Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 13, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-36714 | |
Entity Registrant Name | JAGUAR HEALTH, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-2956775 | |
Entity Address, Address Line One | 200 Pine Street, Suite 400 | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94104 | |
City Area Code | 415 | |
Local Phone Number | 371-8300 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common stock, Par Value $0.0001 Per Share | |
Trading Symbol | JAGX | |
Security Exchange Name | NASDAQ | |
Entity Central Index Key | 0001585608 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Common stock - voting | ||
Document and Entity Information | ||
Entity Common Stock, Shares Outstanding | 9,241,231 | |
Common stock - non-voting | ||
Document and Entity Information | ||
Entity Common Stock, Shares Outstanding | 0 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash | $ 16,049 | $ 6,469 |
Accounts receivable, net | 1,299 | 1,967 |
Other receivable | 65 | 217 |
Inventory | 9,556 | 9,189 |
Prepaid expenses and other current assets | 13,142 | 10,121 |
Total current assets | 40,111 | 27,963 |
Property and equipment, net | 488 | 496 |
Operating lease - right-of-use asset | 1,176 | 1,176 |
Intangible assets, net | 19,408 | 20,116 |
Other assets | 276 | 1,012 |
Total assets | 61,459 | 50,763 |
Current liabilities: | ||
Accounts payable | 4,093 | 4,974 |
Accrued liabilities | 3,339 | 3,798 |
Deferred revenue | 170 | |
Operating lease liability, current | 416 | 348 |
Notes payable, net of discount (includes note designated at Fair Value Option amounting to $10.5 million as of June 30, 2024, and $0 December 31, 2023, respectively) | 11,115 | 4,867 |
Total current liabilities | 19,133 | 13,987 |
Operating lease liability, net of current portion | 812 | 886 |
Deferred revenue - long term | 638 | |
Notes payable, net of discount, net of current portion (includes notes designated at Fair Value Option amounting to $21.8 million as of June 30, 2024, and $31.0 million December 31, 2023, respectively) | 21,813 | 30,993 |
Total liabilities | 42,396 | 45,866 |
Commitments and contingencies (See Note 6) | ||
Redeemable preferred stock: $0.0001 par value; 179 and 0 shares designated from 10,000.000 preferred stock authorized at June 30, 2024, and December 31, 2023; 99 and 0 shares issued and outstanding at June 30, 2024 and December 31, 2023 | 2,485 | |
Stockholders' equity | ||
Additional paid-in capital | 344,155 | 313,861 |
Non-controlling interest | (328) | (64) |
Accumulated deficit | (326,707) | (308,248) |
Accumulated other comprehensive loss | (542) | (652) |
Total stockholders' equity | 16,578 | 4,897 |
Total liabilities, redeemable preferred stock and stockholders' equity | 61,459 | 50,763 |
Series G convertible preferred stock | ||
Stockholders' equity | ||
Preferred stock value | ||
Series H convertible preferred stock | ||
Stockholders' equity | ||
Preferred stock value | ||
Series I convertible preferred stock | ||
Stockholders' equity | ||
Preferred stock value |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Current notes designated at Fair Value Option | $ 10.5 | $ 0 |
Non-current notes designated at Fair Value Option | $ 21.8 | $ 31 |
Redeemable preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Redeemable preferred stock, designated from authorized preferred stock | 179 | 0 |
Redeemable preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Redeemable preferred stock, shares issued (in shares) | 99 | 0 |
Redeemable preferred stock, shares outstanding (in shares) | 99 | 0 |
Convertible preferred stock, shares designated (in shares) | 7,535,013 | 7,534,834 |
Convertible preferred stock, shares issued (in shares) | 99 | 178 |
Convertible preferred stock, shares outstanding (in shares) | 99 | 178 |
Series G convertible preferred stock | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Convertible preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Convertible preferred stock, shares designated (in shares) | 137 | 137 |
Convertible preferred stock, shares issued (in shares) | 0 | 122 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 122 |
Series H convertible preferred stock | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Convertible preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Convertible preferred stock, shares designated (in shares) | 105 | 105 |
Convertible preferred stock, shares issued (in shares) | 0 | 0 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 0 |
Series I convertible preferred stock | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Convertible preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Convertible preferred stock, shares designated (in shares) | 118 | 118 |
Convertible preferred stock, shares issued (in shares) | 0 | 56 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 56 |
Common Stock | Common stock - voting | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 298,000,000 | 298,000,000 |
Common stock, shares issued (in shares) | 7,827,609 | 1,223,553 |
Common stock, shares outstanding (in shares) | 7,827,609 | 1,223,553 |
Common Stock | Common stock - non-voting | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Common stock, shares issued (in shares) | 9 | 9 |
Common stock, shares outstanding (in shares) | 9 | 9 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating expenses | ||||
Cost of product revenue | $ 427 | $ 491 | $ 857 | $ 836 |
Research and development | 3,653 | 4,277 | 7,965 | 9,052 |
Sales and marketing | 1,524 | 1,573 | 2,967 | 3,457 |
General and administrative | 4,314 | 4,437 | 8,695 | 9,250 |
Total operating expenses | 9,918 | 10,778 | 20,484 | 22,595 |
Loss from operations | (7,197) | (8,102) | (15,412) | (17,947) |
Interest income (expense) | 108 | (3,453) | (503) | (5,634) |
Changes in fair value of freestanding and hybrid financial instruments designated at Fair Value Option | (1,810) | (762) | (3,831) | (1,121) |
Gain on extinguishment of debt | 1,245 | |||
Other income (expense) | (729) | 26 | (495) | 14 |
Loss before income tax expense | (9,628) | (12,291) | (18,996) | (24,688) |
Income tax expense | 0 | 0 | 0 | 0 |
Net loss | (9,628) | (12,291) | (18,996) | (24,688) |
Net loss attributable to noncontrolling interest | (136) | (141) | (278) | (336) |
Net loss attributable to common stockholders | $ (9,492) | $ (12,150) | $ (18,718) | $ (24,352) |
Net loss per share, basic | $ (4.04) | $ (41.35) | $ (15.93) | $ (128.12) |
Net loss per share, diluted | $ (4.04) | $ (41.35) | $ (15.93) | $ (128.12) |
Weighted-average common stock outstanding, basic | 2,349,431 | 293,858 | 1,174,716 | 190,073 |
Weighted-average common stock outstanding, diluted | 2,349,431 | 293,858 | 1,174,716 | 190,073 |
Product revenue, net | ||||
Revenue | ||||
Revenue | $ 2,721 | $ 2,676 | $ 5,072 | $ 4,648 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSSES - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSSES | ||||
Net loss | $ (9,628) | $ (12,291) | $ (18,996) | $ (24,688) |
Other comprehensive income (loss) | (94) | 183 | 124 | (49) |
Net comprehensive loss | (9,722) | (12,108) | (18,872) | (24,737) |
Common stockholders: | ||||
Net loss attributable to common stockholders | (9,492) | (12,150) | (18,718) | (24,352) |
Other comprehensive income (loss) attributable to common stockholders | ||||
Translation adjustments | (82) | 161 | 110 | (43) |
Net comprehensive loss attributable to common stockholders | (9,574) | (11,989) | (18,608) | (24,395) |
Non-controlling interests: | ||||
Net loss attributable to non-controlling interests | (136) | (141) | (278) | (336) |
Other comprehensive income (loss) attributable to non-controlling interests | ||||
Translation adjustments | (12) | 22 | 14 | (6) |
Net comprehensive loss attributable to non-controlling interests | $ (148) | $ (119) | $ (264) | $ (342) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY - USD ($) | Warrants issued and outstanding Common Stock Common stock - voting | Standstill warrants Additional paid-in capital Iliad | Standstill warrants Additional paid-in capital Irving | Standstill warrants Iliad | Standstill warrants Irving | At The Market Offering Common Stock Common stock - voting | At The Market Offering Additional paid-in capital | At The Market Offering | PIPE financing Preferred Stock Series G convertible preferred stock | PIPE financing Additional paid-in capital | PIPE financing | Preferred Stock Series G convertible preferred stock | Preferred Stock Series I convertible preferred stock Iliad | Preferred Stock Series I convertible preferred stock | Common Stock Series G convertible preferred stock | Common Stock Series I convertible preferred stock Iliad | Common Stock Common stock - voting Streeterville | Common Stock Common stock - voting Iliad | Common Stock Common stock - voting Irving | Common Stock Common stock - voting | Common Stock Common stock - non-voting | Additional paid-in capital Streeterville | Additional paid-in capital Iliad | Additional paid-in capital Irving | Additional paid-in capital | Noncontrolling Interest | Accumulated deficit Streeterville | Accumulated deficit | Accumulated other comprehensive loss | Redeemable preferred stock Streeterville | Redeemable preferred stock | Series J convertible preferred stock | Series G convertible preferred stock | Series H convertible preferred stock | Series I convertible preferred stock | Streeterville | Iliad | Irving | Total |
Beginning Balance at Dec. 31, 2022 | $ 266,969,000 | $ (699,000) | $ (266,948,000) | $ (680,000) | $ (1,358,000) | ||||||||||||||||||||||||||||||||||
Beginning Balance (in shares) at Dec. 31, 2022 | 36,368 | 9 | |||||||||||||||||||||||||||||||||||||
Increase (decrease) in Stockholders' Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||
Issuance of common stock | $ 19,418,000 | $ 19,418,000 | $ 1,275,000 | $ 2,021,000 | $ 1,275,000 | $ 2,021,000 | |||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | 224,725 | 22,833 | 34,311 | ||||||||||||||||||||||||||||||||||||
Preferred stock issued in exchange of notes payable and accrued interest | $ 612,000 | $ 612,000 | $ 1,730,000 | 758,000 | $ 1,730,000 | 758,000 | |||||||||||||||||||||||||||||||||
Preferred stock issued in exchange of notes payable and accrued interest (shares) | 137 | ||||||||||||||||||||||||||||||||||||||
Additional investment from non-controlling interests | 1,232,000 | 1,232,000 | |||||||||||||||||||||||||||||||||||||
Common stock issued upon exercise of restricted stock units | 9,000 | 9,000 | |||||||||||||||||||||||||||||||||||||
Common stock issued upon exercise of restricted stock units (in shares) | 219 | ||||||||||||||||||||||||||||||||||||||
Common stock issued to other third party for services | 167,000 | 167,000 | |||||||||||||||||||||||||||||||||||||
Common stock issued to other third party for services (in shares) | 164 | ||||||||||||||||||||||||||||||||||||||
Warrants issued | 1,235,000 | 1,235,000 | 535,000 | 1,935,000 | 535,000 | 1,935,000 | |||||||||||||||||||||||||||||||||
Stock-based compensation | 998,000 | 998,000 | |||||||||||||||||||||||||||||||||||||
Net loss | (336,000) | (24,352,000) | (24,688,000) | ||||||||||||||||||||||||||||||||||||
Translation gain (loss) | (6,000) | (43,000) | (49,000) | ||||||||||||||||||||||||||||||||||||
Ending Balance at Jun. 30, 2023 | 297,662,000 | 191,000 | (291,300,000) | (723,000) | 5,830,000 | ||||||||||||||||||||||||||||||||||
Ending Balance (in shares) at Jun. 30, 2023 | 137 | 318,620 | 9 | ||||||||||||||||||||||||||||||||||||
Beginning Balance at Mar. 31, 2023 | 287,384,000 | 310,000 | (279,150,000) | (884,000) | 7,660,000 | ||||||||||||||||||||||||||||||||||
Beginning Balance (in shares) at Mar. 31, 2023 | 236,262 | 9 | |||||||||||||||||||||||||||||||||||||
Increase (decrease) in Stockholders' Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 1,553,000 | 1,553,000 | |||||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | 50,325 | ||||||||||||||||||||||||||||||||||||||
Shares issued in exchange of notes payable and accrued interest | 1,393,000 | 1,393,000 | |||||||||||||||||||||||||||||||||||||
Shares issued in exchange of notes payable and accrued interest (in shares) | 31,811 | ||||||||||||||||||||||||||||||||||||||
Preferred stock issued in exchange of notes payable and accrued interest | 612,000 | 612,000 | 1,730,000 | $ 758,000 | 1,730,000 | $ 758,000 | |||||||||||||||||||||||||||||||||
Preferred stock issued in exchange of notes payable and accrued interest (shares) | 137 | ||||||||||||||||||||||||||||||||||||||
Common stock issued upon exercise of restricted stock units | 9,000 | 9,000 | |||||||||||||||||||||||||||||||||||||
Common stock issued upon exercise of restricted stock units (in shares) | 219 | ||||||||||||||||||||||||||||||||||||||
Common stock issued to other third party for services (in shares) | 3 | ||||||||||||||||||||||||||||||||||||||
Warrants issued | $ 535,000 | $ 1,935,000 | $ 535,000 | $ 1,935,000 | $ 1,235,000 | $ 1,235,000 | |||||||||||||||||||||||||||||||||
Stock-based compensation | 518,000 | 518,000 | |||||||||||||||||||||||||||||||||||||
Net loss | (141,000) | (12,150,000) | (12,291,000) | ||||||||||||||||||||||||||||||||||||
Translation gain (loss) | 22,000 | 161,000 | 183,000 | ||||||||||||||||||||||||||||||||||||
Ending Balance at Jun. 30, 2023 | 297,662,000 | 191,000 | (291,300,000) | (723,000) | $ 5,830,000 | ||||||||||||||||||||||||||||||||||
Ending Balance (in shares) at Jun. 30, 2023 | 137 | 318,620 | 9 | ||||||||||||||||||||||||||||||||||||
Increase (decrease) in Stockholders' Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||
Preferred stock value | |||||||||||||||||||||||||||||||||||||||
Issued | 122 | 0 | 56 | 178 | |||||||||||||||||||||||||||||||||||
Beginning Balance, Redeemable preferred stock (in shares) at Dec. 31, 2023 | 0 | 0 | |||||||||||||||||||||||||||||||||||||
Ending Balance, Redeemable preferred stock at Jun. 30, 2024 | $ 2,485,000 | $ 2,485,000 | |||||||||||||||||||||||||||||||||||||
Ending Balance, Redeemable preferred stock (in shares) at Jun. 30, 2024 | 99 | 99 | 99 | ||||||||||||||||||||||||||||||||||||
Beginning Balance at Dec. 31, 2023 | 313,861,000 | (64,000) | (308,248,000) | (652,000) | $ 4,897,000 | ||||||||||||||||||||||||||||||||||
Beginning Balance (in shares) at Dec. 31, 2023 | 122 | 56 | 1,223,553 | 9 | |||||||||||||||||||||||||||||||||||
Increase (decrease) in Stockholders' Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 24,008,000 | 24,008,000 | |||||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | 5,011,564 | ||||||||||||||||||||||||||||||||||||||
Common shares issued from conversion | 1,740,000 | $ 259,000 | $ (2,000,000) | 1,999,000 | |||||||||||||||||||||||||||||||||||
Common shares issued from conversion(in shares) | 313,958 | (122) | (56) | 50,833 | 44,941 | 305,556 | (80) | ||||||||||||||||||||||||||||||||
Common shares issued to third party in exchange of license agreement | 1,150,000 | 1,150,000 | |||||||||||||||||||||||||||||||||||||
Common shares issued to third party in exchange of license agreement (in shares) | 277,778 | ||||||||||||||||||||||||||||||||||||||
Shares issued in exchange of notes payable and accrued interest | $ 166,000 | 2,257,000 | $ 166,000 | 2,257,000 | |||||||||||||||||||||||||||||||||||
Shares issued in exchange of notes payable and accrued interest (in shares) | 26,461 | 527,034 | |||||||||||||||||||||||||||||||||||||
Preferred stock issued in exchange of notes payable and accrued interest | $ 4,485,000 | ||||||||||||||||||||||||||||||||||||||
Preferred stock issued in exchange of notes payable and accrued interest (shares) | 179 | ||||||||||||||||||||||||||||||||||||||
Common stock issued to other third party for services | 9,000 | 9,000 | |||||||||||||||||||||||||||||||||||||
Common stock issued to other third party for services (in shares) | 45,719 | ||||||||||||||||||||||||||||||||||||||
RSUs issued (in shares) | 212 | ||||||||||||||||||||||||||||||||||||||
Stock-based compensation | 964,000 | 964,000 | |||||||||||||||||||||||||||||||||||||
Net loss | (278,000) | (18,718,000) | (18,996,000) | ||||||||||||||||||||||||||||||||||||
Translation gain (loss) | 14,000 | 110,000 | 124,000 | ||||||||||||||||||||||||||||||||||||
Ending Balance at Jun. 30, 2024 | 344,155,000 | (328,000) | (326,707,000) | (542,000) | 16,578,000 | ||||||||||||||||||||||||||||||||||
Ending Balance (in shares) at Jun. 30, 2024 | 7,827,609 | 9 | |||||||||||||||||||||||||||||||||||||
Beginning Balance, Redeemable preferred stock at Mar. 31, 2024 | $ 2,485,000 | ||||||||||||||||||||||||||||||||||||||
Beginning Balance, Redeemable preferred stock (in shares) at Mar. 31, 2024 | 99 | ||||||||||||||||||||||||||||||||||||||
Ending Balance, Redeemable preferred stock at Jun. 30, 2024 | $ 2,485,000 | $ 2,485,000 | |||||||||||||||||||||||||||||||||||||
Ending Balance, Redeemable preferred stock (in shares) at Jun. 30, 2024 | 99 | 99 | 99 | ||||||||||||||||||||||||||||||||||||
Beginning Balance at Mar. 31, 2024 | 329,674,000 | (180,000) | (317,215,000) | (460,000) | $ 11,819,000 | ||||||||||||||||||||||||||||||||||
Beginning Balance (in shares) at Mar. 31, 2024 | 4,557,991 | 9 | |||||||||||||||||||||||||||||||||||||
Increase (decrease) in Stockholders' Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||
Issuance of common stock | $ 12,668,000 | $ 12,668,000 | |||||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | 2,829,987 | ||||||||||||||||||||||||||||||||||||||
Shares issued in exchange of notes payable and accrued interest | $ 393,700 | $ 1,421,000 | $ 1,421,000 | ||||||||||||||||||||||||||||||||||||
Common stock issued to other third party for services | 9,000 | 9,000 | |||||||||||||||||||||||||||||||||||||
Common stock issued to other third party for services (in shares) | 45,719 | ||||||||||||||||||||||||||||||||||||||
RSUs issued (in shares) | 212 | ||||||||||||||||||||||||||||||||||||||
Stock-based compensation | 383,000 | 383,000 | |||||||||||||||||||||||||||||||||||||
Net loss | (136,000) | (9,492,000) | (9,628,000) | ||||||||||||||||||||||||||||||||||||
Translation gain (loss) | (12,000) | (82,000) | (94,000) | ||||||||||||||||||||||||||||||||||||
Ending Balance at Jun. 30, 2024 | $ 344,155,000 | $ (328,000) | $ (326,707,000) | $ (542,000) | $ 16,578,000 | ||||||||||||||||||||||||||||||||||
Ending Balance (in shares) at Jun. 30, 2024 | 7,827,609 | 9 | |||||||||||||||||||||||||||||||||||||
Increase (decrease) in Stockholders' Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||
Preferred stock value | |||||||||||||||||||||||||||||||||||||||
Issued | 0 | 0 | 0 | 99 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 | Jun. 30, 2023 | |
At The Market Offering | ||
Stock Transactions, Parenthetical Disclosures | ||
Issuance costs | $ 147 | $ 177 |
PIPE financing | ||
Stock Transactions, Parenthetical Disclosures | ||
Offering costs | $ 12 | |
Issuance costs | $ 12 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities | ||
Net comprehensive loss | $ (18,872) | $ (24,737) |
Adjustments to reconcile net loss and comprehensive loss to net cash used in operating activities: | ||
Changes in fair value of freestanding and hybrid financial instruments designated at Fair Value Option | 3,831 | 1,121 |
Stock-based compensation, vested and released restricted stock units, and exercised stock options | 964 | 1,007 |
Depreciation and amortization expenses | 948 | 1,007 |
Amortization of debt issuance costs, debt discount, and non-cash interest expense | 274 | 4,409 |
Amortization of operating lease - right-of-use-asset | 221 | 165 |
Share in joint venture's loss | 46 | 37 |
Shares issued in exchange for services | 9 | 166 |
Gain on extinguishment of debt | (1,245) | |
Changes in assets and liabilities | ||
Accounts receivable | 668 | 482 |
Other receivable | 146 | 436 |
Inventory | (367) | (1,240) |
Prepaid expenses and other current assets | (2,665) | (3,788) |
Other assets | 736 | (16) |
Accounts payable | (875) | (1,160) |
Accrued liabilities | 374 | 3,285 |
Deferred revenue | 808 | |
Operating lease liability | (218) | (175) |
Total cash used in operating activities | (15,217) | (19,001) |
Cash flows from investing activities | ||
Purchase of equipment | (16) | |
Total cash used in investing activities | (16) | |
Cash flows from financing activities | ||
Proceeds from issuance of shares in At the Market offering, net of issuance and offering costs of $109 and $177 in 2024 and 2023, respectively | 24,008 | 19,418 |
Proceeds from issuance of common shares in exchange for License Agreement | 1,150 | |
Payment of Tempesta Note | (50) | (50) |
Repayment of insurance financing | (266) | (293) |
Investment from non-controlling interest | 0 | 1,247 |
Proceeds from issuance of warrants in PIPE financing, net of issuance and offering costs of $12 | 0 | 1,235 |
Proceeds from issuance of preferred stock in PIPE financing, net of issuance cost of $12 | 0 | 611 |
Total cash provided by financing activities | 24,842 | 22,168 |
Effects of foreign exchange rate changes on assets and liabilities | (29) | (9) |
Net increase in cash | 9,580 | 3,158 |
Cash at beginning of the year | 6,469 | 5,469 |
Cash at end of the year | 16,049 | 8,627 |
Supplemental schedule of cash flow information | ||
Cash paid for interest | 13 | 13 |
Supplemental schedule of non-cash financing and investing activities | ||
First Insurance Financing | 519 | 4 |
Recognition of operating lease - right-of-use asset and operating lease liability | 219 | 30 |
Umbrella Insurance Financing | 52 | 93 |
Streeterville | Preferred Stock | ||
Supplemental schedule of non-cash financing and investing activities | ||
Shares issued in exchange of notes payable and accrued interest | 4,485 | 1,730 |
Streeterville | Common Stock | ||
Supplemental schedule of non-cash financing and investing activities | ||
Shares issued in exchange of notes payable and accrued interest | 166 | |
Shares issued in exchange of preferred stock | 1,999 | |
Iliad | Common Stock | ||
Supplemental schedule of non-cash financing and investing activities | ||
Shares issued in exchange of notes payable and accrued interest | $ 2,257 | $ 1,275 |
CONDENSED CONSOLIDATED STATEM_6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
At The Market Offering | ||||
Issuance costs | $ 67 | $ 147 | $ 109 | $ 177 |
PIPE Purchase Agreement | ||||
Issuance costs | 12 | 12 | ||
Warrants issued and outstanding | PIPE Purchase Agreement | ||||
Issuance costs | $ 12 | $ 12 |
Organization and Business
Organization and Business | 6 Months Ended |
Jun. 30, 2024 | |
Organization and Business | |
Organization and Business | 1. Organization and Business Jaguar Health, Inc. (“Jaguar” or the “Company”) was founded in San Francisco, California, as a Delaware corporation on June 6, 2013 (inception). The Company was a majority-owned subsidiary of Napo Pharmaceuticals, Inc. (“Napo”) until the close of the Company’s initial public offering on May 18, 2015. The Company was formed to develop and commercialize first-in-class prescription and non-prescription products for companion animals. On July 31, 2017, Jaguar completed a merger with Napo pursuant to the Agreement and Plan of Merger dated March 31, 2017, by and among Jaguar, Napo, Napo Acquisition Corporation (“Merger Sub”), and Napo’s representative (the “Merger Agreement”). In accordance with the terms of the Merger Agreement, upon the completion of the merger, Merger Sub merged with and into Napo, with Napo surviving as the wholly owned subsidiary (the “Merger” or “Napo Merger”). Immediately following the Merger, Jaguar changed its name from “Jaguar Animal Health, Inc.” to “Jaguar Health, Inc.” Napo now operates as a wholly owned subsidiary of Jaguar focused on human health, including the ongoing development of crofelemer and commercialization of Mytesi. On March 15, 2021, Jaguar established Napo EU S.p.A (which changed its name in December 2021 to “Napo Therapeutics”) in Milan, Italy as a subsidiary of Napo. Napo Therapeutics’ core mission is to provide access to crofelemer in Europe to address significant rare/orphan disease indications, including, initially, two key orphan target indications: short bowel syndrome (“SBS”) with intestinal failure and congenital diarrheal disorders (“CDD”). The Company manages its operations through two segments – human health and animal health – and is headquartered in San Francisco, California. Nasdaq Communication and Compliance Minimum Bid Price Requirement On May 10, 2023, the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC issued to the Company a notification citing its failure to comply with the $1.00 minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was initially provided 180 180 ten On June 25, 2024, the Company received a letter from the Nasdaq Office of General Counsel notifying the Company that the minimum bid price deficiency had been cured and that The Nasdaq Stock Market LLC had determined to continue the listing of the Company’s common stock on The Nasdaq Stock Market. Liquidity and Going Concern The Company, since its inception, has incurred recurring operating losses and negative cash flows from operations and has an accumulated deficit of $326.7 million as of June 30, 2024. The Company expects to incur substantial losses and negative cash flows in future periods. Further, the Company’s future operations, which include the satisfaction of current obligations, are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as securing additional financing and generating positive cash flows from operations. There is no assurance that the Company will have adequate cash balances to maintain its operations. Although the Company plans to finance its operations and cash flow needs through equity and/or debt financing, collaboration arrangements with other entities, license royalty agreements, as well as revenue from future product sales, the Company does not believe its current cash balances are sufficient to fund its operating plan through one year from the issuance of these unaudited condensed consolidated financial statements. There can be no assurance that additional funding will be available to the Company on acceptable terms or on a timely basis, if at all, or that the Company will generate sufficient cash from operations to adequately fund operating needs. If the Company is unable to obtain an adequate level of financing needed for the long-term development and commercialization of the products, the Company will need to curtail planned activities and reduce costs. Doing so will likely have an adverse effect on the ability to execute the Company’s business plan; accordingly, there is substantial doubt about the ability of the Company to continue in existence as a going concern. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or for any other future annual or interim period. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Annual Report on Form 10-K for the year ended December 31, 2023. The condensed consolidated balance sheet at December 31, 2023, has been derived from the audited consolidated financial statements at that date but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. There has been no material change to the Company's significant accounting policies during the six months ended June 30, 2024, as compared to the significant accounting policies described in Note 2 of the “Notes to Condensed Consolidated Financial Statements” in the Company's Annual Report on Form 10-K as of and for the year ended December 31, 2023, which was filed to SEC on April 1, 2024, and amended on April 17, 2024. Except as noted above, the unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to present fairly the financial position as of June 30, 2024, results of operations for the three and six months ended June 30, 2024, and 2023, changes in convertible preferred stock and stockholders' equity for the three and six months ended June 30, 2024, and 2023, and cash flows for the three and six months ended June 30, 2024, and 2023. The interim results are not necessarily indicative of the results for any future interim periods or for the entire year. Principles of Consolidation The consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) and include the accounts of the Company and its subsidiaries with controlling interest. All inter-company transactions and balances have been eliminated in consolidation. The Company's reporting currency is the U.S. dollar. Non-controlling interest The Company consolidates the results of Napo Therapeutics, which was owned 88% by the Company and 12% by private investors as of June 30, 2024, and December 31, 2023. The potential voting rights with a certainty of being exercised in its shares are included in the ownership percentage. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make judgments, assumptions and estimates that affect the amounts reported in its unaudited condensed consolidated financial statements and the accompanying notes. The accounting policies that reflect the Company’s more significant estimates and judgments and that the Company believes are the most critical to aid in fully understanding and evaluating its reported financial results are the valuation of stock options, restricted stock units (“RSUs”), hybrid instruments designated at fair value option (“FVO”), warrant liabilities, acquired in-process research and development (“IPR&D”), and useful lives assigned to long-lived assets; impairment assessment of non-financial assets; valuation adjustments for excess and obsolete inventory; allowance for doubtful accounts; deferred taxes and valuation allowances on deferred tax assets; evaluation and measurement of contingencies; and recognition of revenue, including estimates for product returns. Those estimates could change, and as a result, actual results could differ materially from those estimates. Cash The Company’s cash on deposit may exceed United States federally insured limits at certain times during the year. The Company maintains cash accounts with certain major financial institutions in the United States. The Company does not have cash equivalents as of June 30, 2024, and December 31, 2023. Accounts Receivable, net Accounts receivable is recorded net of allowances for discounts for prompt payment and credit losses. The Company utilizes a loss rate approach to determine its lifetime expected credit losses on receivables from customers. This method calculates an estimate of credit losses based on historical experience, credit quality, age of the accounts receivable balances, and current and forecasted economic and business conditions that may affect a customer’s ability to pay. In determining the loss rates, the Company evaluates information related to its historical losses, adjusted for existing conditions, and further adjusted for the period of time that can reasonably be forecasted. The facts and circumstances as of the balance sheet date are used to adjust the estimate for periods beyond those that can reasonably be forecasted. The past due status of accounts receivable is determined based on the contractual due dates for payments. Receivable is deemed past due when payment hasn’t been received 30 days after the contractual due date. The credit loss allowance was immaterial as of June 30, 2024, and December 31, 2023. The corresponding expense for the credit loss allowance is reflected in general and administrative expenses. Current Expected Credit Losses The Company recognizes an allowance for credit losses for financial assets carried at amortized cost to present the net amount expected to be collected as of the balance sheet date. Such allowance is based on credit losses that are expected to arise over the contractual term of the asset, which includes consideration of historical credit loss information adjusted for current conditions and reasonable and supportable forecasts. Changes in the allowance for credit losses are recorded as provision of (or reversal of) credit loss expense. Assets are written off when the Company determines that such are deemed uncollectible. Write-offs are recognized as a deduction from the allowance for credit losses. Expected recoveries of amounts previously written off, not to exceed the aggregate of the amount previously written off, are included in determining the necessary allowance at the balance sheet date. Concentrations Cash is the financial instrument that potentially subjects the Company to a concentration of credit risk as cash is deposited with a bank, and cash balances generally exceed Federal Deposit Insurance Corporation (“FDIC”) insurance limits. For the three and six months ended June 30, 2024, and 2023, substantially all of the Company’s revenue was derived from the sale of Mytesi. In looking at sales by the Company to specialty pharmacies whose net revenue percentage of total net revenue was equal to or greater than 10% for fiscal years 2024 and 2023, the Company earned Mytesi revenue primarily from three specialty pharmacies located in the United States, respectively. Revenue earned from each major customer as a percentage of total revenue is as follows: Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Customer 1 33 % 29 % 32 % 27 % Customer 2 56 % 54 % 55 % 52 % The Company is subject to credit risk from its accounts receivable related to its sales. The Company generally does not perform evaluations of customers' financial condition and generally does not require collateral. Accounts receivable balance of the significant customers as a percentage of total accounts receivable is as follows: June 30, December 31, 2024 2023 Customer 1 31 % 32 % Customer 2 55 % 57 % The Company is subject to concentration risk from its suppliers. The Company sources raw materials used to produce the active pharmaceutical ingredient (“API”) in Mytesi from two suppliers and is dependent on a single third-party contract manufacturer for the supply of finished products for commercialization. Other Risks and Uncertainties The Company’s future operations results involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations including, but not limited to, war, rapid technological change, obtaining second source suppliers and manufacturers, regulatory approval from the US Food and Drug Administration (“FDA”) or other regulatory authorities, the results of clinical trials and the achievement of milestones, market acceptance of the Company’s product candidates, competition from other products and larger companies, protection of proprietary technology, strategic relationships and dependence on key individuals. Other Global Events Fair Value The Company’s financial instruments include accounts receivable, net, other receivable, accounts payable, accrued liabilities, operating lease liability, and debt. The recorded carrying amount of accounts receivable, other receivable, accounts payable, and accrued liabilities reflect their fair value due to their short-term nature. Other financial liabilities are initially recorded at fair value, and subsequently measured at fair value or amortized cost using the effective interest method. See Note 3 for the fair value measurements. Fair Value Option ASC 825-10, Financial Instruments Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. Cost is initially recorded at the invoiced amount of raw materials or API, including the sum of qualified expenditures and charges for bringing the inventory to its existing condition and location. The Company calculates inventory valuation adjustments when conditions indicate that net realizable value is less than cost due to physical deterioration, usage, obsolescence, reductions in estimated future demand, or reductions in selling price. Inventory write-downs are measured as the difference between the cost of inventory and net realizable value. The Company does not have an allowance for inventory obsolescence as of June 30, 2024, and December 31, 2023. Prelaunch Inventory The Company’s policy is to capitalize costs for prelaunch inventories within the drug development phase, which is evidence that the product’s reasonably likely critical attributes for success are present and feasible, and the key causes of failures are absent based on management’s assumptions. The costs that can be capitalized for pre-launch inventory are recorded as “Prepayments and Other Assets.” Property and Equipment Land is stated at cost, reflecting the fair value of the property at July 31, 2017, the date of the Napo merger. Equipment is stated at cost, net of accumulated depreciation. Equipment begins to be depreciated when it is placed into service. Depreciation is calculated using the straight-line method over estimated useful lives ranging between three Expenditures for repairs and maintenance of assets are charged to expenses as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their estimated useful lives. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts, and any resulting gain or loss is included in the unaudited condensed consolidated statements of operations. Software Developed for Internal Use The Company capitalizes the costs of developing software for internal use. These costs include both purchased software and internally developed software. Costs of developing software are expensed until technological feasibility has been established. Thereafter, all costs are capitalized and are carried at the lower of unamortized cost or net realizable value. Internally developed and purchased software costs are generally amortized over five years. Long-lived Assets The Company regularly reviews the carrying value and estimated lives of all of its long-lived assets, including property and equipment and definite-lived intangible assets, to determine whether indicators of impairment exist that warrant adjustments to carrying values or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and positive cash flow in future periods, as well as the strategic significance of the assets to the Company’s business objectives. If the Company determines that events or changes in circumstances indicate that the carrying amount of the asset group may not be recoverable, the Company evaluates the realizability of its long-lived assets (asset group) based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset. Any write-downs (measured based on the difference between the fair value and the asset's carrying value) are treated as permanent reductions in the carrying amount of the assets (asset group). The Company evaluated the carrying value of its internal use software costs as at December 31, 2023, in accordance with ASC 360-10, Impairment of Long-lived Assets to be Held or Used Fair Value Measurements None of the Company’s long-lived assets were deemed impaired as of June 30, 2024. Indefinite-lived Intangible Assets Acquired IPR&D are intangible assets acquired in the July 2017 Napo merger. Under ASC 80, Business Combination Leases The Company accounts for its leases in accordance with ASC 842, Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. Because the interest rate implicit in lease contracts is typically not readily determinable, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. Lease Modification ASC 842 defines lease modification as a change to the terms and conditions of a contract that results in a change in the scope of or the consideration for a lease. A lease modification can result in either a separate new contract that is accounted for separately from the original contract or a single modified contract. The Company shall account for a modification to a contract as a separate contract when the modification grants the lessee an additional right of use not included in the original lease and the lease payments increase commensurate with the standalone price for the additional right of use, adjusted for the circumstances of the particular contract. When the Company concludes that a lease modification should be accounted for as a new contract that is separate and apart from the original lease, the new contract should be evaluated for whether it is a lease or contains an embedded lease. If the new contract is a lease or contains an embedded lease, the new lease should be accounted for as any other new lease. The new lease is recorded on the commencement date of the new lease, which is the date the lessee has access to the leased asset. If a lease modification is not accounted for as a separate contract, the Company should reassess whether the contract contains a lease. If the modified contract is a lease or contains an embedded lease, a lessee should reallocate contract consideration, reassess the lease classification, remeasure the lease liability, and adjust the right-of-use asset. Research and Development Expense Research and development expense consists of expenses incurred in performing research and development activities, including related salaries, clinical trials, and related drug and non-drug product costs, contract services, and other outside service expenses. Research and development expenses are charged to operating expenses during the period incurred. Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses for clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the costs to be recorded based upon validation with the external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers The Company’s policy typically permits returns if the product is damaged, defective, or otherwise cannot be used when received by the customer if the product has expired. Returns are accepted for products that will expire within three months or that have expired up to one year after their expiration dates. Estimates for expected returns of expired products are based primarily on an ongoing analysis of our historical return patterns. The Company recognizes revenue in accordance with the core principle of ASC 606 or when there is a transfer of control of promised goods or services to customers in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those goods or services. The Company recognizes the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that the Company otherwise would have recognized is one year or less. The Company does not adjust the amount of consideration for the effects of a significant financing component if, at contract inception, the expected period between the transfer of promised goods or services and customer payment is one year or less. The Company has elected to treat shipping and handling activities as fulfillment costs. Additionally, the Company elected to record revenue net of sales and other similar taxes. Contracts and Agreements The Company's Canalevia-CA1 and Neonorm products are primarily sold to distributors, who then sell the products to the end customers. Since 2021, the Company has entered into two distribution agreements with established distributors to distribute the Company’s animal health products in the United States. The distribution agreements and the related purchase orders together meet the contract existence criteria under ASC 606. The Company sells directly to its customers without the use of an agent. Performance obligations For animal health products sold by the Company, the single performance obligation identified above is the Company’s promise to transfer the Company’s animal health products to distributors based on specified payment and shipping terms in the arrangement. Product warranties are assurance-type warranties that do not represent a performance obligation. For the Company’s human health product, Mytesi, the single performance obligation identified above is the Company’s promise to transfer Mytesi to specialty pharmacies based on specified payment and shipping terms as outlined in the Exclusive Distribution Agreement entered into by the Company and Cardinal Health as of January 16, 2019. Transaction price For contracts with Cardinal Health and other distributors, the transaction price is the amount of consideration that which the Company expects to collect in exchange for transferring the promised goods or services. The transaction price of Mytesi is the Wholesaler Acquisition Cost (“WAC”), and the transaction price of Canalevia-CA1 and Neonorm is the manufacturer’s list price, net of discounts, returns, and price adjustments. Allocate transaction price For contracts with Cardinal Health and other distributors, the entire transaction price is allocated to the single performance obligation contained in each contract. Revenue recognition For contracts with Cardinal Health, a single performance obligation is satisfied at a point in time upon each contract's free on board (“FOB”) terms when control, including title and all risks, has transferred to the customer. Disaggregation of Product Revenue Human Sales of Mytesi are recognized as revenue at a point in time when the products are delivered to the wholesaler. Net revenues from the sale of Mytesi were $2.7 million and $2.6 million for the three months ended June 30, 2024, and 2023, respectively. Net revenues from the sale of Mytesi were $5.0 million and $4.6 million for the six months ended June 30, 2024, and 2023, respectively. Animal The Company recognized Canalevia-CA1 products revenues of $26,000 and $39,000 for the three months ended June 30, 2024, and 2023, respectively, and Neonorm revenues of $15,000 and $10,000 for the three months ended June 30, 2024, and 2023, respectively. The Company recognized Canalevia-CA1 products revenues of $66,000 and $67,000 for the six months ended June 30, 2024, and 2023, respectively, and Neonorm revenues of $23,000 and $28,000 for the six months ended June 30, 2024, and 2023, respectively. Revenues are recognized at a point in time upon shipment when title and control are transferred to the buyer. Sales of Canalevia-CA1, Neonorm Calf, and Foal to distributors are made under agreements that may provide distributor price adjustments and rights of return under certain circumstances. Contracts – Specialty Pharmacies Effective October 1, 2020, the Company engaged a private company as an authorized specialty pharmacy provider of the Company’s Mytesi product. Under the Specialty Product Distribution Agreement, the Company shall supply the products directly to the private company’s specialty pharmacies in such amounts as may be ordered. There is no minimum purchase or inventory requirement. The specialty pharmacies were authorized distributors of record for all National Drug Codes of Mytesi. Effective April 20, 2021, the Company engaged another private company as an authorized specialty pharmacy provider of Mytesi. Under the Specialty Pharmacy Distribution and Services Agreement, the private company shall sell and dispense the Mytesi directly ordered from the Company at the agreed price to patients within the territories identified in the agreement. The Company has entered into agreements with a total of five different specialty pharmacy chains that are authorized to provide Mytesi to patients. Performance obligations The single performance obligation is the Company’s promise to transfer Mytesi to specialty pharmacies, based on specified payment and shipping terms outlined in the agreements. Transaction price The transaction price is the amount of consideration the Company expects to collect in exchange for transferring the promised goods or services. The transaction price of Mytesi is the WAC, net of estimated discounts, returns, and price adjustments. Allocate transaction price The entire transaction price is allocated to the single performance obligation contained in each contract. Revenue recognition The single performance obligation is satisfied at a point in time, upon the FOB terms of each contract, when control, including title and all risks, has been transferred to the customer. Product Revenue Sales of Mytesi are recognized as revenue at a point in time when the products are delivered to the specialty pharmacies. Net revenues from the sale of Mytesi to the specialty pharmacies were $2.3 million and $1.5 million for the three months ended June 30, 2024, and 2023, respectively. Net revenues from the sale of Mytesi to the specialty pharmacies were $4.3 million and $3.5 million for the six months ended June 30, 2024, and 2023, respectively. Collaboration Revenue Revenue recognition for collaboration agreements requires significant judgment. The Company’s assessments and estimates are based on contractual terms, historical experience, and general industry practice. Revisions in these values or estimations increase or decrease collaboration revenue in the period of revision. On September 24, 2018, the Company entered into a Distribution, License, and Supply Agreement (“License Agreement”) with Knight Therapeutics (“Knight”). The License Agreement has a term of 15 years (with automatic renewals) and provides Knight with an exclusive right to commercialize current and future Jaguar human health products (including crofelemer, NP-300, and any product containing a proanthocyanidin or with an anti-secretory mechanism) in Canada and Israel. Knight forfeited its right of first negotiation for expansion to Latin America. Under the License Agreement, Knight is responsible for applying for and obtaining necessary regulatory approvals in the territory of Canada and Israel, as well as marketing, sales, and distribution of the licensed products. Knight will pay a transfer price for all licensed products, and upon achievement of certain regulatory and sales milestones, the Company may receive payments from Knight in an aggregate amount of up to approximately $18.0 million, payable throughout the initial 15-year term of the agreement. The Company did not have any license revenues for the three and six months ended June 30, 2024, and 2023. Modifications to Liability-classified Instruments In accounting for debt modifications and exchange transactions, it is the Company’s policy first to determine whether it qualifies as a troubled debt restructuring (“TDR”) pursuant to the guidance provided in ASC 470-60, Debt—Troubled Debt Restructurings by Debtors Modification and Extinguishments For the six months ended June 30, 2024, and June 30, 2023, the Company has entered amendments to the terms of its royalty interests and purchase agreements. Modifications to Equity-classified Instruments In accounting for modifications of equity-classified warrants, the Company’s policy is to determine the impact by analogy to the share-based compensation guidance of ASC 718, Compensation-Stock Compensation Compensation-Stock Compensation—Awards Classified as Equity—Subsequent Measurement The Company did not modify any equity-classified warrants for the three and six months ended June 30, 2024, and 2023. In accounting for amendments to preferred stock, the Company’s policy is to measure the impact by analogy to ASC 470-50 in determining if such an amendment is an extinguishment or a modification. If the amendment results in an extinguishment, the Company follows the SEC staff guidance in ASC 260-10-S99-2, Earnings Per Share—Overall—SEC Materials Debt—Debt with Conversion and Other Options The Company did not modify any equity-classified preferred stock for the three and six months ended June 30, 2024, and 2023. Stock-based Compensation The Company's Stock Incentive Plan (See Note 12) provides for the grant of stock options, restricted stock, and restricted stock unit awards. The Company measures stock awards granted to employees, non-employees, and directors at estimated fair value on the date of grant and recognizes the corresponding compensation expense of the awards, net of estimated forfeitures, over the requisite service periods, which correspond to the vesting periods of the awards. If necessary, forfeitures are estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. The Company issues stock awards with only service-based vesting conditions and records compensation expenses for these awards using the straight-line method. The Company uses its common stock's grant date fair market value to determine the grant date fair value of options granted to employees, non-employees, and directors. The Company measures and recognizes compensation expense for all stock options and restricted stock units (“RSUs”) granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The fair value is recognized as an expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. The determination of the grant date fair value of options using an option pricing model is affected by the Company’s estimated common stock fair value and requires management to make a number of assumptions, including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair market value of common stock is based on the closing price of the Company’s common stock as reported on the date of the grant. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company has adopted the provisions of ASC 740, Income Taxes Foreign Currency Remeasurement and Translation The functional currency of Napo Therapeutics is the Euro. The Company follows ASC 830, Foreign Currency Matters For certain subsidiaries, translation adjustments result from translating the functional currency of subsidiary financial statements into the U.S. Dollar reporting currency. These translation adjustments are reported separately and accumulated in the unaudited condensed consolidated balance sheets as a component of accumulated other comprehensive loss. Comprehensive Loss The Company follows ASC 220, Income Statement—Reporting Comprehensive Income For the three months ended June 30, 2024, and 2023, the other comprehensive losses (gains) from translation adjustments were ($94,000) and $183,000, respectively. For the six months ended June 30, 2024, and 2023, the other comprehensive losses (gains) from translation adjustments were $124,000 and ($49,000), respectively. Basic and Diluted Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss attributable to common stockholders for the year by the weighted average number of common stock outstanding during the year. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders for the year by the weighted average number of common stock, including potential dilutive shares of common stock assuming the dilutive effect of potential dilutive securities. For years in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share because their impact would be anti-dilutive to the calculation of net loss per share. For the three months and six months ended June 30, 2023, the Company reports a separate basic net loss and diluted loss per share of common stock. Diluted net loss per share of common stock is the same as basic net loss per share of common stock for the three and six months ended June 30, 2024, and 2023. Recent Accounting Pronouncements In November 2023, FASB issued ASU 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures The ASU requires all segment profit or loss and assets disclosures to be provided on an annual and interim basis. For each inter |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements ASC 820, Fair Value Measurements ● Level 1 – Observable inputs such as quoted prices (unadjusted) for identical instruments in active markets. ● Level 2 – Observable inputs such as quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-derived valuations whose significant inputs are observable. ● Level 3 – Unobservable inputs that reflect the reporting entity’s own assumptions. The following tables set forth the fair value of the Company’s financial instruments that were measured at fair value on a recurring basis as of June 30, 2024, and December 31, 2023. June 30, 2024 (unaudited) (in thousands) Level 1 Level 2 Level 3 Total Iliad $ — $ — $ 6,140 $ 6,140 Uptown — — 8,235 8,235 Streeterville 2 — — 7,438 7,438 Streeterville Note — — 10,538 10,538 Total fair value $ — $ — $ 32,351 $ 32,351 December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Iliad $ — $ — $ 6,862 $ 6,862 Uptown — — 7,473 7,473 Streeterville 2 — — 6,815 6,815 Streeterville Note — — 9,793 9,793 Total fair value $ — $ — $ 30,943 $ 30,943 The change in the estimated fair value of Level 3 liabilities is summarized below: Six Months Ended June 30, 2024 (in thousands) Iliad Uptown Streeterville 2 Streeterville Note Beginning fair value of Level 3 liability $ 6,862 $ 7,473 $ 6,815 $ 9,793 Additions — — — — Exchanges (2,258) — (165) — Settlements — — — — Change in fair value 1,536 762 788 745 Ending fair value of Level 3 liability $ 6,140 $ 8,235 $ 7,438 $ 10,538 Six Months Ended June 30, 2023 (in thousands) Iliad Uptown Streeterville 2 Streeterville Note Beginning fair value of Level 3 liability $ — $ — $ 7,839 $ — Additions — — — — Exchanges — — — — Change in fair value — — 1,121 — Ending fair value of Level 3 liability $ — $ — $ 8,960 $ — The fair value of the Streeterville Note recognized as a Level 3 liability at the date of issuance and as of June 30, 2024, amounted to $7.8 million and $10.5 million, respectively. The fair value of the remaining Level 3 liabilities at the extinguishment date and as of June 30, 2024, amounted to $20.2 million and $21.7 million. The fair values were based on the weighted average discounted expected future cash flows representing the terms of the notes, discounting them to their present value equivalents. The notes were classified as Level 3 fair values in the fair value hierarchy due to the use of unobservable inputs, including the Company’s own credit risk. The Company determined and performed the valuations with the assistance of an independent valuation service provider. On a quarterly basis, the Company considers the main Level 3 inputs for hybrid instruments used derived as follows: ● Discount rate which was determined using a comparison of various effective yields on bonds as of the valuation date ● Market indications for vouchers, which affect the Return Bonus from the sale of Tropical Disease Priority Review Voucher (“TDPRV”) ● Weighted probability of cash outflows which was estimated based on the entity's knowledge of the business and how the current economic environment is likely to impact the timing of the cash outflows, attributed to the different repayment features of the notes The following table summarizes the quantitative information about the significant unobservable inputs used in Level 3 fair value measurement for hybrid instruments: Range of Inputs (probability-weighted average) Relationship of unobservable inputs Unobservable Inputs 2024 2023 to fair value Risk Adjusted Discount Rate 9.53%-26.10% (26.10%) 9.02%-24.59% (24.59%) If the discount rate is adjusted to a total of additional 100 basis points (bps), the fair value would have decreased by $404,000. Sales Proceeds: Amount of comparable TDPRV $67.5 million to $350 million ($100 million) $67.5 million to $350 million ($100 million) If expected cash flows by Management were considered the lowest market indications for vouchers, FV would have decreased by $1.45 million. Range of Probability for Timing of Cash Flows: 0.75%-13.71% 0.10%-73.27% If expected cash flows by management were considered the scenario with the least indicated value, FV would have decreased by $53,000. For the additional notes designated at FVO that are not hybrid, the company considers only the discount rate which was determined using a comparison of various effective yields on bonds as of valuation date. The following table summarizes the quantitative information about the significant unobservable inputs used in Level 3 fair value measurement for the remaining instruments that are not classified as hybrid instruments: Range of Inputs (probability-weighted average) Relationship of unobservable inputs Unobservable Inputs 2024 2023 to fair value Risk Adjusted Discount Rate 8.53%-28.10% (28.10%) 9.02%-26.59% (26.59%) If the discount rate is adjusted to a total of an additional 100 basis points (bps), the fair value would have decreased by $483,232. Fair Value Option The Company elected to apply the FVO accounting to certain freestanding instruments and to the entire class of hybrid instruments, including structured notes, of which there are assessed embedded derivatives that would be eligible for bifurcation, to align the measurement attributes of those instruments under U.S. GAAP and to simplify the accounting model applied to these financial instruments. The valuations of these instruments were predominantly driven by the discount rate and the derivative features embedded within the instruments. The Company determined and performed the valuations of the freestanding and hybrid instruments with the assistance of an independent valuation service provider. The valuation methodology utilized is consistent with the income approach for estimating the fair value of the interest-bearing portion of the instruments and the related derivatives. Cash flows of the financial instruments in their entirety, including the embedded derivatives, are discounted at an appropriate rate for the applicable duration of the instrument. Interests on the interest-bearing portion of the instruments held to maturity and mark-to-market adjustments are aggregated in the change in fair value of freestanding and hybrid financial instruments designated at FVO in the unaudited condensed consolidated statements of operations. As of June 30, 2024, and December 31, 2023, the Company did not note any fair value movement on FVO liabilities attributable to any instrument-specific credit risk, which should be recorded in other comprehensive income (loss). The following tables summarize the fair value and outstanding balance for items the Company accounts for under FVO: (in thousands) Fair value Unpaid Principal Balance Accrued Interest Fair Value Over (Under) Outstanding Balance At June 30, 2024 Iliad $ 6,140 $ 4,882 $ 4,139 $ (2,881) Uptown 8,235 7,994 4,683 (4,442) Streeterville 2 7,438 10,094 1,516 (4,172) Streeterville Note 10,538 6,000 706 3,832 (in thousands) Fair value Unpaid Principal Balance Accrued Interest Fair Value Over (Under) Outstanding Balance At December 31, 2023 Iliad $ 6,862 $ 7,292 $ 3,621 $ (4,051) Uptown 7,473 7,994 4,058 (4,579) Streeterville 2 6,815 10,273 950 (4,408) Streeterville Note 9,793 6,000 546 3,247 |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2024 | |
Balance Sheet Components | |
Balance Sheet Components | 4. Balance Sheet Components Inventory Inventory at June 30, 2024, and December 31, 2023 consisted of the following: June 30, December 31, 2024 2023 (in thousands) (unaudited) Raw material $ 1,961 $ 2,057 Work in process 6,827 6,517 Finished goods 768 615 Inventory $ 9,556 $ 9,189 Prelaunch Inventory Costs capitalized for the Company’s lyophilized drug amounting to $3.4 million and $2.8 million as of June 30, 2024, and December 31, 2023, respectively, are included in the prepayments and other assets account. The Company’s proof-of-concept (“POC”) data is expected to be completed by the end of 2024. Upon approval, the prelaunch inventory shall be reclassified as part of the Company’s inventory. Property and Equipment, net Property and equipment at June 30, 2024, and December 31, 2023, consisted of the following: June 30, December 31, 2024 2023 (in thousands) (unaudited) Land $ 396 $ 396 Lab equipment 477 477 Software 63 63 Furniture and fixtures 18 18 Computers and peripherals 23 7 Total property and equipment at cost 977 961 Accumulated depreciation (489) (465) Property and equipment, net $ 488 $ 496 Depreciation and amortization expenses were $12,000 and $25,000 for the three and six months ended June 30, 2024, respectively. Depreciation and amortization expenses were $15,000 and $31,000 for the three and six months ended June 30, 2023, respectively. Intangible Assets, net Intangible assets consisted of the following: June 30, December 31, 2024 2023 (in thousands) (unaudited) Developed technology $ 25,000 $ 25,000 Accumulated developed technology amortization (11,528) (10,694) Developed technology, net 13,472 14,306 In-process research and development 4,800 4,800 In process research and development, net 4,800 4,800 Trademarks 515 300 Accumulated trademark amortization (138) (128) Trademarks, net 377 172 Internal use software costs - registry 1,237 1,236 Accumulated internal use software costs impairment (371) (371) Accumulated internal use software costs amortization (441) (370) Internal use software costs - registry, net 425 495 Patents 361 361 Accumulated patents amortization (27) (18) Patents, net 334 343 Total intangible assets, net $ 19,408 $ 20,116 Amortization expense of finite-lived intangible assets was $434,000 and $923,000 for the three and six months ended June 30, 2024, respectively. Amortization expense of finite-lived intangible assets was $488,000 and $976,000 for the three and six months ended June 30, 2023, respectively. The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of June 30, 2024: (in thousands) Amounts Remainder of 2024 $ 923 2025 1,846 2026 1,846 2027 1,846 2028 1,846 Thereafter 6,301 $ 14,608 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2024 | |
