PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multiproduct medical device
company, today reported financial results for the three and six
months ended June 30, 2019 and provided a business update.
“The second quarter and early third quarter has
been a period of solid progress for PAVmed,” said Lishan Aklog,
M.D., PAVmed’s Chairman and Chief Executive Officer. “We advanced
our lead product portfolio on multiple fronts, including the recent
successful completion of all procedures in the CarpX™ clinical
safety study. This progress has set up the remainder of the year to
be an exciting period of major milestones, including the full U.S.
commercial launch of EsoGuard™ and the upcoming FDA 510(k)
re-submission of CarpX.”
UPCOMING MILESTONES
- Complete post-operative clinical follow-up of remaining
patients in the CarpX first-in-human (FIH) clinical safety study in
New Zealand, all of whom have met the study’s primary effectiveness
endpoint by successfully completing their CarpX procedures and
await electrodiagnostic testing at 90 days to document that they
have met the study’s primary safety endpoint;
- Resubmit CarpX’s 510(k) application to the U.S. Food and Drug
Administration (FDA);
- Complete transfer of EsoGuard assay from an academic medical
center laboratory to ResearchDx, Inc. one of the nation’s leading
commercial contract diagnostic organizations;
- Begin full U.S. commercial launch of EsoGuard as a Laboratory
Developed Test (LDT), the first such test designed to detect
Barrett’s Esophagus, a precursor to deadly esophageal cancer which
affects millions of patients;
- Complete Center for Medicare and Medicaid Services (CMS)
process to secure a reimbursement code for EsoGuard LDT;
- Accelerate commercial launch of the EsoCheck™ Esophageal Cell
Collection Device with Collect+Protect™ technology;
- Secure FDA sign-off on EsoGuard IVD clinical trial protocol
during an in-person pre-submission meeting scheduled for October 9,
2019;
- Complete creation of EsoGuard IVD clinical trial operations
infrastructure required to establish EsoGuard as an FDA-registered
In-Vitro Diagnostic (IVD);
- Begin recruiting clinical trial sites and enroll first patient
in the EsoGuard IVD clinical trial;
- Initiate pilot human clinical trials using EsoCheck in other
prevalent diseases including eosinophilic esophagitis and
infectious fungal/viral esophagitis in immunocompromised
patients;
- Complete recently initiated formal M&A process led by
global professional services firm Alvarez & Marsal to secure a
strategic partner or acquirer for the NextFlo Infusion System and
provide a source of non-dilutive capital to the Company;
- Secure FDA sign-off on protocol for a small PortIO™ clinical
safety study in New Zealand during an in-person pre-submission
meeting with the FDA in support of PortIO’s de novo
application;
- Initiate FIH clinical study for long-term PortIO use in
dialysis patients and those with poor venous access in Columbia,
South America;
- Complete PortIO animal study documenting unprecedented
six-month maintenance-free patency; and
- Complete DisappEAR six-month GLP animal study to support future
FDA 510(k) submission.
PRODUCT UPDATES
CarpX Minimally Invasive Carpal Tunnel
Device
- 20 patients underwent successful CarpX procedures in New
Zealand, which completed the enrollment and treatment portion of
the CarpX first-in-human (FIH) clinical safety study in support of
CarpX’s FDA 510(k) re-submission.
- All patients met the study’s primary effectiveness
endpoint.
- All patients who have completed their 90-day follow-up, met the
study’s primary safety endpoint and the remaining are fully
expected to meet it based on clinical observations to date.
- The U.S. Patent and Trademark Office (USPTO) granted PAVmed a
broad patent covering the technology underlying the CarpX device,
expanding the PAVmed intellectual property (IP) portfolio that now
includes over 75 patents and patent applications across 10
families.
