10-K
1
tenx_10k.htm
ANNUAL REPORT
tenx_10k
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington
D.C., 20549
FORM
10-K
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2020
Commission
File No. 001-34600
TENAX
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
ONE
Copley Parkway, Suite 490, Morrisville, NC 27560
(Address
of Principal Executive Offices) (Zip Code)
Registrant’s
Telephone Number, including area code:
(919) 855-2100
Securities
registered pursuant to Section 12(b) of the Act:
Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered
Common Stock, $0.0001 par value per share TENX The Nasdaq Stock Market LLC
Securities
registered pursuant to Section 12(g) of the Act:
NONE
Indicate by check
mark if the registrant is a well-known seasoned issuer, as defined
in Rule 405 of the Securities Act. Yes ☐ No
☒
Indicate by check
mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes ☐
No ☒
Indicate by check
mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past
90 days. Yes ☒ No ☐
Indicate by check
mark whether the registrant has submitted electronically every
Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No
☐
Indicate by check
mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated
filer,” “smaller reporting company” and
“emerging growth company” in Rule 12b-2 of the Exchange
Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
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. ☐
Indicate by check
mark whether the registrant has filed a report on and attestation
to its management’s assessment of the effectiveness of its
internal control over financial reporting under Section 404(b) of
the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report.
☐
Indicate by check
mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of the voting and
non-voting common equity held by non-affiliates computed by
reference to the price at which the common equity was last sold as
of June 30, 2020, the last business day of the registrant’s
most recently completed second fiscal quarter, was
$9,099,973.
The number of
shares outstanding of the registrant’s class of $0.0001 par
value common stock as of March 25, 2021 was
14,969,312.
DOCUMENTS
INCORPORATED BY REFERENCE:
Portions of the
registrant’s proxy statement to be filed with the Securities
and Exchange Commission pursuant to Regulation 14A in connection
with the registrant’s 2021 Annual Meeting of Stockholders,
which will be filed subsequent to the date hereof, are incorporated
by reference into Part III of this Form 10-K. Such proxy statement
will be filed with the Securities and Exchange Commission not later
than 120 days following the end of the registrant’s fiscal
year ended December 31, 2020.
TABLE
OF CONTENTS
PART I 1
ITEM 1—BUSINESS 1
ITEM 1A—RISK FACTORS 8
ITEM 1B—UNRESOLVED STAFF COMMENTS 24
ITEM 2—PROPERTIES 24
ITEM 3—LEGAL PROCEEDINGS 24
ITEM 4—MINE SAFETY DISCLOSURES 24
ITEM 6—SELECTED FINANCIAL DATA 24
ITEM 7A—QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 34
ITEM 8—FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 34
ITEM 9A—CONTROLS AND PROCEDURES 58
ITEM 9B—OTHER INFORMATION 59
PART III 59
PART I
FORWARD-LOOKING STATEMENTS
This
Annual Report on Form 10-K contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, or the Securities Act, and Section 21E of the Securities
Exchange Act of 1934, as amended, or the Exchange Act, which are
subject to the “safe harbor” created by those sections.
Forward-looking statements are based on our management’s
beliefs and assumptions and on information currently available to
them. In some cases, you can identify forward-looking statements by
terminology such as “may”, “will”,
“should”, “expects”, “plans”,
“anticipates”, “believes”,
“estimates”, “predicts”,
“potential” or “continue” or the negative
of such terms or other comparable terminology. These statements are
only predictions and involve known and unknown risks, uncertainties
and other factors, including, but not limited to, progress in our
product development activities, obtaining financing for operations,
development of new technologies and other competitive pressures,
legal and regulatory initiatives affecting our products, conditions
in the capital markets, and the risks discussed in
“Item 1A – Risk
Factors” and elsewhere in this report that may cause
our or our industry’s actual results, levels of activity,
performance or achievements to be materially different from any
future results, levels of activities, performance or achievements
expressed or implied by such forward-looking
statements.
Although
we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results,
levels of activity, performance or achievements. The
forward-looking statements represent our views as of the date of
this Annual Report on Form 10-K. We undertake no obligation to
update any of the forward-looking statements after the date of
filing of this report or to conform such statements to actual
results, except as may be required by law.
