from our internal computational discovery efforts."

Recent Developments

Hemavant: Roivant has launched a new Vant, Hemavant, which entered into a licensing agreement with Eisai Co., Ltd. for exclusive global rights to the investigational agent RVT-2001, a potential first-in-class small molecule SF3B1 modulator. RVT-2001 has achieved a red blood cell transfusion independence rate of over 30% in 19 patients with lower-risk, transfusion-dependent MDS, 15 of whom had documented prior treatment with lenalidomide and/or hypomethylating agents. Hemavant plans to develop RVT-2001 as an oral therapy for transfusion-dependent anemia in patients with lower-risk MDS, with a robust open-label expansion of the ongoing Phase 1/2 clinical trial for RVT-2001 in the first half of calendar year 2022.
Genevant: The Federal Circuit Court of Appeals rejected Moderna’s appeal of the prior Patent Trial and Appeal Board decision holding all claims of U.S. Patent 8,058,069 patentable. The court also dismissed Moderna’s appeal challenging a similar finding of patentability of certain claims of U.S. Patent 9,364,435 for lack of standing. Together, the decisions confirm the strength of Genevant’s nucleic acid delivery-related patent portfolio.
Dermavant: Dermavant’s NDA submission for tapinarof remains on track, with no expectation of an FDA advisory committee and an assigned PDUFA date in Q2 2022. Dermavant continues to build out its organization, with key commercial leadership in place, and manufacturing remains on track for launch upon FDA approval. In December 2021, results from the PSOARING 1 and PSOARING 2 pivotal trials of tapinarof in plaque psoriasis were published in The New England Journal of Medicine. In January 2022, Dermavant presented patient satisfaction data demonstrating consistently high rates of satisfaction and positive perception of treatment with tapinarof, with 81.1% preferring tapinarof to topical drugs used in the past and 67.8% preferring tapinarof to systemic drugs used in the past.
Aruvant: Punam Malik, M.D., Director of the Cincinnati Comprehensive Sickle Cell Center and Program Leader of the Hematology and Gene Therapy Program at the Cincinnati Children’s Hospital Medical Center, presented data highlighting the clinically meaningful reduction in vaso-occlusive events for participants in the ongoing ARU-1801 Phase 1/2 trial and the unique attributes that contribute to the potency of ARU-1801 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 13, 2021.
Immunovant: In December 2021, Immunovant announced it had achieved alignment with the FDA Division of Neurology 1 to move forward in myasthenia gravis. The Phase 3 trial will include an induction (primary efficacy) period during which Immunovant plans to study doses of 680mg and 340mg of batoclimab delivered weekly by subcutaneous injection, followed by alternative dosing regimens (including potential lower maintenance and higher rescue doses) in subsequent study periods. The trial is designed to address unmet patient needs by leveraging batoclimab’s broad therapeutic window and simple subcutaneous delivery device to provide a differentiated treatment option.
Kinevant: In December 2021, the FDA cleared the IND submitted by Kinevant for a Phase 2 trial evaluating namilumab for the treatment of sarcoidosis.
Lysovant: In January 2022, the FDA cleared the IND submitted by Lysovant for a multiple ascending dose study of LSVT-1701 in patients with complicated Staph aureus bacteremia including infective endocarditis.
Major Upcoming Milestones