CarpX is a minimally invasive device designed to
treat carpal tunnel syndrome, which PAVmed believes will
dramatically reduce recovery times compared to traditional open
surgery and target an estimated $1 billion immediately addressable
domestic market opportunity, but do so much less invasively, using
catheters, balloons, radiofrequency energy and other established
tools of the percutaneous intervention and minimally invasive
surgery revolutions. The balloon catheter device is inserted under
the scarred ligament in a minimally invasive fashion, tensioning
the ligament while pushing the nerve and tendons away. When
activated, bipolar radiofrequency electrodes precisely cut the
ligament from the inside out in a matter of seconds. The device
design provides physicians with ongoing feedback to optimize the
safety and completeness of the procedure.
The 20-patient CarpX clinical safety study
nearing completion in New Zealand uses a protocol developed in
close consultation with the FDA to support a 510(k) pre-market
re-submission to commercially market the device for minimally
invasive carpal tunnel release. It builds on extensive pre-clinical
work documenting a narrow sliver of thermal spread, as well as
safety and effectiveness substantially equivalent to a predicate.
The study’s primary effectiveness endpoint is intraoperative
confirmation of complete transverse carpal ligament division by
endoscopic visualization of its cut edges across its entire width.
The study’s primary safety endpoint is the absence of nerve injury
as documented by two electrodiagnostic motor nerve tests performed
at a 90-day follow up visit.
As noted, all 20 study patients underwent
successful minimally invasive carpal tunnel release using the CarpX
device and met the study’s primary effectiveness endpoint. There
were no device-related adverse events. Key intra- and
post-operative observations which strongly support CarpX’s clinical
and commercial potential include:
- The final set of procedures were completed in 15-20 minutes
“skin-to-skin”, indicating that the CarpX procedure can be
performed in the same or less time as traditional carpal tunnel
release after only a short learning curve.
- As they gained experience, surgeons were able to use
progressively smaller incisions. The final set of procedures were
performed through the smallest keyhole incisions that would pass
the introducer sheath, approximately 5-10 mm each, with no incision
crossing the base of the palm, the problematic area for healing,
recovery and persistent pain after traditional surgery.
- CarpX’s balloon appeared to create more space within the carpal
tunnel at completion of the procedure compared to traditional
surgery, a unique feature which has the potential to enhance both
short and long-term outcomes.
- CarpX required less power and lower balloon pressures to cut
the scarred ligament in live human patients than it had previously
demonstrated in cadavers, an unexpected positive finding which
should further enhance procedure safety and effectiveness.
- Most importantly, initial patient feedback has been very
positive, including one patient who noted his recovery was much
faster than a friend who had a “mini-open” carpal tunnel release
and insisted the procedure on his other hand be performed with
CarpX.
As noted, all patients who have completed their
90-day follow-up testing have met the study’s primary safety
endpoint and, based on clinical observations, it is expected that
all the remaining patients will meet it as well. PAVmed will
resubmit the CarpX 510(k) application incorporating the study’s
clinical safety and effectiveness data once 90-day follow-up is
completed in all 20 patients.
U.S. Patent 10,335,189 entitled “Systems and
Methods for Percutaneous Division of Fibrous Structures”, was
recently granted by the USPTO and includes broad independent claims
covering a device such as CarpX with a catheter, an expandable
member such as a balloon, and a cutting element such as a pair of
bipolar radiofrequency electrodes. The claims are not limited to
CarpX or carpal tunnel syndrome and cover device embodiments which
can be developed to treat a broad spectrum of conditions, such as
plantar fasciitis and compartment syndromes, where compression by
fibrous tissue causes pain or other debilitating symptoms. The
CarpX IP portfolio also includes multiple international and
follow-on patent applications.
EsoGuard Esophageal DNA Test and
EsoCheck Esophageal Cell Collection Device
- Received FDA 510(k) marketing clearance for the EsoCheck™ Cell
Collection Device with Collect +Protect technology.
- Engaged ResearchDx Inc., one of the nation’s leading
full-service commercial contract diagnostic organizations (CDO),
and initiated transfer of the EsoGuard Esophageal DNA test from the
clinical laboratory at the academic medical center which developed
the test to ResearchDx.
