Sunday, December 31, 2017 10:41:18 AM
KALTF
Outstanding Shares 129,235,073 a/o Sept 30, 2017
27,582,228 a/o Sept 30, 2016
Company History
Formerly=Santa Maria Petroleum, Inc. until 1-2017
Formerly=Quetzal Energy Ltd. until 6-2012
Security Notes
Capital Change=shs decreased by 1 for 10 split Pay date=06/11/2012.
Capital Change=shs decreased by 1 for 12 split Pay date=03/29/2016.
Capital Change=shs decreased by 1 for 2.3 split. Pay date=01/11/2017.
Non US Stock Exchange Listing
Cash and cash equivalents $55,000
Total current liabilities $1,448,000
Total operating expenses $816,000
OVERVIEW OF THE COMPANY
Kalytera is a clinical-stage specialty pharmaceutical company developing a portfolio of cannabinoid,
cannabinoid-like, and endocannabinoid-like pharmaceutical products. Kalytera believes interest in
cannabinoid therapeutics has increased significantly over the past several years as preclinical and clinical
data has emerged highlighting the potential efficacy and safety benefits of cannabinoid therapeutics.
Kalytera is developing the following product candidates in the following programs: (1) cannabidiol
(“CBD”) therapeutics; (2) proprietary CBD prodrugs; and (3) cannabinoid-like and endocannabinoid-like
compounds, with an initial focus on CBD therapeutics and CBD prodrugs. Kalytera currently has no
product candidate that has received regulatory approval.
Kalytera’s lead clinical-stage program is focused on developing CBD formulations for both treatment and
prevention of acute graft versus host disease (“GVHD”).
Kalytera’s lead program in GVHD has recently completed three Phase 2a clinical studies evaluating the safety and efficacy of (1) short term use of CBD
in the prevention of acute GVHD, (2) prolonged use of CBD in the prevention of acute GVHD, and (3)
prolonged use of CBD in the of treatment steroid-refractory grades 3-4 acute GVHD. Kalytera’s GVHD
program was acquired pursuant to Kalytera’s acquisition of Talent Biotechs Ltd. (“Talent”), a formerly
privately held, Israeli-based developer of CBD therapeutics, as announced on February 16, 2017.
With its recent acquisition of Talent, Kalytera has transitioned from a pre-clinical stage company to a
clinical-stage pharmaceutical company pioneering the development of a next generation of cannabinoid
therapeutics.
Through its experienced leadership, drug development expertise, and intellectual property
rights, Kalytera is seeking to establish a leading position in the development of cannabinoid medicines for
a range of important unmet medical needs, with an initial focus on GVHD.
On November 15, 2017, the Company announced that the United States Patent and Trademark Office has
issued a Notice of Allowance for US Patent Application 15/143,694 covering the use of CBD in the
treatment of GVHD. Securing a patent for this proprietary technology represents an important step forward
for the Company in its work focused on the treatment of this serious and life-threatening disease.
Over the next 12 months, Kalytera intends to advance the development of its CBD therapeutic for the
prevention of acute GVHD by conducting a late-stage clinical study in this indication.
Kalytera is also developing a pre-clinical stage pipeline of CBD prodrugs for the treatment of a variety of
disorders. CBD prodrugs are designed to specifically modify physiochemical properties and functionality
of CBD. These modifications are intended to enhance regional therapy and enable bifunctional therapy.
Over the next 18 months, through Q2 2019, Kalytera also expects to advance at least one of its CBD
prodrugs into Phase 1 human clinical testing.
Cannabidiol (“CBD”)
CBD is a non-psychoactive cannabinoid compound that has been shown to be an effective therapeutic
against a number of pharmacological targets. However, there are limitations associated with natural CBD,
including its poor oral bioavailability. Kalytera is developing CBD formulations and CBD pro-drugs in an
effort to overcome these limitations, and to target delivery of CBD to specific disease sites within the body.
