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): November 1, 2019
PULMATRIX, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-36199 | 46-1821392 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
99 Hayden Avenue, Suite 390
Lexington, MA 02421
(Address of principal executive offices) (Zip Code)
(781) 357-2333
(Registrants telephone number, including area code)
N/A
(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)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of exchange on which registered | ||
Common Stock, par value $0.0001 per share | PULM | The NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 | Results of Operations and Financial Condition. |
On November 1, 2019, Pulmatrix, Inc. (the Company) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2019. 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 the 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 in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. |
Description | |
99.1 | Press release, dated November 1, 2019. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
PULMATRIX, INC. | ||||||
Date: November 1, 2019 | By: | /s/ William Duke, Jr. | ||||
William Duke, Jr. | ||||||
Chief Financial Officer |
Exhibit 99.1
November 1, 2019
Pulmatrix Reports Q3 2019 Results
LEXINGTON, MA Pulmatrix, Inc. (NASDAQ: PULM) today reports its third quarter results.
Q3 2019 Highlights
Pulmatrix achieved clinical and business milestones which reflect the Companys progress. These milestones include the following:
| Received regulatory approval for Poland and India to commence patient enrollment in its Pulmazole Phase 2 clinical trial Pulmatrix now has approval in each country that has a clinical trial site |
| Received US Patent (Pat. No. 10376465) Covering iSPERSETM Formulations for Pulmazole Program |
We are excited with the Pulmazole program momentum over the past quarter. With regulatory approval to commence patient enrollment now achieved in all countries, we activated 12 additional study sites in the third quarter and anticipate increased patient enrollments from the 19 study sites now active, said Ted Raad, chief executive officer of Pulmatrix. In addition to the Pulmazole program progress, we continue to advance the PUR1800 program towards a Phase 1b study start in first half of 2020. Both the Pulmazole Phase 2 and the PUR1800 Phase 1b studies are fully funded with data read-outs expected in the second half of 2020.
Financials
As of September 30, 2019, Pulmatrix had $27.9 million in cash, compared to $2.6 million as of December 31, 2018. In April 2019, Pulmatrix completed a financing that resulted in $16.6 million of total gross proceeds and executed a Definitive Agreement with Cipla for the co-development and commercialization of Pulmazole. In early May 2019, Pulmatrix received a $22 million upfront payment from Cipla. Following the completion of the initiated Phase 2 clinical trial, Pulmatrix and Cipla will equally share costs related to the future development and commercialization of Pulmazole and will equally share worldwide free cash flow from future sales of Pulmazole.
Pulmatrix generated $1.4 million of revenue in the third quarter of 2019, compared to no revenues in the third quarter of 2018. The revenue for the third quarter of 2019 was the result of the recognition of income pursuant to the Cipla Agreement.
Research and development expenses for the third quarter of 2019 were $3.3 million, compared to $3.1 million for the same period last year. The increase was primarily due to increased clinical development costs on the Pulmazole project, partially offset by decreases in clinical development costs on the PUR1800 project and decreased employment costs. General and administrative expenses for the both third quarter of 2019 and for the third quarter of 2018 were $1.8 million.
Net loss was $3.6 million for the third quarter of 2019 and $4.8 million for the third quarter of 2018. The reduction in net loss was primarily due to the increase in revenue recognized.
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 serious lung diseases, including Pulmazole, an inhaled anti-fungal for patients with allergic bronchopulmonary aspergillosis (ABPA), and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and chronic obstructive pulmonary disease (COPD). Pulmatrixs product candidates are based on iSPERSE, its proprietary engineered 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. Such forward-looking statements include, but are not limited to, statements of historical fact, and may be identified by words such as anticipates, assumes, believes, can, could, estimates, expects, forecasts, guides, intends, is confident that, may, plans, seeks, projects, targets, and would, and their opposites and similar expressions are intended to identify forward-looking statements. 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, delays in planned clinical trials; 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 filings with the SEC, including its annual report on Form 10-K filed with the Securities and Exchange Commission on February 19, 2019, as amended on July 24, 2019, as may be supplemented or amended by the Companys Quarterly Reports on Form 10-Q. 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 September 30, 2019 |
At December 31, 2018 |
|||||||
(unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash |
$ | 27,879 | $ | 2,563 | ||||
Prepaid expenses and other current assets |
960 | 717 | ||||||
|
|
|
|
|||||
Total current assets |
28,839 | 3,280 | ||||||
Property and equipment, net |
305 | 394 | ||||||
Long-term restricted cash |
204 | 204 | ||||||
Goodwill |
3,577 | 10,845 | ||||||
|
|
|
|
|||||
Total assets |
$ | 32,925 | $ | 14,723 | ||||
|
|
|
|
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable |
$ | 1,159 | $ | 1,183 | ||||
Accrued expenses |
1,265 | 1,696 | ||||||
Deferred revenue |
9,304 | | ||||||
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|
|
|
|||||
Total current liabilities |
11,728 | 2,879 | ||||||
Deferred revenue, net of current portion |
6,471 | | ||||||
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|
|
|
|||||
Total liabilities |
18,199 | 2,879 | ||||||
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|
|
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Stockholders equity: |
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Common stock, $0.0001 par value 200,000,000 shares authorized; 19,994,560 and 4,932,723 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively |
2 | | ||||||
Additional paid-in capital |
225,844 | 206,409 | ||||||
Accumulated deficit |
(211,120 | ) | (194,565 | ) | ||||
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|
|
|
|||||
Total stockholders equity |
14,726 | 11,844 | ||||||
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|
|
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Total liabilities and stockholders equity |
$ | 32,925 | $ | 14,723 | ||||
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CONDENSED CONSOLIDATED RESULTS OF OPERATIONS
(unaudited)
(in thousands, except share and per share data)
For the Three Months Ended September 30, |
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2019 | 2018 | |||||||
Revenues |
$ | 1,406 | $ | | ||||
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|
|
|
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Operating expenses |
||||||||
Research and development |
3,297 | 3,056 | ||||||
General and administrative |
1,785 | 1,769 | ||||||
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|
|
|
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Total operating expenses |
5,082 | 4,825 | ||||||
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|
|
|
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Loss from operations |
(3,676 | ) | (4,825 | ) | ||||
Interest income |
121 | 8 | ||||||
Other income |
| 1 | ||||||
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|
|
|
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Net loss |
$ | (3,555 | ) | $ | (4,816 | ) | ||
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Net loss per share attributable to common stockholders, basic and diluted |
$ | (0.18 | ) | $ | (1.03 | ) | ||
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Weighted average shares used to compute basic and diluted net loss per share attributable to common stockholders |
20,294,560 | 4,610,205 | ||||||
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Investor Contact
Timothy McCarthy, CFA
212.915.2564
tim@lifesciadvisors.com