Rallybio Corp

1. BUSINESS AND LIQUIDITY

Rallybio Corporation and subsidiaries ("Rallybio", the "Company", "we", "our", or "us") is a clinical-stage biotechnology company comprised of experienced biopharma industry leaders with extensive research, development, and rare disease expertise with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Since Rallybio's launch in January 2018, the Company has built a pipeline of promising product candidates aimed at addressing diseases with unmet medical need in the areas of complement dysregulation and hematology. The Company's lead program, RLYB116, is a differentiated complement component 5 (“C5”) inhibitor with the potential to treat diseases of complement dysregulation. In addition, RLYB332, a long-acting matriptase-2 ("MTP-2") antibody for the treatment of diseases of iron overload is currently in preclinical development. In the second quarter of 2025, Rallybio initiated a confirmatory pharmacokinetic ("PK") and pharmacodynamic ("PD") study of RLYB116 in healthy volunteers and expects to report data in the third and fourth quarters of 2025. In April 2025, the Company announced the discontinuation of its RLYB212 program for the prevention of fetal and neonatal alloimmune thrombocytopenia ("FNAIT") based on PK data from the Phase 2 clinical trial that demonstrated an inability of the RLYB212 dose regimen to achieve predicted target concentrations, as well as the minimum target concentration required for efficacy. In July 2025, the Company announced it had entered into a definitive agreement to sell its interest in REV102, an Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 ("ENPP1") inhibitor in preclinical development for the treatment of patients with hypophosphatasia, to a subsidiary of its joint venture partner Recursion Pharmaceuticals, Inc. ("Recursion") (the "JV Sale").

The Company had cash, cash equivalents and marketable securities of $45.7 million as of June 30, 2025. 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 these unaudited condensed consolidated financial statements are issued. However, the Company does not anticipate that its current cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund any of its product candidates through regulatory approval, and it will need to raise substantial additional capital to complete the development and commercialization of its product candidates, if approved. Rallybio may satisfy its future cash needs through the sale of equity securities, debt financings, corporate collaborations or license agreements, working capital lines of credit, grant funding, interest income earned on invested cash balances or a combination of one or more of these sources.

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"). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates promulgated by the Financial Accounting Standards Board.

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 Rallybio's Annual Report on Form 10-K for the year ended December 31, 2024 (our "Annual

Report"). The Company's significant accounting policies are described in Note 2 of the Notes to the consolidated financial statements included in our Annual Report. There have been no new accounting policies, including the adoption of new accounting standards during the three and six months ended June 30, 2025, unless otherwise noted below, which could be expected to materially impact the Company's unaudited condensed consolidated financial statements.

Recently Issued Accounting Pronouncements—In December 2023, the Financial Accounting Standards Board ("FASB") issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09") which establishes new income tax disclosure requirements in addition to modifying and eliminating certain existing requirements. Public business entities must apply the ASU’s guidance to annual periods beginning after December 15, 2024. The Company has chosen not to early adopt this standard and is currently evaluating the potential impact of adopting this standard on its financial statements.

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses ("ASU 2024-03"). This ASU requires public entities to disclose additional transparency on certain costs and expenses. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company has chosen not to early adopt this standard and is currently evaluating the potential impact of adopting this standard on its financial statements.

3. 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 June 30, 2025 and December 31, 2024 was as follows:

The fair values of marketable securities by classification in the condensed consolidated balance sheets was as follows as of June 30, 2025 and December 31, 2024:

The fair values of available-for-sale debt securities as of June 30, 2025 and December 31, 2024, by contractual maturity, are summarized as follows:

The aggregate fair value of available-for-sale debt securities in an unrealized loss position as of June 30, 2025 and December 31, 2024 was $15.4 million and $10.4 million, respectively. As of June 30, 2025, we didnot have any investments in a continuous unrealized loss position for more than twelve months. As of June 30, 2025, we believe that the cost basis of our available-for-sale debt securities is recoverable. No allowance for credit losses was recorded as of June 30, 2025 and December 31, 2024.

