EX-99.1

2 ea030131201ex99-1.htm

PRESS RELEASE, DATED AUGUST 10, 2026

Exhibit 99.1

Oruka Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

EVERLAST-A Week 28 data expected at the end

of 3Q 2026; 52-week data for all participants expected in December 2026

EVERLAST-B fully enrolled ahead of schedule,

with Week 16 data now expected in 4Q 2026

Phase 3 program for ORKA-001 expected to begin in 1H 2027

ORCA-SURGE Week 16 data accelerated, now expected

in 1Q 2027

ORCA-SPLASH, a Phase 2 trial of ORKA-002 in

moderate-to-severe hidradenitis suppurativa, initiated

ORKA-004, a novel half-life extended monoclonal

antibody targeting TL1A, to enter the clinic in 4Q 2026

Cash, cash equivalents and marketable securities of $1.1 billion expected to fund the Company through a BLA filing for ORKA-001

MENLO PARK, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO) and hidradenitis suppurativa (HS), today reported second quarter 2026 financial results and provided a corporate update.

“The second quarter and recent months were highly productive as we advanced both of our co-lead programs toward a series of important readouts,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “With EVERLAST-B now fully enrolled and a Phase 3 program for ORKA-001 on the horizon, alongside the initiation of ORCA-SPLASH in HS, we are executing on our strategy to establish ORKA-001 and ORKA-002 as potentially best-in-class options across psoriatic disease and beyond. We look forward to multiple significant clinical catalysts over the coming quarters.”

Second Quarter 2026 and Recent Business and Pipeline Updates

ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody

●In April 2026, the Company presented positive data from its EVERLAST-A Phase 2a trial in moderate-to-severe PsO showing 40 of 63 (63.5%) participants treated with ORKA-001 achieved PASI 100 at Week 16. Other key secondary endpoints included PASI 90 at Week 16, achieved by 83% of treated participants, and IGA 0/1 at Week 16, achieved by 84% of treated participants. ORKA-001 was well tolerated with a safety profile similar to placebo and consistent with prior IL-23p19 inhibitors.

●The Company expects to report Week 28 data from EVERLAST-A for all participants at the end of the third quarter of 2026. These data will provide the first look at maintenance of response out to six months and potential deepening of responses for patients who did not reach PASI 100 at Week 16.

●The Company also expects to report 52-week data from EVERLAST-A for all participants in December 2026. These longer-term data are designed to characterize the durability of response and continue to inform the potential for once- to twice-yearly dosing.

●EVERLAST-B, a Phase 2b dose-ranging trial in moderate-to-severe PsO, completed enrollment of 187 subjects in the second quarter. The Company now expects to report Week 16 data for all participants in the fourth quarter of 2026. These data are intended to support the initiation of a Phase 3 program in the first half of 2027.

ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody

●The Company now expects to report Week 16 data from ORCA-SURGE, a Phase 2 trial in moderate-to-severe PsO, in the first quarter of 2027.

●The Company initiated ORCA-SPLASH, a Phase 2 trial in moderate-to-severe HS. ORCA-SPLASH is a randomized, double-blind, placebo-controlled study in approximately 160 participants. The study will enroll patients in the United States and Canada. Patients will be randomized 1:1 to receive 320 mg of ORKA-002 or placebo at Weeks 0, 4, 8, and 12. The primary endpoint is HiSCR75 at Week 16. Participants then enter an open-label maintenance period evaluating 320 mg of ORKA-002 every 12 weeks.

Additional updates

●The Company announced ORKA-004, a novel, subcutaneously administered, half-life extended monoclonal antibody targeting TL1A that is anticipated to enter the clinic in the fourth quarter of 2026. The Company plans to pursue ORKA-004 in combination with ORKA-001 and ORKA-002, with Phase 2 combination studies planned to begin in 2027.

●In April 2026, the Company announced the pricing of an upsized $700 million public offering. Proceeds from this offering, including existing cash, are expected to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.

●In May 2026, Oruka amended its IL-23 license agreement with Paragon Therapeutics to include all therapeutic areas. Prior to the amendment, the Company’s agreement did not include inflammatory bowel disease (IBD). The amendment allows Oruka to pursue ORKA-001 or combinations thereof in IBD, subject to certain timing restrictions on initiating clinical trials.

Second Quarter

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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): April 27, 2026

Oruka Therapeutics, Inc.

(Exact name of Registrant as Specified in its Charter)

Delaware

000-22873

36-3855489

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

855 Oak Grove Avenue

Suite 100

Menlo Park, California

94025

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 606-7910

N/A

(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:

☐ 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 Stock, $0.001 par value

ORKA

The Nasdaq Global 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. ☐

Item 2.02. Results of Operations and Financial Condition.

On April 27, 2026, Oruka Therapeutics, Inc., a Delaware corporation (the “Company”), disclosed in a preliminary prospectus supplement relating to the Offering (as defined below) that the Company estimates that its cash, cash equivalents, and investments were approximately $496 million as of March 31, 2026. The Company is furnishing this information pursuant to Item 2.02 solely because it was disclosed in the preliminary prospectus supplement relating to the Offering.

This preliminary estimate is based on currently available information and is subject to revision based upon, among other things, the finalization and closing of the Company’s accounting books and records. The Company’s financial results for the three months ended March 31, 2026 are not yet finalized. The preliminary financial data included in the prospectus supplement was prepared by, and is the responsibility of, the Company’s management. This estimate should not be viewed as a substitute for financial statements prepared in accordance with accounting principles generally accepted in the United States and is not necessarily indicative of the results to be achieved in any future period.

Such preliminary results are furnished in the excerpt from the preliminary prospectus supplement attached hereto as Exhibit 99.1.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, 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 that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On April 28, 2026, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Leerink Partners LLC, TD Securities (USA) LLC, Goldman Sachs & Co. LLC, Stifel, Nicolaus & Company, Incorporated and Guggenheim Securities, LLC, as the representatives of the several underwriters named in Schedule A thereto (the “Underwriters”), providing for the offering and sale by the Company of 9,660,000 shares of common stock, par value $0.001 per share (the “Common Stock”), at a price to the public of $72.50 per share (the “Offering”). In addition, the Company has granted the Underwriters an option for a period of 30 days to purchase up to an additional 1,449,000 shares of Common Stock at the public offering price, less underwriting discounts and commissions.