All
references in this Annual Report on Form 10-K to the
“Company,” “Tenax Therapeutics”,
“we”, “our” and “us” means
Tenax Therapeutics, Inc.
ITEM
1—BUSINESS
Overview
Tenax
Therapeutics was originally formed as a New Jersey corporation in
1967 under the name Rudmer, David & Associates, Inc., and
subsequently changed its name to Synthetic Blood International,
Inc. Effective June 30, 2008, we changed the domiciliary state of
the corporation to Delaware and changed the company name to Oxygen
Biotherapeutics, Inc. On September 19, 2014, we changed the company
name to Tenax Therapeutics, Inc.
We are
a specialty pharmaceutical company focused on identifying,
developing and commercializing products that address
cardiovascular and pulmonary diseases of high unmet medical
need. On November 13, 2013, through our wholly owned
subsidiary, Life Newco, Inc., or Life Newco, we acquired a license
granting Life Newco an exclusive, sublicensable right to develop
and commercialize pharmaceutical products containing levosimendan,
2.5 mg/ml concentrate for solution for infusion / 5ml vial
in the United States and
Canada. On October 9, 2020, we entered into an amendment to
the license to include two new oral products containing
levosimendan, in capsule and solid dosage form, and a
subcutaneously administered product containing levosimendan, to the
scope of the license, subject to specified
limitations.
On
January 15, 2021, through our wholly owned subsidiary, Life Newco
II, Inc., or Life Newco II, we acquired 100% of the equity of
PHPrecisionMed Inc., a Delaware corporation, or PHPM. In accordance
with the terms of the merger agreement between Life Newco II and
PHPM, Life Newco II merged with and into PHPM, with PHPM surviving
as our wholly-owned subsidiary. As a result of the merger, we plan
to develop and commercialize pharmaceutical products containing
imatinib for the treatment of pulmonary arterial
hypertension.
Business Strategy
Our
principal business objective is to identify, develop, and
commercialize novel therapeutic products for disease indications
that represent significant areas of clinical need and commercial
opportunity. The key elements of our business strategy are outlined
below.
1
Efficiently conduct clinical development to establish clinical
proof of concept with our current product candidates.
Levosimendan and imatinib both represent novel therapeutic
modalities for the treatment of pulmonary hypertension and other
cardiovascular and
pulmonary diseases of high unmet medical need. We are
conducting clinical development with the intent to establish proof
of concept in several important disease areas where these
therapeutics would be expected to have benefit. Our focus is on
conducting well-designed studies to establish a robust foundation
for subsequent development, partnership and expansion into
complementary areas.
Efficiently explore new high potential therapeutic applications,
leveraging third-party research collaborations and our results from
related areas. Levosimendan has shown promise in multiple
disease areas. We are committed to exploring potential clinical
indications where our therapies may achieve best-in-class profile,
and where we can address significant unmet medical needs. In order
to achieve this goal, we have established collaborative research
relationships with investigators from research and clinical
institutions and our strategic partners. These collaborative
relationships have enabled us to cost effectively explore where our
product candidates may have therapeutic relevance, and how it may
be utilized to advance treatment over current clinical care.
Additionally, we believe we will be able to leverage clinical
safety data and preclinical results from some programs to support
accelerated clinical development efforts in other areas, saving
substantial development time and resources compared to traditional
drug development.
Continue to expand our intellectual property portfolio. Our
intellectual property is important to our business and we take
significant steps to protect its value. We have ongoing research
and development efforts, both through internal activities and
through collaborative research activities with others, which aim to
develop new intellectual property and enable us to file patent
applications that cover new applications of our existing
technologies or product candidates.
Enter into licensing or product co-development arrangements.
In addition to our internal development efforts, an important part
of our product development strategy is to work with collaborators
and partners to accelerate product development, reduce our
development costs, and broaden our commercialization capabilities.
We believe this strategy will help us to develop a portfolio of
high-quality product development opportunities, enhance our
clinical development and commercialization capabilities, and
increase our ability to generate value from our proprietary
technologies.
