Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 01, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Amendment Flag | false | |
Entity Central Index Key | 0001739410 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Period End Date | Sep. 30, 2022 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-40693 | |
Entity Registrant Name | RALLYBIO CORPORATION | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-1083789 | |
Entity Address, Address Line One | 234 Church Street | |
Entity Address, Address Line Two | Suite 1020 | |
Entity Address, City or Town | New Haven | |
Entity Address, State or Province | CT | |
Entity Address, Postal Zip Code | 06510 | |
City Area Code | 203 | |
Local Phone Number | 859-3820 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | RLYB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Document Transition Report | false | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Bankruptcy Proceedings, Reporting Current | true | |
Entity Common Stock, Shares Outstanding | 32,034,632 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 51,711 | $ 175,334 |
Marketable securities | 80,709 | 0 |
Prepaid expenses and other assets | 10,009 | 5,535 |
Total current assets | 142,429 | 180,869 |
Property and equipment, net | 424 | 511 |
Operating lease right-of-use assets | 569 | 0 |
Investment in joint venture | 244 | 805 |
Total assets | 143,666 | 182,185 |
Current liabilities: | ||
Accounts payable | 828 | 603 |
Accrued expenses | 10,302 | 5,948 |
Operating lease liabilities | 165 | 0 |
Total current liabilities | 11,295 | 6,551 |
Accrued expenses, noncurrent | 0 | 32 |
Operating lease liabilities, noncurrent | 428 | 0 |
Total liabilities | 11,723 | 6,583 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity | ||
Common stock, value | 3 | 3 |
Preferred stock, value | 0 | 0 |
Additional paid-in capital | 276,852 | 269,626 |
Accumulated other comprehensive loss | (434) | 0 |
Accumulated deficit | (144,478) | (94,027) |
Total stockholders' equity | 131,943 | 175,602 |
Total liabilities and stockholders' equity | $ 143,666 | $ 182,185 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 32,091,398 | 32,129,970 |
Common stock, shares outstanding | 32,091,398 | 32,129,970 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 12,110 | $ 4,960 | $ 29,896 | $ 20,815 |
General and administrative | 6,750 | 5,021 | 20,897 | 12,520 |
Total operating expenses | 18,860 | 9,981 | 50,793 | 33,335 |
Loss from operations | (18,860) | (9,981) | (50,793) | (33,335) |
Other income (expenses): | ||||
Interest income | 525 | 12 | 892 | 42 |
Interest expense | 0 | 0 | 0 | (10) |
Other income (expense) | 98 | 105 | 311 | (13) |
Total other income, net | 623 | 117 | 1,203 | 19 |
Loss from continuing operations | (18,237) | (9,864) | (49,590) | (33,316) |
Loss on investment in joint venture | 133 | 332 | 861 | 1,282 |
Net loss | $ (18,370) | $ (10,196) | $ (50,451) | $ (34,598) |
Net loss per common share, basic | $ (0.60) | $ (0.37) | $ (1.65) | $ (1.44) |
Net loss per common share, diluted | $ (0.60) | $ (0.37) | $ (1.65) | $ (1.44) |
Weighted average number of common shares outstanding, basic | 30,777,797 | 27,527,770 | 30,562,723 | 24,011,862 |
Weighted average number of common shares outstanding, diluted | 30,777,797 | 27,527,770 | 30,562,723 | 24,011,862 |
Other comprehensive loss: | ||||
Net unrealized loss on marketable securities | $ 63 | $ 0 | $ 434 | $ 0 |
Other comprehensive loss | (63) | 0 | (434) | 0 |
Comprehensive loss | $ (18,433) | $ (10,196) | $ (50,885) | $ (34,598) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Total IPO | Common Shares | Common Shares Total IPO | Additional Paid-In Capital | Additional Paid-In Capital Total IPO | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Beginning Balance at Dec. 31, 2020 | $ 136,003 | $ 2 | $ 183,015 | $ (47,014) | ||||
Beginning Balance (in shares) at Dec. 31, 2020 | 23,410,348 | |||||||
Issuance of common stock under the stock award plan (in shares) | 7,130,000 | |||||||
Issuance of common stock under the stock award plan | $ 82,967 | $ 1 | $ 82,966 | |||||
Share-based compensation expense | 2,116 | 2,116 | ||||||
Issuance of restricted common stock (in shares) | 1,589,622 | |||||||
Net loss | (34,598) | (34,598) | ||||||
Other comprehensive loss | 0 | |||||||
Ending Balance (in shares) at Sep. 30, 2021 | 32,129,970 | |||||||
Ending Balance at Sep. 30, 2021 | 186,488 | $ 3 | 268,097 | (81,612) | ||||
Beginning Balance at Jun. 30, 2021 | 112,662 | $ 2 | 184,076 | (71,416) | ||||
Beginning Balance (in shares) at Jun. 30, 2021 | 24,999,970 | |||||||
Issuance of common stock under the stock award plan (in shares) | 7,130,000 | |||||||
Issuance of common stock under the stock award plan | $ 82,967 | $ 1 | $ 82,966 | |||||
Share-based compensation expense | 1,055 | 1,055 | ||||||
Net loss | (10,196) | (10,196) | ||||||
Other comprehensive loss | 0 | |||||||
Ending Balance (in shares) at Sep. 30, 2021 | 32,129,970 | |||||||
Ending Balance at Sep. 30, 2021 | 186,488 | $ 3 | 268,097 | (81,612) | ||||
Beginning Balance at Dec. 31, 2021 | 175,602 | $ 3 | 269,626 | (94,027) | ||||
Beginning Balance (in shares) at Dec. 31, 2021 | 32,129,970 | |||||||
Issuance of common stock under the stock award plan (in shares) | 2,000 | |||||||
Share-based compensation expense | $ 7,205 | 7,205 | ||||||
Forfeiture of restricted common stock, shares | (42,586) | |||||||
Issuance of common stock from exercise of stock options, shares | 2,014 | 2,014 | ||||||
Issuance of common stock from exercise of stock options | $ 21 | 21 | ||||||
Net loss | (50,451) | (50,451) | ||||||
Other comprehensive loss | (434) | $ (434) | ||||||
Ending Balance (in shares) at Sep. 30, 2022 | 32,091,398 | |||||||
Ending Balance at Sep. 30, 2022 | 131,943 | $ 3 | 276,852 | (144,478) | (434) | |||
Beginning Balance at Jun. 30, 2022 | 147,851 | $ 3 | 274,327 | (126,108) | (371) | |||
Beginning Balance (in shares) at Jun. 30, 2022 | 32,130,970 | |||||||
Issuance of common stock under the stock award plan (in shares) | 1,000 | |||||||
Share-based compensation expense | 2,504 | 2,504 | ||||||
Forfeiture of restricted common stock, shares | (42,586) | |||||||
Issuance of common stock from exercise of stock options, shares | 2,014 | |||||||
Issuance of common stock from exercise of stock options | 21 | 21 | ||||||
Net loss | (18,370) | (18,370) | ||||||
Other comprehensive loss | (63) | (63) | ||||||
Ending Balance (in shares) at Sep. 30, 2022 | 32,091,398 | |||||||
Ending Balance at Sep. 30, 2022 | $ 131,943 | $ 3 | $ 276,852 | $ (144,478) | $ (434) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | |
Total IPO | ||
Offering costs | $ 9,721 | $ 9,721 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash Flows used in Operating Activities: | ||
Net loss | $ (50,451) | $ (34,598) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 128 | 74 |
Net accretion of discounts/premiums on debt securities | 27 | 0 |
Stock-based compensation | 7,205 | 2,116 |
Loss on investment in joint venture | 861 | 1,282 |
Changes in operating assets and liabilities: | ||
Prepaid expenses, right-of-use assets and other assets | (3,948) | (4,386) |
Accounts payable | 95 | (607) |
Accrued expenses and operating lease liability | 4,063 | 472 |
Net cash used in operating activities | (42,020) | (35,647) |
Cash Flows used in Investing Activities: | ||
Purchases of marketable securities | (136,670) | 0 |
Proceeds from maturities of marketable securities | 55,500 | 0 |
Purchase of property and equipment | (54) | (196) |
Investment in joint venture | (300) | (2,000) |
Net cash used in investing activities | (81,524) | (2,196) |
Cash Flows from Financing Activities: | ||
Proceeds from the issuance of common stock upon completion of the initial public offering, net of underwriting commissions and discounts of $6,488 | 0 | 86,200 |
Proceeds from issuance of common stock | 21 | 0 |
Payments of offering costs | (100) | (1,612) |
Net cash provided (used) by financing activities | (79) | 84,588 |
Net increase (decrease) in cash and cash equivalents | (123,623) | 46,745 |
