Rallybio Corp
For the period ended Sep 30, 2026. Filed Oct 27, 2026.
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Sep 30, 2026 · Filed Oct 27, 2026
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Notes to Unaudited Condensed Consolidated Financial Statements
- 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. 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 2025, the Company completed a confirmatory pharmacokinetic ("PK") and pharmacodynamic ("PD") study of RLYB116 in healthy volunteers and reported data in the first quarter of 2026. 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 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 ("HPP"), to a subsidiary of its joint venture partner Recursion Pharmaceuticals, Inc. ("Recursion") (the "JV Sale").
On March 1, 2026, Rallybio entered into an Agreement and Plan of Merger and Reorganization with Candid Therapeutics, Inc. (“Candid”) (the “Candid Merger Agreement”) pursuant to which the parties intended to undertake a business combination (the “Candid Merger”).
On May 3, 2026, Candid terminated the Candid Merger Agreement concurrently with entering into a Permitted Alternative Agreement (as defined in the Candid Merger Agreement) with UCB S.A. As a result of the termination of the Candid Merger Agreement, Rallybio was paid on May 4, 2026 a $50.0 million Parent Termination Fee (as defined in the Candid Merger Agreement) and was reimbursed $0.4 million for certain expenses.
Following the termination of the Candid Merger Agreement, Rallybio restarted the evaluation of strategic alternatives. On May 31, 2026, Rallybio entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, pursuant to which, among other matters, Farmington Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of Rallybio (“Merger Sub”), will merge with and into Avenzo (the “Merger”) and Avenzo will survive the Merger as a wholly owned subsidiary of Rallybio. In connection with the Merger, Rallybio will change its name to Avenzo Therapeutics, Inc. (together with its subsidiaries following the Merger, the “combined company”). The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes. The Merger will become effective at the time the Certificate of Merger has been duly filed with the Secretary of State of the State of Delaware or such other date and time as is agreed upon by Rallybio and Avenzo and specified in the Certificate of Merger (such date, the “Closing Date,” and such time, the “Effective Time”).
In connection with the Merger, Avenzo entered into a subscription agreement (the “Subscription Agreement”) with certain investors, pursuant to which Avenzo has agreed to sell, and such investors have agreed to purchase, shares of Avenzo common stock for an aggregate purchase price of $215.0 million, immediately prior to the Effective Time (such transaction, the “Concurrent Financing”). The closing of the Concurrent Financing is conditioned upon the satisfaction or waiver of each of the conditions to the closing of the Merger (the “Closing”) as well as certain other conditions.
Subject to the terms and conditions of the Merger Agreement, at the Effective Time, (a) each then-outstanding share of common stock or preferred stock of Avenzo (each such share, an “Avenzo Share”) (excluding any share described in clauses (b) or (c) below and Avenzo Shares held by stockholders who have exercised and perfected appraisal rights for such shares) will be converted into the right to receive a number of shares of Rallybio common stock, calculated in accordance with the Exchange Ratio as defined in the Merger Agreement, (b) each Avenzo Share issued in the Concurrent Financing will be converted into the right to receive a number of shares of Rallybio common stock calculated in accordance with the Merger Agreement, (c) any Avenzo Shares held as treasury shares or held or owned by Rallybio, Merger Sub or any subsidiary of Rallybio or Avenzo immediately prior to the Effective Time will be canceled and shall cease to exist, and no consideration shall be delivered in exchange therefor. Each then-outstanding option to purchase Avenzo Shares will be converted into an option to purchase Rallybio Common Stock, subject to adjustment as set forth in the Merger Agreement.
