QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
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(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
☒ | Smaller reporting company | |||||
Emerging growth company |
Page |
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PART I. |
1 |
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Item 1. |
1 |
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1 |
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2 |
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3 |
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4 |
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5 |
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Item 2. |
14 |
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Item 3. |
20 |
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Item 4. |
21 |
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PART II. |
22 |
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Item 1. |
22 |
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Item 1A. |
22 |
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Item 2. |
22 |
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Item 3. |
22 |
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Item 4. |
23 |
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Item 5. |
23 |
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Item 6. |
23 |
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25 |
• |
the sufficiency of our existing cash and cash equivalents and marketable securities to fund our future operating expenses and capital expenditure requirements; |
• |
our ability to obtain funding for our operations, including funding necessary to develop and commercialize ACU193, subject to necessary regulatory approvals; |
• |
the ability of our clinical trials to demonstrate the safety and efficacy of ACU193, and other positive results; |
• |
the therapeutic potential of ACU193, including its potential for improved safety and efficacy, as compared to other monoclonal antibodies approved and or in development, as well as the expectations concerning the INTERCEPT-AD trial; |
• |
the success, cost and timing of our development activities, nonclinical studies and clinical trials; |
• |
the timing and focus of our future clinical trials, and the reporting of data from those trials; |
• |
our plans relating to commercializing ACU193, subject to obtaining necessary regulatory approvals; |
• |
our ability to attract and retain key scientific and clinical personnel; |
• |
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
• |
our reliance on third parties to conduct clinical trials of ACU193, and for the manufacture of ACU193 for nonclinical studies and clinical trials; |
• |
the success of competing therapies that are or may become available; |
• |
our plans and ability to obtain or protect our intellectual property rights, including extensions of existing patent terms where available or the use of data market exclusivity to provide protection from generic or biosimilar versions of our product; |
• |
the scope of protection we are able to establish and maintain for intellectual property rights covering ACU193 and technology; |
• |
potential claims relating to our intellectual property; |
• |
existing regulations and regulatory developments in the United States and other jurisdictions; |
• |
unfavorable conditions in our industry, the global economy, including inflation and financial and credit market fluctuations, or the global supply chain, including as a result of geopolitical events such as the ongoing military conflict between Russia and Ukraine and related sanctions against Russia; |
• |
our ability to obtain and maintain regulatory approval of ACU193, and any related restrictions, limitations and/or warnings in the label of any approved product candidate; |
• |
our plans relating to the further development and manufacturing of ACU193, including additional therapeutic indications which we may pursue; |
• |
our ability to develop and maintain our corporate infrastructure, including our ability to design and maintain an effective system of internal controls; |
• |
our financial performance; |
• |
the effects of the ongoing COVID-19 pandemic, geopolitical events such as the pending conflict with Russia and Ukraine; and |
• |
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act. |
March 31, 2022 |
December 31, 2021 |
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(unaudited) |
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ASSETS |
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Current assets |
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Cash and cash equivalents |
$ | $ | ||||||
Marketable securities, short-term |
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Prepaid expenses and other current assets |
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Total current assets |
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Marketable securities, long-term |
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Property and equipment, net |
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Right-of-use |
— | |||||||
Other assets |
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Total assets |
$ | $ | ||||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
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Accounts payable |
$ | $ | ||||||
Accrued expenses and other current liabilities |
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Operating lease liability, current portion |
— | |||||||
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Total current liabilities |
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Operating lease liability, net of current portion |
— | |||||||
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Total liabilities |
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Commitments and contingencies (Note 9 ) |
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Stockholders’ equity |
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Preferred stock, $ 1 |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
( |
) | ( |
