| | The following table sets forth the fair value of its financial assets measured on a recurring basis as of March 31, 2021 and December 31, 2020 and indicates the fair value hierarchy utilized to determine such fair value of the Company’s marketable securities and the gross unrealized gains and losses as of September 30, 2017 (in thousands): | | Amortized cost | | | Unrealized gain | | | Unrealized loss | | | Estimated Fair Value | | US government securities | | $ | 1,799 | | | $ | — | | | $ | — | | | $ | 1,799 | | Total short-term investments | | $ | 1,799 | | | $ | — | | | $ | — | | | $ | 1,799 | |
As of September 30, 2017, the contractual maturity of the available-for-sale marketable securities is less than one year. There was no other-than-temporary impairment recognized during the nine months ended September 30, 2017.
Inventories are stated at the lower of cost or net realizable value using the average cost method. Inventories consist of the following (in thousands):
| | As of March 31, 2021 | | | | | | | | | | | | | | | | | | | | | Level 1 | | | Level 2 | | | Level 3 | | | Total | | Assets | | | | | | | | | | | | | | | | | Money market funds | | $ | 20,583 | | | $ | — | | | $ | — | | | $ | 20,583 | | Cash in checking account | | | — | | | | — | | | | — | | | | 919 | | Total cash and cash equivalents | | $ | 20,583 | | | $ | — | | | $ | — | | | $ | 21,502 | |
| | September 30, 2017 | | | December 31, 2016 | | Raw materials | | $ | 74 | | | $ | 59 | | Work in process | | | 87 | | | | — | | Finished goods | | | 79 | | | | 76 | | Total | | $ | 240 | | | $ | 135 | |
| | As of December 31, 2020 | | | | Level 1 | | | Level 2 | | | Level 3 | | | Total | | Assets | | | | | | | | | | | | | | | | | Money market funds | | $ | 20,662 | | | $ | — | | | $ | — | | | $ | 20,662 | | Cash in checking account | | | — | | | | — | | | | — | | | | 745 | | Total cash and cash equivalents | | $ | 20,662 | | | $ | — | | | $ | — | | | $ | 21,407 | |
Write downs for excess or expired inventory are based on management’s estimates of forecasted usage of inventories and are included in cost of goods sold. A significant change in the timing or level of demand for certain products as compared to forecasted amounts may result in recording additional write downs for excess or expired inventory in the future. Charges to cost of goods sold for inventory write-downs, scrap, shrinkage and expired inventories totaled approximately $15,000 and $57,000 for the three months ended September 30, 2017 and 2016, respectively, and approximately $25,000 and $94,000 for the nine months ended September 30, 2017 and 2016, respectively.
(6)(4)
| Property and Equipment, Net |
Property and equipment, net consist
| | Property and equipment, net consisted of the following (in thousands): |
| | September 30, 2017 | | | December 31, 2016 | | Computer equipment and software | | $ | 186 | | | $ | 143 | | Laboratory and manufacturing equipment | | | 431 | | | | 366 | | Furniture and fixtures | | | 48 | | | | 48 | | Leasehold improvements | | | 326 | | | | 325 | | Property and equipment, gross | | | 991 | | | | 882 | | Less accumulated depreciation | | | (828 | ) | | | (771 | ) | Property and equipment, net | | $ | 163 | | | $ | 111 | |
Depreciation expense totaled approximately $21,000 and $9,000 for the three months ended September 30, 2017 and 2016, respectively, and approximately $57,000 and $30,000 for the nine months ended September 30, 2017 and 2016, respectively.
| | March 31, | | | December 31, | | | | 2021 | | | 2020 | | Computer equipment and software | | $ | 166 | | | $ | 159 | | Laboratory and manufacturing equipment | | | 574 | | | | 550 | | Furniture and fixtures | | | 59 | | | | 59 | | Leasehold improvements | | | 332 | | | | 332 | | Construction in progress | | | 72 | | | | 70 | | Property and equipment, gross | | | 1,203 | | | | 1,170 | | Less accumulated depreciation | | | (1,039 | ) | | | (1,025 | ) | Property and equipment, net | | $ | 164 | | | $ | 145 | |
| | (7)Depreciation expense totaled approximately $14,000 and $22,000 for the three months ended March 31, 2021 and 2020, respectively.
|
(5) | Operating Lease Right-of-Use Asset, Net |
| | The Company’s operating lease is a property lease for its laboratory and corporate offices. BioCardia’s lease agreement does not contain any material residual guarantees or material restrictive covenants, nor does it contain an additional lease extension. The Company determines 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. |
| | Right-of-use (ROU) assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. The Company’s lease does not provide an implicit rate. The Company 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. The Company has no finance leases. |
| | The lease expense for the three months ended March 31, 2021 and 2020 was $150,000. The cash paid under the operating lease during the three months ended March 31, 2021 and 2020 was $162,000 and $158,000, respectively. On March 31, 2021, the weighted average remaining lease term was 0.75 years, and the weighted average discount rate was 12.05%. |
| | Future minimum lease payments under the operating lease as of March 31, 2021 are as follows (in thousands): |
| | Operating Lease March 31, 2021 | | Remainder of 2021 | | $ | 486 | | Total undiscounted lease payments | | | 486 | | Less imputed interest | | | 18 | | Total operating lease liabilities | | $ | 468 | |
(6) | Accrued Expenses and Other Current Liabilities |
| | Accrued expenses and other current liabilities consisted of the following (in thousands): |
Accrued expenses and other current liabilities consisted of the following (in thousands):
| | March 31, | | | December 31, | | | | 2021 | | | 2020 | | Accrued expenses | | $ | 240 | | | $ | 87 | | Accrued salaries and employee benefits | | | 851 | | | | 961 | | Accrued clinical trial costs | | | 457 | | | | 452 | | Grant liability | | | 610 | | | | 615 | | Customer deposits | | | 90 | | | | 90 | | Total | | $ | 2,248 | | | $ | 2,205 | |
| | September 30, 2017 | | | December 31, 2016 | | Accrued expenses | | $ | 487 | | | $ | 478 | | Accrued clinical trial costs | | | 175 | | | | — | | Grant liability | | | 669 | | | | 304 | | Customer deposits | | | 62 | | | | 66 | | Total | | $ | 1,393 | | | $ | 848 | |
| | Warrants - Set forth below is a table of activity of warrants for common stock and the related weighted average exercise price per warrant. |
| | Number of | | | Weighted | | | | Common Stock | | | Average | | | | Warrants | | | Exercise Price | | Balance, December 31, 2020 | | | 2,424,724 | | | $ | 6.36 | | Warrants for common stock sold | | | — | | | | — | | Warrants for common stock exercised | | | — | | | | — | | Balance, March 31, 2021 | | | 2,424,724 | | | $ | 6.36 | |
| | Lincoln Park Capital stock purchase agreement - On March 29, 2021, the Company and Lincoln Park Capital Fund, LLC (Lincoln Park) entered into a purchase agreement (the Purchase Agreement) and a registration rights agreement (the Registration Rights Agreement), pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s common stock having an aggregate value of up to $20 million, subject to certain limitations and conditions set forth in the Purchase Agreement (the Offering). As consideration for entering into the Purchase Agreement, the Company agreed to issue to Lincoln Park 75,000 shares of common stock as commitment shares. In addition, the Company agreed to issue to Lincoln Park up to an aggregate of 50,000 additional shares of common stock as a further commitment fee based on a pro-rata percentage of the $20 million of common stock issued to Lincoln Park under the Purchase Agreement. | | | | | | Pursuant to the Purchase Agreement, Lincoln Park purchased 373,832 shares of common stock, at a price of $5.35 per share, for a total gross purchase price of $2 million (the Initial Purchase) and the Company issued 80,000 shares of common stock as commitment shares, which included 5,000 commitment shares issued on a pro rata basis for the initial $2 million purchase. Thereafter, as often as every business day from and after one business day following the date of the Initial Purchase and over the 36-month term of the Purchase Agreement the Company has the right, from time to time, at its sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 100,000 shares of common stock, with such amount increasing as the closing price of the common stock increases; provided Lincoln Park’s obligation under any single such purchase will not exceed $2 million, unless the Company and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a Regular Purchase). If the Company directs Lincoln Park to purchase the maximum number of shares of common stock it then may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park in an Accelerated Purchase to purchase an additional amount of common stock that may not exceed the lesser of (i) 300% of the number of shares purchased pursuant to the corresponding Regular Purchase in multiple Accelerated Purchases on the same trading day or (ii) 30% of the total number of shares of the Company’s common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, the Company may direct Lincoln Park to purchase shares in multiple Accelerated Purchases on the same trading day. |
(8)
| | Convertible NotesThe Company controls the timing and amount of any sales of its common stock to Lincoln Park. There is no upper limit on the price per share that Lincoln Park must pay for its common stock under the Purchase Agreement. In no event may the Company issue or sell to Lincoln Park under the Purchase Agreement shares of the Company’s common stock in excess of 3,266,177 shares (including the commitment shares), which represents 19.99% of the shares of our common stock outstanding immediately prior to the execution of the Purchase Agreement (the Exchange Cap), unless (i) the Company obtains stockholder approval to issue shares of its common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of the Company’s common stock to Lincoln Park under the Purchase Agreement equals or exceeds $4.2736 per share. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 9.99% of its common stock.