Kalytera has filed composition of matter and method of use patents covering its inventions in the six major
markets (the U.S., the United Kingdom, France, Germany, Italy and Spain, as well as several other
jurisdictions, including Japan, Canada, Brazil and Australia).
Kalytera will also seek to advance a portfolio of synthetic, non-psychoactive cannabinoid-like compounds.
By modifying cannabinoid molecules, and molecules which regulate the endogenous cannabinoid signaling
system, Kalytera will seek to improve pharmacokinetics and increase potency, potentially allowing for the
development of drug candidates with improved activity.
CBD – In Treatment and Prevention of Graft Versus Host Disease (“GVHD”)
GVHD is a multisystem disorder that occurs when the transplanted cells from a donor (“the graft”)
recognize the transplant recipient (“the host”) as foreign. This interaction initiates an immune reaction that
causes disease in the transplant recipient. This reaction can occur within days after the transplant (acute
GVHD) or months to years after the transplant (chronic GVHD).
GVHD commonly occurs following hematopoietic stem cell transplantation (“HCT”), a procedure
whereby the stem cells of the bone marrow or peripheral blood of a healthy donor are transplanted into a
new host after chemotherapy or radiation.
This is a lifesaving procedure for many diseases of the blood and bone marrow including leukemia, Hodgkin and Non-Hodgkin lymphoma, multiple myeloma, sickle cell
anemia, and thalassemia. According to a report prepared by GlobalData PharmaPoint, the Graft- VersusHost-Disease
Opportunity Analysis and Forecasts to 2023 Update (the “GlobalData Report”), there were
over 8,000 HCT procedures in the U.S. in 2014 and the use of HCT is expected to continue to increase at a
rate of 7% per year. Whereas HCT procedures can be lifesaving, they pose many dangerous side effects,
including infection and GVHD.
Acute GVHD is graded from grades 1 to 4, based on the severity of symptoms, and the degree to which
various organ systems are involved. In general, grade 1 can be described as mild, grade 2 can be described
as moderate, grade 3 can be described as severe, and grade 4 can be described as life threatening. Patients
with acute GVHD may suffer from rashes and blistering of the skin, nausea, vomiting, abdominal cramps
accompanied by diarrhea, and jaundice. Generally, acute reactions are more severe and life threatening.
Acute GVHD is a major cause of morbidity and mortality following HCT. As reported in the GlobalData
Report, it is estimated that even with intensive prophylaxis with immunosuppressive treatments, 30-50%
of patients transplanted from fully matched sibling donors and 50-70% of patients transplanted from
unrelated donors will develop some level of acute GVHD.
The first step in prevention of GVHD is the selection of donor cells that closely match the genetics of the
immune system of the transplant recipient, ideally a sibling donor. From there, the patient relies on drugs
that have been developed to prevent or treat GVHD. Medicinal prevention of acute GVHD is dependent on
immunosuppression of the donor cells, either pharmacologically or through T-cell depletion. Common
drugs include methotrexate, cyclosporine tacrolimus, sirolimus, mycophenolate mofetil and ATG.
Preventive measures and clinical practices vary by institution.
Treatment of GVHD involves pharmacologic suppression of the graft’s immune cell activation and reestablishment
of donor-host immune-tolerance. Most patients are prescribed corticosteroids, which directly
suppress the donor’s immune cell attack on host tissue, but also raise the risk of infection and cancer
relapse. As with prevention, the optimal drug strategy for GVHD is not well defined.
As stated in the GlobalData Report, only 30-50% of patients with moderate to severe GVHD respond to corticosteroids,
putting many at risk for fatal outcomes. Better treatment options are needed to improve the mortality and
morbidity outcomes for transplant recipients.