Our Current Programs
Levosimendan Background
Levosimendan
was discovered and developed by Orion Corporation, a Finnish
company, or Orion. Levosimendan is a calcium sensitizer/K-ATP activator
developed for intravenous use in hospitalized patients with acutely
decompensated heart failure. It is currently approved in over 60
countries for this indication and not available in the United
States or Canada. It is estimated that to date over 1.5 million
patients have been treated worldwide with levosimendan.
Levosimendan
is a novel, first in class calcium
sensitizer/K-ATP activator. The therapeutic effects of
levosimendan are mediated through:
-
Increased cardiac
contractility by calcium sensitization of troponin C, resulting in
a positive inotropic effect which is not associated with
substantial increases in oxygen demand.
-
Opening of
potassium channels in the vasculature smooth muscle, resulting in a
vasodilatory effect on all vascular beds.
-
Opening of
mitochondrial potassium channels in cardiomyocytes, resulting in a
cardioprotective effect.
This
triple mechanism of action helps to preserve heart function during
cardiac surgery. Several studies have demonstrated that
levosimendan protects the heart and improves tissue perfusion while
minimizing tissue damage during cardiac surgery.
In
2013, we acquired certain assets of Phyxius Pharma, Inc., or
Phyxius, including its North American rights to develop and
commercialize levosimendan for any indication in the United States
and Canada. In the countries where levosimendan is marketed,
levosimendan is indicated for the short-term treatment of acutely
decompensated severe chronic heart failure in situations where
conventional therapy is not sufficient, and in cases where
inotropic support is considered appropriate. In acute decompensated heart failure patients,
levosimendan has been shown to significantly improve
patients’ symptoms as well as acute hemodynamic measurements
such as increased cardiac output, reduced preload and reduced
afterload.
2
The European Society of Cardiology, or the ESC, recommends
levosimendan as a preferable agent over dobutamine to reverse the
effect of beta blockade if it is thought to be contributing to
hypotension. The ESC guidelines also state that levosimendan is not
appropriate for patients with systolic blood pressure less than
85mmHg or in patients in cardiogenic shock unless it is used in
combination with other inotropes or vasopressors. Other unique
properties of levosimendan include sustained efficacy through the
formation of a long-acting metabolite, lack of impairment of
diastolic function, and evidence of better compatibility with beta
blockers than dobutamine.
Levosimendan Development for Pulmonary Hypertension
Patients
We
recently completed a Phase 2 clinical trial of levosimendan in
North America for the treatment of patients with pulmonary
hypertension associated with heart failure with preserved ejection
fraction, or PH-HFpEF. PH-HFpEF is defined hemodynamically by
a mean pulmonary artery pressure, or mPAP, ≥25 mmHg, and a
pulmonary capillary wedge pressure, or PCWP, >15 mmHg. Pulmonary
hypertension in these patients is believed to arise from a passive
backward transmission of elevated filling pressures from left-sided
heart failure. These mechanical components of pulmonary venous
congestion may trigger pulmonary vasoconstriction, decreased nitric
oxide availability, increased endothelin expression,
desensitization to natriuretic peptide induced vasodilation, and
vascular remodeling. Over time, these changes often lead to
advanced pulmonary arterial and venous disease, increased right
ventricle afterload, and right ventricle failure.
PH-HFpEF
is a common form of pulmonary hypertension with an estimated U.S.
prevalence exceeding 1.5 million patients. Currently, no
pharmacologic therapies are approved for treatment of
PH-HFpEF. Despite the fact that many therapies have been
studied in PH-HFpEF patients, including therapies approved to treat
pulmonary arterial hypertension patients, no therapies have been
shown to be effective in treating PH-HFpEF patients.
Published
pre-clinical and clinical studies indicate that levosimendan may
provide important benefits to patients with pulmonary hypertension.
Data from these published trials indicate that levosimendan may
reduce pulmonary vascular resistance and improve important
cardiovascular hemodynamics such as reduced pulmonary capillary
wedge pressure and pulmonary artery pressure in patients with
pulmonary hypertension. In addition, several published studies
provide evidence that levosimendan may improve right ventricular
dysfunction which is a common comorbidity in patients with
pulmonary hypertension. While none of these studies have focused
specifically on PH-HFpEF patients, the general hemodynamic
improvements in these published studies of various types of
pulmonary hypertension provide a basis to believe that levosimendan
may be beneficial in PH-HFpEF patients.