| | | | | | The Purchase Agreement does not limit the Company’s ability to raise capital from other sources at the Company’s sole discretion, except that during the 36 months after the date of the Purchase Agreement (subject to certain exceptions) the Company may not enter into any agreement to effect the issuance of its common stock or common stock equivalents in any “equity line of credit” or other similar continuous offering in which the Company may offer, issue or sell common stock or common stock equivalents at a future determined price, other than in connection with common stock issued pursuant to an “at-the-market offering” by the Company exclusively through a registered broker-dealer acting as agent of the Company pursuant to a written agreement between the Company and the registered broker-dealer. The Company has the right to terminate the Purchase Agreement at any time, at no cost to the Company. | | | | | | As of March 31, 2021, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase. |
As of September 30, 2017, there are no notes outstanding. Below is a history of previous notes issued and converted.
In May 2015, BioCardia Lifesciences entered into note agreements with various stockholders of BioCardia Lifesciences and other lenders for a total of $7.2 million, or the 2015 Notes. The 2015 Notes accrued 8% annual simple interest, matured 18 months from the issue date and were callable after the maturity date by written demand of a majority of the holders of the outstanding note principle. If BioCardia Lifesciences closed an effective registration statement filed under the Securities Act of 1933, as amended, covering the sale of BioCardia Lifesciences common stock (an IPO) prior to maturity, the outstanding principle and accrued interest would have automatically converted into shares of common stock at 80% of the price of the shares of common stock purchased in the IPO. If at any time prior to the maturity date, the Company closed a private placement of the Company’s preferred stock for aggregate sales proceeds of at least $5.0 million excluding note conversions, at the note holder’s option, or the Optional Conversion Right, the outstanding principle and interest may have been converted into shares of the preferred stock at a conversion price equal to 80% of the price of the preferred shares sold in such financing, plus preferred stock warrant coverage equal to 8% with an exercise price equal to the purchase price of the preferred stock sold in such financing. If the notes were held to maturity, subject to BioCardia Lifesciences authorizing sufficient shares of a new class of preferred stock, or the Maturity Date Preferred Stock, the holder would have had the option to convert the outstanding principle and interest to this new class of Maturity Date Preferred Stock at an exercise price of $0.07 per share, plus 8% warrant coverage.
In August 2016, the Company and the holders of the 2015 Notes amended the 2015 Notes, pursuant to which the outstanding principal amount and all accrued interest through August 31, 2016 automatically converted into shares of BioCardia Lifesciences common stock at 80% of the conversion price of the convertible notes issued in October 2016. In addition, the amendment eliminated the payment of interest for the period subsequent to August 31, 2016, and through the date of the closing of the Merger. Upon the completion of the Merger, the 2015 Notes and accrued interest converted into shares of BioCardia Lifesciences common stock, which were then exchanged at the Exchange Ratio into 67,443,988 shares of the Company’s common stock (approximately 5,620,332 shares after giving effect to the Company’s reverse stock split).
The 2015 Notes had redemption features that were determined to be a compound embedded derivative requiring bifurcation and separate accounting at estimated fair value. The changes in the estimated value are reflected in the change in fair value of convertible shareholder notes derivative liability in the consolidated statements of operations. We estimated the fair value of the compound embedded derivative utilizing a Monte Carlo simulation model. The inputs used to determine the estimated fair value of the compound embedded derivative instrument include the probability of an underlying event triggering the redemption event and its timing prior to the maturity date of the 2015 Notes. The fair value measurement is based upon significant inputs not observable in the market. These assumptions are inherently subjective and involve significant management judgment. Immediately prior to the closing of the Merger, the compound embedded derivative was remeasured based on the settlement value of the common stock exchanged for the notes, and we reclassified the balance of the convertible shareholder notes derivative liability to additional paid-in capital.
The Company recognized interest expense, including amortization of the debt discount of $0 and $520,000 for the three months ended September 30, 2017 and 2016, respectively, and approximately $0 and $1.6 million for the nine months ended September 30, 2017 and 2016, respectively.
(9)(8)
| Share-Based Compensation |
BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2002 Stock Plan in 2002, or the 2002 Plan, and the Company assumed the 2002 Plan in the Merger. The Company will not grant any additional awards under the 2002 Plan following the Merger. In 2016, BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2016 Equity Incentive Plan, or the 2016 Plan, and the Company assumed the 2016 Plan in the Merger. The Company will grant awards, including incentive stock options and nonstatutory stock options, under the 2016 Plan following the Merger.
Stock compensation attributable to manufacturing operations was not significant and was expensed directly to cost of goods sold in the condensed consolidated statements of operations. Share-based compensation expense for the three and nine months ended September 30, 2017 and 2016 was recorded as follows (in thousands):
| | Three Months ended September 30, | | | Nine Months ended September 30, | | | | 2017 | | | 2016 | | | 2017 | | | 2016 | | Cost of goods sold | | $ | 33 | | | $ | - | | | $ | 107 | | | $ | 1 | | Research and development | | | 172 | | | | 30 | | | | 498 | | | | 30 | | Selling, general and administrative | | | 496 | | | | 57 | | | | 1,394 | | | | 114 | | Share-based compensation expense | | $ | 701 | | | $ | 87 | | | $ | 1,999 | | | $ | 145 | |
| | 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 months ended March 31, 2021 and 2020 was recorded as follows (in thousands): |
| | Three Months ended March 31, | | | | 2021 | | | 2020 | | Research and development | | $ | 206 | | | $ | 413 | | Selling, general and administrative | | | 210 | | | | 528 | | Total share-based compensation | | $ | 416 | | | $ | 941 | |
The following table summarizes the activity of stock options and related information:
| | Options outstanding | | | | | | | | | | | | | | | | | Weighted | | | | | | | | average | | | | Number of | | | exercise | | | | shares | | | price | | | | | | | | | | | Balance, December 31, 2016 | | | 3,491,937 | | | $ | 1.78 | | Stock options granted | | | 704,946 | | | | 8.34 | | Stock options exercised | | | (20,243 | ) | | | 2.08 | | Stock options cancelled | | | (33,948 | ) | | | 0.48 | | Balance, September 30, 2017 | | | 4,142,692 | | | $ | 2.90 | |
The weighted average grant-date fair value of options granted during the nine months ended September 30, 2017 was $6.44 per share.
Employee Share-Based Compensation (Stock Options)
During the nine months ended September 30, 2017, the Company granted stock options to certain non-employee directors and employees to purchase 542,631 shares of common stock. The fair value of each option grant was estimated on the date of the grant using the Black-Scholes option pricing model with the weighted average assumptions in the table below:
Risk-free interest rate | | | 1.88 | – | 2.13% | | Volatility | | | 82 | – | 89% | | Dividend yield | | | | None | | | Expected terms (in years) | | | 5.50 | – | 6.25 | |
Unrecognized share-based compensation for employee options granted through September 30, 2017 is approximately $4.7 million to be recognized over a remaining weighted average service period of 3.0 years.
Non-Employee Director Share-Based Compensation (RSUs)
During the nine months ended September 30, 2017, the Company granted to certain non-employee directors 97,996 restricted stock units, or RSUs. The fair value of each RSU is estimated on the closing market price on the grant date.