4. BALANCE SHEET COMPONENTS

Prepaid expenses and other current assets —

Prepaid expenses and other current assets consisted of the following as of June 30, 2025 and December 31, 2024:

Accrued Expenses—

Accrued expenses consisted of the following as of June 30, 2025 and December 31, 2024:

5. STOCKHOLDERS' EQUITY

Common Stock

In April 2024, the Company entered into a securities purchase agreement (the "JJDC Securities Purchase Agreement") with Johnson & Johnson Innovation – JJDC, Inc. ("JJDC"), pursuant to which the Company sold to JJDC, in an unregistered offering,3,636,363 shares of its common stock, at a price of $1.82 per share, which represented a 10% premium on the Company’s closing stock price on April 9, 2024, for aggregate gross proceeds of approximately $6.6 million, before deducting offering expenses.

The Company had 200,000,000 shares of common stock authorized as of June 30, 2025 and December 31, 2024, of which 41,707,153 and 41,510,163 shares were issued and outstanding as of June 30, 2025 and December 31, 2024, respectively.

Preferred Stock

The Company had 50,000,000 shares of preferred stock authorized as of June 30, 2025 and December 31, 2024, of whichno shares were outstanding as of June 30, 2025 and December 31, 2024.

Pre-Funded Warrants

In connection with a follow-on offering, the Company entered into an agreement with certain investors to issue pre-funded warrants in lieu of common stock to purchase up to an aggregate of 3,333,388 shares of common stock at a price of $5.9999, which represents the per share public offering price of the November 2022 follow-on offering for common stock less a $0.0001 per share exercise price for each pre-funded warrant.

The Company may not effect the exercise of any pre-funded warrant, and a holder will not be entitled to exercise any portion of any pre-funded warrant if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates) would exceed 9.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise, which percentage may be increased or decreased at the holder’s election upon 61 days’ notice to the Company subject to the terms of such pre-funded warrants, provided that such percentage may in no event exceed 19.99%.

The Company's pre-funded warrant is a freestanding instrument that does not meet the definition of a liability pursuant to ASC 480, Distinguishing Liabilities from Equity, and does not meet the definition of a derivative pursuant to ASC 815, Derivatives and Hedging. The pre-funded warrant is indexed to the Company’s common stock and meets all other conditions for equity classification under ASC 480 and ASC 815. Accordingly, the pre-funded warrant was classified as equity and accounted for as a component of additional paid-in capital at the time of issuance. All of the pre-funded warrants related to our November 2022 follow-on offering remain outstanding and unexercised as of June 30, 2025.

Share-based Compensation

Share-based compensation is comprised of the Company's stock options, restricted stock awards, restricted stock units and shares issued pursuant to the employee stock purchase plan, and is classified in the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025 and 2024 was as follows:

2021 Equity Incentive Plan

In 2021, the board of directors adopted the Rallybio Corporation 2021 Equity Incentive Plan (the "2021 Plan"). The 2021 Plan initially reserved 5,440,344 shares of the Company's common stock that have been issued in respect of outstanding equity awards granted prior to the Company's initial public offering ("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 increase on January 1st of each year until 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, 2025 and January 1, 2024, the 2021 Plan share pool was automatically increased by 2,075,508 and 1,891,478 shares, respectively. As of June 30, 2025, the total number of shares of the Company's common stock that were issuable under the 2021 Plan was 10,596,653 shares, of which 3,599,545 shares remained available for future issuance.

The following table summarizes stock option activity for the six months ended June 30, 2025:

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the estimated fair value of the Company's common stock. Stock options outstanding with an exercise price below the closing price as of June 30, 2025 had an intrinsic value of approximately $9 thousand based on a common stock fair value of $0.338 per share, which was the closing price of the Company's common stock on June 30, 2025. Stock options outstanding and exercisable with an exercise price above the closing price as of June 30, 2025 are considered to haveno intrinsic value. Using the Black-Scholes option pricing model, the weighted-average grant date fair value of stock options granted during the six months ended June 30, 2025 and 2024 was $0.62 per share and $1.47 per share, respectively. As of June 30, 2025, there was unrecognized share-based compensation expense related to nonvested stock options of $5.4 million which the Company expects to recognize over a weighted-average period of approximately 2.2 years.

