| ☒ | 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 |
Delaware | 36-4108129 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
427 Park St., Charlottesville, Virginia | 22902 | |
(Address of principal executive offices) | (Zip Code) | |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common stock, par value $0.0001 per share | ABOS | The Nasdaq Global Select Market |
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||
| Emerging growth company | ☒ | |||||
Table of Contents
Page | ||||||
PART I. | ||||||
Item 1. | ||||||
Item 2. | ||||||
Item 3. | ||||||
Item 4. | ||||||
PART II. | ||||||
Item 1. | ||||||
Item 1A. | ||||||
Item 2. | ||||||
Item 3. | ||||||
Item 4. | ||||||
Item 5. | ||||||
Item 6. | ||||||
1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form
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 manufacture and conduct clinical trials of ACU193, and for the manufacture of ACU193 for nonclinical studies and clinical trials;of ACU193;
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 that 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;
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;
2
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.
You should not rely on forward-looking statements as predictions of future events. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described under the header “
The forward-looking statements made in this Quarterly Report on Form
Unless the context otherwise indicates, references in this report to the terms “Acumen,” “the Company,” “we,” “our” and “us” refer to Acumen Pharmaceuticals, Inc.
We may announce material business and financial information to our investors using our investor relations website (www.investors.acumenpharm.com). We therefore encourage investors and others interested in Acumen to review the information that we make available on our website, in addition to following our filings with the SEC, webcasts, press releases and conference calls. Our website and information included in or linked to our website are not part of this Quarterly Report on Form
3
March 31, 2022 | December 31, 2021 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current assets | ||||||||
| Cash and cash equivalents | $ | 108,764 | $ | 122,162 | ||||
| Marketable securities, short-term | 80,326 | 72,075 | ||||||
| Prepaid expenses and other current assets | 3,008 | 4,424 | ||||||
| Total current assets | 192,098 | 198,661 | ||||||
| Marketable securities, long-term | 27,658 | 31,619 | ||||||
| Property and equipment, net | 51 | 36 | ||||||
Right-of-use | 201 | — | ||||||
| Other assets | 79 | 14 | ||||||
| Total assets | $ | 220,087 | $ | 230,330 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,219 | $ | 1,088 | ||||
| Accrued expenses and other current liabilities | 2,578 | 4,059 | ||||||
| Operating lease liability, current portion | 139 | — | ||||||
| Total current liabilities | 3,936 | 5,147 | ||||||
| Operating lease liability, net of current portion | 62 | — | ||||||
| Total liabilities | 3,998 | 5,147 | ||||||
Commitments and contingencies (Note 9 ) | 0 | 0 | ||||||
| Stockholders’ equity | ||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized and 0shares issued and outstanding as of March 31, 2022 and December 31, 202 1 | 0— | 0— | ||||||
| Common stock, $0.0001 par value; 300,000,000 shares authorized and 40,473,270 shares issued and outstanding as of March 31, 2022 and December 31, 2021 | 4 | 4 | ||||||
Additional paid-in capital | 353,599 | 352,981 | ||||||
| Accumulated deficit | (136,700 | ) | (127,571 | ) | ||||
| Accumulated other comprehensive loss | (814 | ) | (231 | ) | ||||
| Total stockholders’ equity | 216,089 | 225,183 | ||||||
| Total liabilities and stockholders’ equity | $ | 220,087 | $ | 230,330 | ||||
September 30, 2022 | December 31, 2021 | |||||||
| (unaudited) | ||||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 157,540 | $ | 122,162 | ||||
Marketable securities, short-term | 42,654 | 72,075 | ||||||
Prepaid expenses and other current assets | 2,366 | 4,424 | ||||||
Total current assets | 202,560 | 198,661 | ||||||
Marketable securities, long-term | — | 31,619 | ||||||
Property and equipment, net | 142 | 36 | ||||||
Deferred offering costs | 337 | — | ||||||
Right-of-use | 133 | — | ||||||
Other assets | 92 | 14 | ||||||
Total assets | $ | 203,264 | $ | 230,330 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 2,084 | $ | 1,088 | ||||
Accrued expenses and other current liabilities | 4,396 | 4,059 | ||||||
Operating lease liability, current portion | 133 | — | ||||||
Total current liabilities | 6,613 | 5,147 | ||||||
Total liabilities | 6,613 | 5,147 | ||||||
Commitments and contingencies (Note 9) | ||||||||
Stockholders’ equity | ||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued and September 30, 2022 and December 31, 2021 | — | — | ||||||
Common stock, $0.0001 par value; 300,000,000 shares authorized and 40,503,124 and 40,473,270 s haresissued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 4 | 4 | ||||||
Additional paid-in capital | 355,173 | 352,981 | ||||||
Accumulated deficit | (157,561 | ) | (127,571 | ) | ||||
Accumulated other comprehensive loss | (965 | ) | (231 | ) | ||||
Total stockholders’ equity | 196,651 | 225,183 | ||||||
Total liabilities and stockholders’ equity | $ | 203,264 | $ | 230,330 | ||||
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
Operating expenses | ||||||||
| Research and development | $ | 5,985 | $ | 2,578 | ||||
| General and administrative | 3,221 | 1,215 | ||||||
| Total operating expenses | 9,206 | 3,793 | ||||||
| Loss from operations | (9,206 | ) | (3,793 | ) | ||||
| Other income (expense) | ||||||||
| Interest income, net | 76 | 4 | ||||||
| Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | — | (23,217 | ) | |||||
| Other income, net | 1 | 9 | ||||||
| Total other income (expense) | 77 | (23,204 | ) | |||||
| Net loss | (9,129 | ) | (26,997 | ) | ||||
| Other comprehensive loss | ||||||||
| Unrealized loss on marketable securities | (583 | ) | — | |||||
| Comprehensive loss | $ | (9,712 | ) | $ | (26,997 | ) | ||
| Net loss per common share, basic and diluted | $ | (0.23 | ) | $ | (64.41 | ) | ||
| Weighted-average shares outstanding, basic and diluted | 40,473,270 | 419,124 | ||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
