8-K
Oruka Therapeutics, Inc. (ORKA)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 2, 2022
ARCA biopharma, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 000-22873 | 36-3855489 |
|---|---|---|
| (State or Other Jurisdiction<br><br><br>of Incorporation) | (Commission File Number) | (IRS Employer<br><br><br>Identification No.) |
| 10170 Church Ranch Way, Suite 100, Westminster, CO | 80021 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: (720) 940-2200
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common | ABIO | Nasdaq Capital Market |
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. ☐
Section 2 — Financial Information
| Item 2.02. | Results of Operations and Financial Condition. |
|---|
On May 2, 2022, ARCA biopharma, Inc., or ARCA, issued a press release reporting financial results for the quarter ended March 31, 2022.
The press release is attached hereto as Exhibit 99.1, which is furnished under Item 2.02 of this report and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.
Section 9 — Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Description |
|---|---|
| 99.1 | Press Release titled “ARCA biopharma Announces First Quarter 2022 Financial Results” dated May 2, 2022. |
| 104 | Cover Page Interactive Data File. The cover page XBRL tags are embedded within the inline XBRL document (contained in Exhibit 101). |
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 hereunto duly authorized.
| Dated: May 2, 2022 | |||
|---|---|---|---|
| ARCA biopharma, Inc. | |||
| (Registrant) | |||
| By: | /s/ C. Jeffrey Dekker | ||
| Name: | C. Jeffrey Dekker | ||
| Title: | Chief Financial Officer |
abio-ex991_6.htm
Exhibit 99.1
ARCA biopharma Announces First Quarter 2022 Financial Results
| • | Company is currently engaged in a strategic review process, evaluating additional development of its assets, collaborations and other strategic options |
|---|
Westminster, CO, May 2, 2022 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported first quarter 2022 financial results and provided a corporate update.
Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “We are in the process of evaluating options for creating stockholder value, including potential development of our assets, partnering and other strategic options.”
In April, the Board of Directors established a Special Committee to evaluate strategic options for maximizing stockholder value.
First Quarter 2022 Summary Financial Results
Cash and cash equivalents were $49.1 million as of March 31, 2022, compared to $53.4 million as of December 31, 2021. ARCA believes that its current cash and cash equivalents, will be sufficient to fund its operations at the current levels through at least the middle of 2023. The Company’s review of its strategic options may impact this projection.
Research and development (R&D) expenses were $2.2 million for the quarter ended March 31, 2022, compared to $2.9 million for the corresponding period in 2021. The $0.7 million decrease in R&D expenses in the first quarter was primarily related to the completion of enrollment in the rNAPc2 Phase 2b clinical trial in the fourth quarter of 2021. R&D expenses in 2022 are expected to be lower than 2021.
General and administrative (G&A) expenses were $1.1 million for the quarter ended March 31, 2022, compared to $1.2 million for the corresponding period in 2021. The $0.1 million decrease in expenses was primarily a result of lower personnel costs, offset by increases in consulting costs. G&A expenses in 2022 are expected to be consistent with those in 2021 as the Company maintains administrative activities to support its ongoing operations.
Total operating expenses for the quarter ended March 31, 2022 were $3.3 million compared to $4.1 million for the first quarter of 2021.
Net loss for the quarter ended March 31, 2022 was $3.3 million, or $0.23 per basic and diluted share, compared to $4.1 million, or $0.33 per basic and diluted share in the first quarter of 2021.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically and other targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. At present, ARCA is evaluating options for development of its assets, including partnering and other strategic options. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.
Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for Gencaro and rNAPc2, if any, the Company’s review of strategic options. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or Gencaro or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future clinical trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval processes; the Company’s ability to complete a strategic transaction, and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2021, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.
Investor & Media Contact:
Derek Cole
720.940.2163
derek.cole@arcabio.com
(Tables follow)
ARCA BIOPHARMA, INC.
BALANCE SHEET DATA
(in thousands)
(unaudited)
| March 31, 2022 | December 31, 2021 | |
|---|---|---|
| Cash and cash equivalents | $49,059 | $53,359 |
| Working capital | $47,820 | $50,923 |
| Total assets | $51,014 | $54,924 |
| Total stockholders’ equity | $47,938 | $51,043 |
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS
(unaudited)
| Three Months Ended | ||||||
|---|---|---|---|---|---|---|
| March 31, | ||||||
| 2022 | 2021 | |||||
| (in thousands, except share<br><br><br>and per share amounts) | ||||||
| Costs and expenses: | ||||||
| Research and development | $ | 2,179 | $ | 2,876 | ||
| General and administrative | 1,098 | 1,226 | ||||
| Total costs and expenses | 3,277 | 4,102 | ||||
| Loss from operations | (3,277 | ) | (4,102 | ) | ||
| Interest and other income | 7 | 2 | ||||
| Other loss | (2 | ) | — | |||
| Net loss | $ | (3,272 | ) | $ | (4,100 | ) |
| Net loss per share: | ||||||
| Basic and diluted | $ | (0.23 | ) | $ | (0.33 | ) |
| Weighted average shares outstanding: | ||||||
| Basic and diluted | 14,410,143 | 12,356,928 |