Current Report Filing (8-k)
January 18 2023 - 7:36AM
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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): January 17, 2023
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.) |
One
Grand Central Place, Suite 4600, New York, New York |
|
10165 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (212) 949-4319
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
7.01. Regulation FD Disclosure.
On
January 17, 2023, PAVmed Inc. (the “Company” or
“PAVmed”), together
with its majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”),
issued a joint press release providing a strategic business update. A copy of the press release is attached to this report as Exhibit
99.1 and is incorporated herein by reference.
The
information furnished under Item 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
8.01. Other Events.
In
the press release, the Company addressed the following strategic updates:
|
● |
The
Company and Lucid will prioritize near-term Lucid and Veris Health commercialization efforts. |
|
|
|
|
● |
The
companies have implemented a workforce reduction of approximately 20 percent, product portfolio streamlining, and other cost-cutting
measures which seek to lower quarterly cash burn by at least 25 percent. |
|
|
|
|
● |
Specifically,
pursuant to this initiative, the Company and Lucid plan to take the following steps, among others: |
Lucid
|
○ |
continue
to drive EsoGuard testing volume through ongoing engagement of sales personnel with primary care physicians, specialists and institutions,
with an increasing focus on closing larger strategic accounts and new market development initiatives; |
|
○ |
maintain
current team of approximately forty sales professionals, having completed targeted layoffs and closed prior vacancies; |
|
○ |
shift
sales leadership attention from recruiting and hiring to ongoing engagement with large institutional and strategic accounts, while
continuing to drive productivity of the current team; |
|
○ |
maintain
its team of nurse practitioners and other clinical personnel to support testing volume growth through existing Lucid Test Centers
(LTC) in eleven states, and its burgeoning satellite LTC program, whereby Lucid personnel perform EsoCheck cell sampling procedures
at prescribing physicians’ offices; |
|
○ |
continue
to invest in LucidDx Labs, Lucid’s CLIA-certified commercial clinical laboratory, to assure EsoGuard testing capacity and drive
quality improvements and cost efficiencies; |
|
○ |
complete
ongoing clinical utility studies to support in-network coverage; |
|
○ |
delay
completion of the EsoGuard BE-2 study to the second half of 2023; and |
|
○ |
pause
further development of the EsoCure Esophageal Ablation device. |
PAVmed
|
○ |
with
respect to the Company’s majority-owned subsidiary Veris Health: |
|
■ |
continue
to drive commercial adoption of the Veris Cancer Care Platform utilizing its existing sales personnel, and expand the commercial
team only when commercial traction has been well-established; |
|
■ |
delay
development and regulatory submission of the implantable physiologic monitor to the second half of 2023; and |
|
■ |
focus
its workforce on near-term commercialization of the Veris Cancer Care platform, having already eliminated certain technology positions
focused on future data analytics, while retaining personnel directly involved in customer integration and technical support; |
|
○ |
continue
research and product development activities in support of Lucid commercialization, including next generation EsoGuard and EsoCheck
products; |
|
○ |
continue
product development activities in support of Veris commercialization, namely its implantable physiologic monitor, as discussed above; |
|
○ |
continue
its joint early-stage research and development project with Novosound Ltd. to explore applying its groundbreaking ultrasound technology
to next-generation intravascular ultrasound imaging; |
|
○ |
continue
limited business development activities focused on high value, near-term accretive opportunities that are synergistic with existing
commercial activity; |
|
○ |
indefinitely
pause or halt all other product development activities including CarpX, PortIO and NextFlo; and |
|
○ |
pursue
additional cost-cutting initiatives including not paying annual cash bonuses. |
Forward-Looking Statements
This
Form 8-K includes forward-looking statements that involve risk 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 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, the risk that PAVmed’s change in strategy does not generate the expected
benefits; volatility in the price of PAVmed’s common stock;
general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required
to advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and
results from PAVmed’s clinical and preclinical studies; whether and when PAVmed’s products are cleared by regulatory
authorities; market acceptance of PAVmed’s products once cleared and commercialized; PAVmed’s ability to raise
additional funding as needed to pursue its current business plan; and other competitive developments. In addition, PAVmed continues to monitor the COVID-19 pandemic
and the pandemic’s impact on PAVmed’s business. These factors are difficult or impossible to predict accurately and many
of them are beyond PAVmed’s control. 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
future operations, see Part I, Item 1A, “Risk Factors,” in PAVmed’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 after its most recent Annual Report. PAVmed disclaims 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.
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:
January 18, 2023
|
PAVMED
INC. |
|
|
|
|
By: |
/s/
Dennis M. McGrath |
|
|
Dennis
M. McGrath |
|
|
President
and Chief Financial Officer |
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