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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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): May 14, 2024
PAVMED
INC. |
(Exact
Name of Registrant as Specified in Charter) |
Delaware |
|
001-37685 |
|
47-1214177 |
(State
or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer
Identification No.) |
360
Madison Avenue, 25th Floor, New York, New York |
|
10017 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (917) 813-1828
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 (see General Instruction A.2. below):
☐ |
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 each exchange on which registered |
Common
Stock, Par Value $0.001 Per Share |
|
PAVM |
|
The
Nasdaq Stock Market LLC |
Series
Z Warrants to Purchase Common Stock |
|
PAVMZ |
|
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
May 14, 2024, PAVmed Inc. (the “Company”) issued a press release announcing financial results for its fiscal quarter
ended March 31, 2024 and providing a business update. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated
herein by reference.
Item
7.01. Regulation FD Disclosure.
The
disclosure set forth under Item 2.02 is incorporated herein by reference.
The
information furnished under Items 2.02 and 7.01, including the exhibit related thereto, shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of
the Company, except as shall be expressly set forth by specific reference in such document.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits:
Exhibit
No. |
|
Description |
99.1 |
|
Press release. |
104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
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.
Dated:
May 14, 2024 |
PAVMED
INC. |
|
|
|
By:
|
/s/
Dennis McGrath |
|
|
Dennis
McGrath |
|
|
President
and Chief Financial Officer |
Exhibit
99.1
PAVmed
Provides Business Update and First Quarter 2024 Financial Results
Lucid
strengthens balance sheet and secures a July 17, 2024 MolDX pre-submission meeting date
Veris
Health completes MOU with The Ohio State’s James Cancer Hospital
Conference
call and webcast to be held tomorrow, May 14th at 8:30 AM EDT
NEW
YORK, May 13, 2024 - PAVmed Inc. (NASDAQ: PAVM, PAVMZ) (“PAVmed” or the “Company”), a diversified
commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today provided
a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) (“Lucid”) and Veris Health
Inc. (“Veris”), and presented financial results for the Company for the three months ended March 31, 2024.
Conference
Call and Webcast
The
webcast will take place on Tuesday, May 14, 2024, at 8:30 AM and is accessible in the investor relations section of the Company’s
website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184
and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name “PAVmed
Business Update” to join.
Following
the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s
website at pavmed.com.
Business
Update Highlights
“I
am very pleased with the strong progress PAVmed’s subsidiaries have made on multiple fronts during the first quarter and recent
weeks,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “Lucid, PAVmed’s strongest
and most advanced asset, is making great commercial progress and continues to successfully finance its operations through long-term fundamental
investors. Lucid now has the runway to advance through key reimbursement milestones on the pathway to profitability. As discussed last
quarter, we updated the PAVmed overall strategy to drive shareholder value through independently-financed subsidiaries that leverage
PAVmed’s shared infrastructure. Veris and the PMX Incubator are progressing well in furtherance of this revised strategy.”