The Offering was made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-294852) previously filed with the Securities and Exchange Commission (the “SEC”), which was dec

EX-99.1

18 ea021319301ex99-1_oruka.htm

PRESS RELEASE, ISSUED ON SEPTEMBER 3, 2024

Exhibit 99.1

Oruka Therapeutics Announces Closing of Merger with ARCA biopharma and Previously Announced Private Placement of $275 Million

Oruka is advancing a pipeline of potentially best-in-class biologics that aim to offer greater freedom from disease to people with plaque psoriasis and other associated conditions

Company on track to advance co-lead programs,

ORKA-001 and ORKA-002, into the clinic and show initial pharmacokinetic data for

ORKA-001 next year

Samarth Kulkarni, PhD, appointed Chairman of Oruka’s Board of Directors

Shares to trade on Nasdaq under the ticker symbol “ORKA” commencing today, September 3, 2024

MENLO PARK, Calif. -- (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, including plaque psoriasis, today announced the completion of its previously announced merger with ARCA biopharma, Inc. The combined company will operate under the name Oruka Therapeutics, Inc., and its shares are expected to begin trading on the Nasdaq Global Market today, September 3, 2024, under the ticker symbol “ORKA”. In addition, Oruka announced the appointment of Samarth Kulkarni, PhD, current Chairman and CEO of CRISPR Therapeutics, as Chairman of Oruka’s Board of Directors.

Concurrent with the merger, Oruka completed a previously announced $275 million private placement with a syndicate of new and existing investors including Fairmount, Venrock Healthcare Capital Partners, RTW Investments, Access Biotechnology, Commodore Capital, Deep Track Capital, Perceptive Advisors, Blackstone Multi-Asset Investing, Avidity Partners, Great Point Partners LLC, Paradigm BioCapital, Braidwell LP and Redmile Group, along with multiple large investment management firms. Following the merger, private placement, and reverse stock split, there are approximately 46.3 million shares of the combined company’s common stock and common stock equivalents outstanding, including shares of common stock underlying pre-funded warrants and Series B non-voting convertible preferred stock, and excluding employee and director equity.

“We have made tremendous progress since our founding in February of this year. We have assembled a top-tier team that has executed effectively to both close this transaction and advance our co-lead programs toward human trials,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Our drug candidates are designed to potentially offer both improved dosing regimens and greater clinical activity compared to the current standard of care for patients with psoriasis and related conditions.”

“Oruka’s product candidates have incredible potential to change the landscape of treatment for multiple diseases,” commented Samarth Kulkarni, PhD. “I am very impressed with the work the team has completed to date and believe they are well positioned to deliver on the immense promise of their programs moving forward.”

ORKA-001 is a novel, subcutaneously (SQ) administered, half-life extended

monoclonal antibody targeting IL-23p19. Inhibitors of IL-23p19 have become the preferred first-line therapy for patients with moderate-to-severe plaque psoriasis given their strong efficacy and safety profile. Currently approved therapies are dosed four to six times per year and deliver PASI 100, or fully clear skin, for less than half of patients after four months. ORKA-001 has the potential to be dosed just once or twice a year and is designed to achieve higher exposures than currently marketed IL-23p19 antibodies, which could lead to higher rates of disease clearance.

ORKA-002 is a novel, SQ administered, half-life extended monoclonal

antibody targeting IL-17A/F. Dual inhibition of IL-17A and F has resulted in high PASI 100 rates in psoriasis and is ideally suited to patients with concurrent psoriatic arthritis (PsA) or recalcitrant skin disease. IL-17A/F inhibition has also shown promising efficacy in other diseases such as hidradenitis suppurativa (HS) and axial spondyloarthritis (axSpA). ORKA-002 is designed to provide patients an option with substantially less frequent dosing, while offering similar levels of disease clearance compared to currently marketed agents.

About Oruka Therapeutics

Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.

EX-99.1

2 abio-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

ARCA biopharma Announces Second Quarter 2024 Financial Results and Provides Corporate Update

Westminster, CO, August 1, 2024 – ARCA biopharma, Inc. (Nasdaq: ABIO), (the “Company”) a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported second quarter 2024 financial results and provided a corporate update.

In April 2022, ARCA established a Special Committee of the board of directors (the “Board”) of ARCA to conduct a comprehensive review of strategic alternatives. As part of the strategic review process, the Company explored potential strategic alternatives that included, without limitation, an acquisition, merger, business combination or other transactions. The Company has and is continuing to explore strategic alternatives related to its product candidates and related assets, including, without limitation, licensing transactions and asset sales.

On April 3, 2024, following a comprehensive review of strategic alternatives, the Company, Atlas Merger Sub Corp., a Delaware corporation and a wholly-owned subsidiary of ARCA (“Merger Sub I”), Atlas Merger Sub II LLC, a Delaware limited liability company and a wholly-owned subsidiary of ARCA (“Merger Sub II”) and Oruka Therapeutics, Inc., a Delaware corporation (“Oruka”), entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub I will merge with and into Oruka, with Oruka continuing as a wholly owned subsidiary of ARCA and the surviving corporation of such merger (the “First Merger”) and as part of the same overall transaction, the surviving corporation in the First Merger will merge with and into Merger Sub II with Merger Sub II continuing as a wholly owned subsidiary of ARCA and the surviving entity of such merger (the “Second Merger” and together with the First Merger, the “Merger”). The Merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.

Additional descriptions about the Merger Agreement and related agreements were previously disclosed on a Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 3, 2024. In connection with the proposed Merger, the Company has filed relevant materials with the SEC, including a registration statement on Form S-4 that contains a definitive proxy statement and prospectus of the Company.

In connection with the Merger, the Company will dispose of (or is in the process of disposing of) its legacy technology and intellectual property, including those related to Gencaro™ (bucindolol hydrochloride) and Recombinant Nematode Anticoagulant Protein c2 (“rNAPc2”). Any such disposal of legacy technology and intellectual property will be contingent upon obtaining

stockholder approval for the Merger and is expected to occur immediately prior to or concurrently with the closing of the Merger. In the event that the Company shall enter into an agreement for any such sale or other disposition of its legacy assets at or prior to the closing of the Merger, the net proceeds received at or prior to the closing of the Merger will be included in the calculation of the net cash of the Company as of the closing.

The Company’s future operations are highly dependent on the success of the Merger and there can be no assurances that the Merger will be successfully consummated. In the event that the Company does not complete the Merger, the Company may explore strategic alternatives, including, without limitation, another strategic transaction and/or pursue a dissolution and liquidation of the Company.

Second Quarter 2024 Summary Financial Results

Cash and cash equivalents were $33.3 million as of June 30, 2024, compared to $37.4 million as of December 31, 2023. ARCA believes that its current cash and cash equivalents, consisting primarily of money market funds, will be sufficient to fund its operations through the end of 2025. Our future viability beyond that point is dependent on the results of the strategic review process and our ability to raise additional capital to fund our operations. We expect to continue to incur costs and expenditures in connection with the process of evaluating strategic alternatives. There can be no assurance, however, that we will be able to successfully consummate any particular strategic transaction, including the Merger. The process of continuing to evaluate these strategic options may be very costly, time-consuming and complex and we have incurred, and may in the future incur, significant costs related to this

EX-99.1

2 abio-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

ARCA biopharma Announces First Quarter 2024 Financial Results and Provides Corporate Update

• ARCA biopharma and Oruka Therapeutics announce Merger Agreement

• ARCA biopharma appoints Thomas Keuer as President

Westminster, CO, April 25, 2024 – ARCA biopharma, Inc. (Nasdaq: ABIO), (the “Company”) a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported first quarter 2024 financial results and provided a corporate update.

