United States securities and exchange commission logo





                              June 11, 2024

       Thomas A. Keuer
       President and Chief Operating Officer
       ARCA biopharma, Inc.
       10170 Church Ranch Way, Suite 100
       Westminster, CO 80021

                                                        Re: ARCA biopharma,
Inc.
                                                            Registration
Statement on Form S-4
                                                            Filed May 14, 2024
                                                            File No. 333-279387

       Dear Thomas A. Keuer:

                                                        We have reviewed your
registration statement and have the following comments.

              Please respond to this letter by amending your registration
statement and providing the
       requested information. If you do not believe a comment applies to your
facts and circumstances
       or do not believe an amendment is appropriate, please tell us why in
your response.

              After reviewing any amendment to your registration statement and
the information you
       provide in response to this letter, we may have additional comments.

       Registration Statement on Form S-4

       Cover Page

   1.                                                   Please clarify your
disclosure to state, if true, that upon the completion of the proposed
                                                        merger, the combined
company will be a "controlled company" under the Nasdaq listing
                                                        rules. To the extent
necessary, please also add a risk factor discussing the risks to
                                                        shareholders related to
owning shares in a controlled company.
   2.                                                   We note your disclosure
that ARCA "intends to file an initial listing application for the
                                                        combined company with
Nasdaq." Please revise your disclosure here to clarify whether
                                                        the Merger is
contingent upon the approval of your Nasdaq listing application.
 Thomas A. Keuer
FirstName  LastNameThomas A. Keuer
ARCA biopharma,   Inc.
Comapany
June       NameARCA biopharma, Inc.
     11, 2024
June 11,
Page 2 2024 Page 2
FirstName LastName
Risk Factors
Risks Related to the Merger
ARCA's expected disposal of its historical assets and operations in connection
with its proposed
Merger . . . , page 15

3.       We note your disclosure here that "ARCA has two remaining ongoing
development
         programs, and it will dispose of (or is in the process of disposing
of) its legacy technology
         and intellectual property." Please clarify here and elsewhere as
appropriate whether
         ARCA expects to dispose of its historical assets regardless of whether
the stockholders
         approve the Merger. Additionally, please clarify here and elsewhere as
         appropriate whether the "legacy technology and intellectual property"
that ARCA is in the
         process of disposing of includes the development programs for Gencaro
and rNAPc2.
Risks Related to Oruka's Reliance on Third Parties
Oruka currently relies, and plans to rely in the future, on third parties . . .
, page 72

4.       Please revise your disclosure to explain that the current U.S. House
of Representatives
         version of the BIOSECURE Act identifies WuXi Biologics as a
biotechnology company
         of concern. Additionally, please revise your disclosure to clarify
whether WuXi Biologics
         (Hong Kong) Limited is a subsidiary or affiliate of WuXi Biologics.
The Merger
Background of the Merger, page 96

5.       We note your disclosure that in June of 2022, the Special Committee
determined to
         abandon a non-binding proposal for a reverse merger styled transaction
due to the
         counterparty's "early stage of development and substantial cash
needs." Please revise your
         disclosure here to provide further details about that counterparty's
stage of development.
6.       We note your disclosure that it was the view of the Special Committee
"that the
         $6,000,000 enterprise value ascribed to ARCA was within the range of
values ascribed in
         other recent reverse merger transactions . . . ." Please provide
further details about the
         range of values that the Special Committee examined in this regard,
including, but not
         limited to, the low-end and high-end of those values. Additionally,
please provide further
         details about the companies that were involved in the other recent
reverse merger
         transactions that the Special Committee reviewed.
Material U.S. Federal Income Tax Consequences of the Merger, page 125

7.       We note your disclosure that the parties "intend" for the Merger to
qualify as a
         reorganization within the meaning of Section 368(a) of the Internal
Revenue Code. Please
         revise to make clear whether the parties expect the Merger to be
tax-free to U.S. holders.
         If you are able to conclude that the Merger is likely to be tax-free
to U.S. holders, please
         file a tax opinion supporting such a conclusion. If there is
uncertainty regarding the tax
         treatment of the Merger, counsel   s opinion should discuss the degree
of uncertainty. For
 Thomas A. Keuer
ARCA biopharma, Inc.
June 11, 2024
Page 3
         further guidance see Staff Legal Bulletin No. 19 and Item 601(b)(8) of
Regulation S-K.
ARCA's Business
Overview, page 196

8.       We note your disclosure on page 18 that ARCA plans to dispose of its
historical assets
         and operations in connection with the proposed Merger. Please revise
your disclosure in
         this section and elsewhere as appropriate to explain how and when the
disposal of such
         assets and operations is expected to take place.
ORKA-001, page 212