Related Party Transactions | |
Related Party Transactions | 5. Related Party Transactions Board of Directors (“BOD”) Cash Compensation The Company makes BOD cash compensation quarterly based on the Director Compensation Program. For the three months ended June 30, 2024, and 2023, the Company paid its directors approximately $109,000 and $102,000 in cash compensation, respectively. For the six months ended June 30, 2024, and 2023, the Company paid its directors approximately $218,000 and $217,000 in cash compensation, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies | |
Commitments and Contingencies | 6. Commitments and Contingencies Commitments Leases On April 6, 2021, the Company entered into an office lease agreement of approximately 10,526 square feet of office space in San Francisco, inclusive of office space covered under the previous sublease agreement. The term of the lease began on September 1, 2021, and will expire on February 28, 2025, unless terminated earlier. The lease had an early occupancy provision which entitled the Company to use a portion of the leased premises on June 1, 2021, free of rent obligation. In addition, the Company has the option to extend the lease for one three-year period after the expiration date. This option was not included as part of the lease term as the Company was not reasonably certain to exercise it; hence, the lease term only includes the noncancellable period of three years plus the period of early occupancy. The base rent under the lease was $42,000 monthly for the first 12 months, $43,000 monthly for the next 12 months, and $45,000 for the last twelve months. The lease agreement only contained one lease component, which is the lease of the office space. Non-lease components such as payment of building operating costs and share in real property taxes were accounted for separately and were not considered as part of the total lease payments. The lease was classified as an operating lease. On October 7, 2021, the Company entered an agreement for the lease of office premises from November 1, 2021, to April 30, 2022, subject to automatic renewal for subsequent periods until terminated by either party. Base rent amounted to €10,000 or approximately $10,500. If the contract was not terminated within 12 months, the lease amount would be increased in line with the index of relevant inflation at each annual expiration of the contract's start date. The lessor had the right to decline the renewal of the contract. Upon the happening of certain specified events, the lessor might immediately withdraw from the contract. The Company was required to leave the occupied spaces immediately in the same condition in which they were found in the event of contract termination or expiry. The Company paid a deposit of €20,000, or approximately $21,000, to the lessor. On January 26, 2022, the lease agreement was amended, whereby the term was extended by 20 months from May 1, 2022 to December 31, 2023. All other contract provisions remained the same. On October 25, 2023, the Company entered a second amendment to extend the lease of the office premises whereby Suite 600 shall extend until February 28, 2025, while Suite 400 shall be accounted for as a separate lease commencing on September 1, 2023, and expiring on August 31, 2030. Under the second lease amendment, the office lease premises were remeasured separately, with Suite 400 measuring approximately 5,735 square feet while Suite 600 measuring 5,263 square feet. The base rent for Suite 400 was $18,000 monthly in the first two years, $18,000 monthly in the third and fourth years, $19,000 monthly in the fifth and sixth years, $20,000 monthly in the seventh and eighth years, and $21,000 in the last year. Accordingly, Suite 600’s base rent was amended to $22,000 monthly on its remaining terms. The option to renew at the end of the lease term was amended into a one one On October 10, 2021, the Company also entered a short-term office lease in Milan, Italy. The term of the lease began on November 1, 2021, subject to automatic renewal equal to the present term until terminated by mutual agreement. On January 26, 2022, the lease agreement was amended, whereby the term was extended by 20 months from May 1, 2022 to December 31, 2023. The Company recognized rent expense on a straight-line basis over the non-cancellable lease period. On September 12, 2023, the Company entered into a second lease amendment whereby the term was extended by another year from January 1, 2024 to December 31, 2024. The Company recognized rent expense on a straight-line basis over the non-cancellable lease period. On December 31, 2023, the Company elected not to renew the lease agreement for October 10, 2021. On December 8, 2023, the Company entered a two-year office lease in Milan, Italy. The lease term began on January 1, 2024, until December 31, 2025. The Company recognizes rent expense on a straight-line basis over the non-cancellable lease period. On December 22, 2021, the Company entered an agreement for the lease of two separate vehicles for 48 months On January 25, 2022, the Company entered an agreement for the lease of office premises from March 1, 2022, to December 31, 2023, subject to automatic renewal for subsequent periods until terminated by either party. Base rent amounted to €4,000 or approximately $4,200. A similar agreement was entered with the lessor for the lease of premises to be used as office space from November 1, 2022, to December 31, 2023, subject to automatic renewal for subsequent periods until terminated by either party. Base rent amounted to €3,817 or approximately $4,000. If the contracts are not terminated within 12 months, the lease amounts will be increased in line with the index of relevant inflation at each annual expiration of the contract's start date. The lessor has the right to decline the renewal of the contracts. Upon the happening of certain specified events, the lessor may immediately withdraw from the contracts. The Company is required to leave the occupied spaces immediately in the same conditions in which they were found in the event of contract termination or expiry. The Company paid a deposit of €9,000, or approximately $9,500, to the Lessor. In May 2022, the Company entered an agreement for the lease of one vehicle for 48 months, expiring on April 30, 2026. The total monthly lease payment amounted to €833 or approximately $880, payable in advance. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. The Company also paid a total deposit of €21,000 or approximately $22,000, exclusive of VAT. Early termination of the contracts requires the payment of specified amounts. In October 2022, the Company entered an agreement for the lease of three vehicles for 48 months , expiring on September 30, 2026. The total monthly lease payment amounted to €2,094 or approximately $2,200 , payable in advance. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. In November 2022, the Company entered an agreement for the lease of two vehicles for 48 months , expiring on October 31, 2026. The monthly lease payment amounted to €1,459 or approximately $1,500 , payable in advance. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. The table below provides additional details of the office space lease presented in the unaudited condensed consolidated balance sheet as of June 30, 2024, and December 31, 2023: June 30, December 31, 2024 2023 (in thousands) (unaudited) Operating lease - right-of-use asset $ 1,176 $ 1,176 Operating lease liability, current 416 348 Operating lease liability, net of the current portion 812 886 Total $ 1,228 $ 1,234 Weighted-average remaining life (years) 4.10 4.76 Weighted-average discount rate 20.03% 21.34% Lease costs included in general and administrative expenses in the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2024, were approximately $76,000 and $352,000 , respectively. Lease cost included in general and administrative expenses in the unaudited consolidated statements of comprehensive loss for the three and six months ended June 30, 2023, was approximately $212,000 and $421,000 , respectively For the six months ended June 30, 2024, and 2023, respectively, cash paid for operating lease liabilities recognized under operating cash flows amounted to $218,000 and $175,000, respectively. Non-cash investing and financing activities for the six months ended June 30, 2024, and 2023, including addition to right-of-use assets obtained from new and modified operating liabilities, amount to The following table summarizes the undiscounted cash payment obligations for operating lease liability as of June 30, 2024. June 30, December 31, 2024 2023 (in thousands) (unaudited) (unaudited) Remainder of 2024 $ 589 $ 562 2025 346 346 2026 243 266 2027 236 233 2028 243 240 2029 251 247 2030 42 168 Total undiscounted operating lease payments 1,950 2,062 Imputed interest expenses (722) (828) Total operating lease liability 1,228 1,234 Less: Operating lease liability, current 416 348 Operating lease liability, net of current portion $ 812 $ 886 Purchase Commitment On September 3, 2020, the Company entered into a manufacturing and supply agreement (the “Agreement”) with Glenmark Life Sciences Limited (“Glenmark”), pursuant to which Glenmark will continue to serve as the Company’s manufacturer of crofelemer for use in Mytesi, the Company’s human prescription drug product approved by the FDA, and for other crofelemer-based products manufactured by the Company or its affiliates for human or animal use. The term of the Agreement is approximately 2.5 years (i.e., until March 31, 2023) and may be extended for successive two-year renewal terms upon mutual agreement between the parties thereto. Pursuant to the terms of the Agreement, Glenmark will supply crofelemer to the Company. The Agreement contains provisions regarding the rights and responsibilities of the parties with respect to manufacturing specifications, forecasting and ordering, delivery arrangements, payment terms, confidentiality and indemnification, and other customary provisions. The Agreement includes a commitment to purchase from Glenmark a minimum quantity of 300 kilograms of crofelemer per year, pro-rated for partial years, where the Company may be obligated to pay any shortfall. Either party may terminate the Agreement for any reason with 12 months prior written notice to the other party. In addition, either party may terminate the Agreement upon written notice as a result of a material breach of the Agreement that remains uncured for a period of 90 days. If the Company terminates the Agreement due to a material breach caused by Glenmark, the Company will not be obligated to pay for any minimum quantity shortfall. As of June 30, 2024, the remaining commitment is 500 kilograms. Master Services Agreement (“MSA”) On October 5, 2020, the Company entered into an MSA for clinical research organization services (the “2020 MSA”) and a service order under such 2020 MSA with Integrium, LLC (“Integrium”). The service order covers the Company’s upcoming pivotal Phase 3 clinical trial for cancer-therapy-related diarrhea. As consideration for its services, the Company would pay Integrium a total amount of up to approximately $12.4 million, later reduced to approximately $6.0 million, which would be paid over the term of the engagement and based on the achievement of certain milestones. The 2020 MSA will terminate upon the satisfactory performance of all services to be provided thereunder unless earlier terminated by the parties . Asset Transfer and Transition Commitment On September 25, 2017, the Company entered into the Termination, Asset Transfer, and Transition Agreement with Glenmark dated September 22, 2017. As a result of the agreement, the Company now controls commercial rights for Mytesi for all indications, territories, and patient populations globally and also holds commercial rights to the existing regulatory approvals for crofelemer in Brazil, Ecuador, Zimbabwe, and Botswana. In exchange, the Company agrees to pay Glenmark 25% of any payment it receives from a third party to whom the Company grants a license or sublicense or with whom the Company partners in respect of or sells or otherwise transfers any of the transferred assets, subject to certain exclusions until Glenmark has received a total of $7.0 million. For the six months ending June 30, 2024, the Company paid Glenmark $1.03 million. For the six months ended June 30, 2023, the Company paid Glenmark $1.9 million. Revenue Sharing Commitment Update On December 14, 2017, the Company announced its entry into a collaboration agreement with Seed Mena Businessmen Services LLC (“SEED”) for Equilevia™, the Company's non-prescription, personalized, premium product for total gut health in equine athletes. According to the terms of the Agreement, the Company will pay SEED 15% of total revenue generated from any clients or partners introduced to the Company by SEED in the form of fees, commissions, payments, or revenue received by the Company or its business associates or partners, and the agreed-upon revenue percentage increases to 20% after the first million dollars of revenue. In return, SEED will provide the Company access to its existing United Arab Emirates (“UAE”) network and contacts and assist the Company with any legal or financial requirements. The agreement became effective on December 13, 2017 and will continue indefinitely until terminated by either party pursuant to the terms of the Agreement. No payments have been made to date. Joint Venture - Magdalena Biosciences, Inc. In January 2023, Jaguar and Filament Health (“Filament”), with Funding from One Small Planet, formed the U.S.-based joint venture Magdalena Biosciences, Inc. (“Magdalena”). Magdalena’s focus is on the development of novel, natural prescription medicines derived from plants for mental health indications, including, initially, attention-deficit/hyperactivity disorder (“ADHD”) in adults. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders and to partner with a potential future licensee to develop and commercialize these novel plant-based drugs. This venture aligns with Jaguar's mental health Entheogen Therapeutics Initiative (“ETI”) and Filament's corporate mission to develop novel, natural prescription medicines from plants. Magdalena will leverage Jaguar's proprietary medicinal plant library and Filament's proprietary drug development technology. Jaguar’s library of 2,300 highly characterized medicinal plants and 3,500 plant extracts, all from firsthand ethnobotanical investigation by Jaguar and members of the ETI Scientific Strategy Team, is a key asset Jaguar has generated over 30 years that bridges the knowledge of traditional healers and Western medicine. Magdalena holds an exclusive license to plants and plant extracts in Jaguar's library, not including any sources of crofelemer or NP-300, for specific indications and is in the process of identifying plant candidates in the library that may prove beneficial for addressing indications such as ADHD. The Company accounted for its 40% investment in Magdalena under the equity method. The summarized income statement information for the six months ended June 30, 2024, of Magdalena is as follows: Six months ended June 30, 2024 (in thousands) (unaudited) Revenue $ — Operating expenses (115) Loss before income tax (115) Income tax expense — Net loss $ (115) Net loss attributable to the Company $ (46) Securities Purchase and Licensing Agreement On March 18, 2024, the Company entered into a privately negotiated securities purchase agreement with Gen Ilac Ve Saglik Urunleri Sanayi Ve Ticaret, A.S., pursuant to which the Company issued 16,666,666 shares of the Company’s common stock at $0.12 per share for gross proceeds of approximately $2.0 million. The sale of the securities was consummated in connection with the licensing transaction covering the exclusive license and commercialization agreement for the Company's FDA-approved prescription drug Crofelemer with purchasers in certain Eastern European countries. The Company determined that the issuance of shares and the license grant should be accounted for as a single arrangement under ASC 606. The fair value of the common stock issued was excluded from the consideration allocated to the revenue unit of account following the separation and initial measurement requirements. The deferred revenue amounting to $850,000 will be recognized as revenue evenly over a period of 5 years, which represents the approximate term of the license period considering the license patents' expiration dates. For the six months ended June 30, 2024, the Company recognized $42,000 related to the license granted. April 2024 Agreement for Gelclair On April 12, 2024, the Company entered into an exclusive 5-year in-license agreement with United Kingdom-based Venture Life Group PLC (“Venture Life”), an international consumer health company focused on the global self-care market for Venture Life's FDA-approved oral mucositis prescription product, Gelclair for the U.S. market. The Company plans to launch commercially in the fourth quarter of 2024 for Gelclair. Contingencies From time to time, the Company may become a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value) to adequately address any liabilities related to legal proceedings and other loss contingencies. A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision. The Company did not have any material accruals for any currently active legal action in its unaudited condensed consolidated balance sheets as of June 30, 2024, as the Company could not predict the ultimate outcome of these matters or reasonably estimate the potential exposure. |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt | |
Debt | 7. Debt Notes payable at June 30, 2024, and December 31, 2023 consisted of the following: June 30, December 31, 2024 2023 (in thousands) (unaudited) Notes designated at Fair Value Option $ 32,351 $ 30,943 Royalty Interest* — 5,635 Insurance Financing 477 172 Tempesta Note 100 150 Total 32,928 36,900 Less: Unamortized discount and debt issuance costs — (1,040) Note payable, net of discount $ 32,928 $ 35,860 Notes payable - non-current, net $ 21,813 $ 30,993 Notes payable - current, net $ 11,115 $ 4,867 Weighted average interest rate on short-term borrowings 3.24% 5.04% *Notes with royalty interest not designated at FVO. The Company paid $13,000 and $13,000 in interest on its debt for the six months ended June 30, 2024, and 2023, respectively. All notes payable not designated at FVO are expected to mature in 2025. Future maturities are based on contractual minimum payments. The timing of maturities may fluctuate based on future revenue. Sale of Future Royalty Interest October 2020 Purchase Agreement On October 8, 2020, the Company entered into another royalty interest purchase agreement (the “October 2020 Purchase Agreement”) with Iliad Research and Trading, L.P. (“Iliad”), pursuant to which the Company sold to Iliad a royalty interest entitling Iliad to receive $12.0 million of future royalties on sales of Mytesi and certain up-front license fees and milestone payments from licensees and distributors (the “Royalty Repayment Amount”) for an aggregate purchase price of $6.0 million. Until the Royalty Repayment Amount has been paid in full, the Company will pay Iliad 10% of the Company’s net sales on included products and 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and distributors, but specifically excluding licensing fees and milestone payments that are reimbursements of clinical trial expenses (the “Royalty Payments”). Beginning on the six-month anniversary of the delivery of the October 2020 Purchase Agreement to the Company (the “Purchase Price Date”) and continuing until the 12-month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $250,000, and (b) the actual Royalty Payment amount Iliad is entitled to for such month. Beginning on the 12-month anniversary of the Purchase Price Date and continuing until the 18-month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $400,000 and (b) the actual Royalty Payment amount Iliad is entitled to for such month. Beginning on the 18-month anniversary of the Purchase Price Date and continuing until 24 - month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $600,000 and (b) the actual Royalty Payment amount Iliad is entitled to for such month. Beginning on the 24-month anniversary of the Purchase Price Date and continuing until the Royalty Repayment Amount has been paid in full, the monthly Royalty Payment shall be the greater of (a) $750,000, and (b) the actual Royalty Payment amount Iliad is entitled to for such month. The Royalty Interest amount of $12.0 million was classified as debt, net of a $6.0 million discount, at initial recognition. Under ASC 470-10-35-3, Debt—Overall—Subsequent Measurement (“ASC 470-10-35-3”), Royalty Payments to Iliad will be amortized under the interest method per ASC 835-30, Interest—Imputation of Interest (“ASC 835-30”). The discount rate is variable because there is no set interest rate, and because the royalty payments are variable. After each royalty payment, the Company will use a prospective method to determine a new discount rate based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 34.51% . Pursuant to the October 2020 Purchase Agreement, if the weekly volume weighted average price (“VWAP”) of the Company’s common stock is not equal to or greater than the minimum VWAP of $0.9105 at least twice during each calendar month during the six months beginning on November 1, 2020, then the Royalty Repayment Amount will be automatically increased by $6.0 million at the end of such six-month period. During the observation period starting November 1, 2020, the Company’s weekly VWAP failed to reach the minimum VWAP of $0.9105. On November 13, 2020, the Company concluded that the contingent clause had been met, warranting an additional $6.0 million Royalty Repayment Amount to be added to the outstanding balance commencing on May 10, 2021, for the purpose of cash interest calculation. The change in the Royalty Repayment Amount was accounted for as a debt modification and resulted in a new discount rate of 45.42%. On April 13, 2021, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $3.0 million from the original outstanding balance of the royalty interest and exchange for 131 shares of the Company’s common stock. The exchange agreement was accounted for as a modification and resulted in a new discount rate of 77.09%. On February 11, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $2.4 million from the outstanding balance of the royalty interest and exchange for 385 shares of the Company’s common stock. On March 2, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $1.1 million from the outstanding balance of the royalty interest and exchange for 539 shares of the Company’s common stock. On March 4, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $800,000 from the outstanding balance of the royalty interest and exchange for 444 shares of the Company’s common stock. On March 9, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $700,000 from the outstanding balance of the royalty interest and exchange for 411 shares of the Company’s common stock. Because the period between the first and last exchanges occurred within a 12-month period and each was individually assessed as a modification, the debt terms that existed prior to the February 13 exchange were used in applying the 10% test on the cumulative assessment performed. The exchanges were cumulatively accounted for as an extinguishment and resulted in a loss of $2.2 million. On April 14, 2022, the Company entered into amendments (the “Royalty Interest Global Amendments”) to its existing royalty interests, including the Royalty Interest in the original principal amount of $12.0 million under the October 2020 Royalty Interest. The amendment grants the Company, at its sole discretion, the right to exchange from time to time, all or any portion of the Royalty Interests for shares of the Company’s common stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of the date of the applicable exchange. Under the Royalty Interest Global Amendments, the Company’s ability to exchange the Royalty Interests for shares of the Company’s common stock is subject to certain limitations, on which the Company will not have such right and issue any common stock to investors if (a) the issuance of the Company’s common stock would cause investor’s beneficial ownership to exceed 4.99% of Company’s issued and outstanding common stock as of such date; (b) any of the exchange conditions has not been satisfied as of the applicable exchange date; and (c) the total cumulative number of shares of the Company’s common stock issued pursuant to the Royalty Interests would exceed the requirements of The Nasdaq Capital Market (including the rules related to the aggregation of offerings under Nasdaq Listing Rule 5635(d) if applicable) (the “Exchange Cap”) unless stockholder approval is obtained to issue more than the Exchange Cap. The Exchange Cap shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split, or other similar transactions. On May 13, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $400,000 from the outstanding balance of the royalty interest and exchange for 254 shares of the Company’s common stock. On July 25, 2022, the Company entered into another exchange agreement with Iliad, pursuant to which the parties agreed to partition $750,000 from the outstanding balance of the royalty interest and exchange for 526 shares of the Company’s stock. On November 18, 2022, the Company entered into another exchange agreement with Iliad, pursuant to which the parties agreed to partition $715,000 from the outstanding balance of the royalty interest and exchange for 1,222 shares of the Company’s stock. On March 17 and 23, 2023, the Company entered into another exchange agreement with Iliad, pursuant to which the parties agreed to partition $992,000 and $227,000, respectively, from the outstanding balance of the royalty interest and exchange for 242 and 62 shares, respectively, of the Company’s stock. The exchanges that occurred within the 12 months before the May 13, 2022 exchange were previously accounted for as extinguishment; therefore, cumulative assessment was no longer performed. On May 8, 2023, the Company entered into a standstill agreement (as amended, the “Standstill Agreement”) with Iliad, Uptown Capital, LLC (f/k/a Irving Park Capital, LLC) (“Uptown”) and Streeterville Capital, LLC (“Streeterville”, and together with Iliad and Uptown, collectively, “Investor”) to allow the Company to refrain from making royalty payments with respect to four outstanding royalty interests issued by the Company to Investor dated October 8, 2020, December 22, 2020, March 8, 2021, and August 24, 2022, respectively (each, a “Royalty Interest” and collectively, the “Royalty Interests”), including any royalty payments due and payable as of May 8, 2023 (the ”Standstill Date”), and refrain from buying, selling, or otherwise trading in the Company’s common stock for a period beginning on the Standstill Date and ending on the earliest of (a) the date that is six months following the Standstill Date (b) the date of the public announcement of the probability value in Jaguar’s OnTarget Phase 3 clinical trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (c) and the date of any offering or sale of any debt or equity securities, including without limitation any at-the-market offering (the “Standstill Period”), but excluding any exempt issuances. As a material inducement and consideration for Investor’s agreement to enter into the Standstill Agreement, the Company issued (i) Iliad warrants to purchase up to 13,779 shares of the common stock, (ii) Uptown warrants to purchase up to 18,296 shares of the common stock, and (iii) Streeterville warrants to purchase up to 31,547 shares of the common stock, at an exercise price of $28.8 per share. On June 28, 2023, the Company entered into the first amendment to the Standstill Agreement, pursuant to which the Standstill Agreement was amended to, among other things, permit (i) the Company to issue an aggregate of 105 shares of the Company’s Series H Convertible Preferred Stock to Investor in exchange for a $756,992 reduction in the outstanding balance of the December 2020 Royalty Interest and a $1,726,888 reduction in the outstanding balance of the August 2022 Royalty Interest (the “Exchange Transaction”) without triggering the termination of the Standstill Period, and (ii) Investor to (A) consummate the Exchange Transaction during the Standstill Period and (B) sell all shares of the Company’s common stock beneficially owned by Investor immediately prior to the consummation of the Exchange Transaction during the Standstill Period. On June 30, 2023, the Company entered into a binding memorandum of understanding (the “Binding MOU”) with the Investor to modify the allocation of the warrants as set forth in the Standstill Agreement such that the Company issued (i) Iliad warrants to purchase up to 28,533 shares of the common stock and (ii) Uptown warrants to purchase up to 35,089 shares of the common stock, and no warrants were issued to Streeterville under the Standstill Agreement. On August 14, 2023, the Company entered into an amendment (“the Second Amendment”) to the Standstill Agreement with Iliad and Uptown (together, “Standstill Investor”) to (i) permit the Company to offer and sell securities without triggering the termination of the Standstill Period, and (ii) remove the restriction on Standstill Investor’s ability to buy, sell, or otherwise trade in shares of the Company’s common stock during the Standstill Period. On September 29, 2023, the Company entered into the Global Amendment No. 2 to the October 2020 Royalty Interest with Iliad, pursuant to which, beginning on January 1, 2026, the monthly Royalty Payment under the October 2020 Royalty Interest shall be the greater of (a) $750,000.00, and (b) the actual Royalty Payment amount Iliad is entitled to for such month pursuant to the terms of the October 2020 Royalty Interest. As a material consideration for Iliad’s agreement to enter into this amendment, the Company agreed to issue Iliad warrants to purchase up to 3,875 shares of the Company’s common stock at an exercise price of $22.2 per share. Such warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on September 29, 2023 (the “Issuance Date”) and ending on the five-year anniversary of the Issuance Date. Pursuant to an analysis of the indicators provided in ASC 470-60-55-8, Debt—Troubled Debt Restructurings by Debtors—Implementation Guidance and Illustrations The cumulative effect of the exchanges to the October 2020 Royalty Interest resulted in significant modifications and was accounted for as extinguishment. The Company recorded an extinguishment gain in the unaudited condensed consolidated statements of operations amounting to $2.0 million. The extinguishment triggered a remeasurement event under ASC 825-10 and created an election date on whether to account for the October 2020 Royalty Interest under the FVO. The Company irrevocably elected to initially and subsequently apply the FVO accounting to the entire royalty interest. The Company used the valuation report from an independent valuation service provided to measure the reporting date fair value of the royalty interest. On December 28, 2023, the Company entered into a privately negotiated exchange agreement with