What changed in this filing

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Item 1. Financial Statements

2021-08-04 compared with 2021-05-11 · 52 added, 38 removed, 252 unchanged (26% of the section changed)

22 unchanged sentences

100 million shares authorized

at March 31, 2021 and December 31, 2020;

at June 30, 2021 and December 31, 2020;

and 9,548,150 shares issued and outstanding at

March 31, 2021 and December 31, 2020, respectively

June 30, 2021 and December 31, 2020, respectively

Additional paid-in capital

6 unchanged sentences

Three Months Ended

(in thousands, except share

and per share amounts)

Six Months Ended

(in thousands, except share and per share amounts)

Costs and expenses:

5 unchanged sentences

Interest expense

Loss before income taxes

Income tax benefit

Net loss per share:

27 unchanged sentences

Balance, March 31, 2021

Share-based compensation

Balance, June 30, 2021

See accompanying Notes to Financial Statements

1 unchanged sentence

STATEMENTS OF CASH FLOWS

Three Months Ended

Six Months Ended

(in thousands)

16 unchanged sentences

Common stock offering costs

Repayment of principal on vendor finance agreement

Net cash provided by financing activities

Net increase (decrease) in cash and cash equivalents

Net increase in cash and cash equivalents

Cash and cash equivalents, beginning of period

5 unchanged sentences

transactions:

Purchases of property and equipment in accounts payable

Vendor finance agreement

Leased assets obtained in exchange for operating lease liabilities

Purchases of property and equipment in accounts payable and accrued liabilities

Vendor finance agreement

Common stock offering costs accrued but not yet paid

See accompanying Notes to Financial Statements

11 unchanged sentences

The Company continues to evaluate the feasibility and potential timing for initiating PRECISION-AF relative to the COVID-19 pandemic and prioritizing the development of rNAPc2.

The Company’s other product candidate, AB171, is a thiol-substituted isosorbide mononitrate, which ARCA plans to develop as a genetically-targeted treatment for HF and peripheral arterial disease.

The Company’s other product candidate, AB171, is a thiol-substituted isosorbide mononitrate, which the Company believes could be developed as a genetically-targeted treatment for HF and peripheral arterial disease.

In March 2020, the World Health Organization declared the outbreak of COVID-19, a novel strain of Coronavirus, a global pandemic.

3 unchanged sentences

Liquidity and Going Concern

The Company devotes substantially all of its efforts towards obtaining regulatory approval and raising capital necessary to fund its operations and it is subject to a number of risks associated with clinical research and development, including dependence on key individuals, the development of and regulatory approval of commercially viable products, the need to raise adequate additional financing necessary to fund the development and commercialization of its products, and competition from larger companies.

The Company has not generated revenue to date and has incurred substantial losses and negative cash flows from operations since its inception.

The Company devotes substantially all of its efforts towards clinical research and development, obtaining regulatory approval and raising capital necessary to fund its operations and it is subject to a number of risks associated with clinical research and development, including dependence on key individuals, the development of and regulatory approval of commercially viable products, the need to raise adequate additional financing necessary to fund the development and commercialization of its products, and competition from larger companies.

The Company has no t generated revenue to date and has incurred substantial losses and negative cash flows from operations since its inception.

The Company has historically funded its operations through issuances of common and preferred stock.

The Company believes that its current cash and cash equivalents as of March 31, 2021 will be sufficient to fund its operations through the end of fiscal year 2022.

The Company believes that its current cash and cash equivalents as of June 30, 2021 will be sufficient to fund its operations through the end of fiscal year 2022.

Conducting a Phase 3 rNAPc2 clinical trial or the Phase 3 PRECISION-AF trial would likely require additional financing .

18 unchanged sentences

In the opinion of management, these financial statements include all normal and recurring adjustments considered necessary for a fair presentation of these interim financial statements.

The results of operations for the three months ended March 31, 2021 are not necessarily indicative of results expected for the full year ending December 31, 2021.

The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of results expected for the full year ending December 31, 2021.

The Company has generated no revenue to date and its activities have consisted of seeking regulatory approval, research and development, exploring strategic alternatives for further developing and commercializing rNAPc2 and Gencaro, and raising capital.

9 unchanged sentences

If the Company had comprehensive gains (losses), they would be reflected in the statement of operations and comprehensive loss and as a separate component in the statement of stockholders’ equity.

There were no elements of comprehensive loss during the three months ended March 31, 2021 and 2020.

There were no elements of comprehensive loss during the three and six months ended June 30, 2021 and 2020.

The Company determines if an arrangement is a lease at inception.

