Rallybio Corp

Previous wording

We are 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 our launch in January 2018, we have built a pipeline of promising product candidates aimed at addressing diseases with unmet medical need in the areas of complement dysregulation and hematology. Our 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, we initiated a confirmatory pharmacokinetic ("PK") and pharmacodynamic ("PD") study of RLYB116 in healthy volunteers and expect to report data in the third and fourth quarters of 2025. In April 2025, we announced the discontinuation of our 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, we announced that we had entered into a Membership Interest Purchase Agreement (the “ENPP1 Purchase Agreement”) with Recursion Pharmaceutical, Inc. (“Recursion”) Exscientia Ventures I, Inc., an indirect wholly-owned subsidiary of Recursion (“Buyer”) and Rallybio IPB, LLC, a wholly-owned subsidiary of Rallybio Corporation to sell our interest in REV102, an Ectonucleotide Pyrophosphatase/ Phosphodiesterase 1 ("ENPP1") inhibitor in preclinical development for the treatment of patients with hypophosphatasia ("HPP"), to Buyer (a subsidiary of our joint venture partner Recursion). In connection with the sale, we received an upfront equity payment of $7.5 million and are also 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. We are also eligible to receive low single-digit royalties on all future net sales by Recursion of products comprising or incorporating certain compounds developed by RE Ventures I, LLC ("REV-I") and may be eligible to receive certain payments in the event of Recursion’s sale of the REV102 program.

Current wording

We are 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. Our 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, we initiated a confirmatory pharmacokinetic ("PK") and pharmacodynamic ("PD") study of RLYB116 in healthy volunteers and expects to report data in the fourth quarter of 2025. In April 2025, we announced the discontinuation of our 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, we entered into a Membership Interest Purchase Agreement (the “ENPP1 Purchase Agreement”) with Recursion Pharmaceuticals, Inc. (“Recursion”) Exscientia Ventures I, Inc., an indirect wholly-owned subsidiary of Recursion (“Buyer”) and Rallybio IPB, LLC, a wholly-owned subsidiary of Rallybio Corporation to sell our interest in REV102, an Ectonucleotide Pyrophosphatase/ Phosphodiesterase 1 ("ENPP1") inhibitor in preclinical development for the treatment of patients with hypophosphatasia ("HPP"), to Buyer (a subsidiary of our joint venture partner Recursion) (the "JV Sale"). In connection with the JV Sale, we received a total of $20.0 million in the third quarter of 2025 including $7.5 million from an upfront payment and $12.5 million from a milestone payment related to the initiation of additional preclinical studies. We are eligible to receive a $5.0 million milestone 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 ("REV-I"). We may also be eligible to receive certain payments in the event of Recursion’s sale of the REV102 program.

Previous wording

RLYB116 is a novel, potentially long-acting, subcutaneously injected inhibitor of C5 in development for the treatment of patients with complement-related diseases. We intend to initially focus on two hematologic conditions with significant unmet need including: immune platelet transfusion refractoriness ("PTR") and refractory antiphospholipid syndrome ("APS"). Patients suffering from these potentially life-threatening conditions have no approved or effective therapeutic options.

Current wording

RLYB116 is a novel, potentially long-acting, subcutaneously injected inhibitor of C5 in development for the treatment of patients with complement-related diseases. We intend to initially focus on two hematologic conditions with significant unmet need including: immune platelet transfusion refractoriness ("PTR") and refractory antiphospholipid syndrome ("APS"). Patients suffering from these potentially life-threatening conditions have no approved or effective therapeutic options and together these indications represent a combined market opportunity of $5 billion. Based on the literature, which includes data from investigator initiated trials, we believe C5 inhibition could play an important role in the treatment of both of these conditions.

Previous wording

125 mg weekly dosing) and Cohort 4 (75 mg twice the first week followed by 100 mg twice per week) with post-treatment / study follow-up for 10 weeks. In December 2023, we reported data from the MAD portion of the study that demonstrated a 100 mg low volume (1 mL) once-a-week dose of subcutaneously administered RLYB116 achieved sustained mean reductions in free C5 of greater than 93%, including at Day 29 with measurement prior to the last dose. The reduction from pre-treatment free C5 at 24 hours after the first dose of 100 mg was greater than 99%. RLYB116 administered in the MAD portion of the study as a 100 mg once-a-week dose was also observed to be generally well tolerated.

