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BioCardia Inc

For the period ended Jun 30, 2024. Filed Aug 13, 2024.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 13, 2024

BCDA$0.85-4.5%Stored close · as of Nov 6, 2026
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Item 1. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

BIOCARDIA, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

June 30,December 31,
20242023
(unaudited)
Assets
Current assets:
Cash and cash equivalents$1,421$1,103
Accounts receivable, net of allowance for doubtful accounts of $0 and $34 as of June 30, 2024 and December 31, 2023, respectively1063
Prepaid expenses and other current assets142295
Total current assets1,5731,461
Property and equipment, net6194
Operating lease right-of-use asset, net1,0851,261
Other assets171171
Total assets$2,890$2,987
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable$1,447$890
Accrued expenses and other current liabilities2,2662,385
Operating lease liability - current358333
Total current liabilities4,0713,608
Operating lease liability - noncurrent780982
Total liabilities4,8514,590
Commitments and contingencies (Notes 2, 5 and 12)
Stockholders’ deficit:
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of June 30, 2024 and December 31, 2023——
Common stock, $0.001 par value, 50,000,000 and 100,000,000 shares authorized, 2,123,876 and 1,577,769 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively22
Additional paid-in capital154,125150,570
Accumulated deficit(156,088)(152,175)
Total stockholders’ deficit(1,961)(1,603)
Total liabilities and stockholders’ deficit$2,890$2,987

BIOCARDIA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

Three months ended · Six months ended
June 30,June 30,
2024202320242023
Revenue:
Collaboration agreement revenue343$58$107
Costs and expenses:
Research and development8002,3142,0414,698
Selling, general and administrative8521,1811,9412,371
Total costs and expenses1,6523,4953,9827,069
Operating loss(1,649)(3,452)(3,924)(6,962)
Other income (expense):
Total other income, net3281137
Net loss$(1,646)$(3,424)$(3,913)$(6,925)
Net loss per share, basic and diluted$(0.88)$(2.52)$(2.20)$(5.12)
Weighted-average shares used in computing net loss per share, basic and diluted1,877,0691,358,9681,776,3051,352,094

BIOCARDIA, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(In thousands, except share amounts)

(unaudited)

Common stock · Additional · Accumulated
SharesCostpaid-in capitaldeficitTotal
Balance at December 31, 20221,338,451$1$145,495$(140,604)$4,892
Sale of common stock under ATM, net of issuance costs of $137,083—231—231
Exercise of common stock options13————
Restricted stock units vested and issued1,253————
Share-based compensation——278—278
Net loss———(3,501)(3,501)
Balance at March 31, 20231,346,800$1$146,004$(144,105)$1,900
Sale of common stock under ATM, net of issuance costs of $291,907—29—29
Restricted stock units vested and issued14,827————
Restricted stock units issued to settle management bonus obligations——342—342
Share-based compensation——317—317
Sale of common stock on June 21, 2023, net of issuance costs of $17775,543—2,471—2,471
Net loss———(3,424)(3,424)
Balance at June 30, 20231,439,077$1$149,163$(147,529)$1,635
Balance at December 31, 20231,577,769$2$150,570$(152,175)$(1,603)
Sale of common stock under ATM, net of issuance costs of $3277,127—559—559
Sale of common stock and warrants on February 13, 2024, net of issuance costs of $43134,199—832—832
Share-based compensation——204—204
Net loss———(2,267)(2,267)
Balance at March 31, 20241,789,095$2$152,165$(154,442)$(2,275)
Sale of common stock under ATM, net of issuance costs of $71335,112—1,776—1,776
Reverse stock split fractional share true up(331)————
Share-based compensation——184—184
Net loss———(1,646)(1,646)
Balance at June 30, 20242,123,876$2154,125(156,088)(1,961)

BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

Six months ended June 30,
20242023
Operating activities:
Net loss$(3,913)$(6,925)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation3643
Reduction in the carrying amount of right-of-use assets176159
Share-based compensation388595
Allowance for doubtful accounts(34)—
Changes in operating assets and liabilities:
Accounts receivable8786
Prepaid expenses and other current assets15370
Accounts payable56169
Accrued expenses and other current liabilities(119)353
Deferred revenue—(8)
Operating lease liability(177)(153)
Net cash used in operating activities(2,842)(5,711)
Investing activities:
Purchase of property and equipment(3)(12)
Net cash used in investing activities(3)(12)
Financing activities:
Proceeds from sales of common stock3,3152,950
Issuance costs of sale of common stock(152)(285)
Net cash provided by financing activities3,1632,665
Net change in cash and cash equivalents318(3,058)
Cash and cash equivalents at beginning of period1,1037,363
Cash and cash equivalents at end of period$1,421$4,305
Supplemental disclosure of noncash investing and financing activities:
Unpaid issuance costs of common stock$66$106
Issuance of restricted stock units in lieu of cash bonus obligations$—$564