In
March 2018, we met with the United States Food and Drug
Administration, or FDA, to discuss development of levosimendan in
PH-HFpEF patients. The FDA agreed with our planned Phase 2 design,
patient entry criteria, and endpoints. It was agreed the study
could be conducted under the existing investigational new drug
application with no additional nonclinical studies required to
support full development. The FDA recognized there were no approved
drug therapies to treat PH-HFpEF patients and acknowledged this
provided an opportunity for a limited Phase 3 clinical program.
This topic was discussed further at the End-of-Phase 2 Meeting
following completion of the Phase 2 study in PH-HFpEF patients,
which is known as the HELP Study – Hemodynamic Evaluation of Levosimendan in PH-HFpEF.
We
initiated the first of our expected 10-12 HELP Study clinical sites
in November 2018 and the first of 37 patients were enrolled in the
HELP Study in March 2019. Enrollment in the HELP Study was
completed in March 2020. The primary endpoint of the HELP Study was
based on the change in PCWP during exercise versus baseline
compared to placebo. The HELP Study utilized a double-blind
randomized design following five weekly outpatient infusions of
levosimendan.
On June 2, 2020, we announced preliminary, top-line data from the
study. The primary efficacy analysis, pulmonary capillary wedge
pressure (PCWP) during exercise did not demonstrate a statistically
significant reduction from baseline. Levosimendan did demonstrate a
statistically significant reduction in PCWP compared to baseline
(p=<0.0017) and placebo (p=<0.0475) when the measurements at
rest, with legs up and on exercise were combined. Levosimendan also
demonstrated a statistically significant improvement in 6-minute
walk distance as compared to placebo (p=0.0329). These findings
from the HELP Study represent important discoveries related to the
use of levosimendan in PH-HFpEF patients since this is the first
study to evaluate levosimendan in PH-HFpEF patients and this is the
first study ever conducted of any therapy in PH-HFpEF patients to
show such positive improvements in hemodynamics and 6-minute walk
distance.
3
Hemodynamic Results
Hemodynamic measurements were made at rest (supine), after leg
raise on a supine bicycle (a test of rapid increase in ventricular
filling) and during exercise (25 watts for 3 minutes or until the
patient tired). In the initial open-label phase, 84% of the
patients had a significant reduction in right atrial pressure, or
RAP, pulmonary artery pressure, or PAP and PCWP at rest and during
exercise. In the randomized double-blinded 6-week trial,
levosimendan demonstrated a statistically significant reduction in
PCWP compared to baseline (p=<0.0017) and placebo (p=<0.0475)
when the measurements at rest, with legs up and on exercise were
combined. While there was no significant change in PCWP during
exercise, patients receiving levosimendan had reductions from
baseline at Week 6 in PCWP, PAP, and RAP that were significant when
patients were “at rest” and/or with their “legs
raised” (p<0.05).
Clinical Results (6-Minute Walk Distance)
The clinical efficacy was confirmed by a statistically significant
improvement in 6-minute walk distance of 29 meters (p=0.0329). The
6-minute walk distance was a secondary endpoint in the trial and is
a validated and accepted endpoint used in many pulmonary
hypertension registration trials. Levosimendan was given in
once-weekly home infusions for six weeks.
Safety
The incidence of adverse events or serious adverse events between
the control and treated groups were similar. In addition, there
were no arrhythmias observed, atrial or ventricular, when comparing
baseline electrocardiographic monitoring with 72-hour monitoring
after five weeks of treatment.
The detailed results from the Phase 2 HELP Study of levosimendan in
PH-HFpEF were presented at the Heart Failure Society of America
Virtual Annual Scientific Meeting on October 3, 2020 and at the
American Heart Association Scientific Sessions 2020 on November 13,
2020. Additionally, the full manuscript has been accepted for
publication in the peer-reviewed journal JACC:Heart
Failure.