Iliad, pursuant to which the Company issued an aggregate of 81,250 shares of the Company’s Common Stocks to Iliad in exchange for a $789,000 reduction in the outstanding balance of the October 2020 Royalty Interest. The effect of the exchange was accounted for as a debt modification. On January 29, 2024, the Company entered into a privately negotiated exchange agreement with Iliad pursuant to which the Company issued an aggregate of 133,333 shares of the Company’s common stock to Iliad in exchange for a $836,000.00 reduction in the outstanding balance of the royalty interest dated October 8, 2020, Royalty Interest. The effect of the exchange was accounted for as a debt modification. On June 7, 2024, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $1,500,000 from the outstanding balance of the royalty interest dated October 8, 2020. This reduced the outstanding balance of the original royalty interest. The partitioned royalty was exchanged for 6,562 shares of the Company’s common stock. On June 30, 2024, and December 31, 2023, the fair value was determined to be $6.1 million and $6.9 million. For the three and six months ended June 30, 2024, the net change in the fair value was $840,000 and $1.5 million, respectively. The net change in fair value was recorded in the change in fair value of freestanding and hybrid financial instruments designated at FVO in the unaudited condensed consolidated statements of operations. December 2020 Purchase Agreement On December 22, 2020, the Company entered into a royalty interest purchase agreement (the “December 2020 Purchase Agreement”) with Uptown Capital, LLC(f/k/a Irving Park Capital, LLC) (“Uptown”), a company affiliated with CVP, pursuant to which the Company sold to Uptown a royalty interest entitling Uptown to receive $12.0 million of future royalties on sales of Mytesi and certain up-front license fees and milestone payments from licensees and distributors (the “Royalty Repayment Amount”) for an aggregate purchase price of $6.0 million (the “December 2020 Royalty Interest”). Until such time as the Royalty Repayment Amount has been paid in full, the Company will pay Uptown 10% of the Company’s Net Sales on Included Products and 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and distributors, but specifically excluding licensing fees and milestone payments that are reimbursements of clinical trial expenses (the “Royalty Payments”). Beginning on the payment start date of March 8, 2024, and continuing until the 12-month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $750,000 and (b) the actual Royalty Payment amount Uptown is entitled to for such month. At initial recognition, the December 2020 Royalty Interest amount of $12.0 million is classified as debt, net of a $6.0 million discount. Under ASC 470-10-35-3, royalty payments to Uptown will be amortized under the interest method per ASC 835-30. Because there is no set interest rate and the royalty payments are variable, the discount rate is variable. After each royalty payment, the Company will use a prospective method to determine a new discount rate based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 23.70%. On April 14, 2022, under the Royalty Interest Global Amendments, the Company was granted, at its sole discretion, the right to exchange, from time to time, all or any of the Royalty Interest under the original principal amount of $12.0 million or any portion of the December 2020 Purchase Agreement for shares of the Company’s common stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of date of the applicable exchange, subject to certain limitations. On February 8, 2023, the Company entered into an exchange agreement with Uptown, pursuant to which the parties agreed to partition $675,000 from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 2,500 shares of the Company’s stock. On May 8, 2023, the Company entered into an exchange agreement with Uptown to (i) partition a new royalty interest in the royalty repayment amount of $1,073,807 from the outstanding balance of the royalty interest and exchange for 31,811 shares of the Company’s common stock. On the same date, the Company entered into the Standstill Agreement as described above, pursuant to which the Company may refrain from making royalty payments on the December 2020 Royalty Interest during the Standstill Period. On September 29, 2023, the Company entered into the Global Amendment No. 2 to the December 2020 Royalty Interest with Uptown, pursuant to which, beginning on January 1, 2026, the monthly Royalty Payment under the December 2020 Royalty Interest shall be the greater of (a) $750,000.00, and (b) the actual Royalty Payment amount Uptown is entitled to for such month pursuant to the terms of the December 2020 Royalty Interest. As a material consideration for Uptown’s agreement to enter into this amendment, the Company agreed to issue to Uptown warrants to purchase up to 4,375 shares of the Company’s common stock at an exercise price of $22.2 per share. Such warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on September 29, 2023 (the “Issuance Date”) and ending on the five-year anniversary of the Issuance Date. Pursuant to an analysis of the indicators provided in ASC 470-60-55-8, the Company is not deemed to be experiencing financial difficulty. The debt restructuring is, therefore, not considered a TDR. On the same date, the Company entered into a privately negotiated exchange agreement with Uptown (the “Exchange Agreement”), pursuant to which the Company issued an aggregate of 118 shares of the Company’s newly authorized Series I Convertible Preferred Stock (the “Series I Preferred Stock” or “Preferred Stock”) to Uptown, at an effective exchange price per share equal to the market price (defined as the Minimum Price under Nasdaq Listing Rule 5635(d)) as of the date of the Exchange Agreement, in exchange for a $1,500,000.00 reduction in the outstanding balance of the December 2020 Royalty Interest (“Partitioned Royalty”) (the “Exchange Transaction”). Subject to the terms of the Series I Preferred Stock, each share of Series I Preferred Stock is convertible into shares of the Company’s Common Stock (the “Conversion Shares”). The cumulative effect of the exchanges to the December 2020 Royalty Interest resulted in significant modifications and was accounted for as extinguishment. The Company recorded an extinguishment gain in the unaudited condensed consolidated statements of operations amounting to $2.7 million. The extinguishment triggered a remeasurement event under ASC 825-10 and created an election date on whether to account for the December 2020 Royalty Interest under the FVO accounting. The Company irrevocably elected to initially and subsequently apply the FVO accounting to the entire royalty interest. The Company used the valuation report from an independent valuation service provided to measure the reporting date fair value of the royalty interest. On June 30, 2024, and December 31, 2023, the fair value was determined to be $8.2 million and $7.5 million. For the three and six months ended June 30, 2024, the net change in the fair value was $354,000 and $762,000, respectively. The net change in fair value was recorded in the change in fair value of financial instruments and hybrid instruments designated at FVO in the unaudited condensed consolidated statements of operations. March 2021 Purchase Agreement On March 8, 2021, the Company entered into a purchase agreement (the “March 2021 Purchase Agreement”) with Streeterville Capital, LLC (“Streeterville”), a company affiliated with CVP, pursuant to which the Company sold a royalty interest entitling Streeterville to $10.0 million and any interest, fees, and charges as royalty repayment amount for an aggregate purchase price of $5.0 million (the “March 2021 Royalty Interest”). Interest will accrue on the royalty repayment amount at a rate of 5% per annum, compounding quarterly, and will increase to 10% per annum, compounding quarterly on the 12-month anniversary of the closing date. The Company will be obligated to make minimum royalty payments on a monthly basis beginning at the earlier of (a) 36 months following the closing date or (b) 30 days following the satisfaction of all existing royalties to Streeterville, and its affiliates namely Iliad and Uptown, but not earlier than 18 months following the closing date in an amount equal to the greater of (i) $250,000 beginning on the royalty payment start date and continuing until either the royalty repayment amount has been paid in full or the 6-month anniversary of the royalty payment start date, $400,000 beginning on the 6-month anniversary of the royalty payment start date and continuing until either the royalty repayment amount has been paid in full or the 12-month anniversary of the royalty payment start date, $600,000 beginning on the 12-month anniversary of the royalty payment start date and continuing until either the royalty repayment amount has been paid in full or the 18-month anniversary of the royalty payment start date, $750,000 beginning on the 18-month anniversary of the royalty payment start date and continuing until the royalty repayment amount has been paid in full, and (ii) 10% of the Company’s net sales on included products, 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and/or distributors but specifically excluding licensing fees and/or milestone payments that are reimbursements of clinical trial expenses or associated with the license of Included Products from the Company to Napo EU, including but not limited to the upfront fee payable by Napo EU to Napo for included products and Crofelemer for other indications; and 50% of royalties collected from licenses of the included products to third parties. At initial recognition, the March 2021 Royalty Interest amount of $10.0 million is classified as debt, net of a $5.0 million discount. Under ASC 470-10-35-3, royalty payments to Streeterville will be amortized under the interest method per ASC 835-30. Because there is no set interest rate and the royalty payments are variable, the discount rate is variable. After each royalty payment, the Company will use a prospective method to determine a new discount rate based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 19.36%. On April 14, 2022, under the Royalty Interest Global Amendments, the Company is granted, at its sole discretion, the right to exchange, from time to time, all or any of the Royalty Interest under the original principal amount of $10.0 million of the March 2021 Purchase Agreement for shares of the Company’s common stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of date of the applicable exchange, subject to certain limitations. On August 17, 2022, the Company entered into an exchange agreement (the “Royalty Interest Exchange Agreement”) with Streeterville to (i) partition a new royalty interest in the royalty repayment amount of $3.4 million (“Partitioned Royalty”) from the royalty interest of the March 2021 Purchase Agreement and then cause the outstanding balance of the royalty interest to be reduced by an amount equal to the initial outstanding balance of the Partitioned Royalty, and (ii) exchange (“Royalty Exchange”) the Partitioned Royalty for 2,556 shares of the Company’s common stock with a par value of $0.0001 in accordance with the term of the Royalty Interest Exchange Agreement. On September 30, 2022, the Company entered into an exchange agreement with Streeterville, pursuant to which the parties agreed to partition $2.0 million from the outstanding balance of the royalty interest and exchange the partitioned royalty for 2,614 shares of the Company’s common stock. The exchange was accounted for as a debt modification and resulted in a reduction in the outstanding balance of the royalty interest amounting to $2.0 million. On March 1, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued an aggregate of 179 shares of Series J Preferred Stock to Streeterville in exchange for the surrender of the March 2021 Royalty Interest by Streeterville. Upon completion of the CVP Exchange Transaction, all outstanding balance of the March 2021 Royalty Interest was fully paid, and the March 2021 Royalty Interest was terminated. The exchanges of Series J Preferred Stock were accounted for as extinguishment. Because the fair value of the common stock transferred is less than the carrying amount of the Series J Preferred Stock surrendered, the difference was credited to retained earnings and added to earnings available to common shareholders. Interest expenses were $0 and $448,000 for the three and six months ended June 30, 2024, respectively. Interest expenses for the three and six months ended June 30, 2023, were $497,000 and $944,000, respectively. As of June 30, 2024, and December 31, 2023, the carrying value of the debt was $0 and $4.6 million, respectively. August 2022 Purchase Agreement On August 24, 2022, the Company entered into another royalty interest purchase agreement (the “August 2022 Purchase Agreement”) with Streeterville, pursuant to which the Company sold Streeterville a royalty interest to receive $12.0 million (the “August 2022 Royalty Interest”) of future royalties on sales of Mytesi® (crofelemer) for any indications that could cannibalize crofelemer indications or any other chronic indication and certain up-front license fees and milestone payments from licensees and/or distributors for an aggregate purchase price of $4.0 million (“the Royalty Financing”). The Company will use the proceeds to support the ongoing pivotal Phase 3 clinical trial of crofelemer for prophylaxis of diarrhea in adults receiving targeted cancer therapy. Interest will accrue on the Royalty Repayment Amount at a rate of 5% per annum from the closing of the Royalty Financing until the one-year anniversary of such closing and 10% per annum thereafter, simple interest computed based on a 360-day year comprised of twelve 30-day months. The Company will be obligated to make minimum royalty payments on a monthly basis beginning on January 1, 2024 in an amount equal to the greater of (A) $250,000 (which increases to $400,000 beginning 6 months following the closing of the Royalty Financing, $600,000 beginning 12 months following the closing of the Royalty Financing, and $750,000 beginning 18 months following the closing of the Royalty Financing) and (B) the royalty payments to which Investor is entitled, consisting of (1) 10% of the Company’s net sales of crofelemer for any indications that could cannibalize crofelemer indications or any other chronic indication (including any improvements, modifications and follow-on products, collectively referred to as “Included Products”) (2) 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and/or distributors, but specifically excluding licensing fees and/or milestone payments that are (A) reimbursements of clinical trial expenses or (B) associated with the license of the of the Included Products from the Company to Napo Therapeutics and (3) 50% of royalties collected from licenses of the Included Products to third parties. Pursuant to the terms of the August 2022 Royalty Interest, the Company has the right to exchange from time to time at the Company’s sole discretion all or any portion of the Royalty Interest for shares of common stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of the date of the applicable exchange. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 55.97%. On September 29, 2023, the Company entered into a Global Amendment No. 2 (the “Global Amendment”) with the Investor as described further above, such that the Company issued Streeterville warrants to purchase 255,000 shares of the common stock the Global Amendment No. 1 and Global Amendment No. 2 to the August 2022 Royalty Interest with Streeterville, pursuant to which, (a) beginning on January 1, 2026, the monthly Royalty Payment under the August 2022 Royalty Interest shall be the greater of (x) $750,000.00, and (y) the actual Royalty Payment amount Streeterville is entitled to for such month pursuant to the terms of the August 2022 Royalty Interest, and (b) the Company is prohibited from making prepayments of the Royalty Repayment Amount under the August 2022 Royalty Interest. As a material consideration for Streeterville’s agreement to enter into these a |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2024 | |
Warrants | |
Warrants | 8. Warrants The following table summarizes information about warrants outstanding and exercisable into shares of the Company’s common stock as of June 30, 2024, and December 31, 2023: June 30, December 31, 2024 2023 (unaudited) Warrants outstanding, beginning balance 201,830 125 Issuances — 201,705 Exercises (125,632) — Expirations and cancelations — — Warrants outstanding, ending balance 76,198 201,830 As of June 30, 2024, and 2023, the Company’s outstanding warrants have an exercise price ranging from $29 to $33,000 per common stock and generally expires prior to December 31, 2024. PIPE Warrants On May 8, 2023, the Company entered into a Securities Purchase Agreement (the “PIPE Purchase Agreement”) with certain investors named therein (collectively, the “Purchasers”), pursuant to which the Company agreed to issue and sell to the Purchasers in a private placement an aggregate of (i) 137 shares (the “Preferred Shares”) of Series G Convertible Preferred Stock, par value $0.0001 per share, of the Company (“Series G Preferred Stock”) and (ii) warrants to purchase up to 114,167 shares of the Company’s common stock, at an exercise price of $28.8 per share (the “PIPE Warrants”), for an aggregate purchase price of approximately $1.86 million (the “Private Placement”). The Company intends to use the proceeds from the Private Placement for working capital and general corporate purposes. The PIPE Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on the later of (i) January 1, 2024, and (ii) the date on which the approval by the Company’s stockholders (the “Stockholder Approval”) to remove both the Voting Cap and the Conversion Cap (both as defined below) is obtained (the “PIPE Warrants Initial Exercise Date”) and ending on the fifth On May 10, 2023, the Company issued warrants equivalent to 114,167 shares of the Company’s common stock in relation to the PIPE Purchase Agreement. The PIPE Purchase Agreement provides that during the period commencing on the signing of the PIPE Purchase Agreement and ending October 22, 2023, the Company will not affect or enter into any agreement to (i) issue securities in exchange for any securities of the Company issued and outstanding on the date of the PIPE Purchase Agreement pursuant to Section 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”), or (ii) effect issuance by the Company of common stock or Common Stock Equivalents (as defined in the PIPE Purchase Agreement), subject to certain customary exceptions set forth in the PIPE Purchase Agreement including, among others, issuance of shares of common stock pursuant to the At The Market Offering Agreement, dated December 10, 2021, by and between the Company and Ladenburg Thalmann & Co. Inc., as amended (the “Ladenburg Thalmann ATM”), provided that such issuance in the Ladenburg Thalmann ATM has consented. On August 14, 2023, the Company entered into an amendment (“the First Amendment”) to the PIPE Purchase Agreement with certain holders (the “Holders”) named in the PIPE Purchase Agreement, pursuant to which the parties agreed to terminate the restriction on subsequent equity sales by the Company. In exchange for the Holders’ agreement to enter into the First Amendment, the Company agreed to issue the Holders warrants to purchase 11,417 shares of the Company’s common stock (the “PIPE Amendment Warrants”) in a private placement pursuant to Section 4(a)(2) of the Securities Act. The PIPE Amendment Warrants are substantially the same as the PIPE Warrants and have an exercise price of $28.8 per share. The PIPE Amendment Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on January 1, 2024 (the “PIPE Amendment Warrants Initial Exercise Date”) and ending on the five-year anniversary of the PIPE Amendment Warrants Initial Exercise Date. At the date of the PIPE Amendment Warrants, the warrants were valued at $1.2 million using the Black-Scholes option pricing model as follows: exercise price of $28.8 per share, stock price of $43.2 per share, expected life of five years, volatility of 145.95% and a risk-free rate of 3.37%. The warrants were classified in additional paid-in capital. On February 27, 2024, pursuant to the PIPE Purchase Agreement, each of the PIPE investors entered into an exchange agreement with the Company (each, a “PIPE Warrant Exchange Agreement” and collectively, the “PIPE Warrant Exchange Agreements”). Pursuant to the PIPE Warrant Exchange Agreements, the Company agreed to exchange the PIPE Warrants for shares of common stock at an exchange ratio of 1 On February 29, 2024, the PIPE investors converted 122 shares of Series G preferred stock into 50,833 shares of common stock subject to a six-month lock-up. Standstill Agreement Pursuant to the Company’s entry in the Standstill Agreement, as amended by the Binding MOU, as described further above, the Company agreed to issue (i) Iliad warrants to purchase up to 28,533 shares of the common stock, and (ii) Uptown warrants to purchase up to 35,089 shares of the common stock, at an exercise price of $28.8 per share (the “Standstill Warrants”). The Standstill Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on the later of (i) January 1, 2024, and (ii) the date on which the Stockholder Approval is obtained (the “Standstill Warrant Initial Exercise Date”) and ending on the five-year anniversary of the Standstill Warrant Initial Exercise Date. At the date of the Standstill Agreement, the warrants were valued at $2.5 million using the Black-Scholes option pricing model as follows: exercise price of $28.8 per share, stock price of $43.8 per share, expected life of five years, volatility of 118.88% and a risk-free rate of 3.49%. The warrants were classified in additional paid-in capital. Royalty Interest Global Amendments On September 29, 2023, the Company entered into amendments Royalty Interest Global Amendments to (i) the October 2020 Royalty Interest with Iliad, (ii) the December 2020 Royalty Interest with Uptown, and (iii) the August 2022 Royalty Interest with Streeterville, pursuant to which, among other things, the Company agreed to issue to (i) Iliad warrants to purchase up to 3,875 shares of the Company’s common stock, (ii) Uptown warrants to purchase up to 4,375 shares of the common stock, and (iii) Streeterville warrants to purchase up to 4,250 shares of the Common Stock, at an exercise price of $22.2 per share (collectively, the “Royalty Interest Global Amendment Warrants”). The Royalty Interest Global Amendment Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on September 29, 2023 (the “Royalty Interest Global Amendment Initial Exercise Date”) and ending on the five-year anniversary of the Royalty Interest Global Amendment Initial Exercise Date. At the date of the Royalty Interest Global Amendments, the warrants were valued at $173,000 using the Black-Scholes option pricing model as follows: exercise price of $22.2 per share, stock price of $15.6 per share, expected life of five years, volatility of 139.53% and a risk-free rate of 4.6%. The warrants were classified in additional paid-in capital. |
Preferred Stock
Preferred Stock | 6 Months Ended |
Jun. 30, 2024 | |
Preferred Stock | |
Preferred Stock | 9. Preferred Stock As at June 30, 2024, and December 31, 2023, preferred stock consisted of the following: June 30, 2024 Liquidation ( in thousands, except share and per share data) Shares Issued and Carrying Preference Series Designated Outstanding Value per Share A 5,524,926 — $ — $ — B 11,000 — — — B-1 63 — — — B-2 10,165 — — — C 1,011,000 — — — D 977,300 — — — E 10 — — — F 10 — — — G 137 — — — H 105 — — — I 118 — — — J 179 99 — — Total 7,535,013 99 $ — $ — December 31, 2023 Liquidation ( in thousands, except share and per share data) Shares Issued and Carrying Preference Series Designated Outstanding Value per Share A 5,524,926 — $ — $ — B 11,000 — — — B-1 63 — — — B-2 10,165 — — — C 1,011,000 — — — D 977,300 — — — E 10 — — — F 10 — — — G 137 122 — — H 105 — — — I 118 56 — — Total 7,534,834 178 $ — $ — The Company is authorized to issue a total of 10,000,000 shares of its preferred stock as of June 30, 2024, and December 31, 2023, with a total of 7,535,013 shares and 7,534,834 shares designated to specific Series as of Series G Preferred Stock On May 8, 2023, the Company entered into a securities purchase agreement with certain investors, pursuant to which the Company agreed to issue to such investors (i) 137 shares of Series G Convertible Preferred Stock, par value $0.0001 per share, of the Company (“Series G Preferred Stock”) and (ii) warrants to purchase up to 114,167 shares of the Company’s common stock, at an exercise price of $28.8 per share (the “PIPE Warrants”), for an aggregate purchase price of approximately $1.9 million (the “Private Placement”). On February 29, 2024, the PIPE investors converted 122 shares of Series G preferred stock into 50,833 shares of common stock subject to a six-month lock-up. Series H Preferred Stock On June 28, 2023, the Company entered into privately negotiated exchange agreements with Uptown and Streeterville, under which the Company issued 32 and 73 shares of the Company’s newly authorized Series H Convertible Preferred Stock (the “Series H Preferred Stock”) to Uptown and Streeterville, respectively, at an effective exchange price per share equal to the market price (defined as the Minimum Price under Nasdaq Listing Rule 5635(d)) as of the date of the exchange agreements, in exchange for a $757,000 reduction in the outstanding balance of the December 2020 Royalty Interest and a $1.7 million reduction in the outstanding balance of the August 2022 Royalty Interest, respectively. Series I Preferred Stock On September 29, 2023, the Company entered into a privately negotiated exchange agreement with Uptown, pursuant to which the Company issued an aggregate of 118 shares of the Company’s newly authorized Series I Preferred Stock to Uptown at an effective exchange price per share equal to the market price (defined as the Minimum Price under Nasdaq Listing Rule 5635(d)) as of the date of the Exchange Agreement, in exchange for a $1,500,000.00 reduction in the outstanding balance of the December 2020 Royalty Interest. On January 15, 2024, Uptown converted 56 shares of Series I Preferred Stock into 44,941 shares of common stock. |
Temporary Equity
Temporary Equity | 6 Months Ended |
Jun. 30, 2024 | |
Temporary Equity | |
Temporary Equity | 10. Temporary Equity On March 1, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued an aggregate of 179 shares of Series J Preferred Stock to Streeterville in exchange for the surrender of the March 2021 Royalty Interest by Streeterville (the “CVP Exchange Transaction”). Upon completion of the CVP Exchange Transaction, all outstanding balance of the March 2021 Royalty Interest was fully paid, and the March 2021 Royalty Interest was terminated. At its sole discretion, the Company reserves the right to exchange a portion or all of the outstanding shares of Series J Preferred Stock held by investors for common stock at the stated value of $25,000 per share, divided by the applicable exchange price. The exchange price will be determined based on the lower of the Nasdaq official closing price and the 5-day average Nasdaq official closing price of the common stock immediately preceding the exchange date. The preferences, rights, limitations, and other matters relating to the Series J Preferred Stock are outlined in the Certificate of Designation, which the Company filed with the Secretary of State of the State of Delaware on March 1, 2024. The Company determined that the nature of the Series J Preferred Stock host was more analogous to a debt instrument and that the economic characteristics and risks of the embedded redemption features were clearly and closely related to the Series J Preferred Stock host. As such, the redemption features were not required to be bifurcated under ASC 815, Derivatives and Hedging On March 5, 2024, the Company entered into a privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued 166,667 shares of the Company’s common stock in exchange for the surrender and cancellation of 40 shares of Series J Perpetual Preferred Stock. On March 19, 2024, the Company entered into another privately negotiated exchange agreement with Streeterville, pursuant to which the Company issued 138,889 shares of the Company’s common stock in exchange for the surrender and cancellation of 40 shares of Series J Perpetual Preferred Stock based on an effective exchange price of $7.2 per share of common stock. As of June 30, 2024, and December 31, 2023, the Company had 99 and zero shares outstanding of Series J preferred stock, respectively. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity | |
Stockholders' Equity | 11. Stockholders' Equity As of June 30, 2024, and December 31, 2023, the Company had reserved shares of common stock, on an as-if converted basis, for issuance as follows: June 30, December 31, 2024 2023 (unaudited) Options issued and outstanding 404 26,357 Inducement options issued and outstanding — 1,534 Options available for grant under stock option plans 875,566 120,033 Restricted stock unit awards issued and outstanding 45,788 47,998 Warrants issued and outstanding 76,198 7,505 Total 997,956 203,427 Common Stock The holders of common stock are entitled to one vote for each share of common stock held. The common stockholders are also entitled to receive dividends whenever funds and assets are legally available and when declared by the BOD. The holders of non-voting common stock are not entitled to vote, except on an as-converted basis with respect to any change of control of the Company that is submitted to the stockholders of the Company for approval. Shares of the Company's non-voting common stock have the same rights to dividends and other distributions and are convertible into shares of the Company's common stock on a At a special meeting of stockholders of Jaguar Health, Inc. held on September 30, 2022 (the “Special Meeting”), the Company’s stockholders approved an amendment (the “Sixth Amendment”) to the Company’s Third Amended and Restated Certificate of Incorporation (the “COI”) to effect an increase in the number of authorized shares of the Company’s voting common stock, par value $0.0001 per share (the “Common Stock”), from 150,000,000 to 298,000,000 shares of Common Stock (the “Authorized Share Increase”) on September 30, 2022. Pursuant to such authority granted by the Company’s stockholders, the Company’s BOD approved the Authorized Share Increase and the filing of the Sixth Amendment to effectuate the Authorized Share Increase. On September 30, 2022, the Company filed the Sixth Amendment with the Secretary of State of the State of Delaware (the “DE Secretary of State”), and the Authorized Share Increase became effective in accordance with the terms of the Sixth Amendment immediately upon filing with the DE Secretary of State (the “Effective Time”). The Company is now authorized to issue a total number of 358,000,000 stock, of which 298,000,000 shares are common stock, 50,000,000 are non-voting common stock, and 10,000,000 are preferred stock. Reverse Stock Split On September 3, 2021, the Company filed an amendment to its Third Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1 three On January 20, 2023, the Company approved a seventh amendment to the Company’s Third Amended and Restated Certificate of Incorporation to effect a 1 On May 17, 2024, the Company approved an eighth amendment to the Company’s Third Amended and Restated Certificate of Incorporation to effect a 1 The reverse stock split reduces the number of shares of common stock issuable upon the conversion of the Company’s outstanding non-voting common stock and the exercise or vesting of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and causes a proportionate increase in the conversion and exercise prices of such non-voting common stock, stock options, and warrants. In addition, the number of shares reserved for issuance under the Company’s equity compensation plans immediately prior to the effective time will be reduced proportionately. The reverse stock split did not change the total number of authorized shares of common stock or preferred stock. All share and per share amounts of the Company’s common stock, as well as stock options and restricted stock units (“RSUs”), included in the accompanying condensed consolidated financial statements have been retroactively adjusted to give effect to the reverse stock split for all periods presented, unless indicated otherwise. At the Market Offering (“ATM”) December 2021 ATM Agreement On December 10, 2021, the Company entered into an ATM Agreement (as amended, the “December 2021 ATM Agreement”) with Ladenburg, pursuant to which the Company may offer and sell, from time to time through Ladenburg, shares of common stock having an aggregate offering price of up to $15.0 million, subject to the terms and conditions of the December 2021 ATM Agreement. The offering will terminate upon the earlier of (i) December 10, 2024, and (ii) termination of the December 2021 ATM Agreement as permitted therein. On February 2, 2022, the Company entered into an amendment to the December 2021 ATM Agreement, pursuant to which, the aggregate offering amount of the shares of the Company’s common stock which the Company may sell and issue through Ladenburg, as the sales agent, was increased from $15.0 million to $75.0 million. On May 17, 2024, the Company entered into an amendment to the December 2021 ATM Agreement, pursuant to the February 2, 2022 amendment, the previous $75 million limit on the aggregate offering amount of shares of the Company’s common stock which the Company may sell and issue through Ladenburg, as the sales agent, was removed such that the amount issuable under the December 2021 ATM Agreement is limited solely by certain limitations as specified in the May 17, 2024 amendment. On July 17, 2024, the Company entered into an amendment to the December 2021 ATM Agreement with Ladenburg and Lucid Capital Markets, LLC (“Lucid”). Pursuant to the July 17, 2024 amendment, Lucid was added as a party and manager under the agreement, effective beginning July 17, 2024 and ending on September 30, 2024, unless extended by the parties to the agreement. If not amended or extended prior to September 30, 2024, then after such date Ladenburg will be the sole manager, and Lucid will no longer be a manager under the agreement. During the six months ended June 30, 2024, the Company issued an aggregate of 5,011,751 shares under the ATM Agreement for total net proceeds of $24.0 million. Noncontrolling Interest As a result of the merger on November 3, 2021 between Napo EU and Dragon SPAC, the Company assumed a non-controlling interest amounting to $242,000 as of December 31, 2021 which represents noncontrolling interest held by an investor in Napo Therapeutics. During the three and six months ended June 30, 2024, noncontrolling interest increased by $148,000 and increased by $264,000, respectively. During the three and six months ended June 30, 2023, noncontrolling interest decreased by $118,000 and increased by $891,000, respectively. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Stock-based Compensation | |
Stock-based Compensation | 12. Stock-based Compensation 2013 Equity Incentive Plan In November 2013, the Company's BOD and sole stockholder adopted the Jaguar Health, Inc. 2013 Equity Incentive Plan (the “2013 Plan”). The 2013 Plan allows the Company's BOD to grant stock options, restricted stock awards, and RSUs to employees, officers, directors, and consultants. Following the effective date of the Initial Public Offering (“IPO”) and after the effectiveness of any grants under the 2013 Plan contingent on the IPO, no additional stock awards will be granted under the 2013 Plan. Outstanding grants continue to be exercisable; however, any unissued shares under the plan and any forfeitures of outstanding options do not roll over to the 2014 Stock Incentive Plan. There were zero shares outstanding as of June 30, 2024, and December 31, 2023. 2014 Stock Incentive Plan Effective May 12, 2015, the Company adopted the Jaguar Health, Inc. 2014 Stock Incentive Plan (“2014 Plan”). The 2014 Plan provides options, restricted stock, and RSUs to eligible employees, directors, and consultants to purchase the Company's common stock. The term of an incentive stock option may not exceed 10 years, except that with respect to any participant who owns more than 10% of the voting power of all classes or our outstanding stock, the term must not exceed 5 years. The 2014 Plan provides for automatic share increases on the first day of each fiscal year in the amount of 2% of the outstanding number of shares of the Company's common stock on the last day of the preceding calendar year. The 2014 Plan replaced the 2013 Plan except that all outstanding options under the 2013 Plan remain outstanding until exercised, canceled, or expired. On April 13, 2022, the BOD of the Company approved a Registration Statement to register an additional 2,417,660 shares of the Company’s common stock for issuance pursuant to the awards granted under the 2014 Plan. As of June 30, 2024, 384 options were outstanding, and 867,252 options were available for grant. As of December 31, 2023, 385 options were outstanding, and 47,687 options were available for grant. 2020 New Employee Inducement Award Plan Effective June 16, 2020, the Company adopted the Jaguar Health, Inc. New Employee Inducement Award Plan (“2020 Inducement Award Plan”) and, subject to the adjustment provisions of the Inducement Award Plan, reserved 2,222 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Award Plan. The term of an incentive stock option may not exceed 10 years , except that with respect to any participant who owns more than 10% of the voting power of all classes or our outstanding stock, the term must not exceed 5 years . The 2020 Inducement Award Plan grants non-statutory stock options, RSUs, restricted stock, and performance shares. The 2020 Inducement Award Plan was adopted without Stockholder Approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The terms and conditions of the 2020 Inducement Award Plan are substantially similar to the Company’s 2014 Stock Incentive Plan but with such other terms and conditions intended to comply with the Nasdaq inducement award rules. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, the only persons eligible to receive grants of equity awards under the Inducement Award Plan are individuals who were not previously an employee or director of the Company or following a bona fide period of non-employment, as an inducement material to such persons entering into employment with the Company. On April 13, 2022, the BOD of the Company approved an amendment to the 2020 Inducement Award Plan to reserve an additional 471,833 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Award Plan, thereby increasing the number of shares of the Company’s common stock issuable thereunder from 500,000 shares to 971,833 shares. As of June 30, 2024, 20 options were outstanding, and 8,314 options were available for grant. As of December 31, 2023, 20 options were outstanding, and 8,308 options were available for grant. The Company authorized an additional 498,448 shares for the stock incentive plans. Stock Options and Restricted Stock Units (“RSUs”) The following table summarizes the incentive plan activity for the six months ended June 30, 2024, and the year ended December 31, 2023: Weighted Weighted Average Shares Stock Average Remaining Aggregate Available Options RSUs Stock Option Contractual Life Intrinsic (in thousands, except share and per share data) for Grant Outstanding Outstanding Exercise Price (Years) Value* Outstanding at January 1, 2023 2,045 454 585 $ 35,564.08 7.19 $ — Additional shares authorized 52,772 — — — — — Options granted — — — — — — Options exercised — — — — — — Options canceled 49 (49) — 19,668.87 — — RSUs granted (44,733) — 44,733 — — — RSUs vested and released 243 — (243) — — — RSUs cancelled 87 — (87) — — — Outstanding at December 31, 2023 10,463 405 44,988 $ 35,738.63 6.21 $ — Additional shares authorized 865,902 — — — — — Options granted — — — — — — Options exercised — — — — — — Options canceled 1 (1) — 23,355.00 — — RSUs granted (895) — 895 — — — RSUs exercised 26 — (26) — — — RSUs cancelled 69 — (69) — — — Outstanding at June 30, 2024 875,566 404 45,788 $ 21,057.18 5.72 $ — Exercisable at June 30, 2024 404 $ 21,057.18 5.72 $ — Vested and expected to vest at June 30, 2024 404 $ 21,057.18 5.72 $ — *The fair market value of Jaguar stock on June 30, 2024, was $3.58 per share. The intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the Company's common stock for in-the-money options. The number of options exercised during the six months ended June 30, 2024, and the year ended December 31, 2023, were zero. The weighted average grant date fair value of stock options granted was zero per share during the six months ended June 30, 2024, for the year ended December 31, 2023. The number of options that vested for the six months ended June 30, 2024, and for the year ended December 31, 2023, was 8 and 25, respectively. The grant date weighted average fair value of options that vested for the six months ended June 30, 2024, and for the year ended December 31, 2023, was $20,069 and $16,417, respectively. Stock-Based Compensation The following table summarizes stock-based compensation expenses related to stock options, inducement stock options, and RSUs for the three and six months ended June 30, 2024, and 2023, and are included in the unaudited condensed consolidated statements of operations as follows: Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2024 2023 2024 2023 (unaudited) Research and development expense $ 176 $ 257 $ 465 $ 484 Sales and marketing expense 32 86 72 115 General and administrative expense 175 175 427 399 Total $ 383 $ 518 $ 964 $ 998 As of June 30, 2024, the Company had zero unrecognized stock-based compensation expense for options, inducement options, and RSUs outstanding. No range of assumptions was set forth and used in calculating the fair value of options granted during the six months ended June 30, 2024, and 2023, respectively. 401(k) Plan The Company sponsors a 401(k) defined contribution plan covering all employees. No employer contributions were made to the plan from plan inception through June 30, 2024. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Net Loss Per Share | |
Net Loss Per Share | 13. Net Loss Per Share The following table presents the calculation of basic and diluted net loss per share of common stock for the periods indicated: Three Months Ended Six Months Ended June 30, June 30, (In thousands, except share and per share data) 2024 2023 2024 2023 (unaudited) (unaudited) Net loss attributable to common stockholders $ (9,492) $ (12,150) $ (18,718) $ (24,352) Shares used to compute net loss per common stock, basic 2,349,431 293,858 1,174,716 190,073 Shares used to compute net loss per common stock, diluted 2,349,431 293,858 1,174,716 190,073 Net loss per share attributable to common stockholders, basic $ (4.04) $ (41.35) $ (15.93) $ (128.12) Net loss per share attributable to common stockholders, diluted $ (4.04) $ (41.35) $ (15.93) $ (128.12) Basic net loss per share is calculated by dividing net loss by the weighted average number of common stock outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of shares of common stock, convertible preferred stock, and certain common stock equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. The Company's potential securities, including warrants, convertible preferred series stock and other common stock equivalents, were excluded because their effect is anti-dilutive. For the prior periods presented, there is no difference in the number of shares used to compute basic and diluted shares outstanding. The following are the other common stock equivalents of the Company for the six months ended June 30, 2024, and for the year ended December 31, 2023: June 30, December 31, 2024 2023 (unaudited) Options issued and outstanding 404 26,357 Inducement options issued and outstanding — 1,534 Restricted stock units issued and outstanding 45,788 47,998 Warrants issued and outstanding 76,198 7,505 Total 122,390 83,394 As of August 13, 2024, 739,210 shares of common stock were issued after the balance sheet date. |
Segment Data
Segment Data | 6 Months Ended |
Jun. 30, 2024 | |
Segment Data | |
Segment Data | 14. Segment Data The Company has two reportable segments: animal health and human health. The animal health segment is focused on developing and commercializing prescription and non-prescription products for companion and production animals. The human health segment is focused on developing and commercializing human products and the ongoing commercialization of Mytesi, which the U.S. FDA approves for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. The accounting policies used in the segment reporting are the same as those described in the summary significant accounting policies (Note 2). The Company’s CODM is the chief financial officer. The CODM primarily utilizes segment's net comprehensive profit or loss as the key indicator in assessing the segment's performance and allocating resources. The Company's reportable segments net revenues and net loss for the three and six months ended June 30, 2024, and 2023, consisted of the following: Six Months Ended Six Months Ended June 30, 2024 June 30, 2023 (in thousands) (unaudited) (unaudited) Human Health Animal Health Total Human Health Animal Health Total External revenue $ 4,940 $ 132 $ 5,072 $ 4,553 $ 95 $ 4,648 Less: Segment expenses Cost of revenue 829 28 857 805 31 836 Research and development 6,401 1,565 7,966 7,616 1,433 9,049 Sales and marketing 2,822 145 2,967 3,296 161 3,457 General and administrative 4,411 5,239 9,650 4,812 5,384 10,196 Interest 55 501 556 1 5,632 5,633 Other segment items* 237 2,556 2,793 50 1,075 1,125 Segment expenses 14,755 10,034 24,789 16,580 13,716 30,296 Segment net comprehensive loss $ (9,815) $ (9,902) $ (19,717) $ (12,027) $ (13,621) $ (25,648) Reconciliation of net comprehensive loss Adjustments and reconciling items** 845 911 Consolidated net comprehensive loss $ (18,872) $ (24,737) Three Months Ended Three Months Ended June 30, 2024 June 30, 2023 (in thousands) (unaudited) (unaudited) Human Health Animal Health Total Human Health Animal Health Total External revenue $ 2,637 $ 84 $ 2,721 $ 2,627 $ 49 $ 2,676 Less: Segment expenses Cost of revenue 414 13 427 475 16 491 Research and development 2,914 744 3,658 3,540 732 4,272 Sales and marketing 1,450 74 1,524 1,541 33 1,574 General and administrative 2,108 2,681 4,789 2,373 2,544 4,917 Interest 28 (110) (82) 1 3,452 3,453 Other segment items* 733 1,816 2,549 (282) 805 523 Segment expenses 7,647 5,218 12,865 7,648 7,582 15,230 Segment net comprehensive loss $ (5,010) $ (5,134) $ (10,144) $ (5,021) $ (7,533) $ (12,554) Reconciliation of net comprehensive loss Adjustments and reconciling items** 422 446 Consolidated net comprehensive loss $ (9,722) $ (12,108) *Other segment items for each reportable segment include: ● Human Health - realized gain/loss on foreign exchange transactions, change in fair value of warrants, gain/loss on debt extinguishment and share in net income or loss in joint venture. ● Animal Health - realized and unrealized gain/loss on foreign exchange transactions. **Adjustments and reconciling items include intercompany elimination entries The Company's reportable segments assets consisted of the following: June 30, December 31, 2024 2023 (in thousands) (unaudited) Segment assets Human Health $ 42,859 $ 42,289 Animal Health 173,402 153,190 Total $ 216,261 $ 195,479 The reconciliation of segments assets to the consolidated assets is as follows: June 30, December 31, 2024 2023 (in thousands) (unaudited) Total assets for reportable segments $ 216,261 $ 195,479 Less: Investment in subsidiary (29,232) (29,232) Less: Intercompany loan (125,570) (115,484) Consolidated Totals $ 61,459 $ 50,763 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events | |
Subsequent Events | 15. Subsequent Events December 2021 ATM Agreement From July 1, 2024, to August 13, 2024, the Company issued an aggregate of 739,210 shares of common stock under the December 2021 ATM Agreement for total net proceeds of $2.4 million. Phase 3 OnTarget Trial Results for Cancer Supportive Care Drug Crofelemer On July 23, 2024, the Company announced that the results from its initial analysis of the pivotal Phase 3 OnTarget trial of Crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy with or without standard chemotherapy. Crofelemer is an FDA-approved prescription drug for the symptomatic relief of diarrhea in adult HIV/AIDS patients receiving antiretroviral therapy. The initial results from the OnTarget study show that the multicenter, double-blind, placebo-controller pivotal trial did not meet its primary endpoint for the prespecified analysis of all tumor types in the trial. Unregistered Sales of Equity Securities On July 15, 2024, the Company entered into a privately negotiated exchange agreement with a holder of royalty interest in the Company. Under the exchange agreement, the Company issued 455,000 shares of common stock to such holder in exchange for a $1,851,850 reduction in the outstanding balance of the royalty interest held by such holder. The shares of common stock that were issued in the exchange transaction were issued in reliance on the exemption from registration provided under Section 3(a)(9) of the Securities Act of 1933, as amended. Entry into a Material Definitive Agreement |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||
Net Income (Loss) | $ (9,492) | $ (12,150) | $ (18,718) | $ (24,352) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or for any other future annual or interim period. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Annual Report on Form 10-K for the year ended December 31, 2023. The condensed consolidated balance sheet at December 31, 2023, has been derived from the audited consolidated financial statements at that date but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. There has been no material change to the Company's significant accounting policies during the six months ended June 30, 2024, as compared to the significant accounting policies described in Note 2 of the “Notes to Condensed Consolidated Financial Statements” in the Company's Annual Report on Form 10-K as of and for the year ended December 31, 2023, which was filed to SEC on April 1, 2024, and amended on April 17, 2024. Except as noted above, the unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to present fairly the financial position as of June 30, 2024, results of operations for the three and six months ended June 30, 2024, and 2023, changes in convertible preferred stock and stockholders' equity for the three and six months ended June 30, 2024, and 2023, and cash flows for the three and six months ended June 30, 2024, and 2023. The interim results are not necessarily indicative of the results for any future interim periods or for the entire year. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) and include the accounts of the Company and its subsidiaries with controlling interest. All inter-company transactions and balances have been eliminated in consolidation. The Company's reporting currency is the U.S. dollar. |
Non-controlling interest | Non-controlling interest The Company consolidates the results of Napo Therapeutics, which was owned 88% by the Company and 12% by private investors as of June 30, 2024, and December 31, 2023. The potential voting rights with a certainty of being exercised in its shares are included in the ownership percentage. |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make judgments, assumptions and estimates that affect the amounts reported in its unaudited condensed consolidated financial statements and the accompanying notes. The accounting policies that reflect the Company’s more significant estimates and judgments and that the Company believes are the most critical to aid in fully understanding and evaluating its reported financial results are the valuation of stock options, restricted stock units (“RSUs”), hybrid instruments designated at fair value option (“FVO”), warrant liabilities, acquired in-process research and development (“IPR&D”), and useful lives assigned to long-lived assets; impairment assessment of non-financial assets; valuation adjustments for excess and obsolete inventory; allowance for doubtful accounts; deferred taxes and valuation allowances on deferred tax assets; evaluation and measurement of contingencies; and recognition of revenue, including estimates for product returns. Those estimates could change, and as a result, actual results could differ materially from those estimates. |
Cash | Cash The Company’s cash on deposit may exceed United States federally insured limits at certain times during the year. The Company maintains cash accounts with certain major financial institutions in the United States. The Company does not have cash equivalents as of June 30, 2024, and December 31, 2023. |
Accounts Receivable, net | Accounts Receivable, net Accounts receivable is recorded net of allowances for discounts for prompt payment and credit losses. The Company utilizes a loss rate approach to determine its lifetime expected credit losses on receivables from customers. This method calculates an estimate of credit losses based on historical experience, credit quality, age of the accounts receivable balances, and current and forecasted economic and business conditions that may affect a customer’s ability to pay. In determining the loss rates, the Company evaluates information related to its historical losses, adjusted for existing conditions, and further adjusted for the period of time that can reasonably be forecasted. The facts and circumstances as of the balance sheet date are used to adjust the estimate for periods beyond those that can reasonably be forecasted. The past due status of accounts receivable is determined based on the contractual due dates for payments. Receivable is deemed past due when payment hasn’t been received 30 days after the contractual due date. The credit loss allowance was immaterial as of June 30, 2024, and December 31, 2023. The corresponding expense for the credit loss allowance is reflected in general and administrative expenses. |
Current Expected Credit Losses | Current Expected Credit Losses The Company recognizes an allowance for credit losses for financial assets carried at amortized cost to present the net amount expected to be collected as of the balance sheet date. Such allowance is based on credit losses that are expected to arise over the contractual term of the asset, which includes consideration of historical credit loss information adjusted for current conditions and reasonable and supportable forecasts. Changes in the allowance for credit losses are recorded as provision of (or reversal of) credit loss expense. Assets are written off when the Company determines that such are deemed uncollectible. Write-offs are recognized as a deduction from the allowance for credit losses. Expected recoveries of amounts previously written off, not to exceed the aggregate of the amount previously written off, are included in determining the necessary allowance at the balance sheet date. |
Concentrations | Concentrations Cash is the financial instrument that potentially subjects the Company to a concentration of credit risk as cash is deposited with a bank, and cash balances generally exceed Federal Deposit Insurance Corporation (“FDIC”) insurance limits. For the three and six months ended June 30, 2024, and 2023, substantially all of the Company’s revenue was derived from the sale of Mytesi. In looking at sales by the Company to specialty pharmacies whose net revenue percentage of total net revenue was equal to or greater than 10% for fiscal years 2024 and 2023, the Company earned Mytesi revenue primarily from three specialty pharmacies located in the United States, respectively. Revenue earned from each major customer as a percentage of total revenue is as follows: Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Customer 1 33 % 29 % 32 % 27 % Customer 2 56 % 54 % 55 % 52 % The Company is subject to credit risk from its accounts receivable related to its sales. The Company generally does not perform evaluations of customers' financial condition and generally does not require collateral. Accounts receivable balance of the significant customers as a percentage of total accounts receivable is as follows: June 30, December 31, 2024 2023 Customer 1 31 % 32 % Customer 2 55 % 57 % The Company is subject to concentration risk from its suppliers. The Company sources raw materials used to produce the active pharmaceutical ingredient (“API”) in Mytesi from two suppliers and is dependent on a single third-party contract manufacturer for the supply of finished products for commercialization. |
Other Risks and Uncertainties | Other Risks and Uncertainties The Company’s future operations results involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations including, but not limited to, war, rapid technological change, obtaining second source suppliers and manufacturers, regulatory approval from the US Food and Drug Administration (“FDA”) or other regulatory authorities, the results of clinical trials and the achievement of milestones, market acceptance of the Company’s product candidates, competition from other products and larger companies, protection of proprietary technology, strategic relationships and dependence on key individuals. Other Global Events |
Fair Value | Fair Value The Company’s financial instruments include accounts receivable, net, other receivable, accounts payable, accrued liabilities, operating lease liability, and debt. The recorded carrying amount of accounts receivable, other receivable, accounts payable, and accrued liabilities reflect their fair value due to their short-term nature. Other financial liabilities are initially recorded at fair value, and subsequently measured at fair value or amortized cost using the effective interest method. See Note 3 for the fair value measurements. |
Fair Value Option | Fair Value Option ASC 825-10, Financial Instruments |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. Cost is initially recorded at the invoiced amount of raw materials or API, including the sum of qualified expenditures and charges for bringing the inventory to its existing condition and location. The Company calculates inventory valuation adjustments when conditions indicate that net realizable value is less than cost due to physical deterioration, usage, obsolescence, reductions in estimated future demand, or reductions in selling price. Inventory write-downs are measured as the difference between the cost of inventory and net realizable value. The Company does not have an allowance for inventory obsolescence as of June 30, 2024, and December 31, 2023. |
Prelaunch Inventory | Prelaunch Inventory The Company’s policy is to capitalize costs for prelaunch inventories within the drug development phase, which is evidence that the product’s reasonably likely critical attributes for success are present and feasible, and the key causes of failures are absent based on management’s assumptions. The costs that can be capitalized for pre-launch inventory are recorded as “Prepayments and Other Assets.” |
Property and Equipment | Property and Equipment Land is stated at cost, reflecting the fair value of the property at July 31, 2017, the date of the Napo merger. Equipment is stated at cost, net of accumulated depreciation. Equipment begins to be depreciated when it is placed into service. Depreciation is calculated using the straight-line method over estimated useful lives ranging between three Expenditures for repairs and maintenance of assets are charged to expenses as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their estimated useful lives. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts, and any resulting gain or loss is included in the unaudited condensed consolidated statements of operations. |
Software Developed for Internal Use | Software Developed for Internal Use The Company capitalizes the costs of developing software for internal use. These costs include both purchased software and internally developed software. Costs of developing software are expensed until technological feasibility has been established. Thereafter, all costs are capitalized and are carried at the lower of unamortized cost or net realizable value. Internally developed and purchased software costs are generally amortized over five years. |
Long-lived Assets | Long-lived Assets The Company regularly reviews the carrying value and estimated lives of all of its long-lived assets, including property and equipment and definite-lived intangible assets, to determine whether indicators of impairment exist that warrant adjustments to carrying values or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and positive cash flow in future periods, as well as the strategic significance of the assets to the Company’s business objectives. If the Company determines that events or changes in circumstances indicate that the carrying amount of the asset group may not be recoverable, the Company evaluates the realizability of its long-lived assets (asset group) based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset. Any write-downs (measured based on the difference between the fair value and the asset's carrying value) are treated as permanent reductions in the carrying amount of the assets (asset group). The Company evaluated the carrying value of its internal use software costs as at December 31, 2023, in accordance with ASC 360-10, Impairment of Long-lived Assets to be Held or Used Fair Value Measurements None of the Company’s long-lived assets were deemed impaired as of June 30, 2024. |
Indefinite-lived Intangible Assets | Indefinite-lived Intangible Assets Acquired IPR&D are intangible assets acquired in the July 2017 Napo merger. Under ASC 80, Business Combination |
Leases | Leases The Company accounts for its leases in accordance with ASC 842, Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. Because the interest rate implicit in lease contracts is typically not readily determinable, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. Lease Modification ASC 842 defines lease modification as a change to the terms and conditions of a contract that results in a change in the scope of or the consideration for a lease. A lease modification can result in either a separate new contract that is accounted for separately from the original contract or a single modified contract. The Company shall account for a modification to a contract as a separate contract when the modification grants the lessee an additional right of use not included in the original lease and the lease payments increase commensurate with the standalone price for the additional right of use, adjusted for the circumstances of the particular contract. When the Company concludes that a lease modification should be accounted for as a new contract that is separate and apart from the original lease, the new contract should be evaluated for whether it is a lease or contains an embedded lease. If the new contract is a lease or contains an embedded lease, the new lease should be accounted for as any other new lease. The new lease is recorded on the commencement date of the new lease, which is the date the lessee has access to the leased asset. If a lease modification is not accounted for as a separate contract, the Company should reassess whether the contract contains a lease. If the modified contract is a lease or contains an embedded lease, a lessee should reallocate contract consideration, reassess the lease classification, remeasure the lease liability, and adjust the right-of-use asset. |