BioCardia, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

(1)Summary of Business and Basis of Presentation

Description of Business

BioCardia, Inc. (we, us, our, BioCardia or the Company), is a clinical-stage company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an “off the shelf” cell therapy for two clinical indications: the treatment of ischemic HFrEF and for acute respiratory distress syndrome (ARDS). Our autologous and our allogeneic cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. To date, we have devoted substantially all our resources to research and development efforts relating to our therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting our intellectual property.

We manage our operations as a single segment for the purposes of assessing performance and making operating decisions.

(2)Significant Accounting Policies
(a)Basis of Preparation
The accompanying condensed consolidated balance sheets, statements of operations, stockholders’ equity (deficit), and cash flows as of June 30, 2024, and for the three and six months ended June 30, 2024 and 2023 are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly our financial position as of June 30, 2024, results of operations for the three and six months ended June 30, 2024 and 2023, and cash flows for the six months ended June 30, 2024 and 2023. The results for the three and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ended December 31, 2024 or for any other interim period or for any other future year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024.
(b)Liquidity – Going Concern
We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $156.1 million as of June 30, 2024. Management expects operating losses and negative cash flows to continue through at least the next several years. We expect to incur increasing costs as we advance our trials and development activities. Therefore, absent additional funding, management believes cash and cash equivalents of approximately $1.4 million as of June 30, 2024 are not sufficient to fund our planned expenditures and meet our obligations through September 2024. These factors raise substantial doubt about our ability to continue as a going concern beyond one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Our ability to continue as a going concern and to continue further development of our therapeutic candidates through September 2024 will require us to raise additional capital. We plan to raise additional capital, potentially including debt and equity arrangements, to finance our future operations. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within its control and cannot be assessed as being probable of occurring. If adequate funds are not available, we may be required to reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize, or cease operations.
(c)Use of Estimates
The preparation of the financial statements in accordance with U.S. GAAP requires management to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions include clinical accruals, share-based compensation, right-of-use assets and related liabilities, incremental borrowing rate, the useful lives of property and equipment, allowances for doubtful accounts and sales returns, and assumptions used for revenue recognition.
(d)Principles of Consolidation
The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, BioCardia Lifesciences, Inc. All intercompany accounts and transactions have been eliminated during the consolidation process.
(e)Concentration of Credit Risk
Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents. Our cash at times exceeds federally insured limits of $250,000 per customer. On June 30, 2024, approximately 96% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were approximately $1.1 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.
(f)Changes to Significant Accounting Policies
Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024. There have been no changes to those policies.
(g)Recent Accounting Pronouncements
Recent accounting pronouncements issued by the Financial Accounting Standards Board (FASB), including its Emerging Issues Task Force, did not or are not believed by management to have a material impact on our financial statement presentation or disclosures.
(3)Fair Value Measurement

The fair value of financial instruments reflects the amounts that we estimate to receive in connection with the sale of an asset or paid in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). We follow a fair value hierarchy that prioritizes the use of inputs used in valuation techniques into the following three levels:

Level 1 – quoted prices in active markets for identical assets and liabilities.

Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 – unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table shows the fair value of our financial assets measured on a recurring basis and indicates the fair value hierarchy utilized to determine such fair value (in thousands):

Level 1Level 2Level 3Total
Assets:
Money market funds$2$—$—$2
Cash in savings account———1,283
Cash in checking account———136
Total cash and cash equivalents$2$—$—$1,421
Level 1Level 2Level 3Total
Assets:
Money market funds$2$—$—$2
Cash in savings account———1,072
Cash in checking account———29
Total cash and cash equivalents$2$—$—$1,103
(4)Property and Equipment, Net

Property and equipment, net consisted of the following (in thousands):

June 30,December 31,
20242023
Computer equipment and software$164$161
Laboratory and manufacturing equipment574574
Furniture and fixtures2727
Leasehold improvements2626
Property and equipment, gross791788
Less accumulated depreciation(730)(694)
Property and equipment, net$61$94

Depreciation expense totaled $17,000 and $36,000 for the three and six months ended June 30, 2024, respectively. Depreciation expense totaled $21,000 and $43,000 for the three and six months ended June 30, 2023, respectively.