Under the Exchange Ratio formula in the Merger Agreement, upon the Closing, on a pro forma basis and based upon the number of shares of Rallybio common stock expected to be issued in connection with the Merger and the Concurrent Financing, pre-Merger equityholders of Avenzo (other than investors in the Concurrent Financing) are expected to own approximately 56.6% of the combined company, pre-Merger equityholders of Rallybio will own approximately 2.8% of the combined company and the investors in the Concurrent Financing are expected to own approximately 40.6% (assuming gross proceeds from the Concurrent Financing of $215.0 million), in each case, calculated on a fully diluted basis, using the treasury stock method, and subject to certain assumptions, including (i) a valuation for Rallybio of $15.0 million (calculated after giving effect to the expected payment of the distribution of Rallybio's pre closing cash), (ii) a valuation for Avenzo of $300.0 million, and (iii) the relative capitalization of Rallybio and Avenzo. The percentage of the combined company that each party’s equityholders will own following the Closing is subject to certain adjustments as described in the Merger Agreement, including the amount of the final Rallybio Net Cash (as defined in the Merger Agreement) at Closing. At any time prior to the Closing, Rallybio will declare distributions of Rallybio Net Cash to holders of Rallybio common stock and, if applicable, securities convertible into or exchangeable or exercisable for shares of Rallybio common stock outstanding as of the applicable record date, subject to the terms of the Merger Agreement.
One business day following the Closing Date, the combined company and Computershare Trust Company, N.A. (the “Rights Agent”) are expected to enter into a Contingent Value Rights Agreement (the “Rallybio CVR Agreement”), pursuant to which holders of record of certain Rallybio securities as of the close of business on the last business day prior to the day on which the Effective Time occurs will receive one contingent value right (each, a “Rallybio CVR”) for each outstanding share of Rallybio common stock, pre-funded warrant, Rallybio restricted stock unit or In the Money Parent Option (as defined in the Merger Agreement) held as of such date. Pursuant to the Rallybio CVR Agreement, each Rallybio CVR holder will be entitled to receive their pro rata share of all of the net proceeds (including cash or the value of stock to the extent listed on a national exchange, at the time of disposition), if any, received by Rallybio as a result of payments (“Rallybio CVR Payments”) made to Rallybio of (i) any upfront, milestone, royalty and other payments received under any disposition agreement related to Rallybio’s pre-Merger assets (the “Legacy Assets”), and (ii) all of the cash proceeds, if any, received from Recursion under the Membership Interest Purchase Agreement, dated July 8, 2025, by and among Recursion, Exscientia Ventures I, Inc., Rallybio and Rallybio IPB, LLC. For a period of four months after the Closing Date, the combined company will use commercially reasonable efforts to effect the disposition of the Legacy Assets with respect to a third party that Rallybio had been in discussions with regarding a disposition prior to the Closing Date, subject to certain limitations. Such net proceeds will be subject to certain permitted deductions, including for applicable tax payments, certain expenses incurred or other liabilities borne by Rallybio or its affiliates in respect of the Legacy Assets, and losses incurred by Rallybio or its affiliates due to a third-party proceeding in connection with such disposition.
The Company had cash and cash equivalents of $90.7 million as of September 30, 2026. The Company currently expects that its cash and cash equivalents 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 although we anticipate that the Merger will close prior to the end of 2026. The Company does not anticipate that its current cash and cash equivalents as of September 30, 2026 will be sufficient to fund any of its product candidates through regulatory approval, and if the Company continues to progress the development of its product candidates, it will need to raise substantial additional capital to complete the development and commercialization of those product candidates, if approved. If necessary, Rallybio may satisfy any 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.
- 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 ("ASU") promulgated by the Financial Accounting Standards Board ("FASB").
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, 2025 (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 nine months ended September 30, 2026, unless otherwise noted below, which could be expected to materially impact the Company's unaudited condensed consolidated financial statements.
Significant Accounting Policies —
Future Milestone and Royalty Assets
As part of the JV Sale, the Company received consideration including an estimated $3.0 million in future contingent milestones and royalty payments, which are recognized as a contingent consideration asset on the condensed consolidated balance sheets. The fair value of this contingent consideration was determined using a model that incorporates significant unobservable inputs based on Company estimates, external data, and management’s judgment and forecasts. Key assumptions in the model include the discount rate, the timing of expected cash flows, the probability of achieving the milestone and royalty payments, and projected future net revenues.