Research and Development Expense | Research and Development Expense Research and development expense consists of expenses incurred in performing research and development activities, including related salaries, clinical trials, and related drug and non-drug product costs, contract services, and other outside service expenses. Research and development expenses are charged to operating expenses during the period incurred. |
Clinical Trial Accruals | Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses for clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the costs to be recorded based upon validation with the external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers The Company’s policy typically permits returns if the product is damaged, defective, or otherwise cannot be used when received by the customer if the product has expired. Returns are accepted for products that will expire within three months or that have expired up to one year after their expiration dates. Estimates for expected returns of expired products are based primarily on an ongoing analysis of our historical return patterns. The Company recognizes revenue in accordance with the core principle of ASC 606 or when there is a transfer of control of promised goods or services to customers in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those goods or services. The Company recognizes the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that the Company otherwise would have recognized is one year or less. The Company does not adjust the amount of consideration for the effects of a significant financing component if, at contract inception, the expected period between the transfer of promised goods or services and customer payment is one year or less. The Company has elected to treat shipping and handling activities as fulfillment costs. Additionally, the Company elected to record revenue net of sales and other similar taxes. Contracts and Agreements The Company's Canalevia-CA1 and Neonorm products are primarily sold to distributors, who then sell the products to the end customers. Since 2021, the Company has entered into two distribution agreements with established distributors to distribute the Company’s animal health products in the United States. The distribution agreements and the related purchase orders together meet the contract existence criteria under ASC 606. The Company sells directly to its customers without the use of an agent. Performance obligations For animal health products sold by the Company, the single performance obligation identified above is the Company’s promise to transfer the Company’s animal health products to distributors based on specified payment and shipping terms in the arrangement. Product warranties are assurance-type warranties that do not represent a performance obligation. For the Company’s human health product, Mytesi, the single performance obligation identified above is the Company’s promise to transfer Mytesi to specialty pharmacies based on specified payment and shipping terms as outlined in the Exclusive Distribution Agreement entered into by the Company and Cardinal Health as of January 16, 2019. Transaction price For contracts with Cardinal Health and other distributors, the transaction price is the amount of consideration that which the Company expects to collect in exchange for transferring the promised goods or services. The transaction price of Mytesi is the Wholesaler Acquisition Cost (“WAC”), and the transaction price of Canalevia-CA1 and Neonorm is the manufacturer’s list price, net of discounts, returns, and price adjustments. Allocate transaction price For contracts with Cardinal Health and other distributors, the entire transaction price is allocated to the single performance obligation contained in each contract. Revenue recognition For contracts with Cardinal Health, a single performance obligation is satisfied at a point in time upon each contract's free on board (“FOB”) terms when control, including title and all risks, has transferred to the customer. Disaggregation of Product Revenue Human Sales of Mytesi are recognized as revenue at a point in time when the products are delivered to the wholesaler. Net revenues from the sale of Mytesi were $2.7 million and $2.6 million for the three months ended June 30, 2024, and 2023, respectively. Net revenues from the sale of Mytesi were $5.0 million and $4.6 million for the six months ended June 30, 2024, and 2023, respectively. Animal The Company recognized Canalevia-CA1 products revenues of $26,000 and $39,000 for the three months ended June 30, 2024, and 2023, respectively, and Neonorm revenues of $15,000 and $10,000 for the three months ended June 30, 2024, and 2023, respectively. The Company recognized Canalevia-CA1 products revenues of $66,000 and $67,000 for the six months ended June 30, 2024, and 2023, respectively, and Neonorm revenues of $23,000 and $28,000 for the six months ended June 30, 2024, and 2023, respectively. Revenues are recognized at a point in time upon shipment when title and control are transferred to the buyer. Sales of Canalevia-CA1, Neonorm Calf, and Foal to distributors are made under agreements that may provide distributor price adjustments and rights of return under certain circumstances. Contracts – Specialty Pharmacies Effective October 1, 2020, the Company engaged a private company as an authorized specialty pharmacy provider of the Company’s Mytesi product. Under the Specialty Product Distribution Agreement, the Company shall supply the products directly to the private company’s specialty pharmacies in such amounts as may be ordered. There is no minimum purchase or inventory requirement. The specialty pharmacies were authorized distributors of record for all National Drug Codes of Mytesi. Effective April 20, 2021, the Company engaged another private company as an authorized specialty pharmacy provider of Mytesi. Under the Specialty Pharmacy Distribution and Services Agreement, the private company shall sell and dispense the Mytesi directly ordered from the Company at the agreed price to patients within the territories identified in the agreement. The Company has entered into agreements with a total of five different specialty pharmacy chains that are authorized to provide Mytesi to patients. Performance obligations The single performance obligation is the Company’s promise to transfer Mytesi to specialty pharmacies, based on specified payment and shipping terms outlined in the agreements. Transaction price The transaction price is the amount of consideration the Company expects to collect in exchange for transferring the promised goods or services. The transaction price of Mytesi is the WAC, net of estimated discounts, returns, and price adjustments. Allocate transaction price The entire transaction price is allocated to the single performance obligation contained in each contract. Revenue recognition The single performance obligation is satisfied at a point in time, upon the FOB terms of each contract, when control, including title and all risks, has been transferred to the customer. Product Revenue Sales of Mytesi are recognized as revenue at a point in time when the products are delivered to the specialty pharmacies. Net revenues from the sale of Mytesi to the specialty pharmacies were $2.3 million and $1.5 million for the three months ended June 30, 2024, and 2023, respectively. Net revenues from the sale of Mytesi to the specialty pharmacies were $4.3 million and $3.5 million for the six months ended June 30, 2024, and 2023, respectively. |
Collaboration Revenue | Collaboration Revenue Revenue recognition for collaboration agreements requires significant judgment. The Company’s assessments and estimates are based on contractual terms, historical experience, and general industry practice. Revisions in these values or estimations increase or decrease collaboration revenue in the period of revision. On September 24, 2018, the Company entered into a Distribution, License, and Supply Agreement (“License Agreement”) with Knight Therapeutics (“Knight”). The License Agreement has a term of 15 years (with automatic renewals) and provides Knight with an exclusive right to commercialize current and future Jaguar human health products (including crofelemer, NP-300, and any product containing a proanthocyanidin or with an anti-secretory mechanism) in Canada and Israel. Knight forfeited its right of first negotiation for expansion to Latin America. Under the License Agreement, Knight is responsible for applying for and obtaining necessary regulatory approvals in the territory of Canada and Israel, as well as marketing, sales, and distribution of the licensed products. Knight will pay a transfer price for all licensed products, and upon achievement of certain regulatory and sales milestones, the Company may receive payments from Knight in an aggregate amount of up to approximately $18.0 million, payable throughout the initial 15-year term of the agreement. The Company did not have any license revenues for the three and six months ended June 30, 2024, and 2023. |
Modifications to Liability-classified Instruments | Modifications to Liability-classified Instruments In accounting for debt modifications and exchange transactions, it is the Company’s policy first to determine whether it qualifies as a troubled debt restructuring (“TDR”) pursuant to the guidance provided in ASC 470-60, Debt—Troubled Debt Restructurings by Debtors Modification and Extinguishments For the six months ended June 30, 2024, and June 30, 2023, the Company has entered amendments to the terms of its royalty interests and purchase agreements. |
Modifications to Equity-classified Instruments | Modifications to Equity-classified Instruments In accounting for modifications of equity-classified warrants, the Company’s policy is to determine the impact by analogy to the share-based compensation guidance of ASC 718, Compensation-Stock Compensation Compensation-Stock Compensation—Awards Classified as Equity—Subsequent Measurement The Company did not modify any equity-classified warrants for the three and six months ended June 30, 2024, and 2023. In accounting for amendments to preferred stock, the Company’s policy is to measure the impact by analogy to ASC 470-50 in determining if such an amendment is an extinguishment or a modification. If the amendment results in an extinguishment, the Company follows the SEC staff guidance in ASC 260-10-S99-2, Earnings Per Share—Overall—SEC Materials Debt—Debt with Conversion and Other Options The Company did not modify any equity-classified preferred stock for the three and six months ended June 30, 2024, and 2023. |
Stock-based Compensation | Stock-based Compensation The Company's Stock Incentive Plan (See Note 12) provides for the grant of stock options, restricted stock, and restricted stock unit awards. The Company measures stock awards granted to employees, non-employees, and directors at estimated fair value on the date of grant and recognizes the corresponding compensation expense of the awards, net of estimated forfeitures, over the requisite service periods, which correspond to the vesting periods of the awards. If necessary, forfeitures are estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates. The Company issues stock awards with only service-based vesting conditions and records compensation expenses for these awards using the straight-line method. The Company uses its common stock's grant date fair market value to determine the grant date fair value of options granted to employees, non-employees, and directors. The Company measures and recognizes compensation expense for all stock options and restricted stock units (“RSUs”) granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The fair value is recognized as an expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. The determination of the grant date fair value of options using an option pricing model is affected by the Company’s estimated common stock fair value and requires management to make a number of assumptions, including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair market value of common stock is based on the closing price of the Company’s common stock as reported on the date of the grant. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company has adopted the provisions of ASC 740, Income Taxes |
Foreign Currency Remeasurement and Translation | Foreign Currency Remeasurement and Translation The functional currency of Napo Therapeutics is the Euro. The Company follows ASC 830, Foreign Currency Matters For certain subsidiaries, translation adjustments result from translating the functional currency of subsidiary financial statements into the U.S. Dollar reporting currency. These translation adjustments are reported separately and accumulated in the unaudited condensed consolidated balance sheets as a component of accumulated other comprehensive loss. |
Comprehensive Loss | Comprehensive Loss The Company follows ASC 220, Income Statement—Reporting Comprehensive Income For the three months ended June 30, 2024, and 2023, the other comprehensive losses (gains) from translation adjustments were ($94,000) and $183,000, respectively. For the six months ended June 30, 2024, and 2023, the other comprehensive losses (gains) from translation adjustments were $124,000 and ($49,000), respectively. |
Basic and Diluted Net Loss Per Share of Common Stock | Basic and Diluted Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss attributable to common stockholders for the year by the weighted average number of common stock outstanding during the year. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders for the year by the weighted average number of common stock, including potential dilutive shares of common stock assuming the dilutive effect of potential dilutive securities. For years in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share because their impact would be anti-dilutive to the calculation of net loss per share. For the three months and six months ended June 30, 2023, the Company reports a separate basic net loss and diluted loss per share of common stock. Diluted net loss per share of common stock is the same as basic net loss per share of common stock for the three and six months ended June 30, 2024, and 2023. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2023, FASB issued ASU 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures The ASU requires all segment profit or loss and assets disclosures to be provided on an annual and interim basis. For each interim period, the total of the reportable segments’ amount for the measures of profit or loss is to be reconciled to the public entity's consolidated income before income taxes and discontinued operations The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company early adopted the ASU on its interim period reporting as of and for the period ending June 30, 2024. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) - Customer risk | 6 Months Ended |
Jun. 30, 2024 | |
Total net revenue | |
Schedule of concentration risk | Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Customer 1 33 % 29 % 32 % 27 % Customer 2 56 % 54 % 55 % 52 % |
Total accounts receivable | |
Schedule of concentration risk | June 30, December 31, 2024 2023 Customer 1 31 % 32 % Customer 2 55 % 57 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Measurements | |
Summary of information about the company's financial instruments that were measured at fair value on a recurring basis | June 30, 2024 (unaudited) (in thousands) Level 1 Level 2 Level 3 Total Iliad $ — $ — $ 6,140 $ 6,140 Uptown — — 8,235 8,235 Streeterville 2 — — 7,438 7,438 Streeterville Note — — 10,538 10,538 Total fair value $ — $ — $ 32,351 $ 32,351 December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Iliad $ — $ — $ 6,862 $ 6,862 Uptown — — 7,473 7,473 Streeterville 2 — — 6,815 6,815 Streeterville Note — — 9,793 9,793 Total fair value $ — $ — $ 30,943 $ 30,943 |
Summary of change in the estimated fair value of level 3 liabilities | Six Months Ended June 30, 2024 (in thousands) Iliad Uptown Streeterville 2 Streeterville Note Beginning fair value of Level 3 liability $ 6,862 $ 7,473 $ 6,815 $ 9,793 Additions — — — — Exchanges (2,258) — (165) — Settlements — — — — Change in fair value 1,536 762 788 745 Ending fair value of Level 3 liability $ 6,140 $ 8,235 $ 7,438 $ 10,538 Six Months Ended June 30, 2023 (in thousands) Iliad Uptown Streeterville 2 Streeterville Note Beginning fair value of Level 3 liability $ — $ — $ 7,839 $ — Additions — — — — Exchanges — — — — Change in fair value — — 1,121 — Ending fair value of Level 3 liability $ — $ — $ 8,960 $ — |
Summary of information about the significant unobservable inputs used in level 3 fair value measurements | Range of Inputs (probability-weighted average) Relationship of unobservable inputs Unobservable Inputs 2024 2023 to fair value Risk Adjusted Discount Rate 9.53%-26.10% (26.10%) 9.02%-24.59% (24.59%) If the discount rate is adjusted to a total of additional 100 basis points (bps), the fair value would have decreased by $404,000. Sales Proceeds: Amount of comparable TDPRV $67.5 million to $350 million ($100 million) $67.5 million to $350 million ($100 million) If expected cash flows by Management were considered the lowest market indications for vouchers, FV would have decreased by $1.45 million. Range of Probability for Timing of Cash Flows: 0.75%-13.71% 0.10%-73.27% If expected cash flows by management were considered the scenario with the least indicated value, FV would have decreased by $53,000. |
Summary of information about the significant unobservable inputs used in level 3 fair value measurements for instruments not classified as hybrid instruments | Range of Inputs (probability-weighted average) Relationship of unobservable inputs Unobservable Inputs 2024 2023 to fair value Risk Adjusted Discount Rate 8.53%-28.10% (28.10%) 9.02%-26.59% (26.59%) If the discount rate is adjusted to a total of an additional 100 basis points (bps), the fair value would have decreased by $483,232. |
Summary of the fair value and unpaid principal balance for items the Company accounts for under FVO | (in thousands) Fair value Unpaid Principal Balance Accrued Interest Fair Value Over (Under) Outstanding Balance At June 30, 2024 Iliad $ 6,140 $ 4,882 $ 4,139 $ (2,881) Uptown 8,235 7,994 4,683 (4,442) Streeterville 2 7,438 10,094 1,516 (4,172) Streeterville Note 10,538 6,000 706 3,832 (in thousands) Fair value Unpaid Principal Balance Accrued Interest Fair Value Over (Under) Outstanding Balance At December 31, 2023 Iliad $ 6,862 $ 7,292 $ 3,621 $ (4,051) Uptown 7,473 7,994 4,058 (4,579) Streeterville 2 6,815 10,273 950 (4,408) Streeterville Note 9,793 6,000 546 3,247 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Balance Sheet Components | |
Schedule of inventory | June 30, December 31, 2024 2023 (in thousands) (unaudited) Raw material $ 1,961 $ 2,057 Work in process 6,827 6,517 Finished goods 768 615 Inventory $ 9,556 $ 9,189 |
Schedule of property and equipment | June 30, December 31, 2024 2023 (in thousands) (unaudited) Land $ 396 $ 396 Lab equipment 477 477 Software 63 63 Furniture and fixtures 18 18 Computers and peripherals 23 7 Total property and equipment at cost 977 961 Accumulated depreciation (489) (465) Property and equipment, net $ 488 $ 496 |
Schedule of intangible assets | June 30, December 31, 2024 2023 (in thousands) (unaudited) Developed technology $ 25,000 $ 25,000 Accumulated developed technology amortization (11,528) (10,694) Developed technology, net 13,472 14,306 In-process research and development 4,800 4,800 In process research and development, net 4,800 4,800 Trademarks 515 300 Accumulated trademark amortization (138) (128) Trademarks, net 377 172 Internal use software costs - registry 1,237 1,236 Accumulated internal use software costs impairment (371) (371) Accumulated internal use software costs amortization (441) (370) Internal use software costs - registry, net 425 495 Patents 361 361 Accumulated patents amortization (27) (18) Patents, net 334 343 Total intangible assets, net $ 19,408 $ 20,116 |
Schedule of estimated future amortization expense of intangible assets with finite lives | (in thousands) Amounts Remainder of 2024 $ 923 2025 1,846 2026 1,846 2027 1,846 2028 1,846 Thereafter 6,301 $ 14,608 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies | |
Schedule of additional details of office space lease | June 30, December 31, 2024 2023 (in thousands) (unaudited) Operating lease - right-of-use asset $ 1,176 $ 1,176 Operating lease liability, current 416 348 Operating lease liability, net of the current portion 812 886 Total $ 1,228 $ 1,234 Weighted-average remaining life (years) 4.10 4.76 Weighted-average discount rate 20.03% 21.34% |
Schedule of undiscounted cash payment obligations | June 30, December 31, 2024 2023 (in thousands) (unaudited) (unaudited) Remainder of 2024 $ 589 $ 562 2025 346 346 2026 243 266 2027 236 233 2028 243 240 2029 251 247 2030 42 168 Total undiscounted operating lease payments 1,950 2,062 Imputed interest expenses (722) (828) Total operating lease liability 1,228 1,234 Less: Operating lease liability, current 416 348 Operating lease liability, net of current portion $ 812 $ 886 |
Schedule of summarized income statement information using equity method | Six months ended June 30, 2024 (in thousands) (unaudited) Revenue $ — Operating expenses (115) Loss before income tax (115) Income tax expense — Net loss $ (115) Net loss attributable to the Company $ (46) |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt | |
Schedule of notes payable | June 30, December 31, 2024 2023 (in thousands) (unaudited) Notes designated at Fair Value Option $ 32,351 $ 30,943 Royalty Interest* — 5,635 Insurance Financing 477 172 Tempesta Note 100 150 Total 32,928 36,900 Less: Unamortized discount and debt issuance costs — (1,040) Note payable, net of discount $ 32,928 $ 35,860 Notes payable - non-current, net $ 21,813 $ 30,993 Notes payable - current, net $ 11,115 $ 4,867 Weighted average interest rate on short-term borrowings 3.24% 5.04% *Notes with royalty interest not designated at FVO. |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Warrants | |
Summary of warrant activity | June 30, December 31, 2024 2023 (unaudited) Warrants outstanding, beginning balance 201,830 125 Issuances — 201,705 Exercises (125,632) — Expirations and cancelations — — Warrants outstanding, ending balance 76,198 201,830 |
Preferred Stock (Tables)
Preferred Stock (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Preferred Stock | |
Schedule of convertible preferred stock | June 30, 2024 Liquidation ( in thousands, except share and per share data) Shares Issued and Carrying Preference Series Designated Outstanding Value per Share A 5,524,926 — $ — $ — B 11,000 — — — B-1 63 — — — B-2 10,165 — — — C 1,011,000 — — — D 977,300 — — — E 10 — — — F 10 — — — G 137 — — — H 105 — — — I 118 — — — J 179 99 — — Total 7,535,013 99 $ — $ — December 31, 2023 Liquidation ( in thousands, except share and per share data) Shares Issued and Carrying Preference Series Designated Outstanding Value per Share A 5,524,926 — $ — $ — B 11,000 — — — B-1 63 — — — B-2 10,165 — — — C 1,011,000 — — — D 977,300 — — — E 10 — — — F 10 — — — G 137 122 — — H 105 — — — I 118 56 — — Total 7,534,834 178 $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stockholders' Equity | |
Schedule of common reserved shares of common stock for issuance | June 30, December 31, 2024 2023 (unaudited) Options issued and outstanding 404 26,357 Inducement options issued and outstanding — 1,534 Options available for grant under stock option plans 875,566 120,033 Restricted stock unit awards issued and outstanding 45,788 47,998 Warrants issued and outstanding 76,198 7,505 Total 997,956 203,427 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Stock-based Compensation | |
Summary of incentive plan activity | Weighted Weighted Average Shares Stock Average Remaining Aggregate Available Options RSUs Stock Option Contractual Life Intrinsic (in thousands, except share and per share data) for Grant Outstanding Outstanding Exercise Price (Years) Value* Outstanding at January 1, 2023 2,045 454 585 $ 35,564.08 7.19 $ — Additional shares authorized 52,772 — — — — — Options granted — — — — — — Options exercised — — — — — — Options canceled 49 (49) — 19,668.87 — — RSUs granted (44,733) — 44,733 — — — RSUs vested and released 243 — (243) — — — RSUs cancelled 87 — (87) — — — Outstanding at December 31, 2023 10,463 405 44,988 $ 35,738.63 6.21 $ — Additional shares authorized 865,902 — — — — — Options granted — — — — — — Options exercised — — — — — — Options canceled 1 (1) — 23,355.00 — — RSUs granted (895) — 895 — — — RSUs exercised 26 — (26) — — — RSUs cancelled 69 — (69) — — — Outstanding at June 30, 2024 875,566 404 45,788 $ 21,057.18 5.72 $ — Exercisable at June 30, 2024 404 $ 21,057.18 5.72 $ — Vested and expected to vest at June 30, 2024 404 $ 21,057.18 5.72 $ — *The fair market value of Jaguar stock on June 30, 2024, was $3.58 per share. |
Summary of stock-based compensation expense | Three Months Ended Six Months Ended June 30, June 30, (in thousands) 2024 2023 2024 2023 (unaudited) Research and development expense $ 176 $ 257 $ 465 $ 484 Sales and marketing expense 32 86 72 115 General and administrative expense 175 175 427 399 Total $ 383 $ 518 $ 964 $ 998 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Net Loss Per Share | |
Schedule of calculation of basic and diluted net loss per common share | Three Months Ended Six Months Ended June 30, June 30, (In thousands, except share and per share data) 2024 2023 2024 2023 (unaudited) (unaudited) Net loss attributable to common stockholders $ (9,492) $ (12,150) $ (18,718) $ (24,352) Shares used to compute net loss per common stock, basic 2,349,431 293,858 1,174,716 190,073 Shares used to compute net loss per common stock, diluted 2,349,431 293,858 1,174,716 190,073 Net loss per share attributable to common stockholders, basic $ (4.04) $ (41.35) $ (15.93) $ (128.12) Net loss per share attributable to common stockholders, diluted $ (4.04) $ (41.35) $ (15.93) $ (128.12) |
Schedule of other common stock equivalents | June 30, December 31, 2024 2023 (unaudited) Options issued and outstanding 404 26,357 Inducement options issued and outstanding — 1,534 Restricted stock units issued and outstanding 45,788 47,998 Warrants issued and outstanding 76,198 7,505 Total 122,390 83,394 |
Segment Data (Tables)
Segment Data (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Segment Data | |
Schedule of reportable segments net revenue and net loss | Six Months Ended Six Months Ended June 30, 2024 June 30, 2023 (in thousands) (unaudited) (unaudited) Human Health Animal Health Total Human Health Animal Health Total External revenue $ 4,940 $ 132 $ 5,072 $ 4,553 $ 95 $ 4,648 Less: Segment expenses Cost of revenue 829 28 857 805 31 836 Research and development 6,401 1,565 7,966 7,616 1,433 9,049 Sales and marketing 2,822 145 2,967 3,296 161 3,457 General and administrative 4,411 5,239 9,650 4,812 5,384 10,196 Interest 55 501 556 1 5,632 5,633 Other segment items* 237 2,556 2,793 50 1,075 1,125 Segment expenses 14,755 10,034 24,789 16,580 13,716 30,296 Segment net comprehensive loss $ (9,815) $ (9,902) $ (19,717) $ (12,027) $ (13,621) $ (25,648) Reconciliation of net comprehensive loss Adjustments and reconciling items** 845 911 Consolidated net comprehensive loss $ (18,872) $ (24,737) Three Months Ended Three Months Ended June 30, 2024 June 30, 2023 (in thousands) (unaudited) (unaudited) Human Health Animal Health Total Human Health Animal Health Total External revenue $ 2,637 $ 84 $ 2,721 $ 2,627 $ 49 $ 2,676 Less: Segment expenses Cost of revenue 414 13 427 475 16 491 Research and development 2,914 744 3,658 3,540 732 4,272 Sales and marketing 1,450 74 1,524 1,541 33 1,574 General and administrative 2,108 2,681 4,789 2,373 2,544 4,917 Interest 28 (110) (82) 1 3,452 3,453 Other segment items* 733 1,816 2,549 (282) 805 523 Segment expenses 7,647 5,218 12,865 7,648 7,582 15,230 Segment net comprehensive loss $ (5,010) $ (5,134) $ (10,144) $ (5,021) $ (7,533) $ (12,554) Reconciliation of net comprehensive loss Adjustments and reconciling items** 422 446 Consolidated net comprehensive loss $ (9,722) $ (12,108) *Other segment items for each reportable segment include: ● Human Health - realized gain/loss on foreign exchange transactions, change in fair value of warrants, gain/loss on debt extinguishment and share in net income or loss in joint venture. ● Animal Health - realized and unrealized gain/loss on foreign exchange transactions. **Adjustments and reconciling items include intercompany elimination entries |
Schedule of reportable segments assets | June 30, December 31, 2024 2023 (in thousands) (unaudited) Segment assets Human Health $ 42,859 $ 42,289 Animal Health 173,402 153,190 Total $ 216,261 $ 195,479 |
Schedule of reconciliation of segments assets to the consolidated assets | June 30, December 31, 2024 2023 (in thousands) (unaudited) Total assets for reportable segments $ 216,261 $ 195,479 Less: Investment in subsidiary (29,232) (29,232) Less: Intercompany loan (125,570) (115,484) Consolidated Totals $ 61,459 $ 50,763 |
Organization and Business (Deta
Organization and Business (Details) | 6 Months Ended |
Jun. 30, 2024 segment | |
Organization and Business | |
Number of operations segments | 2 |
Organization and Business - Nas
Organization and Business - Nasdaq Communication and Compliance (Details) - $ / shares | Feb. 15, 2024 | May 10, 2023 |
Grace period | 180 days | 180 days |
Consecutive business days in grace period | 10 days | |
Minimum | ||
Share Price | $ 1 | |
Maximum | ||
Share Price | $ 0.10 |
Organization and Business - Liq
Organization and Business - Liquidity and Going Concern (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Organization and Business | ||
Accumulated deficit | $ (326,707) | $ (308,248) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Non-Controlling Interest (Details) | Jun. 30, 2024 | Dec. 31, 2023 |
Napo Therapeutics | ||
Percentage of ownership interest by parent | 88% | |
Private Investors | ||
Percentage of ownership interest by non-controlling owners | 12% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Accounts receivable and Concentrations (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2024 Distributor | Jun. 30, 2023 Distributor | Jun. 30, 2024 Distributor item | Jun. 30, 2023 Distributor | Dec. 31, 2023 | |
Supplier risk | |||||
Concentrations | |||||
Number of suppliers | item | 2 | ||||
Total net revenue | Customer risk | Customer 1 | |||||
Concentrations | |||||
Concentration risk (as a percentage) | 33% | 29% | 32% | 27% | |
Total net revenue | Customer risk | Customer 2 | |||||
Concentrations | |||||
Concentration risk (as a percentage) | 56% | 54% | 55% | 52% | |
Total net revenue | Customer risk | Three major pharmaceutical distributors | |||||
Concentrations | |||||
Number of major distributors | Distributor | 3 | 3 | 3 | 3 | |
Total net revenue | Customer risk | Minimum | |||||
Concentrations | |||||
Threshold for calculating concentration risk percentage | 0.10% | 0.10% | 0.10% | 0.10% | |
Total accounts receivable | Customer risk | Customer 1 | |||||
Concentrations | |||||
Concentration risk (as a percentage) | 31% | 32% | |||
Total accounts receivable | Customer risk | Customer 2 | |||||
Concentrations | |||||
Concentration risk (as a percentage) | 55% | 57% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Inventory (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Summary of Significant Accounting Policies | ||
Allowance for inventory obsolescence | $ 0 | $ 0 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Property and Equipment and Indefinite-lived Intangible Assets (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Goodwill impairment charges | ||||
Impairment of long lived assets | $ 0 | |||
Impairment of indefinite-lived intangible assets | $ 0 | $ 0 | $ 0 | $ 0 |
Internal use software costs - registry | ||||
Goodwill | ||||
Intangible asset amortization period | 5 years | 5 years | ||
Napo (Member) | Equipment | Minimum | ||||
Goodwill | ||||
Estimated useful lives | 3 years | 3 years | ||
Napo (Member) | Equipment | Maximum | ||||
Goodwill | ||||
Estimated useful lives | 10 years | 10 years |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Revenue Recognition (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 USD ($) item | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) agreement item | Jun. 30, 2023 USD ($) | |
Disaggregation of Product Revenue | ||||
Number of distribution agreements | agreement | 2 | |||
Mytesi | ||||
Disaggregation of Product Revenue | ||||
Product revenue | $ 2,700,000 | $ 2,600,000 | $ 5,000,000 | $ 4,600,000 |
Number of specialty pharmacies. | item | 5 | 5 | ||
Mytesi | Specialty Pharmacies | ||||
Disaggregation of Product Revenue | ||||
Product revenue | $ 2,300,000 | 1,500,000 | $ 4,300,000 | 3,500,000 |
Canalevia-CA1 | ||||
Disaggregation of Product Revenue | ||||
Product revenue | 26,000 | 39,000 | 66,000 | 67,000 |
Neonorm | ||||
Disaggregation of Product Revenue | ||||
Product revenue | $ 15,000 | $ 10,000 | $ 23,000 | $ 28,000 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Revenue Recognition - Collaboration Revenue (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Sep. 24, 2018 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stockholders' Equity | |||||
Collaboration revenue | $ 0 | $ 0 | $ 0 | $ 0 | |
Knight | |||||
Stockholders' Equity | |||||
License agreement term (in years) | 15 years | ||||
Transfer price receivable upon achievement of certain regulatory and sales milestones | $ 18,000,000 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Comprehensive Loss (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Summary of Significant Accounting Policies | ||||
Translation gain (loss) | $ (94,000) | $ 183,000 | $ 124,000 | $ (49,000) |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Jan. 13, 2021 |
Fair value of liabilities measured on a recurring basis | |||
Total fair value | $ 32,351 | $ 30,943 | |
Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 21,700 | $ 20,200 | |
Total fair value | 32,351 | 30,943 | |
Iliad | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 6,140 | 6,862 | |
Iliad | Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 6,140 | 6,862 | |
Uptown | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 8,235 | 7,473 | |
Uptown | Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 8,235 | 7,473 | |
Streeterville 2 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 7,438 | 6,815 | |
Streeterville 2 | Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 7,438 | 6,815 | |
Streeterville Note | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 10,538 | 9,793 | |
Streeterville Note | Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | $ 10,538 | $ 9,793 | $ 7,800 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated fair value of Level 3 (Details) - Level 3 - Recurring - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Iliad | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning fair value of Level 3 liability | $ 6,862 | |
Exchanges | (2,258) | |
Change in fair value | 1,536 | |
Ending fair value of level 3 liability | 6,140 | |
Uptown | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning fair value of Level 3 liability | 7,473 | |
Change in fair value | 762 | |
Ending fair value of level 3 liability | 8,235 | |
Streeterville 2 | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning fair value of Level 3 liability | 6,815 | $ 7,839 |
Exchanges | (165) | |
Change in fair value | 788 | 1,121 |
Ending fair value of level 3 liability | 7,438 | $ 8,960 |
Streeterville Note | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning fair value of Level 3 liability | 9,793 | |
Change in fair value | 745 | |
Ending fair value of level 3 liability | $ 10,538 |
Fair Value Measurements - Stree
Fair Value Measurements - Streeterville Note (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Jan. 13, 2021 |
Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | $ 21,700 | $ 20,200 | |
Streeterville Note | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 10,538 | $ 9,793 | |
Streeterville Note | Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | $ 10,538 | $ 9,793 | $ 7,800 |
Fair Value Measurements - Quant
Fair Value Measurements - Quantitative information about the significant unobservable inputs (Details) - Level 3 | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) | Jun. 30, 2023 | |
Discount rate | Minimum | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Probability (as a percent) | 9.53 | 9.02 | |
Basis point for adjustment of discount rate | 1 | ||
Fair value increase (decrease) | $ (404,000) | ||
Probability (as a percent) | 0.0853 | 0.0902 | |
Basis point for adjustment of discount rate for non-hybrid instruments | 1 | ||
Fair value increase (decrease) for non-hybrid investments | $ 483,232 | ||
Discount rate | Maximum | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Probability (as a percent) | 26.10 | 24.59 | |
Basis point for adjustment of discount rate | 1 | ||
Fair value increase (decrease) | $ 404,000 | ||
Probability (as a percent) | 0.2810 | 0.2659 | |
Basis point for adjustment of discount rate for non-hybrid instruments | 1 | ||
Fair value increase (decrease) for non-hybrid investments | $ 494,667 | ||
Discount rate | Weighted average | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Probability (as a percent) | (26.10) | (24.59) | |
Probability (as a percent) | (0.2810) | (0.2659) | |
Sale Proceeds | Minimum | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Amount of comparable TDPRV | $ 67,500,000 | $ 67,500,000 | |
Fair value increase (decrease) | (1,450,000) | ||
Sale Proceeds | Maximum | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Amount of comparable TDPRV | 350,000,000 | 350,000,000 | |
Fair value increase (decrease) | 11,200,000 | ||
Sale Proceeds | Weighted average | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Amount of comparable TDPRV | $ 100,000,000 | $ 100,000,000 | |
Timing of Cash Flows | Minimum | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Probability (as a percent) | 0.75 | 0.10 | |
Fair value increase (decrease) | $ (53,000) | ||
Timing of Cash Flows | Maximum | |||
Fair Value Measurement Inputs and Valuation Techniques | |||
Probability (as a percent) | 13.71 | 73.27 | |
Fair value increase (decrease) | $ 1,450,000 |
Fair Value Measurements - Fai_2
Fair Value Measurements - Fair Value Option - Hybrid Instruments (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Iliad | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value | $ 6,140 | $ 6,862 |
Unpaid Principal Balance | 4,882 | 7,292 |
Accrued Interest | 4,139 | 3,621 |
Fair Value Over (Under) Outstanding Balance | (2,881) | (4,051) |
Uptown | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value | 8,235 | 7,473 |
Unpaid Principal Balance | 7,994 | 7,994 |
Accrued Interest | 4,683 | 4,058 |
Fair Value Over (Under) Outstanding Balance | (4,442) | (4,579) |
Streeterville 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value | 7,438 | 6,815 |
Unpaid Principal Balance | 10,094 | 10,273 |
Accrued Interest | 1,516 | 950 |
Fair Value Over (Under) Outstanding Balance | (4,172) | (4,408) |
Streeterville Note | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value | 10,538 | 9,793 |
Unpaid Principal Balance | 6,000 | 6,000 |
Accrued Interest | 706 | 546 |
Fair Value Over (Under) Outstanding Balance | $ 3,832 | $ 3,247 |
Balance Sheet Components - Inve
Balance Sheet Components - Inventory and Prelaunch Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory | ||
Raw material | $ 1,961 | $ 2,057 |
Work in process | 6,827 | 6,517 |
Finished goods | 768 | 615 |
Inventory | 9,556 | 9,189 |
Prepaid expenses and other current assets | ||
Inventory | ||
Capitalized costs | $ 3,400 | $ 2,800 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Land, Property and Equipment | |||||
Total property and equipment at cost | $ 977,000 | $ 977,000 | $ 961,000 | ||
Accumulated depreciation | (489,000) | (489,000) | (465,000) | ||
Property and equipment, net | 488,000 | 488,000 | 496,000 | ||
Depreciation and amortization expense | 12,000 | $ 15,000 | 25,000 | $ 31,000 | |
Land | |||||
Land, Property and Equipment | |||||
Total property and equipment at cost | 396,000 | 396,000 | 396,000 | ||
Lab equipment | |||||
Land, Property and Equipment | |||||
Total property and equipment at cost | 477,000 | 477,000 | 477,000 | ||
Software | |||||
Land, Property and Equipment | |||||
Total property and equipment at cost | 63,000 | 63,000 | 63,000 | ||
Furniture and fixtures | |||||
Land, Property and Equipment | |||||
Total property and equipment at cost | 18,000 | 18,000 | 18,000 | ||
Computers and peripherals | |||||
Land, Property and Equipment | |||||
Total property and equipment at cost | $ 23,000 | $ 23,000 | $ 7,000 |
Balance Sheet Components - Inta
Balance Sheet Components - Intangible assets (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Intangible assets | ||
Finite-lived intangible assets, net | $ 14,608 | |
Total intangible assets, net | 19,408 | $ 20,116 |
In process research and development | ||
Intangible assets | ||
Total intangible assets | 4,800 | 4,800 |
Developed technology | ||
Intangible assets | ||
Total intangible assets | 25,000 | 25,000 |
Accumulated amortization | (11,528) | (10,694) |
Finite-lived intangible assets, net | 13,472 | 14,306 |
Trademarks | ||
Intangible assets | ||
Total intangible assets | 515 | 300 |
Accumulated amortization | (138) | (128) |
Finite-lived intangible assets, net | 377 | 172 |
Internal use software costs - registry | ||
Intangible assets | ||
Total intangible assets | 1,237 | 1,236 |
Accumulated impairment | (371) | (371) |
Accumulated amortization | (441) | (370) |
Finite-lived intangible assets, net | 425 | 495 |
Patents | ||
Intangible assets | ||
Total intangible assets | 361 | 361 |
Accumulated amortization | (27) | (18) |
Finite-lived intangible assets, net | $ 334 | $ 343 |
Balance Sheet Components - Amor
Balance Sheet Components - Amortization (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Balance Sheet Components | ||||
Amortization expense | $ 434,000 | $ 488,000 | $ 923,000 | $ 976,000 |
Balance Sheet Components - Esti
Balance Sheet Components - Estimated future amortization expense (Details) $ in Thousands | Jun. 30, 2024 USD ($) |
Balance Sheet Components | |
Remainder of 2024 | $ 923 |
2025 | 1,846 |
2026 | 1,846 |
2027 | 1,846 |
2028 | 1,846 |
Thereafter | 6,301 |
Finite-lived intangible assets, net | $ 14,608 |
Related Party Transactions - BO
Related Party Transactions - BOD Cash compensation (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Related party Transactions | ||||
Cash compensation | $ 4,314,000 | $ 4,437,000 | $ 8,695,000 | $ 9,250,000 |
Affiliated Entity | Board of directors | ||||
Related party Transactions | ||||
Cash compensation | $ 109,000 | $ 102,000 | $ 218,000 | $ 217,000 |
Commitments and Contingencies -
Commitments and Contingencies - Commitments (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||||||||||||
Oct. 25, 2023 USD ($) ft² | Jan. 25, 2022 USD ($) | Jan. 25, 2022 EUR (€) | Dec. 22, 2021 USD ($) item | Dec. 22, 2021 EUR (€) item | Oct. 07, 2021 USD ($) | Oct. 07, 2021 EUR (€) | Apr. 06, 2021 USD ($) ft² | Nov. 30, 2022 USD ($) item | Nov. 30, 2022 EUR (€) item | Oct. 31, 2022 USD ($) item | Oct. 31, 2022 EUR (€) item | May 31, 2022 USD ($) item | May 31, 2022 EUR (€) item | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 08, 2023 | Oct. 24, 2023 | Jan. 26, 2022 | |
Commitments and Contingencies | |||||||||||||||||||||
Lease term | 2 years | ||||||||||||||||||||
Base rent | $ 4,200 | € 4,000 | |||||||||||||||||||
Total deposit paid | 9,500 | 9,000 | |||||||||||||||||||
Cash paid for operating lease liabilities recognized under operating cash flows | $ 218,000 | $ 175,000 | |||||||||||||||||||
Addition to right-of-use assets obtained from new and modified operating liabilities | 219,000 | 30,000 | |||||||||||||||||||
General and administrative expense | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Lease costs | $ 76,000 | $ 212,000 | $ 352,000 | $ 421,000 | |||||||||||||||||
If contracts are terminated within 12 months | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Base rent | $ 4,000 | € 3,817 | |||||||||||||||||||
Office space sub lease | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Area (in square feet) | ft² | 10,526 | ||||||||||||||||||||
Extension period | 3 years | ||||||||||||||||||||
Lease term | 3 years | ||||||||||||||||||||
Monthly base rent for first twelve months | $ 42,000 | ||||||||||||||||||||
Monthly base rent for subsequent twelve months | 43,000 | ||||||||||||||||||||
Monthly base rent for final 12 months | $ 45,000 | ||||||||||||||||||||
Leased office premises | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Extension period | 20 months | ||||||||||||||||||||
Leased vehicle | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Lease term | 48 months | 48 months | 48 months | 48 months | |||||||||||||||||
Number of vehicles on lease | item | 2 | 2 | 3 | 3 | |||||||||||||||||
Total monthly lease payment, payable in advance | $ 1,500 | € 1,459 | $ 2,200 | € 2,094 | |||||||||||||||||
Office lease agreement | Leased office premises | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Extension period | 20 months | ||||||||||||||||||||
Base rent | $ 10,500 | € 10,000 | |||||||||||||||||||
Total deposit paid | $ 21,000 | € 20,000 | |||||||||||||||||||
Office lease agreement | Suite 400 | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Area (in square feet) | ft² | 5,735 | ||||||||||||||||||||
Monthly base rent for first two years | $ 18,000 | ||||||||||||||||||||
Monthly base rent for third and fourth years | 18,000 | ||||||||||||||||||||
Monthly base rent for fifth and sixth years | 19,000 | ||||||||||||||||||||
Monthly base rent for seventh and eighth years | 20,000 | ||||||||||||||||||||
Monthly base rent for ninth years | $ 21,000 | ||||||||||||||||||||
Office lease agreement | Suite 600 | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Area (in square feet) | ft² | 5,263 | ||||||||||||||||||||
Monthly base rent for remaining terms | $ 22,000 | ||||||||||||||||||||
Option to extend the lease | true | ||||||||||||||||||||
Office lease agreement | Suite 600 | Minimum | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Extension period | 1 year | 1 year | |||||||||||||||||||
Office lease agreement | Suite 600 | Maximum | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Extension period | 5 years | 3 years | |||||||||||||||||||
Arval Service Lease Italia Spa agreement | Leased vehicle | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Lease term | 48 months | 48 months | |||||||||||||||||||
Total deposit paid | $ 20,000 | € 19,000 | |||||||||||||||||||
Number of vehicles on lease | item | 2 | 2 | |||||||||||||||||||
Total monthly lease payment, payable in advance | $ 2,100 | € 2,000 | |||||||||||||||||||
Vehicle lease agreement | Leased vehicle | |||||||||||||||||||||
Commitments and Contingencies | |||||||||||||||||||||
Lease term | 48 months | 48 months | |||||||||||||||||||
Total deposit paid | $ 22,000 | € 21,000 | |||||||||||||||||||
Number of vehicles on lease | item | 1 | 1 | |||||||||||||||||||
Total monthly lease payment, payable in advance | $ 880 | € 833 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional details of office space lease (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Commitments and Contingencies | ||
Operating lease - right-of-use asset | $ 1,176 | $ 1,176 |
Operating lease liability, current | 416 | 348 |
Operating lease liability, net of the current portion | 812 | 886 |
Total operating lease liability | $ 1,228 | $ 1,234 |
Weighted-average remaining life (years) | 4 years 1 month 6 days | 4 years 9 months 3 days |
Weighted-average discount rate | 20.03% | 21.34% |
Commitments and Contingencies_3
Commitments and Contingencies - Undiscounted cash payment obligation (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Commitments and Contingencies | ||
Remainder of 2024 | $ 589 | $ 562 |
2025 | 346 | 346 |
2026 | 243 | 266 |
2027 | 236 | 233 |
2028 | 243 | 240 |
2029 | 251 | 247 |
2030 | 42 | 168 |
Total undiscounted operating lease payments | 1,950 | 2,062 |
Imputed interest expenses | (722) | (828) |
Total operating lease liability | 1,228 | 1,234 |
Less: Operating lease liability, current | 416 | 348 |
Operating lease liability, net of current portion | $ 812 | $ 886 |
Commitments and Contingencies_4
Commitments and Contingencies - Purchase Commitment (Details) - Manufacturing and Supply Agreement with Glenmark Life Sciences Limited - kg | 6 Months Ended | |
Sep. 03, 2020 | Jun. 30, 2024 | |
Purchase Commitment | ||
License agreement term (in years) | 2 years 6 months | |
Agreement extension term | 2 years | |
License termination term option | 12 months | |
License termination activated upon written notice of material breach of Agreement | 90 days | |
Number of remaining commitments of kilograms | 500 | |
Minimum | ||
Purchase Commitment | ||
Number of kilograms of crofelemer per agreement year | 300 |
Commitments and Contingencies_5
Commitments and Contingencies - Master Services Agreement (Details) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Oct. 05, 2020 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions | ||||
Lease liabilities | $ 1,228,000 | $ 1,234,000 | ||
Master Services Agreement With Integrium LLC, 2020 | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | ||||
Reduced paid service for achievement of certain milestones | $ 6,000,000 | |||
Lease liabilities | $ 504,674 | $ 900,000 | ||
Master Services Agreement With Integrium LLC, 2020 | Maximum | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | ||||
Consideration payable on achievement of milestones | $ 12,400,000 |
Commitments and Contingencies_6
Commitments and Contingencies - Asset Transfer and Transition Commitment Update (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Sep. 25, 2017 | Jun. 30, 2024 | Jun. 30, 2023 | |
Commitments and Contingencies | |||
Percentage of amount received to be paid to Glenmark | 25% | ||
Maximum amount to be received by Glenmark | $ 7,000 | ||
Payments to Glenmark | $ 1,030 | $ 1,900 |
Commitments and Contingencies_7
Commitments and Contingencies - Revenue Sharing Commitment Update, Joint Venture and Legal Proceedings (Details) | 1 Months Ended | 6 Months Ended | |
Dec. 14, 2017 | Jan. 31, 2023 Plant | Jun. 30, 2024 USD ($) | |
Long term purchase commitment | |||
Number of highly characterized medicinal plants | 2,300 | ||
Number of plant extracts | 3,500 | ||
Magdalena Biosciences, Inc. | |||
Long term purchase commitment | |||
Percentage of equity method investment | 40% | ||
SEED | |||
Long term purchase commitment | |||
Percentage of revenue sharing commitment | 15% | ||
Percentage of revenue sharing commitment after first million dollars of revenue | 20% | ||
Payments made to date to SEED | $ | $ 0 |
Commitments and Contingencies_8
Commitments and Contingencies - Joint Venture - Income Statement Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Long term purchase commitment | ||||
Loss before income tax expense | $ (9,628) | $ (12,291) | $ (18,996) | $ (24,688) |
Income tax expense | 0 | 0 | 0 | 0 |
Net loss | (9,628) | (12,291) | (18,996) | (24,688) |
Net Income (Loss) | $ (9,492) | $ (12,150) | (18,718) | $ (24,352) |
Magdalena Biosciences, Inc. | ||||
Long term purchase commitment | ||||
Revenue | 0 | |||
Operating expenses | (115) | |||
Loss before income tax expense | (115) | |||
Income tax expense | 0 | |||
Net loss | (115) | |||
Net Income (Loss) | $ (46) |
Commitments and Contingencies_9
Commitments and Contingencies - Securities Purchase and Licensing Agreement and April 2024 Agreement (Details) - USD ($) | 6 Months Ended | ||
Apr. 12, 2024 | Mar. 18, 2024 | Jun. 30, 2024 | |
April 2024 Agreement for Gelclair | |||
Long term purchase commitment | |||
Initial term of contract | 5 years | ||
Gen Ilac Ve Saglik Urunleri Sanayi Ve Ticaret, A.S | |||
Long term purchase commitment | |||
Issuance of common stock (in shares) | 16,666,666 | ||
Purchase price of common stock (per shares) | $ 0.12 | ||
Gross proceeds from the issuance of common stock | $ 2,000,000 | ||
Deferred revenue recognized as revenue | $ 850,000 | ||
License granted | $ 42,000 | ||
Initial term of contract | 5 years |
Debt - Notes Payable (Details)
Debt - Notes Payable (Details) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Notes payable | |||
Notes designated at Fair Value Option | $ 32,351 | $ 30,943 | |
Total | 32,928 | 36,900 | |
Less: unamortized discount and debt issuance costs | (1,040) | ||
Notes payable, net of discount | 32,928 | 35,860 | |
Notes payable - non-current, net | 21,813 | 30,993 | |
Notes payable - current, net | $ 11,115 | $ 4,867 | |
Weighted average interest rate on short-term borrowings | 3.24% | 5.04% | |
Cash paid for interest | $ 13 | $ 13 | |
Notes payable | |||
Notes payable | |||
Notes payable - current, net | 11,115 | $ 4,867 | |
Royalty Interest | |||
Notes payable | |||
Total | 5,635 | ||
Insurance Financing | |||
Notes payable | |||
Total | 477 | 172 | |
Tempesta Note | |||
Notes payable | |||
Total | $ 100 | $ 150 |
Debt - Sale of Future Royalty I
Debt - Sale of Future Royalty Interest (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||||||||||||||||||||||||||
Jun. 07, 2024 USD ($) shares | Mar. 19, 2024 shares | Mar. 05, 2024 shares | Mar. 01, 2024 shares | Jan. 29, 2024 USD ($) $ / shares shares | Dec. 28, 2023 USD ($) shares | Sep. 29, 2023 USD ($) $ / shares shares | Jun. 28, 2023 USD ($) shares | May 08, 2023 USD ($) item $ / shares shares | Mar. 23, 2023 USD ($) shares | Mar. 17, 2023 USD ($) shares | Feb. 08, 2023 USD ($) shares | Nov. 18, 2022 USD ($) shares | Sep. 30, 2022 USD ($) shares | Aug. 24, 2022 USD ($) | Aug. 17, 2022 USD ($) $ / shares shares | Jul. 25, 2022 USD ($) shares | May 13, 2022 USD ($) shares | Apr. 14, 2022 USD ($) | Mar. 09, 2022 USD ($) shares | Mar. 04, 2022 USD ($) shares | Mar. 02, 2022 USD ($) shares | Feb. 11, 2022 USD ($) shares | Apr. 13, 2021 USD ($) shares | Mar. 08, 2021 USD ($) | Dec. 22, 2020 USD ($) | Nov. 13, 2020 USD ($) | Oct. 08, 2020 USD ($) | Oct. 31, 2020 USD ($) $ / shares | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2024 USD ($) $ / shares shares | Jun. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) shares | Aug. 14, 2023 | Nov. 01, 2020 $ / shares | |
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Convertible preferred stock, shares issued (in shares) | shares | 99 | 99 | 178 | |||||||||||||||||||||||||||||||||
Gain (loss) on extinguishment of debt | $ 1,245,000 | |||||||||||||||||||||||||||||||||||
Term of warrant | 5 years | |||||||||||||||||||||||||||||||||||
Notes payable | $ 32,928,000 | $ 32,928,000 | $ 35,860,000 | |||||||||||||||||||||||||||||||||
Minimum | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 29 | $ 29 | $ 29 | $ 29 | ||||||||||||||||||||||||||||||||
Iliad | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Royalties incurred | $ 227,000 | $ 992,000 | $ 715,000 | $ 750,000 | $ 400,000 | $ 700,000 | $ 800,000 | $ 1,100,000 | $ 2,400,000 | $ 3,000,000 | ||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 81,250 | 62 | 242 | 1,222 | 526 | 254 | 411 | 444 | 539 | 385 | 131 | |||||||||||||||||||||||||
Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 138,889 | 166,667 | ||||||||||||||||||||||||||||||||||
Royalty Interest Global Amendment Warrants | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 22.2 | |||||||||||||||||||||||||||||||||||
Term of warrant | 5 years | |||||||||||||||||||||||||||||||||||
Royalty Interest Global Amendment Warrants | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 4,250 | |||||||||||||||||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 22.20 | |||||||||||||||||||||||||||||||||||
Streeterville Warrants | Royalty Interest Global Amendment Warrants | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 4,250 | |||||||||||||||||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 22.2 | |||||||||||||||||||||||||||||||||||
Iliad Warrants [Member] | Royalty Interest Global Amendment Warrants | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 3,875 | |||||||||||||||||||||||||||||||||||
Uptown warrants | Royalty Interest Global Amendment Warrants | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 4,375 | |||||||||||||||||||||||||||||||||||
Series H convertible preferred stock | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Convertible preferred stock, shares issued (in shares) | shares | 0 | 0 | 0 | |||||||||||||||||||||||||||||||||
Series H convertible preferred stock | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Royalty interest | $ 756,992 | |||||||||||||||||||||||||||||||||||
Series I convertible preferred stock | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Convertible preferred stock, shares issued (in shares) | shares | 0 | 0 | 56 | |||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 118 | |||||||||||||||||||||||||||||||||||
Series J | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Convertible preferred stock, shares issued (in shares) | shares | 99 | 99 | ||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 179 | |||||||||||||||||||||||||||||||||||
Beginning on March 2021 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Shortfall restoration period | 30 days | |||||||||||||||||||||||||||||||||||
October 2020 Purchase Agreement | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Royalties paid | $ 12,000,000 | |||||||||||||||||||||||||||||||||||
Aggregate purchase price | $ 6,000,000 | |||||||||||||||||||||||||||||||||||
Percentage of net sales | 10% | |||||||||||||||||||||||||||||||||||
Percentage of worldwide revenues | 10% | |||||||||||||||||||||||||||||||||||
Royalty interest | $ 12,000,000 | |||||||||||||||||||||||||||||||||||
Royalty discount | $ 6,000,000 | |||||||||||||||||||||||||||||||||||
Royalty discount rate | 77.09% | 45.42% | 34.51% | |||||||||||||||||||||||||||||||||
Minimum volume weighted average price of stock | $ / shares | $ 0.9105 | $ 0.9105 | ||||||||||||||||||||||||||||||||||
Increase in royalty repayment amount | $ 6,000,000 | |||||||||||||||||||||||||||||||||||
Additional royalty financings committed | $ 6,000,000 | |||||||||||||||||||||||||||||||||||
Gain (loss) on extinguishment of debt | $ (2,200,000) | $ 2,000,000 | ||||||||||||||||||||||||||||||||||
October 2020 Purchase Agreement | Iliad | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Principal amount | $ 12,000,000 | |||||||||||||||||||||||||||||||||||
Fair value of notes | $ 6,100,000 | 6,100,000 | $ 6,900,000 | |||||||||||||||||||||||||||||||||
Net change in the fair value | (840,000) | (1,500,000) | ||||||||||||||||||||||||||||||||||
October 2020 Purchase Agreement | Iliad | Minimum | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Percentage of shares issued and outstanding | 4.99% | |||||||||||||||||||||||||||||||||||
October 2020 Purchase Agreement | Beginning On April 2021 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 250,000 | |||||||||||||||||||||||||||||||||||
October 2020 Purchase Agreement | Beginning On October 2021 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | 400,000 | |||||||||||||||||||||||||||||||||||
October 2020 Purchase Agreement | Beginning On April 2022 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | 600,000 | |||||||||||||||||||||||||||||||||||
October 2020 Purchase Agreement | Beginning On October 2022 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 750,000 | |||||||||||||||||||||||||||||||||||
December 2020 Purchase Agreement | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Aggregate purchase price | $ 6,000,000 | |||||||||||||||||||||||||||||||||||
Percentage of net sales | 10% | |||||||||||||||||||||||||||||||||||
Percentage of worldwide revenues | 10% | |||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 750,000 | |||||||||||||||||||||||||||||||||||
Royalty interest | 12,000,000 | |||||||||||||||||||||||||||||||||||
Royalty discount | $ 6,000,000 | |||||||||||||||||||||||||||||||||||
Royalty discount rate | 23.70% | |||||||||||||||||||||||||||||||||||
Royalties incurred | $ 675,000 | |||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 2,500 | |||||||||||||||||||||||||||||||||||
Gain (loss) on extinguishment of debt | 2,700,000 | |||||||||||||||||||||||||||||||||||
December 2020 Purchase Agreement | Iliad | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Principal amount | $ 12,000,000 | |||||||||||||||||||||||||||||||||||
December 2020 Purchase Agreement | Uptown Park Capital, LLC | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Fair value of notes | 8,200,000 | 8,200,000 | 7,500,000 | |||||||||||||||||||||||||||||||||
Net change in the fair value | (354,000) | (762,000) | ||||||||||||||||||||||||||||||||||
December 2020 Purchase Agreement | Series H convertible preferred stock | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Aggregate shares value | 1,700,000 | |||||||||||||||||||||||||||||||||||
December 2020 Purchase Agreement | Series H convertible preferred stock | Uptown Park Capital, LLC | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Aggregate shares value | 757,000 | |||||||||||||||||||||||||||||||||||
December 2020 Purchase Agreement | Series I convertible preferred stock | Uptown Park Capital, LLC | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Aggregate shares value | $ 1,500,000 | |||||||||||||||||||||||||||||||||||
March 2021 Purchase Agreement | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Aggregate purchase price | $ 5,000,000 | |||||||||||||||||||||||||||||||||||
Percentage of net sales | 10% | |||||||||||||||||||||||||||||||||||
Percentage of worldwide revenues | 10% | |||||||||||||||||||||||||||||||||||
Royalty discount rate | 19.36% | |||||||||||||||||||||||||||||||||||
Threshold price | $ 10,000,000 | |||||||||||||||||||||||||||||||||||
Percentage of royalties collected from licenses | 50% | |||||||||||||||||||||||||||||||||||
Interest expense | 0 | $ 497,000 | 448,000 | $ 944,000 | ||||||||||||||||||||||||||||||||
Carrying value of notes | 0 | 0 | 4,600,000 | |||||||||||||||||||||||||||||||||
March 2021 Purchase Agreement | Iliad | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Principal amount | $ 10,000,000 | |||||||||||||||||||||||||||||||||||
March 2021 Purchase Agreement | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Aggregate purchase price | $ 3,400,000 | |||||||||||||||||||||||||||||||||||
Royalty interest | $ 2,000,000 | |||||||||||||||||||||||||||||||||||
Royalties incurred | $ 2,000,000 | |||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 2,614 | 2,556 | ||||||||||||||||||||||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning on March 2021 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Royalty interest | $ 10,000,000 | |||||||||||||||||||||||||||||||||||
Royalty discount | 5,000,000 | |||||||||||||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning On April 2021 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 250,000 | |||||||||||||||||||||||||||||||||||
Increase in royalty repayment, percent | 5% | |||||||||||||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning On October 2021 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 400,000 | |||||||||||||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning On April 2022 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Increase in royalty repayment, percent | 10% | |||||||||||||||||||||||||||||||||||
Royalty instrument, Debt instrument carrying value | $ 600,000 | |||||||||||||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning On October 2022 | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 750,000 | |||||||||||||||||||||||||||||||||||