Current wording

The MAD portion of the RLYB116 Phase 1 study included an adaptive single-blind design with a 4-week treatment duration to evaluate the safety, tolerability, PK, and PD of RLYB116 with multiple dose SC administration. The MAD portion of the study included four cohorts: Cohort 1 (weekly dosing of 100 mg), Cohort 2 (three doses of 100 mg the first week followed by weekly dosing), Cohort 3 (150 mg weekly dosing reduced to 125 mg weekly dosing) and Cohort 4 (75 mg twice the first week followed by 100 mg twice per week) with post-treatment / study follow-up for 10 weeks. In December 2023, we reported data from the MAD portion of the study that demonstrated a 100 mg low volume (1 mL) once-a-week dose of subcutaneously administered RLYB116 achieved sustained mean reductions in free C5 of greater than 93%, including at Day 29 with measurement prior to the last dose. The reduction from pre-treatment free C5 at 24 hours after the first dose of 100 mg was greater than 99%. RLYB116 administered in the MAD portion of the study as a 100 mg once-a-week dose was also observed to be generally well tolerated.

Previous wording

Based on the results of the RLYB116 Phase 1 trial, we conducted a series of biomarker characterization analyses. These analyses indicate the RLYB116 assay used to measure free C5 in the Phase 1 trial overestimated the levels of free C5 by approximately ten-fold, indicating that RLYB116 produced greater complement inhibition than initially reported. We now believe that RLYB116 has the potential to be an effective treatment for patients with a variety of complement-mediated diseases, including APS and PTR. We also completed manufacturing process enhancements with a goal of further improving the tolerability of RLYB116. Based on the results of enhanced analytical techniques, including mass spectrometry, these process enhancements have successfully further purified the RLYB116 drug substance. As a result, we believe that RLYB116 will have a favorable tolerability profile at doses at and above those evaluated in the Phase 1 MAD trial.

Current wording

Based on the results of the RLYB116 Phase 1 trial, we conducted a series of biomarker characterization analyses. These analyses indicate the RLYB116 assay used to measure free C5 in the Phase 1 trial overestimated the levels of free C5 by approximately ten-fold, indicating that RLYB116 produced greater complement inhibition than initially reported. We now believe that RLYB116 has the potential to be an effective treatment for patients with a variety of complement-mediated diseases, including APS and PTR. We also completed manufacturing process enhancements with a goal of further improving the tolerability of RLYB116. Based on the results of enhanced analytical techniques, including mass spectrometry, these process enhancements have successfully further purified the RLYB116 drug substance.

Previous wording

We initiated a RLYB116 confirmatory clinical PK/PD trial in the second quarter of 2025, which is designed to demonstrate improved tolerability as well as complete and sustained complement inhibition. This single-blind MAD trial will evaluate a 4-week treatment duration that includes two cohorts of eight participants each. Our current plan is that Cohort 1 will evaluate weekly dosing of 150 mg and Cohort 2 will evaluate weekly dosing of 225 mg with 10 weeks of follow-up after the conclusion of treatment.

Current wording

We initiated a RLYB116 confirmatory clinical PK/PD trial in the second quarter of 2025, which is designed to demonstrate improved tolerability as well as complete and sustained complement inhibition. This single-blind MAD trial will evaluate a 4-week treatment duration and 10 weeks of post-treatment follow-up that includes two cohorts of eight participants each. We have completed the dosing of Cohort 1 (150 mg weekly dosing) and the PK/PD profile is consistent with our predictions based on the previous Phase 1 study. More importantly, we have observed a significantly cleaner safety profile and believe the improved tolerability is due to the manufacturing enhancements we implemented. We have initiated dosing for Cohort 2 (300 mg weekly dosing) and anticipate reporting top-line data from this trial in the fourth quarter of 2025.

Previous wording

In April 2025, the Company announced the discontinuation of its FNAIT program and its RLYB212 Phase 2 dose confirmation trial. The single-arm Phase 2 dose confirmation trial was designed to assess the PK and safety of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT. Secondary objectives included the assessment of pregnancy and neonatal/infant outcomes, and the occurrence of emergent HPA-1a alloimmunization. Second trimester PK results from the sentinel participant demonstrated an inability of RLYB212 to achieve predicted target concentrations of 6 ng/mL to 10 ng/mL, as well as the minimum target concentration required for efficacy of 3 ng/mL, with values near or below the assay’s lower limit of quantitation. Dose adjustment is not deemed feasible given that PK levels are meaningfully outside the predicted range and the absence of empiric data to inform an adjustment. No further enrollment in the trial is planned and screening of participants has been stopped. The Company will continue safety follow-up of the sentinel participant as specified in the trial's protocol.