Next Steps
On
October 9, 2020, we entered into an amendment, or the Amendment, to
the License between the Company and Orion to include two new
product formulations containing levosimendan, in a capsule solid
oral dosage form, and a subcutaneously administered dosage form
containing levosimendan, to the scope of the License, subject to
specified limitations.
We plan
to study the utility of the levosimendan oral capsule dosage form
in patients who have participated in the open-label extension of
the HELP Study and who continue to receive weekly infusions of
intravenous levosimendan. These patients are now eligible to
participate in the amendment to the HELP Study that will transition
them from the intravenous to an oral formulation. The investigators
at the centers that participated in the HELP Study have been
invited to participate and enroll their patients into this
study.
In October 2020, we met with the FDA for an End-of-Phase 2 Meeting
to discuss the Phase 2 clinical data and further development of
levosimendan in PH-HFpEF patients. The FDA agreed that one or two
Phase 3 clinical studies (depending on the size) with a primary
endpoint of change in 6-minute walk distance over 12 weeks or a
single Phase 3 trial with clinical worsening (e.g., death,
hospitalization for heart failure, or decline in exercise capacity)
over 24 weeks would be sufficient to demonstrate the effectiveness
of levosimendan in PH-HFpEF. The FDA also agreed to a plan to
replace weekly intravenous levosimendan dosing with daily oral
levosimendan doses in a Phase 3 clinical study. The FDA expressed
concern about a safety database as potentially necessary and
indicated that the need for a further safety database could be
dependent on the final design of the Phase 3 study. We expect that
this will be addressed when the final Phase 3 protocol is submitted
which will better characterize the trial design and primary
endpoints.
4
The HELP Study design was novel in several respects. To date, no
other multi-center study has evaluated levosimendan in heart
failure patients with preserved ejection fraction, or HFpEF,
patients or PH-HFpEF patients. Instead, all previous levosimendan
heart failure studies have enrolled heart failure patients with
reduced ejection fraction, or HFrEF, which specifically excluded
HFpEF patients. Also, the HELP Study utilized a unique 24-hour
weekly infusion regimen of 0.075- 0.1μm/kg/min. Finally, the
HELP Study employed a unique home-based intravenous infusion
administration via an ambulatory infusion pump. This home-based
weekly intravenous administration is unlike all other chronic
dosing studies of levosimendan that have typically employed a
shorter duration and less frequent infusion regimen administered in
a hospital setting. Despite the unique patient population,
weekly dosing, and home-based administration, there have been no
reported serious adverse events.
We believe that the combination of the unique HELP Study patient
population, innovative weekly 24-hour dosing, unique home-based
site of administration, and novel findings of efficacy and safety
in PH-HFpEF patients represent unique discoveries and significant
intellectual property. These discoveries, among others from the
HELP Study, form the basis for a U.S. patent application that we
have filed.
Imatinib Background
Imatinib (also known as “Gleevec”), is a tyrosine
kinase inhibitor, which revolutionized the treatment of chronic
myeloid leukemia, or CML, in 2001. The first clinical trial of
imatinib took place in 1998 and the drug received FDA approval in
May 2001. Encouraged by the success of Imatinib in treating CML
patients, scientists explored its effect in other cancers, and it
was found to produce a similar positive effect in other cancers
where tyrosine kinases were overexpressed.
Tyrosine kinases are important mediators of the signaling cascade,
determining key roles in diverse biological processes like growth,
differentiation, metabolism, and apoptosis in response to external
and internal stimuli. Deregulation of protein kinase activity has
been shown to play a central role in the pathogenesis of human
cancers. Imatinib, a 2-phenyl amino pyrimidine derivative, is a
tyrosine kinase inhibitor with activity against ABL, BCR-ABL,
PDGFRA, and c-KIT. Imatinib works by binding close to the ATP
binding site therefore inhibiting the enzyme activity of the
protein. Imatinib also inhibits the ABL protein of noncancer cells.
Imatinib is well absorbed after oral administration with a
bioavailability exceeding 90%. It is extensively metabolized,
principally by cytochrome P450 (CYP)3A4 and CYP3A5 and can
competitively inhibit the metabolism of drugs that are CYP3A4 or
CYP3A5 substrates. Imatinib is generally well tolerated in cancer
patients. Common side effects include fluid retention, headache,
diarrhea, loss of appetite, weakness, nausea and vomiting,
abdominal distention, edema, rash, dizziness, and muscle cramps.