Operating leases are included in right-of-use (ROU) asset – operating and lease obligations are included in accrued expenses and other liabilities and operating lease liability on the Company’s March 31, 2021 and December 31, 2020 balance sheets.

Operating leases are included in right-of-use (ROU) asset – operating and lease obligations are included in accrued expenses and other liabilities and operating lease liability on the Company’s June 30, 2021 and December 31, 2020 balance sheets.

ROU lease assets represent the Company’s right to use an underlying asset for the lease term and lease obligations represent the Company’s obligation to make lease payments arising from the lease.

Operating ROU lease assets are recognized at the commencement date based on the present value of lease payments over the lease term.

As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments.

The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.

As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments.

The Company’s lease terms may include options to extend or terminate a lease when it is reasonably certain that the Company will exercise that option.

Lease expense for lease payments is recognized on a straight-line basis over the lease term.

10 unchanged sentences

The Company’s potentially dilutive shares include stock options and warrants for common stock .

Because the Company reported a net loss for the three months ended March 31, 2021 and 2020, all potentially dilutive shares of common stock have been excluded from the computation of the dilutive net loss per share for all periods presented.

Because the Company reported a net loss for the three and six months ended June 30, 2021 and 2020, all potentially dilutive shares of common stock have been excluded from the computation of the dilutive net loss per share for all periods presented.

Such potentially dilutive shares of common stock consist of the following:

3 unchanged sentences

(3) Fair Value Disclosures

There were no marketable securities as of March 31, 2021 or December 31, 2020.

There were no marketable securities as of June 30, 2021 or December 31, 2020.

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price).

9 unchanged sentences

The Company does not have any Level 3 assets or liabilities.

As of March 31, 2021 and December 31, 2020, the Company had $66.9 million and $49.1 million, respectively, of cash equivalents consisting of money market funds with original maturities of 90 days or less.

As of June 30, 2021 and December 31, 2020, the Company had $ 63.1 million and $ 49.1 million, respectively, of cash equivalents consisting of money market funds with original maturities of 90 days or less.

The Company has the ability to liquidate these investments without restriction.

The Company determines fair value for these money market funds with Level 1 inputs through quoted market prices.

There were no transfers of assets between fair value hierarchy levels during the three-month period ended March 31, 2021.

There were no transfers of assets between fair value hierarchy levels during the six-month period ended June 30, 2021.

Fair Value of Other Financial Instruments

3 unchanged sentences

Estimated Life

March 31, 2021

Computer equipment

4 unchanged sentences

Property and equipment, net

For the three months ended March 31, 2021 and 2020, depreciation and amortization expense was $3,000 and $3,000, respectively.

For the six months ended June 30, 2021 and 2020, depreciation and amortization expense was $ 6,000 and $ 4,000 , respectively.

(5) Related Party Arrangements

2 unchanged sentences

Funding of any unrestricted research grants is contingent upon the Company’s financial condition, and can be deferred or terminated at the Company’s discretion.

Total expense under these arrangements for the three months ended March 31, 2021 and 2020 was $107,000 and $70,000 respectively.

Total expense under these arrangements for the six months ended June 30, 2021 and 2020 was $ 223,000 and $ 141,000 respectively.

(6) Commitments and Contingencies

4 unchanged sentences

Certain of these agreements also provide for payments to be made under certain conditions related to a change in control of the Company.

Operating Lease

Operating Leases

On August 1, 2013 the Company entered into a lease agreement for approximately 5,300 square feet of office facilities in Westminster, Colorado which served as the Company’s primary business office from October 1, 2013 until September 30, 2020.

3 unchanged sentences

The amounts recorded assume the Company will exercise its renewal option.

The lease includes real estate taxes and insurance, which is not a lease component and is not included in the lease obligation.

In June 2021, the Company entered into a sublease agreement for approximately 3,000 square feet of additional office facilities in the Company’s primary business office (2021 Lease).

The sublease term is 29 months beginning June 2021, with no renewal option.

The leases include real estate taxes and insurance, which is not a lease component and is not included in the lease obligation.

In addition, common area maintenance charges are based on actual costs incurred and are a non-lease component that is not included in the lease obligation.

Future minimum commitments due under the October 2020 Lease agreement as of March 31, 2021 are as follows (in thousands):

Future minimum commitments due under the October 2020 and 2021 Lease agreements as of June 30, 2021 are as follows (in thousands):

Remainder of 2021

3 unchanged sentences

Operating lease liability, net of current portion

Rent expense, which is included in general and administrative expense, for the three months ended March 31, 2021 and 2020 was $22,000 and $23,000, respectively.