Dermavant: Dermavant expects a decision from the FDA on the approval of tapinarof for the treatment of adults with plaque psoriasis in the second quarter of calendar year 2022. Dermavant also expects to report topline data from the Phase 3 clinical trial of tapinarof for the treatment of atopic dermatitis in the first half of calendar year 2023.
Immunovant: Immunovant plans to initiate a pivotal trial evaluating batoclimab for the treatment of myasthenia gravis in 1H 2022, with topline results expected in 2024. Immunovant also plans to re-initiate its programs in thyroid eye disease and warm autoimmune hemolytic anemia in 2022, and to announce at least two new indications by August 2022. Immunovant expects to initiate pivotal trials for two of these four indications in 2022, with a total of three pivotal trials initiating in 2022.
Aruvant: Aruvant expects to announce ongoing new patient and follow up data through 2022 and to initiate its Phase 3 trial for ARU-1801 for the treatment of sickle cell disease in 2023.
Kinevant: Kinevant remains on track to initiate its Phase 2 trial evaluating namilumab for the treatment of sarcoidosis in the first half of calendar year 2022.
Hemavant: Hemavant plans to amend its ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the first half of calendar year 2022, with initial data expected in 2023.
Lysovant: Lysovant remains on track to initiate its multiple ascending dose study of LSVT-1701 in patients with complicated Staph aureus bacteremia including infective endocarditis in the first half of calendar year 2022.
Fiscal Quarter Ended December 31, 2021 Financial Summary

Cash Position

As of December 31, 2021, we had cash and cash equivalents of approximately $2.2 billion.

On February 14, 2022, Roivant entered into a committed equity facility with an affiliate of Cantor Fitzgerald & Co. ("Cantor"). Under the terms of the facility, Cantor has committed to purchase up to an aggregate of $250.0 million in the Company’s common shares from time to time at the request of the Company. This at-the-market-style facility will provide Roivant with the ability to raise additional capital opportunistically in the future.

Research and Development Expenses

Research and development (R&D) expenses were $153.5 million for the three months ended December 31, 2021 compared to $202.3 million for the three months ended December 31, 2020. The decrease was primarily due to reduced consideration for the purchase of in-process research and development through asset acquisitions and license agreements as compared to the comparable prior year period, partially offset by increases in program-specific costs relating to our product candidates, personnel-related expenses, and share-based compensation expense. Non-GAAP R&D expenses were $118.9 million for the three months ended December 31, 2021 compared to $50.8 million for the three months ended December 31, 2020.

General and Administrative Expenses

General and administrative (G&A) expenses were $115.5 million for the three months ended December 31, 2021 compared to $61.9 million for the three months ended December 31, 2020. The increase was largely due to higher share-based compensation expense as compared to the comparable prior year period, primarily as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended December 31, 2020 as the liquidity event requirement had not been met and was not deemed probable of being met. Non-GAAP G&A expenses were $61.4 million for the three months ended December 31, 2021 compared to $47.7 million for the three months ended December 31, 2020.

Net Loss

Net loss for the three months ended December 31, 2021 was $306.1 million compared to $275.6 million for the three months ended December 31, 2020. On a per common share basis, net loss was $0.41 for both the three months ended December 31, 2021 and 2020. Non-GAAP net loss was $157.0 million for the three months ended December 31, 2021 compared to $87.6 million for the three months ended December 31, 2020.

Notes to non-GAAP measures:

(1) Represents share-based compensation expense.

(2) Represents one-time development milestone payments.

(3) Represents one-time in-process research and development expense.

(4) Represents depreciation and amortization expense.

(5) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. This loss (gain) has no direct correlation to the operation of Roivant’s business.

(6) Represents a one-time gain on sale of investment resulting from the merger of Datavant and CIOX Health in July 2021.

(7) Represents the change in fair value of debt and liability instruments, which primarily includes the unrealized loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(8) Represents the one-time gain on termination of the options held by Sumitomo Dainippon Pharma Co., Ltd. to purchase Roivant’s ownership interest in certain Vants (the "Sumitomo Options").

(9) Represents one-time gain on deconsolidation of a subsidiary and the remeasurement of a previously held interest in an unconsolidated entity upon its consolidation.

(10) Represents the estimated tax effect of the adjustments.