In 2015, Professor Moshe Yeshurun, Kalytera’s Chief Medical Officer (“CMO”), and previously the CMO
of Talent and Head of the Bone Marrow Transplantation Department at the Rabin Medical Center in Israel,
published the results of a Phase 2a clinical trial evaluating the safety and efficacy of CBD in the prevention
of acute GVHD. These results were published in Biology of Blood and Marrow Transplantation, 21 (2015)
1770-1775. As reported in this peer-reviewed article, 48 patients undergoing matched unrelated donor
transplantation received oral CBD a week before and 30 days after HCT. The incidence of acute grades 2-
4 GVHD among these patients was 12%, compared to a rate of 48% in 102 consecutive patients evaluated previously at the same unit at Beilinson Hospital in Petach Tikvah, Israel.
Based on the promising results of that study, a subsequent Phase 2a clinical study was undertaken to
evaluate the efficacy of prolonged administration of CBD following HCT. In that study, which enrolled 12
patients, participants were provided daily doses of CBD seven days prior to transplantation and for 100 days
following the procedure. With a median follow-up of 8.5 months following transplantation, 85% of patients
in the study did not develop significant (grades 2-4) acute GVHD, despite the fact that the majority of the
patients in the study (10) received stem cells from unrelated donors, including five patients who received
stem cells from non-fully matched donors. Only 15% of these patients developed grades 2-4 GVHD, versus
the predicted incidence of 60% in the scientific literature, potentially representing a more than four-fold
reduction. In a further Phase 2a study, Professor Yeshurun established that treatment of grades 3-4 steroidrefractory
acute GVHD with oral CBD resulted in a complete response in 7 of 10 patients and a very good
partial response in 2 of 10 patients. These findings contrast with the historical data seen in Dr. Yeshurun’s
unit at Beilinson Hospital, where since 2006, among 32 consecutive patients presenting with grades 3-4
acute GVHD, those with grade 3 GVHD had a mortality rate of 33%, and those with grade 4 GVHD had a
100% mortality rate.
Kalytera intends to carry out additional studies in GVHD to advance this program towards regulatory
approval and market authorization. These additional clinical studies may support U.S. Food and Drug
Administration (“FDA”) Breakthrough Therapy and Fast Track Designations, which could accelerate the
regulatory approval process.
Kalytera, through its wholly-owned subsidiary Talent, has the right to pursue the commercialization and
development of CBD for the prevention and treatment of GVHD as the licensee under a world-wide
exclusive license of certain technology (the “Mor License”) with Mor Research Applications Ltd. (“Mor”).
Under the Mor License, Kalytera (through Talent) has been granted exclusive rights under certain
applications of Mor for method of use patents for certain CBD formulations, and all documentation relating
thereto or created in connection therewith, in the field of cannabidiol compositions in the prevention and
treatment of the acute and chronic forms of GVHD.
Under the Mor License, Mor is entitled to royalties equal to a low single-digit percentage of the Net Sales (as defined in the Mor License) of products covered
by the Mor License received by or on behalf of Talent (or in the case of certain sublicenses that may be
granted by Talent), a low single-digit percentage of Net Sales of products covered by the Mor License
actually received by the sublicensee. Under the Mor License, Talent is required to achieve certain clinical
and regulatory milestones on timelines agreed with Mor, failing which Mor will have the right to terminate
the Mor License following the expiry of all applicable cure periods.
CBD Prodrugs
Kalytera is also developing a pre-clinical stage pipeline of CBD prodrugs for the treatment of a variety of
disorders. CBD prodrugs are designed to specifically modify physiochemical properties and functionality
of CBD. These modifications are intended to enhance regional therapy and enable bifunctional therapy.
Kalytera anticipates that, based on preclinical animal studies conducted by Kalytera to date, its prodrug pipeline will be well tolerated.
Prodrugs are covalently-modified derivatives of a pharmacologically active agent and must undergo transformation in vivo in order to release the active agent.
Kalytera’s product candidate portfolio includes a number of proprietary, synthetic, non-psychoactive CBD prodrugs, all of which remain in preclinical testing. Kalytera’s CBD prodrugs are designed to improve the bioavailability of CBD, as well as to permit targeted delivery of CBD to specific disease sites within the body.