As of March 31, 2021, the lease liability was $450,000, and the current portion is included in accrued expenses and other liabilities and the non-current portion is in operating lease liability, net of current portion in the accompanying balance sheet.

Cash paid for amounts included in the measurement of lease liabilities and the operating cash flows from operating leases for the three months ended March 31, 2021 and 2020 were $7,000 and $25,000, respectively.

The weighted-average remaining lease term for the operating lease as of March 31, 2021 is 6.0 years.

Rent expense, which is included in general and administrative expense, for the six months ended June 30, 2021 and 2020 was $ 47,000 and $ 48,000 , respectively.

As of June 30, 2021, the lease liability was $ 522,000 , and the current portion is included in accrued expenses and other liabilities and the non-current portion is in operating lease liability, net of current portion in the accompanying balance sheet.

Cash paid for amounts included in the measurement of lease liabilities and the operating cash flows from operating leases for the six months ended June 30, 2021 and 2020 were $ 29,000 and $ 51,000 , respectively.

The weighted-average remaining lease term for the operating lease as of June 30, 2021 is 5.2 years.

The discount rate for the operating lease is 7 %.

19 unchanged sentences

On July 22, 2020, the Company entered into a new Capital on Demand TM Sales Agreement (the 2020 Sales Agreement) with JonesTrading, pursuant to which the Company may offer and sell, from time to time through JonesTrading, shares of the Company’s Common Stock, having an aggregate offering price of up to $ 54.0 million.

During the three months ended March 31, 2021 and the year ended December 31, 2020, the Company had sold an aggregate of 4,861,993 and 5,066,279 shares of its Common Stock pursuant to the terms of the 2020 Sales Agreement for net proceeds of approximately $23.3 million and $28.9 million, respectively, after deducting expenses for executing the “at the market offering” and commissions paid to the placement agent.

During the six months ended June 30, 2021 and the year ended December 31, 2020, the Company had sold an aggregate of 4,861,993 and 5,066,279 shares of its Common Stock pursuant to the terms of the 2020 Sales Agreement for net proceeds of approximately $ 23.3 million and $ 28.9 million, respectively, after deducting expenses for executing the “at the market offering” and commissions paid to the placement agent.

In April 2021, the Company amended the 2020 Sales Agreement and has $ 50.0 million available for the offering under its prospectus to the Company’s registration statement on Form S-3 (No.

1 unchanged sentence

All outstanding warrants were recorded in additional paid-in capital at their estimated fair market value at the date of grant using a Black-Scholes option-pricing model.

As of March 31 , 202 1 , these warrants, by year of expiration, are summarized below:

As of June 30, 2021, these warrants, by year of expiration, are summarized below:

Year of Expiration

2 unchanged sentences

(8) Share-based Compensation

For the three month periods ended March 31, 2021 and 2020, the Company recognized the following non-cash, share-based compensation expense in the statements of operations (in thousands):

Ended March 31,

For the three and six month periods ended June 30, 2021 and 2020, the Company recognized the following non-cash, share-based compensation expense in the statements of operations (in thousands):

Ended June 30,

Research and development

General and administrative

Stock option transactions for the three month period ended March 31, 2021 under the Company’s stock incentive plans were as follows:

Stock option transactions for the six month period ended June 30, 2021 under the Company’s stock incentive plans were as follows:

Weighted Average Exercise Price

1 unchanged sentence

Forfeited and cancelled

Options outstanding at March 31, 2021

Options exercisable at March 31, 2021

Options outstanding at June 30, 2021

Options exercisable at June 30, 2021

Options vested and expected to vest

4 unchanged sentences

The Company believes its tax filing positions and deductions related to tax periods subject to examination will be sustained upon audit and, therefore, has no reserve for uncertain tax positions.

(10) Subsequent Event

In July 2021, the Company entered into a patent assignment agreement (the Agreement) with the University Medical Center of Johannes Gutenberg University Mainz , Germany.

Under the terms of the Agreement, the Company received exclusive world-wide patent rights relating to the use of rNAPc2 as a potential treatment for COVID-19, and other indications, based on the research and discoveries from Univ.-Prof.

Wolfram Ruf, the Scientific Director and Alexander von Humboldt Professor at the Center for Thrombosis and Hemostasis (CTH) of the University Medical Center Mainz, and his collaborators.

The Company has upfront and potential milestone obligations to the University Medical Center Mainz that could total approximately € 1.6 million and royalty obligations in the low single digit range, if rNAPc2 receives regulatory approval and is commercialized.

The term of the Agreement extends to the date of expiration of the last to expire of any of the assigned patents.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements