x | Annual Report Pursuant to Section 13 |
o | Transition Report Pursuant to Section 13 |
Delaware | 36-4108129 | |||||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||
427 Park St. | ||||||
Charlottesville, VA | 22902 | |||||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Common | ABOS | The Nasdaq Global Select Market |
Large accelerated filer | o | Accelerated filer | |||||||||||||||
Non-accelerated filer | x | Smaller reporting company | |||||||||||||||
Emerging growth company | x |
Page | |||||||||||||
Measured Outcome** | solanezumab EXPEDITION 3 (Phase 3) | Aduhelm aducanumab EMERGE (Phase 3) | Aduhelm aducanumab ENGAGE† (Phase 3) | lecenamab BAN2401 (Phase 2) | donanemab (Phase 2) | |||||||||||||||
ADAS-cog | -11 | % | -27 | % | -12 | % | -47 | % | -39 | % | ||||||||||
ADCS-ADL | -15 | % | -40 | % | -18 | % | N.A. | -23 | % | |||||||||||
CDR-SB | -15 | % | -23 | % | 2 | % | -26 | % | -23 | % | ||||||||||
MMSE | -13 | % | -15 | % | 3 | % | N.A. | -21 | % | |||||||||||
iADRS | -11 | % | N.A. | N.A. | N.A. | -32 | % |
Targeting Aß Monomers | Targeting Amyloid Plaques | |||||||||||||||||||||||||||||||||||||||||||||||
solanezumab EXPEDITION 3 (Phase 3) | Aduhelm aducanumab EMERGE (Phase 3) | Aduhelm aducanumab ENGAGE (Phase 3) | Lecenamab BAN2401 (Phase2) | donanemab (Phase 2) | ||||||||||||||||||||||||||||||||||||||||||||
PC | Treated | PC | Low | High | PC | Low | High | PC | High | PC | Treated | |||||||||||||||||||||||||||||||||||||
ARIA-E | 0.2 | % | 0.1 | % | 2.2 | % | 26.1 | % | 34.4 | % | 3.0 | % | 25.6 | % | 35.7 | % | 0.8 | % | 9.9 | % | 0.8 | % | 27.5 | % | ||||||||||||||||||||||||
ApoE e 4 carriers | 1.9 | % | 29.8 | % | 42.5 | % | 2.4 | % | 28.7 | % | 41.8 | % | 1.2 | % | 14.6 | % | 3.6 | % | 44.0 | % | ||||||||||||||||||||||||||||
ApoE e 4 non-carriers | 2.9 | % | 18.1 | % | 17.9 | % | 4.3 | % | 17.5 | % | 27.7 | % | 0.0 | % | 8.0 | % | ||||||||||||||||||||||||||||||||
Any ARIA E or H | 10.3 | % | 32.8 | % | 41.2 | % | 9.8 | % | 30.7 | % | 40.3 | % | N.A. | 8.0 | % | 38.9 | % |
Profile | ||||||||||
plaque | fibrils | monomers | oligomers | of ARIA | ||||||
Selectivity | • | |||||
In vivo pharmacology | •ACU193 crosses the blood-brain barrier and demonstrates dose-dependent target engagement in the brain following peripheral administration of antibody. | |||||
Safety | •GLP studies via IV route established no observed adverse effect level, or NOAEL, of 300 mg/kg/dose in a 14-week cynomolgus monkey study and 250 mg/kg/dose in a 28-day rat study. |
Measured Outcome** | solanezumab EXPEDITION 3 (Phase 3) | Aduhelm aducanumab EMERGE (Phase 3) | Aduhelm aducanumab ENGAGE† (Phase 3) | lecanemab BAN2401 (Phase 3) | donanemab (Phase 2) | |||||||||||||||||||||||||||
ADAS-cog | -11 | % | -27 | % | -12 | % | -26 | % | -39 | % | ||||||||||||||||||||||
ADCS-ADL | -15 | % | -40 | % | -18 | % | -37 | % | -23 | % | ||||||||||||||||||||||
CDR-SB | -15 | % | -23 | % | 2 | % | -27 | % | -23 | % | ||||||||||||||||||||||
MMSE | -13 | % | -15 | % | 3 | % | N.A. | -21 | % | |||||||||||||||||||||||
iADRS | -11 | % | N.A. | N.A. | N.A. | -32 | % |
Targeting Aẞ Monomers | Targeting Amyloid Plaques | Targeting Protofibrils | |||||||||||||||||||||||||||||||||||||||||||||
solanezumab EXPEDITION 3 (Phase 3) | Aduhelm aducanumab EMERGE (Phase 3) | Aduhelm aducanumab ENGAGE (Phase 3) | donanemab (Phase 2) | Leqembi lecanemab (Phase 3) | |||||||||||||||||||||||||||||||||||||||||||
PC | Treated | PC | Low | High | PC | Low | High | PC | Treated | PC | Treated | ||||||||||||||||||||||||||||||||||||
ARIA-E | 0.2% | 0.1% | 2.2% | 26.2% | 34.4% | 3.0% | 25.6% | 35.7% | 0.8% | 27.5% | 1.7% | 12.6% | |||||||||||||||||||||||||||||||||||
ApoE e4 carriers | 1.9% | 29.8% | 42.5% | 2.4% | 28.7% | 41.8% | 3.6% | 44.0% | 2.3% | 15.8% | |||||||||||||||||||||||||||||||||||||
ApoE e4 non-carriers | 2.9% | 18.1% | 17.9% | 4.3% | 17.5% | 27.7% | 0.3% | 5.4% | |||||||||||||||||||||||||||||||||||||||
Any ARIA E or H | 10.3% | 32.8% | 41.2% | 9.8% | 30.7% | 40.3% | 8.0% | 38.9% | 9.5% | 21.5% |
Target Selectivity+ | ARIA Profile | |||||||||||||||||||||||||||||||
Product Candidate | Amyloid plaque | Aß fibrils | Aß monomers | Aß oligomers | Lower rate of ARIA | |||||||||||||||||||||||||||
ACU193 | x | untested | x | ✓ | Expected | |||||||||||||||||||||||||||
Leqembi lecanemab | ✓ | ✓ | x | ✓ | No | |||||||||||||||||||||||||||
donanemab | ✓ | untested | x | x | No | |||||||||||||||||||||||||||
Aduhelm aducanumab | ✓ | ✓ | x | ✓ | No | |||||||||||||||||||||||||||
solanezumab* | x | x | ✓ | x | ✓ | |||||||||||||||||||||||||||
gantenerumab | ✓ | ✓ | x | ✓ | No | |||||||||||||||||||||||||||
crenezumab* | ✓ | ✓ | ✓ | ✓ | ✓ | |||||||||||||||||||||||||||
bapineuzumab* | ✓ | ✓ | ✓ | ✓ | No |