The fair value of the stock options granted during the six months ended June 30, 2025 and 2024 was determined using the Black-Scholes option pricing model with the following assumptions:

A summary of the status of the Company's nonvested restricted common stock awards at June 30, 2025 and changes during the six months ended June 30, 2025 was as follows:

As of June 30, 2025, there was unrecognized share-based compensation expense related to nonvested restricted stock awards of $4 thousand, which the Company expects to recognize over a weighted-average period of approximately 0.3 years.

A summary of the status of the Company's nonvested restricted common stock units at June 30, 2025 and changes during the six months ended June 30, 2025 was as follows:

As of June 30, 2025, there was unrecognized share-based compensation expense related to nonvested restricted stock units of $0.8 million, which the Company expects to recognize over a weighted-average period of approximately 1.5 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 initially reserved 291,324 shares of the Company's common stock for future issuances under this plan. The share pool will automatically increase 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, (ii)582,648 shares of the Company’s common stock and (iii) the number of shares of the Company's common stock determined by the board of directors on or prior to such date. The 2021 ESPP share pool didnot increase on January 1, 2025 or January 1, 2024. As of June 30, 2025, the total number of shares of the Company's common stock available for future issuance under the 2021 ESPP was 777,012 shares. During the six months ended June 30, 2025 and 2024, the Company issued 35,000 and 38,289 shares, respectively, of the Company's common stock under the 2021 ESPP.

The 2021 ESPP allows eligible participants to purchase shares of our common stock through authorized payroll deductions. The purchase price of the shares will not be less than 85% of the lower of the fair market value of our common stock on the first day of an offering or on the date of the purchase.

6. INVESTMENT IN JOINT VENTURE

Prior to the JV Sale, the Company, through one of its wholly-owned subsidiaries, had a 50% interest of the joint venture entity, RE Ventures I, LLC, a limited liability company (“REV-I”). For the three months ended June 30, 2025 and 2024, the Company funded $0.5 million and $0.8 million, respectively, associated with the Company's commitment and its share of REV-I development costs. For both the six months ended June 30, 2025 and 2024, the Company funded $1.5 million associated with the Company's commitment and its share of REV-I development costs. The Company didnot provide any additional financial support outside of capital contributions to REV-I during the three and six months ended June 30, 2025 and 2024. However, in connection with the joint venture, the Company provided certain scientific and finance and accounting related support which was reimbursed by REV-I to the Company and is included in other income on the condensed consolidated statements of operations and comprehensive loss. For the three and six months ended June 30, 2025 and 2024, the Company recorded $0.1 million and $0.3 million, respectively, related to such support. While the Company held a 50% interest in the joint venture as of June 30, 2025, based on management’s analysis, the Company was not the primary beneficiary of REV-I and accordingly, the entity was not consolidated in the Company's condensed consolidated financial statements.

For the three and six months ended June 30, 2025, the Company recorded its allocable share of REV-I's losses which totaled $0.3 million and $0.9 million, respectively, and for the three and six ended June 30, 2024, the Company recorded its allocable share of REV-I's losses which totaled and $0.5 million and $1.2 million, respectively. These losses were recorded 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 June 30, 2025 was $0.6 million, which was recorded in investment in joint venture in the Company's condensed consolidated balance sheets. There wasno carrying value remaining of the REV-I investment as of December 31, 2024.

For further details on the JV Sale, please refer to Note 12.

7. 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 June 30, 2025 and December 31, 2024, there wereno amounts accrued related to termination charges.

