Form 8-K - Current report

 

 

 

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 9, 2023

 

 

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.)

 

36 Crosby Drive, Suite 100

Bedford, MA 01730

(Address of principal executive offices) (Zip Code)

 

[phone]

(Registrant’s telephone number, including area code)

 

99 Hayden Avenue, Suite 390

Lexington, MA 02421 

(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 9, 2023, Pulmatrix, Inc. issued a press release announcing its financial results for the third fiscal quarter ended September 30, 2023, and provided a corporate update. 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, being furnished pursuant to Item 2.02, shall not be deemed to be “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, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release dated November 9, 2023*
104		Cover Page Interactive Data File (formatted as Inline XBRL)

 

* This exhibit is furnished pursuant to Item 2.02 and shall not be deemed to be “filed.”

 

 

 

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 9, 2023	By:	/s/ Teofilo Raad
		Teofilo Raad
		Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Pulmatrix Announces Third Quarter 2023 Financial Results and Provides Corporate Update

 

Patient enrollment for the Phase 2b study of PUR1900 is ongoing with four additional sites added during Q3, totaling seventeen active sites to date in four countries; topline data anticipated in H2 2024

 

Received “study may proceed” letter on an IND for a Phase 2 study of PUR3100 for acute migraine

 

$21.3 million in cash and cash equivalents at the end of Q3 2023 providing projected cash runway into Q1 2025

 

Bedford, Mass., November 9, 2023 – Pulmatrix, Inc. (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented dry powder inhalation iSPERSE™ technology, today announced third quarter financial results for 2023 and provided a corporate update on its development programs.

 

Ted Raad, Chief Executive Officer of Pulmatrix commented, “Our PUR1900 Phase 2b study in allergic bronchopulmonary aspergillosis, or ABPA, is ongoing with newly activated sites now contributing to enrollment efforts. With receipt of the FDA “study may proceed” letter for PUR3100 announced in September 2023, we anticipate initiating the PUR3100 Phase 2 study once appropriate financing or partnership has been arranged. While we continue to advance our clinical programs, we believe we have maintained operational efficiency to preserve our projected cash runway into the first quarter of 2025.”

 

Third Quarter 2023 and Recent Program and Corporate Highlights

 

PUR1900

 

	●	Since February 2023, PUR1900 (itraconazole, administered as a dry powder for inhalation using iSPERSE™) has been in a Phase 2 trial for the treatment of ABPA in patients with asthma (NCT05667662). This trial is a randomized, double-blind, multi-center, placebo-controlled study to evaluate PUR1900’s efficacy and safety. The multi-center study is being conducted in the United States, United Kingdom, Australia and France. Endpoints include safety, tolerability, and potential efficacy outcomes to identify potential registrational endpoints in adult patients with asthma and ABPA. Pulmatrix currently anticipates topline data from this study in the second half of 2024.
	●	The current Phase 2 trial of PUR1900 builds on the results of the Phase 1 trial, which were published earlier this year in the peer-reviewed American Association of Pharmaceutical Scientists (AAPS) Journal and titled “Evaluation of the Potential for Drug-Drug Interactions with Inhaled Itraconazole Using Physiologically Based Pharmacokinetic Modelling, Based on Phase 1 Clinical Data”. Results demonstrated a low likelihood of clinically meaningful drug-drug interactions with inhaled PUR1900 as opposed to the known contraindications that exist with various medications when combined with oral itraconazole, demonstrating the potential advantage of inhaled therapeutics.

 

PUR3100

 

●

In September 2023, Pulmatrix announced FDA acceptance of its Phase 2 IND application for PUR3100 and receipt of a “study may proceed” letter for a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100, an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™, will be evaluated in patients with acute migraine. Pulmatrix is currently pursuing potential partnership opportunities to further develop this product candidate.

 

 

 

●

The current planned Phase 2 trial builds on the Phase 1 trial results, which were published earlier this year and presented at the American Headache Society 65th Annual Meeting in June 2023. Compared to patients dosed with intravenously (IV) administered DHE, subjects dosed with PUR3100 showed a lower incidence of nausea, and no vomiting was observed in PUR3100 dose groups compared to the intravenously (IV) administered DHE dose group. The study also showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels.

 

PUR1800

 

●

Earlier this year, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The Company expects that the completed data analysis will inform the study design of a potential Phase 2 study in patients with AECOPD. Pulmatrix plans to pursue partnership opportunities to advance PUR1800 into a potential Phase 2 clinical trial.

