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): August 14, 2015

PULMATRIX, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-36199	46-1821392
(State of incorporation)	(Commission File No.)	(IRS Employer Identification No.)

99 Hayden Avenue, Suite 390

Lexington, MA 02421

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (781) 357-2333

Not Applicable

(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 (see General Instruction A.2. below):

¨ 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))

Section 2 – Financial Information

Item 2.02. Results of Operations and Financial Condition.

On August 14, 2015, Pulmatrix, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2015. A copy of the press release is being furnished hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K (including Exhibit 99.1) is being furnished pursuant to Item 2.02 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities of that section, and such information shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.

Section 9 – Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release, issued on August 14, 2015 (furnished herewith pursuant to Item 2.02).

SIGNATURES

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.

	PULMATRIX, INC.
Date: August 14, 2015	By:	/s/ William Duke, Jr.
		William Duke, Jr.
		Chief Financial Officer

Exhibit Index

Exhibit No.	Description
99.1	Press Release, issued on August 14, 2015 (furnished herewith pursuant to Item 2.02).

EX-99.1

Exhibit 99.1

 

August 14, 2015

Pulmatrix Reports 2^nd Quarter Results; Provides Update on Business & Development Pipeline

LEXINGTON, MA -- Pulmatrix, Inc., (NASDAQ: PULM) reports second quarter financial results and provides an update on the progress year to date on the business and its drug development pipeline.

“During the second quarter, we strengthened our balance sheet, became a publicly traded company listed on NASDAQ, strengthened our management and board, and continued to move our pipeline of inhaled treatments for pulmonary disease forward,” said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. “Specifically, we announced our partnership with Mylan for the development of PUR0200, our branded generic bronchodilator for COPD, in Europe and that we are moving toward a clinical trial for PUR1900, our lead proprietary product, which could be the first inhaled anti-fungal for patients with cystic fibrosis.”

During the next eighteen months, Pulmatrix plans to focus on achieving the following milestones:

· Initiate European pharmacokinetic bioequivalence clinical study to advance development of PUR0200;

· Report pharmacokinetic profile of PUR0200;

· Initiate a Phase 1 trial and generate initial data for PUR1900;

· Identify lead active pharmaceutical ingredient(s) for PUR1500, Pulmatrix’s drug candidate for idiopathic pulmonary fibrosis; and

· Further strengthen patent protection for Pulmatrix’s iSPERSE™ (inhaled Small Particles Easily Respirable and Emitted) platform and related therapeutic applications.

Financials

As of June 30, 2015, Pulmatrix had $25.5 million in cash, cash equivalents, and short-term investments.

“We ended the second quarter in a strong financial position with sufficient capital to invest in the development of our current pipeline and operations into mid-2017,” said William Duke, Jr., chief financial officer of Pulmatrix. “This will fund our business beyond multiple data readouts from ongoing and planned clinical studies, as well as other corporate milestones.”

Research and development expenses for the second quarter of 2015 were $1.6 million, compared to $1.7 million for the same period last year. The company continued to invest predominately in regulatory and clinical development work related to the anticipated European bioequivalence clinical study of PUR0200, conducting investigational new drug-enabling studies for PUR1500, and continued research on the iSPERSE™ technology to further optimize the platform, support patent protection, and expand its utility beyond small molecules.

 

General and administrative expenses for the second quarter of 2015 were $9.9 million, which included $7.8 million of one-time expense relating to the Merger. This compares to $0.7 million for the same period in 2014. The increase of $9.2 million was primarily the result of noted expenses relating to the Merger and increased stock compensation expense relating to the Company’s new incentive program.

Net loss for the second quarter of 2015 was $14.9 million, or $(2.66) per share, compared to a net loss of $7.0 million, or $(2.21) per share in the same period last year. Included in the net loss for the second quarter of 2015 was a net $10.7 million in non-cash expenses, compared to $4.6 million for the same period last year.

About Pulmatrix

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF), as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. In addition, Pulmatrix intends to pursue opportunities in major pulmonary diseases through collaborations, which includes PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD) in partnership with Mylan N.V.  Pulmatrix's product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in quarterly report on Form 10-Q filed by the Company on August 14, 2015. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

###

Financial tables to follow.