In April 2022, ARCA established a Special Committee of the board of directors (the “Board”) of ARCA to conduct a comprehensive review of strategic alternatives. As part of the strategic review process, the Company explored potential strategic alternatives that included, without limitation, an acquisition, merger, business combination or other transactions. The Company has and is continuing to explore strategic alternatives related to its product candidates and related assets, including, without limitation, licensing transactions and asset sales.

On April 3, 2024, following a comprehensive review of strategic alternatives, the Company, Atlas Merger Sub Corp., a Delaware corporation and a wholly-owned subsidiary of ARCA (“Merger Sub I”), Atlas Merger Sub II LLC, a Delaware limited liability company and a wholly-owned subsidiary of ARCA (“Merger Sub II”) and Oruka Therapeutics, Inc., a Delaware corporation (“Oruka”), entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub I will merge with and into Oruka, with Oruka continuing as a wholly owned subsidiary of ARCA and the surviving corporation of the merger (the “First Merger”) and as part of the same overall transaction, the surviving corporation in the First Merger will merge with and into Merger Sub II with Merger Sub II continuing as a wholly owned subsidiary of ARCA and the surviving entity of the merger (the “Second Merger” and together with the First Merger, the “Merger”). The Merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.

Additional descriptions about the Merger Agreement and related agreements were previously disclosed on a Current Report on Form 8-K filed with the SEC on April 3, 2024.

The Company’s future operations are highly dependent on the success of the Merger and there can be no assurances that the Merger will be successfully consummated. In the event that the Company does not complete the Merger, the Company may explore strategic alternatives, including, without limitation, another strategic transaction and/or pursue a dissolution and liquidation of the Company.

Separation of Michael Bristow, M.D., President, Chief Executive Officer and Director

Effective April 3, 2024, ARCA and Dr. Michael Bristow, President, Chief Executive Officer and a member of the Board mutually agreed to conclude Dr. Bristow’s employment and service as a director.

In connection with Dr. Bristow’s separation, ARCA and Dr. Bristow entered into a separation agreement (the “Separation Agreement”) on April 3, 2024. Pursuant to the terms of the Separation Agreement, ARCA provided to Dr. Bristow a lump sum payment equal to (i) twelve (12) months of Dr. Bristow’s base salary as of the last date of his employment and (ii) a cash payment of $25,000, less applicable withholdings. The severance benefits were conditioned on the non-revocation by Dr. Bristow of a legal release of claims.

ARCA and Dr. Bristow entered into a consulting agreement, effective April 3, 2024 (the “Consulting Agreement”), pursuant to which Dr. Bristow is providing certain consulting services provided for in the Consulting Agreement to ARCA until the earlier of (i) the completion of services under the Consulting Agreement, (ii) a termination in accordance with the terms of the Consulting Agreement, and (iii) upon a Change of Control (as defined in ARCA’s 2020 Equity Incentive Plan (the “Plan”)). Pursuant to the Consulting Agreement, Dr. Bristow's provision of services under the Consulting Agreement are deemed to be a Continuous Service (as defined in the Plan) and, as a result, his equity awards under the Plan continue to vest during the term of the Consulting Agreement.

Appointment of Thomas Keuer as President

Effective as of April 3, 2024, the Board appointed Thomas A. Keuer, the Company’s Chief Operating Officer, to serve as ARCA’s President and principal executive officer. Mr. Keuer has been with ARCA since 2006, and as its Chief Operating Officer for the last nine years, a position he will continue to serve

EX-99.1

2 abio-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

ARCA biopharma Announces 2023 Financial Results

• Company is currently engaged in a strategic review process, evaluating additional development of its assets, collaborations and other strategic options

Westminster, CO, February 1, 2024 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported 2023 financial results and provided a corporate update.

In April 2022, the Board of Directors established a Special Committee (the “Special Committee”) and, in May 2022, retained Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic options, including transactions involving a merger, sale of all or part of the Company’s assets, or other alternatives with the goal of maximizing stockholder value (the “Strategic Review”). The Company and Ladenburg have reviewed several potential strategic transactions and continue to evaluate further potential development of the Company’s existing assets, in order to maximize stockholder value. The Company does not have a defined timeline for the strategic review process and the review may not result in any specific action or transaction.

Full Year 2023 Summary Financial Results

Cash and cash equivalents were $37.4 million as of December 31, 2023, compared to $42.4 million as of December 31, 2022. ARCA believes that its current cash and cash equivalents, consisting primarily of money market funds, will be sufficient to fund its operations through the middle of 2025.

General and administrative (G&A) expenses were $6.3 million for the year ended December 31, 2023, compared to $5.8 million for 2022, an increase of approximately $0.4 million. During the year ended December 31, 2023, the Company recorded $159,000 for one-time termination benefits related to the mutually-agreed to conclusion of Christopher D. Ozeroff's employment, the former Secretary, Senior Vice President and General Counsel of ARCA, effective March 31, 2023. During the year ended December 31, 2022, the Company recorded total restructuring charges of approximately $755,000, of which $470,000 and $285,000 were recognized in research and development and general and administrative expenses, respectively, in connection with the restructuring, all in the form of one-time termination benefits. The increase in expenses during 2023 was primarily a result of increases in professional fees and fees to the Special Committee in connection with the Strategic Review, offset by lower one-time termination benefits and lower personnel costs from the reductions discussed above. G&A expenses in 2024 are expected to be consistent with those in 2023 as the Company maintains administrative activities to support our ongoing operations.

Research and development (R&D) expenses were $1.0 million for the year ended December 31, 2023, compared to $4.7 million for 2022, a $3.7 million decrease. R&D personnel costs decreased approximately $1.2 million for the year ended December 31, 2023, as compared to the corresponding periods of 2022, due to one-time termination benefits incurred in 2022 and decreased headcount from the July 2022 personnel reduction discussed above. Clinical expense decreased approximately $1.0 million for the year ended December 31, 2023, as compared to the corresponding period of 2022. Manufacturing process development costs decreased approximately $1.1 million for the year ended December 31, 2023, as compared to the corresponding period of 2022. The majority of clinical and manufacturing close out costs related to the rNAPc2 (AB201) international Phase 2b clinical trial were incurred in the first half of 2022, with no comparable costs for the corresponding periods of 2023. R&D expenses in 2024 are expected to be lower than 2023.

Total operating expenses for the year ended December 31, 2023 were $7.3 million compared to $10.6 million in 2022.

Net loss for the year ended December 31, 2023 was $5.3 million, or $0.37 per basic and diluted share, compared to $9.9 million, or $0.69 per basic and diluted share in 2022.