Year Ended December 31, | Year Ended December 31, | Change | |||||||||||||||||||||||||||||||||
2021 | 2020 | Change | 2022 | 2021 | $ | % | |||||||||||||||||||||||||||||
Grant and other revenue | $ | — | $ | 1,436 | $ | (1,436 | ) | ||||||||||||||||||||||||||||
Costs and operating expenses | Costs and operating expenses | ||||||||||||||||||||||||||||||||||
Research and development | 12,305 | 7,997 | 4,308 | Research and development | $ | 32,361 | $ | 12,305 | $ | 20,056 | 163 | % | |||||||||||||||||||||||
General and administrative | 7,279 | 1,351 | 5,928 | General and administrative | 12,876 | 7,279 | 5,597 | 77 | % | ||||||||||||||||||||||||||
Total operating expenses | 19,584 | 9,348 | 10,236 | Total operating expenses | 45,237 | 19,584 | 25,653 | 131 | % | ||||||||||||||||||||||||||
Loss from operations | (19,584 | ) | (7,912 | ) | (11,672 | ) | Loss from operations | (45,237) | (19,584) | (25,653) | 131 | % | |||||||||||||||||||||||
Other income (expense) | Other income (expense) | ||||||||||||||||||||||||||||||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | (81,157 | ) | 586 | (81,743 | ) | ||||||||||||||||||||||||||||||
Interest income, net | 84 | 1 | 83 | Interest income, net | 2,392 | 84 | 2,308 | * | |||||||||||||||||||||||||||
Other income, net | 51 | — | 51 | Other income, net | (11) | 51 | (62) | (122) | % | ||||||||||||||||||||||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | — | (81,157) | 81,157 | * | ||||||||||||||||||||||||||||||
Total other income (expense) | (81,022 | ) | 587 | (81,609 | ) | Total other income (expense) | 2,381 | (81,022) | 83,403 | * | |||||||||||||||||||||||||
Net loss | (100,606 | ) | (7,325 | ) | (93,281 | ) | Net loss | $ | (42,856) | $ | (100,606) | $ | 57,750 | (57) | % | ||||||||||||||||||||
Other comprehensive loss | |||||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | (231 | ) | — | (231 | ) | ||||||||||||||||||||||||||||||
Comprehensive loss | $ | (100,837 | ) | $ | (7,325 | ) | $ | (93,512 | ) | ||||||||||||||||||||||||||
Year Ended December 31, | |||||||||||
2022 | 2021 | ||||||||||
Net cash used in operating activities | $ | (35,153) | $ | (17,961) | |||||||
Net cash provided by (used in) investing activities | 39,185 | (104,120) | |||||||||
Net cash provided by financing activities | 3,907 | 200,466 | |||||||||
Net change in cash and cash equivalents | $ | 7,939 | $ | 78,385 |
Year Ended December 31, | ||||||||
2021 | 2020 | |||||||
Net cash used in operating activities | $ | (17,961 | ) | $ | (7,450 | ) | ||
Net cash used in investing activities | (104,120 | ) | — | |||||
Net cash provided by financing activities | 200,466 | 44,675 | ||||||
Net change in cash and cash equivalents | $ | 78,385 | $ | 37,225 | ||||
Page | ||||||||
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) | ||||||||
December 31, | |||||||||||
2022 | 2021 | ||||||||||
ASSETS | |||||||||||
Current assets | |||||||||||
Cash and cash equivalents | $ | 130,101 | $ | 122,162 | |||||||
Marketable securities, short-term | 47,504 | 72,075 | |||||||||
Prepaid expenses and other current assets | 2,724 | 4,424 | |||||||||
Total current assets | 180,329 | 198,661 | |||||||||
Marketable securities, long-term | 15,837 | 31,619 | |||||||||
Property and equipment, net | 165 | 36 | |||||||||
Right-of-use asset | 105 | — | |||||||||
Other assets | 151 | 14 | |||||||||
Total assets | $ | 196,587 | $ | 230,330 | |||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
Current liabilities | |||||||||||
Accounts payable | $ | 1,640 | $ | 1,088 | |||||||
Accrued clinical trial expenses | 2,717 | 147 | |||||||||
Accrued expenses and other current liabilities | 3,350 | 3,912 | |||||||||
Operating lease liability, current portion | 105 | — | |||||||||
Total current liabilities | 7,812 | 5,147 | |||||||||
Total liabilities | 7,812 | 5,147 | |||||||||
Commitments and contingencies (Note 11) | |||||||||||
Stockholders’ equity | |||||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding as of December 31, 2022 and 2021 | — | — | |||||||||
Common stock, $0.0001 par value; 300,000,000 shares authorized and 41,025,062 and 40,473,270 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 4 | 4 | |||||||||
Additional paid-in capital | 359,949 | 352,981 | |||||||||
Accumulated deficit | (170,427) | (127,571) | |||||||||
Accumulated other comprehensive loss | (751) | (231) | |||||||||
Total stockholders’ equity | 188,775 | 225,183 | |||||||||
Total liabilities and stockholders’ equity | $ | 196,587 | $ | 230,330 |
December 31, | ||||||||
2021 | 2020 | |||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 122,162 | $ | 43,777 | ||||
Marketable securities, short-term | 72,075 | — | ||||||
Grant receivable | — | 109 | ||||||