Cash and cash equivalents - beginning of period | 175,334 | 140,233 |
Cash and cash equivalents - end of period | 51,711 | 186,978 |
Supplemental Disclosures of Noncash Investing and Financing Activities: | ||
Offering costs in accounts payable and accrued expenses | 294 | 1,621 |
Property and equipment in accounts payable and accrued expenses | $ 0 | $ 36 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) (Unaudited) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Statement of Cash Flows [Abstract] | |
Underwriting commissions and discounts | $ 6,488 |
Business and Liquidity
Business and Liquidity | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business and Liquidity | 1. BUSINESS AND LIQUIDITY Rallybio Corporation and subsidiaries (the "Company", "we", "our", or "us") is a clinical-stage biotechnology company built around a team of seasoned industry experts with a shared purpose and a track record of success in discovering, developing, manufacturing, and delivering therapies to meaningfully improve the lives of patients suffering from severe and rare diseases. In August 2021, the Company completed its initial public offering ("IPO"), pursuant to which it issued and sold 7,130,000 shares of the Company’s common stock, inclusive of 930,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $ 13.00 per share. The gross proceeds from the IPO, including the exercise of the underwriter's option to purchase additional shares were $ 92.7 million and the net proceeds were approximately $ 83.0 million, after deducting underwriting discounts and commissions and other offering costs. The Company had cash, cash equivalents and marketable securities of $ 132.4 million at September 30, 2022. The Company currently expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital requirements for more than 12 months from the date the condensed consolidated financial statements were issued. However, w e do not anticipate that the current cash, cash equivalents and marketable securities as of September 30, 2022 will be sufficient for us to fund any of our product candidates through regulatory approval, and we will need to raise substantial additional capital to complete the development and commercialization of our product candidates, if approved. We may satisfy our future cash needs through the sale of equity securities, debt financings, working capital lines of credit, corporate collaborations or license agreements, grant funding, interest income earned on invested cash balances or a combination of one or more of these sources. |
Summary of Significant Accounti
Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES BASIS OF PRESENTATION AND PRINCIPLES OF CONSOLIDATION Unaudited Financial Information — The unaudited condensed consolidated financial statements of the Company have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP"), and pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC"). In the opinion of the Company, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the financial position and results of operations for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period. The accompanying unaudited condensed consolidated financial statements include the accounts of Rallybio Corporation and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These accompanying unaudited condensed consolidated financial statements and notes should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2021 (our "Annual Report") which includes a description of reorganization and liquidation of Rallybio Holdings, LLC ("Rallybio Holdings") prior to our IPO that resulted in a change in reporting entity as described in Accounting Standards Codification ("ASC") 250. In accordance with the guidance applicable to these circumstances, the equity structure has been adjusted in all comparative periods to reflect the number of shares of the Company’s common stock issued to Rallybio Holdings unitholders in connection with the liquidation. As such, historical Rallybio Holdings convertible redeemable preferred units, common units, and incentive units have been retroactively adjusted in these condensed consolidated financial statements to shares and earnings per share in accordance with the ratio of common shares received by each membership unit class during the liquidation. Our significant accounting policies are described in Note 2 of the Notes to the Consolidated Financial Statements included in our Annual Report. Updates to our accounting policies, including impacts from the adoption of new accounting standards are discussed below. Marketable Securities — We invest our excess cash balances in highly rated U.S. government-backed debt securities and treasuries. We classify our marketable securities as available-for-sale and accordingly, record such securities at fair value. Debt securities with original maturities of greater than 90 days are classified as available-for-sale marketable securities and debt securities with original maturities of less than 90 days from the date of purchase are classified as cash equivalents. Unrealized gains and losses on our marketable debt securities that are deemed temporary are included in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. If any adjustment to fair value reflects a significant decline in the value of the security, we evaluate the extent to which the decline is determined to be other-than-temporary and would mark the security to market through a charge to our condensed consolidated statements of operations and comprehensive loss. Credit losses are identified when we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security. In the event of a credit loss, only the amount associated with the credit loss is recognized in operating results, with the amount of loss relating to other factors recorded in accumulated other comprehensive income (loss). Recently Adopted Accounting Pronouncements — In February 2016, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update ("ASU") 2016-02 "Leases" that requires lessees to recognize leases on-balance sheet and to make certain disclosures associated with their leasing arrangements. The new standard establishes a right-of-use ("ROU") model that requires a lessee to recognize an ROU asset and lease liability on the condensed consolidated balance sheets for all leases with a term longer than twelve months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the condensed consolidated statements of operations and comprehensive loss. The Company adopted ASU 2016-02 Leases on January 1, 2022 using the modified retrospective approach and elected to apply the transition method that allows companies to continue applying guidance under the lease standard in effect at that time in the comparative periods condensed consolidated financial statements and recognize a cumulative-effect adjustment to the condensed consolidated balance sheets on the date of adoption. The Company elected the package of practical expedients to not reassess its prior conclusions about lease identification, lease classification and initial direct costs. At adoption we recognized approximately $ 0.7 million of ROU assets and corresponding lease liabilities. See Note 6. hin the scope of the new standard consist of available for sale debt securities. There was no impact to our condensed consolidated statements of operations and comprehensive loss or condensed consolidated balance sheets upon adoption. See Note 4 for discussion of unrealized losses on our available for sale marketable securities. |
Asset Acquisitions
Asset Acquisitions | 9 Months Ended |
