BioAtla(BCAB)

Search documents
BioAtla(BCAB) - 2022 Q4 - Annual Report
2023-03-22 16:00
Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition peri ...
BioAtla(BCAB) - 2022 Q3 - Earnings Call Transcript
2022-11-06 16:47
BioAtla, Inc. (NASDAQ:BCAB) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Bruce Mackle - Investor Relations Jay Short - Chairman, Chief Executive Officer and Co-Founder Scott Smith - President Philippe Martin - Chief, Clinical Development and Operations Sheri Lydick - Senior Vice President, Commercial Strategy Richard Waldron - Chief Financial Officer Conference Call Participants Brian Cheng - JPMorgan Kelly Shi - Jefferies Tony Butler - ROTH Capital Arthur He - H.C. Wain ...
BioAtla(BCAB) - 2022 Q2 - Earnings Call Transcript
2022-08-13 19:18
BioAtla, Inc. (NASDAQ:BCAB) Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Bruce Mackle - LifeSci Advisors Jay Short - Chairman, CEO and Co-Founder Scott Smith - President Philippe Martin - Chief of Clinical Development and Operations Sheri Lydick - SVP, Commercial Strategy Richard Waldron - CFO Conference Call Participants Kelly Shi - Jefferies Arthur He - H.C. Wainwright Tony Butler - ROTH Capital Operator Hello and welcome to the BioAtla Second Quarter 2022 Earnings Call. ...
BioAtla(BCAB) - 2022 Q1 - Earnings Call Transcript
2022-05-07 19:06
BioAtla, Inc. (NASDAQ:BCAB) Q1 2022 Earnings Conference Call May 4, 2022 4:30 PM ET Company Participants Bruce Mackle - LifeSci Advisors Jay Short - Chairman, CEO and Co-Founder Scott Smith - President Philippe Martin - Chief of Clinical Development and Operations Sheri Lydick - Senior Vice President, Commercial Strategy Richard Waldron - Chief Financial Officer Conference Call Participants Anupam Rama - JPMorgan Tiago Fauth - Credit Suisse Kelly Shi - Jefferies Kaveri Pohlman - BTIG Tony Butler - ROTH Capi ...
BioAtla(BCAB) - 2021 Q4 - Annual Report
2022-02-27 16:00
PART I [Business](index=5&type=section&id=Item%201.%20Business) BioAtla is a clinical-stage biopharmaceutical company developing Conditionally Active Biologics (CABs) for solid tumors, with lead ADC candidates BA3011 and BA3021 in Phase 2 trials and BA3071 in Phase 1 [Our Pipeline](index=6&type=section&id=Our%20Pipeline) The company's pipeline focuses on Conditionally Active Biologics (CABs) for solid tumors, featuring three main clinical-stage candidates - The company's pipeline is focused on developing Conditionally Active Biologics (CABs) for solid tumors, with **three main clinical-stage candidates**[30](index=30&type=chunk) - Mecbotamab vedotin (BA3011) is a CAB ADC targeting AXL, in potentially registration-enabling Phase 2 trials for sarcoma and NSCLC, and has received **Orphan Drug Designation** for soft tissue sarcoma[26](index=26&type=chunk)[31](index=31&type=chunk)[34](index=34&type=chunk) - Ozuriftamab vedotin (BA3021) is a CAB ADC targeting ROR2, in Phase 2 trials for melanoma, NSCLC, and SCCHN, particularly for patients who have failed PD-1 blockade[26](index=26&type=chunk)[35](index=35&type=chunk)[37](index=37&type=chunk) - BA3071 is a CAB anti-CTLA-4 antibody designed to offer the efficacy of ipilimumab with lower toxicity, having initiated a Phase 1/2 dose-escalation trial[26](index=26&type=chunk)[38](index=38&type=chunk)[40](index=40&type=chunk) - The company is advancing multiple preclinical assets, including CAB bispecific antibodies and a next-generation CAB ADC, with plans to file **one IND in 2022** and up to **three more in 2023**[44](index=44&type=chunk) [Our Technology](index=9&type=section&id=Our%20Technology) The company's proprietary Conditionally Active Biologics (CAB) technology aims to overcome limitations of traditional antibody therapies by selectively activating in the acidic tumor microenvironment - The company's proprietary Conditionally Active Biologics (CAB) technology is designed to overcome the limitations of traditional antibody therapies, such as on-target, off-tumor toxicity[25](index=25&type=chunk)[27](index=27&type=chunk) - CAB technology leverages the acidic tumor microenvironment (pH < 6.8) caused by the Warburg Effect, engineering antibodies to bind selectively under these acidic conditions but remain inactive at normal physiological pH of 7.4, thereby sparing healthy tissue[57](index=57&type=chunk)[61](index=61&type=chunk)[63](index=63&type=chunk) - This pH-dependent binding is designed to provide several advantages: a **wider therapeutic window**, **reduced systemic toxicity**, **increased drug exposure to tumors**, and improved pharmacokinetics by minimizing target-mediated drug disposition (TMDD)[66](index=66&type=chunk)[68](index=68&type=chunk) [Clinical Trials](index=13&type=section&id=Clinical%20Trials) Clinical trials for mecbotamab vedotin (BA3011) and ozuriftamab vedotin (BA3021) have shown promising antitumor activity and tolerability, with both candidates advancing into potentially registration-enabling Phase 2 studies - Mecbotamab vedotin (BA3011) Phase 1 trial showed confirmed partial responses in sarcoma and NSCLC patients, with antitumor activity correlating with **high AXL tumor membrane expression (TmPS ≥70%)**, and the therapy was generally well-tolerated[69](index=69&type=chunk)[73](index=73&type=chunk)[77](index=77&type=chunk) - Ozuriftamab vedotin (BA3021) Phase 1 trial demonstrated a **complete response in a metastatic melanoma patient** and partial responses in NSCLC and head and neck cancer patients, with antitumor activity associated with high ROR2 tumor membrane expression[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) - BA3071, a CAB anti-CTLA-4 antibody, showed similar antitumor efficacy to an ipilimumab-analog in preclinical models but with significantly fewer gastrointestinal toxicities in non-human primates, suggesting a **better safety profile**, and a Phase 1 trial was initiated in 2021[133](index=133&type=chunk)[139](index=139&type=chunk)[143](index=143&type=chunk) - The company is conducting potentially registration-enabling Phase 2 trials for both mecbotamab vedotin (in sarcoma and NSCLC) and ozuriftamab vedotin (in melanoma and NSCLC)[99](index=99&type=chunk)[126](index=126&type=chunk) [Collaborations](index=29&type=section&id=Collaborations) BioAtla has strategically engaged in various collaboration and licensing agreements to advance its pipeline and technology, including regaining global rights for BA3071 and licensing CAB antibodies for specific therapeutic areas - In November 2021, the company terminated its co-development and collaboration agreement with BeiGene for BA3071, regaining global development and commercialization rights in exchange for mid-single digit royalties on sales and a share of upfront/milestone payments from sublicenses to BeiGene[159](index=159&type=chunk) - The company has exclusive license agreements with Inversagen, LLC for diseases associated with aging (outside of cancer), with Himalaya Therapeutics SEZC for certain CAB antibodies in Greater China, and with BioAtla Holdings, LLC for CAB antibodies in the field of Adoptive Cell Therapy (CAR-T)[160](index=160&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) - An amended and restated exclusive license agreement with EXUMA Biotech Corp grants EXUMA rights to develop four CAB ACT (CAR-T) preparations for cancer, with BioAtla receiving **mid-single-digit royalties** on net sales[165](index=165&type=chunk)[166](index=166&type=chunk) [Intellectual Property](index=31&type=section&id=Intellectual%20Property) The company maintains a robust intellectual property portfolio, with a focus on protecting its platform technologies and compositions of matter, ensuring patent coverage for its lead product candidates extending into the late 2030s Patent Portfolio Status (as of Dec 31, 2021) | Category | Count | | :--- | :--- | | **Total Patents & Applications** | **584** | | Issued Patents | 319 | | Allowed Applications | 8 | | Pending Applications | 257 | - The company's IP strategy focuses on protecting its platform technologies and compositions of matter, aiming to maximize patent term by timely filing applications, often using the PCT system for international coverage[171](index=171&type=chunk)[173](index=173&type=chunk) - Patents covering mecbotamab vedotin, if issued from the current application, would not expire before **2037**, while those covering ozuriftamab vedotin would not expire before **2037**, and BA3071 patents would not expire before **2039**[179](index=179&type=chunk)[180](index=180&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks, including a history of losses and the need for substantial additional capital, with success heavily dependent on its novel CAB technology platform and the uncertain clinical development and regulatory approval of its product candidates - The company has a history of significant losses (**$95.4 million in 2021**) and expects to continue incurring them for the foreseeable future, requiring substantial additional capital to fund operations[279](index=279&type=chunk)[283](index=283&type=chunk)[285](index=285&type=chunk) - Success is heavily dependent on the proprietary CAB technology platform, and any failures or safety issues with this novel technology could negatively impact the entire product pipeline[279](index=279&type=chunk)[295](index=295&type=chunk) - Clinical development is subject to high risk, as early-stage results may not predict late-stage success, and there is no guarantee that the FDA will find the ongoing Phase 2 trials sufficient for registration[279](index=279&type=chunk)[307](index=307&type=chunk)[308](index=308&type=chunk) - The company faces risks related to its reliance on third parties for manufacturing, conducting clinical trials, and developing companion diagnostics, which could lead to delays and impair commercialization[430](index=430&type=chunk)[434](index=434&type=chunk)[334](index=334&type=chunk) - A portion of research and development occurs in China, exposing the company to risks from Chinese legal and political uncertainties, which could adversely affect operations[279](index=279&type=chunk)[411](index=411&type=chunk) [Properties](index=84&type=section&id=Item%202.