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,

EX-99.1

2 abio-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

ARCA biopharma Announces Third Quarter 2023 Financial Results

• Company is currently engaged in a strategic review process, evaluating additional development of its assets, collaborations and other strategic options

Westminster, CO, October 18, 2023 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported third quarter 2023 financial results and provided a corporate update.

In April 2022, the Board of Directors established a Special Committee and, in May 2022, retained Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic options, including transactions involving a merger, sale of all or part of the Company’s assets, or other alternatives with the goal of maximizing stockholder value. The Company and Ladenburg have reviewed several potential strategic transactions and continue to evaluate further potential development of the Company’s existing assets, in order to maximize stockholder value. The Company does not have a defined timeline for the strategic review process and the review may not result in any specific action or transaction.

Third Quarter 2023 Summary Financial Results

Cash and cash equivalents were $38.5 million as of September 30, 2023, compared to $42.4 million as of December 31, 2022. ARCA believes that its current cash and cash equivalents, consisting primarily of money market funds, will be sufficient to fund its operations through the end of 2024.

General and administrative (G&A) expenses were $1.6 million for the quarter ended September 30, 2023, consistent with $1.5 million for the corresponding period in 2022. G&A expenses in 2023 are expected to be consistent with those in 2022 as the Company maintains administrative activities to support our ongoing operations.

Research and development (R&D) expenses were $0.3 million for the quarter ended September 30, 2023, compared to $1.0 million for the corresponding period in 2022, a $0.7 million decrease. R&D personnel costs decreased approximately $0.6 million for the quarter ended September 30, 2023, as compared to the corresponding period in 2022, due to decreased headcount. In July 2022, we implemented a strategic reduction of our workforce by approximately 67%, or 12 employees. Personnel reductions were primarily focused in research and development and general and administrative functions. The restructuring was a result of our decision to manage our operating costs and expenses. During the nine months ended September 30, 2022, we recorded total restructuring charges of approximately $790,000, of which $490,000 and $300,000 were recognized in research and development and general and administrative expenses, respectively, in

connection with the restructuring, all in the form of one-time termination benefits. R&D expenses in 2023 are expected to be lower than 2022.

Total operating expenses for the quarter ended September 30, 2023 were $2.0 million compared to $2.6 million for the third quarter 2022.

Net loss for the quarter ended September 30, 2023 was $1.4 million, or $0.10 per basic and diluted share, compared to $2.3 million, or $0.16 per basic and diluted share in the third quarter of 2022.

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, and 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’s ability to raise sufficient capital on acceptable terms, or at all; the Company’s ability to continue development of Gencaro or rNAPc2 or to otherwise continue operations in the future; the Company’s ability to complete a strategic transaction; results of earlier clinical trials may not be confirmed in future clinical trials; the protection an

EX-99.1

2 abio-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

ARCA biopharma Announces Second Quarter 2023 Financial Results

• Company is currently engaged in a strategic review process, evaluating additional development of its assets, collaborations and other strategic options

Westminster, CO, July 21, 2023 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported second quarter 2023 financial results and provided a corporate update.

In April 2022, the Board of Directors established a Special Committee and, in May 2022, retained Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic options, including transactions involving a merger, sale of all or part of the Company’s assets, or other alternatives with the goal of maximizing stockholder value. The Company and Ladenburg have reviewed several potential strategic transactions and continue to evaluate further potential development of the Company’s existing assets, in order to maximize stockholder value. The Company does not have a defined timeline for the strategic review process and the review may not result in any specific action or transaction.

Second Quarter 2023 Summary Financial Results

Cash and cash equivalents were $40.2 million as of June 30, 2023, compared to $42.4 million as of December 31, 2022. ARCA believes that its current cash and cash equivalents, consisting primarily of money market funds, will be sufficient to fund its operations through the end of 2024.

General and administrative (G&A) expenses were $1.7 million for the quarter ended June 30, 2023, is consisted with $1.7 million for the corresponding period in 2022. G&A expenses in 2023 are expected to be consistent with those in 2022 as the Company maintains administrative activities to support our ongoing operations.

Research and development (R&D) expenses were $0.3 million for the quarter ended June 30, 2023, compared to $1.5 million for the corresponding period in 2022, a $1.2 million decrease. The majority of clinical and manufacturing close out costs related to our rNAPc2 (AB201) international Phase 2b clinical trial were incurred in the first half of 2022, with no comparable costs for the corresponding periods of 2023. R&D personnel costs decreased approximately $0.5 million for the quarter ended June 30, 2023, as compared to the corresponding period in 2022, due to decreased headcount. In July 2022, we implemented a strategic reduction of our workforce by approximately 67%, or 12 employees. Personnel reductions were primarily focused in research and development and general and administrative functions. The restructuring was a result of our decision to manage our operating costs and expenses. During the year ended December 31, 2022, we recorded total restructuring charges of approximately $755,000, of which $470,000 and

$285,000 were recognized in research and development and general and administrative expenses, respectively, in connection with the restructuring, all in the form of one-time termination benefits. R&D expenses in 2023 are expected to be lower than 2022.

Total operating expenses for the quarter ended June 30, 2023 were $2.0 million compared to $3.2 million for the second quarter 2022.

Net loss for the quarter ended June 30, 2023 was $1.5 million, or $0.10 per basic and diluted share, compared to $3.1 million, or $0.22 per basic and diluted share in the second quarter of 2022.

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, and 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’s ability to raise sufficient capital on acceptable terms, or at all; the Company’s ability to continue development of Gencaro or rNAPc2 or to other

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EX-99.1

EX-99

Exhibit 99.1

ARCA biopharma Announces First Quarter 2023 Financial Results

• Company is currently engaged in a strategic review process, evaluating additional development of its assets, collaborations and other strategic options

Westminster, CO, April 24, 2023 – 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 2023 financial results and provided a corporate update.

In April 2022, the Board of Directors established a Special Committee and, in May 2022, retained Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to evaluate strategic options, including transactions involving a merger, sale of all or part of the Company’s assets, or other alternatives with the goal of maximizing stockholder value. The Company and Ladenburg have reviewed several potential strategic transactions and continue to evaluate further potential development of the Company’s existing assets, in order to maximize stockholder value. The Company does not have a defined timeline for the strategic review process and the review may not result in any specific action or transaction.

First Quarter 2023 Summary Financial Results

Cash and cash equivalents were $40.9 million as of March 31, 2022, compared to $42.4 million as of December 31, 2022. ARCA believes that its current cash and cash equivalents, consisting primarily of money market funds, will be sufficient to fund its operations through the middle of 2024.

Research and development (R&D) expenses were $0.4 million for the quarter ended March 31, 2023, compared to $2.2 million for the corresponding period in 2022. The $1.8 million decrease in R&D expenses in 2023 as compared to 2022 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 2023 are expected to be lower than 2022.

