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false 0000925741 0000925741 2023-05-10 2023-05-10 0000925741 bcda:CommonStockCustomMember 2023-05-10 2023-05-10 0000925741 bcda:WarrantToPurchaseCommonStockCustomMember 2023-05-10 2023-05-10
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 10, 2023
 
BIOCARDIA, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
0-21419
 
23-2753988
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
 
320 Soquel Way
Sunnyvale, California 94085
 
(Address of principal executive offices and zip code)
 
 
Registrant’s telephone number, including area code: (650) 226-0120
 
_____________________________________________
 
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:
 
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
BCDA
The Nasdaq Capital Market
Warrant to Purchase Common Stock
BCDAW
The Nasdaq Capital Market
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter) ☐
 
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 10, 2023, BioCardia, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2023. A copy of the press release is furnished as Exhibit 99.1 to this report.
 
The information in this Item 2.02, including the Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
 
Item 9.01   Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit No.
 
Description
99.1
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 


 
SIGNATURES
 
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.
 
 
BIOCARDIA, INC.
 
   
/s/ Peter Altman, Ph.D.
 
Peter Altman, Ph.D.
 
President and Chief Executive Officer
 
   
Date: May 10, 2023
 
 
 
EX-99.1 2 ex_517817.htm EXHIBIT 99.1 ex_517817.htm

Exhibit 99.1

 

BIOCARDIA REPORTS FIRST QUARTER 2023 BUSINESS HIGHLIGHTS AND FINANCIAL RESULTS

 

Sunnyvale, Calif. – May 10, 2023 - BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the first quarter of 2023 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2023 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session.

 

“Our autologous and allogeneic cell therapy programs are advancing in the clinic, with three enabled by our Helix cardiac biotherapeutic delivery system and a fourth using intravenous delivery,” said Peter Altman, Ph.D., President, and CEO.  “This past quarter our lead CardiAMP cell therapy for heart failure program had positive two-year data, additional patients enrolled and new centers consenting their first patients.  For this program, we have had productive interactions with the FDA towards implementing an adaptive statistical analysis plan and have been preparing for submission towards approval in Japan.  We are also engaged in discussions for six out licensing and product distribution opportunities with an intent to close two in 2023, in parallel to delivering our product milestones.”

 

RECENT BUSINESS HIGHLIGHTS:

 

CardiAMP® Autologous Cell Therapy for Patients with Ischemic Heart Failure (BCDA-01)

 

The CardiAMP Cell Therapy Trial for Heart Failure is a Phase III, multi-center, randomized, double-blinded, sham-controlled study intended to include up to 260 patients. The Phase III pivotal trial, which was granted Breakthrough designation by the U.S. Food and Drug Administration (FDA), is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for the treatment of heart failure with reduced ejection fraction (HFrEF). This trial is active at 20 clinical sites in the United States and Canada. One hundred twenty (120) patients have been enrolled to date, with 10 additional control patients having crossed over to receive the study treatment after completing their two-year follow-up study visit.

 

In March, positive echocardiography data from the trial was presented at the 2023 American College of Cardiology annual meeting in New Orleans. Detailed echocardiography data from the roll-in cohort from baseline through one and two years showed a more than doubling in the number of heart segments functioning normally and restoration of function to 30 percent of previously non-functioning segments.  Despite severe, symptomatic ischemic HFrEF, two-year survival was 100 percent, and all patients completed 24 months of follow-up. Echocardiography outcomes were consistent with improvement in functional capacity as measured by median change in six-minute walk distance that was clinically meaningful at both 12 months and 24 months, and improvement in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire in the majority of patients at both one year and two years.  

 







 

The Company has been actively working with the FDA to incorporate an adaptive statistical analysis plan in the next Data Safety Monitoring Board (DSMB) meeting. This plan will enable the ongoing trial to be stopped early if there is a high probability of success or futility. After a “Sprint” Discussion with the FDA in March, the adaptive statistical analysis plan incorporating the FDA’s feedback was submitted to the FDA on April 26. We anticipate that the FDA will approve the supplement in time for the next DSMB meeting, currently being scheduled for the last week of June.

 

The Company has prepared a submission towards approval by Japan’s Pharmaceutical and Medical Device Agency (PMDA), based on existing data, which we expect to submit in the current quarter. It is expected that review, consultation, and clarity on potential approval will follow over subsequent months.

 

CardiAMP® Autologous Cell Therapy for Patients with Chronic Myocardial Ischemia (BCDA-02)

 

The CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia is a Phase III, multi-center, randomized, double-blinded, controlled study intended to include up to 343 patients at up to 40 clinical sites. The Phase III pivotal trial is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for the indication of chronic myocardial ischemia. The trial has been activated at two clinical sites and three patients have been enrolled and treated. The Company expects to complete the roll-in cohort in 2023.

 

CardiALLO™ Allogeneic Cell Therapy for Ischemic HFrEF (BCDA-03)

 

The CardiALLO Cell Therapy Trial for heart failure is a Phase I/II, multi-center, randomized, double-blinded, controlled study intended to include up to 69 patients and designed to assess the safety and efficacy of this therapeutic candidate. The investigational New Drug Application was approved by the FDA in December 2022. The trial is designed for patients with New York Heart Association Class II and III ischemic HFrEF whose own cell composition makes them ineligible for the Company’s Phase III CardiAMP Cell Therapy Trial for Heart Failure. Clinical-grade allogeneic cells have been manufactured in our facility and are available for use. We have completed contracting and budget negotiations with our first center and expect to begin enrolling patients as soon as the clinical site agreements and IRB approvals are in place.