%20Properties) The company leases approximately 43,377 square feet of office and laboratory space for its headquarters in San Diego, California, under a lease that expires on February 28, 2025 - The company's headquarters are located at 11085 Torreyana Road, San Diego, California, where it leases **43,377 square feet** of office and lab space[517](index=517&type=chunk) - The current lease agreement terminates on **February 28, 2025**[517](index=517&type=chunk) [Legal Proceedings](index=84&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, BioAtla is not a party to any legal proceedings that are expected to have a material adverse effect on its business, operating results, or financial condition - The company is not currently a party to any material legal proceedings[518](index=518&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=85&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) BioAtla's common stock began trading on the Nasdaq Global Market on December 16, 2020, under the symbol "BCAB", with the company having never paid cash dividends and no intention to do so in the foreseeable future, retaining earnings to fund growth - The company's common stock trades on the Nasdaq Global Market under the ticker symbol "**BCAB**" since **December 16, 2020**[521](index=521&type=chunk) - The company has never declared or paid cash dividends and intends to retain all future earnings to support operations and growth[523](index=523&type=chunk) - As of **February 25, 2022**, there were **16 stockholders of record** for common stock and **2 for Class B common stock**[522](index=522&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=87&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In fiscal year 2021, BioAtla's net loss increased to $95.4 million from $35.9 million in 2020, driven by a significant rise in R&D and G&A expenses, with $245.0 million in cash and cash equivalents expected to fund operations into the first half of 2024 [Results of Operations](index=90&type=section&id=Results%20of%20Operations) In 2021, the company experienced a significant increase in net loss, primarily due to higher research and development expenses for clinical programs and increased general and administrative costs associated with operating as a public company Comparison of Operations for Years Ended December 31 | Financial Metric | 2021 (in thousands) | 2020 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Collaboration and other revenue | $250 | $429 | $(179) | | Research and development expense | $58,274 | $19,933 | $38,341 | | General and administrative expense | $38,416 | $10,595 | $27,821 | | **Loss from operations** | **$(96,440)** | **$(30,099)** | **$(66,341)** | | **Consolidated net loss** | **$(95,402)** | **$(35,853)** | **$(59,549)** | - Research and development expenses increased by **$38.3 million** in 2021 compared to 2020, primarily due to higher external costs for manufacturing and clinical development of BA3011 and BA3021, increased preclinical development for other pipeline programs, and higher stock-based compensation[561](index=561&type=chunk) - General and administrative expenses increased by **$27.8 million** in 2021, mainly driven by an **$18.2 million increase in stock-based compensation**, higher insurance costs, increased personnel expenses, and higher professional fees associated with being a public company[562](index=562&type=chunk) [Liquidity and Capital Resources](index=91&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2021, the company held $245.0 million in cash and cash equivalents, which is projected to fund operations into the first half of 2024 - As of **December 31, 2021**, the company had cash and cash equivalents of **$245.0 million**[565](index=565&type=chunk) - Based on the current operating plan, existing cash and cash equivalents are expected to be sufficient to fund operations into the **first half of 2024**[569](index=569&type=chunk) Summary of Cash Flows for Years Ended December 31 | Cash Flow Activity | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(62,214) | $(36,334) | | Net cash used in investing activities | $(924) | $(590) | | Net cash provided by financing activities | $69,512 | $271,825 | - In July 2021, the company's **$0.7 million Paycheck Protection Program (PPP) loan** was fully forgiven by the SBA[567](index=567&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=96&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to minimal market risk, with interest rate risk on its cash and cash equivalents not considered significant and foreign currency exchange risk not material, as contracts are primarily denominated in U.S. dollars - The company's primary market risk