Full Press Release Details
Reports 2020 Financial Results and Provides Business Update
PUR1800 Phase 1b study with data anticipated in Q4 2021
Ph2b study start anticipated Q1 2022
development candidate declared for pulmonary delivered DHE (dihydroergotamine) acute migraine treatment
runway extends beyond all anticipated PUR1800 Ph1b, PUR3100 Ph1/Ph2, and Pulmazole Ph2b data milestones
Mass., March 23, 2021 - Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative
inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, today reports
its Q4 and full year 2020 financial results and provides a business update.
recent months, we have made important progress advancing iSPERSE enabled programs that both strengthen our foundation in respiratory
indications and expand the reach of our platform to lung cancer and acute migraine," said Ted Raad, Chief Executive Officer
of Pulmatrix. "Our strengthened balance sheet fully funds our operations through key data milestones across our ongoing
and planned studies including the PUR1800 Phase 1b study, the PUR3100 Phase 1 / Phase 2 study and Pulmazole Phase 2b study. We
look forward to a milestone rich 2021 which includes toxicology and clinical data packages from ongoing PUR1800 studies, potential
license option execution from Johnson & Johnson, and continued execution as we advance therapies to address significant unmet
and Recent Highlights:
of December 31, 2020, Pulmatrix had $31.7 million in cash and cash equivalents, compared to $23.4 million for the year ended December
for 2020 was $12.6 million, compared to $7.9 million for 2019. The increase resulted from an increase in revenue recorded of $6.9
million as a result of the JJEI License Agreement and includes reimbursement of pass-through expenses, partially offset by a decrease
in revenue recorded of $2.2 million as a result of the Cipla Agreement.
and development expense was $15.6 million in 2020 compared to $12.8 million in 2019. The increase year-over-year was
primarily due to increased spending on manufacturing, clinical, and preclinical study costs of $4.4 million and $0.3 million,
on the PUR1800 and PUR3100 programs, respectively, $1.1 million on employment costs in support of our programs, $0.6 million in
allocated fixed expenses and lab services which were partially offset by a decrease of $3.6 million on the Phase 2 Pulmazole clinical
and administrative expense was $6.9 million for 2020 and $8.5 million for 2019. The decrease year-over-year was primarily due
to decreased employment costs of $1.2 million because of lower share-based compensation expense and salary costs, $0.1 million
in patent and legal expenses and $0.3 million of a milestone payment to the CFFT made in 2019.
was not impaired in 2020 compared to a $7.3 million impairment charge in 2019.
loss for 2020 was $19.3 million. The net loss in 2020 was primarily attributable to Pulmazole project costs as we advanced our
Phase 2 clinical study and PUR1800 manufacturing, preclinical, and clinical study costs for the upcoming Phase 1b clinical study.
is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary
disease using its patented iSPERSE technology. The Company's proprietary product pipeline includes treatments for
serious lung diseases such as allergic bronchopulmonary aspergillosis ("ABPA") and lung cancer, as well as neurologic
disorders such as acute migraine. Pulmatrix's 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.
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, 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; and 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 SEC, including its annual report on Form 10-K filed with the Securities and
Exchange Commission on March 26, 2020 as may be supplemented or amended by the Company's 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.
& Johnson Enterprise Innovation Inc. is the legal entity to the agreement.
thousands, except share and per share data)
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 31,657 | $ | 23,440 | ||||
| Accounts receivable | 84 | 7,200 | ||||||
| Prepaid expenses and other current assets | 797 | 777 | ||||||
| Total current assets | 32,538 | 31,417 | ||||||
| Property and equipment, net | 361 | 270 | ||||||
| Operating lease right-of-use asset | 1,489 | 630 | ||||||
| Long-term restricted cash | 204 | 204 | ||||||
| Goodwill | 3,577 | 3,577 | ||||||
| Total assets | $ | 38,169 | $ | 36,098 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 925 | $ | 600 | ||||
| Accrued expenses | 2,028 | 2,514 | ||||||
| Operating lease liability | 1,135 | 675 | ||||||
| Deferred revenue | 4,166 | 13,411 | ||||||
| Total current liabilities | 8,254 | 17,200 | ||||||
| Deferred revenue, net of current portion | 6,168 | 7,879 | ||||||
| Operating lease liability, net of current portion | 608 | - | ||||||
| Total liabilities | 15,030 | 25,079 | ||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, $0.0001 par value - 500,000 shares authorized at December 31, 2020 and December 31, 2019, respectively; no shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively | - | - | ||||||
| Common stock, $0.0001 par value - 200,000,000 shares authorized at December 31, 2020 and December 31, 2019, respectively; 36,105,097 and 19,994,560 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively | 4 | 2 | ||||||
| Additional paid-in capital | 257,604 | 226,178 | ||||||
| Accumulated deficit | (234,469 | ) | (215,161 | ) | ||||
| Total stockholders' equity | 23,139 | 11,019 | ||||||
| Total liabilities and stockholders' equity | $ | 38,169 | $ | 36,098 |
Statements of Operations
thousands, except share and per share data)
| Years ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| Revenues | $ | 12,634 | $ | 7,910 | ||||
| Operating expenses | ||||||||
| Research and development | 15,609 | 12,845 | ||||||
| General and administrative | 6,887 | 8,489 | ||||||
| Impairment of goodwill | - | 7,268 | ||||||
| Total operating expenses | 22,496 | 28,602 | ||||||
| Loss from operations | (9,862 | ) | (20,692 | ) | ||||
| Other income/(expense) | ||||||||
| Interest income | 82 | 301 | ||||||
| Settlement expense | - | (200 | ) | |||||
| Warrant inducement expense | (9,289 | ) | - | |||||
| Other expense, net | (239 | ) | (5 | ) | ||||
| Total other income/(expense) | (9,446 | ) | 96 | |||||
| Net loss | $ | (19,308 | ) | $ | (20,596 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.67 | ) | $ | (1.23 | ) | ||
| Weighted average shares used to compute basic and diluted net loss per share attributable to common stockholders | 28,753,310 | 16,733,909 |
Timothy McCarthy, CFA