| Balance as of December 31, 2021 | 40,473,270 | $ | 4 | $ | 352,981 | $ | (127,571 | ) | $ | (231 | ) | $ | 225,183 | |||||||||||
| Unrealized loss on marketable securities | — | — | — | — | (583 | ) | (583 | ) | ||||||||||||||||
| Share-based compensation | — | — | 618 | — | — | 618 | ||||||||||||||||||
| Net loss | — | — | — | (9,129 | ) | — | (9,129 | ) | ||||||||||||||||
| Balance as of March 31, 2022 | 40,473,270 | $ | 4 | $ | 353,599 | $ | (136,700 | ) | $ | (814 | ) | $ | 216,089 | |||||||||||
Series A | Series A-1 | Series B | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders’ Deficit | |||||||||||||||||||||||||||||||||||||||||||
Convertible Preferred Stock | Convertible Preferred Stock | Convertible Preferred Stock | Common Stock | |||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||
| Balance as of December 31, 2020 | 477,297 | $ | 1,067 | 7,537,879 | $ | 16,333 | 11,862,043 | $ | 39,253 | 419,124 | $ | — | $ | 8,374 | $ | (26,965 | ) | $ | (18,591 | ) | ||||||||||||||||||||||||||||
| Share-based compensation | — | — | — | — | — | — | — | — | 126 | — | 126 | |||||||||||||||||||||||||||||||||||||
| Net loss | — | — | — | — | — | — | — | — | — | (26,997 | ) | (26,997 | ) | |||||||||||||||||||||||||||||||||||
| Balance as of March 31, 2021 | 477,297 | $ | 1,067 | 7,537,879 | $ | 16,333 | 11,862,043 | $ | 39,253 | 419,124 | $ | — | $ | 8,500 | $ | (53,962 | ) | $ | (45,462 | ) | ||||||||||||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses | ||||||||||||||||
Research and development | $ | 8,309 | $ | 1,800 | $ | 21,615 | $ | 6,632 | ||||||||
General and administrative | 3,062 | 2,135 | 9,374 | 4,537 | ||||||||||||
Total operating expenses | 11,371 | 3,935 | 30,989 | 11,169 | ||||||||||||
Loss from operations | (11,371 | ) | (3,935 | ) | (30,989 | ) | (11,169 | ) | ||||||||
Other income (expense) | ||||||||||||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | — | — | — | (81,157 | ) | |||||||||||
Interest income, net | 663 | 14 | 1,000 | 22 | ||||||||||||
Other income, net | (2 | ) | 19 | (1 | ) | 47 | ||||||||||
Total other income (expense) | 661 | 33 | 999 | (81,088 | ) | |||||||||||
Net loss | (10,710 | ) | (3,902 | ) | (29,990 | ) | (92,257 | ) | ||||||||
Other comprehensive loss | ||||||||||||||||
Unrealized loss on marketable securities | — | (28 | ) | (734 | ) | (28 | ) | |||||||||
Comprehensive loss | $ | (10,710 | ) | $ | (3,930 | ) | $ | (30,724 | ) | $ | (92,285 | ) | ||||
Net loss per common share, basic and diluted | $ | (0.26 | ) | $ | (0.10 | ) | $ | (0.74 | ) | $ | (7.00 | ) | ||||
Weighted-average shares outstanding, basic and diluted | 40,502,860 | 38,266,593 | 40,491,181 | 13,177,983 | ||||||||||||
Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders’ Equity | |||||||||||||||||||||
Common Stock | ||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance as of June 30, 2022 | 40,501,258 | $ | 4 | $ | 354,331 | $ | (146,851 | ) | $ | (965 | ) | $ | 206,519 | |||||||||||
Stock options exercised for cash | 1,866 | — | 2 | — | — | 2 | ||||||||||||||||||
Stock-based compensation | — | — | 840 | — | — | 840 | ||||||||||||||||||
Net loss | — | — | — | (10,710 | ) | — | (10,710 | ) | ||||||||||||||||
Balance as of September 30, 2022 | 40,503,124 | $ | 4 | $ | 355,173 | $ | (157,561 | ) | $ | (965 | ) | $ | 196,651 | |||||||||||
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities | ||||||||
| Net loss | $ | (9,129 | ) | $ | (26,997 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 4 | — | ||||||
| Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | — | 23,217 | ||||||
| Stock-based compensation expense | 618 | 126 | ||||||
| Amortization of premiums and accretion of discounts on marketable securities, net | 216 | — | ||||||
Amortization of right-of-use | 33 | — | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | 1,416 | (44 | ) | |||||
| Other assets | (65 | ) | (13 | ) | ||||
| Accounts payable | 121 | 387 | ||||||
| Operating lease liability | (32 | ) | — | |||||
| Accrued expenses and other current liabilities | (1,481 | ) | 954 | |||||
| Net cash used in operating activities | (8,299 | ) | (2,370 | ) | ||||
Cash flows from investing activities | ||||||||
| Purchases of marketable securities | (9,090 | ) | — | |||||
Proceeds from maturities and sales of marketable securities | 4,000 | — | ||||||
| Purchases of property and equipment | (9 | ) | — | |||||
| Net cash used in investing activities | (5,099 | ) | — | |||||
| Net change in cash and cash equivalents | (13,398 | ) | (2,370 | ) | ||||
| Cash and cash equivalents at the beginning of the period | 122,162 | 43,777 | ||||||
| Cash and cash equivalents at the end of the period | $ | 108,764 | $ | 41,407 | ||||
Supplemental disclosure of cash flow information | ||||||||
| Cash paid for income taxes | $ | — | $ | — | ||||
| Cash paid for interest | $ | — | $ | — | ||||
Supplemental disclosure of noncash investing and financing activities | ||||||||
| Purchases of property and equipment in accounts payable | $ | 10 | $ | — | ||||
| Deferred offering costs in accrued expenses and other current liabilities | $ | — | $ | 257 | ||||
Accumulated Other Comprehensive Loss | Total Stockholders’ Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||||||||||
Series A | Series A-1 | Series B | Additional Paid-in Capital | |||||||||||||||||||||||||||||||||||||||||||||
Convertible Preferred Stock | Convertible Preferred Stock | Convertible Preferred Stock | Common Stock | Accumulated Deficit | ||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2021 | 477,297 | $ | 1,067 | 7,985,305 | $ | 22,963 | 19,770,070 | $ | 150,474 | 556,570 | $ | — | $ | 9,241 | $ | (115,320 | ) | $ | — | $ | (106,079 | ) | ||||||||||||||||||||||||||
Conversion of convertible preferred stock into common stock upon initial public offering | (477,297 | ) | (1,067 | ) | (7,985,305 | ) | (22,963 | ) | (19,770,070 | ) | (150,474 | ) | 28,232,672 | 3 | 174,501 | — | — | 174,504 | ||||||||||||||||||||||||||||||
Issunce of stock for cash, net of issuance costs of $15,441 | — | — | — | — | — | — | 11,499,998 | 1 | 168,558 | — | — | 168,559 | ||||||||||||||||||||||||||||||||||||