Outstanding Shares 129,235,073 a/o Sept 30, 2017
27,582,228 a/o Sept 30, 2016
Company History
Formerly=Santa Maria Petroleum, Inc. until 1-2017
Formerly=Quetzal Energy Ltd. until 6-2012
Security Notes
Capital Change=shs decreased by 1 for 10 split Pay date=06/11/2012.
Capital Change=shs decreased by 1 for 12 split Pay date=03/29/2016.
Capital Change=shs decreased by 1 for 2.3 split. Pay date=01/11/2017.
Non US Stock Exchange Listing
Cash and cash equivalents $55,000
Total current liabilities $1,448,000
Total operating expenses $816,000
OVERVIEW OF THE COMPANY
Kalytera is a clinical-stage specialty pharmaceutical company developing a portfolio of cannabinoid,
cannabinoid-like, and endocannabinoid-like pharmaceutical products. Kalytera believes interest in
cannabinoid therapeutics has increased significantly over the past several years as preclinical and clinical
data has emerged highlighting the potential efficacy and safety benefits of cannabinoid therapeutics.
Kalytera is developing the following product candidates in the following programs: (1) cannabidiol
(“CBD”) therapeutics; (2) proprietary CBD prodrugs; and (3) cannabinoid-like and endocannabinoid-like
compounds, with an initial focus on CBD therapeutics and CBD prodrugs. Kalytera currently has no
product candidate that has received regulatory approval.
Kalytera’s lead clinical-stage program is focused on developing CBD formulations for both treatment and
prevention of acute graft versus host disease (“GVHD”).
Kalytera’s lead program in GVHD has recently completed three Phase 2a clinical studies evaluating the safety and efficacy of (1) short term use of CBD
in the prevention of acute GVHD, (2) prolonged use of CBD in the prevention of acute GVHD, and (3)
prolonged use of CBD in the of treatment steroid-refractory grades 3-4 acute GVHD. Kalytera’s GVHD
program was acquired pursuant to Kalytera’s acquisition of Talent Biotechs Ltd. (“Talent”), a formerly
privately held, Israeli-based developer of CBD therapeutics, as announced on February 16, 2017.
With its recent acquisition of Talent, Kalytera has transitioned from a pre-clinical stage company to a
clinical-stage pharmaceutical company pioneering the development of a next generation of cannabinoid
therapeutics.
Through its experienced leadership, drug development expertise, and intellectual property
rights, Kalytera is seeking to establish a leading position in the development of cannabinoid medicines for
a range of important unmet medical needs, with an initial focus on GVHD.
On November 15, 2017, the Company announced that the United States Patent and Trademark Office has
issued a Notice of Allowance for US Patent Application 15/143,694 covering the use of CBD in the
treatment of GVHD. Securing a patent for this proprietary technology represents an important step forward
for the Company in its work focused on the treatment of this serious and life-threatening disease.
Over the next 12 months, Kalytera intends to advance the development of its CBD therapeutic for the
prevention of acute GVHD by conducting a late-stage clinical study in this indication.
Kalytera is also developing a pre-clinical stage pipeline of CBD prodrugs for the treatment of a variety of
disorders. CBD prodrugs are designed to specifically modify physiochemical properties and functionality
of CBD. These modifications are intended to enhance regional therapy and enable bifunctional therapy.
Over the next 18 months, through Q2 2019, Kalytera also expects to advance at least one of its CBD
prodrugs into Phase 1 human clinical testing.
Cannabidiol (“CBD”)
CBD is a non-psychoactive cannabinoid compound that has been shown to be an effective therapeutic
against a number of pharmacological targets. However, there are limitations associated with natural CBD,
including its poor oral bioavailability. Kalytera is developing CBD formulations and CBD pro-drugs in an
effort to overcome these limitations, and to target delivery of CBD to specific disease sites within the body.