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Accumulated other comprehensive loss |
( |
) | ( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | $ | ||||||
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Three Months Ended March 31, |
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2022 |
2021 |
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Operating expenses |
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Research and development |
$ | $ | ||||||
General and administrative |
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Total operating expenses |
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Loss from operations |
( |
) | ( |
) | ||||
Other income (expense) |
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Interest income, net |
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Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability |
— | ( |
) | |||||
Other income, net |
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Total other income (expense) |
( |
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Net loss |
( |
) | ( |
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Other comprehensive loss |
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Unrealized loss on marketable securities |
( |
) | — | |||||
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Comprehensive loss |
$ | ( |
) | $ | ( |
) | ||
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Net loss per common share, basic and diluted |
$ | ( |
) | $ | ( |
) | ||
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Weighted-average shares outstanding, basic and diluted |
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Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Loss |
Total Stockholders’ Equity |
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Shares |
Amount |
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Balance as of December 31, 2021 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
Unrealized loss on marketable securities |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||
Share-based compensation |
— | — | — | — | ||||||||||||||||||||
Net loss |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||
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Balance as of March 31, 2022 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
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Series A |
Series A-1 |
Series B |
Additional Paid-in Capital |
Accumulated Deficit |
Total Stockholders’ Deficit |
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Convertible Preferred Stock |
Convertible Preferred Stock |
Convertible Preferred Stock |
Common Stock |
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Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
Shares |
Amount |
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Balance as of December 31, 2020 |
$ | $ | $ | $ | — | $ | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||||||||||||
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Balance as of March 31, 2021 |
$ | $ | $ | $ | — | $ | $ | ( |
) | $ | ( |
) | ||||||||||||||||||||||||||||||||||||
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Three Months Ended March 31, |
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2022 |
2021 |
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Cash flows from operating activities |
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Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
— | |||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability |
— | |||||||
Stock-based compensation expense |
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Amortization of premiums and accretion of discounts on marketable securities, net |
— | |||||||
Amortization of right-of-use |
— | |||||||
Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
( |
) | ||||||
Other assets |
( |
) | ( |
) | ||||
Accounts payable |
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Operating lease liability |
( |
) | — | |||||
Accrued expenses and other current liabilities |
( |
) | ||||||
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Net cash used in operating activities |
( |
) | ( |
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Cash flows from investing activities |
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Purchases of marketable securities |
( |
) | — | |||||
Proceeds from maturities and sales of marketable securities |
— | |||||||
Purchases of property and equipment |
( |
) | — | |||||
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Net cash used in investing activities |
( |
) | — | |||||
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Net change in cash and cash equivalents |
( |
) | ( |
) | ||||
Cash and cash equivalents at the beginning of the period |
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Cash and cash equivalents at the end of the period |
$ | $ | ||||||
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Supplemental disclosure of cash flow information |
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Cash paid for income taxes |
$ | — | $ | — | ||||
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Cash paid for interest |
$ | — | $ | — | ||||
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Supplemental disclosure of noncash investing and financing activities |
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Purchases of property and equipment in accounts payable |
$ | $ | — | |||||
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Deferred offering costs in accrued expenses and other current liabilities |
$ | — | $ | |||||
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March 31, 2022 |
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Amortized Cost |
Gross Unrealized Gains |
Gross Unrealized Losses |
Fair Value |
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Available-for-sale |
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Commercial paper |
$ | $ | — | $ | — | $ | ||||||||||
Corporate debt securities |
— | ( |
) | |||||||||||||
Asset-backed securities |
— | ( |
) | |||||||||||||
U.S. treasury securities |
— | ( |
) | |||||||||||||
Total available-for-sale |
