UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 9, 2022, BioAtla, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2022 and provided an interim topline data update from its mecbotamab vedotin (CAB-AXL-ADC, BA3011) Phase 2 studies in NSCLC and sarcoma, clinical progress of ozuriftamab vedotin (CAB-ROR2-ADC, BA3021) Phase 2 studies in NSCLC and melanoma, and an operational update on additional ongoing clinical programs. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information set forth in Item 2.02 of this Current Report on Form 8-K (“Current Report”), including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information set forth in Item 2.02 of this Current Report, including Exhibit 99.1 attached hereto, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File-the cover page XBRL tags are embedded within the Inline XBRL document. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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BioAtla, Inc. |
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Date: |
August 9, 2022 |
By: |
/s/ Richard Waldron |
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Richard Waldron |
BIOATLA REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PROGRESS
SAN DIEGO, August 9, 2022 – BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced its financial results for the second quarter ended June 30, 2022, and provided an interim topline data update from the mecbotamab vedotin (BA3011) Phase 2 study in NSCLC as well as an operational update on its ongoing clinical programs, including BA3011, ozuriftamab vedotin (BA3021) and CAB-CTLA-4 (BA3071) addressing multiple tumor types.
“BioAtla continues to progress our CAB-ADC programs, most recently with important signals observed this quarter in our Phase 2 BA3011 NSCLC study. In parallel, we continue to advance with our Phase 2 studies for BA3011 in multiple sarcoma subtypes, with positive signals identified in liposarcoma and synovial sarcoma and official enrollments into part 2 for UPS and osteosarcoma expected to begin this year. We also are progressing with our additional clinical assets, ozuriftamab vedotin (BA3021) in Phase 2 NSCLC, melanoma and head & neck cancer, as well as with our Phase 1/2 naked immuno-oncology antibody CAB-CTLA-4 (BA3071) across multiple tumor types, and anticipate several updates later this year,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc.
“We are very encouraged by our Phase 2 NSCLC preliminary observations, which are consistent with results from our Phase 1 NSCLC and Phase 2 sarcoma studies. Collectively, these data further strengthen the potential opportunity of BA3011 as a best-in-class therapeutic across multiple solid tumor types,” said Scott Smith, President of BioAtla. He continued, “We are also very excited with the continued execution across all the other important programs in our pipeline, including BA3021, BA3071, and BA3182. BioAtla
has a strong cash position to support our robust clinical and preclinical programs into the second half of 2024, and we will remain acutely focused on prioritizing the indications we view have the highest probability of success to maximize value for patients and our shareholders.”
Key Developments, Operational Updates and Upcoming Milestones
Second Quarter Financial Results
Cash and cash equivalents as of June 30, 2022 were $202.3 million, compared to $245.0 million as of December 31, 2021. We expect current cash and cash equivalents will be sufficient to fund planned operations including all ongoing CAB product development programs into second half 2024.
Research and development (R&D) expenses were $20.7 million for the quarter ended June 30, 2022 compared to $14.9 million for the same quarter in 2021. The increase of $5.8 million was primarily driven by expansion of our product development efforts including clinical development for CAB-CTLA-4 (BA3071) and pre-clinical development of additional CAB candidates. We expect our R&D expenses to remain variable from quarter to quarter and generally increase as we continue to invest in R&D activities to advance our product candidates and our clinical programs.
General and administrative (G&A) expenses were $8.3 million for the quarter ended June 30, 2022 compared to $15.9 million for the same quarter in 2021. The $7.6 million change was attributle to a decrease in stock-based compensation for the 2022 period. We expect our G&A expenses to moderately increase to support development of our product candidates, advance our intellectual property portfolio, support focused pre-commercialization activities for our product candidate mecbotamab vedotin (BA3011) and satisfy requirements as a public company.
Net loss for the quarter ended June 30, 2022 was $28.9 million compared to a net loss of $30.4 million for the same quarter in 2021.
Net cash used in operating activities for the six months ended June 30, 2022 was $42.1 million compared to net cash used in operating activities of $28.5 million for the same period in 2021. The increase in net
cash used in operating activities for the first six months of 2022 is primarily due to an increase in research and development expense related to our program development efforts as compared to the first six months of 2021.
Second Quarter 2022 Conference Call and Webcast Details
The management of BioAtla, Inc. will host a conference call and webcast for the investment community today, August 9, 2022, at 4:30 pm Eastern Time. A live webcast may be accessed here: https://edge.media-server.com/mmc/p/czrtgcet. The conference call can be accessed by dialing toll-free (844) 826-3035. The passcode for the conference call is 10169204.
A replay of the webcast and slides with topline interim clinical data referenced on the call will be available through “Events & Presentations” in the Investors section of the company’s website after the conclusion of the presentation and will be archived on the BioAtla website for one year.
