Tekmira Pharma (TKMR) Posts Wider than Expected Q2 Loss of 28c/Share; Expects FDA Hold to Resolved by Q4 2014

Tekmira Pharma (NASDAQ: TKMR) reported Q2 EPS of ($0.28), $0.02 worse than the analyst estimate of ($0.26). Revenue for the quarter came in at $1.8 million versus the consensus estimate of $3.72 million.

"We continue to monitor the tragic Ebola virus outbreak very closely. The current outbreak underscores the critical need for an effective therapeutic agent to treat the Ebola virus,"said Dr. Mark J. Murray, Tekmira's President and CEO.

"We remain sharply focused on our clinical programs and the key milestones to be reached by year end. Importantly, our Hepatitis B program continues to advance, with the goal of filing an IND, or equivalent, for our TKM-HBV program in the second half of 2014. Within our TKM-PLK1 oncology platform, we expect to present Phase IIa interim data from our clinical trial with GI-NET and ACC patients before the end of this year, and we have begun enrollment in an additional Phase I/II trial targeting HCC patients," stated Dr. Murray.

Corporate Update

• For the second quarter ended June 30, 2014 we had cash, cash equivalents and investments of $129.5 million. The company has 22.1 million common shares issued and outstanding, and 24.6 million shares on a fully diluted basis.
• The single ascending dose portion of the TKM-Ebola Phase I clinical trial has been successfully completed in healthy human volunteers. As per the protocol maximum tolerated dose (MTD) was established to be 0.3 mg/kg for healthy subjects without steroid premedication.
• In July, we received notice from the U.S. Food & Drug Administration (FDA) that our TKM-Ebola program was on clinical hold. Subsequently, the company received written notice from the FDA modifying the clinical hold to a "partial clinical hold," allowing for the potential use of TKM-Ebola in individuals who have a confirmed or suspected Ebola infection. The company remains on clinical hold as it relates to the multiple-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM-Ebola. The company expects this matter to be resolved by Q4 2014.
• Our therapeutic, TKM-Ebola, is currently an unapproved agent and the regulatory framework to support its use in Africa has not yet been established. Given the severity of the situation, we are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols. This includes discussions with government agencies and NGO's, including the WHO, in various countries on the potential use of TKM-Ebola to treat Ebola virus infected individuals. There can be no assurance that an appropriate framework for the use of this product will be found. We will continue to provide updates as necessary when clinical and regulatory pathways become confirmed.
• Within our TKM-PLK1 clinical trial targeting GI-NET and ACC patients, we saw an additional RECIST qualifying Partial Response (PR), defined as a greater than 30 percent reduction in target tumor lesions. This patient is continuing on therapy and has achieved a 44 percent reduction in their target tumor mass, located outside of the liver. Furthermore, scans of the target tumor lesions demonstrate signs of necrosis, indicative of anti-tumor activity.
• We have initiated a Phase I/II clinical study of TKM-PLK1 in patients with Hepatocellular Carcinoma (HCC).
• We intend to file an Investigational New Drug (IND) application, or equivalent, in the second half of 2014, in order to advance our TKM-HBV program into a Phase I clinical study, with initial data available in 2015.
• We received an additional $1.5 million payment from Monsanto following completion of specified program developments.

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