Sep. 30, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Asset Acquisitions | 3. ASSET ACQUISITIONS The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If this screen criteria is met, the transaction is accounted for as an asset acquisition. If not, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the definition of a business. The Company measures and recognizes asset acquisitions that are not deemed to be business combinations based on the cost to acquire the assets, which includes transaction costs. In an asset acquisition, the cost allocated to acquire in-process research and development ("IPR&D") with no alternative future use is charged to research and development expense at the acquisition date. In May 2022, we obtained worldwide exclusive rights to Sanofi’s KY1066, now referred to as RLYB331, a preclinical potentially first-in-class antibody that has the potential to address a significant unmet need for patients with severe anemias with ineffective erythropoiesis and iron overload, including beta thalassemia and a subset of myelodysplastic syndromes. Under the terms of the license agreement, we made an upfront payment to Sanofi of $ 3.0 million in the second quarter of 2022 for the exclusive license to KY1066. We could also be required to pay up to an aggregate of $ 43.0 million in development and regulatory milestone payments and up to an aggregate of $ 150.0 million in commercial milestone payments for a product in its first indication, plus tiered low-to-mid double digit percentages of such milestone amounts for up to three additional indications, and mid to high single digit royalties on net sales. The license was accounted for as an asset acquisition as substantially all of the fair value of the asset acquired was concentrated in a single asset and thus the acquisition was deemed not to be a business combination. The acquired license rights represent an IPR&D asset that was determined to have no alternative future use. Accordingly, the Company recorded an IPR&D charge of $ 3.1 million to research and development expense, including transaction costs associated with this asset acquisition of $ 0.1 million, in the accompanying condensed consolidated statements of operations and comprehensive loss for the nine months ended September 30, 2022 . |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 4. MARKETABLE SECURITIES The amortized cost, gross unrealized holding gains, gross unrealized holding losses and fair value of our marketable securities by type of security as of September 30, 2022 was as follows: SEPTEMBER 30, 2022 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. treasury securities $ 71,268 $ — $ ( 392 ) $ 70,876 U.S. government agency securities 9,875 — ( 42 ) 9,833 Money market funds 15,480 — — 15,480 $ 96,623 $ — $ ( 434 ) $ 96,189 The fair values of marketable securities by classification in the condensed consolidated balance sheets was as follows: (in thousands) SEPTEMBER 30, 2022 Cash and cash equivalents $ 15,480 Marketable securities 80,709 $ 96,189 The fair values of available-for-sale debt securities as of September 30, 2022, by contractual maturity, are summarized as follows: (in thousands) SEPTEMBER 30, 2022 Due in one year or less $ 96,189 Due after one year through two years — $ 96,189 The aggregate fair value of available-for-sale debt securities in an unrealized loss position as of September 30, 2022 was $ 77.7 million. We did no t have any investments in a continuous unrealized loss position for more than twelve months as of September 30, 2022. As of September 30, 2022 , we believe that the cost basis of our available-for-sale debt securities is recoverable. No allowance for credit losses was recorded as of September 30, 2022 . |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. FAIR VALUE MEASUREMENTS ASC Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). ASC 820 identifies fair value as the price that would be received to sell an asset or paid to transfer a liability, in an orderly transaction between market participants at the measurement date. The Company’s principal financial instruments comprise of cash, cash equivalents and marketable securities. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tiered value hierarchy that distinguishes between the following: Level 1—Quoted market prices in active markets for identical assets or liabilities. Level 2—Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. Level 3—Unobservable inputs for the asset or liability (i.e. supported by little or no market activity). Level 3 inputs include management’s own assumptions about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk). In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible, as well as considers counterparty credit risk in its assessment of fair value. Financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type as of September 30, 2022 was as follows : SEPTEMBER 30, 2022 (in thousands) Level 1 Level 2 Level 3 Financial assets: Money market funds $ 15,480 $ — $ — U.S. treasury securities 70,876 — — U.S. government agency securities 9,833 — — Total financial assets $ 96,189 $ — $ — There were no securities transferred between Level 1, 2 and 3 during the nine months ended September 30, 2022. For the year ended December 31, 2021, the Company held money market funds that were classified as cash and cash equivalents on the Company's consolidated balance sheets of $ 4.0 million. These money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | 6. LEASES At the inception of an arrangement, we determine if an arrangement is, or contains, a lease based on the facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease we i) identify lease and non-lease components, ii) determine the consideration in the contract, iii) determine whether the lease is an operating or financing lease; and iv) recognize lease ROU assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of fixed, or in substance fixed, lease payments over the expected lease term. When the interest rate implicit in lease contracts is not readily determinable we use our incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. The weighted average discount rate utilized on our operating lease liabilities as of September 30, 2022 was 4.00 %. We have operating leases for approximately nine thousand square feet of corporate office space and we have elected to combine lease components with non-lease components on our office real estate asset class. Fixed, or in substance fixed, lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Variable lease expenses that are not considered fixed, or in substance fixed, are recognized as incurred. Fixed and variable lease expense on operating leases is recognized within operating expenses within our condensed consolidated statements of operations and comprehensive loss. Some leases include options to extend or terminate the lease and the Company includes these options in the recognition of the Company’s ROU assets and lease liabilities when it is reasonably certain that the Company will exercise such options. We have elected the short-term lease exemption and, therefore, do not recognize a ROU asset or corresponding liability for lease arrangements with an original term of 12 months or less. The weighted average remaining lease term is 2.8 years. Operating leases are included in ROU operating assets, other current liabilities, and noncurrent operating lease liabilities in our condensed consolidated balance sheets as of September 30, 2022. The following table summarizes the presentation of the Company's operating lease as presented on the condensed consolidated balance sheets: (in thousands) SEPTEMBER 30, 2022 Assets: Operating lease right-of-use assets $ 569 Liabilities: Operating lease liabilities $ 165 Operating lease liabilities, noncurrent 428 Total operating lease liabilities $ 593 Future minimum lease payments from September 30, 2022 until the expiration of the operating lease are as follows: (in thousands) 2022 $ 43 2023 200 2024 230 2025 156 Thereafter — Total lease payments 629 Less: imputed discount rate ( 36 ) Carrying value of operating lease liabilities $ 593 The Company incurred $ 51 thousand and $ 37 thousand in operating lease rent expense for the three months ended September 30, 2022 and 2021 , respectively and $ 153 thousand and $ 91 thousand for the nine months ended September 30, 2022 and 2021 , respectively. Lease payments made were $ 29 thousand and $ 30 thousand for the three months ended September 30, 2022 and 2021 , respectively and $ 116 thousand and $ 69 thousand for the nine months ended September 30, 2022 and 2021, respectively, with such amounts