Cashless exercise of common stock warrants | — | — | — | — | — | — | 178,847 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Stock options exercised | — | — | — | — | — | — | 2,236 | — | 2 | — | — | 2 | ||||||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | — | — | — | — | (28 | ) | (28 | ) | ||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | — | — | 304 | — | — | 304 | ||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | (3,902 | ) | — | (3,902 | ) | ||||||||||||||||||||||||||||||||||
Balance as of September 30, 2021 | — | $ | — | — | $ | — | — | $ | — | 40,470,323 | $ | 4 | $ | 352,606 | $ | (119,222 | ) | $ | (28 | ) | $ | 233,360 | ||||||||||||||||||||||||||
Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders’ Equity | |||||||||||||||||||||
Common Stock | ||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance as of December 31, 2021 | 40,473,270 | $ | 4 | $ | 352,981 | $ | (127,571 | ) | $ | (231 | ) | $ | 225,183 | |||||||||||
Unrealized loss on marketable securities | — | — | — | — | (734 | ) | (734 | ) | ||||||||||||||||
Stock options exercised for cash | 25,108 | — | 19 | — | — | 19 | ||||||||||||||||||
Cashless stock options exercise | 4,746 | — | — | — | — | — | ||||||||||||||||||
Stock-based compensation | — | — | 2,173 | — | — | 2,173 | ||||||||||||||||||
Net loss | — | — | — | (29,990 | ) | — | (29,990 | ) | ||||||||||||||||
Balance as of September 30, 2022 | 40,503,124 | $ | 4 | $ | 355,173 | $ | (157,561 | ) | $ | (965 | ) | $ | 196,651 | |||||||||||
Accumulated Other Comprehensive Loss | Total Stockholders’ Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||||||||||
Additional Paid-in Capital | ||||||||||||||||||||||||||||||||||||||||||||||||
Series A Convertible Preferred Stock | Series A-1 Convertible Preferred Stock | Series B Convertible Preferred Stock | Common Stock | Accumulated Deficit | ||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2020 | 477,297 | $ | 1,067 | 7,537,879 | $ | 16,333 | 11,862,043 | $ | 39,253 | 419,124 | $ | — | $ | 8,374 | $ | (26,965 | ) | $ | — | $ | (18,591 | ) | ||||||||||||||||||||||||||
Issuance of milestone shares for cash, net of issuance costs of $16 | — | — | — | — | 7,908,027 | 30,031 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Exercise of preferred stock warrant | — | — | 447,426 | 1,250 | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Reclassification of preferred stock tranche rights liability upon issuance of milestone shares | — | — | — | — | — | 81,190 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Reclassification of warrant liability upon exercise of preferred stock warrant | — | — | — | 5,380 | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Exercise of common stock warrants | — | — | — | — | — | — | 137,446 | — | 614 | — | — | 614 | ||||||||||||||||||||||||||||||||||||
Conversion of convertible preferred stock into common stock upon initial public offering | (477,297 | ) | (1,067 | ) | (7,985,305 | ) | (22,963 | ) | (19,770,070 | ) | (150,474 | ) | 28,232,672 | 3 | 174,501 | — | — | 174,504 | ||||||||||||||||||||||||||||||
Issuance of common stock for cash, net of issuance costs of $15,441 | — | — | — | — | — | — | 11,499,998 | 1 | 168,558 | — | — | 168,559 | ||||||||||||||||||||||||||||||||||||
Cashless exercise of common stock warrants | — | — | — | — | — | 178,847 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||
Stock options exercised | — | — | — | — | — | — | 2,236 | — | 2 | — | — | 2 | ||||||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | — | — | — | — | (28 | ) | (28 | ) | ||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | — | — | 557 | — | — | 557 | ||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | (92,257 | ) | — | (92,257 | ) | ||||||||||||||||||||||||||||||||||
Balance as of September 30, 2021 | — | $ | — | — | $ | — | — | $ | — | 40,470,323 | $ | 4 | $ | 352,606 | $ | (119,222 | ) | $ | (28 | ) | $ | 233,360 | ||||||||||||||||||||||||||
Nine Months Ended September 30, | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (29,990 | ) | $ | (92,257 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | 20 | 1 | ||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | — | 81,157 | ||||||
Stock-based compensation expense | 2,173 | 557 | ||||||
Amortization of premiums and accretion of discounts on marketable securities, net | 575 | (6 | ) | |||||
Amortization of right-of-use | 100 | — | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other current assets | 2,058 | (4,297 | ) | |||||
Other assets | (78 | ) | (13 | ) | ||||
Accounts payable | 996 | (149 | ) | |||||
Operating lease liability | (100 | ) | — | |||||
Accrued expenses and other current liabilities | 296 | 685 | ||||||
Net cash used in operating activities | (23,950 | ) | (14,322 | ) | ||||
Cash flows from investing activities | ||||||||
Purchases of marketable securities | (12,129 | ) | (94,095 | ) | ||||
Proceeds from maturities and sales of marketable securities | 71,860 | — | ||||||
Purchases of property and equipment | (126 | ) | (14 | ) | ||||
Net cash provided by (used in) investing activities | 59,605 | (94,109 | ) | |||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of Series B milestone shares, net of issuance costs | — | 30,031 | ||||||
Proceeds from exercise of Series A-1 warrant | — | 1,250 | ||||||
Proceeds from exercise of common stock warrants | — | 614 | ||||||
| Proceeds from issuance of common stock upon initial public offering, net of offering costs | — | 168,559 | ||||||
| Payment of deferred offering costs | (296 | ) | — | |||||
Proceeds from the exercise of stock options | 19 | 2 | ||||||
Net cash provided by (used in) financing activities | (277 | ) | 200,456 | |||||
Net change in cash and cash equivalents | 35,378 | 92,025 | ||||||
Cash and cash equivalents at the beginning of the period | 122,162 | 43,777 | ||||||
Cash and cash equivalents at the end of the period | $ | 157,540 | $ | 135,802 | ||||
Supplemental disclosure of noncash investing and financing activities | ||||||||
Right-of-use | $ | 233 | $ | — | ||||
Deferred offering costs in accrued expenses and other current liabilities | $ | 41 | $ | — | ||||
Conversion of convertible preferred stock into common stock upon initial public offering | $ | — | $ | 174,504 | ||||
Reclassification of preferred stock tranche rights liability upon share issuance | $ | — | $ | 81,190 | ||||
