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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): March 28, 2024
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)
(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 2.02 Results of Operations and Financial Condition.
On March 28, 2024, Pulmatrix, Inc. issued a press release announcing its financial results for the fourth fiscal quarter and twelve months ended December 31, 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 March 28, 2024* | |
| 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: March 28, 2024 | By: | /s/ Teofilo Raad |
| Teofilo Raad | ||
| Chief Executive Officer | ||
Exhibti 99.1
Pulmatrix Announces Year-End and Q4 2023 Financial Results and Provides Corporate Update
2023 year-end $19.2 million cash and cash equivalents provide projected cash runway into Q1 2026
3rd amendment to Cipla partnership resulted in the wind down of the PUR1900 Phase 2b study and a significant reduction in expected cash burn for Pulmatrix
Cipla to take sole responsibility for development of PUR1900, refocused on markets with greatest unmet need and faster path to approval, in exchange for 2% royalty on net sales payable to Pulmatrix
Bedford, Mass., March 28, 2024 – Pulmatrix, Inc. (“Pulmatrix” or the “Company”) (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious central nervous system and pulmonary disease using its patented dry powder inhalation iSPERSE™ technology, today announced fourth quarter and year-end financial results for 2023 and provided a corporate update on its development programs.
Ted Raad, Chief Executive Officer of Pulmatrix, commented, “Winding down the Phase 2b study for PUR1900, along with other cost-savings measures, is expected to extend Pulmatrix’s cash runway into Q1 2026. We will continue our focus on strategic alternatives that leverage the potential of PUR3100, iSPERSE™ technology and our extended cash resources.”
2023 and Recent Program and Corporate Highlights
PUR3100
| ● | In September 2023, Pulmatrix announced the FDA’s acceptance of an 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 investigated in patients with acute migraine. | |
| ● | The planned Phase 2 trial builds on the Phase 1 trial results, which were published in 2023 and presented at the American Headache Society 65th Annual Meeting in June 2023. Compared to observations of nausea and vomiting in the intravenously (IV) administered DHE dose group, the PUR3100 dose groups showed a lower incidence of nausea and no vomiting. 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
| ● | In February 2023, 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 results indicated PUR1800 was safe and well tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases. Pulmatrix plans to pursue partnership or other alternatives to monetize or advance PUR1800. |
PUR1900
| ● | On January 8, 2024, in agreement with its partner Cipla, Pulmatrix announced plans to stop patient enrollment at 8 subjects in the Phase 2b study of PUR1900, effective immediately. PUR1900 is the Company’s inhaled iSPERSE™ formulation of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. The decision to stop the study was unrelated to any safety concerns. This study had been ongoing since the first quarter of 2023. The Company expects to complete all Phase 2b activities by the third quarter of 2024. | |
| ● | After the study wind down, Pulmatrix will bear no further financial responsibility for the development of PUR1900 and will receive 2% royalties on any potential future net sales by Cipla outside the United States. Within the United States, Pulmatrix and Cipla will seek to monetize PUR1900. |
Fourth Quarter and Year-End Financial Results
Revenues increased $1.2 million to $7.3 million for the year ended December 31, 2023, compared to $6.1 million for the year ended December 31, 2022. The increase is related to higher activity under the Cipla Agreement for PUR1900 during the period.
Research and development expenses decreased approximately $2.7 million to $15.5 million for the year ended December 31, 2023, compared to $18.2 million for the year ended December 31, 2022. The decrease was primarily due to decreased spend of $2.7 million in costs related to the Company’s PUR3100 program, $1.0 million of employment costs, and $0.7 million in costs related to the Company’s PUR1800 program, partially offset by an increase of $1.3 million in costs related to the Company’s PUR1900 program and $0.4 million of other operating costs.
General and administrative expenses decreased $0.3 million to $6.5 million for the year ended December 31, 2023, compared to $6.8 million for the year ended December 31, 2022. The decrease was primarily due to decreased spend of $0.7 million in employment costs, partially offset by an increase of $0.4 million in legal and professional services costs.
The Company’s total cash and cash equivalents balance as of December 31, 2023, was $19.2 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 2026.
PULMATRIX, INC.
Consolidated Balance Sheets
(in thousands, except share and per share data)
December 31, 2023 |
December 31, 2022 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,173 | $ | 35,628 | ||||
| Restricted cash | - | 153 | ||||||
| Accounts receivable | 928 | 1,298 | ||||||
| Prepaid expenses and other current assets | 742 | 1,068 | ||||||
| Total current assets | 20,843 | 38,147 | ||||||
| Property and equipment, net | 1,158 | 235 | ||||||
| Operating lease right-of-use asset | 10,309 | 710 | ||||||
| Long-term restricted cash | 1,472 | 1,472 | ||||||
| Other long-term assets | 176 | 389 | ||||||
| Total assets | $ | 33,958 | $ | 40,953 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,915 | $ | 1,188 | ||||
| Accrued expenses and other current liabilities | 947 | 1,638 | ||||||
| Operating lease liability | 429 | 857 | ||||||
| Deferred revenue | 618 | 1,339 | ||||||
| Total current liabilities | 3,909 | 5,022 | ||||||
| Deferred revenue, net of current portion | 3,727 | 4,822 | ||||||
| Operating lease liability, net of current portion | 8,327 | - | ||||||
| Total liabilities | 15,963 | 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 December 31, 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 December 31, 2023 and December 31, 2022, respectively | - | - | ||||||
| Additional paid-in capital | 305,592 | 304,585 | ||||||
| Accumulated deficit | (287,597 | ) | (273,476 | ) | ||||
| Total stockholders’ equity | 17,995 | 31,109 | ||||||
| Total liabilities and stockholders’ equity | $ | 33,958 | $ | 40,953 | ||||
PULMATRIX, INC.
Consolidated Statements of Operations
(in thousands, except share and per share data)
|
Year Ended December 31, |
||||||||
| 2023 | 2022 | |||||||
| Revenues | $ | 7,298 | $ | 6,071 | ||||
| Operating expenses | ||||||||
| Research and development | 15,518 | 18,240 | ||||||
| General and administrative | 6,520 | 6,778 | ||||||
| Total operating expenses | 22,038 | 25,018 | ||||||
| Loss from operations | (14,740 | ) | (18,947 | ) | ||||
| Other income (expense) | ||||||||
| Interest income | 867 | 309 | ||||||
| Other expense, net | (248 | ) | (198 | ) | ||||
| Total other income (expense), net | 619 | 111 | ||||||
| Net loss | $ | (14,121 | ) | $ | (18,836 | ) | ||
| Net loss per share attributable to common stockholders – basic and diluted | $ | (3.87 | ) | $ | (5.46 | ) | ||
| Weighted average common shares outstanding – basic and diluted | 3,651,911 | 3,447,701 | ||||||
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company’s proprietary product pipeline includes treatments for central nervous system (“CNS”) disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease (“COPD”) and allergic bronchopulmonary aspergillosis (“ABPA”). 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 the Company’s 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
tim@lifesciadvisors.com