Kalytera has filed composition of matter and method of use patents covering its inventions in the six major
markets (the U.S., the United Kingdom, France, Germany, Italy and Spain, as well as several other
jurisdictions, including Japan, Canada, Brazil and Australia).
Kalytera will also seek to advance a portfolio of synthetic, non-psychoactive cannabinoid-like compounds.
By modifying cannabinoid molecules, and molecules which regulate the endogenous cannabinoid signaling
system, Kalytera will seek to improve pharmacokinetics and increase potency, potentially allowing for the
development of drug candidates with improved activity.
CBD – In Treatment and Prevention of Graft Versus Host Disease (“GVHD”)
GVHD is a multisystem disorder that occurs when the transplanted cells from a donor (“the graft”)
recognize the transplant recipient (“the host”) as foreign. This interaction initiates an immune reaction that
causes disease in the transplant recipient. This reaction can occur within days after the transplant (acute
GVHD) or months to years after the transplant (chronic GVHD).
GVHD commonly occurs following hematopoietic stem cell transplantation (“HCT”), a procedure
whereby the stem cells of the bone marrow or peripheral blood of a healthy donor are transplanted into a
new host after chemotherapy or radiation.
This is a lifesaving procedure for many diseases of the blood and bone marrow including leukemia, Hodgkin and Non-Hodgkin lymphoma, multiple myeloma, sickle cell
anemia, and thalassemia. According to a report prepared by GlobalData PharmaPoint, the Graft- VersusHost-Disease
Opportunity Analysis and Forecasts to 2023 Update (the “GlobalData Report”), there were
over 8,000 HCT procedures in the U.S. in 2014 and the use of HCT is expected to continue to increase at a
rate of 7% per year. Whereas HCT procedures can be lifesaving, they pose many dangerous side effects,
including infection and GVHD.
Acute GVHD is graded from grades 1 to 4, based on the severity of symptoms, and the degree to which
various organ systems are involved. In general, grade 1 can be described as mild, grade 2 can be described
as moderate, grade 3 can be described as severe, and grade 4 can be described as life threatening. Patients
with acute GVHD may suffer from rashes and blistering of the skin, nausea, vomiting, abdominal cramps
accompanied by diarrhea, and jaundice. Generally, acute reactions are more severe and life threatening.
Acute GVHD is a major cause of morbidity and mortality following HCT. As reported in the GlobalData
Report, it is estimated that even with intensive prophylaxis with immunosuppressive treatments, 30-50%
of patients transplanted from fully matched sibling donors and 50-70% of patients transplanted from
unrelated donors will develop some level of acute GVHD.
The first step in prevention of GVHD is the selection of donor cells that closely match the genetics of the
immune system of the transplant recipient, ideally a sibling donor. From there, the patient relies on drugs
that have been developed to prevent or treat GVHD. Medicinal prevention of acute GVHD is dependent on
immunosuppression of the donor cells, either pharmacologically or through T-cell depletion. Common
drugs include methotrexate, cyclosporine tacrolimus, sirolimus, mycophenolate mofetil and ATG.
Preventive measures and clinical practices vary by institution.
Treatment of GVHD involves pharmacologic suppression of the graft’s immune cell activation and reestablishment
of donor-host immune-tolerance. Most patients are prescribed corticosteroids, which directly
suppress the donor’s immune cell attack on host tissue, but also raise the risk of infection and cancer
relapse. As with prevention, the optimal drug strategy for GVHD is not well defined.
As stated in the GlobalData Report, only 30-50% of patients with moderate to severe GVHD respond to corticosteroids,
putting many at risk for fatal outcomes. Better treatment options are needed to improve the mortality and
morbidity outcomes for transplant recipients.