The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), unless otherwise noted as non-GAAP. Roivant believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. Management uses certain non-GAAP information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Roivant’s operating results as reported under GAAP. Non-GAAP financial information generally excludes (i) share-based compensation expense and the change in fair value of debt and liability instruments, (ii) consideration for the purchase of in-process research and development through asset acquisitions and license agreements, including upfront cash payments, the fair value of equity liability instruments issued, and the fair value of certain future contingent consideration payments, and (iii) other items that are considered unusual or not representative of underlying trends of Roivant’s business. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the tables above.

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, February 14, 2022 to report its third fiscal quarter ended December 31, 2021 financial results, and provide a corporate update.

To access the live conference call, please dial +1-844-224-1923 (domestic) or +1-214-989-7105 (international) and use conference ID 8648616. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

Upcoming Investor Events

SVB Leerink Global Healthcare Conference on February 17, 2022 at 1:00 p.m. ET
Truist AI Symposium on Tuesday, March 1, 2022 at 10:10 a.m. ET
Cowen Healthcare Conference on Tuesday, March 8, 2022 at 9:10 a.m. ET

On February 14, 2022 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is biologically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported plans to report fourth quarter and full year 2021 financial results on Friday, February 25, 2022, before market open (Press release, Rubius Therapeutics, FEB 14, 2022, View Source [SID1234608066]).

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The company will not be hosting a teleconference in conjunction with its financial results press release.

On February 14, 2022 2seventy bio, Inc. (NASDAQ: TSVT) reported that Steven Bernstein, M.D. will join the company effective today and assume the role of chief medical officer (CMO) (Press release, 2seventy bio, FEB 14, 2022, View Source [SID1234608082]). Also announced today, Susan Abu-Absi, Ph.D. has been appointed chief technology & manufacturing officer at 2seventy bio.

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"We are thrilled to welcome Steve to the 2seventy team as we bring our next-generation cell therapy product engine to the clinic. He brings both experience as a treating heme/oncology physician as well as extensive translational clinical expertise, including a deep knowledge of T-cell biology and immunology," said Nick Leschly, chief kairos officer. "I’m also pleased to share the promotion of Dr. Susan Abu-Absi to chief technology & manufacturing officer, leading 2seventy’s manufacturing and supply chain organization. Susan has already made significant contributions during her time at bluebird and now 2seventy as we continue to build both our collaborative manufacturing network and in-house capabilities. We look forward to both Susan and Steve’s contributions toward the development and delivery of transformational cell therapies for people living with cancer."

"I am excited to join 2seventy during the company’s first full year and am inspired by their patient-driven mission to outmaneuver cancer and provide people with the chance for more time. As a treating physician, I have witnessed firsthand the devastating impact that cancer can have and understand how precious time is to all of us," said Steven Bernstein, M.D., chief medical officer. "I look forward to applying my experience in early clinical development to support the team in evolving the treatment landscape in cell therapy to make a meaningful impact on the lives of patients, their families and care partners."

Steven Bernstein, M.D., has more than 25 years of experience as a treating physician, translational scientist, and pharmaceutical executive. Prior to joining 2seventy, Dr. Bernstein served as Chief Translational Officer at Turnstone Biologics. Before that, he served as Chair, Immuno-Oncology Translational Research and Development, and Head, Integrated Science, at Bristol-Myers Squibb (BMS). Prior to BMS, he was an academic physician scientist most recently at the University of Rochester’s James P. Wilmot Cancer Institute, where he was Professor of Medicine, Co-Director of the Hematological Malignancy and Lymphoma Biology Programs and Co-Principal Investigator of the University of Rochester/Arizona Cancer Center NCI SPORE grant in lymphoma. Dr. Bernstein was a member of the Lymphoma Working Group of SWOG, and the Scientific Advisory Boards of both the Lymphoma Research Foundation and the Leukemia and Lymphoma Society. He has a B.A. from Brandeis University and a M.D. from New York University School of Medicine.