- Successfully replicated the EsoGuard assay at ResearchDx and
began validation testing to establish the EsoGuard Laboratory
Developed Test (LDT) under ResearchDx’s CLIA/CAP certificate.
- Filed pre-submission package and scheduled October 9, 2019
pre-submission meeting to secure FDA sign-off on the EsoGuard IVD
clinical trial protocol to support a future de novo or Pre-Market
Approval (PMA) application, which will seek a specific Barrett’s
Esophagus screening indication for EsoGuard on samples collected
with EsoCheck in high-risk GERD patients.
- Hired former director of global clinical trial operations of a
large multi-billion-dollar Fortune 500 medical device company to
serve as Lucid’s Chief Operating Officer, tasked with building the
clinical trial operations infrastructure for the upcoming EsoGuard
IVD clinical trials.
- Secured CPT reimbursement code for the EsoGuard LDT under the
Proprietary Laboratory Analysis (PLA) process, and successfully
advanced the code through the CMS Clinical Laboratory Fee Schedule
(CLFS) process, leading to an in-person meeting with CMS to discuss
reimbursement under this code.
EsoGuard and EsoCheck are revolutionary
technologies licensed in 2018 by PAVmed’s majority-owned
subsidiary, Lucid Diagnostics Inc. (“Lucid”), from Case Western
Reserve University.
The EsoCheck cell collection device, which is
now FDA 510(k)-cleared, is a non-invasive device designed to sample
cells from a targeted region of the esophagus in a five-minute
office-based procedure, without the need for endoscopy. (EsoCheck
animation). The sampled cells can then be subjected to any
commercially available diagnostic test including EsoGuard.
EsoGuard is an esophageal DNA test which has
been shown in a 408-patient human study published in Science
Translational Medicine to be highly accurate at detecting Barrett’s
Esophagus (BE), a pre-cursor to highly lethal esophageal cancer
(EAC) in patients with chronic heart burn or acid reflux
(GERD).
Even though published society guidelines
recommend screening in high-risk patients to detect and treat BE
before it progresses to EAC, very few such patients currently
undergo screening. In fact, most patients diagnosed with EAC are
neither aware of their underlying BE, nor that they missed the
opportunity to undergo treatment which could have prevented
progression to EAC if the BE had been diagnosed earlier.
The estimated immediately addressable domestic
market opportunity for EsoGuard is at least $2 billion based on
very modest penetration of tens of millions of U.S. GERD patients
currently recommended for BE screening according to published
society guideline.
EsoGuard uses next generation sequencing (NGS)
of bisulfite-converted DNA to detect methylation at 31 sites on two
genes (VIM and CCNA1). Complex bioinformatic algorithms are used to
quantify the percentage of DNA with methylation at more than a
specified proportion of sites, generating a binary result on
whether or not the patient has BE. Clinical studies of EsoGuard
have demonstrated greater than 90% sensitivity and specificity at
detecting BE.
Lucid’s strategy is to advance EsoGuard down two
parallel paths, denoted EsoGuard LDT and EsoGuard IVD, which allows
it to enter the commercial market and generate revenue while
seeking to maximize the long-term value of the product as a
widespread screening test.
EsoGuard LDT is a Laboratory Developed Test
which uses the above DNA NGS assay to detect BE. Although EsoGuard
has completed CLIA/CAP certification and is available as an LDT
from the clinical laboratory affiliated with the academic medical
center which developed the test, Lucid decided to transfer EsoGuard
LDT to a high-capacity commercial laboratory before initiating
marketing and a full commercial launch.
As noted, ResearchDx Inc., one of the nation’s
leading full-service commercial contract diagnostic organizations
(CDO), has initiated transfer of the EsoGuard assay. Their team has
quickly replicated, with near perfect correlation, the results from
the academic laboratories that had previously performed the assay
and has begun the validation testing required to establish EsoGuard
as an LDT under their CLIA/CAP certificate. Once this transfer is
complete, Lucid will initiate a full commercial launch of EsoGuard
LDT. ResearchDx is also manufacturing the custom EsoGuard specimen
collection kits and will be performing the assay for the EsoGuard
IVD clinical trial.
