The surge in volume is being fueled in part by the Sunrise, Fla.-based company’s Mar. 17 has announcement that it has entered into a joint venture with Magnum Cell Therapies.
Magnum Cell Therapies mission is to provide the latest regenerative medicine therapies to patients suffering from degenerative diseases. Magnum’s facilities include a state of the art clinic and laboratory located in Honduras.
“We are thrilled to work with the team of specialists and scientists at Magnum. The facilities are top-notch and we are hopeful that Bioheart therapies can help many patients,” said Bioheart’s Chief Science Officer Kristin Comella.
Bioheart will provide the necessary training and expertise to transfer Bioheart therapies to Magnum. Bioheart and Magnum will work closely with the Honduran Ministry of Health to make Bioheart protocols part of the standard of care for patients in Honduras and neighboring countries. Bioheart will assume 10% ownership of Magnum Cell Therapies. Magnum will offer these therapies to the more than 8 million people living in Honduras as well as being a premier site for medical tourism.
On Mar. 4 Bioheart reported on the positive results of 6 months of data from its phase I ANGEL Trial.
Positive Data on Trial
Fully funded by Bioheart, the trial is being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute.
“The six month data has far exceeded our expectations. We were excited to see that patients continued to improve from 3 months to 6 months demonstrating the power of a biological product which can actually remodel tissue and change the course of a disease,” said Kristin Comella, Bioheart's chief science officer, in a written statement. “This phase I study will provide necessary safety and preliminary efficacy of adipose derived stem cells in patients with congestive heart failure. Endpoints include safety, exercise capacity, quality of life, and ejection fraction at 3 months, 6 months and 12 months,” she added.
At the 6 month time point, patients are demonstrating an average improvement in exercise capacity or a six minute walk test of approximately 68 meters as compared to an average improvement of 47 meters at 3 months. Eighty percent of the patients showed an improvement in their exercise capacity from 3 months to 6 months post stem cell injection.
On Mar. 18, BHRT’s share price closed 6 cents, unchanged from share price of the previous day.
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For the fourth quarter of 2013, total operating expenses were $46.6 million, compared to $33.5 million for the fourth quarter of 2012, an increase of $13.1 million.
Research and development expenses were $29.0 million for the fourth quarter of 2013, compared to $25.3 million for the corresponding quarter in 2012, due to an increase in non-cash stock compensation expense of $4.3 million that was offset by a decrease in clinical trial related expenses of $1.3 million.
General and administrative expenses increased by $9.4 million to $17.6 million for the fourth quarter of 2013, compared to $8.2 million in the fourth quarter of 2012. The increase in G&A expenses was due to an increase in non-cash stock compensation expense of $6.0 million and increased professional legal and financing fees of $2.2 million as compared to the corresponding quarter of the prior year.
For fiscal year 2013, operating expenses totaled $169.4 million, compared to $147.0 million for fiscal year 2012. Total R&D expenses for fiscal year 2013 increased by $8.2 million, or 8.1%, to $109.7 million for fiscal year 2013 as compared to $101.5 million for fiscal year 2012, due to an increase in non-cash stock compensation expense of $14.2 million that was offset by a decrease in clinical trial related expense in 2013.
G&A expenses increased by $14.2 million, or 31.2%, to $59.7 million for fiscal year 2013 as compared to $45.5 million in fiscal year 2012, due to increased non-cash stock compensation expense of $17.7 million and increased professional legal and financing fees of $2.3 million in 2013 that was offset by the $6.5 million litigation settlement accrual recorded in 2012.
The net loss applicable to common stockholders for fiscal year 2013 was $(191.5) million, or $(0.64) per share based on 299.6 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $(169.4) million, or $(0.94) per share based on 180.9 million weighted average shares outstanding for fiscal year 2012. The number of common shares outstanding at December 31, 2013 was 369,391,972.
Cash and cash equivalents were $70.8 million at December 31, 2013 and $61.8 million at December 31, 2012. Currently, there is $30.1 million of available borrowings under the amended loan arrangement with The Mann Group.
Of the 5 analyst firms covering MNKD, 1 rates it a “strong buy,” 3 a “hold” and 1 an “underperform.”
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Find out what could be the best investor’s move when it comes to AVNR by getting the complete report here, or by cutting and pasting the following link in your Web browser:
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