(5)Operating Lease Right-of-Use (ROU) Asset, Net

We determine if an arrangement is a lease at inception by assessing whether it conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Our operating lease relates to a property lease for its laboratory and corporate offices which expires in January 2027. BioCardia’s lease agreement does not contain any material residual guarantees or material restrictive covenants.

ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. Our lease does not provide an implicit rate. We used an adjusted historical incremental borrowing rate, based on the information available at the approximate lease commencement date, to determine the present value of lease payments. Variable rent expense is made up of expenses for common area maintenance and shared utilities and were not included in the determination of the present value of lease payments. We have no finance leases.

Our lease expense was $120,000 for both the three months ended June 30, 2024 and 2023, and $241,000 for both the six months ended June 30, 2024 and 2023. The cash paid under the operating lease for base rent was $121,000 and $242,000 for the three and six months ended June 30, 2024, respectively, and was $118,000 and $236,000 for the three and six months ended June 30, 2023, respectively. On June 30, 2024, the weighted average remaining lease term was 2.59 years, and the weighted average discount rate was 10.74%.

Future minimum lease payments under the operating lease as of June 30, 2024 were as follows (in thousands):

Remainder of 2024$242
2025499
2026514
202744
Total undiscounted lease payments1,299
Less imputed interest161
Total operating lease liabilities$1,138
(6)Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

June 30,December 31,
20242023
Accrued expenses$4$75
Accrued salaries and employee benefits677661
Accrued clinical trial costs1,0041,017
Grant liability470471
Customer deposits6990
Payable to related party4271
Total$2,266$2,385
(7)Stockholders’ Equity

Warrants - Set forth below is a table of activity of warrants for common stock and the related weighted average exercise price per warrant.

Number ofWeighted
Common StockAverage
EquivalentsExercise Price
Balance as of December 31, 2023141,889$94.50
Warrants for common stock sold67,1046.60
Balance as of June 30, 2024208,993$66.30

Reverse Stock Split- On May 30, 2024, we effected a 1-for-15 reverse stock split of our common stock, and reduced the authorized common shares from 100,000,000 to 50,000,000. The par value was not adjusted as a result of the reverse stock split. All issued and outstanding common stock, warrants, stock options, restricted stock units and per share amounts contained in the accompanying consolidated financial statements and notes have been retroactively adjusted to give effect to the reverse stock split for all periods presented.

*February 2024 Financing -*On February 9, 2024, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, which closed on February 13, 2024. Pursuant to the agreement, we sold 134,199 shares of our common stock, and warrants to purchase 67,104 shares of our common stock at an exercise price equal to $6.60 per warrant share, subject to certain adjustments, as provided under the terms of the warrant, which are exercisable at any time before February 13, 2026. The gross proceeds of the Offering were $875,000, with associated issuance costs of $43,000.

At-the-Market (ATM) Offerings– On April 12, 2022, we entered into a sales agreement (Cantor Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) as the sales agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of common stock having an aggregate offering price of up to $10.5 million (ATM Offering). Under the terms of the Cantor Sales Agreement, Cantor was paid a commission of 3% of the aggregate proceeds from the sale of shares and reimbursed certain legal fees. The prospectus supplement expired in conjunction with the expiration of the corresponding registration statement on October 20, 2023. On June 20, 2023, we agreed with Cantor to indefinitely suspend sales under the ATM Offering, and on November 14, 2023, we agreed to terminate the Cantor Sales Agreement.

On December 6, 2023, we entered into an At The Market Offering Agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering price of up to $2.75 million during the term of the Sales Agreement through or to HCW as sales agent or principal, of which $264,000 was available as of June 30, 2024. We have filed a prospectus supplement relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares will be made pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-275099), which was initially filed with the Securities and Exchange Commission (the SEC) on October 19, 2023 and declared effective on December 5, 2023. We have agreed to pay HCW a commission equal to 3% of the gross proceeds from the sales of shares and have agreed to provide HCW with customary indemnification and contribution rights.

During the three months ended June 30, 2024 and 2023, we sold 335,112 and 1,907 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $1.8 million and $58,000, with associated issuance costs of $71,000 and $29,000, respectively. During the six months ended June 30, 2024 and 2023, we sold 412,239 and 8,990 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of approximately $2.4 million and $302,000, respectively, with associated issuance costs of $103,000 and $42,000, respectively.

(8)Share-Based Compensation

The share-based compensation expense is recorded in research and development, and selling, general and administrative expenses based on the employee's or non-employee’s respective function. No share-based compensation was capitalized during the periods presented. Share-based compensation expense for the three and six months ended June 30, 2024 and 2023 was recorded as follows (in thousands):

Three months ended · Six months ended
June 30,June 30,
2024202320242023
Research and development$102$134$217$273
Selling, general and administrative82183171322
Total share-based compensation$184$317$388$595

The following table summarizes the activity of stock options and related information:

Number of sharesWeighted average exercise priceWeighted average remaining contractual term (years)Aggregate intrinsic value (in thousands)
Balance, December 31, 2023165,784$52.676.8$43
Stock options forfeited(3,177)33.97
Stock options expired(6,965)57.37
Balance, June 30, 2024155,642$52.856.7$—
Exercisable, June 30, 2024106,464$65.795.9$—

Unrecognized share-based compensation for employee and nonemployee options granted through June 30, 2024 is approximately $1.0 million to be recognized over a remaining weighted average service period of 2.0 years.

Share-Based Compensation (RSUs)

There wereno RSUs outstanding and hence there is no unrecognized share-based compensation at June 30, 2024 and December 31, 2023.

(9)Net Loss per Share

Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding and fully vested restricted stock units. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of unvested restricted stock units, warrants to purchase common stock and options outstanding under the stock option plans. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding since the effects of potentially dilutive securities are antidilutive due to the net loss position.

The following outstanding common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive:

June 30,
20242023
Stock options to purchase common stock155,642173,738
Common stock warrants208,993161,648
Total364,635335,386
(10)Income Taxes

During the three and six months ended June 30, 2024 and 2023, there wasno income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statements of operations due to our net loss and a full valuation allowance on the resulting deferred tax assets.

As of June 30, 2024, we retain a full valuation allowance on our deferred tax assets in all jurisdictions. The realization of our deferred tax assets depends primarily on our ability to generate future taxable income which is uncertain. We do not believe that our deferred tax assets are realizable on a more-likely-than-not basis; therefore, the net deferred tax assets have been fully offset by a valuation allowance.

(11)Related Party Transactions

On April 9, 2020, we entered into a Litigation Funding Agreement (Funding Agreement) with BSLF, L.L.C. (Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia’s board of directors, for the purpose of funding our legal proceedings and any and all claims, actions and/or proceedings relating to or arising from the case captioned Boston Scientific Corp., et al., v. BioCardia Inc., Case No. 3:19-05645-VC, U.S.D.C., N. D. Cal (the Litigation). On April 12, 2021, all parties to the Litigation entered into a confidential settlement agreement and all claims were dismissed.

In March 2022, we entered into confidential settlement agreements with our litigation service providers and the Funder to terminate the Funding Agreement and conclude all remaining matters thereunder (the Litigation Funding Settlement). Under the terms of the Litigation Funding Settlement, litigation and corporate counsel provided credits and refunds of legal fees totaling $688,000 , which offset the amounts owed to us by the Funder under the Funding Agreement, and provided up to $300,000 in future discounts on legal services. As a result of the Litigation Funding Settlement, we remitted the discounts, as received, to the Funder on a quarterly basis. During the three and six months ended June 30, 2024, we received discounts totaling $0 and $42,000, respectively. During the three and six months ended June 30, 2023, we received discounts totaling $20,000 and $53,000, respectively. As of June 30, 2024 and December 31, 2023, we recorded a related party payable for discounts owed to the Funder in accrued expenses and other current liabilities of $42,000 and $71,000, respectively. As of June 30, 2024, all of the future potential discounts have been collected on behalf of the Funder.

(12)Contingencies

We may be subject to various claims, complaints, and legal actions that arise from time to time in the normal course of business. Management is not aware of any current legal or administrative proceedings that are likely to have an adverse effect on our business, financial position, results of operations, or cash flows.

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