The process to secure CMS and subsequently
private payor coverage for EsoGuard LDT is steadily progressing.
Since securing a CPT reimbursement code from the American Medical
Association (AMA) under the Proprietary Laboratory Analysis (PLA),
EsoGuard LDT has cleared additional hurdles, including technical
advisory review, the CPT Editorial Review Panel, the CMS Clinical
Laboratory Fee Schedule (CLFS) Annual Public Meeting and the CLFS
panel. Lucid has engaged a leading law firm whose CMS reimbursement
consultants previously served in leadership positions in the CMS
group which reviews LDT reimbursement codes and held an in-person
meeting with CMS to discuss the EsoGuard LDT code.
The EsoGuard IVD path seeks to secure a specific
Barrett’s Esophagus screening indication for EsoGuard as an
FDA-cleared In-Vitro Diagnostic (IVD) device in high-risk GERD
patients as defined by published society guidelines. This will
allow EsoGuard and EsoCheck to be broadly marketed together as a
single diagnostic tool to screen patients for BE. It requires a de
novo or PMA submission to the FDA supported by strong clinical data
demonstrating that EsoGuard performed on samples collected with
EsoCheck is sufficiently sensitive and specific to serve as a
widespread screening tool in high-risk GERD patients recommended
for screening.
Lucid, its world class medical advisors, which
include the authors of the published society guidelines, and its
regulatory advisors, which includes the former head of the FDA’s
IVD branch, have designed a robust two-arm clinical study to
support an FDA de novo or PMA submission. The screening arm will
enroll GERD patients without a prior diagnosis of BE who satisfy
the American College of Gastroenterology (ACG) BE screening
guidelines. The case control arm will enroll patients with a
previous diagnosis of non-dysplastic BE, dysplastic BE or EAC. In
both arms EsoGuard/EsoCheck will be compared to the goal standard
of endoscopy with biopsies.
Lucid recently hired Randy W. Brown, former
director of global clinical trial operations of a large
multi-billion-dollar Fortune 500 medical device company, to serve
as Lucid’s Chief Operating Officer. He is tasked with building the
clinical trial operations infrastructure for the EsoGuard/EsoCheck
clinical trials, including a contract clinical research
organization (CRO) partner, allied clinical research personnel and
the quality design control process required to establish EsoGuard
as an FDA-registered In-Vitro Diagnostic (IVD). Lucid plans to
begin recruiting clinical trial sites soon and is targeting
enrollment the first EsoGuard IVD clinical trial patient by the end
of 2019.
Since EsoCheck is FDA-cleared as a generic
esophageal cell collection device, Lucid is also aggressively
pursuing market opportunities in prevalent esophageal conditions
other than BE.
Eosinophilic esophagitis (EoE) is a common
inflammatory condition of the esophagus whose incidence has grown
dramatically in the past two decades and frequently coexists with
Inflammatory Bowel Disease (IBD). EoE patients currently undergo
multiple invasive endoscopies to monitor response to treatment. The
University of Pennsylvania is initiating a Lucid-sponsored pilot
study to determine whether EsoCheck can replace endoscopy in the
surveillance of EoE patients, which would have a dramatic clinical
and economic impact on the disease.
Patients with compromised immune systems, such
as bone marrow transplant and HIV patients, often undergo endoscopy
to evaluate swallowing difficulties to rule out fungal or viral
infectious esophagitis. Lucid is engaged with physicians caring for
these patients to determine whether these conditions can be
diagnosed with EsoCheck instead of endoscopy in these compromised
patients.
Other Lead Products
PAVmed’s PortIO™ is an implantable intraosseous
vascular access device which allows direct access to the bone
marrow, a well-established route for the delivery of medications,
fluids and other substances, addressing an estimated $700 million
market opportunity based on patients with poor veins and those with
renal failure whose veins must be carefully preserved for current
or future hemodialysis.
