What changed in this filing

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Item 1. Financial Statements

2022-05-02 compared with 2021-11-02 · 47 added, 84 removed, 231 unchanged (36% of the section changed)

2 unchanged sentences

BALANCE SHEETS

September 30,

(in thousands, except share

18 unchanged sentences

100 million shares authorized

at September 30, 2021 and December 31, 2020;

and 9,548,150 shares issued and outstanding at

September 30, 2021 and December 31, 2020, respectively

at March 31, 2022 and December 31, 2021;

shares issued and outstanding at

March 31, 2022 and December 31, 2021

Additional paid-in capital

6 unchanged sentences

Three Months Ended

Nine Months Ended

September 30,

(in thousands, except share and per share amounts)

(in thousands, except share

and per share amounts)

Costs and expenses:

4 unchanged sentences

Interest and other income

Interest expense

Loss before income taxes

Income tax benefit

Net loss per share:

8 unchanged sentences

Balance, December 31, 2020

Issuance of common stock for cash,

net of offering costs

Share-based compensation

Balance, March 31, 2021

Issuance of common stock and exercise

of prefunded warrants for cash,

net of offering costs

Share-based compensation

Balance, June 30, 2021

Issuance of common stock for cash,

net of offering costs

Share-based compensation

Balance, September 30, 2021

Issuance of common stock for cash,

net of offering costs

Share-based compensation

Balance, December 31, 2021

Issuance of common stock for cash,

net of offering costs

Share-based compensation

Balance, March 31, 2022

Share-based compensation

Balance, June 30, 2021

Share-based compensation

Balance, September 30, 2021

See accompanying Notes to Financial Statements

1 unchanged sentence

STATEMENTS OF CASH FLOWS

Nine Months Ended

September 30,

Three Months Ended

(in thousands)

4 unchanged sentences

Share-based compensation

Loss from disposal of property and equipment

Change in operating assets and liabilities:

10 unchanged sentences

Common stock offering costs

Repayment of principal on vendor finance agreement

Net cash provided by financing activities

Net increase in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

Cash and cash equivalents, beginning of period

5 unchanged sentences

transactions:

Leased assets obtained in exchange for operating lease liabilities

Purchases of property and equipment in accrued liabilities

Vendor finance agreement

Common stock offering costs accrued but not yet paid

Proceeds receivable from the issuance of common stock

See accompanying Notes to Financial Statements

7 unchanged sentences

The Company’s lead product candidates are rNAPc2 (AB201) as a potential treatment for COVID-19, the disease caused by SARS-CoV-2 virus, and potentially other viral diseases and Gencaro™ (bucindolol hydrochloride) for the treatment of atrial fibrillation (AF) in patients with chronic heart failure (HF).

rNAPc2 is a protein therapeutic in clinical development as a potential treatment for patients hospitalized with COVID-19.

Based on its unique mechanism of action, development history and the clinical evidence from the SARS‑CoV-2 pandemic, the Company believes rNAPc2 has potential to be a beneficial therapy for patients with this serious viral disease.

The Company initiated the Phase 2b clinical trial of rNAPc2 as a potential treatment for patients hospitalized with COVID-19 in the fourth quarter of 2020.

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 the Company believes could be developed as a genetically-targeted treatment for HF and peripheral arterial disease.

In April 2022, the Board of Directors established a Special Committee to evaluate strategic options, including transactions involving the merger or sale of all or part of the Company’s assets, and other alternatives with the goal of maximizing 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 .

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

6 unchanged sentences

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 September 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 .

However, changing circumstances may cause us to consume capital significantly faster or slower than currently anticipated.

The Company believes that its current cash and cash equivalents as of March 31, 2022 will be sufficient to fund its operations at the current levels through at least the middle of fiscal year 2023.

The Company’s review of its strategic options may impact this projection.

Changing circumstances may cause us to consume capital significantly faster or slower than currently anticipated.

The Company has based these estimates on assumptions that may prove to be wrong, and the Company could exhaust its available financial resources sooner than the Company currently anticipates.

16 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 and nine months ended September 30, 2021 are not necessarily indicative of results expected for the full year ending December 31, 2021.

The results of operations for the three months ended March 31, 2022 are not necessarily indicative of results expected for the full year ending December 31, 2022.

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 and nine months ended September 30, 2021 and 2020.

There were no elements of comprehensive loss during the three months ended March 31, 2022 and 2021.

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 September 30, 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 March 31, 2022 and December 31, 2021 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.

14 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 and nine months ended September 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.

Because the Company reported a net loss for the three months ended March 31, 2022 and 2021, 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:

September 30,

Potentially dilutive securities, excluded:

2 unchanged sentences

(3) Fair Value Disclosures

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

There were no marketable securities as of March 31, 2022 or December 31, 2021.

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 September 30, 2021 and December 31, 2020, the Company had $ 58.2 million and $ 49.1 million, respectively, of cash equivalents consisting of money market funds with original maturities of 90 days or less.

As of March 31, 2022 and December 31, 2021, the Company had $ 49.1 million and $ 53.3 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 nine-month period ended September 30, 2021.

There were no transfers of assets between fair value hierarchy levels during the three-month period ended March 31, 2022.

Fair Value of Other Financial Instruments

3 unchanged sentences

Estimated Life

September 30,

March 31, 2022

Computer equipment

4 unchanged sentences

Property and equipment, net

For the nine months ended September 30, 2021 and 2020, depreciation and amortization expense was $ 11,000 and $ 6,000 , respectively.

For the three months ended March 31, 2022 and 2021, depreciation and amortization expense was $ 5,000 and $ 3,000 , 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 nine months ended September 30, 2021 and 2020 was $ 331,000 and $ 248,000 respectively.

Total expense under these arrangements for the three months ended March 31, 2022 and 2021 was $ 108,000 and $ 107,000 respectively.

(6) Commitments and Contingencies

5 unchanged sentences

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.

On August 29, 2020 the Company entered into a lease agreement for approximately 5,200 square feet of office facilities in Westminster, Colorado which serves as the Company’s primary business office effective October 1, 2020 (October 2020 Lease).

6 unchanged sentences

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 and 2021 Lease agreements as of September 30, 2021 are as follows (in thousands):

Future minimum commitments due under the October 2020 and 2021 Lease agreements as of March 31, 2022 are as follows (in thousands):

Remainder of 2022

3 unchanged sentences

Operating lease liability, net of current portion

Rent expense, which is included in general and administrative expense, for the nine months ended September 30, 2021 and 2020 was $ 78,000 and $ 73,000 , respectively.

As of September 30, 2021, the lease liability was $ 507,000 , 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 nine months ended September 30, 2021 and 2020 were $ 52,000 and $ 76,000 , respectively.

The weighted-average remaining lease term for the operating lease as of September 30, 2021 is 5.0 years.

Rent expense, which is included in general and administrative expense, for the three months ended March 31, 2022 and 2021 was $ 31,000 and $ 22,000 , respectively.

As of March 31, 2022, the lease liability was $ 460,000 , 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, 2022 and 2021 were $ 32,000 and $ 7,000 , respectively.

The weighted-average remaining lease term for the operating lease as of March 31, 2022 is 4.5 years.

The discount rate for the operating lease is 7 %.

3 unchanged sentences

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.

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.

(7) Equity Financings and Warrants

Registered Direct Financing

On June 3, 2020, the Company closed a registered direct offering with certain institutional and accredited investors of 348,000 shares of the Company’s common stock, at a purchase price of $ 9.00 per share, and pre-funded warrants to purchase 325,500 shares of common stock at a purchase price of $ 8.999 per warrant.

All warrants were exercised by the closing date.

The net proceeds were approximately $ 5.3 million, after deducting placement agent fees and other offering expenses.

The Company paid JonesTrading a placement agent fee equal to 8.0 % of the aggregate gross proceeds and agreed to provide JonesTrading with customary indemnification and contribution rights.

