iBio, Inc. (NYSE: IBIO) is a leader in developing plant-based biopharmaceuticals, providing a range of product and process development, analytical, and manufacturing services at the large-scale development and manufacturing facility of its subsidiary iBio CDMO, LLC. in Bryan, Texas.
On October 16th, the company announced the establishment of an agreement with Aethlon Medical, Inc. (AEMD) to support the potential large-scale production of the Aethlon Hemopurifier® blood purification device. Aethlon Medical is a therapeutic technology company focused on unmet needs in global health and biodefense.
The goal and synergies of the “Aethlon-iBio” collaboration are, to advance large-scale production of a recombinant form of Galanthus nivalis agglutinin (GNA), a plant-derived lectin that is immobilized within the Hemopurifier® to bind infectious enveloped viruses. Aethlon further disclosed that it completed a feasibility study with iBio researchers that has confirmed the ability to produce highly active recombinant GNA through the use of iBio’s plant-based technology.
In collaboration with leading government and non-government research institutes, Aethlon has validated the ability of the Hemopurifier® to capture a broad-spectrum of pandemic influenza viruses, mosquito-borne viruses, and deadly hemorrhagic viruses. Based on its use to treat Ebola virus, the Hemopurifier® was named a “Top 25 Invention” and one of the “Eleven Most Remarkable Advances in Healthcare,” by TIME Magazine.
As per management, Aethlon’s clinical success and product development expertise is now backed by IBIO’ cGMP compliant therapeutic protein production capacity and expanded classified manufacturing space. This is an ideal combination for Aethlon to deliver a new therapeutic approach to pandemic disease and biothreats.
The surge in demand for novel drug development to meet new or persistent chronic illnesses, as well as the ongoing need for biotech drugs, are key growth drivers for the positive outlook for the biotech industry over the near to medium term.
Several pharma analysts are projecting for the entire industry, a significant growth of above 43% over the next few years. Therefore, given these promising developments, it is now the appropriate time to consider IBIO, who is leading its competitors in the industry.
In fact, driven by the notable news and events, price targets for the company were raised by the analyst firms and the current consensus price is $0.50.
About IBio: iBio applies its technology for the benefit of its clients and the advancement of its own product interests. The Company’s pipeline is comprised of proprietary candidates for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, based on the Company’s proprietary gene expression technology, is the Company’s lead therapeutic candidate being advanced for IND development.
IBIO-CFB03 Fibrosis Therapeutic Product Candidate:
Preclinical Data for IBIO-CFB03 Indicates Ability to Stop or Even Reverse Fibrosis
Data published in 2012 by Dr. Feghali-Bostwick demonstrate that specific endostatin-derived peptides are useful for both inhibition and reversal of fibrosis in preclinical mouse models of fibrosis, as well as in human skin.
iBio has produced the active pharmaceutical ingredient using its patented iBio Technology and has made the clinical development of this promising product a key priority.
The company is working steadily towards filing an IND for IBIO-CFB03, and are encouraged by its progress. During this year, it obtained Orphan Drug Designation from the FDA and achieved key development milestones concerning the Company’s lead candidate CFB03, including:
- Development of an improved cGMP manufacturing process allowing iBio to move forward on completing the CMC (Chemistry, Manufacturing, and Controls) section for its upcoming Investigational New Drug (IND) application to the FDA;
- Completion of initial preclinical pharmacokinetic and toxicology studies; and
- Expansion of preclinical research beyond previously announced systemic scleroderma and pulmonary fibrosis models to include liver, kidney, corneal, and cardiac fibrosis as potential additional clinical indications.”
Global Market Opportunity: Global biologics market is expected to grow at 11% CAGR to $221 billion by 2017
Other Recent Developments and Strategic Initiatives:
The company recently announced the appointment of James Abbey, Ph.D. as Vice President of Strategic Business Development He has a proven track record of successfully executing domestic and international strategic business development collaborations. Adding James’ capabilities to IBIO’s recently-achieved capacity for multiple, concurrent product development projects at cGMP quality is expected to accelerate the growth of its CDMO business.
On September 19, 2017, iBio received US patent serial number 9,765,349 entitled “SYSTEM FOR EXPRESSION OF GENES IN PLANTS” from the U.S. Patent and Trademark Office. iBio is actively pursuing further development of new inventions in both the product and technology categories at its iBio CDMO laboratories in Texas and in collaboration with high-quality collaborators. The Company intends to pursue appropriate U.S. and international patent protection for these inventions and will also maintain trade secret protection for certain innovations it prefers to keep confidential.
On September 18th, IBIO announced the partnership with TheoremDx, Inc., in Edina, Minnesota, to develop proteins for rapid diagnostic testing products. The collaboration will leverage the TheoremDx point-of-care diagnostic system and the protein development and manufacturing capabilities of iBio.
Financial results:
Gross revenue for 2017 and 2016 was $394,000 and $948,000, respectively, a decrease of $554,000. Revenue has been attributable to technology services provided to Fiocruz in connection with the development by Fiocruz of a yellow fever vaccine using our iBioLaunch™ technology.
IBIO’ have incurred significant losses and negative cash flows from operations since its spin-off from Integrated BioPharma, Inc. in August 2008. As of June 30, 2017, the accumulated deficit was approximately $72.1 million, and the company used approximately $13.2 million of cash for operating activities for Fiscal 2017. As of June 30, 2017, cash on hand is approximately $8.1 million.
As of June 30, 2017, IBIO had cash of $8.1 million as compared to $23.0 million as of June 30, 2016. Cash at June 30, 2016, included the remaining proceeds received from stock purchase agreements from Eastern and the contribution for the formation of iBio CDMO of $15 million.
Key risk factors and potential stock drivers:
The progress towards filing an IND for IBIO-CFB03.
The progress on large-scale production of Galanthus nivalis agglutinin (GNA).
Improvement in the ongoing cash burn rate
The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. Therefore, company’s business profile is subject to the competitive landscape and changing dynamics of the industry.
IBIO has incurred significant losses since its inception. Furthermore, it is expected to suffer losses during next fiscal year, and it will need substantial incremental funding. Therefore, timely financial closure would continue to remain a critical stock sensitivity factor for the company
Also, raising additional capital may cause dilution to existing stockholders.
Stock Chart:
- On Friday, October 20th, 2017, IBIO closed at $0.374 on an above average volume of 1.13 million shares exchanging hands. Market capitalization is $34.70 million. The current RSI is 66.63
- In the past 52 weeks, shares of IBIO have traded as low as $0.26 and as high as $0.56
- At $0.359, shares of IBIO are trading above its 50-day moving average (MA) at $0.31 and above its 200-day MA at $0.37
- The present support and resistance levels for the stock are at $0.35 & $0.40 respectively.
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