PortIO continues to advance through the FDA’s de
novo pathway as PAVmed seeks an initial 7-day implant duration. The
FDA-requested GLP animal study has been completed along with
supplementary cadaver and acute animal studies. This excellent
pre-clinical data will form the basis of an upcoming in-person
pre-submission meeting to secure FDA sign-off on the protocol for a
small PortIO clinical safety study in New Zealand in support of
PortIO’s de novo application.
A separate animal study has now documented that
PortIO remains patent and functional for an unprecedented four
months, without fluid flushes or any other form of maintenance,
with full expectation that this will remain the case when the
six-month study is completed in a few weeks. This is highly
differentiating because all other vascular access devices require
regular flushes with anti-coagulants or other substances to
maintain their patency and functionality.
Based on this encouraging animal data, PAVmed
will initiate a first-in-human clinical study for long-term (up to
60 days) PortIO use in dialysis patients and those with poor venous
access in Columbia, South America.
PAVmed’s NextFlo™ disposable intravenous (IV)
infusion set seeks to eliminate the need for complex and expensive
electronic infusion pumps for most of the estimated one million
infusions of fluids, medications and other substances delivered
each day in hospitals and outpatient settings in the United States.
NextFlo is designed to deliver highly accurate gravity-driven
infusions independent of the height of the IV bag, using
inexpensive, easy-to-manufacture disposable mechanical parts.
NextFlo testing has demonstrated constant flow rates across a wide
range of IV bag heights, with accuracy rates comparable to
electronic infusion pumps. (NextFlo Demonstration Video). PAVmed
has finalized commercial-ready and packaged working samples of the
NextFlo infusion set for use in strategic discussions.
PAVmed recently engaged Deloitte Consulting LLP
to perform a comprehensive market research and strategic analysis
of NextFlo. They demonstrated a very large addressable market and
recommended PAVmed seek a long-term strategic partnership or
acquisition for NextFlo. PAVmed subsequently engaged the global
professional services firm Alvarez and Marsal, which, armed with
the detailed Deloitte Consulting report, has initiated a formal
M&A process targeting over 70 potential strategic partners or
acquirers, including the market leader in the space, who has
contacted the company expressing interest in the technology.
PAVmed’s DisappEAR™ resorbable pediatric ear
tubes, manufactured from a proprietary aqueous silk technology
licensed from Tufts University and two Harvard teaching hospitals,
seeks to revolutionize the care of the estimated one million
children who undergo bilateral ear tube placement each year to
treat complex or recurrent middle ear infections or fluid
collections, by eliminating the need for a second procedure as well
as the standard difficult-to-administer post-operative ear drop
regimen.
A three-month animal study of DisappEAR to
support a future FDA 510(k) submission has been completed with
excellent results. The resorbable ear tubes, machined from blocks
of proprietary silk, performed very well from a functional and
anatomic point of view, retaining their position and remaining
patent for the duration of the study. In addition, the ear tubes
demonstrated unexpected surfactant properties which appear to
provide several unique benefits over traditional plastic tubes,
including enhanced flow of fluids in and out of the tube and
potential intrinsic antimicrobial properties.
Additional animals are being followed for longer
durations to confirm device stability and corroborate these
findings. In vitro antimicrobial testing is also being performed to
determine whether the surface properties have an intrinsic
antimicrobial effect which would obviate the need for antibiotic
coating. A separate GLP animal study is comparing DisappEAR to
standard plastic ear tubes with and without antibiotic ear
drops.
Other Recent Corporate
Highlights
- Engaged an external investor and public relations firm, KCSA
Strategic Communications, to assist in raising PAVmed’s profile
within the investment community;
- Joined the Russell Microcap® Index on July 1st which results in
automatic inclusion in the appropriate growth and value style
indexes; and
- Closed on a registered direct offering of common stock for net
proceeds of approximately $1.8 million in late June.