The following summarizes the activity of non-vested RSUs:
| | | | | | Weighted | | | | | | | | average | | | | | | | | grant date | | | | Number of | | | fair value | | | | shares | | | per share | | Balance, December 31, 2016 | | | — | | | | | | RSUs granted | | | 97,996 | | | $ | 8.71 | | RSUs vested | | | — | | | | | | RSUs forfeited | | | — | | | | | | Balance, September 30, 2017 | | | 97,996 | | | $ | 8.71 | |
Unrecognized share-based compensation for employee RSUs granted through September 30, 2017 is approximately $642,000 to be recognized over a remaining weighted average service period of 2.0 years.
Nonemployee Share-Based Compensation
During the nine months ended September 30, 2017, the Company granted options to purchase 162,315 shares of common stock to consultants. These options were granted in exchange for consulting services to be rendered and vest over the term specified in the grant, which correlates to the period the services are rendered. The Company recorded approximately $188,000 and $20,000 for the three months ended September 30, 2017 and 2016, respectively, and approximately $698,000 and $21,000 for the nine months ended September 30, 2017 and 2016, respectively, as nonemployee share-based compensation expense.
The Company accounts for share-based compensation arrangements with nonemployees, using the Black-Scholes option pricing model, based on the fair value as these instruments vest. Accordingly, at each reporting date, the Company revalues the unearned portion of the share-based compensation and the resulting change in fair value is recognized in the consolidated statements of operations over the period the related services are rendered. The following assumptions were used to value the awards for the nine months ended September 30, 2017:
Risk-free interest rate | 2.25 | – | 2.29% | Volatility | 84 | – | 87% | Dividend yield | | None | | Expected terms (in years) | 8.9 | – | 9.5 |
| | (10)On January 29, 2020 (the repricing date), the Company’s Board of Directors repriced certain previously granted and still outstanding vested and unvested stock option awards held by employees, executives and certain service providers of the Company; as a result, the exercise price was lowered to $5.32 per share. No other terms of the repriced stock options were modified, and the repriced stock options will continue to vest according to their original vesting schedules and will retain their original expiration dates. As a result of the repricing, 515,036 vested and unvested stock options outstanding with original exercise prices ranging from $10.05 to $97.21, were repriced.
| | | | | | The repricing on January 29, 2020 resulted in incremental stock-based compensation expense of $569,000, of which $412,000 related to vested employee stock option awards and was expensed on the repricing date, and $157,000 related to unvested stock option awards is being amortized on a straight-line basis over the approximately three year remaining weighted average vesting period of those awards. |
| | The following table summarizes the activity of stock options and related information: |
| | Options outstanding | | | | | | | | | | | | Number of shares | | | Weighted average exercise price | | | Weighted average remaining contractual term (years) | | | Aggregate intrisinsic value (in thousands) | | | | | | | | | | | | | | | | | | | Balance, December 31, 2020 | | | 1,114,306 | | | $ | 5.89 | | | | 7.5 | | | $ | 177.1 | | Stock options granted | | | 18,850 | | | | 4.63 | | | | | | | | | | Stock options exercised | | | (1,580 | ) | | | 2.49 | | | | | | | | | | Stock options forfeited | | | (44,643 | ) | | | 4.30 | | | | | | | | | | Stock options expired | | | (125 | ) | | | 5.32 | | | | | | | | | | Balance, March 31, 2021 | | | 1,086,808 | | | $ | 5.94 | | | | 6.9 | | | $ | 423.8 | | Exercisable, March 31, 2021 | | | 661,430 | | | $ | 7.29 | | | | 5.6 | | | $ | 73.0 | |
| | Unrecognized share-based compensation for employee and nonemployee options granted through March 31, 2021 is approximately $1.7 million to be recognized over a remaining weighted average service period of 2.2 years. | | | | | | Share-Based Compensation (RSUs) | | | | | | The following summarizes the activity of non-vested RSUs: |
| | | | | | Weighted | | | | | | | | average | | | | | | | | grant date | | | | Number of | | | fair value | | | | shares | | | per share | | Balance, December 31, 2020 | | | 224,311 | | | $ | 4.12 | | RSUs granted | | | 18,792 | | | | 4.34 | | RSUs released | | | (40,100 | ) | | | 4.20 | | Balance, March 31, 2021 | | | 203,003 | | | $ | 4.12 | |
| | Unrecognized share-based compensation for employee and nonemployee RSUs granted through March 31, 2021 is approximately $24,000 to be recognized over a remaining weighted average service period of 2.1 years. |
Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period. Since we were in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive.
| | Basic net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period. 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. 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 its 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:
| | September 30, | | | | 2017 | | | 2016 | | Convertible preferred stock | | | - | | | | 9,208,376 | | Notes convertible into shares | | | - | | | | 5,620,332 | | Convertible preferred stock warrants | | | - | | | | 92,116 | | Stock options to purchase common stock | | | 4,142,692 | | | | 3,716,947 | | Unvested restricted stock units | | | 97,996 | | | | - | | Total | | | 4,240,688 | | | | 18,637,771 | |
| | (11)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:
|
| | March 31, | | | December 31, | | | | 2021 | | | 2020 | | | | | | | | | | | Stock options to purchase common stock | | | 1,086,808 | | | | 1,114,306 | | Unvested restricted stock units | | | 8,200 | | | | 8,200 | | Common stock warrants | | | 2,424,724 | | | | 2,424,724 | | Total | | | 3,519,732 | | | | 3,547,230 | |
| | During the three months ended March 31, 2021 and 2020, there was no income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statements of operations due to the Company’s net loss and a full valuation allowance on the resulting deferred tax assets. | | | | | | As of March 31, 2021, the Company retains a full valuation allowance on its deferred tax assets in all jurisdictions. The realization of its deferred tax assets depends primarily on its ability to generate future taxable income which is uncertain. The Company does not believe that its 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, the Company entered into a Litigation Funding Agreement (the Funding Agreement) with BSLF, L.L.C. (the Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia’s board of directors, for the purpose of funding the Company’s 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). BioCardia sought imposition of constructive trusts both on the patents naming Ms. Sarna as an inventor and the proceeds received from the sale of nVision to Boston Scientific, as well as damages, including unjust enrichment damages measured by the proceeds received from the sale of nVision to Boston Scientific. | | | | | | Under the terms of the Funding Agreement, the Funder agreed to fund the legal fees and costs incurred by the Company in connection with the Litigation on and after March 1, 2020 on a non-recourse basis. The Company agreed to repay the Funder from any proceeds arising from the Litigation (the Litigation Proceeds), (i) any taxes paid by or imposed upon Funder (other than taxes imposed upon Funder as a consequence of Funder’s income) with respect to the claims, the litigation proceeds or as a consequence of any settlement in connection with the Litigation, if any, plus (ii) an amount, without reduction, set-off or counterclaim, equal to the amount actually paid by the Funder pursuant to the Funding Agreement (the Actual Funding Amount) plus (iii) the greater of: | | | | | | (a) 50% of the remaining Litigation Proceeds, up to three times the Actual Funding Amount; or | | | | | | (b) 30% of the remaining Litigation Proceeds. | | | | | | Although the Company is required under the terms of the Funding Agreement to consult with the Funder regarding any settlement in connection with the Litigation and to allow Funder to participate in any real-time settlement negotiations, the Company has the sole and exclusive right to settle on whatever terms it deems acceptable. | | | | | | The Funding Agreement may be terminated by Funder upon ten days’ written notice to the Company. Funder is obligated to fund only the fees and costs incurred in the Litigation through the end of the month in which the termination notice was served. The Company may terminate the agreement upon ten days’ written notice to Funder from and after a failure by Funder to fulfill its obligations under the Funding Agreement if such failure or material breach is continuing at the end of such ten-day period. Under the terms of the agreement, the total due from the related party as of March 31, 2021 was approximately $623,000. |
(12) | Contingencies and Uncertainties |
| | Contingencies - The Company 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 the Company’s business, financial position, results of operations, or cash flows. |
| | Uncertainties - The results for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other interim period or for any other future year, particularly in light of the novel coronavirus pandemic, or COVID-19, and its impact on domestic and global economies. To limit the spread of COVID-19, governments have taken various actions including the issuance of stay-at-home orders and social distancing guidelines, causing some businesses to suspend operations and/or experience a reduction in demand for many products from direct or ultimate customers. Accordingly, businesses have adjusted, reduced or suspended operating activities and are continuing to adapt to these changing actions and guidelines. | | | | | | Beginning March 17, 2020, substantially all of the Company’s workforce began working from home. On April 6, 2020, manufacturing operations resumed at the Company’s facilities, with a number of other staff continuing to work from home. While the direct effects of the stay-at-home orders and BioCardia’s work-from-home policies have been largely mitigated as of March 31, 2021, the overall impact of the pandemic resulted in disruption to the Company’s business and in delays in the Company’s development programs and regulatory and commercialization timelines. The overall magnitude of the continuing impact will depend, in part, on the length and severity of changing restrictions and other limitations on BioCardia’s ability to conduct the Company’s business. BioCardia’s future research and development expenses and general and administrative expenses may vary significantly if the Company experiences an increased impact from COVID-19 on the costs and timing associated with the conduct of BioCardia’s clinical trials and other related business activities. | | | | | | As the outbreak continues to mutate and spread, it may affect the Company’s operations and those of third parties on which the Company relies, including causing disruptions in the supply of the Company’s product candidates and the conduct of current and planned preclinical and clinical studies. BioCardia may need to limit operations and may experience limitations in employee resources. There are risks that the COVID-19 outbreak may be more difficult to contain if the outbreak reaches a larger population or broader geography, in which case the risks described herein could be elevated significantly. The extent to which the coronavirus impacts the Company’s results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. | | | | | | Additionally, while the potential economic impact brought by, and the duration of, a coronavirus pandemic is difficult to assess or predict, the impact of the coronavirus on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact the Company’s short-term and long-term liquidity, and the Company’s ability to complete its preclinical and clinical studies on a timely basis, or at all. The Company was successful in raising additional funding in 2020. However, the ultimate impact of coronavirus is highly uncertain and subject to change. The Company does not yet know the full extent of potential delays or impacts on its business, financing, preclinical and clinical trial activities or the global economy as a whole. However, these effects could have a material, adverse impact on the Company’s liquidity, capital resources, operations and business and those of the third parties on which BioCardia relies. |
DuringOn April 12, 2021, all parties to the nine months ended September 30, 2017 and 2016, there was no income tax expense or benefit for federal or state income taxesLitigation entered into a confidential settlement agreement. All claims in the accompanying condensed consolidated statement of operations dueLitigation have been dismissed. The settlement did not result in any material benefit or liability to the Company. The Company expects to terminate the Funding Agreement once all remaining matters thereunder are concluded.
