On September 27, 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported its financial results for the fiscal fourth quarter and year ended June 30, 2021 (Press release, iBioPharma, SEP 27, 2021, View Source [SID1234590302]).
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"Fiscal 2021 was a transformative period for iBio, highlighted by our entry into oncology and continued progress as a next-gen COVID-19 vaccine developer," said Tom Isett, Chairman & CEO of iBio. "In the fiscal fourth quarter, we established our new oncology drug discovery team in San Diego. Subsequently, we entered into a partnership with FairJourney Biologics that provides us access to proprietary antibodies and announced the addition of three new anti-cancer targets to our pipeline. Then in August, we announced an exclusive license agreement with RubrYc Therapeutics for a second generation anti-CD25 antibody for the treatment of solid tumors. This collaboration also provides us access to RubrYc’s AI-driven antibody discovery platform, which should enable iBio to develop multiple novel immuno-oncology targets. Coupled with our FastPharming and Glycaneering Technologies, we believe iBio is now well positioned to capture discovery and development synergies across these proprietary platforms, enabling us to further build our pipeline of differentiated, next-gen oncology therapeutics."
"Although we are pleased to have executed on our November promise to build a high-value oncology portfolio, we are even more pleased to deliver results in other areas of our Biopharmaceutical segment, especially our next-generation COVID-19 vaccine, IBIO-202. We believe that there is a critical need to design new vaccines that can target regions of the virus aside from the frequently mutating spike protein, in order to address the looming risk of an escape variant. IBIO-202 could potentially represent one such option, given that it targets the more highly conserved nucleocapsid protein of SARS-CoV-2, and in preclinical models of disease, drove robust memory T cell responses. We look forward to updating investors on IBIO-202 after we receive feedback on our pre-IND package, which was submitted earlier this month."
"While we were aggressively building our Biopharmaceutical segment and recruiting our new Management Team in FY21, we also grew our Bioprocess segment. Revenues in the Services business were up 50% over prior year. We also established a new ‘Products’ business unit to further exploit our FastPharming System and capabilities to deliver greener products to researchers and biomanufacturers. All things considered, this past year was one of exceptional achievement towards creating a multifaceted business that fully leverages our technologies and capabilities to help iBio and our customers address unmet medical needs in the fields of oncology, fibrosis, and infectious diseases."
Fiscal Fourth Quarter and Recent Business Developments:
BIOPHARMACEUTICAL SEGMENT
Therapeutics
In June 2021, iBio established a new drug discovery team based in San Diego.
In July 2021, iBio added three new antibody programs to its oncology drug discovery pipeline.
In August 2021, the Company signed a definitive worldwide exclusive license agreement with RubrYc Therapeutics, Inc., for a monoclonal antibody candidate designed to deplete immunosuppressive regulatory T cells from the tumor microenvironment. Additionally, iBio acquired an equity stake in RubrYc along with an option to license antibodies developed with RubrYc’s artificial intelligence ("AI")-based antibody discovery platform.
iBio continues pre-clinical development of IBIO-100. The Company expects to initiate IND-enabling studies during FY2022.
For regulatory and business reasons, the Company discontinued development of its discovery-stage ACE2-Fc project.
Vaccines
In July 2021, the Company reported robust, antigen-specific, memory T-cell responses from preclinical studies of IBIO-202.
In September 2021, iBio submitted a pre-IND package for IBIO-202 with the expectation that a nucleocapsid-based protein subunit vaccine could address several unmet needs that remain with first-generation vaccines targeting the spike protein.
The Company is continuing to develop its Classical Swine Fever Vaccine, IBIO-400, while concurrently seeking regulatory clearances for the animal health markets.
BIOPROCESS SEGMENT
Services
In May 2021, iBio announced that it concluded its lawsuit with Fraunhofer USA, Inc. One outcome of the settlement was that iBio received a $1.8 million fee in exchange for a license to Fraunhofer for use of certain iBio trade secrets relating to the FastPharming System. The Company expects to recognize the license fee as Services revenues in the future. Another outcome of the case was that iBio realized, net of legal fees and other expenses, Settlement Income of $10.2 million.
The Company also announced in May an expanded menu of Bioanalytical Services, including intact protein analysis, new proteomic assays, and middle-down characterization for monoclonal antibodies.