Susan Abu-Absi, Ph.D. has over 20 years of experience in biologics and cell & gene therapy process development and manufacturing. She most recently served as our Senior Vice President and Head of Technical Development & Operations at 2seventy bio. Previously, Susan led the oncology manufacturing organization at bluebird bio, having joined in 2017 as Head of Process and Analytical development and advancing through roles of increasing responsibility during her tenure. Prior to joining bluebird, she spent more than ten years in the Global Product Development & Supply organization at Bristol Myers Squibb supporting clinical and commercial biologics drug substance manufacturing at internal sites and at contract manufacturers. Before BMS, Susan was a member of the Process Sciences organization at Bayer Healthcare in Berkeley, CA. Susan has led several teams developing the manufacturing processes, analytical methods and CMC packages for license applications and has directly contributed to the approval of seven products, including Abecma, Zynteglo, and Skysona. Susan earned a Ph.D. in Chemical Engineering from the University of Minnesota, where she was a National Science Foundation Fellow, and a B.S. in Chemical Engineering, Summa Cum Laude with Honors, from the University of Toledo (Toledo, OH).

On February 14, 2022 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) and other diseases with significant unmet medical needs, reported its cash position as of December 31, 2021, and its 2021 full-year revenues1 (Press release, Inventiva Pharma, FEB 14, 2022, View Source [SID1234608067]).

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Cash Position

As of December 31, 2021, Inventiva’s cash position2 stood at €95.4 million, including €86.6 million of cash and cash equivalents and €8.8 million of short-term deposits, compared to €105.7 million as of September 30, 2021 (comprising only cash and cash equivalent), and €113.0 million as of December 31, 2020, including
€105.7 million of cash and cash equivalents and €7.3 million of short-term deposits, respectively.

Net cash used in operating activities amounted to (€47.7) million for the full year 2021, compared
to (€30.6) million in 2020. Research and Development expenses for 2021 doubled at €48.5 million compared to €23.7 million for 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 in the second half of 2021, and to a lesser extent, by the 31% increase of general and administrative expenses from 2020 primarily resulting from Inventiva’s first full fiscal year as a dual listed company in 2021.

Net cash used in investing activities (excluding the increase in short-term deposits of €1.4 million in 2021 and €7.7 million in 2020) amounted to (€0.5) million for the full year 2021, a slight decrease compared to (€0.9) million in 2020.

Net cash from financing activities for the full year 2021 amounted to €25.4 million, mainly due to the sale of $31.5 million (or €27.2 million3) in gross proceeds of the Company’s ordinary shares in the form American Depositary Shares on the second half of 2021. The sales were made through the Company’s At-The-Market 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 €111.7 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 million (gross proceeds) following the successful initial public offering on the Nasdaq Global Market in July 2020.

In 2021, the Company recorded a positive exchange rate effect on cash and cash equivalents of €5.0 million.

Considering its current R&D and clinical development programs and excluding any potential additional financial resources that may originate from funding activities, the Company estimates that its cash, cash equivalents and short-term deposits will allow the Company to fund its operations through the first quarter of 20234.

Revenues

The Company’s revenues for the full year 2021 amounted to €4.2 million compared to €0.4 million in 2020 primarily due to the payment to the Company of €4.0 million for a milestone reached at the end of 2021, and received on January 31, 2022, following the launch by AbbVie of the Phase IIb clinical trial with cedirogant in the fourth quarter of 2021. As part of its collaboration in auto-immune diseases on cedirogant with AbbVie, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments.

Next key milestones expected

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

11th Annual SVB Leerink Global Healthcare Conference, February 16, 2022
Cowen 42nd Annual Health Care Conference, March 7, 2022
Invest securities Biomed Event, March 8, 2022
H.C. Wainwright Annual Global Life Sciences Conference, May 23-25, 2022
Jefferies 2021 Healthcare Conference, June 8-10, 2022
Upcoming scientific conference presentations

International Conference on Fatty Liver – April 28-30, 2022

Next financial results publication

Full-Year 2021 financial results: Monday, March 7, 2022 (after U.S. market close)