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): July 11, 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.)

99 Hayden Avenue, Suite 390

Lexington, MA 02421

(Address of principal executive offices) (Zip Code)

(781) 357-2333

(Registrant’s 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 7.01 Regulation FD Disclosure.

On July 11, 2023, Pulmatrix, Inc. (the “Company”) issued a press release, which is attached hereto as Exhibit 99.1, announcing the submission of an investigational new drug application to the United States Food and Drug Administration for PUR3100, an orally inhaled dry powder formulation of dihydroergotamine, under development to treat acute migraine.

The Company also intends, from time to time, to present and/or distribute to the investment community and utilize at various industry and other conferences a slide presentation, which is attached hereto as Exhibit 99.2. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibits 99.1 or 99.2.

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, 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. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute a determination by the Company that the information contained herein, including the exhibit hereto, is material or that the dissemination of such information is required by Regulation FD.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description

99.1		Press Release, dated July 11, 2023 (furnished herewith pursuant to Item 7.01)
99.2		Investor Presentation, dated July 2023 (furnished herewith pursuant to Item 7.01)
104		Cover Page Interactive Data File (formatted as Inline XBRL)

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: July 11, 2023	By:	/s/ Teofilo Raad
		Teofilo Raad
		Chief Executive Officer

Exhibit 99.1

Pulmatrix Announces Submission of IND Application to FDA to Initiate a Phase 2 Trial of Investigational Drug PUR3100 to Treat Acute Migraine

LEXINGTON, Mass., July 11, 2023 – Pulmatrix, Inc. (“Pulmatrix” or the “Company”) (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease, today announced the submission of an investigational new drug (“IND”) application to the United States Food and Drug Administration (“FDA”) for PUR3100, an orally inhaled dry powder formulation of dihydroergotamine (“DHE”), under development to treat acute migraine. The PUR3100 formulation uses Pulmatrix’s novel, proprietary dry powder delivery technology, iSPERSE™ to deliver DHE directly into the lungs using a dry-powder inhaler.

Pulmatrix’s IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The Phase 1 study data were presented at the American Headache Society 65^th Annual Meeting in June 2023. Results showed that the pharmacokinetics (“PK”) of PUR3100 were similar to the PK of intravenous (“IV”) DHE with fewer side effects.

Dr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix, commented. “In the U.S. there are approximately 40 million patients with acute migraine needing additional therapeutic options. We are excited to see how this pharmacokinetic differentiation potentially translates into clinical efficacy and safety in the proposed Phase 2 proof-of-concept study. Based on study results seen to date, we believe that PUR3100 using Pulmatrix’s iSPERSE technology could offer a DHE therapy with maximized efficacy, while also providing the convenience of self-administration and reduced systemic side effects.”

About PUR3100

PUR3100 is an orally inhaled DHE engineered with iSPERSE™ for the treatment of acute migraine. Pulmatrix presented results from the PUR3100 Phase 1 trial at the 65^th Annual Meeting of the American Headache society in June 2023. The Phase 1 trial was a randomized, double-dummy, double-blinded design to assesses the safety, tolerability, and PK of three dose groups of inhaled PUR3100 with IV placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo. PUR3100 was generally well tolerated with fewer study drug related treatment-emergent adverse events compared to the IV DHE-treated group.

The PK for PUR3100 showed a T_max was at the first time point (5 min) for all PUR3100 doses. All three doses achieved ‘therapeutic’ exposure levels (>1000 pg/mL). C_max was within the desired exposure window, with similar T_max and dose normalized AUC relative to IV DHE.

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) 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

tim@lifesciadvisors.com

Exhibit 99.2

Cover	Jul. 11, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 11, 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	99 Hayden Avenue
Entity Address, Address Line Two	Suite 390
Entity Address, City or Town	Lexington
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02421
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