Products
In June 2021, iBio launched a new line of growth factors, cytokines and lectins via its new e-shop. The Company plans to add more FastPharming-produced recombinant proteins to the catalog over time, including monoclonal antibodies for research that are scalable for cGMP bioprocessing uses.
Fiscal Fourth Quarter and Recent Corporate Developments:
Throughout fiscal 2021 and FY22 year-to-date, iBio increased its bench strength and enhanced its leadership team to support its growth strategy. Overall staffing grew by approximately 60% to 87 employees, with new hiring focused in the areas of drug discovery, process development, and finance. Between December and March, the Executive Team was increased from one member to five.
In June 2021, the Company further strengthened its Board of Directors with the appointment of Evert (Eef) Schimmelpennink, who has a strong history of success leading companies with novel protein expression platforms to develop and commercialize biopharmaceutical products.
In August 2021, iBio appointed William D. (Chip) Clark to its Board, adding deep expertise in business management and immuno-oncology. Also in August, Seymour Flug resigned from the Board.
iBio recently presented at the UBS Global Healthcare Virtual Conference and the H.C. Wainwright 23rd Annual Global Investment Conference. Today, the Company is scheduled to participate in a fireside chat at the Cantor Virtual Global Healthcare Conference.
Financial Results:
Revenues for the fiscal year ended June 30, 2021, were $2.4 million, an increase of 50% over fiscal 2020. In the fourth quarter ended June 30, 2021, revenue was $0.5 million, a decrease of $0.6 million from Q4 FY2020, and a decrease of $0.3 million from Q3 FY2021. Significant quarter-to-quarter revenue variability is commonplace for early-stage pharma services companies, given the relatively small number of contracts and timing of revenue recognition. Based upon the current outlook, iBio expects a sequential decline in revenue during the first half of fiscal 2022 compared to the second half of fiscal 2021, followed by higher growth in the second half of fiscal 2022. Irrespective of quarterly fluctuations, continued year-on-year revenue growth is anticipated as the Bioprocess businesses continue to attract interest from organizations wishing to rapidly develop biologics using more sustainable manufacturing methods.
R&D and G&A expenses for the fourth quarter and full fiscal year 2021 increased significantly over the comparable periods in fiscal year 2020. R&D expense was up $6.4 million to $10.0 million in fiscal 2021, with an increase of $2.5 million to $3.1 million in the fourth quarter. G&A expense was up $10.6 million to $22.0 million in fiscal 2021, rising $3.5 million to $6.6 million in the fourth quarter. The growth in R&D and G&A reflects the strategy to invest in iBio’s proprietary biopharmaceutical pipeline and platform technology. Across R&D and G&A, the company invested in additional staff and made external investments to implement its strategy. While iBio expects R&D and G&A will continue to grow in fiscal 2022, it anticipates a slower growth rate compared to fiscal 2021.
In the fourth quarter of fiscal 2021, iBio recorded $10.2 million in Settlement Income, reflecting the value of settlement of litigation with Fraunhofer. While iBio recognized this income in fiscal 2021, actual payment by Fraunhofer will be made in two separate payments of $5.1 million each in March 2022 and March 2023. Fraunhofer also agreed to pay iBio $1.8 million for a license to iBio’s intellectual property. Revenue for that license will be recognized when Fraunhofer pays for the license in two installments of $0.9 million each, expected in March 2022 and March 2023.
iBio’s consolidated net loss for fiscal 2021 ending June 30, 2021, was $23.2 million, an increase of $6.8 million compared to 2020. The increase in consolidated net loss would have been greater except for the Settlement Income of $10.2 million recognized in the fourth quarter of 2021. iBio had a consolidated net gain of $0.1 million in the fourth quarter because of the Settlement Income versus a consolidated net loss in Q4 FY2020 of $3.5 million.
iBio had $97.0 million in cash, marketable securities, and investments in debt securities as of June 30, 2021. iBio used $30.1 million in net cash for operating activities in fiscal 2021 versus net cash used in operating activities of $13.3 million in 2020. Based on current plans, iBio believes the current cash position is sufficient to fund operations through the first calendar quarter of 2023.
Webcast and Conference Call
iBio management will host a webcast and conference call at 8:30 a.m. Eastern Time today, September 27, 2021, 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: 7159935.