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Thorough DD $IBIO
Who is IBIO?
- IBIO is an innovator biologics company developing therapeutics and vaccines for the betterment of human and animal health, including a virus-like particle (VLP) -based vaccine against SARS-CoV-2.
- IBio’s subsidiary, iBio CDMO is a global leader in plant-based manufacturing. Its FastPharming and FastGlycaneering platforms provide contract development and manufacturing services via its 130,000-square foot facility in Bryan, Texas.
- The speed and scalability of FastPharming make it an ideal choice for other innovator. companies who want to rapidly produce COVID-19 biologics.
- IBio is a full-service biologics CDMO equipped to take you from pre-clinical development through regulatory approval, to commercial product launch.
- Dedicated to maintaining the effectiveness of the quality system, complying with applicable regulatory requirements and exceeding customer expectations by delivering quality products through process management and continual improvement.
- Fast. Shortens the timelines to the clinic and can move a program from gene sequence to protein production in as little as 3 weeks.
- Economical. No Expensive, labor-intensive, and costly cell line development.
- Quality. Production of consistent therapeutics that are well-accepted by global regulatory bodies.
- Scalable. No time-consuming scale-up challenges.
- Safe. Mammalian viruses can’t grow in plants; Ibio’s plant-based production platform minimizes contamination risks.
- No animal products or animal-derived components are used at any point.
- No Inherent adventitious agents and no competency for agent replication.
- Demands are as high as ever for technologies that can support production of complex glycoproteins.
- N-linked glycosylation is a critical post-translational modification to an original, naked protein that influences biological activity, protein conformation, stability, solubility, secretion, pharmacokinetics (PK), and antigenicity.
- Can provide the power, speed and control needed to develop next-gen monoclonal antibodies, bio-betters, and fast-follower products.
- Consistency. Ibio’s N. benthamiana expression system delivers products with inherently greater homogeneity versus traditional platforms:
- Bacteria do not glycosylate. Yeast hyper glycosylate, and Chinese hamster ovary (CHO) cell lines do not precisely mimic human glycosylation patterns.
- Plants do not naturally attach α1,6-fucose, terminal β1,4-galactose residues or any sialic acid residues, leading to simpler, more homogeneous N-linked glycosylation patterns.
- Afucosylation. Desirable afucosylated G0, G1, and G2 side chains can be engineered via the removal of plant-specific sugars (core α1,3-fucose and β1,2-xylose) and the addition of terminal β1,4-galactose residues to enhance effector functions, especially antibody-dependent-cell-mediated cytotoxicity (ADCC).
- Oligomannose Modification. FastGlycaneering enables the production of glycoproteins exclusively decorated with oligomannose residues without altering the amino acid sequence of the target protein. This can be useful for the development of lysosomal enzymes, proteins with a high clearance rate, or certain effector functions.
- IBIO-100 (Human Health)
- Ibio’s therapeutic candidate for the treatment of systemic scleroderma, pulmonary fibrosis, and other fibrotic diseases.
- It has been granted orphan-drug designation by the FDA for treatment of systemic sclerosis.
- IBIO-100 is a fusion of the endostatin derived E4 antifibrotic peptide to the hinge and heavy chain of human IgG1.
- This fusion is produced using Ibio’s proprietary FastPharming transient plant expression technology and has achieved significant reductions in fibrotic systems in both cellular and animal models.
- IBIO-200 (Human Health)
- A virus-like particle (VLP) based vaccine for COVID-19 disease caused by the SARS-CoV-2 strain of coronavirus.
- VLP based vaccines are known to interact with immune cells differently than soluble antigens and can trigger both humoral and cellular responses.
- IBIO-200 was designed to maximized uptake by antigen presenting cells in order to increase the overall immune response.
- A SARS-CoV-2 derived antigen is fused to a self-assembling protein partner to generate the VLP.
- The antigen is displayed in a repetitive structure and the geometry, and the particle is decorated with oligomannose molecules to resemble the structure of a naturally occurring virus.
- FastPharming delivers a tightly controlled particle size which offers many quality and scale up advantages given that the uniform antigen display enables better dose definition and higher product yields.
- IBIO-201 (Human Health)
- A second SARS-CoV-2 vaccine candidate.
- Based on a subunit platform that combines antigens derived from the SARS-CoV-2 spike protein fused with Ibio’s patented lichenase booster molecule (“LicKM”).
- Designed to enhance immune responses.
- Subunit vaccines have a proven track-record in protecting humans against deadly diseases, however, one of the challenges is that they often require the use of an adjuvant to boost their immunogenicity.
- Additionally, they are often insufficiently stable to be formulated into a vaccine.
- iBio has addressed both of these issues with the use of LicKM, a modified thermostable variant of the lichenase protein from Clostridium thermocellum.
- LicKM fusion proteins can strengthen the initial immune response to the antigen (as measured by antibody titer) and extend the duration of the immune response, thus lowering vaccine antigen dose requirements or enabling fewer doses to establish prolonged immunity.
- As a result, antigens fused to LicKM generally demonstrate stronger immune responses and promote long-lasting immunity.
- Fusing the SARS-CoV-2 spike protein antigens with iBio’s LicKM technology may be advantageous in achieving prolonged immune response against COVID-19, while enabling unmatched scalability for a population-wide immunization program through FastPharming capabilities.