Reclassification of warrant liability upon exercise of preferred stock warrant | $ | — | $ | 5,380 | ||||
March 31, 2022 | September 30, 2022 | |||||||||||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||||||||||||||||||
Available-for-sale | ||||||||||||||||||||||||||||||||
| Commercial paper | $ | 47,961 | $ | — | $ | — | $ | 47,961 | ||||||||||||||||||||||||
| Corporate debt securities | 15,373 | — | (117 | ) | 15,256 | $ | 16,531 | $ | — | $ | (369 | ) | $ | 16,162 | ||||||||||||||||||
| Asset-backed securities | 8,077 | — | (45 | ) | 8,032 | 3,008 | — | (120 | ) | 2,888 | ||||||||||||||||||||||
| U.S. treasury securities | 9,093 | — | (16 | ) | 9,077 | 24,080 | — | (476 | ) | 23,604 | ||||||||||||||||||||||
| �� | ||||||||||||||||||||||||||||||||
Total available-for-sale | 80,505 | — | (178 | ) | 80,326 | 43,619 | — | (965 | ) | 42,654 | ||||||||||||||||||||||
Available-for-sale | ||||||||||||||||||||||||||||||||
| Corporate debt securities | 9,275 | — | (227 | ) | 9,048 | |||||||||||||||||||||||||||
| Asset-backed securities | 7,033 | — | (107 | ) | 6,926 | |||||||||||||||||||||||||||
| U.S. treasury securities | 11,985 | — | (302 | ) | 11,684 | |||||||||||||||||||||||||||
Total available-for-sale | 28,294 | — | (636 | ) | 27,658 | |||||||||||||||||||||||||||
Total available-for-sale | $ | 108,798 | $ | — | $ | (814 | ) | $ | 107,984 | $ | 43,619 | $ | — | $ | (965 | ) | $ | 42,654 | ||||||||||||||
December 31, 2021 | December 31, 2021 | |||||||||||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||||||||||||||||||
Available-for-sale | ||||||||||||||||||||||||||||||||
| Commercial paper | $ | 47,939 | $ | — | $ | — | $ | 47,939 | $ | 47,939 | $ | — | $ | — | $ | 47,939 | ||||||||||||||||
| Corporate debt securities | 7,992 | — | (11 | ) | 7,981 | 7,992 | — | (11 | ) | 7,981 | ||||||||||||||||||||||
| Asset-backed securities | 16,177 | — | (22 | ) | 16,155 | 16,177 | — | (22 | ) | 16,155 | ||||||||||||||||||||||
Total available-for-sale | 72,108 | — | (33 | ) | 72,075 | 72,108 | — | (33 | ) | 72,075 | ||||||||||||||||||||||
Available-for-sale | ||||||||||||||||||||||||||||||||
| Corporate debt securities | 16,816 | — | (103 | ) | 16,713 | 16,816 | — | (103 | ) | 16,713 | ||||||||||||||||||||||
| Asset-backed securities | 3,013 | — | (25 | ) | 2,988 | 3,013 | — | (25 | ) | 2,988 | ||||||||||||||||||||||
| U.S. treasury securities | 11,988 | — | (70 | ) | 11,918 | 11,988 | — | (70 | ) | 11,918 | ||||||||||||||||||||||
Total available-for-sale | 31,817 | — | (198 | ) | 31,619 | 31,817 | — | (198 | ) | 31,619 | ||||||||||||||||||||||
Total available-for-sale | $ | 103,925 | $ | — | $ | (231 | ) | $ | 103,694 | $ | 103,925 | $ | — | $ | (231 | ) | $ | 103,694 | ||||||||||||||
Fair value measurements at reporting date using | 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 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Fair Value at September 30, 2022 | |||||||||||||||||||||||||
Assets included in: | ||||||||||||||||||||||||||||||||
Cash and cash equivalents | ||||||||||||||||||||||||||||||||
| Money market securities | $ | 108,086 | $ | 0 | $ | 0 | $ | 108,086 | $ | 156,540 | $ | — | $ | — | $ | 156,540 | ||||||||||||||||
| Marketable securities | ||||||||||||||||||||||||||||||||
| Commercial paper | 0 | 47,961 | 0 | 47,961 | ||||||||||||||||||||||||||||
| Corporate debt securities | 0 | 24,304 | 0 | 24,304 | — | 16,162 | — | 16,162 | ||||||||||||||||||||||||
| Asset-backed securities | 0 | 14,958 | 0 | 14,958 | — | 2,888 | — | 2,888 | ||||||||||||||||||||||||
| U.S. treasury securities | 0 | 20,761 | 0 | 20,761 | — | 23,604 | — | 23,604 | ||||||||||||||||||||||||
| Total fair value | $ | 108,086 | $ | 107,984 | $ | 0 | $ | 216,070 | $ | 156,540 | $ | 42,654 | $ | — | $ | 199,194 | ||||||||||||||||
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 | |||||||||||||
Assets included in: | ||||||||||||||||
Cash and cash equivalents | ||||||||||||||||
| Money market securities | $ | 121,162 | $ | 0 | $ | 0 | $ | 121,162 | ||||||||
| Marketable securities | ||||||||||||||||
| Commercial paper | — | 47,939 | — | 47,939 | ||||||||||||
| Corporate debt securities | — | 24,694 | — | 24,694 | ||||||||||||
| Asset-backed securities | — | 19,143 | — | 19,143 | ||||||||||||
| U.S. treasury securities | — | 11,918 | — | 11,918 | ||||||||||||
| Total fair value | $ | 121,162 | $ | 103,694 | $ | 0 | $ | 224,856 | ||||||||
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 | |||||||||||||
Assets included in: | ||||||||||||||||
Cash and cash equivalents | ||||||||||||||||
Money market securities | $ | 121,162 | $ | — | $ | — | $ | 121,162 | ||||||||
Marketable securities | ||||||||||||||||
Commercial paper | — | 47,939 | — | 47,939 | ||||||||||||
Corporate debt securities | — | 24,694 | — | 24,694 | ||||||||||||
Asset-backed securities | — | 19,143 | — | 19,143 | ||||||||||||
U.S. treasury securities | — | 11,918 | — | 11,918 | ||||||||||||
| Total fair value | $ | 121,162 | $ | 103,694 | $ | — | $ | 224,856 | ||||||||
March 31, 2022 | December 31, 2021 | September 30, 2022 | December 31, 2021 | |||||||||||||
Prepaid insurance | $ | 1,666 | $ | 1,514 | ||||||||||||
Prepaid raw materials | 201 | 83 | ||||||||||||||
| Research and development service agreements | $ | 1,653 | $ | 2,591 | 172 | 2,591 | ||||||||||
| Prepaid insurance | 749 | 1,514 | ||||||||||||||
| Dues and subscriptions | 158 | 96 | 121 | 96 | ||||||||||||
| Prepaid raw materials | 333 | 83 | ||||||||||||||
| Other | 115 | 140 | 206 | 140 | ||||||||||||
| Total prepaid expenses and other current assets | $ | 3,008 | $ | 4,424 | $ | 2,366 | $ | 4,424 | ||||||||
March 31, 2022 | December 31, 2021 | |||||||
| Research and development | $ | 1,638 | $ | 2,623 | ||||
| Bonuses and other employee liabilities | 541 | 1,102 | ||||||
| Legal | 294 | 130 | ||||||
Professional fees | 6 | — | ||||||
| Other | 99 | 204 | ||||||
Total accrued expenses and other current li a bilities | $ | 2,578 | $ | 4,059 | ||||
September 30, 2022 | December 31, 2021 | |||||||
Research and development | $ | 2,837 | $ | 2,623 | ||||
Compensat and other employee liabilitiesion | 1,455 | 1,102 | ||||||
Legal | 67 | 130 | ||||||
Other | 37 | 204 | ||||||
Total accrued expenses and other current liabilities | $ | 4,396 | $ | 4,059 | ||||