reflected in the condensed consolidated statements of cash flows in operating activities. As the result of adopting ASU 2016-02 Leases using the modified retrospective transition method, we did not restate periods prior to the adoption date of January 1, 2022. These periods continue to be presented in accordance with ASC 840. As of December 31, 2021, the future undiscounted minimum lease payments on our operating leases were as follows: YEAR ENDING DECEMBER 31, (in thousands) 2022 $ 170 2023 195 2024 230 2025 176 Thereafter — $ 771 |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 7. BALANCE SHEET COMPONENTS Prepaid expenses and other assets— Prepaid expenses and other assets consisted of the following as of September 30, 2022 and December 31, 2021: (in thousands) SEPTEMBER 30, DECEMBER 31, Research and development $ 6,781 $ 3,303 Insurance 1,337 1,467 Other prepaids 715 370 Other assets 1,176 395 $ 10,009 $ 5,535 Accrued Expenses— Accrued expenses consisted of the following as of September 30, 2022 and December 31, 2021: (in thousands) SEPTEMBER 30, DECEMBER 31, Research and development $ 5,117 $ 1,937 Compensation and related expenses 4,178 2,955 Professional fees 588 539 Other 419 517 $ 10,302 $ 5,948 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | 8. STOCKHOLDERS' EQUITY In August 2021, the Company completed its IPO, pursuant to which it issued and sold 7,130,000 shares of the Company’s common stock, inclusive of 930,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a public offering price of $ 13.00 per share. The gross proceeds from the IPO, including the exercise of the underwriter's option to purchase additional shares were $ 92.7 million and the net proceeds were approximately $ 83.0 million, after deducting underwriting discounts and commissions and other offering costs. Preferred Stock —The Company had 50,000,000 shares of preferred stock authorized as of September 30, 2022 and December 31, 2021, respectively, of which no shares were outstanding as of September 30, 2022 and December 31, 2021. Common Stock —The Company had 200,000,000 shares of common stock authorized as of September 30, 2022 and December 31, 2021 , respectively, of which 32,091,398 and 32,129,970 shares were issued and outstanding as of September 30, 2022 and December 31, 2021. Share-based Compensation — Share-based compensation comprised of stock options, restricted stock awards, restricted stock units and the employee stock purchase plan is classified in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2022 and 2021 was as follows: FOR THE THREE MONTHS ENDED FOR THE NINE MONTHS ENDED (in thousands) 2022 2021 2022 2021 Research and development $ 984 $ 266 $ 2,620 $ 620 General and administrative 1,520 789 4,585 1,496 $ 2,504 $ 1,055 $ 7,205 $ 2,116 2021 Equity Incentive Plan In 2021, the board of directors adopted the Rallybio Corporation 2021 Equity Incentive Plan (the "2021 Plan"). The 2021 Plan reserves 5,440,344 for shares of the Company's common stock that have been issued in respect of outstanding equity awards granted prior to the registrant’s IPO and for future issuances of shares to employees, directors and consultants in the form of stock options, SARs, restricted and unrestricted stock and stock units, performance awards and other awards that are convertible into or otherwise based on the Company's common stock. Dividend equivalents may also be provided in connection with awards under the 2021 Plan. The share pool will automatically incr ease on January 1st of each year from 2022 to 2031 by the lesser of (i) five percent of the number of shares of the Company's common stock outstanding as of such date and (ii) the number of shares of the Company's common stock determined by the board of directors on or prior to such date. On January 1, 2022, the 2021 Plan share pool was automatically increased by 1,606,549 shares. As of September 30, 2022 , the total number of shares of common stock that were issuable under the 2021 Plan was 4,699,542 shares, of which 1,817,719 shares remained available for future issuance. The following table summarizes stock option activity for the nine months ended September 30, 2022: Stock Options Number of Option Shares Weighted-Average Exercise Price Weighted-Average Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2021 1,357,784 $ 12.72 9.7 $ — Granted 1,458,800 $ 13.45 Forfeited ( 58,807 ) $ 14.13 Expired ( 13,440 ) $ 13.00 Exercised ( 2,014 ) $ 10.38 Outstanding at September 30, 2022 2,742,323 $ 13.08 8.9 $ 4,359 Options exercisable at September 30, 2022 534,872 $ 13.38 8.6 $ 658 was $ 9.99 per share and $ 9.40 per share, respectively. Options vested during the nine months ended September 30, 2022 with an exercise price above the closing price have an intrinsic value of $ 0.7 million. No options vested during the nine months ended September 30, 2021. As of September 30, 2022 , there was unrecognized share-based compensation expense related to unvested stock options of $ 20.6 million, which the Company expects to recognize over a weighted-average period of approximately 3.1 years. The fair value of the stock options granted during the nine months ended September 30, 2022 was determined using the Black-Scholes option pricing model with the following assumptions: FOR THE NINE MONTHS ENDED FOR THE NINE MONTHS ENDED 2022 2021 Expected volatility 89.31 % - 91.62 % 87.76 % - 87.87 % Expected term (years) 5.50 - 6.08 5.50 - 6.08 Risk free interest rate 1.42 % - 2.94 % 0.79 % - 0.97 % Expected dividend yield — — Exercise price $ 7.54 - $ 15.04 $ 12.80 - $ 13.00 A summ ary of the status of the Company's nonvested restricted common stock awards at September 30, 2022 and changes during the nine months ended September 30, 2022 was as follows: Restricted Stock Awards Shares Weighted Average Grant Date Fair Value Per Share Nonvested restricted stock awards at December 31, 2021 2,272,707 $ 3.22 Granted — $ — Vested ( 973,238 ) $ 3.02 Forfeited ( 42,586 ) $ 2.97 Outstanding nonvested restricted stock awards at September 30, 2022 1,256,883 $ 3.39 As of September 30, 2022 , there was unrecognized share-based compensation expense related to unvested restricted stock awards of $ 4.2 million, which the Company expects to recognize over a weighted-average period of approximately 2.3 years. A summary of the status of the Company's nonvested restricted common stock units at September 30, 2022 and changes during the nine months ended September 30, 2022 was as follows: Restricted Stock Units Shares Weighted Average Grant Date Fair Value Per Share Nonvested restricted stock units at December 31, 2021 2,000 $ 10.76 Granted 150,400 $ 11.69 Forfeited ( 10,900 ) $ 15.04 Vested ( 2,000 ) $ 10.76 Outstanding nonvested restricted stock units at September 30, 2022 139,500 $ 11.43 , there was unrecognized share-based compensation expense related to unvested restricted stock units of $ 1.5 million, which the Company expects to recognize over a weighted-average period of approximately 2.5 years. 2021 Employee Stock Purchase Plan In connection with the Company's IPO, the board of directors adopted the Rallybio Corporation 2021 Employee Stock Purchase Plan (the "2021 ESPP"), which reserves 291,324 shares of the Company's common stock for future issuances under this plan. The share pool will automatically incr ease on January 1st of each year from 2022 to 2031 by the lesser of (i) one percent of the number of shares of the Company's common stock outstanding as of such date and (ii) the number of shares of the Company's common stock determined by the board of directors on or prior to such date. On January 1, 2022, the 2021 ESPP share pool was automatically increased by 321,309 shares. During the nine months ended September 30, 2022 , the Company did no t issue any shares under the 2021 ESPP. For the three and nine months ended September 30, 2022 , the total share-based compensation for ESPP was $ 64 thousand, respectively. |
Investment In Joint Venture
Investment In Joint Venture | 9 Months Ended |
Sep. 30, 2022 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Investment in Joint Venture | 9. INVESTMENT IN JOINT VENTURE The Company, through one of its wholly-owned subsidiaries, has a 50 % interest of the joint venture entity, RE Ventures I, LL C, a limited liability company (“REV-I”). For the nine months ended September 30, 2022 and 2021 the Company funded $ 0.3 million and $ 2.0 million, respectively, associated with the Company's commitment and its share of REV-I development. The Company did not provide any additional financial support outside of capital contributions to REV-I during the nine months ended September 30, 2022 and 2021. While the Company held a 50% interest in the joint venture as of September 30, 2022, based on management’s analysis, the Company is not the primary beneficiary of REV-1 and accordingly, the entity is not consolidated in the Company's condensed consolidated financial statements. For the three months ended September 30, 2022 and 2021, the Company recorded its allocable share of REV-I’s losses, which totaled $ 0.1 million and $ 0.3 million, respectively, and $ 0.9 million and $ 1.3 million for the nine months ended September 30, 2022 and 2021, respectively, as a loss on investment in joint venture within the condensed consolidated statements of operations and comprehensive loss. After recognition of its share of losses for the period, the carrying value and maximum exposure to risk of the REV-I investment as of September 30, 2022 and December 31, 2021 was $ 0.2 million and $ 0.8 million, respectively, which was recorded in investment in joint venture in the accompanying condensed consolidated balance sheets. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. COMMITMENTS AND CONTINGENCIES Purchase Commitments —The Company enters contracts in the normal course of business with contract research organizations and other third-party vendors for clinical trials and testing and manufacturing services. These contracts generally do not contain minimum purchase commitments and are cancellable by us upon written notice. Payments that may be due upon cancellation consist of payments for services provided or expenses incurred prior to cancellation. As of September 30, 2022 and December 31, 2021 there were no amounts accrued related to termination charges. |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | 11. NET LOSS PER COMMON SHARE Basic and diluted loss per common share was calculated as follows: FOR THE THREE MONTHS ENDED FOR THE NINE MONTHS ENDED 2022 2021 2022 2021 Net loss $ ( 18,370 ) $ ( 10,196 ) $ ( 50,451 ) $ ( 34,598 ) Weighted average number of common shares 30,777,797 27,527,770 30,562,723 24,011,862 Net loss per common share, basic and diluted $ ( 0.60 ) $ ( 0.37 ) $ ( 1.65 ) $ ( 1.44 ) The weighted average number of common shares outstanding diluted for the three and nine months ended September 30, 2022 excludes approximately 4.1 million stock options and unvested restricted share awards/units, which were not dilutive and not included in the computation of net loss per common share. The weighted average number of common shares outstanding diluted for the three and nine months ended September 30, 2021 excludes approximately 3.6 million stock options and unvested restricted share awards/units, which were not dilutive and not included in the computation of net loss per common share. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Unaudited Financial Information | Unaudited Financial Information — The unaudited condensed consolidated financial statements of the Company have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP"), and pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC"). In the opinion of the Company, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the financial position and results of operations for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period. The accompanying unaudited condensed consolidated financial statements include the accounts of Rallybio Corporation and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These accompanying unaudited condensed consolidated financial statements and notes should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2021 (our "Annual Report") which includes a description of reorganization and liquidation of Rallybio Holdings, LLC ("Rallybio Holdings") prior to our IPO that resulted in a change in reporting entity as described in Accounting Standards Codification ("ASC") 250. In accordance with the guidance applicable to these circumstances, the equity structure has been adjusted in all comparative periods to reflect the number of shares of the Company’s common stock issued to Rallybio Holdings unitholders in connection with the liquidation. As such, historical Rallybio Holdings convertible redeemable preferred units, common units, and incentive units have been retroactively adjusted in these condensed consolidated financial statements to shares and earnings per share in accordance with the ratio of common shares received by each membership unit class during the liquidation. Our significant accounting policies are described in Note 2 of the Notes to the Consolidated Financial Statements included in our Annual Report. Updates to our accounting policies, including impacts from the adoption of new accounting standards are discussed below. |
Marketable Securities | Marketable Securities — We invest our excess cash balances in highly rated U.S. government-backed debt securities and treasuries. We classify our marketable securities as available-for-sale and accordingly, record such securities at fair value. Debt securities with original maturities of greater than 90 days are classified as available-for-sale marketable securities and debt securities with original maturities of less than 90 days from the date of purchase are classified as cash equivalents. Unrealized gains and losses on our marketable debt securities that are deemed temporary are included in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. If any adjustment to fair value reflects a significant decline in the value of the security, we evaluate the extent to which the decline is determined to be other-than-temporary and would mark the security to market through a charge to our condensed consolidated statements of operations and comprehensive loss. Credit losses are identified when we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security. In the event of a credit loss, only the amount associated with the credit loss is recognized in operating results, with the amount of loss relating to other factors recorded in accumulated other comprehensive income (loss). |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements — In February 2016, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Update ("ASU") 2016-02 "Leases" that requires lessees to recognize leases on-balance sheet and to make certain disclosures associated with their leasing arrangements. The new standard establishes a right-of-use ("ROU") model that requires a lessee to recognize an ROU asset and lease liability on the condensed consolidated balance sheets for all leases with a term longer than twelve months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the condensed consolidated statements of operations and comprehensive loss. The Company adopted ASU 2016-02 Leases on January 1, 2022 using the modified retrospective approach and elected to apply the transition method that allows companies to continue applying guidance under the lease standard in effect at that time in the comparative periods condensed consolidated financial statements and recognize a cumulative-effect adjustment to the condensed consolidated balance sheets on the date of adoption. The Company elected the package of practical expedients to not reassess its prior conclusions about lease identification, lease classification and initial direct costs. At adoption we recognized approximately $ 0.7 million of ROU assets and corresponding lease liabilities. See Note 6. hin the scope of the new standard consist of available for sale debt securities. There was no impact to our condensed consolidated statements of operations and comprehensive loss or condensed consolidated balance sheets upon adoption. See Note 4 for discussion of unrealized losses on our available for sale marketable securities. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Fair Value of Marketable Securities by Type of Marketable Securities | The amortized cost, gross unrealized holding gains, gross unrealized holding losses and fair value of our marketable securities by type of security as of September 30, 2022 was as follows: SEPTEMBER 30, 2022 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. treasury securities $ 71,268 $ — $ ( 392 ) $ 70,876 U.S. government agency securities 9,875 — ( 42 ) 9,833 Money market funds 15,480 — — 15,480 $ 96,623 $ — $ ( 434 ) $ 96,189 |
Schedule of Marketable Securities by Balance Sheet Location Classification | The fair values of marketable securities by classification in the condensed consolidated balance sheets was as follows: (in thousands) SEPTEMBER 30, 2022 Cash and cash equivalents $ 15,480 Marketable securities 80,709 $ 96,189 |
Schedule of Fair Values of Available-for-Sale Debt Securities by Contractual Maturity | The fair values of available-for-sale debt securities as of September 30, 2022, by contractual maturity, are summarized as follows: (in thousands) SEPTEMBER 30, 2022 Due in one year or less $ 96,189 Due after one year through two years — $ 96,189 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value Measurements on a Recurring Basis and Level of Inputs | Financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type as of September 30, 2022 was as follows : SEPTEMBER 30, 2022 (in thousands) Level 1 Level 2 Level 3 Financial assets: Money market funds $ 15,480 $ — $ — U.S. treasury securities 70,876 — — U.S. government agency securities 9,833 — — Total financial assets $ 96,189 $ — $ — |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Summary of Company's Operating Lease on the Condensed Consolidated Balance Sheets | The following table summarizes the presentation of the Company's operating lease as presented on the condensed consolidated balance sheets: (in thousands) SEPTEMBER 30, 2022 Assets: Operating lease right-of-use assets $ 569 Liabilities: Operating lease liabilities $ 165 Operating lease liabilities, noncurrent 428 Total operating lease liabilities $ 593 |
Schedule of Future Minimum Annual Lease Payments | Future minimum lease payments from September 30, 2022 until the expiration of the operating lease are as follows: (in thousands) 2022 $ 43 2023 200 2024 230 2025 156 Thereafter — Total lease payments 629 Less: imputed discount rate ( 36 ) Carrying value of operating lease liabilities $ 593 As of December 31, 2021, the future undiscounted minimum lease payments on our operating leases were as follows: YEAR ENDING DECEMBER 31, (in thousands) 2022 $ 170 2023 195 2024 230 2025 176 Thereafter — $ 771 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Prepaid Expenses | Prepaid expenses and other assets consisted of the following as of September 30, 2022 and December 31, 2021: (in thousands) SEPTEMBER 30, DECEMBER 31, Research and development $ 6,781 $ 3,303 Insurance 1,337 1,467 Other prepaids 715 370 Other assets 1,176 395 $ 10,009 $ 5,535 |
Schedule of Accrued Expenses | Accrued expenses consisted of the following as of September 30, 2022 and December 31, 2021: (in thousands) SEPTEMBER 30, DECEMBER 31, Research and development $ 5,117 $ 1,937 Compensation and related expenses 4,178 2,955 Professional fees 588 539 Other 419 517 $ 10,302 $ 5,948 |
Stockholder's Equity (Tables)
Stockholder's Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Share-Based Compensation for Stock Options, Restricted Stock Awards and Restricted Stock Units | Share-based compensation comprised of stock options, restricted stock awards, restricted stock units and the employee stock purchase plan is classified in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2022 and 2021 was as follows: FOR THE THREE MONTHS ENDED FOR THE NINE MONTHS ENDED (in thousands) 2022 2021 2022 2021 Research and development $ 984 $ 266 $ 2,620 $ 620 General and administrative 1,520 789 4,585 1,496 $ 2,504 $ 1,055 $ 7,205 $ 2,116 |
Summary of Stock Option Activity | The following table summarizes stock option activity for the nine months ended September 30, 2022: Stock Options Number of Option Shares Weighted-Average Exercise Price Weighted-Average Contractual Term Aggregate Intrinsic Value Outstanding at December 31, 2021 1,357,784 $ 12.72 9.7 $ — Granted 1,458,800 $ 13.45 Forfeited ( 58,807 ) $ 14.13 Expired ( 13,440 ) $ 13.00 Exercised ( 2,014 ) $ 10.38 Outstanding at September 30, 2022 2,742,323 $ 13.08 8.9 $ 4,359 Options exercisable at September 30, 2022 534,872 $ 13.38 8.6 $ 658 |
Summary of Assumptions of Fair Value of Option Pricing Granted | The fair value of the stock options granted during the nine months ended September 30, 2022 was determined using the Black-Scholes option pricing model with the following assumptions: FOR THE NINE MONTHS ENDED FOR THE NINE MONTHS ENDED 2022 2021 Expected volatility 89.31 % - 91.62 % 87.76 % - 87.87 % Expected term (years) 5.50 - 6.08 5.50 - 6.08 Risk free interest rate 1.42 % - 2.94 % 0.79 % - 0.97 % Expected dividend yield — — Exercise price $ 7.54 - $ 15.04 $ 12.80 - $ 13.00 |
Summary of Nonvested Restricted Common Stock Awards | A summ ary of the status of the Company's nonvested restricted common stock awards at September 30, 2022 and changes during the nine months ended September 30, 2022 was as follows: Restricted Stock Awards Shares Weighted Average Grant Date Fair Value Per Share Nonvested restricted stock awards at December 31, 2021 2,272,707 $ 3.22 Granted — $ — Vested ( 973,238 ) $ 3.02 Forfeited ( 42,586 ) $ 2.97 Outstanding nonvested restricted stock awards at September 30, 2022 1,256,883 $ 3.39 |
Summary of Nonvested Restricted Common Stock Units | A summary of the status of the Company's nonvested restricted common stock units at September 30, 2022 and changes during the nine months ended September 30, 2022 was as follows: Restricted Stock Units Shares Weighted Average Grant Date Fair Value Per Share Nonvested restricted stock units at December 31, 2021 2,000 $ 10.76 Granted 150,400 $ 11.69 Forfeited ( 10,900 ) $ 15.04 Vested ( 2,000 ) $ 10.76 Outstanding nonvested restricted stock units at September 30, 2022 139,500 $ 11.43 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Basic and Diluted Loss Per Common Share | Basic and diluted loss per common share was calculated as follows: FOR THE THREE MONTHS ENDED FOR THE NINE MONTHS ENDED 2022 2021 2022 2021 Net loss $ ( 18,370 ) $ ( 10,196 ) $ ( 50,451 ) $ ( 34,598 ) Weighted average number of common shares 30,777,797 27,527,770 30,562,723 24,011,862 Net loss per common share, basic and diluted $ ( 0.60 ) $ ( 0.37 ) $ ( 1.65 ) $ ( 1.44 ) |
Business and Liquidity - Additi
Business and Liquidity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |
Aug. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Proceeds from issuance of common stock | $ 21 | $ 0 | |
Cash, cash equivalents and marketable securities | $ 132,400 | ||
Total IPO | |||
Stock issued during period, shares, new issues | 7,130,000 | ||
Shares issued price per share | $ 13 | ||
Proceeds from issuance of common stock | $ 92,700 | ||
Net proceeds | $ 83,000 | ||
Over-Allotment Option [Member] | |||
Stock issued during period, shares, new issues | 930,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation (Details) - USD ($) $ in Thousands | Jan. 01, 2022 | Sep. 30, 2022 |
Lease, Cost [Abstract] | ||
ROU assets | $ 700 | |
Lease liability | $ 700 | $ 593 |
Asset Acquisitions - Additional
Asset Acquisitions - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
May 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Business Acquisition [Line Items] | |||||
Upfront payment | $ 3,000 | ||||
Aggregate development and regulatory milestone payments | 43,000 | ||||
Obligation to payment upon maximum achievement of certain clinical and commercial milestones | $ 150,000 | ||||
Transaction costs associated with asset acquisition | $ 100 | ||||
Research and development | $ 12,110 | $ 4,960 | 29,896 | $ 20,815 | |
IPR&D | |||||
Business Acquisition [Line Items] | |||||
Research and development | $ 3,100 |
Marketable Securities - Summary
Marketable Securities - Summary of available-for-sale marketable securities (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Debt Securities, Available-for-Sale [Line Items] | |
Amortized cost | $ 96,623 |
Gross unrealized gains | 0 |
Gross unrealized losses | (434) |
Fair value | 96,189 |
U.S. government agency securities Member | |
Debt Securities, Available-for-Sale [Line Items] | |
Amortized cost | 9,875 |
Gross unrealized gains | 0 |
Gross unrealized losses | (42) |
Fair value | 9,833 |
U S Treasury Securities Member | |
Debt Securities, Available-for-Sale [Line Items] | |
Amortized cost | 71,268 |
Gross unrealized gains | 0 |
Gross unrealized losses | (392) |
Fair value | 70,876 |
Money Market Funds Member | |
Debt Securities, Available-for-Sale [Line Items] | |
Amortized cost | 15,480 |
Gross unrealized gains | 0 |
Gross unrealized losses | 0 |
Fair value | $ 15,480 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Available-for-Sale Securities by Balance Sheet Location Classification (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Debt Securities, Available-for-Sale [Line Items] | |
Debt securities available-for-sale | $ 96,189 |
Cash and Cash Equivalents Member | |
Debt Securities, Available-for-Sale [Line Items] | |
Debt securities available-for-sale | 15,480 |
Marketable Securities Member | |
Debt Securities, Available-for-Sale [Line Items] | |
Debt securities available-for-sale | $ 80,709 |
Marketable Securities - Sched_2
Marketable Securities - Schedule of Fair Values of Available-For-Sale Debt Securities By Contractual Maturity (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due in one year or less | $ 96,189 |
Due after one year through two years | 0 |
Total available-for-sale debt securities by contractual maturity | $ 96,189 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Aggregate fair value of available-for-sale debt securities in an unrealized loss position | $ 77,700 |
Continuous unrealized loss position for more than twelve months | 0 |
Allowance for credit losses | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value Measurements on a Recurring Basis and Level of Inputs (Details) - Fair Value Measurements Recurring Member $ in Thousands | Sep. 30, 2022 USD ($) |
Fair Value Inputs Level1 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | $ 96,189 |
Fair Value Inputs Level2 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 0 |
Fair Value Inputs Level3 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 0 |
U S Treasury Securities Member | Fair Value Inputs Level1 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 70,876 |
U S Treasury Securities Member | Fair Value Inputs Level2 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 0 |
U S Treasury Securities Member | Fair Value Inputs Level3 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 0 |
U.S. Government Agency Securities Member | Fair Value Inputs Level1 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 9,833 |
U.S. Government Agency Securities Member | Fair Value Inputs Level2 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 0 |
U.S. Government Agency Securities Member | Fair Value Inputs Level3 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 0 |
Money Market Funds Member | Fair Value Inputs Level1 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 15,480 |
Money Market Funds Member | Fair Value Inputs Level2 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | 0 |
Money Market Funds Member | Fair Value Inputs Level3 Member | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Total financial assets | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Cash And Cash Equivalents | $ 51,711,000 | $ 175,334,000 |
Transfers of securities between fair value levels | $ 0 | |
Money Market Funds Member | Fair Value Inputs Level1 Member | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Cash And Cash Equivalents | $ 4,000,000 |
Leases - Additional Information
Leases - Additional Information (Details) - Office [Member] $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) ft² | Sep. 30, 2021 USD ($) | |
Operating Leased Assets [Line Items] | ||||
Operating Lease, Weighted Average Remaining Lease Term (Year) | 2 years 9 months 18 days | 2 years 9 months 18 days | ||
Operating Lease, Weighted Average Discount Rate, Percent | 4% | 4% | ||
Operating lease rent expense | $ 51 | $ 37 | $ 153 | $ 91 |
Lease payments | $ 29 | $ 30 | $ 116 | $ 69 |
Lessor operating lease description | We have operating leases for approximately nine thousand square feet of corporate office space and we have elected to combine lease components with non-lease components on our office real estate asset class. Fixed, or in substance fixed, lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Variable lease expenses that are not considered fixed, or in substance fixed, are recognized as incurred. Fixed and variable lease expense on operating leases is recognized within operating expenses within our condensed consolidated statements of operations and comprehensive loss. Some leases include options to extend or terminate the lease and the Company includes these options in the recognition of the Company’s ROU assets and lease liabilities when it is reasonably certain that the Company will exercise such options. We have elected the short-term lease exemption and, therefore, do not recognize a ROU asset or corresponding liability for lease arrangements with an original term of 12 months or less. The weighted average remaining lease term is 2.8 years. | |||
Area of real estate property | ft² | 9,000 | 9,000 |
Leases - Summary of Company's O
Leases - Summary of Company's Operating Lease on the Condensed Consolidated Balance Sheets (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
Leases [Abstract] | |||
Operating lease right-of-use assets | $ 569 | $ 0 | |
Operating lease liabilities | 165 | 0 | |
Operating lease liabilities, noncurrent | 428 | $ 0 | |
Total operating lease liabilities | $ 593 | $ 700 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Annual Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
Leases [Abstract] | |||
2022 | $ 43 | $ 170 | |
2023 | 200 | 195 | |
2024 | 230 | 230 | |
2025 | 156 | 176 | |
Thereafter | 0 | 0 | |
Total lease payments | 629 | $ 771 | |
Less: imputed discount rate | (36) | ||
Carrying value of operating lease liabilities | $ 593 | $ 700 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Prepaid Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Research and development | $ 6,781 | $ 3,303 |
Insurance | 1,337 | 1,467 |
Other prepaids | 715 | 370 |
Other assets | 1,176 | 395 |
Prepaid expenses and other assets | $ 10,009 | $ 5,535 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule Of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current [Abstract] | ||
Research and development | $ 5,117 | $ 1,937 |
Compensation and related expenses | 4,178 | 2,955 |
Professional fees | 588 | 539 |
Other | 419 | 517 |
Accrued expenses | $ 10,302 | $ 5,948 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jan. 01, 2022 | Aug. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Class of Stock [Line Items] | ||||||
Proceeds from issuance of common stock, gross including exercise of the underwriter's option to purchase additional shares | $ 21 | $ 0 | ||||
Preferred stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | |||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||
Common stock, shares issued | 32,091,398 | 32,091,398 | 32,129,970 | |||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | |||
Common stock, shares outstanding | 32,091,398 | 32,091,398 | 32,129,970 | |||
Fair value of underlying shares | $ 9.99 | $ 9.40 | ||||
Vested - shares | 0 | |||||
Granted - shares | 1,458,800 | |||||
Intrinsic value of stock options vested | $ 700 | |||||
Unrecognized share-based compensation expense | $ 20,600 | $ 20,600 | ||||
Options exercisable, end of period - weighted average remaining contractual term (years) | 8 years 7 months 6 days | |||||
Total unrecognized compensation cost, period for recognition | 3 years 1 month 6 days | |||||
Stock option activity | 2,742,323 | 2,742,323 | 1,357,784 | |||
Restricted Stock Awards [Member] | ||||||
Class of Stock [Line Items] | ||||||
Unrecognized share-based compensation expense | $ 4,200 | $ 4,200 | ||||
Options exercisable, end of period - weighted average remaining contractual term (years) | 2 years 3 months 18 days | |||||
Restricted Stock Units (RSUs) [Member] | ||||||
Class of Stock [Line Items] | ||||||
Unrecognized share-based compensation expense | $ 1,500 | $ 1,500 | ||||
Total unrecognized compensation cost, period for recognition | 2 years 6 months | |||||
2021 Equity Incentive Plan | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares increased | 1,606,549 | |||||
Common stock issuable | 4,699,542 | 4,699,542 | ||||
Common shares reserved for issuance | 5,440,344 | 5,440,344 | ||||
Common shares remained for issuance | 1,817,719 | 1,817,719 | ||||
2021 Employee Stock Purchase Plan | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares increased | 321,309 | |||||
Common shares reserved for issuance | 291,324 | 291,324 | ||||
Stock option activity | 0 | 0 | ||||
Total share based compensation | $ 64 | $ 64 | ||||
IPO [Member] | ||||||
Class of Stock [Line Items] | ||||||
Stock issued during period, shares, new issues | 7,130,000 | |||||
Shares issued price per share | $ 13 | |||||
Proceeds from issuance of common stock, gross including exercise of the underwriter's option to purchase additional shares | $ 92,700 | |||||
Net proceeds | $ 83,000 | |||||
Common stock, shares issued | 7,130,000 | |||||
Over-Allotment Option [Member] | ||||||
Class of Stock [Line Items] | ||||||
Stock issued during period, shares, new issues | 930,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Equity-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 2,504 | $ 1,055 | $ 7,205 | $ 2,116 |
Research and Development | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | 984 | 266 | 2,620 | 620 |
General and Administrative | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 1,520 | $ 789 | $ 4,585 | $ 1,496 |
Stockholder's Equity - Summary
Stockholder's Equity - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | ||
Share-based payment award, options, outstanding, number, beginning balance | shares | 1,357,784 | |
Granted - shares | shares | 1,458,800 | |
Options forfeited - shares | shares | (58,807) | |
Options expired - shares | shares | (13,440) | |
Options exercised - shares | shares | (2,014) | |
Share-based payment award, options, outstanding, number, ending balance | shares | 2,742,323 | 1,357,784 |
Options exercisable, end of period (in shares) | shares | 534,872 | |
Options outstanding, beginning of period - weighted average exercise price per share | $ / shares | $ 12.72 | |
Weighted-average exercise price granted | $ / shares | 13.45 | |
Options exercised - weighted average exercise price per share | $ / shares | 10.38 | |
Options forfeited - weighted average exercise price per share | $ / shares | 14.13 | |
Options expired - weighted average exercise price per share | $ / shares | 13 | |
Options outstanding, end of period - weighted average exercise price per share | $ / shares | 13.08 | $ 12.72 |
Options exercisable, end of period - weighted average exercise price per share | $ / shares | $ 13.38 | |
Options outstanding, beginning of period - weighted average remaining contractual term (years) | 8 years 10 months 24 days | 9 years 8 months 12 days |
Options outstanding, end of period - weighted average remaining contractual term (years) | 8 years 10 months 24 days | 9 years 8 months 12 days |
Options exercisable, end of period - weighted average remaining contractual term (years) | 8 years 7 months 6 days | |
Options outstanding, beginning of period - aggregate intrinsic value | $ | $ 0 | |
Options outstanding, end of period - aggregate intrinsic value | $ | 4,359 | $ 0 |
Options exercisable, end of period - aggregate intrinsic value | $ | $ 658 |
Stockholder's Equity - Summar_2
Stockholder's Equity - Summary of Assumptions of Fair Value of Option Pricing Granted (Details) - Employee Stock Options - Two Thousand and Twenty One Equity Incentive Plan [Member] - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected volatility, minimum | 89.31% | 87.76% |
Expected volatility, maximum | 91.62% | 87.87% |
Risk-free interest rate, minimum | 1.42% | 0.79% |
Risk-free interest rate, maximum | 2.94% | 0.97% |
Expected dividend yield | 0% | 0% |
Maximum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term (years) | 6 years 29 days | 6 years 29 days |
Exercise price | $ 15.04 | $ 13 |
Minimum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term (years) | 5 years 6 months | 5 years 6 months |
Exercise price | $ 7.54 | $ 12.80 |
Stockholder's Equity - Summar_3
Stockholder's Equity - Summary of Nonvested Restricted Common Stock Awards (Details) - Restricted Stock Awards | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Weighted average grant date fair value, beginning balance | $ / shares | $ 3.22 |
Weighted average grant date fair value, shares granted | $ / shares | 0 |
Weighted average grant date fair value, shares vested | $ / shares | 3.02 |
Weighted average grant date fair value, shares forfeited | $ / shares | 2.97 |
Weighted average grant date fair value, ending balance | $ / shares | $ 3.39 |
Outstanding, beginning balance | shares | 2,272,707 |
Shares granted | shares | 0 |
Shares vested | shares | (973,238) |
Shares forfeited | shares | (42,586) |
Outstanding, ending balance | shares | 1,256,883 |
Stockholder's Equity - Summar_4
Stockholder's Equity - Summary of Nonvested Restricted Common Stock Units (Details) - Restricted Stock Units | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Outstanding, beginning balance | shares | 2,000 |
Shares granted | shares | 150,400 |
Shares forfeited | shares | (10,900) |
Shares vested | shares | (2,000) |
Outstanding, ending balance | shares | 139,500 |
Weighted average grant date fair value, beginning balance | $ / shares | $ 10.76 |
Weighted average grant date fair value, shares granted | $ / shares | 11.69 |
Weighted average grant date fair value, shares forfeited | $ / shares | 15.04 |
Weighted average grant date fair value, shares vested | $ / shares | 10.76 |
Weighted average grant date fair value, ending balance | $ / shares | $ 11.43 |
Investment In Joint Venture - A
Investment In Joint Venture - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Schedule of Equity Method Investments [Line Items] | |||||
Joint venture investment payments | $ 300 | $ 2,000 | |||
Allocable share of losses recorded | $ 133 | $ 332 | 861 | 1,282 | |
Investment in joint venture | 244 | $ 244 | $ 805 | ||
RE Ventures I, LLC | |||||
Schedule of Equity Method Investments [Line Items] | |||||
Percentage of interest of joint venture entity | 50% | ||||
Allocable share of losses recorded | 100 | $ 300 | $ 900 | $ 1,300 | |
Investment in joint venture | $ 200 | $ 200 | $ 800 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Other Commitments [Line Items] | ||
Termination charges | $ 0 | $ 0 |
Net Loss Per Common Share - Sum
Net Loss Per Common Share - Summary of Basic and diluted loss per common share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (18,370) | $ (10,196) | $ (50,451) | $ (34,598) |
Weighted average number of common shares outstanding, basic | 30,777,797 | 27,527,770 | 30,562,723 | 24,011,862 |
Weighted average number of common shares outstanding, diluted | 30,777,797 | 27,527,770 | 30,562,723 | 24,011,862 |
Net loss per common share, basic | $ (0.60) | $ (0.37) | $ (1.65) | $ (1.44) |
Net loss per common share, diluted | $ (0.60) | $ (0.37) | $ (1.65) | $ (1.44) |
Net Loss Per Common Share - Add
Net Loss Per Common Share - Additional Information (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock Options And Unvested Restricted Share | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 4,100,000 | 3,600,000 | 4,100,000 | 3,600,000 |