Prepaid expenses and other current assets | 4,424 | 543 | ||||||
Total current assets | 198,661 | 44,429 | ||||||
Marketable securities, long-term | 31,619 | — | ||||||
Property and equipment, net | 36 | — | ||||||
Other assets | 14 | — | ||||||
Total assets | $ | 230,330 | $ | 44,429 | ||||
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 1,088 | $ | 531 | ||||
Accrued expenses and other current liabilities | 4,059 | 423 | ||||||
Preferred stock tranche rights liability | — | 5,033 | ||||||
Preferred stock warrant liability | — | 380 | ||||||
Total liabilities | 5,147 | 6,367 | ||||||
Series A convertible preferred stock, $0.0001 par value; 0 shares authorized, issued and outstanding as of December 31, 2021; 711,203 shares authorized and 477,297 shares issued and outstanding as of December 31, 2020; liquidation preference of $1,067 as of December 31, 2020 | — | 1,067 | ||||||
Series A-1 convertible preferred stock, $0.0001 par value; 0 shares authorized, issued and outstanding as of December 31, 2021; 11,898,177 shares authorized and 7,537,879 shares issued and outstanding as of December 31, 2020; liquidation preference of $16,847 as of December 31, 2020 | — | 16,333 | ||||||
Series B convertible preferred stock, $0.0001 par value; 0 shares authorized, issued and outstanding as of December 31, 2021; 29,457,450 shares authorized and 11,862,043 shares issued and outstanding as of December 31, 2020; liquidation preference of $45,070 as of December 31, 2020 | — | 39,253 | ||||||
Stockholders’ equity (deficit) | ||||||||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding as of December 31, 2021; 0 shares authorized, issued and outstanding as of December 31, 2020 | 0— | — | ||||||
Common stock, $0.0001 par value; 300,000,000 shares authorized and 40,473,270 shares issued and outstanding as of December 31, 2021; 50,500,000 shares authorized and 419,124 shares issued and outstanding as of December 31, 2020 | 4 | — | ||||||
Additional paid-in capital | 352,981 | 8,374 | ||||||
Accumulated deficit | (127,571 | ) | (26,965 | ) | ||||
Accumulated other comprehensive loss | (231 | ) | — | |||||
Total stockholders’ equity (deficit) | 225,183 | (18,591 | ) | |||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 230,330 | $ | 44,429 | ||||
Year Ended December 31, | |||||||||||
2022 | 2021 | ||||||||||
Operating expenses | |||||||||||
Research and development | $ | 32,361 | $ | 12,305 | |||||||
General and administrative | 12,876 | 7,279 | |||||||||
Total operating expenses | 45,237 | 19,584 | |||||||||
Loss from operations | (45,237) | (19,584) | |||||||||
Other income (expense) | |||||||||||
Interest income, net | 2,392 | 84 | |||||||||
Other income (expense), net | (11) | 51 | |||||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | — | (81,157) | |||||||||
Total other income (expense) | 2,381 | (81,022) | |||||||||
Net loss | (42,856) | (100,606) | |||||||||
Other comprehensive loss | |||||||||||
Unrealized loss on marketable securities | (520) | (231) | |||||||||
Comprehensive loss | $ | (43,376) | $ | (100,837) | |||||||
Net loss per common share, basic and diluted | $ | (1.06) | $ | (5.02) | |||||||
Weighted-average shares outstanding, basic and diluted | 40,601,936 | 20,057,534 |
Year Ended December 31, | ||||||||
2021 | 2020 | |||||||
Grant and other revenue | $ | — | $ | 1,436 | ||||
Operating expenses | ||||||||
Research and development | 12,305 | 7,997 | ||||||
General and administrative | 7,279 | 1,351 | ||||||
Total operating expenses | 19,584 | 9,348 | ||||||
Loss from operations | (19,584 | ) | (7,912 | ) | ||||
Other income (expense) | ||||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | (81,157 | ) | 586 | |||||
Interest income, net | 84 | 1 | ||||||
Other income, net | 51 | — | ||||||
Total other income (expense) | (81,022 | ) | 587 | |||||
Net loss | (100,606 | ) | (7,325 | ) | ||||
Other comprehensive loss | ||||||||
Unrealized loss on marketable securities | (231 | ) | — | |||||
Comprehensive loss | $ | (100,837 | ) | $ | (7,325 | ) | ||
Net loss per common share, basic and diluted | $ | (5.02 | ) | $ | (17.48 | ) | ||
Weighted-average shares outstanding, basic and diluted | 20,057,534 | 419,124 | ||||||