On April 26, 2021, the Company issued a press release announcing that it has entered into an agreement with a leading Japanese biotechnology company related to the Company’s net loss and a full valuation allowance onHelix catheter biotherapeutic delivery product candidates. This is the resulting deferred tax assets. As of September 30, 2017,second new biotherapeutic delivery partnership for the Company retains a full valuation allowance on its deferred tax assets in all jurisdictions. The realization2021. Under the terms of the Company’s deferred tax assets depends primarily on its ability to generate future taxable incomeagreement, the Company will receive $500,000, a portion of which is uncertain.creditable for biotherapeutic delivery products and support services. The Company does not believe that its deferred tax assets are realizable onagreement has a more-likely-than-not basis; therefore, the net deferred tax assets have been fully offset by a valuation allowance.
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| Related Party Transactions
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In August 2016, the Company grantedone-year term with an option for the Japanese biotechnology company to purchase 5,027,726 sharesnegotiate a non-exclusive worldwide license for therapeutic delivery of common stock (418,977 shares after giving effect to the Company’s reverse stock split effected on November 3, 2017) with 4-year vesting period, to OPKO Health, Inc., or OPKO, as considerationcertain cell types for consulting services to be provided by OPKO in accordance with the consulting agreement entered into between the Company and OPKO. The unearned portion of the share-based compensation related to the OPKO option was revalued at September 30, 2017, and the Company recorded $126,000 and $432,000 as expense during the three and nine months ended September 30, 2017, respectively. The term of the consulting agreement is 4 years and will be automatically renewed for successive one year periods. The chairman and chief executive officer of OPKO is a beneficial owner of more than 5% of the outstanding shares of the Company’s common stock and OPKO itself is also a beneficial owner of more than 5% of the outstanding shares of the Company’s common stock. cardiac indications.
ITEM 2. MANAGEMENT’S’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any and all statements contained in this Annual Report that involve riskare not statements of historical fact may be deemed forward-looking statements. Terms such as “may,”“might,”“would,”“should,”“could,”“project,”“estimate,”“pro-forma,”“predict,”“potential,”“strategy,”“anticipate,”“attempt,”“develop,”“plan,”“help,”“believe,”“continue,”“intend,”“expect,”“future” and uncertainties.terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this Quarterly Report may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of our cell therapy systems and our clinical trials, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) our ability to raise additional capital, (iv) our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the SEC and (vi) the assumptions underlying or relating to any statement described in points (i) – (iv) above. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and elsewhere in this Quarterly Report on Form 10-Q, those listed in our Annual Report on Form 10-K and elsewhere in this report.for the year ended December 31, 2020. Historical results are not necessarily indicative of future results. Special Note Regarding Smaller Reporting Company Status
We are filing Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q as a “smaller reporting company” (as definedto conform these statements to actual results or to changes in Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act) based on our public float (the aggregate market value of our common equity held by non-affiliates of the Company) as of the last business day of our second fiscal quarter of 2016. As a result of being a smaller reporting company, we are allowed and have elected to omit certain information, including tabular disclosure of contractual obligations, from this Management’s Discussion and Analysis of Financial Condition and Results of Operations; however, we have provided all information for the periods presented that we believe to be appropriate and necessary.expectations.
Overview We are a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular and pulmonary diseases with large unmet medical needs. We are committed to applying our expertise in the fields of autologous and allogeneic cell-based therapies to improve the lives of patients with cardiovascular and pulmonary conditions. Our lead therapeutic candidate is the CardiAMP Cell Therapy System, or CardiAMPcell therapy platform provides an autologous bone marrow derived cell therapy (using a patient’s own cells) for the treatment of heart failure. We initiated our U.S. Food and Drug Administration, or FDA, accepted Phase III pivotal trial for CardiAMP in ischemic systolictwo clinical indications: heart failure that develops after a heart attack (BCDA-01) and chronic myocardial ischemia (BCDA-02). Our allogeneic mesenchymal stem cell therapy platform, derived from donor cells and intended to be provided “off the shelf,” is also being advanced for two indications, heart failure (BCDA-03) and for the pulmonary indication of acute respiratory distress that has developed from COVID-19 (BCDA-04). Our Helix™ Biotherapeutic Delivery System platform, or Helix, delivers therapeutics into the heart muscle with a helical needle from within the heart. It enables local delivery of cell, gene and protein-based therapies, including our own cell therapies to treat cardiac indications. The Helix system is CE marked in December 2016. Europe and under investigational use in the United States. We selectively partner with firms developing other cell, gene and protein therapies utilizing the Helix and other biotherapeutic delivery systems that we have developed. Our AVANCE™ product offering for transseptal cardiac procedures has begun early commercialization activities in the United States through commission-only 1099 sales representatives. CardiAMP Cell Therapy for Heart Failure and Chronic Myocardial Ischemia The Company’s lead platform, CardiAMP cell therapy, is an autologous cell therapy being advanced for two indications in pivotal clinical trials: heart failure and chronic myocardial ischemia. The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at 40 centers nationwide, which includes a 10-patient roll-in cohort. The trial’s primary endpointPhase III pivotal trial is an improvement in six minute walking distance at 12 months post-treatment. In addition,designed to provide the primary endpoint analysis incorporatessupport for the impactsafety and efficacy of major adverse cardiac eventsthe CardiAMP Cell Therapy System for heart failure which develops after a patient has a heart attack (BCDA-01). The trial is active at 24 clinical sites and other clinically meaningful events. In September 2017, the94 patients have been enrolled to date. The independent Data Safety Monitoring Board (DSMB) completed the pre-specified interim analysis of safety outcomesa prespecified data review on December 17, 2020, including all data for the first 1086 patients treated in the Phase 3 trial of its investigational CardiAMP cell therapy product.enrolled and 60 randomized patients that had reached their one-year follow-up at that date. The DSMB performed a risk-benefit review, indicated there wereit had no significant safety concerns, with the CardiAMP study results and recommended in writing that the trialstudy continue as planned. Currently five world class centers are actively enrolling in the study.
We anticipate filing an investigational device exemption (IDE) supplementThe CardiAMP Chronic Myocardial Ischemia Trial is a Phase III, multi-center, randomized, double-blinded, controlled study of up to add an interim efficacy readout in the fourth quarter of 2018 and expect top line data in the fourth quarter of 2019. If our343 patients at up to 40 clinical sites. The Phase III pivotal trial is successful, we believe we will bedesigned to provide the first company to reachprimary support for the market with a cell-based therapy to treat heart failure. Additionally, safety and efficacy of the Company anticipates an FDA filingCardiAMP Cell Therapy System for a second CardiAMPthe indication inof chronic myocardial ischemia (CMI)(BCDA-02). This therapeutic approach uses many of the same novel aspects as the CardiAMP Heart Failure Trial and is expected to leverage our experience and investment in 2017 insteadthe heart failure trial. The trial has been activated and we are working towards initial patient enrollment in the second quarter of in post myocardial infarction as previously disclosed.2021.
The Department of Health & Human Services Centers for Medicare & Medicaid Services, or CMS, has designated that both CardiAMP pivotal trials qualify for Medicare national coverage. Covered costs include patient screening, the CardiAMP Cell Therapy System and procedure, and clinical follow-up at one and two years after the procedure. Private insurance plans covering 50 million insured Americans follow this CMS reimbursement policy and are similarly anticipated to cover these costs. This coverage significantly reduces our cost of conducting these pivotal trials. ALLOGENEIC Cell Therapy for Cardiac and Pulmonary Disease Our second therapeutic candidateplatform is the CardiALLO Cell Therapy System, or CardiALLO, which utilizesour investigational culture expanded bone marrow derived allogeneic, Neurokinin-1 Receptor Positive mesenchymal stem cells from a donor(NK1R+ MSC). This “off the shelf” mesenchymal cell therapy is being advanced for cardiac and pulmonary disease. We are actively working to treat heart failure. We anticipate submittingsecure FDA acceptance of an Investigational New Drug (IND) application for submission to the FDA for a Phase I/II trial forusing the CardiALLO Cell Therapy System to deliver these allogeneic cells for the treatment of ischemic systolic heart failure (BCDA-03). We are working to receive FDA acceptance of the IND in 2018. This2021. The Company also intends to submit an IND for the use of its allogeneic cell therapy for Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19 (BCDA-04). Based on clinical reports on COVID-19, respiratory failure complicated by ARDS is expected to have improved Chemistry Manufacturing Controlsa leading cause of death for COVID-19 patients. ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. BCDA-04 is on a similar timeline with BCDA-03 and we are working towards FDA acceptance of the IND relative to our previous co-sponsored investigations utilizing culture expanded bone marrow derived mesenchymal stem cells. We are committed to applying our expertise in the fields of autologous and allogeneic cell-based therapies to improve the lives of patients with cardiovascular conditions. As we engage in clinical trials of our therapeutic candidates, we have compensated and intend to compensate all parties performing the trials or studies (including all the parties identified in our Annual Report on Form 10-K) only on terms that are standard and customary in clinical study arrangements. 2021.
To date, we have devoted substantially all of 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 have also generated modest revenues from sales of our approved products. We have funded our operations primarily through the sales of equity and convertible debt securities, and certain government and private grants. All convertible debt securities were converted into shares of our Common Stock in connection with the Merger.
We have incurred net losses in each year since our inception. Our net losses were approximately $3.0 million and $3.3 million for the three months ended September 30, 2017 and 2016, respectively, and approximately $8.8 million and $6.7 million for the nine months ended September 30, 2017 and 2016, respectively. As of September 30, 2017, we had an accumulated deficit of approximately $69.0 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs, clinical trials, intellectual property matters, building our manufacturing and sales capabilities, and from general and administrative costs associated with our operations. As discussed in more detail under “Liquidity and Capital Resources”, we plan to raise additional capital, potentially including debt and equity arrangements, to finance our future operations.
Financial Overview Revenue We currently have a portfolio of enabling and delivery products, from which we have generated modest revenue. Net product revenues include commercial sales of our Morph vascular access system in the US and EU and collaboration agreement revenues include revenue from partnering agreements with corporate and academic institutions. Under these partnering agreements, we provide our Helix biotherapeutic delivery system and customer training and support for use in preclinical and clinical studies. Cost of Goods Sold
Cost of goods sold includes the costs of raw materials and components, manufacturing personnel and facility costs and other indirect and overhead costs associated with manufacturing our enabling and delivery products.
Research and Development Expenses Our research and development expenses consist primarily of: salaries and related overhead expenses, which include share-based compensation and benefits for personnel in research and development functions;
fees paid to consultants and contract research organizations, or CROs, including in connection with our preclinical studies and clinical trials and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial material management and statistical compilation and analysis;
costs related to acquiring and manufacturing clinical trial materials;
costs related to compliance with regulatory requirements; and
payments related to licensed products and technologies.
| • | salaries and related overhead expenses, which include, but are not limited to share-based compensation and benefits for personnel in research and development functions; | | | | | • | fees paid to consultants and contract research organizations, or CROs, including in connection with our preclinical studies and clinical trials and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial management and statistical compilation and analysis; | | | | | • | costs related to acquiring and manufacturing clinical trial materials; | | | | | • | costs related to compliance with regulatory requirements; and | | | | | • | payments related to licensed products and technologies. |
We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress toof completion of specific tasks using information and data provided to us by our vendors and clinical sites. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and the services are performed.received. We plan to increase our research and development expenses for the foreseeable future as we continue to developthe pivotal CardiAMP and subject to the availability of additional funding, furtherHeart Failure Trial, advance the development of CardiALLOpivotal CardiAMP Chronic Myocardial Ischemia Trial, and any other therapeutic candidates for additional indications.further develop our autologous and allogeneic cell therapy candidates. We typically use our employee and infrastructure resources across multiple research and development programs, and accordingly, we have not historically allocated resources specifically to our individual programs. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our therapeutic candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our therapeutic candidates.
Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, sales, corporate development and administrative support functions, including share-based compensation expenses and benefits. Other significant selling, general and administrative expenses include sales commissions, rent, accounting and legal services, obtaining and maintaining patents, the cost of consultants, occupancy costs, insurance premiums and information systems costs. We expect that our selling, general and administrative expenses will increase as we advance our Phase III pivotal heart failure trial for CardiAMP, and subject to the availability of additional funding, conduct our Phase II trial for CardiALLO and prepare for commercialization. We believe that these increases will likely include increased costs for director and officer liability insurance, costs related to the hiring of additional personnel to support product commercialization efforts and operations and increased fees for outside consultants, attorneys and accountants. We also expect to incur increased costs to comply with corporate governance, internal controls, investor relations and disclosures, and similar requirements applicable to public companies.
Other Income (Expense) Other income and expense consistsconsist primarily of interest income we earn on our cash,, cash equivalents and investments, interest charges we incurred in periods when we have convertible debt outstanding, and changes in the fair value of our warrant and convertible shareholder note derivative liabilities in periods when we have warrants or convertible debt outstanding. Subsequent to the Merger, we have no interest charges related to the convertible debt and changes in the fair value of our warrant and convertible shareholder note derivative liabilities as such instruments were converted, cancelled or exchanged as part of the Merger. We expect our interest income to increase following the completion of the Merger as we invest our cash on hand pending its use in our operations.investments. Critical Accounting Policies and Estimates Our management’smanagement’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP.States. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported expenses during the periods presented.liabilities. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on other factorsvarious judgements that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparentclear from other sources. Actual results may differ from these estimates under different assumptions or conditions. Other than below, there were no material changesThe full extent to which the ongoing COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including revenues, expenses, reserves and allowances, manufacturing, clinical trials and research and development will depend on future developments that continue to remain highly uncertain at this time. As events continue to evolve and additional information becomes available, our estimates may change materially in future periods.
We define our critical accounting policies as those that require us to make subjective estimates orand judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations as well as the specific manner in which we apply those principles. Our critical accounting policies are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations”Item 2 in our 2016 Annual Report on Form 10-K duringfor the nine monthsyear ended September 30, 2017. Share-Based Compensation
We measure and recognize share-based compensation expense for equity awards to employees, directors and consultants based on fair value at the grant date. We use the Black-Scholes-Merton option-pricing model, or BSM, to calculate the fair value of stock options. Restricted stock units (RSUs) are measured based on the fair market values of the underlying stock on the dates of grant. Share-based compensation expense recognized in the statements of operations is based on awards at the time of grant, and is reduced for actual forfeitures at the time that the forfeitures occur. Compensation cost for employee share-based awards will be recognized over the vesting period of the applicable award on a straight-line basis.
For options granted to nonemployees, we revalue the unearned portion of the share-based compensation and the resulting change in fair value is recognized in the statements of operations over the period the related services are rendered.
The BSM option-pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility in the value of our Common Stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, our share-based compensation expense could be materially different in the future. December 31, 2020.
Results of Operations Comparison of Three Months Ended September 30, 2017March 31, 2021 and 20162020 The following table summarizes our results of operations for the three months ended September 30, 2017March 31, 2021 and 20162020 (in thousands): | | Three Months ended September 30, | | | Three Months ended | | | | 2017 | | | 2016 | | | 2021 | | | 2020 | | Revenue: | | | | | | | | | | | | | | | | | Net product revenue | | $ | 88 | | | $ | 100 | | | $ | — | | | $ | 5 | | Collaboration agreement revenue | | | 42 | | | | 17 | | | | 46 | | | | 33 | | Total revenue | | | 130 | | | | 117 | | | | 46 | | | | 38 | | Costs and expenses: | | | | | | | | | | | | | | | | | Cost of goods sold | | | 147 | | | | 196 | | | | — | | | | 4 | | Research and development | | | 1,700 | | | | 684 | | | | 1,841 | | | | 2,786 | | Selling, general and administrative | | | 1,322 | | | | 919 | | | | 1,177 | | | | 1,857 | | Total costs and expenses | | | 3,169 | | | | 1,799 | | | | 3,018 | | | | 4,647 | | Operating loss | | | (3,039 | ) | | | (1,682 | ) | | | (2,972 | ) | | | (4,609 | ) | Other income (expense): | | | | | | | | | | | | | | | | | Interest income | | | 35 | | | | — | | | | 4 | | | | 16 | | Interest expense | | | — | | | | (520 | ) | | Other income (expense) | | | 3 | | | | (1,052 | ) | | Total other income (expense), net | | | 38 | | | | (1,572 | ) | | Other expense | | | | (1 | ) | | | (1 | ) | Total other income (expense) | | | | 3 | | | | 15 | | Net loss | | $ | (3,001 | ) | | $ | (3,254 | ) | | $ | (2,969 | ) | | $ | (4,594 | ) | | | | | | | | | | | Net loss per share, basic and diluted | | $ | (0.08 | ) | | $ | (2.06 | ) | | | | | | | | | | | | Weighted-average shares used in computing net loss per share, basic and diluted | | | 38,146,751 | | | | 1,579,852 | | |
Revenue. Revenue increased by approximately $13,000to $46,000 in the three months ended September 30, 2017first quarter of 2021 as compared to $38,000 in the three months ended September 30, 2016, primarily due to higherfirst quarter of 2020. The amount and timing of collaboration revenues partially offset by a reductionis largely dependent on our partners clinical activities and may be inconsistent and create significant quarter-to-quarter variation in Morph sales. We expect current sales volumesour revenues. Collaboration revenue is expected to remain relatively stable, with modestly lower netincrease in 2021. Net product revenue in 2021 will be subject to customer demand, the availability of production resources for 2017 relativeour new Morph product family members, and the timing of FDA clearance for market release of different models and sizes during the year. Net product revenue is also expected to 2016. Cost of Goods Sold. Cost of goods sold decreased by approximately $49,000increase in the three months ended September 30, 2017 compared to the three months ended September 30, 2016, primarily due to $57,000 charged to cost of goods sold for inventory write-downs and reserves in the three months ended September 30, 2016 coupled with lower revenues in the three months ended September 30, 2017. We expect cost of goods sold for 2017 to be relatively consistent with 2016.2021.
Research and Development Expenses.Research and development expenses increaseddecreased by approximately $1,016,000 in$945,000 to $1,841,000 during the three months ended September 30, 2017first quarter of 2021 compared to the three months ended September 30, 2016,first quarter of 2020, primarily due to expenses incurredlower compensation expense following a repricing of stock options in the planning, preparationfirst quarter of 2020, and inception ofreduced clinical service provider costs and clinical site expenses in conducting the CardiAMP Phase III pivotal heart failure trial.Heart Failure Trial. We expect research and development expenses for the year 2021 to increase moderately compared to 2020, as we continue to enrollthe lower compensation expenses discussed above are partially offset by increasing expenses associated with our clinical trials, obtaining regulatory approvals for our therapies, and treat patients in the trialimproving our cell processing, manufacturing capabilities and incur additional development expenses related to CardiALLO therapeutic program. delivery platforms. Selling, General and Administrative Expenses. Selling, general and administrative expenses increasedfor the first quarter of 2021 decreased by approximately $403,000 in the three months ended September 30, 2017$680,000 to $1,177,000 compared to the three months ended September 30, 2016,first quarter of 2020, primarily due to additional costs forlower compensation expense following a repricing of stock options in the organizational structure needed to support the CardiAMP Phase III pivotal trial and operations as a public company. These expenses include additional salary expenses, stock compensation and legal, accounting, tax and other corporate expenses.first quarter of 2020, coupled with reduced professional service fees. We expect selling, general and administrative expenses for the remaining quarter of 2017 to increase moderately from the three months ended September 30, 2017 as we continue to build the supporting staff and infrastructure to support the CardiAMP Phase III pivotal trial and public company operations. Interest Income. Interest income for the three months ended September 30, 2017 consisted primarily of interest income earned on cash equivalents and short-term investments.
Interest Expense. Interest expense for the three months ended September 30, 2016 consisted primarily of interest expense related to convertible notes which are no longer outstanding.
Other Income (Expense). Other income (expense) for the three months ended September 30, 2016 consisted primarily of the changesdecrease modestly in value of the convertible preferred stock warrant liabilities and the change in value of the convertible shareholder note derivative liability.
Comparison of Nine Months Ended September 30, 2017 and 2016
The following table summarizes our results of operations for the nine months ended September 30, 2017 and 2016 (in thousands):
| | Nine Months ended September 30, | | | | 2017 | | | 2016 | | Revenue: | | | | | | | | | Net product revenue | | $ | 298 | | | $ | 406 | | Collaboration agreement revenue | | | 81 | | | | 33 | | Total revenue | | | 379 | | | | 439 | | Costs and expenses: | | | | | | | | | Cost of goods sold | | | 525 | | | | 578 | | Research and development | | | 4,028 | | | | 1,622 | | Selling, general and administrative | | | 4,708 | | | | 2,375 | | Total costs and expenses | | | 9,261 | | | | 4,575 | | Operating loss | | | (8,882 | ) | | | (4,136 | ) | Other income (expense): | | | | | | | | | Interest income | | | 58 | | | | — | | Interest expense | | | — | | | | (1,627 | ) | Other income (expense) | | | 2 | | | | (965 | ) | Total other income (expense), net | | | 60 | | | | (2,592 | ) | Net loss | | $ | (8,822 | ) | | $ | (6,728 | ) | | | | | | | | | | Net loss per share, basic and diluted | | $ | (0.23 | ) | | $ | (4.26 | ) | | | | | | | | | | Weighted-average shares used in computing net loss per share, basic and diluted | | | 38,141,654 | | | | 1,579,264 | |
Revenue. Revenue decreased by approximately $60,000 in the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016, primarily due to a reduction in Morph sales volumes. We expect current sales volumes to remain relatively stable, with modestly lower net product revenue for 20172021 relative to 2016.
Cost of Goods Sold. Cost of goods sold decreased by approximately $53,000 in the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016, primarily due to the decrease in revenues, partially offset by increased stock compensation cost for manufacturing personnel. We expect cost of goods sold for 2017 to be relatively consistent with 2016.
Research and Development Expenses. Research and development expenses increased by approximately $2.4 million in the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016, primarily due to expenses incurred in the planning, preparation and inception of the CardiAMP Phase III pivotal heart failure trial, including fees paid to consultants and contract research organization (CRO), higher personnel costs and increased stock compensation expense. We expect research and development expenses to increase as we continue to enroll and treat patients in the trial and incur additional development expenses related to CardiALLO therapeutic program.
Selling, General and Administrative Expenses. Selling, general and administrative expenses increased by approximately $2.3 million in the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016, primarily due to additional costs for the organizational structure needed to support the CardiAMP Phase III pivotal trial and operations as a public company. These costs include additional salary expenses, stock compensation and legal, accounting, tax, and other corporate expenses. We expect selling, general and administrative expenses for the final quarter of 2017 to increase moderately from the three months ended September 30, 2017, as we continue to build the supporting staff and infrastructure to support the CardiAMP Phase III pivotal trial and public company operations.
Interest Income. Interest income for the nine months ended September 30, 2017 consisted primarily of interest income earned on cash equivalents and short-term investments.
Interest Expense. Interest expense for the nine months ended September 30, 2016 consisted primarily of interest expense related to convertible notes which are no longer outstanding.
Other Income (Expense). Other income (expense) for the nine months ended September 30, 2016 consisted primarily of the changes in value of the convertible preferred stock warrant liabilities and the change in value of the convertible shareholder note derivative liability.2020.
Liquidity and Capital Resources We have incurred net losses each year since our inception and as of September 30, 2017,March 31, 2021, we had an accumulated deficit of approximately $69.0$119.0 million. We anticipate that we will continue to incur net losses for at least the next several years. We have funded our operations principally through the sales of equity and convertible debt securities as well as the cash acquired through the Merger.securities. As of September 30, 2017,March 31, 2021, we had cash and cash equivalents of approximately $13.3$21.5 million. The following table shows a summary of our cash flows for the periods indicated (in thousands): | | Nine Months ended September 30, | | | Three Months ended March 31, | | | | 2017 | | | 2016 | | | 2021 | | | 2020 | | Net cash provided by (used in): | | | | | | | | | | | | | | | | | Operating activities | | $ | (6,146 | ) | | $ | (3,007 | ) | | $ | (1,883 | ) | | $ | (2,993 | ) | Investing activities | | | (1,906 | ) | | | — | | | | (27 | ) | | | (5 | ) | Financing activities | | | 26 | | | | 2 | | | | 2,005 | | | | — | | Net decrease in cash and cash equivalents | | $ | (8,026 | ) | | $ | (3,005 | ) | | Net increase (decrease) in cash and cash equivalents | | | $ | 95 | | | $ | (2,998 | ) |
Cash Flows from Operating Activities. The increasedecrease in overall spending for operating activities of approximately $3.1 million in$1.1million through the nine months ended September 30, 2017first quarter of 2021 compared to the nine months ended September 30, 2016 relatesfirst quarter of 2020 related primarily to increasedthe timing of advance payments from collaboration partners coupled with decreases in payments to third parties for professional fees. We expect net cash outflowsused in operating activities to conduct the CardiAMP Phase III pivotal trial, further develop the CardiAMP and CardiALLO programs andremain relatively consistent in 2021 compared to build the supporting infrastructure to sustain these efforts and support operations as a public company. 2020. Cash Flows from Investing Activities. Net cash used in investing activities of $1.9 million$27,000 and $5,000 during the nine months ended September 30, 2017first quarter of 2021 and 2020, respectively consists of the purchases of property and equipment, primarily lab and short-term investments. office equipment. Cash Flows from Financing Activities. Net cash provided by financing activities of $26,000$2.0 million during the nine months ended September 30, 2017 consistsfirst quarter of the2021 consisted of gross proceeds from the exercisesale of common stock options.in March 2021 less issuance costs. Lincoln Park Capital Stock Purchase Agreement In March 2021, we and Lincoln Park Capital Fund, LLC (Lincoln Park) entered into a purchase agreement (the Purchase Agreement) and a registration rights agreement (the Registration Rights Agreement), pursuant to which we have the right to sell to Lincoln Park shares of our common stock having an aggregate value of up to $20 million, subject to certain limitations and conditions set forth in the Purchase Agreement. Pursuant to the terms of the Purchase Agreement, at the time we signed the Purchase Agreement, we sold 373,832 shares of our common stock at a price of $5.35 per share pursuant to the Purchase Agreement for gross proceeds of $2 million (and issued 80,000 shares of common stock to Lincoln Park as consideration for its commitment to purchase shares of our common stock, which consisted of 75,000 shares for Lincoln Park’s initial commitment and 5,000 shares issued on a pro rata basis in respect of Lincoln Park’s initial purchase of 373,832 shares). Thereafter, as often as every business day from and after one business day following the date of the Initial Purchase and over the 36-month term of the Purchase Agreement, we have the right, from time to time, at our sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 100,000 shares of common stock, with such amount increasing as the closing sale price of the common stock increases; provided Lincoln Park’s obligation under any single such purchase will not exceed $2 million, unless we and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a Regular Purchase). If we direct Lincoln Park to purchase the maximum number of shares of common stock it then may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, we may direct Lincoln Park in an Accelerated Purchase to purchase an additional amount of common stock that may not exceed the lesser of (i) 300% of the number of shares purchased pursuant to the corresponding Regular Purchase or (ii) 30% of the total number of shares of our common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, we may direct Lincoln Park to purchase shares in multiple Accelerated Purchases on the same trading day. As of March 31, 2021, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase. Future Funding Requirements To date, we have generated modest revenue from sales of our approved products. We do not know when, or if, we will generate any revenue from our development stage biotherapeutic programs. We do not expect to generate any revenue from sales of our CardiAMP or CardiALLO therapeuticautologous and allogeneic cell therapy candidates unless and until we obtain regulatory approval. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our therapeutic candidates. In addition, subject to obtaining regulatory approval for any of our therapeutic candidates and companion diagnostic, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need additional funding in connection with our continuing operations. Based upon our current operating plan, we believe that the cash and cash equivalents of $13.3$21.5 million coupled with $1.8 million in short-term investments as of September 30, 2017March 31, 2021 are sufficient to fund our operations intofor at least the third quarternext 12 months from the date of 2018. In order to continue to further the development of our lead therapeutic candidate, the CardiAMP cell therapy system, and our second therapeutic candidate, the CardiALLO cell therapy system, through and beyond the third quarter of 2018, we will be required to raise additional capital. We plan to raise additional capital, potentially including debt and equity arrangements, to finance our future operations. 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 ourselves, or cease operations. While we believe in the viability of our strategy to raise additional funds, there can be no assurances that we will be able to obtain additional capital on acceptable terms and in the amounts necessary to fully fund our operating needs.this filing. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates. Our future capital requirements will depend on many factors, including: the progress, costs, results, and timing of our CardiAMP and CardiALLO clinical trials and related development programs; FDA acceptance of our CardiAMPautologous and CardiALLOallogeneic therapies for heart failure and for other potential indications; the outcome, costs, and timing of seeking and obtaining FDA and any other regulatory approvals; the costs associated with securing, establishing, and maintaining commercialization and manufacturing capabilities; the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development; the ability of our product candidates to progress through clinical development successfully; our need to expand our research and development activities; the costs of acquiring, licensing, or investing in businesses, products, product candidates and technologies; our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; the general and administrative expenses related to being a public company; our need and ability to hire additional management and scientific, medical and sales personnel; the effect of competing technological and market developments; and our need to implement additional internal systems and infrastructure, including financial and reporting systems. Until such time that we can generate meaningful revenue from the sales of approved therapies and products, if ever, we expect to finance our operating activities through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our Common Stock holderscommon stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our Common Stock holders.common stockholders. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, products, or therapeutic candidates or to grant licenses on terms that may not be favorable to us. Our condensed consolidated financial statements as of and for the three and nine months ended September 30, 2017 have been prepared on the basis that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. Due to the factors described above, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date these financial statements are issued. Our ability to continue as a going concern will depend in a large part, on our ability to raise additional capital. If we are unable to obtain funding on a timely basis, our ability to continue as a going concern would be jeopardized and we may be required to significantly curtail, delay or discontinue one or more of our research and development programs, implement general cost saving measures, reduce expenditures for third party contractors, including professional advisors and other vendors, which could have a negative impact on our ability to continue our business as currently contemplated, including our ability to develop and commercialize products within planned timelines and materially adversely affect our business, financial condition and results of operations.
The financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are unable to continue as a going concern, we may be forced to liquidate assets. In such a scenario, the values received for assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements.
Off-Balance Sheet Arrangements During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under the rules of the SEC.Securities and Exchange Commission. Recent Accounting Pronouncements See Note 2 of our notes to condensed consolidated financial statements for information regarding recent accounting pronouncements that are of significance or potential significance to us. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable.There have been no material changes in our market risks during the three months ended March 31, 2021.
Our exposure to market risk is currently limited to our cash and cash equivalents, all of which have maturities of less than three months. The goals of our investment policy are preservation of capital, maintenance of liquidity needs, and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk or departing from our investment policy. We currently do not hedge interest rate exposure. Because of the short-term nature of our cash equivalents, we do not believe that an increase in market rates would have a material negative impact on the value of our portfolio. Interest Rate Risk As of March 31, 2021, based on current interest rates and total borrowings outstanding, a hypothetical 100 basis point increase or decrease in interest rates would have an immaterial pre-tax impact on our results of operations. Foreign Currency Exchange Risks We are a U.S. entity and our functional currency is the U.S. dollar. The vast majority of our revenues were derived from sales in the United States. We have business transactions in foreign currencies; however, we believe we do not have significant exposure to risk from changes in foreign currency exchange rates at this time. We do not currently engage in hedging or similar transactions to reduce our foreign currency risks. We will continue to monitor and evaluate our internal processes relating to foreign currency exchange, including the potential use of hedging strategies. ITEM 4. CONTROLS AND PROCEDURES Evaluation of Disclosure Controls and Procedures We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the Company’s reports under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as the Company’s controls are designed to do, and management necessarily was required to apply its judgment in evaluating the risk related to controls and procedures.
In connection with the preparation of this Quarterly Report on Form 10-Q, as of September 30, 2017,March 31, 2021, an evaluation was performed under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer,Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). We disclosed the existence of a material weakness in internal control over financial reporting described in our Annual ReportBased on 10-K for the fiscal year end dated December 31, 2016, resulting from an insufficient number of qualified personnel and inadequate processes within our accounting function which has impacted our ability to appropriately segregate duties and to perform timely and effective reviews over general ledger account reconciliations and non-routine transactions. We have implemented measures designed to improve our internal control over financial reporting to remediate this material weakness, including hiring additional qualified accounting, operations and clinical personnel, formalizing our business processes and internal controls documentation and strengthening supervisory review. These actions are subject to review and testing by our senior management, as well as oversight by the Audit Committee of our Board of Directors. Although we believe that our efforts will be successful, we cannot be certain at this time, that the material weaknesses will be remediated at December 31, 2017. As a result, we concluded that the material weakness identified above continued to exist as of September 30, 2017. Accordingly,evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of March 31, 2021, our disclosure controls and procedures were, notin design and operation, effective as of September 30, 2017. These conclusions were communicated to our Audit Committee. Notwithstanding the existence of this material weakness, management has concluded that the condensed consolidated financial statements in this Quarterly Report on Form 10-Q fairly present, in all material respects, the Company’s financial position, results of operations and cash flows for all periods and dates presented.at a reasonable assurance level. Changes in Internal Control over Financial Reporting Except for the remediation efforts described above, thereThere were no changes into our internal control over financial reporting identified in connection with the evaluation required by rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three month period covered by this Quarterly Report on Form 10-Qmonths ended March 31, 2021 that have materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS As previously reported, BioCardia and its wholly-owned subsidiary BioCardia Lifesciences, Inc. were party to several related legal proceedings (the Litigation) in Federal Court in San Francisco. The Company may be subjectvarious counterparties were Boston Scientific Corporation, Boston Scientific Scimed Inc., Fortis Advisors LLC, Ms. Surbhi Sarna and nVision Medical Corporation. All parties to variousthe Litigation entered into a confidential settlement agreement on March 12, 2021. All claims complaints, and legal actions that arise from time to time in the normal course of business. Management doesLitigation were then dismissed. The settlement did not believe thatresult in any material benefit or liability to the Company is party to any currently pending legal proceedings. There can be no assurance that existing or future legal proceedings arising in the ordinary course of business or otherwise will not have a material adverse effect on the Company’s business, financial position, results of operations, or cash flows.BioCardia and BioCardia Lifesciences, Inc. ITEM 1A. RISK FACTORS In addition to the risk factor set forth below and the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors”Factors in our Annual Report on Form 10-K for the year ended December 31, 2016,2020, which could materially affect our business, financial condition, or future results. The risks described in this report, and in our Annual Report on Form 10-K for the year ended December 31, 2020, and our Quarterly Reports on Form 10-Q filed periodically with the SEC are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results. We will require additional financing in 2018 in order to continue the trial and to continue operations at the current level.
As discussed above in “Management Discussion and Analysis – Future Funding Requirements,” our current cash resources are sufficient to fund operations at the expected level of activity only into the third quarter of 2018. We will need additional capital to continue operations at the current level and to continue the Phase III trial. While we plan to raise additional capital to fund operations, including the trial, there can be no assurances as to the availability of capital or the terms on which capital will be available.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES None. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. ITEM 5. OTHER INFORMATION None.As reported in our Current Report on Form 8-K filed with the SEC on March 31, 2021, we announced that we expect to hold our 2021 Annual Meeting of Stockholders (the “2021 Annual Meeting”) on June 15, 2021. As the expected date of the 2021 Annual Meeting is more than 30 days before the anniversary of the Company’s 2020 Annual Meeting of Stockholders, we informed our stockholders of the change and the resulting changes to deadlines for proposals. No such proposals were received by such deadlines and we filed our proxy statement for the 2021 Annual Meeting on April 30, 2021.
ITEM 6. EXHIBIT INDEX Exhibit Number | Exhibit Description |
The exhibits listed in the Exhibit Index to this Quarterly Report on Form 10-Q are incorporated herein by reference.
3.1(1) | Amended and Restated Certificate of Incorporation, as amended May 6, 2019 | 3.2(2) | Amended and Restated Bylaws | 10.1(3) | Purchase Agreement, dated as of March 29, 2021, by and between BioCardia, Inc. and Lincoln Park Capital Fund, LLC | 10.2(4) | Registration Rights Agreement, dated as of March 29, 2021, by and between BioCardia, Inc. and Lincoln Park Capital Fund, LLC | 10.3* | Consulting Agreement dated February 15, 2021, by and between BioCardia, Inc. and Henricus Duckers, M.D., Ph.D., FESC. | 31.1* | Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. | 31.2* | Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. | 32.1 | Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | 32.2** | Certification of Principal Financial Officer Pursuant to Rule 13a-14(b) and Section 906 of the Sarbanes-Oxley Act of 2002. |
101.INS+ | XBRL Instance Document | 101.SCH+ | XBRL Taxonomy Extension Schema Document | 101.CAL+ | XBRL Taxonomy Extension Calculation Linkbase Document | 101.DEF+ | XBRL Taxonomy Extension Definition Linkbase Document | 101.LAB+ | XBRL Taxonomy Extension Label Linkbase Document | 101.PRE+ | XBRL Taxonomy Extension Presentation Linkbase Document |
* | Filed herewith. | ** | Furnished herewith. | + | The financial information contained in these XBRL documents is unaudited and is furnished, not filed with the Securities and Exchange Commission. | (1) | Previously filed as Exhibit 3.1 to the Form 10-Q for the quarterly period ended June 30, 2019 filed by us on August 14, 2019. | (2) | Previously filed as Exhibit 3.2 to the Current Report on Form 8-K filed by us on April 11, 2017. | (3) | Previously filed as Exhibit 10.1 to the Current Report on Form 8-K filed by us on March 29, 2021. | (4) | Previously filed as Exhibit 10.2 to the Current Report on Form 8-K filed by us on March 29, 2021. |
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 thereunto duly authorized. | BIOCARDIA, INC. (Registrant) | | | | | | | | | | | | Date: November 9, 2017 May 13, 2021 | By: | /s/ Peter Altman | | | | Peter Altman | | | | President and Chief Executive Officer | | | | (Principal Executive Officer) | | | |
| | | Date: November 9, 2017 May 13, 2021 | By: | /s/ David McClung | | | | David McClung | | | | Chief Financial Officer | | | | (Principal Financial and Accounting Officer) | |
EXHIBIT INDEX
(1) Previously filed as an exhibit to the Current Report on Form 8-K filed on March 18, 2008.
(2) Previously filed as an exhibit to the Current Report on Form 8-K filed on November 7, 2017.
101.INS+
| XBRL Instance Document
| 101.SCH+
| XBRL Taxonomy Extension Schema Document
| 101.CAL+
| XBRL Taxonomy Extension Calculation Linkbase Document
| 101.DEF+
| XBRL Taxonomy Extension Definition Linkbase Document
| 101.LAB+
| XBRL Taxonomy Extension Label Linkbase Document
| 101.PRE+
| XBRL Taxonomy Extension Presentation Linkbase Document
|
**
| Furnished herewith.
| +
| The financial information contained in these XBRL documents is unaudited and is furnished, not filed with the Securities and Exchange Commission.
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23
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