The Company periodically reviews the carrying value of the contingent consideration when impairment indicators arise and records an impairment loss if the carrying amount materially exceeds the reassessed fair value. Increases in the carrying value are recognized only when contingent gains are realized. Since the contingent payments are tied to Phase 1 clinical study milestones and future royalty payments, the Company believes the likelihood of timely payment by Recursion is uncertain.
Income Taxes
The Company’s effective tax rates for the nine months ended September 30, 2026 and 2025 were 7.5% and 0%, respectively. The primary drivers of the variance from the statutory rate were state taxes, Section 162 disallowed compensation, nondeductible stock-based compensation, and valuation allowance. The Company will continue to assess its estimated annual effective tax rate each reporting period.
In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the period in which those temporary differences become deductible. Management considers the Company’s history of cumulative net losses, the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. The Company has determined that, based on objective positive and negative evidence currently available, it is more likely than not that the Company will not realize the benefits of all deferred tax assets. Accordingly, the Company has provided a full valuation allowance for the deferred tax assets. The Company is expecting to have net taxable income for the current year, resulting in current income tax expense for the period. This is primarily due to income resulting from the termination of the Candid Merger Agreement and the termination fee recorded.
As of September 30, 2026, the Company has federal and state post-apportioned net operating loss (“NOL”) carryforwards of approximately $185.8 million and $168.9 million, respectively. All federal NOL carryforwards have an indefinite carryforward period. All state NOL carryforwards have a limited carryforward period and will begin to expire in 2038. As of September 30, 2026, the Company has federal general business tax credits of approximately $24.8 million which have a limited carryforward period and will begin to expire in 2039.
Utilization of the NOL carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 (the "Code"), and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period.
The Company completed a Section 382 study through June 30, 2021 and concluded that it underwent an ownership change as defined by the Code on March 27, 2020. The Company completed a high-level analysis for the period July 1, 2021 through September 30, 2026 and does not believe any additional ownership changes occurred during that period. Any future ownership changes that may occur after June 30, 2026, may limit the Company’s ability to utilize remaining tax attributes. Due to the existence of the valuation allowance, limitations created by the 2020 ownership change and any potential future ownership changes will not impact the Company’s effective tax rate.
Recently Issued Accounting Pronouncements—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.
- 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, 2026 and December 31, 2025 was as follows:
| (in thousands) | Fair Value Hierarchy Level | Amortized Cost | Gross Unrealized Holding Gains | Gross Unrealized Holding Losses | Fair Value |
|---|---|---|---|---|---|
| Cash and cash equivalents | Level 1 | $88,044 | $— | $— | $88,044 |
| $88,044 | $— | $— | $88,044 | ||
| (in thousands) | Fair Value Hierarchy Level | Amortized Cost | Gross Unrealized Holding Gains | Gross Unrealized Holding Losses | Fair Value |
|---|---|---|---|---|---|
| Cash and cash equivalents | Level 1 | $6,695 | $— | $— | $6,695 |
| U.S. treasury securities | Level 1 | 19,212 | 17 | — | 19,229 |
| U.S. government agency securities | Level 2 | 4,630 | 1 | — | 4,631 |
| $30,537 | $18 | $— | $30,555 | ||
The fair values of marketable securities by classification in the condensed consolidated balance sheets as of September 30, 2026 and December 31, 2025 was as follows:
| (in thousands) | SEPTEMBER 30, 2026 | DECEMBER 31, 2025 |
|---|---|---|
| Cash and cash equivalents | $88,044 | $7,193 |
| Marketable securities | — | 23,362 |
| $88,044 | $30,555 |
The fair values of available-for-sale debt securities as of September 30, 2026 and December 31, 2025, by contractual maturity, are summarized as follows:
| (in thousands) | SEPTEMBER 30, 2026 | DECEMBER 31, 2025 |
|---|---|---|
| Due in one year or less | $88,044 | $30,555 |
| $88,044 | $30,555 |
The aggregate fair value of available-for-sale debt securities in an unrealized loss position as of December 31, 2025 was $0.7 million. There wasno aggregate fair value of available-for-sale debt securities in an unrealized loss position as of September 30, 2026. As of September 30, 2026, the Company didnot have any investments in a continuous unrealized loss position for more than twelve months. No allowance for credit loss was recorded as of September 30, 2026 and December 31, 2025.