 

Third Quarter 2023 Financial Results

 

Revenues decreased $0.1 million to $1.8 million for the three months ended September 30, 2023 compared to $1.9 million for the three months ended September 30, 2022. The decrease is related to the Company’s revenues recognized in accordance with the Cipla Agreement for PUR1900 during the period.

 

Research and development expenses decreased approximately $1.3 million to $4.0 million for the three months ended September 30, 2023 compared to $5.3 million for the three months ended September 30, 2022. The decrease was primarily due to decreased spend of $0.7 million in costs related to the Company’s PUR3100 program, $0.4 million in costs related to the Company’s PUR1900 program, $0.1 million in costs related to the Company’s PUR1800 program and $0.1 million of employment and operating costs.

 

General and administrative expenses remained at $1.7 million for both the three months ended September 30, 2023 and 2022, as an increase in facilities costs was offset by a decrease in personnel costs.

 

Pulmatrix’s total cash and cash equivalents balance as of September 30, 2023 was $21.3 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations into the first quarter of 2025.

 

 

 

PULMATRIX, INC.

Consolidated Balance Sheets

(in thousands, except share and per share data)

 

		September 30, 2023				December 31, 2022
		(unaudited)
Assets
Current assets:
Cash and cash equivalents		$	21,336			$	35,628
Restricted cash			153				153
Accounts receivable			841				1,298
Prepaid expenses and other current assets			899				1,068
Total current assets			23,229				38,147
Property and equipment, net			1,166				235
Operating lease right-of-use asset			10,686				710
Long-term restricted cash			1,472				1,472
Other long-term assets			217				389
Total assets		$	36,770			$	40,953
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	707			$	1,188
Accrued expenses and other current liabilities			2,535				1,638
Operating lease liability			199				857
Deferred revenue			988				1,339
Total current liabilities			4,429				5,022
Deferred revenue, net of current portion			4,038				4,822
Operating lease liability, net of current portion			8,422				-
Total liabilities			16,889				9,844
Stockholders’ equity:
Preferred stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at September 30, 2023 and December 31, 2022			-				-
Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 and 3,639,185 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively			-				-
Additional paid-in capital			305,395				304,585
Accumulated deficit			(285,514	)			(273,476	)
Total stockholders’ equity			19,881				31,109
Total liabilities and stockholders’ equity		$	36,770			$	40,953

 

 

 

PULMATRIX, INC.

Consolidated Statements of Operations

(in thousands, except share and per share data)

(unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Revenues		$	1,753			$	1,872			$	5,096			$	4,363
Operating expenses
Research and development			3,963				5,287				12,002				13,773
General and administrative			1,729				1,685				5,609				5,212
Total operating expenses			5,692				6,972				17,611				18,985
Loss from operations			(3,939	)			(5,100	)			(12,515	)			(14,622	)
Other income (expense)
Interest income			217				102				675				118
Other expense, net			(52	)			(54	)			(198	)			(116	)
Total other income (expense), net			165				48				477				2
Net loss		$	(3,774	)		$	(5,052	)		$	(12,038	)		$	(14,620	)
Net loss per share attributable to common stockholders – basic and diluted		$	(1.03	)		$	(1.45	)		$	(3.30	)		$	(4.32	)
Weighted average common shares outstanding – basic and diluted			3,652,285				3,478,157				3,651,785				3,383,171

 

 

 

About Pulmatrix, Inc.

 

Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases and central nervous system (“CNS”) disorders using its patented iSPERSE™ technology. The Company’s proprietary product pipeline includes treatments for lung diseases, such as allergic bronchopulmonary aspergillosis (“ABPA”), Chronic Obstructive Pulmonary Disease (“COPD”) and CNS disorders such as acute migraine. Pulmatrix’s product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes. For more on our inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html.

 

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 federal securities laws. 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, the impact of the novel coronavirus (COVID-19) endemic on the Company’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on the Company’s ability to conduct its business and raise capital in the future when needed; 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 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; 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 the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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.

 

Investor Contact:
Timothy McCarthy, CFA
917-679-9282
[e-mail]

 

 

 

 

Cover	Nov. 09, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 09, 2023
Entity File Number	001-36199
Entity Registrant Name	PULMATRIX, INC.
Entity Central Index Key	0001574235
Entity Tax Identification Number	46-1821392
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	36 Crosby Drive
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Bedford
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	01730
City Area Code	(781)
Local Phone Number	357-2333
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	PULM
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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