Series A Convertible Preferred Stock | Series A-1 Convertible Preferred Stock | Series B Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders’ Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance as of January 1, 2021 | 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 $15,445 | — | — | — | — | — | — | 11,499,998 | 1 | 168,555 | — | — | 168,556 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cashless exercise of common stock warrants | — | — | — | — | — | — | 178,847 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock options exercised | — | — | — | — | — | — | 5,183 | — | 15 | — | — | 15 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | — | — | — | — | (231) | (231) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | — | — | 922 | — | — | 922 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | (100,606) | — | (100,606) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2021 | — | — | — | — | — | — | 40,473,270 | 4 | 352,981 | (127,571) | (231) | 225,183 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock for cash, net of issuance costs of $412 | — | — | — | — | — | — | 422,160 | — | 3,792 | — | — | 3,792 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | — | — | — | — | (520) | (520) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock options exercised | — | — | — | — | — | — | 124,886 | — | 115 | — | — | 115 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cashless exercise of stock options | — | — | — | — | — | — | 4,746 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | — | — | 3,061 | — | — | 3,061 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | (42,856) | — | (42,856) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2022 | — | $ | — | — | $ | — | — | $ | — | 41,025,062 | $ | 4 | $ | 359,949 | $ | (170,427) | $ | (751) | $ | 188,775 |
Series A Convertible Preferred Stock | Series A-1 Convertible Preferred Stock | Series B Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders’ Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2019 | 477,297 | $ | 1,067 | 7,537,879 | $ | 16,333 | 0 | $ | 0 | 419,124 | $ | 0 | $ | 8,220 | $ | (19,640 | ) | $ | 0 | $ | (11,420 | ) | ||||||||||||||||||||||||||
Issuance of Series B convertible preferred stock for cash, net of issuance costs of $395 | — | — | — | — | 11,862,043 | 39,253 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | — | — | 154 | — | 0 | 154 | ||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | (7,325 | ) | 0 | (7,325 | ) | ||||||||||||||||||||||||||||||||||
Balance as of December 31, 2020 | 477,297 | 1,067 | 7,537,879 | 16,333 | 11,862,043 | 39,253 | 419,124 | 0 | 8,374 | (26,965 | ) | 0 | (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 $15,445 | — | — | — | — | — | — | 11,499,998 | 1 | 168,555 | — | — | 168,556 | ||||||||||||||||||||||||||||||||||||
Cashless exercise of common stock warrants | — | — | — | — | — | — | 178,847 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Stock options exercised | — | — | — | — | — | — | 5,183 | — | 15 | — | — | 15 | ||||||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | — | — | — | — | (231 | ) | (231 | ) | ||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | — | — | 922 | — | — | 922 | ||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | (100,606 | ) | — | (100,606 | ) | ||||||||||||||||||||||||||||||||||
Balance as of December 31, 2021 | 0 | $ | 0 | 0 | $ | 0 | 0 | $ | 0 | 40,473,270 | $ | 4 | $ | 352,981 | $ | (127,571 | ) | $ | (231 | ) | $ | 225,183 | ||||||||||||||||||||||||||
Year Ended December 31, | |||||||||||
2022 | 2021 | ||||||||||
Cash flows from operating activities | |||||||||||
Net loss | $ | (42,856) | $ | (100,606) | |||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Depreciation | 32 | 4 | |||||||||
Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | — | 81,157 | |||||||||
Stock-based compensation expense | 3,061 | 922 | |||||||||
Amortization of premiums and accretion of discounts on marketable securities, net | 487 | 155 | |||||||||
Amortization of right-of-use asset | 137 | — | |||||||||
Other non-cash expense | — | 109 | |||||||||
Changes in operating assets and liabilities: | |||||||||||
Prepaid expenses and other current assets | 1,700 | (3,881) | |||||||||
Other assets | (137) | (14) | |||||||||
Accounts payable | 552 | 557 | |||||||||
Accrued clinical trial expenses | 2,570 | 147 | |||||||||
Operating lease liability | (137) | — | |||||||||
Accrued expenses and other current liabilities | (562) | 3,489 | |||||||||
Net cash used in operating activities | (35,153) | (17,961) | |||||||||
Cash flows from investing activities | |||||||||||
Purchases of marketable securities | (41,514) | (104,080) | |||||||||
Proceeds from maturities and sales of marketable securities | 80,860 | — | |||||||||
Purchases of property and equipment | (161) | (40) | |||||||||
Net cash provided by (used in) investing activities | 39,185 | (104,120) | |||||||||
Cash flows from financing activities | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | 3,792 | 168,556 | |||||||||
Proceeds from exercise of stock options | 115 | 15 | |||||||||
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 | |||||||||
Net cash provided by financing activities | 3,907 | 200,466 | |||||||||
Net change in cash and cash equivalents | 7,939 | 78,385 | |||||||||