 

Allogeneic Cell Therapy for Acute Respiratory Distress Syndrome (BCDA-04)

 

Our Allogeneic Cell Therapy Trial for Acute Respiratory Distress Syndrome (ARDS) is a Phase I, multi-center, open label study intended to include up to nine patients. This ARDS trial is expected to commence in the fourth quarter of 2023, following the initiation of the trial studying these allogeneic MSC cells for HFrEF.

 

Intellectual Property

 

Two enabling device patents issued in March, related to our steerable introducer catheter systems which enable our cardiac biotherapeutic delivery procedures.

 

Quality System

 

The FDA completed an audit of the Company’s Medical Device Quality System that underlies our clinical programs and those of our biotherapeutic delivery partners with no written observations.

 

Business Development

 

In February, the Company announced an amendment and extension of its partnership to work together on CellProthera’s next clinical study, and potential early access commercialization, which could begin in 2024. 

 







 

First Quarter 2023 Financial Results:

 

 

>

Revenues were approximately $64 thousand for the three months ended March 2023, compared for approximately $60 thousand in the three months ended March 2022.

 

 

>

Research and development expenses increased to approximately $2.4 million for the three months ended March 2023 compared to approximately $2.2 million for the three months ended March 2022, primarily due to increased expenses in support of the CardiAMP Cell Therapy Trial for Heart Failure.

 

 

>

Selling, general and administrative expenses were approximately $1.2 million for the three months ended March 2023 and for the three months ended March 2022.

 

 

>

Our net loss was approximately $3.5 million for the three months ended March 2023, compared to approximately $3.3 million for the three months ended March 2022.

 

 

>

Net cash used in operations for the three months ended March 2023 was approximately $2.6 million, as compared to approximately $2.9 million for the three months ended March 2022.

 

ANTICIPATED UPCOMING MILESTONES AND EVENTS:

 

 

>

BCDA-01: CardiAMP Cell Therapy for Heart Failure Phase III Trial

 

 

-

Q2 2023: DSMB review

 

 

-

Q2 2023: Japan’s Pharmaceutical and Medical Device Agency Submission

 

 

>

BCDA-02: CardiAMP Cell Therapy for Chronic Myocardial Ischemia Phase III Trial

 

 

-

Q4: 2023: Roll-in cohort top line safety data presentation

 

 

>

BCDA-03: NK1R+ MSC Allogeneic Cell Therapy in ischemic HFrEF Phase I/II Trial

 

 

-

Q2 2023: First patient enrolled

 

 

>

BCDA-04: NK1R+ MSC Allogeneic Cell Therapy in ARDS Phase I/II Trial

 

 

-

Q4 2023: First patient enrolled

 

About BioCardia®

 

BioCardia, Inc., headquartered in Sunnyvale, California, is a developer of two biotherapeutic platforms – the CardiAMP autologous bone marrow derived mononuclear cell therapy for cardiovascular indications, and the NK1R+ allogeneic bone marrow derived mesenchymal stem cell therapy for cardiovascular and pulmonary diseases. These platforms underly four product candidates, each with the potential to meaningfully benefit millions of patients. Three of BioCardia’s investigational therapies are enabled by the Company’s proprietary biotherapeutic delivery platform, which the Company also selectively licenses to other biotherapeutic development firms. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services.  For more information visit: www.BioCardia.com.

 







 

Conference call access:

 

Participants can register for the conference by navigating to https://dpregister.com/sreg/10178872/f96d986c90.  Please note that registered participants will receive their dial-in number upon registration.  For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=qLPC1TiA.

 

A webcast replay of the call will be available approximately one hour after the end of the call through August 10, 2023, at the above links. A telephonic replay of the call will be available through May 24, 2023 and may be accessed by calling 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada) by using access code 8791101 or by the link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=qLPC1TiA.

 

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 in our clinical trials, the availability of data from our clinical trials, filings with the FDA and Japan’s Pharmaceutical and Medical Device Agency, FDA and Japanese 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, the ability to enter into licensing and partnering arrangements 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 29, 2023, 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:
Anne Laluc, Marketing
Email: alaluc@BioCardia.com
Phone: 650-226-0120

 

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

 



 

BioCardia, Inc.

Condensed Consolidated Statements of Operations
(Unaudited in thousands, except share and per share amounts)

 

   

Three Months ended
March 31,

 
   

2023

   

2022

 

Revenue:

               

Net product revenue

  $     $ 1  

Collaboration agreement revenue

    64       59  

Total revenue

    64       60  

Costs and expenses:

               

Research and development

    2,384       2,186  

Selling, general and administrative

    1,190       1,201  

Total costs and expenses

    3,574       3,387  

Operating loss

    (3,510 )     (3,327 )

Other income (expense):

               

Total other income, net

    9       2  

Net loss

  $ (3,501 )   $ (3,325 )
                 

Net loss per share, basic and diluted

  $ (0.17 )   $ (0.19 )
                 

Weighted-average shares used in computing net loss per share, basic and diluted

    20,177,167       17,066,068  

 



 

BioCardia, Inc.

Selected Balance Sheet Data

(amounts in thousands)

 

   

March 31,

   

December 31,

 
   

2023(1)

   

2022(1)

 
                 

Assets:

               

Cash and cash equivalents

  $ 4,857     $ 7,363  

Other current assets

    432       501  

Property, equipment and other noncurrent assets

    1,839       1,929  

Total assets

  $ 7,128     $ 9,793  

Liabilities and Stockholders’ Equity

               

Current liabilities

  $ 4,000     $ 3,585  

Operating lease liability - noncurrent

    1,228       1,316  

Total stockholders’ equity

    1,900       4,892  

Total liabilities and stockholders’ equity

  $ 7,128     $ 9,793  

 

(1)  March 31, 2023 amounts are unaudited. December 31, 2022 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, 2022, filed with the U.S. Securities and Exchange Commission on March 29, 2023.