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BCDA - BioCardia Inc News Story

$3.47 0.0  0.6%

Last Trade - 05/05/21

Sector
Healthcare
Size
Micro Cap
Market Cap £41.7m
Enterprise Value £26.3m
Revenue £104k
Position in Universe 5547th / 6846

BioCardia Reports 2020 Financial Results and Recent Business Highlights

Tue 30th March, 2021 1:00pm
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SAN CARLOS, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- BioCardia(®), Inc.
(https://www.globenewswire.com/Tracker?data=oMT8NgocTGjiAAmLCyJ7lMBQVH5FOecsSWrqf2azWEENgsKx-yzxFR0EosDlwc8l5Yefmif4-80KlXa4iBiYdg==) [Nasdaq:
BCDA], a leader in the development of comprehensive solutions for
cardiovascular and pulmonary regenerative therapies, today reported financial
results for the fourth quarter and full year ended December 31, 2020 and
recent business highlights. BioCardia has filed its annual 10-K with the
Securities and Exchange Commission.

“We continue to recognize and thank our many outstanding clinical partners
and their teams who are on the front lines of dealing with the COVID-19
situation nationwide as we work with them to accelerate our pivotal cell
therapy clinical trials,” said BioCardia CEO Peter Altman, Ph.D. “We also
recognize the proactive efforts of the FDA to provide guidelines to help
protect patients and preserve the integrity of ongoing clinical trials. The
ongoing dedication to patient care, even at the potential risk to healthcare
workers’ own health, is a testament to the commitment we have seen ourselves
in their work on our clinical programs.”

Q4 and Recent Business Highlights:
* CardiAMP™ Cell Therapy

   * CardiAMP™ Heart Failure Trial (BCDA-01) received positive DSMB
recommendations – the independent Data Safety Monitoring Board (DSMB) has
completed its prespecified data review for the Phase III pivotal CardiAMP
(http://www.biocardia.com/pipeline/cardiamp-cell-therapy/id/8)™ Heart
Failure Trial. The DSMB based its review on all available data for the 86
patients enrolled in the trial, including 60 randomized patients who have
reached their one-year follow-up. The DSMB performed a risk-benefit
assessment, indicated no safety concerns, and recommended that the study
continue as designed.  


* Peer reviewed initial data from the ongoing pivotal Phase III Clinical Trial
was in press in the International Journal of Cardiology in October 2020.
Results showed improvements at one-year follow-up in heart failure patients
measured by exercise outcomes and cardiac function.    
  
*    Helix™ Biotherapeutic Delivery System

   * The journal, Cardiovascular Revascularization Medicine published a study
showing the Helix System, which is being used in the pivotal Phase III
CardiAMP Heart Failure Trial currently enrolling nationwide for infusion of
BioCardia’s CardiAMP cell therapy to the myocardium, demonstrated the best
safety profile among clinical transendocardial catheter injection systems used
for cardiac cell therapy delivery.


* U.S. Patent No: 10,874,831 for “Devices and Methods for Accessing the
Vasculature of a Patient” was issued, which further protects our Helix™
Biotherapeutic Delivery System
(http://www.biocardia.com/products/helix-biotherapeutic-delivery-system/id/18).
This patent covers a steerable catheter design intended to provide uniform
bending rigidity in all orientations.  This uniform bending rigidity is
expected to significant enhance physician control in tortuous anatomy.  The
patented technology is incorporated in the Company’s recently approved Morph
DNA and AVANCE™ steerable catheter offerings.  The advances are also
expected to strengthen the Company’s clinical stage biotherapeutic programs
in heart failure and chronic myocardial ischemia. 
  
* Business Development

   * The Company entered into an agreement with a leading Japanese
pharmaceutical company related to BioCardia Helix catheter biotherapeutic
delivery product candidates.  Under the terms of the agreement, BioCardia
received a $500,000 up-front payment, a portion of which is creditable for
biotherapeutic delivery products and support services. The agreement has a
one-year term with an option to negotiate for a non-exclusive world-wide
license to BioCardia Helix catheter biotherapeutic delivery product candidates
for certain cell types for cardiac indications.   
   
* Corporate

   * Dr. Sujith Shetty has taken the role of Chief Medical Officer, replacing
Dr. Eric Duckers, who resigned as Chief Medical Officer of the Company in
February 2021.  Dr. Shetty has been with the Company for almost two years in
the capacity of Vice President of Clinical and Regulatory. Dr. Duckers has
entered into a consulting agreement to continue to provide support for the
ongoing CardiAMP™ Heart Failure Trial and its leadership team.  Ms. Debby
Holmes-Higgin who has been with the Company for more than three years will
continue to serve as Vice President of Clinical with expanded
responsibilities. 


* Krisztina Zsebo, Ph.D., a veteran of the biotech industry and cardiovascular
biotherapeutic development, joined BioCardia’s Board of Directors in
December 2020, following her election at BioCardia’s 2020 Annual Meeting of
Stockholders.
  
* Financial

   * $19 million financing – the company closed two public equity offerings
during the fourth quarter of 2020, one for $8.5 million at $4.75 per share and
one for 10.5 million at $5.15 per share.


