8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 10, 2016

PRONAI THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

001-37490	20-0138994
(Commission File Number)	(IRS Employer Identification No.)

2150 – 885 West Georgia Street Vancouver, British Columbia, Canada	V6C 3E8
(Address of principal executive offices)	(Zip Code)

(604) 558-6536

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02. Results of Operations and Financial Condition.

On May 10, 2016, ProNAi Therapeutics, Inc. (the “Company”) reported its financial results for the quarter ended March 31, 2016. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.

The information furnished with Item 2.02 of this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

Exhibit Number	Description
99.1	Press release dated May 10, 2016.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	PRONAI THERAPEUTICS, INC.
Date: May 10, 2016	By:	/s/ Sukhi Jagpal
		Sukhi Jagpal
		Chief Financial Officer

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EXHIBIT INDEX

Exhibit Number	Description
99.1	Press release dated May 10, 2016.

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EX-99.1

Exhibit 99.1

ProNAi Therapeutics Reports First Quarter 2016 Results

Vancouver – May 10, 2016. ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases, today reported its financial and operational results for the first quarter of 2016.

“During the first quarter, we continued to advance our lead cancer drug, PNT2258, in two Phase 2 trials, Wolverine and Brighton, and we remain on track to report interim data from the Wolverine trial in third-line diffuse large B-cell lymphoma (DLBCL) in June 2016,” said Dr. Nick Glover, President and CEO of ProNAi Therapeutics. “In addition, we continued to evaluate novel drug candidates for potential licensing or acquisition, with the vision of establishing a broad and diversified pipeline under our development. Supporting this vision, in the first quarter we further strengthened ProNAi’s core infrastructure by adding two industry veterans to our Board of Directors, Mr. Jeffrey H. Cooper and Mr. Tran Nguyen, and by opening an office in the San Francisco area where our world-class clinical development team resides led by Dr. Barbara Klencke.”

First Quarter 2016 Financial Results (all amounts reported in U.S. currency)

Total operating expenses for the three months ended March 31, 2016 were $10.6 million compared to $6.7 million for the three months ended March 31, 2015. Total operating expenses included non-cash stock based compensation of $1.4 million and $0.2 million for the three months ended March 31, 2016 and 2015, respectively.

Research and development expenses increased to $6.6 million for the three months ended March 31, 2016 from $5.3 million for the three months ended March 31, 2015. These increases were primarily due to expenses related to the continuation of our PNT2258 clinical trials and an increase in personnel-related costs. These increased costs were partially offset by a decrease in third-party manufacturing costs for PNT2258.

General and administrative expenses increased to $4.0 million for the three months ended March 31, 2016 from $1.4 million for the three months ended March 31, 2015. These increases were primarily due to increased personnel-related costs and professional fees incurred in support of activities as a public company and corporate growth, and costs pertaining to business development activities.

For the three months ended March 31, 2016, ProNAi incurred a net loss of $10.5 million compared to a net loss of $8.0 million for the three months ended March 31, 2015. The net loss included a non-cash charge related to the change in fair value of preferred stock warrants of $1.3 million for the three months ended March 31, 2015.

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At March 31, 2016, ProNAi had $140.9 million in cash and cash equivalents compared to $150.2 million in cash and cash equivalents at December 31, 2015.

At March 31, 2016, there were 30,174,778 shares of common stock issued and outstanding and stock options to purchase 4,153,460 shares of common stock issued and outstanding.

About ProNAi Therapeutics

ProNAi Therapeutics is a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases. ProNAi’s lead product candidate, PNT2258, is designed to target cancers that overexpress BCL2, an important and validated oncogene known to be dysregulated in many types of cancer. ProNAi is evaluating PNT2258 in two Phase 2 trials: “Wolverine”, a Phase 2 trial evaluating PNT2258 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL); and “Brighton”, a Phase 2 trial evaluating PNT2258 for the treatment of Richter’s transformation. For more information, please visit www.pronai.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding ProNAi’s anticipated clinical development and potential business development strategies. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that ProNAi may be unable to successfully develop and commercialize PNT2258 or any other future product candidates, PNT2258 may fail to demonstrate safety and efficacy or may not otherwise produce positive results, ProNAi may experience delays in clinical trials, including due to difficulties enrolling patients, ProNAi’s third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, ProNAi’s cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, ProNAi may be unable to obtain and enforce intellectual property protection for its technologies and product candidates and the other factors described under the heading “Risk Factors” set forth in ProNAi’s filings with the Securities and Exchange Commission from time to time. ProNAi undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

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PRONAI THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except share and per share data)

	March 31, 2016			December 31, 2015
ASSETS:
CURRENT ASSETS:
Cash and cash equivalents	$	140,871		$	150,180
Prepaid expenses and other current assets		1,746			1,673
Total current assets		142,617			151,853
Property and equipment, net		623			566
Other assets		196			349
TOTAL ASSETS	$	143,436		$	152,768
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accrued liabilities	$	5,342		$	7,016
Accounts payable		1,779			358
Other current liabilities		7			23
Total current liabilities		7,128			7,397
TOTAL LIABILITIES		7,128			7,397
STOCKHOLDERS’ EQUITY (DEFICIT):
Common stock		30			30
Additional paid-in capital		681,003			679,528
Accumulated deficit		(544,725	)		(534,187	)
TOTAL STOCKHOLDERS’ EQUITY		136,308			145,371
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	143,436		$	152,768

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PRONAI THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share data)

	Three Months Ended March 31,
	2016			2015
Operating expenses:
Research and development	$	6,636		$	5,296
General and administrative		3,977			1,441
Total operating expenses		10,613			6,737
Loss from operations		(10,613	)		(6,737	)
Other income (expense), net:
Change in fair value of preferred stock warrants		—			(1,326	)
Other income		83			25
Total other income (expense), net		83			(1,301	)
Loss before provision for income taxes		(10,530	)		(8,038	)
Provision for income tax		8			10
Net loss		(10,538	)		(8,048	)
Adjustment to redemption value on redeemable convertible preferred stock		—			(11,005	)
Net loss attributable to common stockholders	$	(10,538	)	$	(19,053	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.35	)	$	(12.83	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted		30,070,227			1,485,609

Contact:

James Smith

Vice President of Corporate Affairs

ProNAi Therapeutics

604.558.6545

jsmith@pronai.com

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