- BALANCE SHEET COMPONENTS
Prepaid expenses and other current assets —
Prepaid expenses and other current assets consisted of the following as of September 30, 2026 and December 31, 2025:
| (in thousands) | SEPTEMBER 30, 2026 | DECEMBER 31, 2025 |
|---|---|---|
| Research and development | $257 | $3,372 |
| Insurance | 593 | 409 |
| Other prepaids | 762 | 219 |
| Other current assets | 2,464 | 2,517 |
| $4,076 | $6,517 |
Other current assets consists of approximately $2.2 million related to a contingent payment receivable tied to a Phase 1 clinical study milestone in connection with the JV Sale, and approximately $0.3 million of interest income and other current assets.
Accrued expenses and other current liabilities —
Accrued expenses and other current liabilities consisted of the following as of September 30, 2026 and December 31, 2025:
| (in thousands) | SEPTEMBER 30, 2026 | DECEMBER 31, 2025 |
|---|---|---|
| Compensation and related expenses | $1,173 | $2,334 |
| Professional fees | 364 | 1,039 |
| Research and development | — | 394 |
| Other current liabilities | 390 | 24 |
| $1,927 | $3,791 |
- STOCKHOLDERS' EQUITY
Common Stock
The Company had 200,000,000 shares of common stock authorized as of September 30, 2026 and December 31, 2025, of which 5,333,190 and 5,283,321 shares were issued and outstanding as of September 30, 2026 and December 31, 2025, respectively.
Preferred Stock
The Company had 50,000,000 shares of preferred stock authorized as of September 30, 2026 and December 31, 2025, of whichno shares were issued or outstanding as of September 30, 2026 and December 31, 2025.
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 416,673 shares of common stock at a price of $47.9992, which represents the per share public offering price of the November 2022 follow-on offering for common stock less a $0.0008 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("ASC 480"), and does not meet the definition of a derivative pursuant to ASC 815, Derivatives and Hedging("ASC 815"). 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 the November 2022 follow-on offering remain outstanding and unexercised as of September 30, 2026.
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) income for the three and nine months ended September 30, 2026 and 2025 was as follows:
| FOR THE THREE MONTHS ENDED SEPTEMBER 30, | FOR THE NINE MONTHS ENDED SEPTEMBER 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Research and development | $45 | $500 | $264 | $1,928 |
| General and administrative | 360 | 547 | 1,178 | 2,612 |
| $405 | $1,047 | $1,442 | $4,540 | |
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 680,043 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, 2026 and January 1, 2025, the 2021 Plan share pool was automatically increased by 264,166 and 259,438 shares, respectively. As of September 30, 2026, the total number of shares of the Company's common stock that were issuable under the 2021 Plan was 1,474,672 shares, of which 846,367 shares remained available for future issuance.