* $20 million equity line – the company recently closed a $20 million equity
line, including $2.0 million initial sale of common stock priced more than 10%
above market at $5.35 per share with additional modest commitment shares.
Dr. Altman continued, “We continue to press on our cell therapy programs.
With three positive DSMB reviews to date and two new peer reviewed manuscripts
supporting the program in the last quarter, our CardiAMP autologous cell
therapy (BCDA-01) for the treatment of ischemic heart failure, remains our top
priority. Our CardiAMP autologous cell therapy is also under Phase III
pivotal development for the treatment of chronic myocardial ischemia
(BCDA-02), with the first patient enrolled in this second large unmet clinical
indication expected in the near future.

“In coordination with our lead programs, we are actively pursuing multiple
avenues for value creation and revenue generation in addition to those based
on the autologous CardiAMP cell therapy product candidates. We are working
towards FDA acceptance of both our allogeneic ‘off the shelf’ Neurokinin-1
receptor positive mesenchymal stem cell Phase I/II programs for patients who
were excluded from our BCDA-01 program, and separately for patients with acute
respiratory distress syndrome. Our AVANCE™ product offering for transseptal
cardiac procedures has begun early commercialization activities in the United
States through commission-only 1099 sales representation. We also continue to
selectively partner with other therapeutic developers, such as the one
recently announced with a well-respected Japanese pharmaceutical company.

“With a secure cash position from the three recent financial transactions,
continued diligence to spend resources wisely even as we build a
commission-only sales capability and increase business development activities,
we will advance our data driven therapeutic development programs rigorously
with patient safety as our number-one priority. We are optimistic about the
coming year, and believe we are well positioned to achieve our goals. We look
forward to sharing our success with shareholders ahead,” concluded Dr.
Altman.

Full Year 2020 Financial Results:
* Revenues decreased significantly year over year with $145,000 in 2020
compared to $710,000 in 2019, which can be attributed to lower
revenue-generating partnership activities, coupled with reduced volumes of
commercial catheter sales as we transition our commercial offerings to a
limited launch of the AVANCE™ and Morph DNA product families.


* Research and development expenses were up approximately 15% to $9.8 million,
compared to $8.6 million in 2019, primarily due to the cost of additional
personnel and supporting systems to enhance enrollment and monitoring in our
ongoing pivotal CardiAMP™ Heart Failure and Myocardial Ischemia trials.


* Selling, general and administrative expenses decreased to $5.9 million in
2020, compared to $6.0 million in 2019.


* Net loss was approximately $15.0 million for 2020, compared to $14.7 million
for 2019.


* Net cash used in operations in 2020 was $12.4 million, as compared to $9.4
million in 2019.
 Anticipated Upcoming Milestones:
* Q2 2021: Phase III pivotal trial prespecified independent DSMB Review of
CardiAMP Heart Failure trial (BCDA-01).
* Q2 2021: Phase III pivotal trial first patient enrolled in CardiAMP Chronic
Myocardial Ischemia Trial (BCDA-02).
* Other 2021 anticipated milestones include:   * Roll in cohort safety data
from BCDA-02, our CardiAMP autologous cell therapy under Phase III development
for the treatment of chronic myocardial ischemia.
* Investigational New Drug (IND) acceptance of Phase I/II program of BCDA-03,
our allogeneic Neurokinin-1 receptor positive (NK1R+) Mesenchymal Stem Cells
(MSC) for the treatment of ischemic heart failure intended initially for those
patients excluded from BCDA-01.
* IND acceptance of Phase I/II program for BCDA-04, our allogeneic NK1R+ MSC
Phase I/II program for the treatment of acute respiratory distress resulting
from COVID-19.
About BioCardia(®)
BioCardia, Inc.
(https://www.globenewswire.com/Tracker?data=oMT8NgocTGjiAAmLCyJ7lF9x75xgta_igugrEgKeRR8RR8TGj1Ot-qUi9U28nhQ4V5UdIVwIhT1aq8UFru-4YA==),
headquartered in San Carlos, California, is developing regenerative biologic
therapies to treat cardiovascular and pulmonary disease. CardiAMP™
autologous and NK1R+ allogeneic cell therapies are the Company’s
biotherapeutic product candidates in clinical development. The Company's
current products include the Helix™ transendocardial delivery system, the
Morph(®) steerable guide and sheath catheter portfolio and the AVANCE™
steerable introducer family. BioCardia also partners with other biotherapeutic
companies to provide its Helix systems and development support to their
programs studying therapies for the treatment of heart failure, chronic
myocardial ischemia and acute myocardial infarction.

