U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): March 18, 2020 (March 18, 2020)
iBio, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or jurisdiction of incorporation or organization)
001-35023
(Commission File Number)
26-2797813
(I.R.S. Employer Identification Number)
600 Madison Avenue, Suite 1601, New York, NY 10022-1737
(Address of principal executive offices (Zip Code)
Registrant's telephone number: (302) 355-0650
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
¨ Emerging growth company
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Ticker symbol(s) | Name of each exchange on which registered | ||
| Common Stock | IBIO | NYSE American |
| Item 8.01 | Other Events. |
On March 18, 2020, iBio, Inc. (the “Company” or “iBio”) issued a press release announcing its progress towards developing vaccine candidates for preventing infection from the SARS-CoV-2 virus that causes the COVID-19 coronavirus disease. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
iBio created its SARS-CoV-2 Virus-Like Particle (“VLP”)-based constructs using its FastPharming System™ to produce the nanoparticles in, and purify them from, plants. The manufacturing platform not only provides for rapid development of research quantities of product, but also high-quality material that is readily scalable for producing doses for clinical trials and commercial use.
As previously disclosed in the Company’s Current Report on Form 8-K filed on March 13, 2020, iBio filed four provisional patent applications with the U.S. Patent and Trademark Office in support of the VLP platform, as well as other technologies for treating or preventing infections with the SARS-CoV-2 virus.
| Item 9.01 | Exhibits. |
| 99.1 | Press Release, dated March 18, 2020 issued by iBio, Inc. |
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| IBIO INC. | ||||
| Date: March 18, 2020 | By: | /s/ Thomas F. Isett | ||
| Name: | Thomas F. Isett | |||
| Title: | Chief Executive Officer and Executive Co-Chairman | |||
Exhibit 99.1
iBio Announces Development of Proprietary COVID-19 Vaccine Candidates
- Several Provisional Patents Filed with USPTO -
NEW YORK / March 18, 2020 / (GLOBE NEWSWIRE) / iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”), a biologics contract manufacturing organization and biotechnology company, today announced its progress towards developing vaccine candidates for preventing infection from the SARS-CoV-2 virus that causes the COVID-19 coronavirus disease.
iBio created its SARS-CoV-2 Virus-Like Particle (“VLP”)-based constructs in just a few weeks using its FastPharming System™ to produce the nanoparticles in, and purify them from, plants. The manufacturing platform not only provides for rapid development of research quantities of product, but also high-quality material that is readily scalable for producing doses for clinical trials and commercial use.
On March 11, 2020, iBio filed four provisional patent applications with the U.S. Patent and Trademark Office in support of the VLP platform, as well as other technologies for treating or preventing infections with the SARS-CoV-2 virus.
“We are pleased with both the speed of our development activities and the quality of the VLPs our technology is yielding in practice,” said Tom Isett, Co-Chairman & CEO of iBio. “The tightly controlled particle size allows for uniform antigen display, which should translate to a consistent dose response and a highly efficient production process, facilitating a ramp-up to tens of millions of doses if we are successful in the clinic.”
Originally built in 2010 with funding from the Defense Advanced Research Projects Agency (DARPA), part of the U.S. Department of Defense, iBio’s FastPharming Facility was part of the “Blue Angel” initiative to establish facilities capable of rapid delivery of medical countermeasures in response to a disease pandemic. The factory is equipped with automated hydroponics and vertical farming systems for the production of a wide array of biological medicines using a relative of the tobacco plant as the “bioreactor.”
“I am optimistic about the potential of our COVID-19 vaccine program,” said Dr. Sylvain Marcel, iBio’s VP of Protein Expression Sciences. “In addition to our core VLP production capabilities, we are coating VLPs with oligomannose so that their glycosylation profile closely resembles that of naturally occurring SARS-CoV-2 viruses. This may allow for more efficient uptake of the vaccine by human antigen presenting cells via their mannose receptors. If so, it could result in enhanced protection against SARS-CoV-2. We look forward to providing further updates on our progress as developments unfold.”
About iBio
iBio, Inc., is a global leader in plant-based biologics manufacturing. Its FastPharming System™ combines vertical farming, automated hydroponics, and glycan engineering technologies to rapidly deliver gram quantities of high-quality monoclonal antibodies, vaccines, bioinks and other proteins. The Company’s subsidiary, iBio CDMO LLC, provides FastPharming Contract Development and Manufacturing Services via its 130,000 square foot facility in Bryan, Texas. Originally built in 2010 with funding from the U.S. Defense Advanced Research Projects Agency (DARPA), iBio’s FastPharming Facility was part of the “Blue Angel” initiative to establish facilities capable of rapid delivery of medical countermeasures in response to a disease pandemic. iBio CDMO enables innovators to use the FastPharming System for insourced manufacturing with Factory Solutions “design-and-build” services. iBio’s FastGlycaneering Development Service™ includes an array of new glycosylation technologies for engineering high-performance recombinant proteins. Additionally, iBio is developing proprietary products which include IBIO-100 for the treatment of fibrotic diseases. For more information, visit www.ibioinc.com.
FORWARD-LOOKING STATEMENTS
STATEMENTS INCLUDED IN THIS NEWS RELEASE RELATED TO IBIO, INC. MAY CONSTITUTE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. SUCH STATEMENTS INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES SUCH AS COMPETITIVE FACTORS, TECHNOLOGICAL DEVELOPMENT, MARKET DEMAND, AND THE COMPANY'S ABILITY TO OBTAIN NEW CONTRACTS AND ACCURATELY ESTIMATE NET REVENUES DUE TO VARIABILITY IN SIZE, SCOPE, AND DURATION OF PROJECTS. FURTHER INFORMATION ON POTENTIAL RISK FACTORS THAT COULD AFFECT THE COMPANY'S FINANCIAL RESULTS CAN BE FOUND IN THE COMPANY'S REPORTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
Contact:
Stephen Kilmer
Investor Relations
(646) 274-3580
skilmer@ibioinc.com