The following table summarizes stock option activity for the nine months ended September 30, 2026:
| Stock Options | Number of Option Shares | Weighted-Average Exercise Price | Weighted-Average Contractual Term (in years) | Aggregate Intrinsic Value(in thousands) |
|---|---|---|---|---|
| Outstanding stock options at December 31, 2025 | 628,280 | $43.42 | 7.6 | $89 |
| Granted | 32,360 | $4.45 | ||
| Forfeited | (11,404) | $15.70 | ||
| Expired | (13,317) | $93.52 | ||
| Exercised | (38,298) | $6.30 | ||
| Outstanding stock options at September 30, 2026 | 597,621 | $43.10 | 2.9 | $2,438 |
| Exercisable stock options at September 30, 2026 | 456,886 | $52.10 | 2.4 | $1,361 |
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 September 30, 2026 had an intrinsic value of approximately $2.4 million. Stock options outstanding and exercisable with an exercise price below the closing price as of September 30, 2026 had an intrinsic value of $1.4 million. These values are based on a common stock fair value of $17.20 per share, which was the closing price of the Company's common stock on September 30, 2026. Using the Black-Scholes option pricing model, the weighted-average grant date fair value of stock options granted during the nine months ended September 30, 2026 and 2025 was $3.60 per share and $4.96 per share, respectively. As of September 30, 2026, there was unrecognized share-based compensation expense related to nonvested stock options of $1.4 million, which the Company expects to recognize over a weighted-average period of approximately 1.6 years. As of September 30, 2026, in connection with the proposed Merger, all nonvested stock options are expected to vest and the remaining expense will be recognized before the Closing Date.
The fair value of the stock options granted during the nine months ended September 30, 2026 and 2025 was determined using the Black-Scholes option pricing model with the following assumptions:
| FOR THE NINE MONTHS ENDED SEPTEMBER 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Expected volatility | 109.21% | 91.88% - 119.61% |
| Expected term (years) | 5.25 | 5.27 - 6.02 |
| Risk free interest rate | 3.68% | 4.03% - 4.39% |
| Expected dividend yield | — | — |
| Exercise price | $4.45 | $2.40 - $7.60 |
A summary of the status of the Company's nonvested restricted common stock units at September 30, 2026 and changes during the nine months ended September 30, 2026 was as follows:
| Restricted Stock Units | Shares | Weighted-Average Grant Date Fair Value Per Share |
|---|---|---|
| Nonvested restricted stock units at December 31, 2025 | 38,603 | $9.60 |
| Granted | 5,000 | $4.45 |
| Forfeited | (4,150) | $2.40 |
| Vested | (8,769) | $9.38 |
| Nonvested restricted stock units at September 30, 2026 | 30,684 | $9.79 |
As of September 30, 2026, there was unrecognized share-based compensation expense related to nonvested restricted stock units of $0.2 million, which the Company expects to recognize over a weighted-average period of approximately 1.6 years. As of September 30, 2026, in connection with the proposed Merger, all nonvested restricted stock units are expected to vest and the remaining expense will be recognized before the Closing Date.
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 36,415 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)72,831 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, 2026 or January 1, 2025. As of September 30, 2026, the total number of shares of the Company's common stock available for future issuance under the 2021 ESPP was 91,479 shares. During the nine months ended September 30, 2026 and 2025, the Company issued 2,802 and 4,375, respectively, of the Company's common stock under the 2021 ESPP.
The 2021 ESPP allows eligible participants to purchase shares of the Company's 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 the Company's common stock on the first day of an offering or on the date of the purchase.
- INVESTMENT IN JOINT VENTURE
In July 2025, the Company entered into a Membership Interest Purchase Agreement (the "ENPP1 Purchase Agreement") to sell its interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with HPP, to Recursion Exscientia Ventures I, Inc, an indirect wholly-owned subsidiary of Recursion ("Buyer"). In connection with the JV Sale, the Company received compensation in the form of Recursion common stock (which is a non-cash investing activity). The Company subsequently sold the Recursion common stock for cash proceeds of $20.0 million in the third quarter of 2025 which included $7.5 million from an upfront payment and $12.5 million from a milestone payment related to the initiation of additional preclinical studies. The Company is eligible to receive 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 and low single-digit royalties on all future net sales by Recursion of products comprising or incorporating certain compounds developed by RE Ventures I, LLC, a limited liability company (“REV-I”). The Company may also be eligible to receive certain payments in the event of Recursion’s sale of the REV102 program.
