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Harvard Apparatus Regenerative Technology Posts 2Q Financial Results

August 16, 2014

Harvard Apparatus Regenerative Technology (HART) reported unaudited financial results for the three and six months ended June 30.

In its release on Aug. 8, the Company noted operating highlights for the second quarter:

-A sixth human tracheal transplant was performed using the Company's HART-Trachea product on June 3, at Krasnodar Regional Hospital in Russia. The patient was a 24-year-old male suffering from extensive tracheal damage following an automobile accident. The surgery was a success and the patient was recovering well in the days following the procedure.

-In June, HART responded to the information request by the U.S. Food and Drug Administration (FDA) following its initial review of the Company's application for an orphan drug designation for its HART-Trachea product. The Company expects this additional submission to be sufficient for the FDA to determine whether or not it will grant orphan drug designation to the HART-Trachea.

-The European Medicines Agency (EMA), through its Committee for Advanced Therapies (CAT), informed HART of CAT's conclusion that the Company's HART-Trachea product is classified as a tissue- engineered, advanced therapy medicinal product, or Combined ATMP. This classification grants the Company a pathway to clinical trials on a European Union-wide basis, although clinical trials are managed through individual countries' regulatory agencies.

-The Company met with the Medicines and Healthcare Products Regulatory Agency of the U.K. (MHRA) to discuss the HART-Trachea product and the MHRA's views on certain preclinical studies, as well as the Company's planned approach to clinical studies. The Company was very pleased with the feedback it received from the MHRA, and reiterates its previously disclosed statement that it expects to enter clinical trials in Europe earlier than in the U.S.

-For the first six months of 2014, the Company used $3.8 million of cash in operating activities and ended the second quarter with $10.1 million of cash on-hand.

David Green, President and CEO of Harvard Apparatus Regenerative Technology, said: "Our Company had a very productive second quarter. We were glad to receive the EMA's classification of our HART- Trachea as a Combined ATMP. We were also very encouraged by our first meeting with the MHRA. We chose the U.K. to approach first in Europe due to the MHRA's familiarity with cell therapies, and the availability of surgeons and hospitals there that are already familiar with early progress in tissue-engineered products. Based on that discussion we continue to see a path to clinical trials in Europe prior to the United States. Domestically, although we submitted our responses to the FDA's request for additional information regarding our orphan designation application later than we expected during the quarter, we anticipate the information we provided will result in the FDA ruling on our application in the next several weeks. Further, our management team was strengthened with the onboarding of Dr. Saverio La Francesca, our new Chief Medical Officer, at the beginning of the quarter."

Green continued, "In addition to pursuing our HART-Trachea program we continue to work closely with a number of leading researchers on their efforts to regenerate other organs as well. We continue to believe that our approach to trachea transplant could someday be translated to other tubular organs in the body."

Second Quarter Reported Results

During the second quarter of 2014, we recognized revenues of $23,000 from the sale of bioreactor systems for organ regeneration research. Prior to our spin-off from Harvard Bioscience on November 1, 2013, we did not record revenues on the sale of research systems. Thus, revenues were first recorded during the fourth quarter of 2013.

Net loss was $2.5 million, or $0.32 per diluted share, for the three months ended June 30, compared to a $2.1 million net loss, or $0.27 per diluted share, for the same period in 2013. The unfavorable year-to-year quarterly net loss comparison was primarily due to an increase in general and administrative expenses related to the fact that the Company became an independent, publicly traded entity in November 2013.

At the time of the spin-off on Nov. 1, 2013, Harvard Bioscience contributed the assets of its regenerative medicine business and cash of $15 million to HART. At June 30, HART had cash on hand of $10.1 million, and had no debt.

Harvard Apparatus Regenerative Technology is a clinical stage biotechnology company developing regenerated organs for transplant, initially focused on the trachea.

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