General and administrative (G&A) expenses were $1.4 million for the quarter ended March 31, 2023, compared to $1.1 million for the corresponding period in 2022, an increase of approximately $0.3 million. During the quarter ended March 31, 2023, ARCA recorded $159,000 for one-time termination benefits related to the mutually agreed to conclusion of Christopher D. Ozeroff's employment, the former Secretary, Senior Vice President and General Counsel of ARCA, effective March 31, 2023. The increase in expenses was primarily a result of increases in consulting costs and one-time termination benefits discussed above in 2023. G&A expenses in 2023 are expected to be consistent with those in 2022 as the Company maintains administrative activities to support our ongoing operations.

Total operating expenses for the quarter ended March 31, 2023 were $1.8 million compared to $3.3 million for the first quarter 2022.

Net loss for the quarter ended March 31, 2023 was $1.3 million, or $0.09 per basic and diluted share, compared to $3.3 million, or $0.23 per basic and diluted share in the first quarter of 2022.

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 Gencaro or rNAPc2 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 ide

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EX-99

Exhibit 99.1

ARCA biopharma Announces 2022 Financial Results and Provides Corporate Update

• Company is currently engaged in a strategic review process, evaluating additional development of its assets, collaborations and other strategic options

Westminster, CO, February 24, 2023 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported 2022 financial results and provided a corporate update.

In May 2022, the Company retained Ladenburg Thalmann & Co. Inc. to act as its financial advisor to explore and evaluate strategic options for maximizing stockholder value. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. The Board has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction.

Full Year 2022 Summary Financial Results

Cash and cash equivalents were $42.4 million as of December 31, 2022, compared to $53.4 million as of December 31, 2021. ARCA believes that its current cash and cash equivalents, consisting primarily of money market funds, will be sufficient to fund its operations through the middle of 2024.

Research and development (R&D) expenses were $4.7 million for the year ended December 31, 2022, compared to $13.8 million for 2021. In the third quarter of 2022, ARCA implemented a strategic reduction of the workforce and recorded total restructuring charges of approximately $0.8 million, of which $0.5 million and $0.3 million were recognized in research and development and general and administrative expenses, respectively, in connection with the restructuring, all in the form of one-time termination benefits. The $9.1 million decrease in R&D expenses in 2022 as compared to 2021 was primarily related to the completion of enrollment in the rNAPc2 Phase 2b clinical trial in the fourth quarter of 2021, partially offset by the restructuring charges discussed above. R&D expenses in 2023 are expected to be lower than 2022.

General and administrative (G&A) expenses were $5.8 million for the year ended December 31, 2022, compared to $5.5 million for 2021, an increase of approximately $0.3 million. The increase in expenses during 2022 was primarily a result of increases in professional fees and consulting costs and one-time termination benefits discussed above in 2022. G&A expenses in

2023 are expected to be consistent with those in 2022 as the Company maintains administrative activities to support our ongoing operations.

Total operating expenses for the year ended December 31, 2022 were $10.6 million compared to $19.3 million in 2021.

Net loss for the year ended December 31, 2022 was $9.9 million, or $0.69 per basic and diluted share, compared to $19.3 million, or $1.39 per basic and diluted share in 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 Gencaro or rNAPc2 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

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abio-ex991_6.htm

Exhibit 99.1

ARCA biopharma Announces Third 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, October 28, 2022 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported third quarter 2022 financial results and provided a corporate update.

In May 2022, the Company retained Ladenburg Thalmann & Co. Inc. to act as its financial advisor to explore and evaluate strategic options for maximizing stockholder value. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. The Board has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction.

Third Quarter 2022 Summary Financial Results

Cash and cash equivalents were $43.9 million as of September 30, 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 end of 2023. The Company’s review of its strategic options may impact this projection.

Research and development (R&D) expenses were $1.0 million for the quarter ended September 30, 2022, compared to $3.4 million for the corresponding period in 2021. In the third quarter of 2022, ARCA implemented a strategic reduction of the workforce and recorded total restructuring charges of approximately $0.8 million, of which $0.5 million and $0.3 million were recognized in research and development and general and administrative expenses, respectively, in connection with the restructuring, all in the form of one-time termination benefits. The $2.4 million decrease in R&D expenses in the third quarter was primarily related to the completion of enrollment in the rNAPc2 Phase 2b clinical trial in the fourth quarter of 2021, partially offset by the restructuring charges discussed above. R&D expenses in 2022 are expected to be lower than 2021.

General and administrative (G&A) expenses were $1.5 million for the quarter ended September 30, 2022, compared to $1.3 million for the corresponding period in 2021. The $0.2 million increase in G&A expenses was primarily a result of the restructuring charges discussed above. G&A expenses in 2022 are expected to be slightly higher than 2021 as we maintain administrative activities to support our ongoing operations along with the one-time termination benefits recorded in the third quarter 2022.

Total operating expenses for the quarter ended September 30, 2022 were $2.6 million compared to $4.7 million for the third quarter of 2021.

Net loss for the quarter ended September 30, 2022 was $2.3 million, or $0.16 per basic and diluted share, compared to $4.7 million, or $0.33 per basic and diluted share in the third 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 transa

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abio-ex991_6.htm

Exhibit 99.1

ARCA biopharma Announces Second 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, August 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 second 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 May 2022, the Company retained Ladenburg Thalmann & Co. Inc. to act as its financial advisor to explore and evaluate strategic options for maximizing stockholder value. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. The Board has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction.

Second Quarter 2022 Summary Financial Results

Cash and cash equivalents were $46.4 million as of June 30, 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 end of 2023. The Company’s review of its strategic options may impact this projection.

Research and development (R&D) expenses were $1.5 million for the quarter ended June 30, 2022, compared to $3.6 million for the corresponding period in 2021. The $2.1 million decrease in R&D expenses in the second 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 $1.7 million for the quarter ended June 30, 2022, compared to $1.3 million for the corresponding period in 2021. The $0.5 million increase in G&A expenses was primarily a result of increases in professional fees and 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 June 30, 2022 were $3.2 million compared to $4.8 million for the second quarter of 2021.

Net loss for the quarter ended June 30, 2022 was $3.1 million, or $0.22 per basic and diluted share, compared to $4.8 million, or $0.34 per basic and diluted share in the second 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 yea

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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.

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abio-ex991_6.htm

Exhibit 99.1

ARCA biopharma Announces 2021 Financial Results and Provides Corporate Update

•

Topline data from Phase 2b ASPEN-COVID-19 clinical trial evaluating rNAPc2 as a potential treatment for COVID‑19 anticipated in the last week of March 2022

Westminster, CO, March 14, 2022 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported 2021 financial results and provided a corporate update.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “We have completed blinded data collection from the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 and look forward to unblinding and subsequently reporting results of the study in the last week of this month.  We believe rNAPc2 has the potential to be effective in addressing the impact of COVID-19 from multiple pathways due to its combination of anticoagulant, anti-inflammatory and antiviral properties.  We look forward to sharing the data with the FDA at an end of Phase 2 meeting.”