— | ( |
) | |||||||||||||
Available-for-sale |
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Corporate debt securities |
— | ( |
) | |||||||||||||
Asset-backed securities |
— | ( |
) | |||||||||||||
U.S. treasury securities |
— | ( |
) | |||||||||||||
Total available-for-sale |
— | ( |
) | |||||||||||||
Total available-for-sale |
$ | $ | — | $ | ( |
) | $ | |||||||||
December 31, 2021 |
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Amortized Cost |
Gross Unrealized Gains |
Gross Unrealized Losses |
Fair Value |
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Available-for-sale |
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Commercial paper |
$ | $ | — | $ | — | $ | ||||||||||
Corporate debt securities |
— | ( |
) | |||||||||||||
Asset-backed securities |
— | ( |
) | |||||||||||||
Total available-for-sale |
— | ( |
) | |||||||||||||
Available-for-sale |
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Corporate debt securities |
— | ( |
) | |||||||||||||
Asset-backed securities |
— | ( |
) | |||||||||||||
U.S. treasury securities |
— | ( |
) | |||||||||||||
Total available-for-sale |
— | ( |
) | |||||||||||||
Total available-for-sale |
$ | $ | — | $ | ( |
) | $ | |||||||||
Fair value measurements at reporting date using |
||||||||||||||||
Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
Fair Value at March 31, 2022 |
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Assets included in: |
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Cash and cash equivalents |
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Money market securities |
$ | $ | $ | $ | ||||||||||||
Marketable securities |
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Commercial paper |
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Corporate debt securities |
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Asset-backed securities |
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U.S. treasury securities |
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Total fair value |
$ | $ | $ | $ | ||||||||||||
Fair value measurements at reporting date using |
||||||||||||||||
Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
Fair Value at December 31, 2021 |
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Assets included in: |
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Cash and cash equivalents |
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Money market securities |
$ | $ | $ | $ | ||||||||||||
Marketable securities |
||||||||||||||||
Commercial paper |
— |
— |
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Corporate debt securities |
— |
— |
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Asset-backed securities |
— |
— |
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U.S. treasury securities |
— |
— |
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Total fair value |
$ | $ | $ | $ | ||||||||||||
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March 31, 2022 |
December 31, 2021 |
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Research and development service agreements |
$ | $ | ||||||
Prepaid insurance |
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Dues and subscriptions |
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Prepaid raw materials |
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Other |
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Total prepaid expenses and other current assets |
$ | $ | ||||||
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March 31, 2022 |
December 31, 2021 |
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Research and development |
$ | $ | ||||||
Bonuses and other employee liabilities |
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Legal |
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Professional fees |
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— |
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Other |
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Total accrued expenses and other current li a bilities |
$ | $ | ||||||
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Three Months Ended March 31, | ||||
2022 |
2021 | |||
Risk-free interest rate |
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Expected term (in years) |
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Expected volatility |
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Expected dividend yield |
Stock Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Life (in years) |
Aggregate Intrinsic Value (in thousands) |
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Outstanding at December 31, 2021 |
$ | |
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Granted |
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Forfeited |
( |
) | ||||||||||||||
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Outstanding at March 31, 2022 |
$ | $ | |
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Vested and exercisable at March 31, 2022 |
$ | $ | ||||||||||||||
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Three Months Ended March 31, |
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2022 |
2021 |
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General and administrative |
$ | $ | ||||||
Research and development |
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Total stock-based compensation |
$ | $ | |
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Three Months Ended March 31, 2022 |
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Operating leases |
||||
Operating lease cost |
$ | |||
Less: sublease income |
( |
) | ||
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Operating lease expense |
||||
Short-term lease rent expense |
||||
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Total rent expense |
$ | |||
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Three Months Ended March 31, 2022 |
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Operating cash flows from operating leases |
$ | |||
Right-of-use |
$ | |||
Weighted-average remaining lease term – operating leases |
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Weighted-average discount rate – operating leases |