Nine Months Ended September 30, | ||||
2022 | 2021 | |||
Risk-free interest rate | 1.71% - 4.17% | 0.4% - 1.1% | ||
Expected term (in years) | 5.8 - 6.1 | 5.3 - 6.1 | ||
Expected volatility | 90% | 90% | ||
Expected dividend yield | 0% | 0% | ||
Three Months Ended March 31, | ||||
2022 | 2021 | |||
| Risk-free interest rate | 1.71% | 0.4% - 0.5% | ||
| Expected term (in years) | 6.1 | 5.3 - 6.1 | ||
| Expected volatility | 90% | 90% | ||
| Expected dividend yield | 0% | 0% | ||
Stock Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (in years) | Aggregate Intrinsic Value (in thousands) | |||||||||||||
Outstanding at December 31, 2021 | 3,835,618 | $ | 2.51 | |||||||||||||
Granted | 1,932,050 | $ | 5.00 | |||||||||||||
Exercised | (31,848 | ) | $ | 0.86 | ||||||||||||
Forfeited | (79,872 | ) | $ | 6.35 | ||||||||||||
Outstanding at September 30, 2022 | 5,655,948 | $ | 3.31 | 8.3 | $ | 39,818 | ||||||||||
Vested and exercisable at September 30, 2022 | 2,084,736 | $ | 1.75 | 7.1 | $ | 17,772 | ||||||||||
Stock Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (in years) | Aggregate Intrinsic Value (in thousands) | |||||||||||||
| Outstanding at December 31, 2021 | 3,835,618 | $ | 2.51 | |||||||||||||
| Granted | 1,104,550 | 5.19 | ||||||||||||||
| Forfeited | (18,149 | ) | 1.19 | |||||||||||||
| Outstanding at March 31, 2022 | 4,922,019 | $ | 3.11 | 8.6 | $ | 9,562 | ||||||||||
| Vested and exercisable at March 31, 2022 | 1,755,794 | $ | 1.54 | 7.5 | $ | 4,805 | ||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||
Three Months Ended March 31, | ||||||||||||||||||||||||
2022 | 2021 | |||||||||||||||||||||||
| General and administrative | $ | 453 | $ | 79 | $ | 563 | $ | 254 | $ | 1,525 | $ | 412 | ||||||||||||
| Research and development | 166 | 47 | 277 | 50 | 648 | 145 | ||||||||||||||||||
| Total stock-based compensation | $ | 618 | $ | 126 | $ | 840 | $ | 304 | $ | 2,173 | $ | 557 | ||||||||||||
Three Months Ended March 31, 2022 | ||||
| Operating leases | ||||
| Operating lease cost | $ | 38 | ||
| Less: sublease income | (16 | ) | ||
| Operating lease expense | 22 | |||
| Short-term lease rent expense | 5 | |||
| Total rent expense | $ | 27 | ||
Three Months Ended September 30, 2022 | Nine Months Ended September 30, 2022 | |||||||
Operating leases | ||||||||
Operating lease cost | $ | 38 | $ | 114 | ||||
Less: sublease income | (12 | ) | (44 | ) | ||||
Operating lease expense | 26 | 70 | ||||||
Short-term lease rent expense | 1 | 11 | ||||||
Total rent expense | $ | 27 | $ | 81 | ||||
Three Months Ended March 31, 2022 | ||||
| Operating cash flows from operating leases | $ | 38 | ||
Right-of-use | $ | 233 | ||
| Weighted-average remaining lease term – operating leases | 1.4 | |||
| Weighted-average discount rate – operating leases | 10.0 | % | ||
Nine Months Ended September 30, 2022 | ||||
Operating cash flows from operating leases | $ | 114 | ||
Right-of-use assets obtained in exchange for operating lease liabilities | $ | 233 | ||
Weighted-average remaining lease term – operating leases (in years) | 0.9 | |||
Weighted-average discount rate – operating leases | 10.0 | % | ||
| Remaining Period Ended December 31, 2022 | $ | 115 | ||
| Year Ended December 31, 2023 | 102 | |||
| Total | 217 | |||
| Less: present value discount | (16 | ) | ||
| Operating lease liabilities | $ | 201 | ||
Remaining period ended December 31, 2022 | $ | 39 | ||
Year ended December 31, 2023 | 102 | |||
Total | 141 | |||
Less: present value discount | (8 | ) | ||
Operating lease liabilities | $ | 133 | ||
| Year ended December 31, 2022 | $ | 153 | ||
| Year ended December 31, 2023 | 102 | |||
| Total | $ | 255 | ||
Year ended December 31, 2022 | $ | 153 | ||
Year ended December 31, 2023 | 102 | |||
Total | $ | 255 | ||
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
| Shares issuable upon exercise of stock options | 4,922,019 | 3,481,178 | ||||||
| Shares issuable upon conversion of Series A Preferred Stock | 0 | 477,297 | ||||||
Shares issuable upon conversion of Series A-1 Preferred Stock | 0 | 7,537,879 | ||||||
| Shares issuable upon conversion of Series B Preferred Stock | 0 | 11,862,043 | ||||||
| Shares issuable upon exercise of common stock warrants | 0 | 385,693 | ||||||
| Shares issuable upon exercise of preferred stock warrant | 0 | 447,426 | ||||||
| Total | 4,922,019 | 24,191,516 | ||||||
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report on Form
Overview
We are a clinical-stage biopharmaceutical company developing a novel disease-modifying approach to target what we believe to be a key underlying cause of Alzheimer’s Disease, or AD. Alzheimer’s disease is a progressive neurodegenerative disease of the brain that leads to loss of memory and cognitive functions and ultimately results in death. Our scientific founders pioneered research on soluble amyloid-beta oligomers, or AβAßOs, which are globular assemblies of the Aß peptide that are distinct from Aß monomers and amyloid plaques. We are currently focused on advancing a targeted immunotherapy drug candidate, ACU193, through clinical proof of mechanism trials in early AD patients. We have confirmed that ACU193 is a consensus IgG2 subclass. We initiated a Phase 1 clinical trial of ACU193 in 2021, which we named“INTERCEPT-AD. “INTERCEPT-AD.”are expandingexpanded the anticipated number of trial sites to support our enrollment objectives and anticipated timelines. ClinicalAs of November 11, 2022, 17 clinical trial site activationsites have been activated, and patient recruitment and enrollment is ongoing.ongoing and progressing. Based on current site activations and enrollment rates, we anticipate completing enrollment in INTERCEPT-AD in the first quarter of 2023 and reporting our topline data from the
We have incurred net losses and negative cash flows from operations since our inception. Our net losses were $9.1$30.0 million and $27.0$92.3 million for the threenine months ended March 31,September 30, 2022 and 2021, respectively. As of March 31,September 30, 2022, we had an accumulated deficit of $136.7$157.6 million and working capital of $195.9 million. Our net losses and cash flows from operations may fluctuate significantly from
We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, manufacturing and distribution activities.