The Company evaluated the JV Sale under ASC 860, Transfers and Servicing of Financial Assets(“ASC 860”). Based on the Company’s evaluation of the JV Sale under ASC 860, the Company recognized a gain from the sale of its equity interests in REV102 of $22.4 million, based on the excess of the total net consideration allocated to the sale of the Company’s equity interests (based on relative fair value) of $23.0 million over the carrying value of the equity interests sold of $0.6 million. The total net consideration of $23.0 million included cash received of $20.0 million, plus an estimated $3.0 million representing the fair value of the future milestone payments and future royalties (which is a non-cash investing activity).
The contingent consideration was initially measured at fair value using a probability based present value model of the risk-adjusted estimated cash flows, with a discount rate of 15.4%. This valuation model relied on significant unobservable inputs (level 3 inputs) based on management’s estimates, which were informed by external data, judgment, and forecasts. Key assumptions included the probability of achieving the milestone and royalties, timing of cash flows, discount rate, and forecasted net revenues. The fair value of the contingent consideration is a non-recurring fair value measurement and is recorded as other assets and other assets, non-current on the Company's condensed consolidated balance sheets and as gain on sale of joint venture and other income (expense) within the Company's condensed consolidated statements of operations and comprehensive (loss) income.
Prior to the JV Sale, the Company, through one of its wholly-owned subsidiaries, had a 50% interest of the joint venture entity, REV-I. For the three and nine months ended September 30, 2026 and the three months ended September 30, 2025, the Company didnot fund REV-I due to the JV Sale. For the nine months ended September 30, 2025, 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 nine months ended September 30, 2026 and 2025. 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 included in other income on the condensed consolidated statements of operations and comprehensive (loss) income. For the three and nine months ended September 30, 2026 and the three months ended September 30, 2025, the Company didnot provide such support due to the JV Sale. For the nine months ended September 30, 2025, the Company provided $0.3 million related to such support. Prior to the JV Sale, the Company held a 50% interest in the joint venture and 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 both the three and nine months ended September 30, 2026 and the three months ended September 30, 2025, the Company didnot have an allocable share of REV-I losses due to the JV Sale. For the nine months ended September 30, 2025, the Company recorded its allocable share of REV-I's losses which totaled $0.9 million. These losses were recorded as a loss on investment in joint venture within the condensed consolidated statements of operations and comprehensive (loss) income. As of September 30, 2026 and December 31, 2025 there wasno carrying value remaining of the REV-I investment due to the JV Sale in July 2025.
- 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 the Company 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, 2026 and December 31, 2025, there wereno amounts accrued related to termination charges.
- NET (LOSS) INCOME PER COMMON SHARE
Basic and diluted net (loss) income per common share for the three and nine months ended September 30, 2026 and 2025 was calculated as follows:
| FOR THE THREE MONTHS ENDED SEPTEMBER 30, · FOR THE NINE MONTHS ENDED SEPTEMBER 30, | ||||||
|---|---|---|---|---|---|---|
| (in thousands except share and per share amounts) · 2026 · 2025 · 2026 · 2025 | ||||||
| Net (loss) income | $(2,725) | $16,016 | $32,662 | $(3,126) | ||
| Weighted-average number of common shares outstanding, basic | 5,715,048 | 5,632,291 | 5,701,011 | 5,611,536 | ||
| Effect of potentially dilutive securities: | ||||||
| Stock options | 70,245 | |||||
| Restricted stock units | 17,496 | |||||
| Weighted-average number of common shares outstanding, diluted | 5,715,048 | 5,632,291 | 5,788,752 | 5,611,536 | ||
| Net (loss) income per common share, basic | $(0.48) | $2.84 | $5.73 | $(0.56) | ||
| Net (loss) income per common share, diluted | $(0.48) | $2.84 | $5.64 | $(0.56) | ||
Basic net (loss) income 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 416,673 shares of common stock that were issued in connection with the November 2022 follow-on offering are included in the weighted-average number of common shares outstanding for the three and nine months ended September 30, 2026 and 2025. The weighted-average number of common shares outstanding diluted for the three and nine months ended September 30, 2026 and 2025 excluded approximately 0.4 million and 0.8 million stock options and nonvested restricted stock awards and units, respectively, which were not dilutive.