% |
Remaining Period Ended December 31, 2022 |
$ | |
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Year Ended December 31, 2023 |
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Total |
||||
Less: present value discount |
( |
) | ||
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Operating lease liabilities |
$ | |||
|
|
Year ended December 31, 2022 |
$ | |||
Year ended December 31, 2023 |
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Total |
$ | |||
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|
Three Months Ended March 31, |
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2022 |
2021 |
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Shares issuable upon exercise of stock options |
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Shares issuable upon conversion of Series A Preferred Stock |
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Shares issuable upon conversion of Series A-1 Preferred Stock |
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Shares issuable upon conversion of Series B Preferred Stock |
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Shares issuable upon exercise of common stock warrants |
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Shares issuable upon exercise of preferred stock warrant |
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Total |
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• | costs of funding research performed by third parties that conduct research and development and nonclinical and clinical activities on our behalf; |
• | costs of manufacturing drug supply and drug product; |
• | costs of conducting nonclinical studies and clinical trials of our product candidates; |
• | consulting and professional fees related to research and development activities, including equity-based compensation to non-employees; |
• | costs related to compliance with clinical regulatory requirements; and employee-related expenses, including salaries, benefits and stock-based compensation expense for our research and development personnel. |
Three Months Ended March 31, |
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2022 |
2021 |
Change |
||||||||||
Costs and operating expenses |
||||||||||||
Research and development |
$ | 5,985 | $ | 2,578 | $ | 3,407 | ||||||
General and administrative |
3,221 | 1,215 | 2,006 | |||||||||
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|
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Total operating expenses |
9,206 | 3,793 | 5,413 | |||||||||
|
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|
|
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Loss from operations |
(9,206 | ) | (3,793 | ) | (5,413 | ) | ||||||
Other income (expense) |
||||||||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability |
— | (23,217 | ) | 23,217 | ||||||||
Interest income, net |
76 | 4 | 72 | |||||||||
Other income, net |
1 | 9 | (8 | ) | ||||||||
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|
|
|
|
|
|||||||
Total other income (expense) |
77 | (23,204 | ) | 23,281 | ||||||||
|
|
|
|
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|
|||||||
Net loss |
(9,129 | ) | (26,997 | ) | 17,868 | |||||||
|
|
|
|
|
|
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Other comprehensive loss |
||||||||||||
Unrealized loss on marketable securities |
(583 | ) | — | (583 | ) | |||||||
|
|
|
|
|
|
|||||||
Comprehensive loss |
$ | (9,712 | ) | $ | (26,997 | ) | $ | 17,285 | ||||
|
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|
|
|
|
Three Months Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Net cash used in operating activities |
$ | (8,299 | ) | $ | (2,370 | ) | ||
Net cash used in investing activities |
(5,099 | ) | — | |||||
|
|
|
|
|||||
Net change in cash and cash equivalents |
$ | (13,398 | ) | $ | (2,370 | ) | ||
|
|
|
|
• | the scope, progress, results and costs of discovery, nonclinical development, laboratory testing and clinical trials for other potential product candidates we may develop, if any; |
• | the costs, timing and outcome of regulatory review of ACU193 or any future product candidates; |
• | our ability to establish and maintain collaborations on favorable terms, if at all; |
• | the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements we might have at such time; |
• | the costs and timing of future commercialization activities, including product sales, marketing, manufacturing and distribution, for any of ACU193 or any future product candidates for which we receive marketing approval; |
• | the amount of revenue, if any, received from commercial sales of ACU193 or any future product candidates, should any of our product candidates receive marketing approval; |
• | the costs of preparing, filing and prosecuting patent applications, obtaining, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; |
• | our headcount growth and associated costs as we expand our business operations and our research and development activities; and |
• | the costs of operating as a public company. |
• | an exception from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended; |
• | reduced disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements; |
• | exemptions from the requirements of holding non-binding advisory votes on executive compensation or golden parachute arrangements; and |
• | an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on financial statements. |
(a) |
Recent Sales of Unregistered Equity Securities |
(b) |
Use of Proceeds |
(c) |
Issuer Purchases of Equity Securities |
Exhibit Number |
Description of Exhibit | |
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* | Filed herewith |
# | These certifications are being furnished solely to accompany this annual report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
ACUMEN PHARMACEUTICALS, INC. | ||||
Date: May 16, 2022 | By: | /s/ Daniel O’Connell | ||
Daniel O’Connell | ||||
President and Chief Executive Officer (Principal Executive Officer) | ||||
Date: May 16, 2022 | By: | /s/ Matthew Zuga | ||
Matthew Zuga | ||||
Chief Financial Officer and Chief Business Officer (Principal Financial and Accounting Officer) |