BioCardia, Inc. (NASDAQ:BCDA) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Jules Abraham - Investor Relations, CORE IR Peter Altman - President & Chief Executive Officer David McClung - Chief Financial Officer Conference Call Participants Kumaraguru Raja - Brookline Capital Markets Emanuela Branchetti - H.C. Wainwright Jim Molloy - Alliance Global Partners Operator Ladies and gentlemen, thank you for standing by. Good day and welcome to the BioCardia 2022 First Quarter Confe ...

Financial Performance - Total revenue for the three months ended March 31, 2022, was $60,000, compared to $46,000 for the same period in 2021, representing a 30.4% increase[16] - Net loss for the three months ended March 31, 2022, was $3,325,000, compared to a net loss of $2,969,000 for the same period in 2021, indicating an increase in losses of 12%[16] - Research and development expenses for the three months ended March 31, 2022, were $2,186,000, up from $1,841,000 in the same period in 2021, reflecting a 18.7% increase[16] - Share-based compensation expense for the three months ended March 31, 2022 was $319,000, compared to $41,000 for the same period in 2021, representing a significant increase[57] Cash and Liquidity - Cash and cash equivalents at the end of the period were $9,930,000, down from $12,872,000 at the end of the previous year, a decrease of 22.5%[21] - The company's cash and cash equivalents were $9.9 million as of March 31, 2022, which are insufficient to fund planned expenditures beyond the first quarter of 2023 without additional funding[28] - Total cash and cash equivalents decreased from $12.872 million as of December 31, 2021, to $9.930 million as of March 31, 2022[38] Assets and Liabilities - Total current assets decreased to $10,661,000 as of March 31, 2022, from $13,481,000 as of December 31, 2021, a decline of 20.9%[12] - Total liabilities increased to $5,471,000 as of March 31, 2022, compared to $5,343,000 as of December 31, 2021, an increase of 2.4%[12] - Accrued expenses and other current liabilities totaled $1.920 million as of March 31, 2022, an increase from $2.12 million as of December 31, 2021[47] Capital and Financing - The company plans to raise additional capital through debt and equity arrangements to finance future operations, but these plans are not entirely within its control[29] - Lincoln Park Capital has a purchase agreement allowing the company to sell up to $20 million of common stock, with an initial purchase of 373,832 shares at $5.35 per share for a total of $2 million[50] - The company has 2,424,724 common stock warrants outstanding with a weighted average exercise price of $6.36 as of March 31, 2022[49] - The Company entered into a Sales Agreement with Cantor Fitzgerald & Co. to offer and sell shares of its common stock with an aggregate offering price of up to $10.5 million[71] - In April 2022, the Company sold 575,000 shares of common stock under the ATM Offering for total gross proceeds of approximately $1.5 million[71] Research and Development - The company has focused its resources on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with significant investments in research and development[24] - BioCardia has three enabling device product lines, including the CardiAMP cell processing system, Helix biotherapeutic delivery system, and Morph vascular access product line, indicating ongoing innovation in product development[25] Stock and Equity - The company has no preferred stock issued and outstanding as of March 31, 2022, maintaining a focus on common stock for equity financing[12] - The balance of stock options outstanding as of March 31, 2022 was 1,616,364, with a weighted average exercise price of $4.98[59] - Unrecognized share-based compensation for employee and nonemployee options granted through March 31, 2022 is approximately $2.2 million, to be recognized over a remaining weighted average service period of 2.7 years[59] - The total outstanding common stock equivalents as of March 31, 2022 was 4,046,556, which includes stock options, unvested restricted stock units, and common stock warrants[64] Other Financial Information - The company incurred depreciation expense of approximately $16,000 for the three months ended March 31, 2022, compared to $14,000 for the same period in 2021[41] - The Company received discounts from litigation service providers totaling $4,000 during the three months ended March 31, 2022, which has been recorded as a related party payable[68] - The Company retains a full valuation allowance on its deferred tax assets as of March 31, 2022, due to uncertainty in generating future taxable income[66] - The company does not currently hedge interest rate exposure, and a hypothetical 100 basis point change in interest rates would have an immaterial pre-tax impact on results of operations[116] - As of March 31, 2022, the company had an accumulated deficit of approximately $132.0 million and expects operating losses and negative cash flows to continue for several years[28]

Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2021, totaled just over $1 million, compared to $145,000 for the year ended December 31, 2020, representing an increase of approximately 7-fold [17] - The net loss for 2021 was $12.6 million, compared to a net loss of $15 million in 2020, indicating a reduction in losses [18] - Net cash used in operating activities in 2021 was $10.4 million, down from $12.4 million in 2020, reflecting a decrease in overall spending for operations of approximately $2 million [18] - The company ended 2021 with just under $13 million in cash and equivalents, which is anticipated to be sufficient for planned activities in 2022 [18] Business Line Data and Key Metrics Changes - The CardiAMP autologous cell therapy pivotal clinical trials received FDA breakthrough designation, which is expected to enhance the credibility and attractiveness of the therapy [8][9] - The company has initiated discussions with Japan's Pharmaceutical and Medical Device Agency regarding the registration of CardiAMP Cell Therapy based on existing clinical data [14] Market Data and Key Metrics Changes - The company is targeting to complete enrollment in the heart failure trial and the chronic myocardial ischemia trial by 2023, indicating a strategic focus on accelerating clinical programs [20][55] Company Strategy and Development Direction - The company aims to significantly accelerate both autologous CardiAMP Cell Therapy clinical programs and grow partnering and commercial product revenues in 2022 [20] - The company is actively seeking partnerships for CardiAMP outside the United States, particularly in Japan, to address the unmet need for heart failure therapies [57] - The company is also focused on monetizing assets that do not fit core initiatives, such as the AVANCE transseptal sheet, to support other initiatives [59] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the waning impact of COVID-19 on clinical trial enrollment and highlighted efforts to reduce barriers for patient enrollment [25][38] - The management noted that the FDA's recognition of the CardiAMP Cell Therapy as a breakthrough therapy enhances physician and patient comfort, which is expected to facilitate trial progress [25][26] Other Important Information - The company completed the transition of its laboratories and manufacturing to a new facility in Sunnyvale, which is designed to accommodate clinical and commercial manufacturing needs [19] - The company has received a new CMS reimbursement code to support both treatment and control arms of the CardiAMP Cell Therapy procedures [12] Q&A Session Summary Question: When will patient recruitment start in Canada and what is the enrollment pace in the U.S.? - Management expects to activate all four sites in Canada within a handful of weeks and anticipates a more rapid enrollment pace in the U.S. due to recent regulatory support [24][25] Question: How many patients did not access the trial due to lack of insurance coverage? - Management estimates that approximately 50% of patients are Medicare patients, and efforts are being made to address insurance coverage issues to enhance enrollment [31][32] Question: What are the expectations for the next DSMB review? - The next DSMB review is scheduled for the cusp of August-September, and management is hopeful for increased enrollment following this review [28] Question: What are the critical measures associated with the trial's endpoint? - The trial uses the Finkelstein-Schoenfeld hierarchical analysis, which includes mortality, major adverse cardiac events, and functional capacity as measured by the 6-minute walk [61][62]