 

PULMATRIX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

	At June 30, 2015			At December 31, 2014
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	25,507		$	451
Prepaid expenses and other current assets		510			380
Total current assets		26,017			831
Property and equipment, net		545			470
Long-term restricted cash		253			250
Intangible assets		7,534			—
Goodwill		15,942			—
Other assets		22			—
Total assets	$	50,313		$	1,551
Liabilities and stockholders’ deficit
Current liabilities:
Convertible notes payable to stockholders, net of discount	$	—		$	39,703
Accounts payable		314			216
Accrued expenses		1,013			3,544
Total current liabilities		1,327			43,463
Loan payable, net of discount		6,706			—
Derivative liability		11			—
Preferred stock warrant liability		—			1,309
Deferred tax liability		2,959			—
Total liabilities		11,003			44,772
Redeemable convertible preferred stock, $0.0001 par value—authorized 500,000 shares and 209,297,265 shares at June 30, 2015 and December 31, 2014, respectively
Series B redeemable convertible preferred stock, $0.01 par value — 0 shares and 180,980,200 shares designated at June 30, 2015 and December 31, 2014; 0 shares and 41,788,790 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively (liquidation preference of $0 and $20,894 at June 30, 2015 and December 31, 2014)		—			20,894
Seed Redeemable Convertible Preferred Stock, $0.01 par value — 0 shares and 1,219,508 shares designated at June 30, 2015; 0 shares and 1,219,508 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively (liquidation preference of $0 and $1,331 at June 30, 2015 and December 31, 2014)		—			1,331
Series A-4 Redeemable Convertible Preferred Stock, $0.01 par value — 0 shares and 1,307,190 shares designated; 0 shares and 1,307,190 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively; (liquidation preference of $0 and $4,000 at June 30, 2015 and December 31, 2014)		—			4,000
Series B-1 Redeemable Convertible Preferred Stock, $0.01 par value — 0 shares and 18,687,554 shares designated; 0 shares and 18,687,554 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively; (liquidation preference of $0 and $9,344 at June 30, 2015 and December 31, 2014)		—			9,344
Junior Seed Convertible Preferred Stock, $0.01 par value — 0 shares and 410,000 shares designated; 0 shares and 410,000 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively; (liquidation preference of $0 and $820 at June 30, 2015 and December 31, 2014)		—			4
Stockholders’ Equity (Deficit):
Common stock, $0.0001 par value — 100,000,000 shares and 233,500,000 shares authorized at June 30, 2015 and December 31, 2014; 14,646,108 shares and 188,625 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively		1			—
Additional paid-in capital		157,944			23,142
Accumulated deficit		(118,635	)		(101,936	)
Total stockholders’ equity (deficit)		39,310			(78,794	)
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)	$	50,313		$	1,551

PULMATRIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except share and per share data)

	For the Three Months Ended June 30,						For the Six Months Ended June 30,
	2015			2014			2015			2014
Revenues	$	170		$	—		$	275		$	8
Operating expenses
Research and development		1,610			1,729			2,528			3,491
General and administrative		9,879			722			11,812			1,379
Total operating expenses		11,489			2,451			14,340			4,870
Loss from operations		(11,319	)		(2,451	)		(14,065	)		(4,862	)
Interest expense		(327	)		(5,613	)		(511	)		(6,868	)
Loss on the conversion of convertible notes		(1,170	)		—			(1,170	)		—
Fair value adjustment of preferred stock warrant liability		582			1,123			1,309			1,275
Fair value adjustment of derivative liability		(2,692	)		—			(2,291	)		—
Other income, net		29			—			29			1
Net loss	$	(14,897	)	$	(6,941	)	$	(16,699	)	$	(10,454	)
Net Loss Attributable to Common Stockholders	$	(14,897	)	$	(6,954	)	$	(16,699	)	$	(10,481	)
Net loss per share attributable to common stockholders, basic and diluted	$	(2.66	)	$	(2.21	)	$	(3.79	)	$	(3.33	)
Weighted average shares used to compute basic and diluted net loss per share attributable to common stockholders		5,608,429			3,145,521			4,401,087			3,145,283

Investor Contact	Media Contact
Tom Baker	David Schull, Russo Partners
Direct: (617) 532-0624	Direct: (858) 717-2310
tbaker@pulmatrix.com	David.Schull@russopartnersllc.com