- 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 and Chief Financial Officer. The Company manages its operations as a single operating and reportable segment and the measure of segment profit or loss is net 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) income for the three and nine months ended September 30, 2026 and 2025:
| FOR THE THREE MONTHS ENDED SEPTEMBER 30, | FOR THE NINE MONTHS ENDED SEPTEMBER 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Revenue | $— | $212 | $212 | $636 |
| Less: | ||||
| Research and development: | ||||
| RLYB212 | 123 | 1,213 | 131 | 5,028 |
| RLYB116 | 215 | 1,014 | 1,136 | 2,907 |
| Other program candidates | — | 39 | 7 | (29) |
| Personnel expenses (including share-based compensation) | 212 | 1,707 | 2,672 | 7,457 |
| Other expenses | 34 | 170 | 267 | 579 |
| General and administrative, excluding personnel expenses | 1,765 | 1,440 | 9,714 | 4,437 |
| General and administrative, personnel expenses (including share-based compensation) | 1,074 | 1,554 | 4,094 | 6,909 |
| Other segment items* | (698) | (22,941) | (50,471) | (23,526) |
| Segment net (loss) income | $(2,725) | $16,016 | $32,662 | $(3,126) |
*Other segment items include total other income, net, inclusive of the $50 million termination fee related to the Candid Merger Agreement, income tax expense, and loss on investment in joint venture.
- RESTRUCTURING AND SEVERANCE
In connection with entering into the Candid Merger Agreement in the first quarter of 2026, the Company incurred severance charges of approximately $2.3 million of which $1.6 million was included in research and development expenses and $0.7 million was included in general and administrative expenses, with such amounts reflected in the condensed consolidated statements of operations and comprehensive (loss) income. The charges related to the Merger Agreement were cash-based expenditures related primarily to severance and benefit payments. The Company recognized all such charges during the first quarter of 2026, with such amounts reflected in the condensed consolidated statements of operations and comprehensive (loss) income. The accrued severance liability is included in accrued expenses in the condensed consolidated balance sheets as of September 30, 2026.
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) income. 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) income.
All restructuring and severance payments related to the Candid Merger Agreement are expected to be paid within the next 12 months.
The following table summarizes the restructuring and severance accrual activity as of September 30, 2026:
| (in thousands) | SEPTEMBER 30, 2026 |
|---|---|
| Beginning accrued severance as of January 1, 2026 | $523 |
| Severance incurred during the period | 2,302 |
| Severance paid and adjustments made during the period | (1,988) |
| Ending accrued severance as of September 30, 2026 | $837 |
- COLLABORATION AND LICENSE AGREEMENTS`
In April 2024, the Company entered into atwo-year collaboration agreement (the "J&J Collaboration Agreement"), with Johnson & Johnson ("J&J") through its wholly-owned subsidiary, Momenta Pharmaceuticals, Inc. 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 PK 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.
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 a securities purchase agreement ("JJDC Securities Purchase Agreement") with Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”). Under the terms of the JJDC Securities Purchase Agreement, JJDC purchased 454,545 shares of the Company's common stock with a par value of $0.0001 per share for a share purchase price of $14.56 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 was 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 recognizedno revenue during the three months ended September 30, 2026 and recognized revenue of $0.2 million during the nine months ended September 30, 2026. During the three and nine months ended September 30, 2025 the Company recognized $0.2 million and $0.6 million, respectively, 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. As of September 30, 2026, all revenue was recognized due to the performance obligations being satisfied. On April 9, 2026, the J&J Collaboration Agreement terminated upon completion of the initial term of the agreement.
The Company determined that the J&J Collaboration Agreement is not in the scope of ASC 808, Collaborative Arrangements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.