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As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable terms, or at all. However, global economic conditions have been worsening, with disruptions to, and volatility in, the credit and financial markets in the U.S. and worldwide, rising inflation and supply disruptions resulting from the effects of COVID-19, the ongoing conflict between Russia and Ukraine and related sanctions, and otherwise. If these conditions persist and deepen, we could experience an inability to access additional capital, or our liquidity could otherwise be impacted. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs and/or future commercialization efforts. Our failure to raise capital or enter into such agreements as, and when needed, could have a material adverse effect on our business, results of operations and financial condition.
As of March 31,September 30, 2022, we had cash and cash equivalents and marketable securities totaling $216.7$200.2 million. Based on our current operating plan, we expect that our existing cash and cash equivalents and marketable securities will be sufficient to enable us to fund our operating expenses and capital expenditure requirements at least through 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and Capital Resources.”
COVID-19
In March 2020, the World Health Organization declared
Business travel has been limited, and online video and teleconference technology is used to meet virtually rather than in person. We have taken measures to secure our research and development activities, while work in laboratories by our partners has been organized to reduce risk of
In October 2021, we announced the initial dosing of the first patient inarewere principally related to effects ofare expandingexpanded the anticipated number of trial sites to support our enrollment objectives and anticipated timelines. However, we cannot assure that we will not experience additional delays in site activation or enrollment. ClinicalAs of November 11, 2022, 17 clinical trial site activationsites have been activated and patient recruitment and enrollment is ongoing.ongoing and progressing. Based on current site activations and enrollment rates, we anticipate completing enrollment in INTERCEPT-AD in the first quarter of 2023 and reporting our topline data from this trial in the firstsecond half of 2023.
The ultimate impact of the
Components of Results of Operations
Operating Expenses
Our operating expenses consist of research and development expenses and general and administrative expenses.
Research and Development Expenses
Research and development costs primarily consist of direct costs associated with consultants and materials, biologic storage, third party, contract research organization costs and contract development and manufacturing expenses, salaries and other personnel-related expenses. Research and development costs are expensed as incurred. More specifically, these costs include:
costs of funding research performed by third parties that conduct research and development and nonclinical and clinical activities on our behalf;
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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.
As we currently only have one product candidate, ACU193, in development, we do not separately track expenses by program. We expect that our research and development expenses will increase substantially in connection with our clinical development activities for our ACU193 program.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and other personnel related expenses, including stock-based compensation, as well as costs for insurance, professional fees for legal, consulting, accounting, auditing, tax and recruiting services, investor and public relations, board of directors’ expenses, franchise taxes, meetings, travel and rent, among others.
We expect that our general and administrative expenses will increase as our organization and headcount needed in the future grows to support continued research and development activities and potential commercialization of our product candidates. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, attorneys and accountants, among other expenses. Additionally, we expect to incur increased expenses associated with being a public company, including costs of additional personnel, accounting, audit, legal, regulatory
Other Income (Expense)
Other income (expense) primarily includes interest income, net and other income, net. Following our initial public offering, or IPO, we made investments in marketable securities and the interest income earned, as well as the amortization and accretion of premiums and discounts are recorded in interest income, net. Other income, net generally consists of sublease income offset by fees incurred on our investments in marketable securities.
Prior to our IPO on July 6, 2021, changes in the fair values of the Series
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Results of Operations
Comparison of the Three Months Ended March 31,September 30, 2022 and 2021
The following table summarizes our results of operations for the three months ended March 31,September 30, 2022 and 2021 (in thousands):
Three Months Ended March 31, | ||||||||||||
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 | |||||||||
Total operating expenses | 9,206 | 3,793 | 5,413 | |||||||||
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 | ) | ||||||||
Total other income (expense) | 77 | (23,204 | ) | 23,281 | ||||||||
Net loss | (9,129 | ) | (26,997 | ) | 17,868 | |||||||
Other comprehensive loss | ||||||||||||
Unrealized loss on marketable securities | (583 | ) | — | (583 | ) | |||||||
Comprehensive loss | $ | (9,712 | ) | $ | (26,997 | ) | $ | 17,285 | ||||
| Three Months Ended September 30, | ||||||||||||
| 2022 | 2021 | Change | ||||||||||
Operating expenses | ||||||||||||
Research and development | $ | 8,309 | $ | 1,800 | $ | 6,509 | ||||||
General and administrative | 3,062 | 2,135 | 927 | |||||||||
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Total operating expenses | 11,371 | 3,935 | 7,436 | |||||||||
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| |||||
Loss from operations | (11,371 | ) | (3,935 | ) | (7,436 | ) | ||||||
Other income (expense) | ||||||||||||
Interest income, net | 663 | 14 | 649 | |||||||||
Other income, net | (2 | ) | 19 | (21 | ) | |||||||
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Total other income | 661 | 33 | 628 | |||||||||
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Net loss | (10,710 | ) | (3,902 | ) | (6,808 | ) | ||||||
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Other comprehensive loss | ||||||||||||
Unrealized loss on marketable securities | — | (28 | ) | 28 | ||||||||
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Comprehensive loss | $ | (10,710 | ) | $ | (3,930 | ) | $ | (6,780 | ) | |||
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Research and Development Expenses
Research and development expenses were $6.0$8.3 million and $2.6$1.8 million for the three months ended March 31,September 30, 2022 and 2021, respectively. The $3.4$6.5 million increase was primarily due to increases of $1.5 million in consulting expenses, $0.8$2.1 million in contract research organization, expenses, $0.6or CRO, costs, $1.7 million for materials, $1.2 million in additional personnel related expenses, $0.3expense, $1.0 million in consulting costs and $0.4 million in drug safety testing, and $0.2 millionas well as increases in materials expenses. The net increase in research and developmentmiscellaneous expenses during the three months ended March 31, 2022 from the three months ended March 31, 2021 was primarily duetotaling $0.1 million; all related to our ongoing clinical trial which was initiated in 2021.
General and Administrative Expenses
General and administrative expenses were $3.2$3.1 million and $1.2$2.1 million for the three months ended March 31,September 30, 2022 and 2021, respectively. The $2.0$0.9 million increase was primarily due to increases of $0.7 million in insurancepersonnel expenses, $0.7$0.2 million in personnel expenses, $0.4accounting costs, $0.2 million in legal expenses, $0.1 million for investor relationsmarketing costs and $0.1 million for other office expenses, including rent.
Other Income (Expense)
Other income was $0.1$0.7 million for the three months ended March 31,September 30, 2022, which was primarily due to net interest income on the Company’s portfolio of marketable securities. Other expenseincome was $23.2 millionde minimis for the three months ended March 31,September 30, 2021.