Highlights
from the first quarter and recent weeks include:
● |
Yesterday,
Lucid reported that 1Q24 EsoGuard® revenue was $1.0 million, which was flat compared to 4Q23 and represents
a 124 percent increase from 1Q23. |
|
|
● |
Strengthened
balance sheet by Lucid’s completion of a $29.8 million Series B Preferred Stock Offering. |
● |
Peer-reviewed
publication of positive data from landmark National Cancer Institute (NCI)-sponsored clinical validation study, strengthening
EsoGuard’s clinical data supporting ongoing payor engagement. |
|
|
● |
Secured
July 17, 2024 MolDX pre-submission meeting to review data for technical assessment (TA) under its foundational Local Coverage Determination
(LCD). |
|
|
● |
Completed
Memorandum of Understanding (MOU) with The Ohio State’s James Cancer Hospital to implement pilot program enrolling their patients
onto Veris Cancer Care Platform. |
|
|
● |
Clear
path to FDA clearance for Veris implantable monitor pending financing. |
|
|
● |
Actively
seeking to raise capital for PortIO Corp. as part of the PMX incubator initiative, which will also include other technologies such
as EsoCure and CarpX. |
Financial
Results:
● |
For
the three months ended March 31, 2024, EsoGuard related revenues were $1.0 million. Operating expenses were approximately $15.0 million
which include stock-based compensation expenses of $1.9 million. GAAP net loss attributable to common stockholders was approximately
$22.8 million, or $(2.62) per common share. |
|
|
● |
As
shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on
the Company’s financial results, the Company’s non-GAAP adjusted loss was approximately $8.6 million or $(0.99) per common
share. |
|
|
● |
PAVmed
had cash and cash equivalents of $25.5 million as of March 31, 2024, compared to $19.6 million as of December 31, 2023. |
|
|
● |
The
unaudited financial results for the three months ended March 31, 2024 were filed with the SEC on Form 10-Q on May 13, 2024, and are
available at www.pavmed.com or www.sec.gov. |
PAVmed
Non-GAAP Measures
● |
To
supplement our financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides
certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss
before interest, taxes, depreciation, and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based
compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible
securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not
recognized terms under U.S. GAAP. |
|
|
● |
Non-GAAP
financial measures are presented with the intent of providing greater transparency to the information used by us in our financial
performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information
to assist investors, shareholders, and other readers of our financial statements in making comparisons to our historical financial
results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended
to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most
directly comparable GAAP financial measures. |
|
|
● |
Non-GAAP
financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further
information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management
and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business
outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the
reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value
of convertible securities, the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance.
In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods. |
|
|
● |
A
reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for
the three months ended March 31, 2024 and 2023 are as follows: |
Condensed
Consolidated Statement of Operations (Unaudited)
| |
For the three months ended March 31, | |
| |
2024 | | |
2023 | |
(in thousands except per-share amounts) | |
| | |
| |
Revenue | |
$ | 1,010 | | |
$ | 446 | |
Operating expenses | |
| 15,046 | | |
| 20,847 | |
Other (Income) Expense | |
| 4,476 | | |
| 1,813 | |
Net Loss | |
| 18,512 | | |
| 22,214 | |
Net income (loss) per common share, basic and diluted | |
$ | (2.62 | ) | |
$ | (2.78 | ) |
Net loss attributable to common stockholders | |
| (22,788 | ) | |
| (18,005 | ) |
Preferred Stock dividends and deemed dividends | |
| 7,576 | | |
| 74 | |
Net income (loss) as reported | |
| (15,212 | ) | |
| (17,931 | ) |
Adjustments: | |
| | | |
| | |
Depreciation and amortization expense1 | |
| 586 | | |
| 727 | |
Interest expense (income), net2 | |
| (56 | ) | |
| 62 | |
NCI ownership share of Interest and Depreciation adjustments | |
| (131 | ) | |
| (168 | ) |
EBITDA | |
| (14,813 | ) | |
| (17,310 | ) |
| |
| | | |
| | |
Other non-cash or financing related expenses: | |
| | | |
| | |
Stock-based compensation expense3 | |
| 1,882 | | |
| 4,419 | |
ResearchDx acquisition/settlement paid in stock1 | |
| — | | |
| 713 | |
Change in FV convertible debt2 | |
| 2,163 | | |
| 1,040 | |
Offering costs convertible debt2 | |
| — | | |
| 1,186 | |
Loss on debt extinguishment2 | |
| 369 | | |
| 525 | |
Debt modification expense | |
| 2,000 | | |
| — | |
Other non-cash charges | |
| — | | |
| — | |
NCI ownership share of non-GAAP adjustments | |
| (239 | ) | |
| (1,742 | ) |
Non-GAAP adjusted (loss) | |
$ | (8,638 | ) | |
$ | (11,169 | ) |
Basic and Diluted shares outstanding | |
| 8,695 | | |
| 6,473 | |
Non-GAAP adjusted (loss) income per share | |
$ | (0.99 | ) | |
$ | (1.73 | ) |
1
Included in general and administrative expenses in the financial statements.