Pipeline Update

rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases.

▪

Topline data from Phase 2b ASPEN-COVID-19 clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 anticipated in the last week of March 2022.

GencaroTM (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

▪

In January 2022, ARCA announced that the paper entitled “Dose Limiting, Adverse Event Associated Bradycardia with β-blocker Treatment of Atrial Fibrillation in the GENETIC-AF Trial” (William Abraham, et al) was published in Heart Rhythm O2, a publication of the Hearth Rhythm Society.  The paper details an analysis that examined the prevalence of bradycardia and its association with adverse events (AEs) and failure to achieve target dose in the GENETIC-AF Phase 2b clinical trial.  In the genetically defined population of GENETIC-AF (all ADRB1 Arg389Arg genotype), the prevalence of clinically important bradycardia was lower for Gencaro compared to metoprolol.

▪

The Company continues to evaluate the feasibility and potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial.

Full Year 2021 Summary Financial Results

Cash and cash equivalents were $53.4 million as of December 31, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents, will be sufficient to fund its operations through the middle of 2023.

Research and development (R&D) expenses were $13.8 million for the year ended December 31, 2021, compared to $5.0 million for 2020. The $8.8 million increase in R&D expenses in 2021 as compared to 2020 was primarily related to the conduct of the rNAPc2 clinical trial.  R&D expenses in 2022 are expected to be consistent with 2021.

General and administrative (G&A) expenses were $5.5 million for the year ended December 31, 2021, compared to $4.8 million for 2020, an increase of approximately $0.7 million. The increase in expenses during 2021 was comprised primarily of increased personnel and insurance costs, offset by lower legal costs in 2021, as compared to 2020.  G&A expenses in 2022 are expected to be consistent with those in 2021 as the Company maintains administrative activities to support our ongoing operations.

Total operating expenses for the year ended December 31, 2021 were $19.3 million compared to $9.8 million in 2020.

Net loss for the year ended December 31, 2021 was $19.3 million, or $1.39 per basic and diluted share, compared to $9.7 million, or $2.07 per basic and diluted share in 2020.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID‑19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetical

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Exhibit 99.1

ARCA biopharma Announces Third Quarter 2021 Financial Results and Provides Corporate Update

•

On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for COVID‑19

•

DSMC interim analysis of safety and efficacy data from ASPEN-COVID-19 completed with recommendation to continue trial to completion with no modifications

•

Topline data anticipated in first quarter of 2022

•

Cash and cash equivalents of $58.3 million at September 30, 2021, sufficient to fund operations through 2022

Westminster, CO, November 2, 2021 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported third quarter 2021 financial results and provided a corporate update.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “The continuing pandemic and the emergence of multiple variants that have led to a resurgence of infections and hospitalizations, highlight the need for additional safe and effective therapeutic tools to treat patients that develop severe COVID-19.  With rNAPc2’s combination of anticoagulant, anti-inflammatory and potential antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients.  Our international Phase 2b clinical trial is nearing completion and we look forward to sharing its results in the first quarter.”

Pipeline Update

rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases.

▪

On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19, enrolling patients at investigative sites in United States, Argentina and Brazil.

▪

Clinical trial Data and Safety Monitoring Committee (DSMC) completed a pre-specified interim analysis and, based on the DSMC’s review of approximately 75% of the projected final efficacy and safety data, recommended completion of the clinical trial with no modifications to the clinical trial design.

▪

Phase 2b topline data anticipated in first quarter of 2022.

GencaroTM (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

▪

ARCA currently has an agreement with the U.S. FDA, known as a Special Protocol Assessment, or SPA, for the requirements of a Gencaro Phase 3 clinical trial, PRECISION-AF, that would support potential approval of Gencaro if successful. The Company is currently evaluating the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.

Third Quarter 2021 Summary Financial Results

Cash and cash equivalents were $58.3 million as of September 30, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.

Research and development (R&D) expenses were $3.4 million for the quarter ended September 30, 2021, compared to $1.1 million for the corresponding period in 2020. The $2.3 million increase in R&D expenses in the third quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020.  R&D expenses in 2021 are expected to be higher than 2020 as the Company continues the rNAPc2 Phase 2b clinical trial.

General and administrative (G&A) expenses were $1.3 million for the quarter ended September 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.4 million increase in G&A expenses was primarily a result of higher personnel costs in 2021.  G&A expenses in the last quarter of 2021 are expected to be consistent with the third quarter of 2021 as the Company maintains administrative activities to support its ongoing operations.

Total operating expenses for the quarter ended September 30, 2021 were $4.7 million compared to $2.0 million for the third quarter of 2020.

Net loss for the quarter ended September 30, 2021 was $4.7 million, or $0.33 per basic and diluted share, compared to $2.0 million, or $0.33 per basic and diluted share for the third quarter of 2020.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for COVID-19 and potentially other viral diseases. The U.S. FDA has

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Exhibit 99.1

ARCA biopharma Announces Second Quarter 2021 Financial Results and Provides Corporate Update

•

Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID‑19 expanded to South America

•

Topline data anticipated in the fourth quarter of  2021

Westminster, CO, August 4, 2021 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported second quarter 2021 financial results and provided a corporate update.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “We continue to be encouraged with the opportunities we see in our development pipeline compounds, rNAPc2 and Gencaro.  With the ASPEN-COVID-19 Phase 2b trial of rNAPc2 expanding to South America, we look forward to completing the trial and we anticipate sharing the results in the fourth quarter.  Given the rate of global vaccination and the continued emergence of variants, along with rNAPc2’s combination of anticoagulant, anti-inflammatory and antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients. For Gencaro, we believe that, if approved, it may be a safe and effective therapy for the treatment of higher ejection fraction heart failure patients with atrial fibrillation and look forward to evaluating it in the planned PRECISION-AF Phase 3 clinical study.”

Pipeline Update

rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.

▪

On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19.

▪

ASPEN-COVID-19 expanding to South America with regulatory clinical trial commencement authorizations in Argentina and Brazil.

▪

Phase 2b topline data anticipated in the fourth quarter of 2021.

▪

In July, the Company entered into a patent assignment agreement with the University Medical Center of Johannes Gutenberg University Mainz, Germany, under which ARCA received exclusive world-wide patent rights related to the use of rNAPc2 as a potential treatment for COVID-19, and other potential indications.

GencaroTM (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

▪

Gencaro Phase 2b data on AF burden and rhythm control interventions was published in Circulation: Arrhythmia and Electrophysiology, a journal of the American Heart Association.  In the Phase 2b superiority clinical trial, although the prespecified primary endpoint was not met, compared with metoprolol, Gencaro reduced AF burden, delayed AF progression, increased maintenance of sinus rhythm, and reduced the need for additional rhythm control interventions in patients with HF and the genotype which responds most favorably to Gencaro.