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Comparison of the Nine Months Ended September 30, 2022 and 2021
The following table summarizes our results of operations for the nine months ended September 30, 2022 and 2021 (in thousands):
| Nine Months Ended September 30, | ||||||||||||
| 2022 | 2021 | Change | ||||||||||
Operating expenses | ||||||||||||
Research and development | $ | 21,615 | $ | 6,632 | $ | 14,983 | ||||||
General and administrative | 9,374 | 4,537 | 4,837 | |||||||||
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Total operating expenses | 30,989 | 11,169 | 19,820 | |||||||||
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Loss from operations | (30,989 | ) | (11,169 | ) | (19,820 | ) | ||||||
Other income (expense) | ||||||||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | — | (81,157 | ) | 81,157 | ||||||||
Interest income, net | 1,000 | 22 | 978 | |||||||||
Other income, net | (1 | ) | 47 | (48 | ) | |||||||
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Total other income (expense) | 999 | (81,088 | ) | 82,087 | ||||||||
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Net loss | (29,990 | ) | (92,257 | ) | 62,267 | |||||||
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Other comprehensive loss | ||||||||||||
Unrealized loss on marketable securities | (734 | ) | (28 | ) | (706 | ) | ||||||
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Comprehensive loss | $ | (30,724 | ) | $ | (92,285 | ) | $ | 61,561 | ||||
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Research and Development Expenses
Research and development expenses were $21.6 million and $6.6 million for the nine months ended September 30, 2022 and 2021, respectively. The $15.0 million increase was primarily due almost entirely to our ongoing clinical trial which was initiated in 2021 and nonclinical research and development activity, and includes increases of $4.2 million of CRO costs, $3.4 million in consulting costs, $3.0 million for materials, $2.7 million in personnel costs, and $1.5 million for drug safety testing, as well as $0.2 million for other miscellaneous expenses.
General and Administrative Expenses
General and administrative expenses were $9.4 million and $4.5 million for the changesnine months ended September 30, 2022 and 2021, respectively. The $4.8 million increase was primarily due to increases of $2.1 million in personnel costs, $1.3 million in insurance costs, $0.5 million in legal costs, $0.4 million in marketing costs, $0.2 million for each of the following: travel expenses and recruiting costs, and $0.1 million for other miscellaneous expense.
Other Income (Expense)
Other income was $1.0 million for the nine months ended September 30, 2022, which was due to net interest income on the Company’s portfolio of marketable securities. Other expense was $81.1 million for the nine months ended September 30, 2021, primarily due to increases in the fair values of the
Liquidity and Capital Resources
On July 6, 2021, we issued 9,999,999 shares of common stock in our IPO, and on July 8, 2021, we issued an additional 1,499,999 shares of common stock that were purchased by the underwriters pursuant to the underwriters’ option to purchase additional shares at the public offering price less underwriting discounts and commissions. The price to the public for each share was $16.00. The aggregate net proceeds from our IPO, after underwriting discounts and commissions and other offering expenses of $15.4 million, were $168.6 million.
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As of March 31,September 30, 2022, our cash and cash equivalents and marketable securities totaled $216.7$200.2 million. Our
We enter into contracts in the
Future minimum lease payments under our Indiana lease agreement total approximately $0.2$0.1 million.
Shelf Registration and At-The-Market Equity Offering
On July 1, 2022, we filed a shelf registration statement on Form S-3, or the Registration Statement. Pursuant to the Registration Statement, we may offer and sell securities having an aggregate public offering price of up to $200.0 million. In connection with the filing of the Registration Statement, we also entered into a sales agreement with BofA Securities, Inc. and Stifel, Nicolaus & Company, Incorporated, or the Sales Agents, pursuant to which we may issue and sell shares of our common stock for an aggregate offering price of up to $50.0 million under an at-the-market offering program, or ATM, which is included in the $200.0 million of securities that may be offered pursuant to the Registration Statement. Pursuant to the ATM, we will pay the Sales Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of our common stock. We are not obligated to make any sales of shares of our common stock under the ATM. We had not sold any shares of our common stock under the ATM as of September 30, 2022.
Cash Flows
The following table summarizes our sources and uses of cash (in thousands):
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 | ) | ||
Nine Months Ended September 30, | ||||
2022 | 2021 | |||
Net cash used in operating activities | $ (23,950) | $ (14,322) | ||
Net cash provided by (used in) investing activities | 59,605 | (94,109) | ||
Net cash provided by (used in) financing activities | (277) | 200,456 | ||
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| |||
Net change in cash and cash equivalents | $ 35,378 | $ 92,025 | ||
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| |||
Operating Activities
Net cash used in operating activities was $8.3$24.0 million and $2.4$14.3 million for the threenine months ended March 31,September 30, 2022 and 2021, respectively. Net cash used in operating activities during the threenine months ended March 31,September 30, 2022 primarily consisted of our net loss of $9.1$30.0 million, which was reduced by
Net cash used in operating activities during the threenine months ended March 31,September 30, 2021 was primarily due toconsisted of our net loss of $27.0$92.3 million, including other expenseswhich was reduced by non-cash adjustments of $23.2$81.2 million related to the change in the fair values of the Series
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Investing Activities
Cash provided by investing activities for the nine months ended September 30, 2022 was $59.6 million and was primarily related to maturities and sales of marketable securities of $71.9 million, partially offset by purchases of marketable securities and property and equipment of $12.1 million and $0.1 million, respectively.
Cash used in investing activities for the threenine months ended March 31, 2022September 30, 2021 was $5.1$94.1 million and was predominantly related to purchases and maturitiesthe purchase of marketable securities, but also included nominal purchases of $9.1 million and $4.0 million, respectively. Cashcomputer hardware.
Financing Activities
Net cash used in investedfinancing activities was $0.3 million for the threenine months ended March 31,September 30, 2022 and was primarily due to payment of deferred offering costs related to the Registration Statement, which were partially offset by proceeds from stock option exercises.
Net cash provided by financing activities was $200.5 million for the nine months ended September 30, 2021 and was nil.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue our research and development, conduct clinical trials, and seek marketing approval for our current and any of our future product candidates. Furthermore, we have and expect to incur additional costs associated with operating as a public company following our July 2021 IPO. It is likely that we will seek third-party collaborators for the future commercialization of ACU193 or any other product candidate that is approved for marketing. However, we may seek to commercialize our products at our own expense, which would require us to incur significant additional expenses for marketing, sales, manufacturing and distribution, which costs we may seek to offset through entry into collaboration agreements with third parties. As a result, we expect that we will need to obtain substantial additional funding in connection with our future operations. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
Based on our current operating plan, we expect that our existing cash and cash equivalents and our marketable securities will be sufficient to enable us to fund our operating expenses and capital expenditure requirements at least through 2025. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:
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.
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Until such time, if ever, as we can generate substantial product revenue, we expect to finance our longer-term cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interests may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect your rights as a common stockholder. Any debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business.
If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Critical Accounting Policies, Significant Judgments and Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements and the reported amounts of expenses during the reporting period. A description of our significant accounting policies is included in our Annual Report. You shouldPlease read the unaudited condensed financial statements in conjunction with our audited financial statements and accompanying notes in our Annual Report.
