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 5, 2016
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)
Registrants 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)) |
Item 2.02. | Results of Operations and Financial Condition. |
On May 5, 2016, Pulmatrix, Inc. (the Company) issued a press release announcing its financial results for the first fiscal quarter ended March 31, 2016. A copy of the press release is furnished as Exhibit 99.1 hereto 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.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit No. |
Description | |
99.1 | Press Release, issued on May 5, 2016 (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: May 5, 2016 | By: | /s/ William Duke, Jr. | ||
William Duke, Jr. | ||||
Chief Financial Officer |
Exhibit 99.1
May 5, 2016
Pulmatrix Reports Q1 2016 Financial Results
LEXINGTON, MA Pulmatrix, Inc. (NASDAQ: PULM) today reports its first quarter financial results and provides an update on the progress of its drug development pipeline.
During the first quarter, we continued to make progress across our development pipeline of inhaled therapeutics, said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. In the second quarter, we expect to report data from the European bioequivalence study for our COPD program, PUR0200.
Financials
Revenues for the first quarter of 2016 were $0.4 million, compared to $0.1 million for the first quarter of 2015. The increase was the result of revenue recognized under our collaboration agreement to develop PUR0200 for COPD.
Research and development expenses for the first quarter of 2016 were $3.4 million, compared to $0.9 million for the same period last year. The increase was primarily due to increases in clinical development costs and external service costs on the PUR1900 and PUR0200 projects. General and administrative expenses for the first quarter of 2016 were $2.4 million, compared to $1.9 million for the same period in 2015. The increase was primarily due to an increase in stock-based compensation expense.
Net loss for the first quarter of 2016 was $5.7 million compared to a net loss of $1.8 million in the same period last year. The increase in net loss is attributable to the noted operating expense increases and the non-recurring impact of the fair value adjustments of our preferred stock warrant liability and derivative liability that were recorded in the first quarter of 2015.
As of March 31, 2016, Pulmatrix had $14.8 million in cash and cash equivalents, compared to $18.9 million as of December 31, 2015.
Through continued financial discipline, we ended the first quarter in a strong financial position with sufficient capital to invest in the development of our current pipeline and operations into mid-2017 based on current expectations, said William Duke, Jr., chief financial officer of Pulmatrix. We believe that this will fund our business beyond multiple data readouts from ongoing and planned clinical studies, as well as other corporate milestones.
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE technology. The Companys proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for lung disease patients. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD). Pulmatrixs
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 Companys 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 establish or maintain collaborations on the development of therapeutic candidates; 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 and to obtain such funding on commercially reasonable terms; the Companys 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 Companys products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Companys annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2016. 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.
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Financial Tables to Follow
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
At March 31, 2016 |
At December 31, 2015 |
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(unaudited) | ||||||||
Assets |
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Current assets: |
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Cash and cash equivalents |
$ | 14,753 | $ | 18,902 | ||||
Prepaid expenses and other current assets |
1,011 | 1,560 | ||||||
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|
|
|
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Total current assets |
15,764 | 20,462 | ||||||
Property and equipment, net |
783 | 685 | ||||||
Long-term restricted cash |
200 | 250 | ||||||
Intangible assets |
7,534 | 7,534 | ||||||
Goodwill |
15,942 | 15,942 | ||||||
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|
|
|
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Total assets |
$ | 40,223 | $ | 44,873 | ||||
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Liabilities and stockholders equity |
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Current liabilities: |
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Loan payable, net of debt discount |
$ | 1,682 | $ | 1,029 | ||||
Accounts payable |
1,272 | 1,090 | ||||||
Accrued expenses |
1,060 | 1,486 | ||||||
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|
|
|
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Total current liabilities |
4,014 | 3,605 | ||||||
Loan payable, net of current portion, debt discount and issuance costs |
5,069 | 5,692 | ||||||
Derivative liability |
11 | 11 | ||||||
Deferred tax liability |
2,959 | 2,959 | ||||||
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|
|
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Total liabilities |
12,053 | 12,267 | ||||||
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Stockholders Equity (Deficit): |
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Common stock, $0.0001 par value 100,000,000 shares and 233,500,000 shares authorized at March 31, 2016 and December 31, 2015; 14,795,408 shares and 14,745,754 shares issued and outstanding, including vested restricted stock units of 279,398 and 229,744, at March 31, 2016 and December 31, 2015, respectively |
1 | 1 | ||||||
Additional paid-in capital |
161,941 | 160,708 | ||||||
Accumulated deficit |
(133,772 | ) | (128,103 | ) | ||||
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Total stockholders equity (deficit) |
28,170 | 32,606 | ||||||
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Total liabilities, redeemable convertible preferred stock and stockholders equity |
$ | 40,223 | $ | 44,873 | ||||
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CONDENSED CONSOLIDATED RESULTS OF OPERATIONS
(unaudited)
(in thousands, except share and per share data)
For the Three Months Ended March 31, |
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2016 | 2015 | |||||||
Revenues |
$ | 396 | $ | 105 | ||||
Operating expenses |
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Research and development |
3,430 | 918 | ||||||
General and administrative |
2,409 | 1,934 | ||||||
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Total operating expenses |
5,839 | 2,852 | ||||||
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Loss from operations |
(5,443 | ) | (2,747 | ) | ||||
Interest expense |
(223 | ) | (184 | ) | ||||
Fair value adjustment of preferred stock warrant liability |
| 727 | ||||||
Fair value adjustment of derivative liability |
| 401 | ||||||
Other expense, net |
(3 | ) | | |||||
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Net loss |
$ | (5,669 | ) | $ | (1,803 | ) | ||
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Net loss attributable to common stockholders |
$ | (5,669 | ) | $ | (1,803 | ) | ||
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Net loss per share attributable to common stockholders, basic and diluted |
$ | (0.38 | ) | $ | (9.55 | ) | ||
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Weighted average shares used to compute basic and diluted net loss per share attributable to common stockholders |
14,754,484 | 188,742 | ||||||
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Investor Contact | ||
Robert Clarke, CEO | William Duke, CFO | |
(781) 357-2333 | (781) 357-2333 | |
rclarke@pulmatrix.com | wduke@pulmatrix.com | |
Chris Brinzey, Westwicke Partners | ||
(339) 970-2843 | ||
IR@pulmatrix.com |