Cash and cash equivalents at the beginning of the period | 122,162 | 43,777 | |||||||||
Cash and cash equivalents at the end of the period | $ | 130,101 | $ | 122,162 | |||||||
Supplemental disclosure of cash flow information | |||||||||||
Cash paid for income taxes | $ | — | $ | — | |||||||
Cash paid for interest | $ | — | $ | — | |||||||
Supplemental disclosure of noncash financing activities | |||||||||||
Right-of-use assets obtained in exchange for operating lease liabilities | $ | 242 | $ | — | |||||||
Conversion of convertible preferred stock into common stock upon IPO | $ | — | $ | 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 |
Year Ended December 31, | ||||||||
2021 | 2020 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (100,606 | ) | $ | (7,325 | ) | ||
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 | 81,157 | (586 | ) | |||||
Stock-based compensation expense | 922 | 154 | ||||||
Amortization of premiums and accretion of discounts on marketable securities, net | 155 | — | ||||||
Other non-cash expense | 109 | — | ||||||
Changes in operating assets and liabilities: | ||||||||
Grant receivable | — | (79 | ) | |||||
Prepaid expenses and other current assets | (3,881 | ) | 53 | |||||
Other assets | (14 | ) | 144 | |||||
Accounts payable | 557 | 308 | ||||||
Accrued expenses and other current liabilities | 3,636 | (119 | ) | |||||
Net cash used in operating activities | (17,961 | ) | (7,450 | ) | ||||
Cash flows from investing activities | ||||||||
Purchases of available-for-sale | (104,080 | ) | — | |||||
Purchases of property and equipment | (40 | ) | — | |||||
Net cash used in investing activities | (104,120 | ) | — | |||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of Series B milestone shares, net of issuance costs | 30,031 | — | ||||||
Proceeds from issuance of convertible preferred stock, net of issuance costs | — | 44,675 | ||||||
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 issuance costs | 168,556 | — | ||||||
Proceeds from stock option exercises | 15 | — | ||||||
Net cash provided by financing activities | 200,466 | 44,675 | ||||||
Net change in cash and cash equivalents | 78,385 | 37,225 | ||||||
Cash and cash equivalents at the beginning of the period | 43,777 | 6,552 | ||||||
Cash and cash equivalents at the end of the period | $ | 122,162 | $ | 43,777 | ||||
Supplemental disclosure of cash flow information | ||||||||
Cash paid for income taxes | $ | 0 | $ | 0 | ||||
Cash paid for interest | $ | 0 | $ | 0 | ||||
Supplemental disclosure of noncash financing activities | ||||||||
Reclassification of preferred stock tranche rights liability upon share issuance | $ | 81,190 | $ | 0 | ||||
Reclassification of warrant liability upon exercise of preferred stock warrant | $ | 5,380 | $ | 0 | ||||
Conversion of convertible preferred stock into common stock upon IPO | $ | 174,504 | $ | 0 | ||||
Level 3 — Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
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 | $ | 121,162 | ||||||||
Marketable securities | ||||||||||||||||
Commercial paper | — | 47,939 | 0 | 47,939 | ||||||||||||
Corporate debt securities | — | 24,694 | 0 | 24,694 | ||||||||||||
Asset-backed securities | — | 19,143 | 0 | 19,143 | ||||||||||||
U.S. treasury securities | — | 11,918 | 0 | 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, 2020 | |||||||||||||
Assets included in: | ||||||||||||||||
Cash and cash equivalents | ||||||||||||||||
Money market securities | $ | 36,758 | $ | — | $ | — | $ | 36,758 | ||||||||
Total fair value | $ | 36,758 | $ | — | $ | — | $ | 36,758 | ||||||||
Liabilities included in: | ||||||||||||||||
Preferred stock tranche rights liability | $ | — | $ | — | $ | 5,033 | $ | 5,033 | ||||||||
Preferred stock warrant liability | — | — | 380 | 380 | ||||||||||||
Total fair value | $ | — | $ | — | $ | 5,413 | $ | 5,413 | ||||||||
December 31, 2022 | |||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||||||||||
Available-for-sale securities, short-term | |||||||||||||||||||||||
Corporate debt securities | $ | 30,174 | $ | — | $ | (249) | $ | 29,925 | |||||||||||||||
Asset-backed securities | 3,006 | — | (102) | 2,904 | |||||||||||||||||||
U.S. treasury securities | 15,032 | — | (357) | 14,675 | |||||||||||||||||||
Total available-for-sale securities, short-term | 48,212 | — | (708) | 47,504 | |||||||||||||||||||
Available-for-sale securities, long-term | |||||||||||||||||||||||
Corporate debt securities | 15,880 | — | (43) | 15,837 | |||||||||||||||||||
Total available-for-sale securities, long-term | 15,880 | — | (43) | 15,837 | |||||||||||||||||||
Total available-for-sale securities | $ | 64,092 | $ | — | $ | (751) | $ | 63,341 |