At the Market Equity Financing

On January 11, 2017, the Company entered into a Capital on Demand TM Sales Agreement (the Sales Agreement) with JonesTrading Institutional Services LLC, as agent (JonesTrading), pursuant to which the Company may offer and sell, from time to time through JonesTrading, shares of the Company’s common stock, par value $ 0.001 per share (the Common Stock), having an aggregate offering price of up to $ 7.3 million.

On August 21, 2017, January 25, 2019, March 11, 2019, May 9, 2019, May 20, 2019, June 28, 2019, July 2, 2020 and July 14, 2020, the Company amended its Capital on Demand Sales Agreement.

The amendments, among other things, increased the maximum aggregate offering value of shares of the Company’s common stock which the Company may issue and sell from time to time under the Sales Agreement from $7.3 million to $ 32.4 million (the Shares).

Under the amended Sales Agreement, JonesTrading may sell the Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market, on any other existing trading market for the Common Stock or to or through a market maker.

On July 22, 2020, the Company entered into a Capital on Demand TM Sales Agreement (the Sales Agreement) with JonesTrading Institutional Services LLC, as agent (JonesTrading), pursuant to which the Company may offer and sell, from time to time through JonesTrading, shares of the Company’s common stock, par value $ 0.001 per share (the Common Stock), having an aggregate offering price of up to $ 54.0 million (the Shares).

Under the Sales Agreement, JonesTrading may sell the Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market, on any other existing trading market for the Common Stock or to or through a market maker.

In addition, under the amended Sales Agreement, JonesTrading may sell the Shares by any other method permitted by law, including in negotiated transactions.

The Company may instruct JonesTrading not to sell Shares if the sales cannot be effected at or above the price designated by the Company from time to time.

The Company is not obligated to make any sales of the Shares under the amended Sales Agreement.

The offering of Shares pursuant to the amended Sales Agreement will terminate upon the earlier of (a) the sale of all of the Shares subject to the amended Sales Agreement or (b) the termination of the amended Sales Agreement by JonesTrading or the Company, as permitted therein.

The Company is not obligated to make any sales of the Shares under the Sales Agreement.

The offering of Shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by JonesTrading or the Company, as permitted therein.

The Company paid JonesTrading a commission rate equal to 3.0 % of the aggregate gross proceeds from each sale of Shares and agreed to provide JonesTrading with customary indemnification and contribution rights.

The Company will also reimburse JonesTrading for certain specified expenses in connection with entering into and amending the Sales Agreement.

Under the amended Sales Agreement, the Company sold an aggregate of 2,214,301 shares of Common Stock, for net proceeds of approximately $ 14.4 million, during the year ended December 31, 2020, including initial expenses for executing the “at the market offering” and commissions to the placement agent.

This sales agreement terminated in July 2020.

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 nine months ended September 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.

The Company will also reimburse JonesTrading for certain specified expenses in connection with entering into the Sales Agreement.

No sales were made in 2022.

During the year ended December 31, 2021, the Company had sold an aggregate of 4,861,993 shares of its Common Stock pursuant to the terms of the Sales Agreement for net proceeds of approximately $ 23.3 million, 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 the amount available for the offering under its prospectus to the Company’s registration statement on Form S-3 (No.

The amount available for the offering under the prospectus supplement is subject to the limitation of not selling a total value amount of shares exceeding more than one-third of the Company’s public float in any 12-month period.

Warrants to purchase shares of common stock were previously granted as part of various financing and business agreements.

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

As of March 31, 2022, these warrants, by year of expiration, are summarized below:

Year of Expiration

2 unchanged sentences

(8) Share-based Compensation

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

Three Months Ended

September 30,

Nine Months Ended

September 30,

For the three month periods ended March 31, 2022 and 2021, the Company recognized the following non-cash, share-based compensation expense in the statements of operations (in thousands):

Ended March 31,

Research and development

General and administrative

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

Stock option transactions for the three month period ended March 31, 2022 under the Company’s stock incentive plans were as follows:

Weighted Average Exercise Price

1 unchanged sentence

Forfeited and cancelled

Options outstanding at September 30, 2021

Options exercisable at September 30, 2021

Options outstanding at March 31, 2022

Options exercisable at March 31, 2022

Options vested and expected to vest

5 unchanged sentences

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