August 2022 Purchase Agreement | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Gain (loss) on extinguishment of debt | (1,000,000) | |||||||||||||||||||||||||||||||||||
Fair value | 7,400,000 | 7,400,000 | $ 6,800,000 | |||||||||||||||||||||||||||||||||
August 2022 Purchase Agreement | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Aggregate purchase price | $ 4,000,000 | |||||||||||||||||||||||||||||||||||
Percentage of net sales | 10% | |||||||||||||||||||||||||||||||||||
Percentage of worldwide revenues | 10% | |||||||||||||||||||||||||||||||||||
Royalty interest | $ 12,000,000 | |||||||||||||||||||||||||||||||||||
Royalty discount rate | 55.97% | |||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 26,461 | |||||||||||||||||||||||||||||||||||
Aggregate shares value | $ 165,000 | |||||||||||||||||||||||||||||||||||
Percentage of royalties collected from licenses | 50% | |||||||||||||||||||||||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||||||||||||||||||||||||
August 2022 Purchase Agreement | Until One Year Anniversary | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Accrued interest rate on royalty | 5% | |||||||||||||||||||||||||||||||||||
August 2022 Purchase Agreement | After One Year Anniversary | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Accrued interest rate on royalty | 10% | |||||||||||||||||||||||||||||||||||
August 2022 Purchase Agreement | Beginning On September 2022 | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 250,000 | |||||||||||||||||||||||||||||||||||
August 2022 Purchase Agreement | Beginning On March 2023 | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | 400,000 | |||||||||||||||||||||||||||||||||||
August 2022 Purchase Agreement | Beginning On September 2023 | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | 600,000 | |||||||||||||||||||||||||||||||||||
August 2022 Purchase Agreement | Beginning On March 2024 | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 750,000 | |||||||||||||||||||||||||||||||||||
Standstill Agreement | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Number of royalty interests issued | item | 4 | |||||||||||||||||||||||||||||||||||
Agreement term | 6 months | |||||||||||||||||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 28.8 | |||||||||||||||||||||||||||||||||||
Standstill Agreement | Streeterville Warrants | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 31,547 | |||||||||||||||||||||||||||||||||||
Standstill Agreement | Iliad Warrants [Member] | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 13,779 | 28,533 | 28,533 | |||||||||||||||||||||||||||||||||
Standstill Agreement | Uptown warrants | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 18,296 | 35,089 | 35,089 | |||||||||||||||||||||||||||||||||
Standstill Agreement | Standstill Warrants [Member] | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 28.8 | $ 28.8 | $ 28.8 | |||||||||||||||||||||||||||||||||
Term of warrant | 5 years | |||||||||||||||||||||||||||||||||||
Standstill Agreement | Series H convertible preferred stock | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Royalty interest | $ 1,726,888 | |||||||||||||||||||||||||||||||||||
Number of shares to be exchanged | shares | 105 | |||||||||||||||||||||||||||||||||||
Global Amendment No 2 to Royalty Interest October 2020 Purchase Agreement | Iliad | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 3,875 | |||||||||||||||||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 22.2 | |||||||||||||||||||||||||||||||||||
Threshold monthly royalty payment payable | $ 750,000 | |||||||||||||||||||||||||||||||||||
Term of warrant | 5 years | |||||||||||||||||||||||||||||||||||
Global Amendment No 2 to Royalty Interest October 2020 Purchase Agreement | Streeterville Warrants | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Net change in the fair value | $ (321,000) | $ (788,000) | ||||||||||||||||||||||||||||||||||
Global Amendment No 2 to Royalty Interest December, 2020 Purchase Agreement | Uptown Park Capital, LLC | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 4,375 | |||||||||||||||||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 22.2 | |||||||||||||||||||||||||||||||||||
Threshold monthly royalty payment payable | $ 750,000 | |||||||||||||||||||||||||||||||||||
Term of warrant | 5 years | |||||||||||||||||||||||||||||||||||
Global Amendment No 2 to Royalty Interest August, 2022 Purchase Agreement | Streeterville | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Warrants to purchase shares of Common stock | shares | 255,000 | |||||||||||||||||||||||||||||||||||
Threshold monthly royalty payment payable | $ 750,000 | |||||||||||||||||||||||||||||||||||
Term of warrant | 5 years | |||||||||||||||||||||||||||||||||||
October 2020 royalty interest agreements | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Notes payable | $ 1,500,000 | |||||||||||||||||||||||||||||||||||
Shares for royalty exchanged | shares | 6,562 | |||||||||||||||||||||||||||||||||||
October 2020 royalty interest agreements | Iliad | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 133,333 | |||||||||||||||||||||||||||||||||||
Aggregate shares value | $ 836,000 | $ 789,000 | ||||||||||||||||||||||||||||||||||
Royalty Interest Exchange Agreement December 2020 [Member] | ||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||
Number of shares to be exchanged | shares | 31,811 | |||||||||||||||||||||||||||||||||||
Partitioned Royalty | $ 1,073,807 |
Debt - Streeterville Note (Deta
Debt - Streeterville Note (Details) - Streeterville Note | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Jan. 13, 2021 USD ($) | Jan. 31, 2021 | Jun. 30, 2024 USD ($) | Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) | |
Debt | |||||
Principal amount | $ 6,200,000 | ||||
Aggregate purchase price | $ 6,000,000 | ||||
Debt term | 4 years | ||||
Interest rate (as a percent) | 3.25% | ||||
Percentage of return bonus payable | 1 | ||||
Percentage of reduction in return bonus | 1 | ||||
Term for initiation of human trials | 6 months | ||||
Percentage of outstanding balance payable elected to prepay | 112.5 | ||||
Capped percentage of aggregate default | 25% | ||||
Fair value | $ 6,000,000 | $ 10,500,000 | $ 10,500,000 | $ 9,800,000 | |
Transaction expense | $ 25,000 | ||||
Net change in the fair value | $ (295,000) | $ (745,000) | |||
Maximum | |||||
Debt | |||||
Interest rate (as a percent) | 18% | ||||
Percentage of gross proceeds received from return | 18 | ||||
Percentage of default effect | 15% | ||||
Minimum | |||||
Debt | |||||
Interest rate (as a percent) | 1% | 1% | |||
Percentage of default effect | 5% | ||||
Accounts Receivable Purchase Agreement | |||||
Debt | |||||
Interest rate (as a percent) | 25% | ||||
Transaction fee | $ 25,000 |
Debt - Insurance Financing (Det
Debt - Insurance Financing (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
May 31, 2024 | Mar. 31, 2024 | May 31, 2023 | Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
May 2023 First Insurance Financing | ||||||
Short-term Debt [Line Items] | ||||||
Principal amount | $ 575,000 | |||||
Unpaid balance | $ 676,000 | |||||
Interest rate (as a percent) | 8.60% | |||||
Finance charge | $ 23,000 | |||||
Debt term | 10 months | |||||
Interest expense | $ 0 | $ 7,000 | ||||
Financing balance | 0 | 0 | $ 172,000 | |||
March 2024 First Insurance Financing | ||||||
Short-term Debt [Line Items] | ||||||
Principal amount | $ 97,000 | |||||
Unpaid balance | $ 52,000 | |||||
Interest rate (as a percent) | 9.30% | |||||
Finance charge | $ 2,000 | |||||
Debt term | 10 months | |||||
Interest expense | 1,000 | 1,000 | ||||
Financing balance | 36,000 | 36,000 | ||||
May 2024 First Insurance Financing | ||||||
Short-term Debt [Line Items] | ||||||
Principal amount | $ 519,000 | |||||
Unpaid balance | $ 611,000 | |||||
Interest rate (as a percent) | 9.20% | |||||
Finance charge | $ 22,000 | |||||
Debt term | 10 months | |||||
Interest expense | 4,000 | 4,000 | ||||
Financing balance | $ 441,000 | $ 441,000 |
Debt - 2019 Tempesta Note (Deta
Debt - 2019 Tempesta Note (Details) - Tempesta Note - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Oct. 31, 2019 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Debt Instrument [Line Items] | ||||||
Cash received in the settlement | $ 50,000 | |||||
Principal amount | $ 550,000 | |||||
Common stock issued in exchange of debt | 13,333 | |||||
Interest rate (as a percent) | 2.50% | |||||
Semi-annual principal and interest payments | $ 50,000 | |||||
Interest expense | $ 1,000 | $ 1,000 | $ 1,000 | $ 3,000 | ||
Carrying value of notes | $ 100,000 | $ 100,000 | $ 150,000 |
Warrants - Warrants outstanding
Warrants - Warrants outstanding and exercisable (Details) - shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Warrants | ||
Warrants outstanding, beginning balance | 201,830 | 125 |
Issuances | 201,705 | |
Exercises | (125,632) | |
Warrants outstanding, ending balance | 76,198 | 201,830 |
Warrants - Agreements 2 (Detail
Warrants - Agreements 2 (Details) | Feb. 29, 2024 shares | Feb. 27, 2024 shares | May 08, 2023 USD ($) Y $ / shares shares | Jun. 30, 2024 $ / shares | Feb. 15, 2024 $ / shares | Sep. 29, 2023 USD ($) Y $ / shares shares | Aug. 14, 2023 USD ($) Y $ / shares shares | Jun. 30, 2023 $ / shares shares | May 10, 2023 $ / shares shares |
PIPE warrant exchange ratio | 0.4 | ||||||||
Term of warrant | 5 years | ||||||||
Common Stock | |||||||||
Share Price | $ 3.58 | ||||||||
Shares issued on conversion on common stock | shares | 50,833 | 313,958 | |||||||
Minimum | |||||||||
Exercise price (in dollars per share) | 29 | $ 29 | |||||||
Share Price | $ 1 | ||||||||
Maximum | |||||||||
Exercise price (in dollars per share) | $ 33,000 | 33,000 | |||||||
Share Price | $ 0.10 | ||||||||
PIPE Purchase Agreement | |||||||||
Exercise price (in dollars per share) | $ 28.8 | ||||||||
Proceeds from Issuance of Private Placement | $ | $ 1,860,000 | ||||||||
Term of warrant | 5 years | ||||||||
Standstill Agreement | |||||||||
Exercise price (in dollars per share) | $ 28.8 | ||||||||
Warrants | $ | $ 2,500,000 | ||||||||
Share Price | $ 43.8 | ||||||||
Standstill Agreement | Expected life | |||||||||
Warrants - Measurement input | Y | 5 | ||||||||
Standstill Agreement | Volatility | |||||||||
Warrants - Measurement input | 1.1888 | ||||||||
Standstill Agreement | Risk free rate | |||||||||
Warrants - Measurement input | 0.0349 | ||||||||
PIPE Warrants | |||||||||
Shares converted | shares | 125,583 | ||||||||
PIPE Warrants | Expected life | |||||||||
Warrants - Measurement input | Y | 5 | ||||||||
PIPE Amendment Warrants | |||||||||
Warrants to purchase shares of Common stock | shares | 11,417 | ||||||||
Exercise price (in dollars per share) | $ 28.8 | ||||||||
Warrants | $ | $ 1,200,000 | ||||||||
Share Price | $ 43.2 | ||||||||
PIPE Amendment Warrants | Volatility | |||||||||
Warrants - Measurement input | 1.4595 | ||||||||
PIPE Amendment Warrants | Risk free rate | |||||||||
Warrants - Measurement input | 0.0337 | ||||||||
Royalty Interest Global Amendment Warrants | |||||||||
Exercise price (in dollars per share) | $ 22.2 | ||||||||
Warrants | $ | $ 173,000 | ||||||||
Share Price | $ 15.6 | ||||||||
Term of warrant | 5 years | ||||||||
Royalty Interest Global Amendment Warrants | Expected life | |||||||||
Warrants - Measurement input | Y | 5 | ||||||||
Royalty Interest Global Amendment Warrants | Volatility | |||||||||
Warrants - Measurement input | 1.3953 | ||||||||
Royalty Interest Global Amendment Warrants | Risk free rate | |||||||||
Warrants - Measurement input | 0.046 | ||||||||
Series G Preferred Stock | PIPE Purchase Agreement | |||||||||
Warrants to purchase shares of Common stock | shares | 114,167 | 114,167 | |||||||
Standstill warrants | Standstill Agreement | |||||||||
Exercise price (in dollars per share) | $ 28.8 | $ 28.8 | |||||||
Term of warrant | 5 years | ||||||||
Iliad Warrants | Standstill Agreement | |||||||||
Warrants to purchase shares of Common stock | shares | 13,779 | 28,533 | |||||||
Iliad Warrants | Royalty Interest Global Amendment Warrants | |||||||||
Warrants to purchase shares of Common stock | shares | 3,875 | ||||||||
Uptown warrants | Standstill Agreement | |||||||||
Warrants to purchase shares of Common stock | shares | 18,296 | 35,089 | |||||||
Uptown warrants | Royalty Interest Global Amendment Warrants | |||||||||
Warrants to purchase shares of Common stock | shares | 4,375 | ||||||||
Streeterville Warrants | Standstill Agreement | |||||||||
Warrants to purchase shares of Common stock | shares | 31,547 | ||||||||
Streeterville Warrants | Royalty Interest Global Amendment Warrants | |||||||||
Warrants to purchase shares of Common stock | shares | 4,250 | ||||||||
Exercise price (in dollars per share) | $ 22.2 | ||||||||
Series G Preferred Stock | |||||||||
Shares converted | shares | 122 | ||||||||
Series G Preferred Stock | PIPE Purchase Agreement | |||||||||
Number of shares issued | shares | 137 | ||||||||
Common stock, par value (in dollars per share) | $ 0.0001 |
Preferred Stock (Details)
Preferred Stock (Details) - shares | Jun. 30, 2024 | Dec. 31, 2023 |
Class of Stock [Line Items] | ||
Shares designated | 7,535,013 | 7,534,834 |
Issued | 99 | 178 |
Outstanding | 99 | 178 |
Shares Authorized | 10,000,000 | 10,000,000 |
Series A | ||
Class of Stock [Line Items] | ||
Shares designated | 5,524,926 | 5,524,926 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series B | ||
Class of Stock [Line Items] | ||
Shares designated | 11,000 | 11,000 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series B-1 | ||
Class of Stock [Line Items] | ||
Shares designated | 63 | 63 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series B-2 | ||
Class of Stock [Line Items] | ||
Shares designated | 10,165 | 10,165 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series C | ||
Class of Stock [Line Items] | ||
Shares designated | 1,011,000 | 1,011,000 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series D | ||
Class of Stock [Line Items] | ||
Shares designated | 977,300 | 977,300 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series E | ||
Class of Stock [Line Items] | ||
Shares designated | 10 | 10 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series F | ||
Class of Stock [Line Items] | ||
Shares designated | 10 | 10 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series G | ||
Class of Stock [Line Items] | ||
Shares designated | 137 | 137 |
Issued | 0 | 122 |
Outstanding | 0 | 122 |
Series H | ||
Class of Stock [Line Items] | ||
Shares designated | 105 | 105 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Shares Authorized | 10,000,000 | 10,000,000 |
Series I | ||
Class of Stock [Line Items] | ||
Shares designated | 118 | 118 |
Issued | 0 | 56 |
Outstanding | 0 | 56 |
Shares Authorized | 10,000,000 | 10,000,000 |
Series J | ||
Class of Stock [Line Items] | ||
Shares designated | 179 | |
Issued | 99 | |
Outstanding | 99 |
Preferred Stock - Series G Pref
Preferred Stock - Series G Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 29, 2024 | Feb. 27, 2024 | May 08, 2023 | Jun. 30, 2024 | Dec. 31, 2023 |
Preferred Stock, Shares Issued | 99 | 178 | |||
Common Stock | |||||
Shares issued on conversion on common stock | 50,833 | 313,958 | |||
Series G Preferred Stock | |||||
Preferred Stock, Shares Issued | 0 | 122 | |||
Shares converted | 122 | ||||
Certain investors | Securities purchase agreement | Series G Preferred Stock | |||||
Preferred Stock, Shares Issued | 137 | ||||
Convertible preferred stock, par value (in dollars per share) | $ 0.0001 | ||||
Warrants to purchase shares of Common stock | 114,167 | ||||
Exercise price (in dollars per share) | $ 28.8 | ||||
Proceeds from Issuance of Private Placement | $ 1.9 |
Preferred Stock - Series H Pref
Preferred Stock - Series H Preferred Stock (Details) - Series H convertible preferred stock - December 2020 Purchase Agreement | Jun. 28, 2023 USD ($) shares |
Uptown Park Capital, LLC | |
Aggregate shares issued | shares | 32 |
Aggregate shares value | $ | $ 757,000 |
Streeterville | |
Aggregate shares issued | shares | 73 |
Aggregate shares value | $ | $ 1,700,000 |
Preferred Stock - Series I Pref
Preferred Stock - Series I Preferred Stock (Details) - USD ($) | Jan. 15, 2024 | Sep. 29, 2023 |
Number of shares issued for convertible preferred stock | 44,941 | |
Series I convertible preferred stock | ||
Shares converted | 56 | |
Series I convertible preferred stock | Uptown Park Capital, LLC | December 2020 Purchase Agreement | ||
Aggregate shares issued | 118 | |
Aggregate shares value | $ 1,500,000 |
Temporary Equity (Details)
Temporary Equity (Details) - $ / shares | Mar. 19, 2024 | Mar. 05, 2024 | Mar. 01, 2024 | Jun. 30, 2024 | Dec. 31, 2023 |
Temporary Equity | |||||
Outstanding | 99 | 0 | |||
Streeterville | |||||
Temporary Equity | |||||
Issuance of common stock (in shares) | 138,889 | 166,667 | |||
Price per share | $ 7.2 | ||||
Series J Preferred Stock | |||||
Temporary Equity | |||||
Right to exchange shares at per share price | $ 25,000 | ||||
Outstanding | 99 | 0 | |||
Series J Preferred Stock | Streeterville | |||||
Temporary Equity | |||||
Shares issued | 179 | ||||
Series J Perpetual Preferred Stock | |||||
Temporary Equity | |||||
Surrender and cancellation of shares | 40 | 40 |
Stockholders' Equity - Reserved
Stockholders' Equity - Reserved shares and Common stock (Details) | 6 Months Ended | ||||||
May 23, 2024 | Jan. 23, 2023 | Sep. 08, 2021 | Jun. 30, 2024 Vote $ / shares shares | Dec. 31, 2023 $ / shares shares | Sep. 30, 2022 $ / shares shares | Sep. 29, 2022 shares | |
Shares of common stock reserved for issuance | |||||||
Options issued and outstanding | 404 | 26,357 | |||||
Options available for grant under stock option plans | 875,566 | 120,033 | |||||
Restricted stock unit awards issued and outstanding | 45,788 | 47,998 | |||||
Warrants issued and outstanding | 76,198 | 7,505 | |||||
Total | 997,956 | 203,427 | |||||
Number of voting rights entitled for each share of common stock held | Vote | 1 | ||||||
Reverse stock split ratio | 0.0167 | 0.0133 | 0.33 | ||||
Total shares authorized | 358,000,000 | ||||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | |||||
Inducement options issued and outstanding | |||||||
Shares of common stock reserved for issuance | |||||||
Options issued and outstanding | 1,534 | ||||||
Common Stock | Common stock - voting | |||||||
Shares of common stock reserved for issuance | |||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Common stock, shares authorized (in shares) | 298,000,000 | 298,000,000 | 298,000,000 | 150,000,000 | |||
Common Stock | Common stock - non-voting | |||||||
Shares of common stock reserved for issuance | |||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||||
Common stock, shares authorized (in shares) | 50,000,000 | 50,000,000 | |||||
Convertible non-voting common stock | |||||||
Shares of common stock reserved for issuance | |||||||
Reverse stock split ratio | 1 |
Stockholders' Equity - Reverse
Stockholders' Equity - Reverse Stock Split and ATM (Details) $ in Millions | 6 Months Ended | ||||||
May 23, 2024 | Jan. 23, 2023 | Feb. 02, 2022 USD ($) | Feb. 01, 2022 USD ($) | Dec. 10, 2021 USD ($) | Sep. 08, 2021 | Jun. 30, 2024 USD ($) shares | |
Reverse stock split ratio | 0.0167 | 0.0133 | 0.33 | ||||
December 2021 ATM Agreement | |||||||
Issuance of common stock (in shares) | shares | 5,011,751 | ||||||
Proceeds from issuance of Common stock | $ 24 | ||||||
December 2021 ATM Agreement | Maximum | |||||||
Aggregate offering price | $ 75 | $ 15 | |||||
December 2021 ATM Agreement | Minimum | |||||||
Aggregate offering price | $ 15 |
Stockholders' Equity- Noncontro
Stockholders' Equity- Noncontrolling Interest (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2021 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions | ||||||
Non-controlling interest | $ (328,000) | $ (328,000) | $ (64,000) | |||
Decrease in noncontrolling interest | $ 118,000 | |||||
Increase in noncontrolling interest | $ 148,000 | $ 264,000 | $ 891,000 | |||
Napo Therapeutics | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | ||||||
Non-controlling interest | $ 242,000 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock Incentive Plans (Details) - USD ($) | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Apr. 13, 2022 | Jun. 16, 2020 | May 12, 2015 | Nov. 30, 2013 | Jun. 30, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stock-based Compensation | |||||||
Option outstanding | 404 | 26,357 | |||||
Options available for grant under stock option plans | 875,566 | 120,033 | |||||
Shares Available for Grant | |||||||
Beginning balance (in shares) | 120,033 | ||||||
Ending balance (in shares) | 875,566 | 120,033 | |||||
Stock Options Outstanding | |||||||
Beginning balance (in shares) | 26,357 | ||||||
Ending balance (in shares) | 404 | 26,357 | |||||
RSUs Outstanding | |||||||
Beginning balance (in shares) | 47,998 | ||||||
Ending balance (in shares) | 45,788 | 47,998 | |||||
Options vested, exercisable and expected to vest | |||||||
Weighted average grant date fair value of stock options granted (in dollars per share) | $ 0 | $ 0 | |||||
Number of options vested (in shares) | 8 | 25 | |||||
Weighted average fair value of options vested on grant date | $ 20,069 | $ 16,417 | |||||
Stock options | |||||||
Stock-based Compensation | |||||||
Option outstanding | 404 | 405 | 454 | ||||
Stock Options Outstanding | |||||||
Beginning balance (in shares) | 405 | 454 | |||||
Options exercised (in shares) | 0 | 0 | |||||
Options cancelled (in shares) | (1) | (49) | |||||
Ending balance (in shares) | 404 | 405 | 454 | ||||
Weighted Average Stock Option Exercise Price | |||||||
Beginning balance (in dollars per share) | $ 35,738.63 | $ 35,564.08 | |||||
Options cancelled (in dollars per share) | 23,355 | 19,668.87 | |||||
Ending balance (in dollars per share) | $ 21,057.18 | $ 35,738.63 | $ 35,564.08 | ||||
Weighted Average Remaining Contractual Life (Years) | |||||||
Weighted Average Remaining Contractual Life (Years) | 5 years 8 months 19 days | 6 years 2 months 15 days | 7 years 2 months 8 days | ||||
Options vested, exercisable and expected to vest | |||||||
Options exercisable (in shares) | 404 | ||||||
Options exercisable (in dollars per share) | $ 21,057.18 | ||||||
Options exercisable (in years) | 5 years 8 months 19 days | ||||||
Options vested and expected to vest (in shares) | 404 | ||||||
Options vested and expected to vest (in dollars per share) | $ 21,057.18 | ||||||
Options vested and expected to vest (in years) | 5 years 8 months 19 days | ||||||
Options exercised (in shares) | 0 | 0 | |||||
Stock options and RSUs | |||||||
Stock-based Compensation | |||||||
Options available for grant under stock option plans | 875,566 | 10,463 | 2,045 | ||||
Shares Available for Grant | |||||||
Beginning balance (in shares) | 10,463 | 2,045 | |||||
Additional shares authorized (in shares) | 865,902 | 52,772 | |||||
Options cancelled (in shares) | 1 | 49 | |||||
RSUs granted (in shares) | (895) | (44,733) | |||||
RSUs exercised | 26 | ||||||
RSUs cancelled | 69 | 87 | |||||
RSUs vested and released (in shares) | 243 | ||||||
Ending balance (in shares) | 875,566 | 10,463 | 2,045 | ||||
RSUs Outstanding | |||||||
RSUs vested and released (in shares) | 243 | ||||||
Restricted stock units issued and outstanding | |||||||
Shares Available for Grant | |||||||
RSUs vested and released (in shares) | (243) | ||||||
RSUs Outstanding | |||||||
Beginning balance (in shares) | 44,988 | 585 | |||||
RSUs Granted (in shares) | 895 | 44,733 | |||||
RSUs Exercised (in shares) | (26) | ||||||
RSUs vested and released (in shares) | (243) | ||||||
RSUs Cancelled (in shares) | (69) | (87) | |||||
Ending balance (in shares) | 45,788 | 44,988 | 585 | ||||
2013 Plan | |||||||
Stock-based Compensation | |||||||
Option shares outstanding | 0 | 0 | |||||
2013 Plan | Stock options | |||||||
Stock Options Outstanding | |||||||
Options granted (in shares) | 0 | ||||||
2014 Plan | |||||||
Stock-based Compensation | |||||||
Incentive stock option term | 10 years | ||||||
Increase in share reserve based on outstanding number of shares (as a percent) | 2% | ||||||
Option outstanding | 384 | 385 | |||||
Options available for grant under stock option plans | 867,252 | 47,687 | |||||
Shares Available for Grant | |||||||
Beginning balance (in shares) | 47,687 | ||||||
Additional shares authorized (in shares) | 2,417,660 | ||||||
Ending balance (in shares) | 867,252 | 47,687 | |||||
Stock Options Outstanding | |||||||
Beginning balance (in shares) | 385 | ||||||
Ending balance (in shares) | 384 | 385 | |||||
2020 Inducement Award Plan | |||||||
Stock-based Compensation | |||||||
Incentive stock option term | 10 years | ||||||
Options available for grant under stock option plans | 2,222 | ||||||
Number of shares reserved for issuance | 500,000 | ||||||
Shares Available for Grant | |||||||
Ending balance (in shares) | 2,222 | ||||||
2020 New Employee Inducement Award Plan | |||||||
Stock-based Compensation | |||||||
Option outstanding | 20 | 20 | |||||
Options available for grant under stock option plans | 8,314 | 8,308 | |||||
Number of shares reserved for issuance | 971,833 | ||||||
Shares Available for Grant | |||||||
Beginning balance (in shares) | 8,308 | ||||||
Additional shares authorized (in shares) | 471,833 | 498,448 | |||||
Ending balance (in shares) | 8,314 | 8,308 | |||||
Stock Options Outstanding | |||||||
Beginning balance (in shares) | 20 | ||||||
Ending balance (in shares) | 20 | 20 | |||||
Common Stock | |||||||
Options vested, exercisable and expected to vest | |||||||
Share Price | $ 3.58 | ||||||
Participants Voting Power More than Ten Percent | 2014 Plan | |||||||
Stock-based Compensation | |||||||
Incentive stock option term | 5 years | ||||||
Participants Voting Power More than Ten Percent | 2020 Inducement Award Plan | |||||||
Stock-based Compensation | |||||||
Incentive stock option term | 5 years |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stock-based Compensation | ||||
Total stock-based compensation expense | $ 383 | $ 518 | $ 964 | $ 998 |
Research and development expense | ||||
Stock-based Compensation | ||||
Total stock-based compensation expense | 176 | 257 | 465 | 484 |
Sales and marketing expense | ||||
Stock-based Compensation | ||||
Total stock-based compensation expense | 32 | 86 | 72 | 115 |
General and administrative expense | ||||
Stock-based Compensation | ||||
Total stock-based compensation expense | 175 | $ 175 | 427 | $ 399 |
Stock options and RSUs | ||||
Stock-based Compensation | ||||
Unrecognized stock-based compensation expense | $ 0 | $ 0 |
Stock-based Compensation - 401(
Stock-based Compensation - 401(k) Plan (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Stock-based Compensation | |
Employer contributions to the plan | $ 0 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net Loss Per Share | ||||
Net loss attributable to common stockholders (basic) | $ (9,492) | $ (12,150) | $ (18,718) | $ (24,352) |
Net loss attributable to common stockholders (diluted) | $ (9,492) | $ (12,150) | $ (18,718) | $ (24,352) |
Shares used to compute net loss per common stock, basic (in shares) | 2,349,431 | 293,858 | 1,174,716 | 190,073 |
Shares used to compute net loss per common stock, diluted (in shares) | 2,349,431 | 293,858 | 1,174,716 | 190,073 |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (4.04) | $ (41.35) | $ (15.93) | $ (128.12) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (4.04) | $ (41.35) | $ (15.93) | $ (128.12) |
Net Loss Per Share - Excluded F
Net Loss Per Share - Excluded From Calculation (Details) - shares | 6 Months Ended | 12 Months Ended | |
Aug. 13, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 122,390 | 83,394 | |
Subsequent event | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Shares issued after balance sheet date | 739,210 | ||
Options issued and outstanding | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 404 | 26,357 | |
Inducement options issued and outstanding | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 1,534 | ||
Restricted stock units issued and outstanding | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 45,788 | 47,998 | |
Warrants issued and outstanding | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 76,198 | 7,505 |
Segment Data (Details)
Segment Data (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) segment | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Segment Information | |||||
Number of reportable segments | segment | 2 | ||||
Cost of revenue | $ 427 | $ 491 | $ 857 | $ 836 | |
Research and development | 3,653 | 4,277 | 7,965 | 9,052 | |
Sales and marketing | 1,524 | 1,573 | 2,967 | 3,457 | |
General and administrative | 4,314 | 4,437 | 8,695 | 9,250 | |
Interest | (108) | 3,453 | 503 | 5,634 | |
Consolidated net comprehensive loss | (9,722) | (12,108) | (18,872) | (24,737) | |
Segment net loss | (9,628) | (12,291) | (18,996) | (24,688) | |
Segment assets | 61,459 | 61,459 | $ 50,763 | ||
Product revenue, net | |||||
Segment Information | |||||
External revenue | 2,721 | 2,676 | 5,072 | 4,648 | |
Operating Segments | |||||
Segment Information | |||||
External revenue | 2,721 | 2,676 | 5,072 | 4,648 | |
Cost of revenue | 427 | 491 | 857 | 836 | |
Research and development | 3,658 | 4,272 | 7,966 | 9,049 | |
Sales and marketing | 1,524 | 1,574 | 2,967 | 3,457 | |
General and administrative | 4,789 | 4,917 | 9,650 | 10,196 | |
Interest | (82) | 3,453 | 556 | 5,633 | |
Other segment items | 2,549 | 523 | 2,793 | 1,125 | |
Segment expenses | 12,865 | 15,230 | 24,789 | 30,296 | |
Consolidated net comprehensive loss | (10,144) | (12,554) | (19,717) | (25,648) | |
Segment assets | 216,261 | 216,261 | 195,479 | ||
Operating Segments | Human Health | |||||
Segment Information | |||||
External revenue | 2,637 | 2,627 | 4,940 | 4,553 | |
Cost of revenue | 414 | 475 | 829 | 805 | |
Research and development | 2,914 | 3,540 | 6,401 | 7,616 | |
Sales and marketing | 1,450 | 1,541 | 2,822 | 3,296 | |
General and administrative | 2,108 | 2,373 | 4,411 | 4,812 | |
Interest | 28 | 1 | 55 | 1 | |
Other segment items | 733 | (282) | 237 | 50 | |
Segment expenses | 7,647 | 7,648 | 14,755 | 16,580 | |
Consolidated net comprehensive loss | (5,010) | (5,021) | (9,815) | (12,027) | |
Segment assets | 42,859 | 42,859 | 42,289 | ||
Operating Segments | Animal Health | |||||
Segment Information | |||||
External revenue | 84 | 49 | 132 | 95 | |
Cost of revenue | 13 | 16 | 28 | 31 | |
Research and development | 744 | 732 | 1,565 | 1,433 | |
Sales and marketing | 74 | 33 | 145 | 161 | |
General and administrative | 2,681 | 2,544 | 5,239 | 5,384 | |
Interest | (110) | 3,452 | 501 | 5,632 | |
Other segment items | 1,816 | 805 | 2,556 | 1,075 | |
Segment expenses | 5,218 | 7,582 | 10,034 | 13,716 | |
Consolidated net comprehensive loss | (5,134) | (7,533) | (9,902) | (13,621) | |
Segment assets | 173,402 | 173,402 | 153,190 | ||
Eliminations And Reconciling Items [Member] | |||||
Segment Information | |||||
Consolidated net comprehensive loss | 422 | $ 446 | 845 | $ 911 | |
Segment Reconciling Items | |||||
Segment Information | |||||
Segment assets | (29,232) | (29,232) | (29,232) | ||
Intersegment Eliminations | |||||
Segment Information | |||||
Segment assets | $ (125,570) | $ (125,570) | $ (115,484) |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 1 Months Ended | 6 Months Ended | ||
Aug. 13, 2024 | Jul. 15, 2024 | Aug. 13, 2024 | Jun. 30, 2024 | |
December 2021 ATM Agreement | ||||
Subsequent Events. | ||||
Issuance of common stock (in shares) | 5,011,751 | |||
Subsequent event | ||||
Subsequent Events. | ||||
Issuance of common stock (in shares) | 739,210 | |||
Subsequent event | Unregistered Sales of Equity Securities | ||||
Subsequent Events. | ||||
Issuance of common stock (in shares) | 455,000 | |||
Amount of exchange of outstanding balance in royalty interest | $ 1,851,850 | |||
Subsequent event | December 2021 ATM Agreement | ||||
Subsequent Events. | ||||
Number of shares issued | 739,210 | |||
Total net proceeds | $ 2,400,000 |