 | Aursos,inc. Executive Summary
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Aursos (www.aursos.com) is a biotechnology company leveraging the evolutionary advantages the black bear has developed
over millions of years to escape the debilitating effects of osteoporosis and other bone related diseases. Black bears hibernate
for 6 months each year without loss of bone density whereas humans placed on bed rest due to age, surgery or an accident can
show detectable bone loss in just 14 days. Black bears have developed a mechanism to maintain bone mass while inactive, while
inactivity in humans generally results in osteoporosis. This provides a poor prognosis for the elderly, patients with spinal
cord injuries, patients left bed ridden or otherwise immobilized by disease. The Company’s platform technology is based on the amino acid sequence
of Black Bear Parathyroid Hormone (BB-PTH). This platform consists of three distinct constructs; BB-PTH 1-34, BB-PTH 1-84
and BB-PTH 7-84. The strategic vision for the Company is to develop each of the BB-PTH constructs for different clinical indications.
BB-PTH has important implications in not only the osteoporosis market but the orthopedic market as
well. Only one product is currently FDA approved for site-specific, local application in spinal fusions (rBMP-2) and has been
associated with significant morbidity and mortality. No bone-building (i.e. anabolic) products are currently approved for
site-specific application to promote “accelerated healing” in open orthopedic procedures such as long bone fractures.
The intent of the Company is to develop BB-PTH for site specific delivery in spinal fusions and long bone fractures, to promote
healing, via the anabolic actions of this peptide. The peptide will be delivered with a novel (patent pending) resorbable
reverse thermal hydrogel. The PTH-loaded hydrogel is stable in liquid state at refrigeration temperatures, but when exposed
to body temperature, gels within 5 minutes and resides for 30-60 days at the site of application. Concomitant to development of BB-PTH for site-specific orthopedic applications, Aursos will continue to pursue a development
path with BB-PTH 1-34, BB-PTH 1-84 and 7-84 to support indications of primary osteoporosis, disuse osteoporosis (orphan indications)
and possibly osteoarthritis. Aursos has developed a relationship with a delivery company that is conducting a feasibility
study for non-parental delivery of BB-PTH 1-34. Aursos is seeking additional pharmaceutical partnering efforts for the BB-PTH
constructs to provide a means to potentially administer these peptides by delivery methods other than subcutaneous injection.
The Company was established in 2007 under the guidance of The Apjohn Group, LLC, (www.apjohngroup.com) a business development accelerator with seven life science companies
under its direction. The Apjohn Group brings together valuable resources of management talent and angel/seed financing to
enhance start-up activities of promising new technologies.
Aursos has licensed technology developed at Michigan Technological University (Houghton, MI) in the laboratory
of Dr. Seth Donahue on the family of naturally-occurring Parathyroid Hormone (PTH) peptides found in the black bear (Ursus
americanus) and methods for their use. An option to the license for the hydrogel is currently being negotiated
with Michigan Technological University.
In 2006, more than $1.8 billion was spent on spinal fixation and dynamic stabilization devices in the U.S. Sales of
these products are expected to grow at a compound annual rate of 10.4% reaching more than $3.2 billion in the year 2012. The
incidence of spine disorders totaled approximately 75,000 in 2006. Back pain is the second most common medical condition for
which individuals seek treatment, accounting for more than 50 million physician office visits annually in the U.S. It is estimated that more than 75% of the entire U.S. population will be affected by low back pain over the course
of their lifetime. In 2006, U.S. sales of orthopedic implant, reconstruction, and trauma products totaled approximately
$12.2 billion. Sales of these products are expected to increase at a compound annual rate of 6.9%, reaching more than $18.1
billion in the year 2012.
Approximately 56 million people in the U.S. fall prey to musculoskeletal injuries annually at a cost
of approximately $215 billion. According to the Centers for Disease Control and Prevention, approximately 6 million fractures
occur in the U.S. each year, and an estimated 1.5
million people suffer a fracture caused by bone disease. Many experts predict a future epidemic of hip fractures due to the
growing number of elderly in the U.S. and the prevalence
of osteoporosis.
Osteoporosis is currently a health issue for approximately 44 million Americans (10 million with osteoporosis, and an
additional 34 million with low bone mass who are at risk for osteoporosis). These numbers are expected to rise to 62 million
Americans (14 and 48 million, respectively) by 2020. Approximately 40% of women and 13% of men over age
50 are at risk for spine, hip or forearm or other long bone fractures within their lifetime. The costs associated with treatment
of osteoporosis-related fractures were approximately $18 billion dollars in 2002, and continues to climb. In addition to primary (age-related) osteoporosis, disuse osteoporosis
is an important clinical problem, especially for patients partially or completely immobilized due to long bone fracture, stroke,
muscular dystrophy or spinal cord injury. Disuse further increases fracture rates primarily because
reduced skeletal loading causes unbalanced bone remodeling, which leads to bone loss (disuse osteoporosis). Though inactivity leads to bone loss in humans, bears
maintain balanced bone remodeling and do not lose bone during hibernation, a period that may reach 6 months of the year. Bears
may prevent bone loss during disuse via the anabolic effects of endogenous parathyroid hormone (PTH). Serum
PTH levels increase during hibernation and are positively correlated with osteocalcin (a serum marker of osteoblast bone formation
activity) in hibernating and active bears. Thus, PTH may govern the mechanism by which bears maintain balanced
bone remodeling and prevent osteoporosis during disuse and may lead us down a development path to novel and highly effective
treatments for humans. |
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| New Treatment Concepts for Osteoporosis | Assessment
of bone building cell (osteoblast) survival has been accomplished. These in vitro experiments demonstrated that mouse
osteoblasts treated with BB-PTH 1-34 have a greater potential to survive and produce new bone compared to cells treated with
human PTH 1-34. This finding suggests BB-PTH has potential to be a more efficacious osteoporosis drug than human PTH because
of its enhanced ability to maintain osteoblast survival. A proof-of-concept
in vivo study was also completed and demonstrated that human and BB-PTH 1-34 increase cortical
bone strength equivalently in young healthy male rats following short (6 week) treatment. The Company has also recently completed
a study in which BB-PTH 1-34 was compared to human PTH 1-34, in the validated preclinical ovariectomized (OVX) rat model.
In this study, rats rapidly lost bone volume over a 6 week period following OVX. They were then treated with either vehicle
or ascending doses of human or bear PTH (3, 10, or 30 ug/kg, s.c.). Injections were performed 5 times per week for 8 weeks
and then the animals were terminated and the bones assessed utilizing µCT. Both human and bear PTH 1-34 restored bone,
in a dose-dependent manner, returning bone volume to pre-OVX levels. Most recently, studies on male mice
demonstrated that BB-PTH 1-84 is a more efficacious at increasing bone volume and strength than human PTH 1-84. Currently studies are being conducted in long
bone defect models in rodents to demonstrate that BB-PTH 1-34, when applied locally to bone in the reverse thermal hydrogel,
promotes accelerated healing of the fracture site. This work has important implications for not only patients requiring spinal
fusions and long bone repair from falls and other injuries but also has distinct applications to the military when soldiers
suffer debilitating bone injuries on the battlefield and require open orthopedic procedures to repair the defect.
| Financing | Aursos is currently raising up to $2.0 million in new capital to develop novel peptide treatments
for osteoporosis, osteoarthritis and site specific delivery to enhance recovery from orthopedic procedures. Subsequent financing
rounds will fund the continuation of the development plan. Aursos is currently working under support from the Michigan Universities
Commercialization Initiative (MUCI) and has been approved for a Phase I STTR NIH grant in collaboration with Proteos (Kalamazoo, MI) and is in the process of applying for the Phase II award to support continued development of BB-PTH
1-84 for primary and disuse osteoporosis. | Disclaimer |
aursos should be viewed as a Highly speculative
investment. THIS BUSINESS SUMMARY DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY SECURITIES. OFFERS OF
SECURITIES WILL BE MADE ONLY TO QUALIFIED INVESTORS PURSUANT TO DOCUMENTATION PREPARED SPECIFICALLY FOR SUCH PURPOSE.
STATEMENTS CONTAINED IN THIS BUSINESS PLAN REGARDING AURSOS’S EXPECTATIONS WITH RESPECT TO ITS BUSINESS
PROSPECTS, FINANCIAL PERFORMANCE AND OTHER INFORMATION, WHICH CAN BE IDENTIFIED BY THE USE OF FORWARD-LOOKING TERMINOLOGY,
SUCH AS “MAY”, “WILL”, “EXPECT”, “COULD”, ANTICIPATE”, “ESTIMATE”
OR “CONTINUE”, THE NEGATIVE THEREOF, OTHER VARIATIONS THEREON OR COMPARABLE TERMINOLOGY, ARE FORWARD LOOKING STATEMENTS. |
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