▪

ARCA currently has an agreement with the U.S. FDA, known as a Special Protocol Assessment, or SPA, for the requirements of a Gencaro Phase 3 clinical trial, PRECISION-AF, that would support potential approval of Gencaro if successful. The Company is currently evaluating the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.

Corporate

▪

The Company added to its executive team with the hiring of Jeff Dekker as Chief Financial Officer and Christopher Graybill as Vice President, Clinical Development.

Second Quarter 2021 Summary Financial Results

Cash and cash equivalents were $63.2 million as of June 30, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.

Research and development (R&D) expenses were $3.6 million for the quarter ended June 30, 2021, compared to $0.4 million for the corresponding period in 2020. The $3.2 million increase in R&D expenses in the second quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020.  R&D expenses in 2021 are expected to be higher than 2020, as the Company continues the rNAPc2 Phase 2b clinical trial.

General and administrative (G&A) expenses were $1.3 million for the quarter ended June 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.3 million increase in G&A expenses was primarily a result of higher personnel costs in 2021.  G&A expenses in the second half of 2021 are expected to

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Exhibit 99.1

ARCA biopharma Announces First Quarter 2021 Financial Results and Provides Corporate Update

•

Topline data from Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID‑19 anticipated in the third quarter of 2021

Westminster, CO, May 11, 2021 – 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 2021 financial results and provided a corporate update.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “We are continuing to advance the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19, actively enrolling patients at 7 clinical trial sites in the United States.  We look forward to sharing the trial results early in the third quarter of this year. We believe rNAPc2’s combination of anticoagulant, anti-inflammatory and antiviral properties, give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways. As a therapeutic aimed at a host response to a disease syndrome, we believe rNAPc2 has therapeutic potential for future viral outbreaks beyond the current pandemic, even after safe and effective vaccines for SARS-CoV-2 are successfully deployed.”

Pipeline Update

rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.

▪

Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 initiated in December 2020.

▪

Currently enrolling patients in ASPEN-COVID-19 at 7 clinical trial sites in the United States.

▪

Phase 2b topline data anticipated early in the third quarter of 2021.

▪

U.S. Food and Drug Administration (FDA) designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program.

GencaroTM (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

▪

In February 2021, ARCA was issued a new patent by the United States Patent and Trademark Office (USPTO) for use of Gencaro in treating AF in patients with HF. The Company believes this patent would provide effective patent coverage in the United States into 2039.  ARCA has filed similar patent applications in other countries.

▪

The Company continues to evaluate the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.

First Quarter 2021 Summary Financial Results

Cash and cash equivalents were $66.9 million as of March 31, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.

Research and development (R&D) expenses were $2.9 million for the quarter ended March 31, 2021, compared to $0.4 million for the corresponding period in 2020. The $2.5 million increase in R&D expenses in the first quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020.  R&D expenses in 2021 are expected to be higher than 2020, as the Company continues the rNAPc2 Phase 2b clinical trial.

General and administrative (G&A) expenses were $1.2 million for the quarter ended March 31, 2021, compared to $1.0 million for the corresponding period in 2020. The $0.3 million increase in G&A expenses was primarily a result of higher personnel costs in 2021.  G&A expenses in 2021 are expected to be consistent with those in 2020 as the Company maintains administrative activities to support its ongoing operations.

Total operating expenses for the quarter ended March 31, 2021 were $4.1 million compared to $1.3 million for the first quarter of 2020.

Net loss for the quarter ended March 31, 2021 was $4.1 million, or $0.33 per basic and diluted share, compared to $1.3 million, or $0.83 per basic and diluted share for the first quarter of 2020.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. The U.S. FDA has granted Fast Track designation to the rNAPc2 development program, currently in Phase 2 clinical testing. ARCA is also developing GencaroTM (bucindolol hydrochlo

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Exhibit 99.1

ARCA biopharma Announces 2020 Financial Results and Provides Corporate Update

•

Topline data from Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for COVID‑19 anticipated in the third quarter of 2021

•

New patent issued by USPTO for use of Gencaro in treating atrial fibrillation in heart failure patients with ejection fractions greater than 40%

Westminster, CO, March 18, 2021 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported 2020 financial results and provided a corporate update.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “We are currently actively enrolling patients in a Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 who are at high risk for thrombotic complications, as indicated by elevated D-dimer levels, which are elevated in nearly 70% of hospitalized COVID-19 patients and are associated with adverse clinical outcomes.  We believe rNAPc2’s combination of anticoagulant, anti-inflammatory and antiviral properties, give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways. We look forward to sharing the trial results in the third quarter of this year. As a therapeutic aimed at a host response to a disease syndrome, we believe rNAPc2 has therapeutic potential for future viral outbreaks beyond the current pandemic, even after safe and effective vaccines for SARS-CoV-2 are successfully deployed.”

Pipeline Update

rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.

▪

Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID‑19 initiated in December 2020.

▪

Phase 2b topline data anticipated in the third quarter of 2021.

▪

U.S. Food and Drug Administration (FDA) designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program.

GencaroTM (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

▪

In February 2021, ARCA was issued a new patent by the United States Patent and Trademark Office (USPTO) for use of Gencaro in treating AF in the HF population that ARCA plans to enroll in Phase 3 development, a population that includes more than half of all HF patients in the United States and Europe and has few approved or effective drug therapies. The Company believes this patent would provide effective patent coverage in the United States into 2039.  ARCA has filed similar patent applications in other countries.

▪

The FDA has issued a Special Protocol Assessment (SPA) agreement for a single Phase 3 clinical trial (PRECISION-AF) to examine Gencaro as a genetically targeted therapy for the prevention of AF recurrence in certain heart failure patients. We continue to evaluate the feasibility and potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial.

Full Year 2020 Summary Financial Results

Cash and cash equivalents were $49.1 million as of December 31, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents, together with the $23.3 million of net proceeds raised through February 2021 from sales of the common stock under the Company’s “at-the-market” offering, will be sufficient to fund its operations through 2022.

Research and development (R&D) expenses were $5.0 million for the year ended December 31, 2020, compared to $1.8 million for 2019. The $3.2 million increase in R&D expenses in 2020 as compared to 2019 was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020.  R&D expenses in 2021 are expected to be higher than 2020, as the Company continues the rNAPc2 Phase 2b clinical trial.

General and administrative (G&A) expenses were $4.8 million for the year ended December 31, 2020, compared to $4.0 million for 2019, an increase of approximately $0.8 million. The increase in expenses during 2020 was comprised primarily of increased legal and professional costs, insurance costs and higher personnel costs in 2020, as compared to 2019.  G&A expenses in 2021 are expected to be consistent with those in 2020 as the Company maintains administrative activities to support our ongoing operations.