8. NET LOSS PER COMMON SHARE

Basic and diluted net loss per common share for the three and six months ended June 30, 2025 and 2024 was calculated as follows:

Basic net loss per share of common stock is based on the weighted-average number of shares of common stock outstanding during the period. Pre-funded warrants to purchase 3,333,388 shares of common stock that were issued in connection with the November 2022 follow-on offering were included in the weighted-average number of common shares outstanding for the three and six months ended June 30, 2025 and 2024. The weighted average number of common shares outstanding diluted for the three and six months ended June 30, 2025 and 2024 excludes approximately 7.0 million and 5.4 million stock options and nonvested restricted stock awards and units, respectively, which were not dilutive.

9. SEGMENTS

The Company defines its segments on the basis of the way in which internally reported financial information is regularly reviewed by the chief operating decision maker ("CODM") to analyze financial performance, make decisions, and allocate resources. The Company’s CODM consists of its Chief Executive Officer, Chief Financial Officer and Chief Medical Officer. The Company manages its operations as a single operating and reportable segment and the measure of segment profit or loss is net loss and comprehensive loss. The CODM uses net loss in the budget and forecasting process and considers budget-to-actual variances on a quarterly basis when making decisions about the allocation of operating and capital resources.

The following table summarizes the information about reported segment revenues and significant segment expenses presented on the Company's condensed consolidated statements of operations and comprehensive loss for the three and six months ended 2025 and 2024:

*Other segment items include total other income, net and loss on investment in joint venture.

10. RESTRUCTURING

On May 2, 2025, the Company approved a workforce reduction to focus resources on the Company’s lead program, RLYB116 and its preclinical development programs.

As part of this effort, the Company eliminated approximately 40% of its positions. As a result of these actions, the Company incurred charges of approximately $1.7 million of which $1.2 million was included in research and development expenses and $0.5 million was included in general and administrative expenses, with such amounts reflected in the condensed consolidated statements of operations and comprehensive loss. The charges related to the workforce reduction were cash-based expenditures related primarily to severance and benefit payments. The Company recognized all such charges during the second quarter of 2025, with such amounts reflected in the condensed consolidated statements of operations and comprehensive loss. The accrued restructuring liability is included in accrued expenses in the condensed consolidated balance sheets as of June 30, 2025.

In February 2024, the Company announced a workforce reduction.

As part of this effort, the Company eliminated approximately 45% of its positions. As a result of these actions, the Company incurred charges of approximately $3.3 million of which $2.0 million was included in research and development expenses and $1.3 million was included in general and administrative expenses, with such amounts reflected in the condensed consolidated statements of operations and comprehensive loss. The charges related to the workforce reduction were cash-based expenditures related primarily to severance and benefit payments. The Company recognized all such charges during the first quarter of 2024, with such amounts reflected in the condensed consolidated statements of operations and comprehensive loss. The accrued restructuring liability is included in accrued expenses in the condensed consolidated balance sheets as of June 30, 2025.

Substantially all restructuring payments are expected to be completed by June 2026.

The following table summarizes the restructuring accrual activity as of June 30, 2025:

11. COLLABORATION AND LICENSE AGREEMENTS`

In April 2024, the Company entered into atwo-year collaboration agreement (the "J&J Collaboration Agreement"), with Johnson & Johnson through its wholly-owned subsidiary, Momenta Pharmaceuticals, Inc. (“J&J”) to facilitate the advancement of research into products to address unmet needs relating to FNAIT.

In April 2025, the Company announced that RLYB212 Phase 2 pharmacokinetic results did not achieve target concentrations, including the minimum target concentration required for efficacy, and that the Company would discontinue its RLYB212 program for the prevention of FNAIT. The Company will continue to follow any previously screened Phase 2 participant who was also eligible to enroll in the multinational FNAIT natural history study, in accordance with the study's protocol. A total of 14,300 pregnant women of different racial and ethnic characteristics in North America and Europe were screened in the FNAIT natural history study, and two are currently enrolled, including the participant from the Phase 2 trial.

