XML 32 R15.htm IDEA: XBRL DOCUMENT

Intangible Assets

6 Months Ended

Jun. 30, 2020

Intangible Assets, Net (Including Goodwill) [Abstract]

Note 8. Intangible Assets

In June 2014, we completed the acquisition of substantially all of the assets of EGEN, Inc., an Alabama corporation, which has changed its company name to EGWU, Inc. after the closing of the acquisition (“EGEN”). We acquired all of EGEN’s right, title and interest in and to substantially all of the assets of EGEN, including cash and cash equivalents, patents, trademarks and other intellectual property rights, clinical data, certain contracts, licenses and permits, equipment, furniture, office equipment, furnishings, supplies and other tangible personal property. In addition, CLSN Laboratories assumed certain specified liabilities of EGEN, including the liabilities arising out of the acquired contracts and other assets relating to periods after the closing date.

Acquired In-process Research and Development

Acquired in-process research and development (IPR&D) consists of EGEN’s drug technology platforms: TheraPlas and TheraSilence. The fair value of the IPR&D drug technology platforms was estimated to be $24.2 million as of the acquisition date. As of the closing of the acquisition, the IPR&D was considered indefinite lived intangible assets and will not be amortized. IPR&D is reviewed for impairment at least annually as of our third quarter ended September 30, and whenever events or changes in circumstances indicate that the carrying value of the assets might not be recoverable. The Company’s IPR&D consisted of three core elements, its RNA delivery system, its glioblastoma multiforme cancer (GBM) product candidate and its ovarian cancer indication.

The Company’s ovarian cancer indication, with original value of $13.3 million, has not been impaired since its acquisition. At September 30, 2019, the Company evaluated its IPR&D of the ovarian cancer indication and concluded that it is not more likely than not that the asset is impaired. As no other indicators of impairment existed during the fourth quarter of 2019, or first half of 2020, no impairment charges were recorded during the six months ended June 30, 2020 and 2019.

The Company’s GBM candidate, with original value of $9.4 million had cumulative impairments through 2018 of $7 million, with remaining carrying value of $2.4 million at December 31, 2019 and March 31, 2020, On September 30, 2019, the Company evaluated its IPR&D of the (GBM) product candidate and concluded that it is not more likely than not that the asset is further impaired. As no other indicators of impairment existed during the fourth quarter of 2019 and in the first half of 2020, no impairment charges were recorded during the six months ended June 30, 2020 and 2019.

The Company’s RNA delivery system, with an initial value of $1.5, million was previously fully impaired.

Covenants Not to Compete

Pursuant to the EGEN Purchase Agreement, EGEN provided certain covenants (“Covenant Not To Compete”) to the Company whereby EGEN agreed, during the period ending on the seventh anniversary of the closing date of the acquisition on June 20, 2014, not to enter into any business, directly or indirectly, which competes with the business of the Company nor will it contact, solicit or approach any of the employees of the Company for purposes of offering employment. The Covenant Not to Compete which was valued at approximately $1.6 million at the date of the EGEN acquisition has a definitive life and is amortized on a straight-line basis over its life of 7 years. The Company recognized amortization expense of $56,829 in each of the three-month periods ended June 30, 2020 and 2019. The Company recognized amortization expense of $113,658 in each of the six-month periods ended June 30, 2020 and 2019.

The carrying value of the Covenant Not to Compete was $227,318, net of $1,363,896 accumulated amortization as of June 30, 2020 and $340,976, net of $1,250,238 accumulated amortization, as of December 31, 2019.

Following is a schedule of future amortization amounts during the remaining life of the Covenant Not to Compete.

	Year Ended June 30,
2021	$	227,318
2022 and thereafter		─
Total	$	227,318

Goodwill

The purchase price exceeded the estimated fair value of the net assets acquired by approximately $2.0 million which was recorded as Goodwill. Goodwill represents the difference between the total purchase price for the net assets purchased from EGEN and the aggregate fair values of tangible and intangible assets acquired, less liabilities assumed. Goodwill is reviewed for impairment at least annually as of our third quarter ended September 30 or sooner if we believe indicators of impairment exist. As of June 30, 2020, we concluded that the Company’s fair value exceeded its carrying value therefore “it is not more likely than not” that the Goodwill was impaired.

As described in Note 3, on July 13, 2020, the Company announced that it has received a recommendation from the DMC to consider stopping the global Phase III OPTIMA Study of ThermoDox® in combination with RFA for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer. This event will be incorporated in the Company’s assessment of the carrying value of goodwill and intangible assets as of the date the information was available, which is the third quarter of 2020.

Following is a summary of the net fair value of the assets acquired in the EGEN asset acquisition for the three-month period ended June 30, 2020:

	IPR&D		Goodwill		Covenant Not To Compete
For the six-months ended June 30, 2020
Balance at January 1, 2020, net	$	15,736,491	$	1,976,101	$	340,976
Amortization		-		-		(113,658	)
Balance at June 30, 2020, net	$	15,736,491	$	1,976,101	$	227,318