9.       We note your disclosure that "[b]ased on recent precedent for PsO,
Oruka anticipates that
         the entire development program from first-in-human to biologics
license application []
         filing could take as little as six to seven years based on the
averages for recently approved
         medicines." Please revise your disclosure here to note that Oruka has
no control over the
         length of time needed for FDA review.
Oruka's Business
Overview, page 212

10.      We note your disclosure on page 73 that Oruka currently relies on
foreign CROs and
         CMOs, "including WuXi Biologics (Hong Kong) Limited [] and will likely
continue to
         rely on foreign CROs and CMOs in the future." Please revise your
disclosure in this
         section to disclose the nature of the business that Oruka conducts
with WuXi Biologics
         (Hong Kong) Limited.
Oruka's Pipeline, page 212

11.      Please revise your disclosure to explain what is meant by the term
"Combinations" as it
         appears in the pipeline table.
Clinical Development Plans, page 223

12.      Please clarify whether Oruka has submitted an IND with the FDA for
Phase 1 clinical
         trials involving either ORKA-001 or ORKA-002.
Management Following the Merger
Non-Employee Directors, page 272
FirstName LastNameThomas A. Keuer
13.    Please revise your disclosure here with respect to Ms. Ball to
specifically identify the
Comapany   NameARCA
       experience,        biopharma,
                   qualifications,      Inc. or skills that led to the
conclusion that Ms. Ball
                                    attributes
       should
June 11, 2024 serve
               Page 3as a director. Refer to Item 401(e) of Regulation S-K.
FirstName LastName
 Thomas A. Keuer
FirstName  LastNameThomas A. Keuer
ARCA biopharma,   Inc.
Comapany
June       NameARCA biopharma, Inc.
     11, 2024
June 11,
Page 4 2024 Page 4
FirstName LastName
Unaudited Pro Forma Condensed Combined Financial Information
Notes to Unaudited Pro Forma Condensed Combined Financial Information
Accounting for the Merger, page 289

14.      Please provide us an analysis concerning whether ARCA will become a
shell company as
         defined in Rule 12b-2 of the Exchange Act prior to the closing of the
Merger. Explain the
         plans for ARCA's two remaining ongoing development programs. Revise
your disclosures
         as necessary to support the reverse recapitalization accounting
planned for the Merger.
5. Adjustments to Unaudited Pro Forma Condensed Combined Balance Sheet as of
March 31,
2024, page 290

15.      Please revise your disclosure in this note to more clearly explain how
you arrived to the
         amounts presented for adjustment 5(c.) For example, it is not clear
from your narrative
         whether the $249.8 million adjustment to cash is net of transaction
costs of $20.0 million
         given that the transaction costs appear to have been accounted for on
a separate line
         through adjustment 5(d.) Consider disaggregating the $249.8 million
adjustments recorded
         to cash and to APIC similar to the table presented for adjustment
5(j.)
Comparison of Rights of Holders of ARCA Capital Stock and Oruka Capital Stock,
page 299

16.      We note your disclosure here, as well as in your risk factor on page
84 that the combined
         company will provide for the federal district courts of the United
States of America to be
         the exclusive forum for the resolution of any complaint asserting a
cause of action against
         the combined company or any of its directors, officers, employees, or
agents and arising
         under the Securities Act. Please disclose that there is uncertainty as
to whether a court
         would enforce such a provision. Please also state that investors
cannot waive compliance
         with the federal securities laws and the rules and regulations
thereunder. In that regard, we
         note that Section 22 of the Securities Act creates concurrent
jurisdiction for federal and
         state courts over all suits brought to enforce any duty or liability
created by the Securities
         Act or the rules and regulations thereunder. Additionally, please
revise to note that this
         provision may also make it more costly for a shareholder to bring a
claim against you.
Principal Stockholders of ARCA, page 309

17.      For the table here, as well as the table on page 312, please identify
in footnotes all natural
         persons who have voting and/or investment power over the shares held
by named entities.
 Thomas A. Keuer
FirstName  LastNameThomas A. Keuer
ARCA biopharma,   Inc.
Comapany
June       NameARCA biopharma, Inc.
     11, 2024
June 11,
Page 5 2024 Page 5
FirstName LastName
        We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.

       Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.

       Please contact Ibolya Ignat at 202-551-3636 or Daniel Gordon at
202-551-3486 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tamika Sheppard at 202-551-8346 or Joshua Gorsky at 202-551-7836 with
any other
questions.



                                                           Sincerely,

                                                           Division of
Corporation Finance
                                                           Office of Life
Sciences
cc:      Brent D. Fassett