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Inventiva reports cash position and revenues for Full-Year 2021

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)

Rubius Therapeutics to Announce Fourth Quarter and Full Year 2021 Financial Results

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]).

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

iBio Reports Fiscal Second Quarter 2022 Financial Results and Provides Corporate Update

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]).

"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.

MacroGenics Announces Date of Fourth Quarter 2021 Financial Results Conference Call

On February 14, 2022 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the fourth quarter of 2021 after the market closes on Thursday, February 24, 2022 (Press release, MacroGenics, FEB 14, 2022, View Source [SID1234608064]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, February 24, 2022, at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 1067087.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

Invitation to presentation of Isofol’s year-end report 2021 on February 24, 2022

On February 14, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL) ("Isofol"), reported that it will publish the company’s year-end report 2021 on Thursday, February 24, 2022 (Press release, Isofol Medical, FEB 14, 2022, View Source [SID1234608063]). On the same day, Isofol invites investors, analysts, and media to an audiocast with a subsequent question time.

In conjunction with the publication of the year-end report 2021, Isofol invites investors, analysts, and media to an audiocast on February 24, at 11:00 a.m. CET. The presentation will be held by Isofol´s CEO Ulf Jungnelius and CFO Gustaf Albèrt, who will present and comment the report, followed by a Q&A-session. The presentation will be held in English.