Total operating expenses for the year ended December 31, 2020 were $9.8 million compared to $5.8 millio

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Exhibit 99.1

ARCA biopharma Announces Third Quarter 2020 Financial Results and Provides Corporate Update

•

Initiation of Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID‑19 anticipated in fourth quarter

•

Topline data from trial anticipated Q2 2021

Westminster, CO, November 2, 2020 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported financial results for the third quarter of 2020 and provided a corporate update.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “With the resurgence of SARS-CoV-2 across the country and around the globe, the need for effective therapies to treat patients hospitalized with COVID-19 remains an urgent priority. AB201’s combination of anticoagulant, anti-inflammatory and antiviral properties, give it the potential to be effective in addressing the impact of COVID-19 from multiple pathways.   We are working rapidly towards initiating the Phase 2b clinical trial evaluating AB201 as a potential treatment for COVID-19.”

Pipeline Update

AB201 (rNAPc2) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.

▪

Advancing development of AB201 as a potential treatment for patients hospitalized with COVID‑19

▪

U.S. Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for AB201 as a potential treatment for COVID-19

▪

ARCA estimates initiating Phase 2b clinical testing of AB201 in fourth quarter of this year

GencaroTM (bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF). The FDA has issued a Special Protocol Assessment (SPA) agreement for a single Phase 3 clinical trial (PRECISION-AF) to examine Gencaro as a genetically targeted therapy for the prevention of AF recurrence in certain heart failure patients. Initiation of the PRECISION-AF Phase 3 clinical trial is on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. Future development of Gencaro, including initiating any Phase 3 clinical trial, is dependent on obtaining additional financing.

Third Quarter 2020 Summary Financial Results

Cash and cash equivalents were $51.1 million as of September 30, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022, including the projected costs for the AB201 Phase 2b clinical trial.

Research and development (R&D) expense for the three months ended September 30, 2020 was $1.1 million compared to $0.3 million for the corresponding period of 2019, an increase of $0.7 million. R&D expense for the nine months ended September 30, 2020 was $1.8 million compared to $1.4 million for the corresponding period of 2019, an increase of approximately $0.3 million.

Clinical expense increased approximately $0.3 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. Manufacturing process development costs increased approximately $0.2 million for the three and nine months ended September 30, 2020, as compared to the corresponding periods of 2019. The increase in costs were related to initial costs for the AB201 clinical trial, which the Company plans to initiate in the fourth quarter of 2020. The remaining increase is primarily a result of higher outside services and consulting costs.

General and administrative (G&A) expenses were $0.9 million for both the three months ended September 30, 2020 and 2019. G&A expenses were $2.9 million and $3.1 million for the nine months ended September 30, 2020 and 2019, respectively. The $0.2 million decrease was primarily a result of lower personnel costs and lower outside services and consulting costs in 2020.

Total operating expenses for the three months ended September 30, 2020 were $1.9 million compared to $1.2 million for the corresponding period in 2019.  Total operating expenses for the nine months ended September 30, 2020 were $4.6 million compared to $4.5 million for the corresponding period in 2019.

Net loss for the three months ended September 30, 2020 was $2.0 million, or $0.33 per basic and diluted share, compared to $1.2 million, or $0.76 per basic and diluted share, for the corresponding period in 2019.  Net loss for the nine months ended September 30, 2020 was $4.6 million, or $1.46 per basic and diluted share, compared to $4.3 million, or $3.46 per basic and diluted share, for the corresponding period in 2019.

A

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Exhibit 99.1

ARCA Biopharma announces second quarter 2020 financial results AND Provides CorporatE update

•

AB201 being developed as a potential treatment for COVID-19 and other RNA virus associated diseases

•

ARCA anticipates filing an IND for AB201 in Q3 2020 and initiating Phase 2 clinical testing in Q4 2020

Westminster, CO, August 5, 2020 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today reported financial results for the second quarter of 2020 and provided a corporate update.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, “As the SARS-CoV-2 pandemic has progressed, serious complications relating to over-activation of the coagulation and immune systems have increasingly been observed in patients hospitalized with severe disease. Based on previous and emerging work on mechanisms of virus pathogenesis, we believe this evidence implicates involvement of tissue factor pathways, of which AB201 is a potent and long-acting inhibitor, providing a strong rationale to evaluate AB201 as a potential therapeutic for COVID-19.  With this rationale along with significant safety data from prior human clinical trials, we look forward to initiating Phase 2 clinical development later this year.”

Pipeline Update

AB201 (rNAPc2) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.

▪

Initiated planning for development of AB201 as a potential treatment for patients with severe COVID‑19.

▪

Clinical collaboration established with the Colorado Prevention Center, the University of Colorado's Academic Research Organization.

▪

The Company anticipates filing an Investigational New Drug (IND) application for AB201 as a potential treatment for COVID-19 with the U.S. Food and Drug Administration (FDA) in third quarter of this year.

▪

Pending FDA concurrence, ARCA estimates initiating Phase 2 clinical testing of AB201 in the fourth quarter of this year.

GencaroTM (bucindolol hydrochloride) - a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF).

▪

Initiation of the PRECISION-AF Phase 3 clinical trial is on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. ARCA estimates that enrollment in PRECISION-AF could start in 2021; however, this estimate is subject to change due to the uncertainties of the ongoing COVID-19 pandemic and the availability of patients for non-COVID-19 related clinical trials.  Any future development of Gencaro, including initiating any Phase 3 clinical trial, is dependent on obtaining additional financing.

▪

The FDA has issued a Special Protocol Assessment (SPA) agreement for a single Phase 3 clinical trial (PRECISION-AF) to examine Gencaro as a genetically targeted therapy for the prevention of AF recurrence in certain heart failure patients.

Second Quarter 2020 Summary Financial Results

Cash and cash equivalents were $11.0 million as of June 30, 2020, compared to $8.4 million as of December 31, 2019. ARCA believes that its current cash and cash equivalents, together with net proceeds of $24.1 million raised in July from sales of its common stock, will be sufficient to fund its operations, at its current cost structure, plus projected costs for the AB201 clinical development program, through the end of the fourth quarter of 2021.

Research and development (R&D) expense for the three months ended June 30, 2020 was $0.4 million compared to $0.4 million for the corresponding period of 2019, a decrease of approximately $68,000. R&D expense for the six months ended June 30, 2020 was $0.7 million compared to $1.1 million for the corresponding period of 2019, a decrease of approximately $0.4 million.

R&D personnel costs decreased approximately $0.1 million for the three months ended June 30, 2020, as compared to the corresponding period of 2019. R&D personnel costs decreased approximately $0.3 million for the six months ended June 30, 2020, as compared to the corresponding period of 2019. The remaining decrease is primarily a result of lower outside services and consulting costs.

General and administrative (G&A) expenses were $0.9 million and $1.1 million for the three months ended June 30, 2020 and 2019, respectively. The $0.1 million decrease was primarily a result of lower personnel costs and lower outside services and consulting costs in 2020. G&A expenses were $1.9 million and $2.2 million for the six months ended June 30, 2020 and 2019, respectively. The $0.3 million decrease was primarily a result of lower personnel co