Pursuant to the J&J Collaboration Agreement, the Company received an upfront payment of $0.5 million from J&J for the information dissemination and data provision services under the agreement. The J&J Collaboration Agreement provides that the Company is eligible for payments upon the achievement of certain screening-related events, however, the Company has discontinued screening and enrollment in both the FNAIT natural history study and the RLYB212 Phase 2 clinical trial.

The Company evaluated the agreement and determined it was within the scope of ASC 606, Revenue Recognition ("ASC 606"). The Company determined there were performance obligations as follows:

(1) Data collection and submission revenue – derived from Rallybio’s ongoing management of the studies including the maintenance of a minimum site footprint, the license to utilize, and timely, semi-annual submission of the anonymized data, in the required formats.

(2) Dissemination of J&J materials & participant revenue – derived from Rallybio’s dissemination of content, information or materials related to the J&J-Sponsored Studies that are developed by J&J and are provided by Rallybio for the purpose of disseminating such content, information, or materials to staff at Rallybio study sites to provide to potential eligible participants regarding J&J’s independent study.

In April 2024, the Company also entered into the JJDC Securities Purchase Agreement. Under the terms of the JJDC Securities Purchase Agreement, JJDC purchased 3,636,363 shares of the Company's common stock with a par value of $0.0001 per share for a share purchase price of $1.82 per share which included a 10% premium on the then-current market price, for an aggregate purchase price of $6.6 million. The JJDC Securities Purchase Agreement contains provisions related to the registration of the shares and the restriction on the sale or transfer of the shares for a period of time. The Company determined the J&J Collaboration Agreement and the JJDC Securities Purchase Agreement represented combined agreements. In accordance with ASC 606 and ASC Topic 820, Fair Value Measurement, total consideration of $1.2 million for the shares of common stock from the JJDC Securities Purchase Agreement, which represents the premium of $0.7 million and discount for lack of marketability of $0.5 million, has been allocated to revenue and will be recognized over thetwo year expected performance period.

The Company valued the common stock issued to JJDC, in connection with the JJDC Securities Purchase Agreement at fair value. The resulting fair value of $5.4 million was determined by applying the discount due to lack of marketability during the registration and lock-up period to the public trading price of the common stock, which is a Level 1 input, on the date of sale. The Company determined the value of the lack of marketability during the registration and lock-up period by utilizing put option models, which are considered Level 3 inputs. Such option models included the Company’s historical volatility of 113.2% and the risk-free rate of 5.28% based on U.S. Treasury bond rates, as key inputs.

The Company recognized revenue of $0.2 million and $0.4 million during the three and six months ended June 30, 2025, respectively, and $0.3 million for both the three and six months ended June 30, 2024, related to data collection and data submission with the identified performance obligations, and the premium and discount allocated to revenue from the sale of the common stock to JJDC. The remaining revenue is included in deferred revenue on the Company's condensed consolidated balance sheets as of June 30, 2025, and will be recognized as the performance obligations are satisfied.

The Company determined that the J&J Collaboration Agreement is not in the scope of ASC 808, Collaborative Arrangements.

12. SUBSEQUENT EVENTS

In July 2025, the Company announced that it had entered into a Membership Interest Purchase Agreement (the “ENPP1 Purchase Agreement”) with Recursion to sell our interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with hypophosphatasia. In connection with the sale, the Company received an upfront equity payment of $7.5 million. In addition, the Company is eligible to receive a contingent equity payment of $12.5 million upon the initiation of additional preclinical studies and a $5.0 million milestone cash payment in connection with the initiation of dosing in a Phase 1 clinical study, as defined in the ENPP1 Purchase Agreement. The Company is also eligible to receive low single-digit royalties on all future net sales by Recursion of products comprising or incorporating certain compounds developed by REV-I and may be eligible to receive certain payments in the event of Recursion’s sale of the REV102 program.

For further details prior to the JV Sale, please refer to Note 6.