About Mecbotamab Vedotin (BA3011)
Mecbotamab vedotin (BA3011), CAB-AXL-ADC, is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL. This Phase 2 stage clinical asset is targeting multiple solid tumor types, including soft tissue and bone sarcoma, and non-small cell lung cancer (NSCLC) that have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies. We are also supporting a multi-center investigator-initiated clinical trial in combination with a PD-1 inhibitor in patients with platinum-resistant ovarian cancer, with other potential indications in the future. The Office of Orphan Drug Products (OODP) at FDA granted Orphan Drug Designation to mecbotamab vedotin for the treatment of soft tissue sarcoma. In the Phase 1 clinical study in sarcoma patients mecbotamab vedotin was generally well-tolerated, few patients discontinued due to an adverse event, and no clinically meaningful on-target toxicity to healthy AXL-expressing tissue was observed. Of the seven sarcoma patients who had an AXL tumor membrane percent score (TmPS) of greater than or equal to 70, four of these obtained a confirmed partial response, including patients with leiomyosarcoma, UPS, and Ewing sarcoma. Multiple subtypes of sarcoma present a significant unmet medical need. For example, UPS is one of the most aggressive sarcoma subtypes with the highest recurrence rate and has approximately 4,000 new cases annually in the U.S. There is no FDA approved treatment for UPS and current first and second line therapies are typically limited to doxorubicin, gemcitabine and docetaxel.
About Ozuriftamab Vedotin (BA3021)
Ozuriftamab vedotin, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are advancing this Phase 2 stage clinical asset for multiple solid tumor types, including NSCLC that have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies, melanoma, SCCHN that have previously progressed on a PD-1 inhibitor and ovarian cancers that have previously progressed on platinum therapy.
About BA3071
BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody, ipilimumab, but with lower toxicities due to the CAB's tumor microenvironment-restricted activity. This may enable safer anti-CTLA-4 antibody combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors, and potentially broaden the patient population tolerant to combination therapy and deliver greater efficacy. Like mecbotamab vedotin, ozuriftimab vedotin and our other CAB candidates, BA3071 is designed to be
conditionally and reversibly active in the tumor microenvironment. BA3071 is being developed as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer.
About BioAtla®, Inc.
BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 600 patents, more than 350 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 1 stage CAB-CTLA-4 antibody, BA3071, is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.
Forward-looking statements
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects, including potential selective licensing and collaborations, expectations about the sufficiency of our cash and cash equivalents, expected R&D and G&A expenses, the timing and expectations with respect to enrollment in our clinical trials, the timing and success of our clinical trials and related data, plans to advance development of several bispecific CAB candidates, including the timing of potential IND submissions and our market opportunity. Forward-looking statements are based on BioAtla's current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: potential delays in clinical and pre-clinical trials due to the global COVID-19 pandemic; other potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the success of our current and future collaborations with third parties; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 28, 2022 and in our Quarterly Reports on Form 10-Q filed with the SEC on May 4, 2022 and August 9, 2022 and our other reports as filed with
the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable law.
Internal Contact:
Richard Waldron
Chief Financial Officer
BioAtla, Inc.
rwaldron@bioatla.com
858.356.8945
External Contact:
Bruce Mackle
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
BioAtla, Inc.
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Collaboration and other revenue |
$ |
— |
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$ |
250 |
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$ |
— |
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$ |
250 |
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Operating expenses: |
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Research and development expense |
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20,711 |
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14,850 |
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37,634 |
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25,273 |
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General and administrative expense |
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8,344 |
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15,860 |
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15,767 |
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24,234 |
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Total operating expenses |
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29,055 |
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30,710 |
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53,401 |
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49,507 |
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Loss from operations |
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(29,055 |
) |
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(30,460 |
) |
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(53,401 |
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(49,257 |
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Other income (expense): |
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Interest income |
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146 |
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80 |
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231 |
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178 |
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Interest expense |
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— |
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(1 |
) |
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— |
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(3 |
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Other income |
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3 |
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— |
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10 |
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— |
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Total other income (expense) |
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149 |
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79 |
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241 |
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175 |
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Consolidated net loss and comprehensive loss |
$ |
(28,906 |
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$ |
(30,381 |
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$ |
(53,160 |
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$ |
(49,082 |
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BioAtla, Inc.
Condensed Consolidated Balance Sheets Data
(in thousands)
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June 30, |
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December 31, |
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(unaudited) |
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Cash and cash equivalents |
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$ |
202,290 |
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$ |
244,979 |
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Total assets |
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213,496 |
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254,422 |
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Total current liabilities |
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25,507 |
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19,813 |
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Total liabilities |
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48,544 |
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43,601 |
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Total stockholders’ equity |
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164,952 |
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210,821 |
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Total liabilities and stockholders’ equity |
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213,496 |
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254,422 |
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