FINANCIAL RESULTS
For the three months ended June 30, 2019,
research and development expenses were $1,405,060 and general and
administrative expenses were $1,914,154. GAAP net loss attributable
to common stockholders was $3,660,403, or $(0.13) per common share.
As illustrated below and for the purpose of helping the reader
understand the effect of derivative accounting for non-cash income
and expenses on the Company’s financial results, the Company
reported a non-GAAP adjusted loss for the three months ended June
30, 2019 of $2,782,047, or $(0.10) per common share.
PAVmed had cash and cash equivalents of
$6,908,068 as of June 30, 2019, compared with $8,222,119 as of
December 31, 2018.
The audited financial results for the three and
six months ended June 30, 2019 as reported to the SEC on Form 10-Q
can be obtained at www.pavmed.com or www.sec.gov.
Non-GAAP Measures
To supplement our unaudited 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 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 unaudited 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 and six months ended June 30, 2019 and
2018 is as follows:
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share, basic
and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.84 |
) |
|
$ |
(0.77 |
) |
Net loss attributable to common
stockholders |
|
|
(3,660,403 |
) |
|
|
(5,128,963 |
) |
|
|
(18,750,798 |
) |
|
|
(10,398,134 |
) |
Preferred Stock
dividends and deemed dividends |
|
|
66,792 |
|
|
|
63,623 |
|
|
|
981,289 |
|
|
|
878,865 |
|
Series B Preferred
stock issued upon exchange of Series A and Series A-1 Preferred
stock |
|
|
- |
|
|
|
- |
|
|
|
(199,241 |
) |
|
|
- |
|
|
Net income (loss) as
reported |
|
|
(3,593,611 |
) |
|
|
(5,065,340 |
) |
|
|
(17,968,750 |
) |
|
|
(9,519,269 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
Depreciation expense1 |
|
|
3,282 |
|
|
|
1,802 |
|
|
|
9,790 |
|
|
|
7,110 |
|
|
Interest expense, net3 |
|
|
- |
|
|
|
500,304 |
|
|
|
2,392,447 |
|
|
|
724,684 |
|
EBITDA |
|
|
(3,590,329 |
) |
|
|
(4,563,234 |
) |
|
|
(15,566,513 |
) |
|
|
(8,787,475 |
) |
|
|
|
|
|
|
|
|
|
|
Other non-cash expenses: |
|
|
|
|
|
|
|
|
|
Stock-based compensation expense2 |
|
|
388,363 |
|
|
|
303,890 |
|
|
|
1,228,699 |
|
|
|
1,048,127 |
|
|
Loss from issuance of Preferred Stock3 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,124,285 |
|
|
Change in fair value of Series A Warrant
Liabiity3 |
|
- |
|
|
|
- |
|
|
|
96,480 |
|
|
|
(1,942,501 |
) |
|
Change in fair value of Series A Preferred Stock conversion
option embedded derivative liabiity3 |
|
|
- |
|
|
|
- |
|
|
|
(64,913 |
) |
|
|
(643,318 |
) |
|
Debt extinguishment3 |
|
|
258,811 |
|
|
|
- |
|
|
|
1,408,296 |
|
|
|
- |
|
|
Change in FV convertible debt3 |
|
|
161,108 |
|
|
|
- |
|
|
|
903,000 |
|
|
|
- |
|
Non-GAAP adjusted (loss) |
|
|
(2,782,047 |
) |
|
|
(4,259,344 |
) |
|
|
(9,120,644 |
) |
|
|
(6,978,882 |
) |
|
Basic and Diluted shares outstanding |
|
|
27,149,095 |
|
|
|
16,544,221 |
|
|
|
22,276,347 |
|
|
|
13,495,951 |
|
|
Non-GAAP adjusted (loss) income per share |
|
|
($0.102 |
) |
|
|
($0.26 |
) |
|
|
($0.41 |
) |
|
|
($0.52 |
) |
1 |
Included in general and administrative expenses in the
financial statements |
2 |
For the three
months ended March 31, 2019 includes $284,663 of stock-based
compensation expense reported as general and administrative
expenses and $174,023 reported as research and development expense.