December 31, 2021 | |||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||||||||||
Available-for-sale securities, short-term | |||||||||||||||||||||||
Commercial paper | $ | 47,939 | $ | — | $ | — | $ | 47,939 | |||||||||||||||
Corporate debt securities | 7,992 | — | (11) | 7,981 | |||||||||||||||||||
Asset-backed securities | 16,177 | — | (22) | 16,155 | |||||||||||||||||||
Total available-for-sale securities, short-term | 72,108 | — | (33) | 72,075 | |||||||||||||||||||
Available-for-sale securities, long-term | |||||||||||||||||||||||
Corporate debt securities | 16,816 | — | (103) | 16,713 | |||||||||||||||||||
Asset-backed securities | 3,013 | — | (25) | 2,988 | |||||||||||||||||||
U.S. treasury securities | 11,988 | — | (70) | 11,918 | |||||||||||||||||||
Total available-for-sale securities, long-term | 31,817 | — | (198) | 31,619 | |||||||||||||||||||
Total available-for-sale securities | $ | 103,925 | $ | — | $ | (231) | $ | 103,694 |
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||||||
Available-for-sale | ||||||||||||||||
Commercial paper | $ | 47,939 | $ | — | $ | — | $ | 47,939 | ||||||||
Corporate debt securities | 7,992 | — | (11 | ) | 7,981 | |||||||||||
Asset-backed securities | 16,177 | — | (22 | ) | 16,155 | |||||||||||
Total available-for-sale | 72,108 | — | (33 | ) | 72,075 | |||||||||||
Available-for-sale | ||||||||||||||||
Corporate debt securities | 16,816 | — | (103 | ) | 16,713 | |||||||||||
Asset-backed securities | 3,013 | — | (25 | ) | 2,988 | |||||||||||
U.S. treasury securities | 11,988 | — | (70 | ) | 11,918 | |||||||||||
Total available-for-sale | 31,817 | — | (198 | ) | 31,619 | |||||||||||
Total available-for-sale | $ | 103,925 | $ | — | $ | (231 | ) | $ | 103,694 | |||||||
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, 2022 | ||||||||||||||||||||
Assets included in: | |||||||||||||||||||||||
Cash and cash equivalents | |||||||||||||||||||||||
Money market securities | $ | 129,100 | $ | — | $ | — | $ | 129,100 | |||||||||||||||
Marketable securities | |||||||||||||||||||||||
Corporate debt securities | — | 45,762 | — | 45,762 | |||||||||||||||||||
Asset-backed securities | — | 2,904 | — | 2,904 | |||||||||||||||||||
U.S. treasury securities | — | 14,675 | — | 14,675 | |||||||||||||||||||
Total fair value | $ | 129,100 | $ | 63,341 | $ | — | $ | 192,441 |
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 |
June 17, 2021 | December 31, 2020 | ||||||||||
Risk-free interest rate | 0.07% | 0.12% | |||||||||
Expected time to Milestone Closing (in years) | 0.8 | 1.3 | |||||||||
Probability of achievement of Milestone Closing | 100% | 65% |
June 22, 2021 | December 31, 2020 | ||||||||||
Risk-free interest rate | 0.25% | 0.13% | |||||||||
Expected term (in years) | 2.0 | 2.0 | |||||||||
Expected volatility | 90% | 90% | |||||||||
Expected dividend yield | 0% | 0% |
Series A-1 Preferred Stock Warrant | Series B Tranche Rights | Total | |||||||||||||||
Balance, January 1, 2021 | $ | 380 | $ | 5,033 | $ | 5,413 | |||||||||||
Change in fair value | 5,000 | 76,157 | 81,157 | ||||||||||||||
Settlement of tranche liability due to issuance of Milestone Shares | — | (81,190) | (81,190) | ||||||||||||||
Settlement of warrant liability upon exercise of warrant | (5,380) | — | (5,380) | ||||||||||||||
Balance, December 31, 2021 | $ | — | $ | — | $ | — |
December 31, | |||||||||||
2022 | 2021 | ||||||||||
Prepaid insurance | $ | 1,106 | $ | 1,514 | |||||||
Research and development service agreements | 1,077 | 2,591 | |||||||||
Prepaid raw materials | 199 | 83 | |||||||||
Dues and subscriptions | 105 | 96 | |||||||||
Other | 237 | 140 | |||||||||
Total prepaid expenses and other current assets | $ | 2,724 | $ | 4,424 |
December 31, | ||||||||
2021 | 2020 | |||||||
Research and development service agreements | $ | 2,591 | $ | 432 | ||||
Prepaid insurance | 1,514 | 5 | ||||||
Dues and subscriptions | 96 | — | ||||||
Prepaid raw materials | 83 | 91 | ||||||
Other | 140 | 15 | ||||||
Total prepaid expenses and other current assets | $ | 4,424 | $ | 543 | ||||
December 31, | |||||||||||
2022 | 2021 | ||||||||||
Research and development | $ | 1,211 | $ | 2,476 | |||||||
Compensation and other employee liabilities | 2,008 | 1,102 | |||||||||
Legal | — | 130 | |||||||||
Other | 131 | 204 | |||||||||
Total accrued expenses and other current liabilities | $ | 3,350 | $ | 3,912 |
December 31, | ||||||||
2021 | 2020 | |||||||
Research and development | $ | 2,623 | $ | 133 | ||||
Bonuses and other employee liabilities | 1,102 | — | ||||||
Legal | 130 | — | ||||||
Professional fees | 0 | 200 | ||||||
Other | 204 | 90 | ||||||
Total accrued expenses and other current liabilities | $ | 4,059 | $ | 423 | ||||
Operating leases | |||||||||||