Our significantcritical accounting policies that require significant judgments and estimates are more fully described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies, Significant Judgments and Use of Estimates” in our Annual Report and in Note 2 to our audited financial statements contained in our Annual Report. There have been no significant changes to our critical accounting policies that require significant judgments and estimates from those disclosed in our Annual Report.
Recent Accounting Pronouncements
Information regarding recent accounting pronouncements applicable to us, adopted and not yet adopted as of the date of this report, is included in Note 2 to our unaudited condensed financial statements located in “Part I – Financial Information, Item 1. Financial Statements” in this Quarterly Report on Form
Emerging Growth Company and Smaller Reporting Company Status
In April 2012, the Jumpstart Our Business Startups Act of 2012, or JOBS Act, was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We elected the extended transition period for complying with new or revised accounting standards, which delays the adoption of these accounting standards until they would apply to private companies.
In addition, as an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:
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.
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We may take advantage of these provisions until we no longer qualify as an emerging growth company. We will cease to qualify as an emerging growth company on the date that is the earliest of: (i) December 31, 2025, (ii) the last day of the fiscal year in which we have more than $1.07$1.235 billion in total annual gross revenues, (iii) the date on which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means the market value of our common stock that is held by
We are also a “smaller reporting company,” meaning that the market value of our shares held by
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As a “smaller reporting company” as defined by Item 10 of Regulation
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting, as such term is defined in
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Inherent Limitations on Effectiveness of Internal Controls
In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are not subject to any material legal proceedings. From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report on Form
The FDA granted Fast Track designation for ACU193 for the treatment of early Alzheimer’s disease, and we may seek Fast Track designation for other product candidates. Even if received, Fast Track designation may not actually lead to a faster review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
The FDA granted Fast Track designation for ACU193 for the treatment of early Alzheimer’s disease, and we may seek Fast Track designation for our other product candidates. If a drug or biologic is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs for this condition, the sponsor may apply for FDA Fast Track designation for a particular indication. There is no assurance that the FDA will grant this status to any of our other product candidates. If granted, Fast Track designation makes a product eligible for more frequent interactions with FDA to discuss the development plan and clinical trial design, as well as rolling review of the application, which means that the company can submit completed sections of its marketing application for review prior to completion of the entire submission. Marketing applications of product candidates with Fast Track designation may qualify for priority review under the policies and procedures offered by the FDA, but the Fast Track designation does not assure any such qualification or ultimate marketing approval by the FDA. The FDA has broad discretion whether or not to grant Fast Track designation, so even if we believe a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if we do receive Fast Track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures, and receiving a Fast Track designation does not provide any assurance of ultimate FDA approval. In addition, the FDA may withdraw Fast Track designation at any time if it believes that the designation is no longer supported by data from our clinical development program.
Healthcare legislative or regulatory reform measures may have a negative impact on our business and results of operations.
In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.
Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA) was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The ACA, among other things: (i) established an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs; (ii) expanded the entities eligible for discounts under the 340B drug pricing program; (iii) increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively, and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP; (iv) expanded the eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new eligibility categories for individuals with income at or below 133% (as calculated, it constitutes 138%) of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability; (v) addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated
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for certain drugs and biologics that are inhaled, infused, instilled, implanted or injected; (vi) introduced a new Medicare Part D coverage gap discount program in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D (increased from 50%, effective January 1, 2019, pursuant to the Bipartisan Budget Act of 2018); (vii) created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and (viii) established the Center for Medicare and Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug.
There have been executive, judicial and Congressional challenges to certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017 (the Tax Act) included a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On June 17, 2021 the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Prior to the U.S. Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period from February 15, 2021 through May 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. Further, on August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 (IRA) into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost through a newly established manufacturer discount program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is also unclear how any additional healthcare reform measures of the Biden administration will impact the ACA or our business.
Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year ended December 31, 2021, filedpursuant to the Budget Control Act of 2011, which began in 2013, and due to subsequent legislative amendments to the statute, including the Bipartisan Budget Act of 2018 and the Infrastructure Investment and Jobs Act, will remain in effect through 2031, with the Securitiesexception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional Congressional action is taken. Under current legislation the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester. The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals, and Exchange Commissionincreased the statute of limitations period for the government to recover overpayments to providers from three to five years. These laws may result in additional reductions in Medicare and other healthcare funding, which could have an adverse effect on customers for our product candidates, if approved, and, accordingly, our financial operations. Additionally, on March 28, 2022.11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.
Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. For example, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to President Biden’s executive order, on September 9, 2021, the U.S. Department of Health and Human Services (HHS) released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. In addition, the IRA, among other things, (1) directs HHS to negotiate the price of certain single-source drugs and biologics covered under Medicare and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry. Further, the Biden administration released an additional executive order on October 14, 2022, directing HHS to submit a report within ninety (90) days on how the Center for Medicare and Medicaid Innovation can be further leveraged to test new models for lowering drug costs for Medicare and Medicaid beneficiaries. It is unclear whether this executive order or similar policy initiatives will be implemented in the future. It is unclear whether these or similar policy initiatives will be implemented in the future.
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We expect that these and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved drug. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our drugs.
In addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may impose additional costs or lengthen FDA review times for ACU193 or any other product candidate we may develop. We cannot determine how changes in regulations, statutes, policies, or interpretations when and if issued, enacted or adopted, may affect our business in the future. Such changes could, among other things, require:
additional clinical trials to be conducted prior to obtaining approval;
changes to manufacturing methods;
recalls, replacements, or discontinuance of one or more of our products, and
additional recordkeeping.
Such changes would likely require substantial time and impose significant costs, or could reduce the potential commercial value of ACU193 or other product candidates, and could materially harm our business and our financial results. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any other products would harm our business, financial condition and results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(a) | Recent Sales of Unregistered Equity Securities |
None.
(b) | Use of Proceeds |
On June 30, 2021, our Registration Statement on Form
The initial public offering closed on July 6, 2021 with respect to 9,999,999 shares of common stock. On July 8, 2021, the offering closed with respect to an additional 1,499,999 shares purchased by the underwriters pursuant to the underwriters’ option to purchase additional shares. The aggregate net proceeds from our initial public offering, after underwriting discounts and commissions, and other offering expenses of $15.4 million, were $168.6 million. In connection with our initial public offering, no payments were made by us to directors, officers or persons owning ten percent or more of our common stock or to their associates or to our affiliates. There has been no material change in the planned use of proceeds from our initial public offering as described in our prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on July 2, 2021.
(c) | Issuer Purchases of Equity Securities |
None.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
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Item 6. Exhibits.
Number | ||
| 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 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| ACUMEN PHARMACEUTICALS, INC. | ||||||
| Date: | By: | /s/ Daniel O’Connell | ||||
| Daniel O’Connell | ||||||
President and Chief Executive Officer (Principal Executive Officer) | ||||||
| Date: | By: | /s/ Matthew Zuga | ||||
| Matthew Zuga | ||||||
Chief Financial Officer and Chief Business Officer (Principal Financial and Accounting Officer) | ||||||
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