For the three months ended March 31, 2018 includes $219,394 of
stock-based compensation expense reported as general and
administrative expenses and $51,892 reported as research and
development expense. |
|
3 |
Included in other income and expenses |
Conference Call and Webcast
The Company will hold a conference call and
webcast on Thursday, September 5, 2019 beginning at 4:30 p.m.
Eastern time. During the call, Lishan Aklog, M.D., Chairman and
Chief Executive Officer of the Company, will provide a business
update including an overview of the Company’s near-term milestones
and growth strategy. In addition, Dennis McGrath, President and
Chief Financial Officer, will review second quarter 2019 financial
results.
To access the conference call, U.S.-based
listeners should dial (877) 407-3982 and international listeners
should dial (201) 493-6780. All listeners should provide the
operator with the conference call name “PAVmed, Inc. Business
Update Conference Call” to join. The conference call will also be
available via a live listen-only webcast, which can be accessed by
visiting the investor relations section of the Company’s website at
www.pavmed.com.
Following the conclusion of the conference call,
a replay will be available for one week and can be accessed by
dialing (844) 512-2921 (domestic) or (412) 317-6671
(international). To access the replay, all listeners should provide
the following pin number: 13692960. The webcast also will be
available for replay on the investor relations section of the
Company’s website at www.pavmed.com.
About PAVmed
PAVmed Inc. is a highly differentiated,
multiproduct medical device company employing a unique business
model designed to advance innovative products to commercialization
much more rapidly and with significantly less capital than the
typical medical device company. This proprietary model enables
PAVmed to pursue an expanding pipeline strategy with a view to
enhancing and accelerating value creation. PAVmed’s diversified
pipeline of products address unmet clinical needs encompassing a
broad spectrum of clinical areas with attractive regulatory
pathways and market opportunities. Its five lead technologies
provide groundbreaking approaches to carpal tunnel syndrome
(CarpX™), precancerous conditions of the esophagus
(EsoGuard™/EsoCheck™), vascular access (PortIO™), pediatric ear
infections (DisappEAR™) and medical infusions (NextFlo™). The
company is also developing innovative products in other areas, such
as catheters and tissue ablation, while seeking to further expand
its pipeline through engagements with clinician innovators and
leading academic medical centers. For more information, please
visit www.pavmed.com, follow us on Twitter, connect with us on
LinkedIn, and watch our videos on YouTube. For more information on
our majority owned subsidiary, Lucid Diagnostics Inc., please visit
www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on
LinkedIn.
Forward-Looking Statements
This press release includes forward-looking
statements that involve risks and uncertainties. Forward-looking
statements are statements that are not historical facts. Such
forward-looking statements, 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, volatility in the
price of PAVmed’s common stock, Series W Warrants and Series Z
Warrants; general economic and market conditions; the uncertainties
inherent in research and development, including the cost and time
required advance PAVmed’s products to regulatory submission;
whether regulatory authorities will be satisfied with the design of
and results from PAVmed’s preclinical studies; whether and when
PAVmed’s products are cleared by regulatory authorities; market
acceptance of PAVmed’s products once cleared and commercialized;
our ability to raise additional funding and other competitive
developments. PAVmed has not yet received clearance from the FDA or
other regulatory body to market any of its products. New risks and
uncertainties may arise from time to time and are difficult to
predict. All of these factors are difficult or impossible to
predict accurately and many of them are beyond PAVmed’s control.
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 IA, “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 Reports 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.
Contacts:
InvestorsMike HavrillaDirector of Investor
Relations(814) 241-4138JMH@PAVmed.com
MediaShaun O’NeilChief Commercial Officer(518)
812-3087SMO@PAVmed.com
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