Operating lease cost | $ | 154 | |||||||||
Less: sublease income | (43) | ||||||||||
Operating lease expense | 111 | ||||||||||
Short-term lease rent expense | 13 | ||||||||||
Total rent expense | $ | 124 |
Operating cash flows from operating leases | $154 | ||||
Right-of-use assets obtained in exchange for operating lease liabilities | $242 | ||||
Weighted-average remaining lease term – operating leases (in years) | 0.7 | ||||
Weighted-average discount rate – operating leases | 10.0% |
Year ended December 31, 2023 | $ | 109 | |||
Less: present value discount | (4) | ||||
Operating lease liabilities | $ | 105 |
Shares Authorized | Shares Issued and Outstanding | Weighted Average Issuance Price per Share | Carrying Value | Liquidation Preference | ||||||||||||||||
Series A | 711,203 | 477,297 | $ | 2.24 | $ | 1,067 | $ | 1,067 | ||||||||||||
Series A-1 | 11,898,177 | 7,537,879 | 2.24 | 16,333 | 16,847 | |||||||||||||||
Series B | 29,457,450 | 11,862,043 | 3.80 | 39,253 | 45,070 | |||||||||||||||
Total | 42,066,830 | 19,877,219 | $ | 56,653 | $ | 62,984 | ||||||||||||||
June 17, 2021 | December 31, 2020 | |||||||
Risk-free interest rate | 0.07 | % | 0.12 | % | ||||
Expected time to Milestone Closing (in years) | 0.8 | 1.3 | ||||||
Probability of achievement of Milestone Closing | 100 | % | 65 | % |
June 2021 | December 31, 2020 | |||
Risk-free interest rate | 0.25% | 0.13% | ||
Expected term (in years) | 2.0 | 2.0 | ||
Expected volatility | 90% | 90% | ||
Expected dividend yield | 0% | 0% |
Series A-1 Preferred Stock Warrant | Series B Tranche Rights | Total | ||||||||||
Balance, December 31, 201 9 | $ | 577 | $ | — | $ | 577 | ||||||
Fair value at issuance of Series B convertible preferred stock (November 2020) | — | 5,422 | 5,422 | |||||||||
Change in fair valu e | (197 | ) | (389 | ) | (586 | ) | ||||||
Balance, December 31, 2020 | 380 | 5,033 | 5,413 | |||||||||
Change in fair value | 5,000 | 76,157 | 81,157 | |||||||||
Settlement of tranche liability due to issuance of Milestone Shares | — | (81,190 | ) | (81,190 | ) | |||||||
Settlement of warrant liability upon exercise of | (5,380 | ) | — | (5,380 | ) | |||||||
Balance, December 31, 2021 | $ | 0 | $ | 0 | $ | 0 |
Equity Upon Exercise | Exercise Price | Expiration Dates | Number of Warrants | |||||||||||||
Warrants issued in 2014 | Common Stock | $ | 4.47 | 3/21/2024 – 6/30/2025 | 83,726 | |||||||||||
Warrants issued in 2015 | Common Stock | $ | 4.47 | 6/30/2025 | 209,690 | |||||||||||
Warrants issued in 2016 | Common Stock | $ | 4.47 | 6/30/2025 | 34,396 | |||||||||||
Warrants issued in 2017 | Common Stock | $ | 4.47 | 6/30/2025 | 57,881 | |||||||||||
Total Warrants | 385,693 |
Year Ended December 31, | |||||||||||
2022 | 2021 | ||||||||||
Risk-free interest rate | 1.7% – 4.2% | 0.4% – 1.3% | |||||||||
Expected term (in years) | 5.8 – 6.1 | 5.3 – 6.1 | |||||||||
Expected volatility | 90% | 90% | |||||||||
Expected dividend yield | 0% | 0% |
Risk-free interest rate | ||||||
Expected time to liquidity event (in years) | 2.0 | |||||
Expected volatility | 90% | |||||
Expected dividend yield | 0% |
Stock Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (in years) | Aggregate Intrinsic Value (in thousands) | ||||||||||||||||||||
Outstanding at January 1, 2022 | 3,835,618 | $ | 2.51 | ||||||||||||||||||||
Granted | 1,999,050 | $ | 5.04 | ||||||||||||||||||||
Exercised | (131,626) | $ | 0.93 | ||||||||||||||||||||
Forfeited | (79,872) | $ | 6.35 | ||||||||||||||||||||
Expired | (12,277) | $ | 16.00 | ||||||||||||||||||||
Outstanding at December 31, 2022 | 5,610,893 | $ | 3.36 | 8.1 | $ | 14,980 | |||||||||||||||||
Vested and exercisable at December 31, 2022 | 2,188,874 | $ | 2.03 | 7.1 | $ | 8,714 |
Stock Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (in years) | Aggregate Intrinsic Value (in thousands) | |||||||||||||
Outstanding at December 31, 2020 | 1,001,517 | $ | 1.13 | |||||||||||||
Granted | 2,839,284 | 2.99 | ||||||||||||||
Exercised | (5,183 | ) | 2.85 | |||||||||||||
Outstanding at December 31, 2021 | 3,835,618 | $ | 2.51 | 8.5 | $ | 19,458 | ||||||||||
Vested and exercisable at December 31, 2021 | 1,004,510 | $ | 1.56 | 6.9 | $ | 5,523 |
Year Ended December 31, | |||||||||||
2022 | 2021 | ||||||||||
General and administrative | $ | 2,163 | $ | 690 | |||||||
Research and development | 898 | 232 | |||||||||
Total stock-based compensation | $ | 3,061 | $ | 922 |
Year Ended December 31, | ||||||||
2021 | 2020 | |||||||
General and administrative | $ | 690 | $ | 103 | ||||
Research and development | 232 | 51 | ||||||
Total stock-based compensation | $ | 922 | $ | 154 |
Year Ended December 31, | |||||||||||
2022 | 2021 | ||||||||||
Statutory federal income tax rate | 21.0 | % | 21.0 | % | |||||||