exposure is interest rate risk on its cash and cash equivalents (**$245.0 million as of Dec 31, 2021**), but historical fluctuations have not been significant[597](index=597&type=chunk) - Foreign currency transaction gains and losses have not been material to the financial statements, and the company has not engaged in foreign currency hedging[598](index=598&type=chunk) [Financial Statements and Supplementary Data](index=97&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements for the year ended December 31, 2021, report a net loss of $95.4 million, with total assets of $254.4 million, primarily cash and cash equivalents, and total liabilities of $43.6 million, all audited with an unqualified opinion by Ernst & Young LLP Consolidated Balance Sheet Data (as of December 31) | Account | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $244,979 | $238,605 | | **Total assets** | **$254,422** | **$244,937** | | Total current liabilities | $19,813 | $32,261 | | **Total liabilities** | **$43,601** | **$34,963** | | **Total stockholders' equity** | **$210,821** | **$209,974** | Consolidated Statement of Operations Data (for the year ended December 31) | Account | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Collaboration and other revenue | $250 | $429 | | Research and development expense | $58,274 | $19,933 | | General and administrative expense | $38,416 | $10,595 | | **Loss from operations** | **$(96,440)** | **$(30,099)** | | **Consolidated net loss** | **$(95,402)** | **$(35,853)** | | Net loss per common share | $(2.76) | $(3.19) | Consolidated Statement of Cash Flows Data (for the year ended December 31) | Account | 2021 (in thousands) | 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(62,214) | $(36,334) | | Net cash used in investing activities | $(924) | $(590) | | Net cash provided by financing activities | $69,512 | $271,825 | [Controls and Procedures](index=126&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2021, with no material changes during the fourth quarter - As of **December 31, 2021**, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[798](index=798&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2021**[799](index=799&type=chunk) - No material changes were made to the company's internal control over financial reporting during the **fourth quarter of fiscal 2021**[800](index=800&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=129&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's definitive proxy statement for its 2022 Annual Meeting of Stockholders - The information required for this item will be included in the company's Proxy Statement for the **2022 Annual Meeting of Stockholders** and is incorporated by reference[809](index=809&type=chunk) [Executive Compensation](index=129&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive proxy statement for its 2022 Annual Meeting of Stockholders - The information required for this item will be included in the company's Proxy Statement for the **2022 Annual Meeting of Stockholders** and is incorporated by reference[811](index=811&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=129&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners, management, and related stockholder matters is incorporated by reference from the company's definitive proxy statement for its 2022 Annual Meeting of Stockholders - The information required for this item will be included in the company's Proxy Statement for the **2022 Annual Meeting of Stockholders** and is incorporated by reference[812](index=812&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=129&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related party transactions, and director independence is incorporated by reference from the company's definitive proxy statement for its 2022 Annual Meeting of Stockholders - The information required for this item will be included in the company's Proxy Statement for the **2022 Annual Meeting of Stockholders** and is incorporated by reference[813](index=813&type=chunk) [Principal Accountant Fees and Services](index=129&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the company's definitive proxy statement for its 2022 Annual Meeting of Stockholders - The information required for this item will be included in the company's Proxy Statement for the **2022 Annual Meeting of Stockholders** and is incorporated by reference[814](index=814&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=130&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the Annual Report on Form 10-K, with financial statements included under Item 8 and all financial statement schedules omitted as not applicable - The financial statements are located under **Item 8** of the report[816](index=816&type=chunk) - All financial statement schedules have been omitted because they are not applicable or the required information is already included in the financial statements or notes[816](index=816&type=chunk)