2
Included in other income and expenses.
3
Stock-based compensation (“SBC”) expense included in operating expenses is detailed as follows in the table below by
category within operating expenses for the non-GAAP Net operating expenses:
Reconciliation
of GAAP Operating Expenses to Non-GAAP Net Operating Expenses
(in thousands except per-share amounts) | |
For the three months ended March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cost of revenue | |
$ | 1,744 | | |
$ | 1,346 | |
Stock-based compensation expense3 | |
| (36 | ) | |
| (23 | ) |
Net cost of revenue | |
| 1,708 | | |
| 1,323 | |
| |
| | | |
| | |
Amortization of acquired intangible assets | |
| 372 | | |
| 505 | |
| |
| | | |
| | |
Sales and marketing | |
| 4,311 | | |
| 4,539 | |
Stock-based compensation expense3 | |
| (403 | ) | |
| (444 | ) |
Net sales and marketing | |
| 3,908 | | |
| 4,095 | |
| |
| | | |
| | |
General and administrative | |
| 6,678 | | |
| 10,407 | |
Depreciation expense | |
| (214 | ) | |
| (222 | ) |
ResearchDx acquisition/settlement paid in stock | |
| — | | |
| (713 | ) |
Stock-based compensation expense3 | |
| (1,078 | ) | |
| (3,588 | ) |
Net general and administrative | |
| 5,386 | | |
| 5,884 | |
| |
| | | |
| | |
Research and development | |
| 1,941 | | |
| 4,050 | |
Stock-based compensation expense3 | |
| (365 | ) | |
| (364 | ) |
Net research and development | |
| 1,576 | | |
| 3,686 | |
| |
| | | |
| | |
Total operating expenses | |
| 15,046 | | |
| 20,847 | |
Depreciation and amortization expense | |
| (586 | ) | |
| (727 | ) |
ResearchDx acquisition/settlement paid in stock | |
| — | | |
| (713 | ) |
Stock-based compensation expense3 | |
| (1,882 | ) | |
| (4,419 | ) |
Net operating expenses | |
$ | 12,578 | | |
$ | 14,988 | |
About
PAVmed and its Subsidiaries
PAVmed
Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors.
Its majority-owned subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a commercial-stage cancer prevention medical diagnostics company
that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device—the
first and only commercial tools for widespread early detection of esophageal precancer to mitigate the risks of esophageal cancer deaths.
Its other majority-owned subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through
remote patient monitoring using implantable biologic sensors with wireless communication along with a custom suite of connected external
devices. Veris is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port,
which will interface with the Veris Cancer Care Platform.
For
more and for more information about PAVmed, please visit pavmed.com.
For
more information about Lucid Diagnostics, please visit luciddx.com.
For
more information about Veris Health, please visit verishealth.com.
Forward-Looking
Statements
This
press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are any statements
that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of PAVmed’s
and Lucid’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking
statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s
and Lucid’s common stock; PAVmed’s Series Z warrants; general economic and market conditions; the uncertainties inherent
in research and development, including the cost and time required to advance PAVmed’s and Lucid’s products to regulatory
submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s and Lucid’s clinical
and preclinical studies; whether and when PAVmed’s and Lucid’s products are cleared by regulatory authorities; market acceptance
of PAVmed’s and Lucid’s products once cleared and commercialized; PAVmed’s and Lucid’s ability to raise additional
funding as needed; and other competitive developments. In addition, new risks and uncertainties may arise from time to time and are difficult
to predict. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s and
Lucid’s future operations, see Part I, Item 1A, “Risk Factors,” in PAVmed’s and Lucid’s most recent Annual
Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors”
in any Quarterly Report on Form 10-Q filed by PAVmed or Lucid after its most recent Annual Report. PAVmed and Lucid disclaim any intention
or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions,
or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those
contained in the forward-looking statements.
Investor
and Media Contact
Matt
Riley
PAVmed and Lucid Diagnostics
610.348.8926
mjr@pavmed.com
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PAVmed (NASDAQ:PAVMZ)
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