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Note 1 - Organization and Operations
6 Months Ended
Jun. 30, 2019
Notes to Financial Statements  
Nature of Operations [Text Block]
1.
 
Organization and Operations
 
The Company
 
Proteon Therapeutics, Inc. (the “Company”) is a biopharmaceutical company that has historically focused on the development of novel,
first
-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular disease. The Company was formed in
June 2001
and incorporated on
March 24, 2006.
 
On
March 28, 2019,
the Company announced that its
second
Phase
3
trial, PATENCY-
2,
for vonapanitase did
not
meet its co-primary endpoints of fistula use for hemodialysis (
p=0.328
) and secondary patency (
p=0.932
). The PATENCY-
2
clinical trial was the
second
of
two
randomized, double-blind Phase
3
trials, comparing a
30
microgram dose of investigational vonapanitase to placebo in patients with chronic kidney disease, or CKD, undergoing creation of a radiocephalic fistula for hemodialysis. Following the release of top-line data from the PATENCY-
2
clinical trial of vonapanitase on
March 28, 2019,
the Company began to evaluate its strategic alternatives focusing on enhancing stockholder value. It is conducting the process with the assistance of financial and legal advisors and is evaluating the full range of potential strategic alternatives, including but
not
limited to, a merger or sale of the Company, including a sale of assets or intellectual property, business combinations, joint ventures, public and private capital raises and recapitalization options. As part of these efforts, on
April 15, 2019,
the Company announced the engagement of H.C. Wainwright & Co., LLC as its financial advisor to assist in the strategic review process. Since these efforts
may
not
be successful, the Company is also considering other possible alternatives, including a wind-down of operations and a liquidation and dissolution of the Company. The Company has discontinued substantially all its research and development activities, including a reduction in workforce, to reduce operating expenses while it evaluates these opportunities. As of
June 30, 2019,
the Company has terminated all but
four
of its employees. In
2019,
the Company expects to incur severance costs of
$2.9
million related to these terminations. These severance related expenses were fully recorded in the
three
months ending
June 30, 2019.
The Company remains subject to a number of risks similar to other companies in the biotechnology industry, including compliance with government regulations, protection of proprietary technology, dependence on
third
parties and product liability.
 
On
June 22, 2017,
the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a syndicate of current and new institutional investors, led by an affiliate of Deerfield Management Company, L.P., pursuant to which the Company agreed to issue and sell to the investors an aggregate of
22,000
shares of the Company’s Series A Convertible Preferred Stock, par value
$0.001
per share (the “Series A Preferred”), for a purchase price of
$1,000
per share, or an aggregate gross purchase price of
$22.0
million, all upon the terms and conditions set forth in the Purchase Agreement (the “Series A Financing”). The Company closed the Series A Financing on
August 2, 2017 (
see Note
6
).
 
Pursuant to the Series A Financing, on
August 2, 2017,
the Company entered into a registration rights agreement with the holders of the Series A Preferred (the “Registration Rights Agreement”). On
August 3, 2017,
in accordance with the Registration Rights Agreement, the Company filed a registration statement on Form S-
3
to register the Common Stock (“Common Stock”) issuable upon conversion of the Series A Preferred. The registration statement became effective on
August 21, 2017.
As of
June 30, 2019,
340
shares of the Series A Preferred were converted into
341,743
shares of the Company’s Common Stock.
 
Liquidity and Going Concern
 
As of
June 30, 2019,
the Company had cash and cash equivalents of
$10.8
million. The Company believes that its existing cash and cash equivalents will be sufficient to fund operations and capital expenditures into
2020.
The Company had an accumulated deficit of
$222.3
million as of
June 30, 2019.
The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to its administrative organization. Additionally, as stated above, the Company announced that its
second
Phase
3
trial, PATENCY-
2,
for vonapanitase did
not
meet its co-primary endpoints. As a result, the Company has begun to evaluate its strategic alternatives and has discontinued substantially all its research and development activities to reduce operating expenses while it evaluates these opportunities. These conditions raise substantial doubt about its ability to continue as a going concern within
one
year after the date that the financial statements are issued. To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, management has implemented a reduction in expenditures plan and is currently exploring strategic alternatives. While the current reduction in spending expenditure plans will allow the Company to fund its operations in the near-term, there can be
no
assurance that the Company will be able to achieve its future strategic alternatives raising substantial doubt about its ability to continue as a going concern.
 
Pursuant to the requirements of Accounting Standards Codification (ASC)
205
-
40,
Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern
management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within
one
year after the date that the financial statements are issued. This evaluation initially does
not
take into consideration the potential mitigating effect of management’s plans that have
not
been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (
1
) it is probable that the plans will be effectively implemented within
one
year after the date that the financial statements are issued, and (
2
) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within
one
year after the date that the financial statements are issued.
 
Under ASC
2015
-
40,
the strategic alternatives being pursued by the Company cannot be considered probable at this time because
none
of the Company’s current plans have been finalized at the time of filing this Quarterly Report on Form
10
-Q and the implementation of any such plan is
not
probable of being effectively implemented as
none
of the plans are entirely within the Company’s control. Accordingly, substantial doubt is deemed to exist about the Company’s ability to continue as a going concern within
one
year after the date these financial statements are issued.
 
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do
not
include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.