State tax, net of federal benefit | 2.7 | 0.7 | |||||||||
Non-deductible stock compensation | (0.5) | — | |||||||||
Rate change | (1.1) | (0.2) | |||||||||
Change in fair value of tranche and warrant liabilities | — | (16.9) | |||||||||
Non-deductible expense | — | (0.1) | |||||||||
R&D credit | — | (0.3) | |||||||||
Other | — | 0.1 | |||||||||
Change in valuation allowance | (22.1) | (4.3) | |||||||||
Income tax provision (benefit) | 0.0 | % | 0.0 | % |
For the Year Ended December 31, | ||||||||
2021 | 2020 | |||||||
Statutory federal income tax rate | 21.0 | % | 21.0 | % | ||||
State tax, net of federal benefit | 0.7 | 5.1 | ||||||
Change in fair value oftranche and warrant liabilities | (16.9 | ) | 1.7 | |||||
Non-deductible expense | (0.1 | ) | — | |||||
R&D credit | (0.3 | ) | 4.1 | |||||
Rate change | (0.2 | ) | — | |||||
Other | 0.1 | — | ||||||
Change in valuation allowance | (4.3 | ) | (31.9 | ) | ||||
Income tax provision (benefit) | 0.0 | % | 0.0 | % | ||||
December 31, | |||||||||||
2022 | 2021 | ||||||||||
Deferred tax assets: | |||||||||||
Net operating loss | $ | 13,125 | $ | 10,819 | |||||||
R&D credit | 1,381 | 1,381 | |||||||||
Capitalized R&D | 6,788 | — | |||||||||
Stock compensation | 675 | 263 | |||||||||
Accruals and other temporary differences | 179 | 58 | |||||||||
Gross deferred tax assets | 22,148 | 12,521 | |||||||||
Valuation allowance | (22,118) | (12,520) | |||||||||
Total deferred tax assets | 30 | 1 | |||||||||
Deferred tax liabilities: | |||||||||||
Depreciation | (30) | (1) | |||||||||
Total deferred tax liabilities | (30) | (1) | |||||||||
Net deferred tax assets | $ | — | $ | — |
December 31, | ||||||||
2021 | 2020 | |||||||
Deferred tax assets: | ||||||||
Net operating loss | $ | 10,819 | $ | 6,354 | ||||
R&D credit | 1,381 | 1,681 | ||||||
Stock compensation | 263 | 85 | ||||||
Accruals and other temporary differences | 58 | — | ||||||
Gross deferred tax assets | 12,521 | 8,120 | ||||||
Depreciation | (1 | ) | — | |||||
Valuation allowance | (12,520 | ) | (8,120 | ) | ||||
Deferred tax assets, net of allowance | $ | 0 | $ | 0 | ||||
Year ended December 31, 2022 | $ | 153 | ||
Year ended December 31, 2023 | 102 | |||
Total | $ | 255 | ||
Year Ended December 31, | ||||||||
2021 | 2020 | |||||||
Shares issuable upon exercise of stock options | 3,835,618 | 1,001,517 | ||||||
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 | 3,835,618 | 21,711,855 | ||||||
Number | Description of Exhibit | |||||||
10.7+ | ||||||||
Number | ||||||||
Amended and Restated Employment Agreement, by and between the Registrant and Eric Siemers, M.D. (incorporated by reference to Exhibit 10.9 to the Company’s Annual Report on Form 10-K (File No. 001-40551), filed with the Securities and Exchange Commission on March 28, 2022). | ||||||||
23.1* | ||||||||
24.1* | ||||||||
31.1* | ||||||||
31.2* | ||||||||
32.1# | ||||||||
32.2# | ||||||||
101.INS* | Inline XBRL Instance | |||||||
101.SCH* | Inline XBRL Taxonomy Extension Schema | |||||||
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase | |||||||
101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase | |||||||
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase | |||||||
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase | |||||||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* | Filed herewith. |
† | Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks [***] as the identified confidential portions (i) are not material and (ii) the Registrant customarily and actually treats that information as private or confidential. |
+ | Indicates management contract or compensatory plan. |
# | 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: March | By: | /s/ Daniel O’Connell | |||||||||
Daniel O’Connell President and Chief Executive Officer |
Signature | Title | Date | ||||||||||||
/s/ Daniel O’Connell | Chief Executive Officer and Director | March 27, 2023 | ||||||||||||
Daniel O’Connell | (Principal Executive Officer) | |||||||||||||
/s/ William Matthew Zuga | Chief Financial Officer and Chief Business Officer | March | ||||||||||||
William Matthew Zuga | (Principal Financial Officer and Principal Accounting Officer) | |||||||||||||
/s/ Kimberlee C. Drapkin | Director | March 27, 2023 | ||||||||||||
Kimberlee C. Drapkin | ||||||||||||||
/s/ Nathan B. Fountain | Director | March | ||||||||||||
Nathan B. Fountain, M.D. | ||||||||||||||
/s/ Jeffrey L. Ives | Director | March | ||||||||||||
Jeffrey L. Ives, PhD | ||||||||||||||
/s/ Derrell D. Porter | Director | March 27, 2023 | ||||||||||||
Derrell D. Porter, M.D. | ||||||||||||||
/s/ Sean Stalfort | Director | March | ||||||||||||
Sean Stalfort | ||||||||||||||
/s/ Laura Stoppel | Director | March | ||||||||||||
Laura Stoppel, PhD | ||||||||||||||