Serious side effects may include myelosuppression, heart failure,
and liver function abnormalities. Novartis is the manufacturer of
Gleevec.
Previous Imatinib Development for Pulmonary Arterial Hypertension
Patients
In pulmonary arterial hypertension, or PAH, a rare disease,
subjects who remain symptomatic despite available therapies have a
high morbidity and mortality. Though several therapies are now
available, there is no cure for the disease, and there is no data
supporting that the existing therapies, all of which are pulmonary
vasodilators, halt progression or induce regression of the disease.
Imatinib is a tyrosine kinase inhibitor that has been shown in
animal models of pulmonary hypertension to induce disease reversal
by an effect on platelet derived growth factor, or PDGF, which
appears to be causal in the disease. After that discovery was made,
several case reports and small case series of patients with
advanced PAH failing combination pulmonary vasodilator therapy were
published showing a dramatic effect of imatinib on stabilizing and
improving these patients. This led Novartis to develop imatinib as
a treatment of PAH.
Novartis sponsored a Phase 2 proof-of-concept trial to evaluate the
safety, tolerability, and efficacy of imatinib as an adjunct to PAH
specific therapy in patients with PAH. This was a 24-week
randomized, double-blind, placebo-controlled study of PAH subjects
who remained symptomatic on one or more PAH therapies in WHO
Functional Class (FC) II-IV. The Phase 2 trial of imatinib in PAH
caused significant hemodynamic improvement in some patients but
failed to meet the primary endpoint of an increase in 6-minute walk
distance (22 meters, p=NS). Novartis then sponsored a Phase 3 trial
(IMPRES) which met its primary endpoint of significant increase in
6-minute walk (32 meters, p=0.002), an effect maintained in the
extension study in patients remaining on imatinib. However, the
data were confounded by a high rate of dropouts in the patients
randomized to imatinib attributed largely to gastric intolerance
during the first eight weeks. The sponsor proposed consideration of
a surrogate endpoint under the subpart H provision as a basis for
approval but was denied. Consequently, Novartis chose to withdraw
the Investigational New Drug application as the drug went off
patent.
5
Current Imatinib Development for Pulmonary Arterial Hypertension
Patients
On May
30, 2019, PHPM met with the FDA to discuss a proposal for a Phase 3
trial of imatinib for PAH. At that meeting, PHPM received agreement
for a single Phase 3 trial using change in 6-minute walk distance
as the primary endpoint (p<0.05). PHPM also received agreement
for submission under the 505(b)(2) regulatory pathway, and
thereafter received orphan designation. In August of 2019, PHPM was
given preliminary advice on its plans to submit an application for
Breakthrough Therapy Designation. In July 2020, PHPM received
agreement from the FDA for the development of a modified release
formulation that would require only a small comparative
PK/bioavailability study in 12 volunteers receiving a single dose
of the modified release formulation to be compared to a single dose
of the existing immediate release formulation. A Phase 3 study is
planned with the modified release formulation of
imatinib.
Suppliers
Pursuant
to the terms of our license for levosimendan, Orion is our sole
manufacturing source for levosimendan. We intend to engage various
third-party suppliers and contract manufacturing organizations for
the supply and manufacture of imatinib for planned, upcoming
clinical trials.
Intellectual Property
We rely
on a combination of patent applications, patents, trade secrets,
proprietary know-how, trademarks, and contractual provisions to
protect our proprietary rights. We believe that to have a
competitive advantage, we must develop and maintain the proprietary
aspects of our technologies. Currently, we require our officers,
employees, consultants, contractors, manufacturers, outside
scientific collaborators and sponsored researchers, and other
advisors to execute confidentiality agreements in connection with
their employment, consulting, or advisory relationships with us,
where appropriate. We also require our employees, consultants, and
advisors who we expect to work on our products to agree to disclose
and assign to us all inventions conceived during the workday,
developed using our property, or which relate to our
business.
To
date, we own or in-license the rights to one U.S. patent and three
foreign patents. In addition, we have three U.S. patent