- IBIO-400 (Animal Health)
- A Classical Swine Fever Vaccine:
- Classical Swine Fever (CSF) is a contagious, often fatal, disease affecting both feral and domesticated pigs.
- Outbreaks in Europe, Asia, Africa, and South America have impacted animal health and food security.
- Severe socio-economic impacts on both the pig industry worldwide and small-scale pig farming.
- In collaboration with the Institute of Infectious Animal (IIAD) at Texas A&M University and Kansas State University.
- Developing a safe and effective DIVA-capable subunit vaccine using FastPharming.
- Studies have shown after single-dose vaccination, the adjuvant, plant-made CSF E2 subunit vaccine provides complete protection in challenged pigs and is accompanied by strong virus neutralization antibody responses.
Advantages of IBIO-400
- Reduced Costs. Producing a subunit vaccine in plants saves time and money.
- Efficacy. Studies showed protection after a single dose.
- Safety. All vaccinated animals were protected from CSF clinical signs.
- DIVA. Provided through the absence of Ems response.
- Flexibility. Potential for use in bait for feral hogs (natural virus reservoirs) without substantial purification, unlike live attenuated vaccines.
- Adaptability. Possible rapid adaptation to regional strain variations and emerging novel subgenotypes.
- Sylvain Marcel, Ph.D.
- Vice President of Protein Expression Sciences.
- Ph.D. in plant cell and molecular biology at the RWTH University – Fraunhofer Institute, Aachen, Germany.
- Joined team of Dr. Barry Holtz in 2010 to develop and implement midstream manufacturing protocols during the construction and operation of the Caliber bio-therapeutics manufacturing facility.
- Over 17 peer reviewed articles published in the field of plant biotechnology.
- Holds one patent related to a glycan remodeling technology.
- Brian R. Berquist, Ph.D.
- Vice President of Downstream Process Development and Manufacturing.
- Prior to career with iBio, Dr. Berquist was a research assistant professor in the College of Medicine at the Texas A&M Health Science Center investigating aspects of Eukaryotic DNA replication and repair.
- Earned a doctorate in Molecular Medicine from University of Maryland School of Medicine.
- Post-Doctoral studies in the Lab of Molecular Gerontology at the National Institute of Aging, a part of the National Institutes of Health.
- Authored more than 25 peer-reviewed papers and book chapters.
- Jack Owens
- 10+ years of experience working at facilities that use plant-based transient expression systems for recombinant protein production. Experience includes:
- Facility Design
- Development of Quality Management Systems
- Method Development
- Owens professional experience includes work in regulated environments that are both cGMP and ISO compliant.
- Market Cap: $658.88 million
- Outstanding Shares: 119.8 million
- Float: 101.8 million
- % held by insiders: 8.78%
- % held by institutions: 11.56%
- Shares Short: 4.03 million
- As of March 31, 2020, the Company’s accumulated deficit was $146.9 million.
- For the 9 months ended March 31, 2020, the Company’s net loss was approximately $12.9 million and it had cash used in operating activities of $9.5 million.
- On May 1, 2020, the Company paid off the total balance on the notes payable of $1,196,000.
- As of March 31, 2020, cash on hand totaled approximately $10.0 million as compared to $4.4 million as of June 30, 2019.
- Gross revenue for Fiscal 2020 and Fiscal 2019 were approximately $96,000 and $527,000, respectively, a decrease of approximately $431,000.
- The decrease is primarily attributable to the timing of income earned under the strategic relationship with CC-Pharming Ltd. of Beijing, China (“CC-Pharming”) for the joint development of products and manufacturing facilities for the Chinese biopharmaceutical market, utilizing iBio’s technology. Revenue earned from CC-Pharming totaled approximately $75,000 in Fiscal 2020 versus $467,000 in Fiscal 2019. Revenue earned from other third-party customers in Fiscal 2020 totaled approximately $20,000 versus $60,000 in Fiscal 2019.
· A few very important quotes from the 10-Q filed 05/15/2020
· “To become and remain profitable, the Company must succeed in commercializing its technologies, alone or with its licensees
, the service offerings provided by its CDMO facility, and in developing and eventually commercializing products that generate significant revenue. In addition, profitability will depend on continuing to attract and retain customers for the development, manufacturing and technology transfer services offered by the Company.”
· “Based on the total cash on hand of approximately $10.0 million as of March 31, 2020, combined with subsequent purchases of the Company’s common stock by Lincoln Park through the date of the filing of this report totaling approximately $10 million, we believe the Company has adequate cash on hand to support the Company’s activities for at least one year from this report date.”
I am bullish medium/long term on IBIO if they can mange to effectively license their technology platforms as well as continue to further research and develop their vaccination candidates. IF either IBIO 200 and/or 201 show positive results soon in combating SARS-CoV-2, this is could lead to government funding (possible OWS) as the ability to mass produce 500 million vaccines annually on their own is huge. They have burned through a good bit of cash and are reliant on some key factors, but overall with the direction the world is going and the increased popularity/demand for vaccines, I am positive on the future outlook of IBIO for now.
I own a position of 200 shares @ 5.29 and plan to hold until a SP of $15-20
Hope everyone enjoys and as always I invite comments, concerns, and additional information I missed. Best of luck to everyone with their trades and have a great weekend!
submitted by ntidwell98