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Celsion (NASDAQ:CLSN) released their second quarter 2013 financial results this morning, and held a conference call subsequent to that at 10AM CST.
From this morning's press release, we received even more affirmation that the company has in no way ruled out the potential for its ThermoDox, even after its failed Phase III HEAT trial results that were posted earlier in the year.
From this morning's press release:
"As we continue to follow patients in the HEAT Study to the secondary endpoint, Overall Survival, there is clear evidence that ThermoDox® can benefit patients when RFA is optimized," said Dr.Nicholas Borys, Celsion's Chief Medical Officer. "It is impressive that a single dose of ThermoDox® can demonstrate a meaningful impact on patient survival. The influence of longer RFA heating time on local tissue concentration is consistent with the mechanism of ThermoDox® activity."
So, the company is now almost six months into examining the data and they're still contesting that there's a likely chance ThermoDox could play a role in cancer treatment in the future. The press release also states (underlines are my emphasis):
While the Overall Survival data reported above should be viewed with caution since the HEAT Study has not reached its median point for Overall Survival analysis, there is a strong signal which our investigators consider to be encouraging and sufficient to warrant additional clinical investigation.
The press release goes on to talk about some of the aforementioned restructuring and cost cutting that the company has implemented, again emphasizing that the company is committed to maintaining a strong balance sheet as it moves forward.
"Our recent expense reduction initiatives ensure a strong balance sheet and positions the Company to fully explore the appropriate regulatory path forward for ThermoDox® and to evaluate opportunities with the potential to broaden our product pipeline through acquisition of complementary products and technologies."
A disappointment, from the call and press release, was that there was no mention of how the acquisition search was going, and definitely no announcement of any acquisition. I had previously argued that acquiring a company that was either profitable or had an entire other pipeline could have been the grand slam for Celsion this quarter. They've been speaking about doing it for six months now, but have offered little update to shareholders.
The PR then goes on to recap some of the business events that have transpired since April, notably reaffirming the company's relationship with Hisun Pharma yet again.
The company's research and development costs were one of the most prominent factors pointed out in the PR:
Research and development expenses decreased by $2.1 million (50%), from $4.1 million in the second quarter of 2012 to $2.0 million in the second quarter of 2013. Research and development expenses decreased by $3.6 million (41%), from $8.8 million in the six month period ended June 30, 2012 to $5.2 million in the same period of 2013. These decreases were primarily due to reduced clinical development costs associated with the Phase III HEAT Study and activities related to the development of commercial manufacturing capabilities for ThermoDox®.
Operating costs for the first six months of 2013 totaled $3.1 million, or roughly $500k a month, a number that's $300k/month lower than the $800k I postulated in my previous article.
The call at 10AM EST led off with Michael Tardugno, alongside Dr. Borys and Jeff Church.
Tardugno began by offering a Phase III HEAT update. He again stated that the post-hoc data reviewed showed that optimized RFA may provide a meaningful benefit. He noted that more RFA means more drug released from the liposomal transport system.
Tardugno then went on and announced that the company's restructuring that was announced is in full effect. He reiterated that the company's balance sheet bolstered by what he called both a timely and "smart" offering that took place several months ago. Tardugno said that the company is generally "well positioned in oncology".
He alluded to the acquisition project again, but failed to offer any type of update - something that I had hoped they were going to cover on this call.
Tardugno went on to note that patients with small lesions did well, but the company still needs to isolate some of the variables to find out why. He noted that RFA treatment time appears to be a significant factor because heating is an important piece in making sure the doxorubicin is concentrated properly. More data is being collected quarterly, so the data used for this call is from June 30, 2013.
Tardugno concluded "with confidence" that RFA optimization is going to make a difference. He stated that oncology leaders have been anxious and "excited" to present Celsion's data around the world. The company is expecting a meeting with the FDA "early in the fourth quarter" to review a proposal regarding the post-hoc data and moving forward with ThermoDox. They're hoping by the end of the year to be able to disclose to shareholders progress with the FDA and the company expects beginning of 2014 to mark enrollment of a new study.
Both Church and Tardugno boasted about the equity financing completed both at the market price and without warrants. I had previously argued that this financing was a bullish sign for the company going forward, and it's clear the executives for Celsion felt the same way.
In terms of the DIGNITY study, they reported that they hope to begin reporting results in the beginning of 2014, and that the company restructuring has no effect on the DIGNITY study.
Tardugno again reaffirmed the partnership with Hisun and said that more details on the partnership will be available when "final documents" are completed. So, it sounds like something is in the works with Hisun and China.
The company ended the quarter with about $50 million cash on hand, plenty to do their business with, and 61.2 million common shares outstanding. There are no preferreds outstanding.
Tardugno had a generally confident sounding tone throughout his introduction of the call, ending by saying that the company is "excited about the potential" for ThermoDox and "optimistic about the future".
This call, although lacking more information on acquisitions, showed me that Celsion is still heading in the direction which I can be confident about. I reaffirm my sentiment that this has potential to be a $4 stock in the future and remain bullish on Celsion's future heading into the second half of 2013.
Best of luck to all investors.
Disclosure: I am long CLSN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.