Forward Looking Statements 
This press release contains forward-looking statements that are subject to
many risks and uncertainties. Forward-looking statements include, among other
things, references to the enrollment of our clinical trials, the availability
of data from our clinical trials, filings with the FDA, FDA product
clearances, the efficacy and safety of our products and therapies, preliminary
conclusions about new data, the achievement of any of the anticipated upcoming
milestones, our positioning for growth or the market for our products and
therapies, statements regarding our intentions, beliefs, projections, outlook,
analyses or current expectations. Such risks and uncertainties include, among
others, the inherent uncertainties associated with developing new products or
technologies, regulatory approvals, unexpected expenditures, the ability to
raise the additional funding needed to continue to pursue BioCardia’s
business and product development plans and overall market conditions.  We may
find it difficult to enroll patients in our clinical trials due to many
factors, some of which are outside of our control.  Slower than targeted
enrollment could delay completion of our clinical trials and delay or prevent
development of our therapeutic candidates.  These forward-looking statements
are made as of the date of this press release, and BioCardia assumes no
obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,”
“might,” “will,” “should,” “approximately” or other words that
convey the uncertainty of future events or outcomes to identify these
forward-looking statements. Although we believe that we have a reasonable
basis for each forward-looking statement contained herein, we caution you that
forward-looking statements are not guarantees of future performance and that
our actual results may differ materially from the forward-looking statements
contained in this press release. As a result of these factors, we cannot
assure you that the forward-looking statements in this press release will
prove to be accurate.  Additional factors that could materially affect actual
results can be found in BioCardia’s Form 10-K filed with the Securities and
Exchange Commission on March 30, 2021, under the caption titled “Risk
Factors.” BioCardia expressly disclaims any intent or obligation to update
these forward-looking statements, except as required by law. 



Media Contact: 
Michelle McAdam, Chronic Communications, Inc.
Email: michelle@chronic-comm.com 
Phone: 310-902-1274

Investor Contact: 
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

                                                                                                                                                                        
                                                                                                                                                                        
 BIOCARDIA, INC.                                                                                                                                                        
 Consolidated Statements of Operations                                                                                                                                  
 (In thousands, except share and per share amounts)                                                                                                                     
                                                                                                                                                                        
                                                                                                                          Year ended December 31,                       
                                                                                                                          2020                      2019                
                                                                                                                                                                        
 Revenue:                                                                                                                                                               
                Net product revenue                                                                    $                  13                 $      182                 
                Collaboration agreement revenue                                                                           132                       528                 
                                             Total revenue                                                                145                       710                 
 Costs and expenses:                                                                                                                                                    
                Cost of goods sold                                                                                        4                         358                 
                Research and development                                                                                  9,809                     8,562               
                Selling, general and administrative                                                                       5,861                     6,003               
                                             Total costs and expenses                                                     15,674                    14,923              
                                             Operating loss                                                               (15,529     )             (14,213    )        
 Other income (expense):                                                                                                                                                
                Interest income                                                                                           21                        87                  
                Gain on extinguishment of Paycheck Protection Program note payable                                        509                       -                   
                Gain on change in fair value of redemption feature embedded in convertible notes                          -                         52                  
                Interest expense                                                                                          (3          )             (112       )        
                Loss on extinguishment of convertible notes                                                               -                         (521       )        
                Other expense                                                                                             (2          )             (2         )        
                                             Total other income (expense)                                                 525                       (496       )        
 Net loss                                                                                              $                  (15,004     )      $      (14,709    )        
                                                                                                                                                                        
 Net loss per share, basic and diluted                                                                 $                  (1.48       )      $      (2.61      )        
                                                                                                                                                                        
 Weighted-average shares used in computing                                                                                                                              
                net loss per share, basic and diluted                                                                     10,118,682                5,644,328           
                                                                                                                                                                        



                                                                                                                                                                                                                                                                                                         
 BioCardia, Inc.                                                                                                                                                                                                                                                                                         
 Selected Balance Sheet Data                                                                                                                                                                                                                                                                             
 (amounts in thousands)                                                                                                                                                                                                                                                                                  
                                                                                                                                                                                                                                                                                                         
                                                                                                                                                                                                                                                                                                         
                                                            December 31,                                                                                                                                                                                December 31,                                     
                                                            2020 ((1))                                                                                                                                                                                  2019 ((1))                                       
                                                                                                                                                                                                                                                                                                         
 Assets:                                                                                                                                                                                                                                                                                                 
 Cash and cash equivalents                                  $                                              21,407                                                                                        $                                              5,585                                            
 Other current assets                                                                                      1,251                                                                                                                                        793                                              
 Property, plant and equipment and other noncurrent assets                                                 766                                                                                                                                          1,300                                            
 Total assets                                               $                                              23,424                                                                                        $                                              7,678                                            
 Liabilities and Stockholders’ Equity                                                                                                                                                                                                                                                                    
 Current liabilities                                        $                                              4,248                                                                                         $                                              4,003                                            
 Noncurrent liabilities                                                                                    —                                                                                                                                            1,305                                            
 Total stockholders’ equity                                                                                19,176                                                                                                                                       2,370                                            
 Total liabilities and stockholders’ equity                 $                                              23,424                                                                                        $                                              7,678                                            
                                                                                                                                                                                                                                                                                                         
 (1) December 31, 2020 and 2019 amounts were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission on March 30, 2021.                             
                                                                                                                                                                                                                                                                                                         

(https://www.globenewswire.com/NewsRoom/AttachmentNg/4641bb53-4913-4654-a337-79383a5c7ab9)



GlobeNewswire, Inc. 2021
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