In 2015, Professor Moshe Yeshurun, Kalytera’s Chief Medical Officer (“CMO”), and previously the CMO
of Talent and Head of the Bone Marrow Transplantation Department at the Rabin Medical Center in Israel,
published the results of a Phase 2a clinical trial evaluating the safety and efficacy of CBD in the prevention
of acute GVHD. These results were published in Biology of Blood and Marrow Transplantation, 21 (2015)
1770-1775. As reported in this peer-reviewed article, 48 patients undergoing matched unrelated donor
transplantation received oral CBD a week before and 30 days after HCT. The incidence of acute grades 2-
4 GVHD among these patients was 12%, compared to a rate of 48% in 102 consecutive patients evaluated previously at the same unit at Beilinson Hospital in Petach Tikvah, Israel.
Based on the promising results of that study, a subsequent Phase 2a clinical study was undertaken to
evaluate the efficacy of prolonged administration of CBD following HCT. In that study, which enrolled 12
patients, participants were provided daily doses of CBD seven days prior to transplantation and for 100 days
following the procedure. With a median follow-up of 8.5 months following transplantation, 85% of patients
in the study did not develop significant (grades 2-4) acute GVHD, despite the fact that the majority of the
patients in the study (10) received stem cells from unrelated donors, including five patients who received
stem cells from non-fully matched donors. Only 15% of these patients developed grades 2-4 GVHD, versus
the predicted incidence of 60% in the scientific literature, potentially representing a more than four-fold
reduction. In a further Phase 2a study, Professor Yeshurun established that treatment of grades 3-4 steroidrefractory
acute GVHD with oral CBD resulted in a complete response in 7 of 10 patients and a very good
partial response in 2 of 10 patients. These findings contrast with the historical data seen in Dr. Yeshurun’s
unit at Beilinson Hospital, where since 2006, among 32 consecutive patients presenting with grades 3-4
acute GVHD, those with grade 3 GVHD had a mortality rate of 33%, and those with grade 4 GVHD had a
100% mortality rate.
Kalytera intends to carry out additional studies in GVHD to advance this program towards regulatory
approval and market authorization. These additional clinical studies may support U.S. Food and Drug
Administration (“FDA”) Breakthrough Therapy and Fast Track Designations, which could accelerate the
regulatory approval process.
Kalytera, through its wholly-owned subsidiary Talent, has the right to pursue the commercialization and
development of CBD for the prevention and treatment of GVHD as the licensee under a world-wide
exclusive license of certain technology (the “Mor License”) with Mor Research Applications Ltd. (“Mor”).
Under the Mor License, Kalytera (through Talent) has been granted exclusive rights under certain
applications of Mor for method of use patents for certain CBD formulations, and all documentation relating
thereto or created in connection therewith, in the field of cannabidiol compositions in the prevention and
treatment of the acute and chronic forms of GVHD.
Under the Mor License, Mor is entitled to royalties equal to a low single-digit percentage of the Net Sales (as defined in the Mor License) of products covered
by the Mor License received by or on behalf of Talent (or in the case of certain sublicenses that may be
granted by Talent), a low single-digit percentage of Net Sales of products covered by the Mor License
actually received by the sublicensee. Under the Mor License, Talent is required to achieve certain clinical
and regulatory milestones on timelines agreed with Mor, failing which Mor will have the right to terminate
the Mor License following the expiry of all applicable cure periods.
CBD Prodrugs
Kalytera is also developing a pre-clinical stage pipeline of CBD prodrugs for the treatment of a variety of
disorders. CBD prodrugs are designed to specifically modify physiochemical properties and functionality
of CBD. These modifications are intended to enhance regional therapy and enable bifunctional therapy.
Kalytera anticipates that, based on preclinical animal studies conducted by Kalytera to date, its prodrug pipeline will be well tolerated.
Prodrugs are covalently-modified derivatives of a pharmacologically active agent and must undergo transformation in vivo in order to release the active agent.
Kalytera’s product candidate portfolio includes a number of proprietary, synthetic, non-psychoactive CBD prodrugs, all of which remain in preclinical testing. Kalytera’s CBD prodrugs are designed to improve the bioavailability of CBD, as well as to permit targeted delivery of CBD to specific disease sites within the body.
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