Current wording

In April 2025, we announced the discontinuation of its FNAIT program and its RLYB212 Phase 2 dose confirmation trial. The single-arm Phase 2 dose confirmation trial was designed to assess the PK and safety of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT. Secondary objectives included the assessment of pregnancy and neonatal/infant outcomes, and the occurrence of emergent HPA-1a alloimmunization. Second trimester PK results from the sentinel participant demonstrated an inability of RLYB212 to achieve predicted target concentrations of 6 ng/mL to 10 ng/mL, as well as the minimum target concentration required for efficacy of 3 ng/mL, with values near or below the assay’s lower limit of quantitation. Dose adjustment is not deemed feasible given that PK levels are meaningfully outside the predicted range and the absence of empiric data to inform an adjustment. No further enrollment in the trial is planned and screening of participants has been stopped. We will continue safety follow-up of the sentinel participant as specified in the trial's protocol.

Previous wording

Although we are no longer screening patients in the prospective, non-interventional, multinational natural history study, we continue the required follow-up activities in accordance with the study's protocol. This study was designed to screen expectant mothers presenting at gestational week 10 to 14 prenatal visit to determine the frequency of women at higher FNAIT risk among expectant mothers of different racial and ethnic characteristics, as well as the frequency of HPA-1a alloimmunization and pregnancy outcomes among these women. At the time screening concluded, more than 14,300 pregnant women had been screened in this study.

Current wording

Although we are no longer screening patients in the prospective, non-interventional, multinational natural history study, we continue the required follow-up activities in accordance with the study's protocol.

Previous wording

In April 2024, we entered into a securities purchase agreement (the "JJDC Securities Purchase Agreement") with Johnson & Johnson Innovation – JJDC, Inc. ("JJDC"), pursuant to which we sold to JJDC, in an unregistered offering, 3,636,363 shares of our 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. We agreed, among other things, to file with the Securities and Exchange Commission (the "SEC") a registration statement covering the resale of the shares, which we filed on May 10, 2024.

Current wording

In April 2024, we entered into a securities purchase agreement (the "JJDC Securities Purchase Agreement") with Johnson & Johnson Innovation – JJDC, Inc. ("JJDC"), pursuant to which we sold to JJDC, in an unregistered offering, 3,636,363 shares of our common stock at a price of $1.82 per share, which represented a 10% premium on our closing stock price on April 9, 2024, for aggregate gross proceeds of approximately $6.6 million, before deducting offering expenses. We agreed, among other things, to file with the Securities and Exchange Commission (the "SEC") a registration statement covering the resale of the shares, which we filed on May 10, 2024.

Previous wording

In July 2025, we announced that we had entered into the ENPP1 Purchase Agreement to sell our interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with HPP, to Buyer (a subsidiary of our joint venture partner Recursion). In connection with the sale, we received an upfront equity payment of $7.5 million. In addition, we are 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. We are 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.

Current wording

In July 2025, we announced that we had entered into the ENPP1 Purchase Agreement to sell our interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with HPP, to Buyer (a subsidiary of our joint venture partner Recursion). In connection with the JV Sale, we received a total of $20.0 million in the third quarter of 2025 including $7.5 million from an upfront payment and $12.5 million from a milestone payment related to the initiation of additional preclinical studies. We are 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 REV-I. We may also be eligible to receive certain payments in the event of Recursion’s sale of the REV102 program.

Previous wording

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $45.7 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the middle of 2027. This estimate and our expectation to advance the preclinical and clinical development of RLYB116 and any other product candidates are based on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect, or our clinical trials may be more expensive, time consuming or difficult to design or implement than we currently anticipate. See “—Liquidity and Capital Resources.”

Current wording

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $59.3 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through 2027. This estimate and our expectation to advance the preclinical and clinical development of RLYB116 and any other product candidates are based on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect, or our clinical trials may be more expensive, time consuming or difficult to design or implement than we currently anticipate. See “—Liquidity and Capital Resources.”

Previous wording

We have incurred significant operating losses since inception, including net losses of $9.7 million and $19.1 million for the three and six months ended June 30, 2025, respectively and $16.2 million and $35.3 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $312.2 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We have not commercialized any products and have never generated revenue from the commercialization of any product. We expect to incur significant additional operating losses in the foreseeable future as we advance our programs through preclinical and clinical development, expand our research and development activities, acquire and develop new product candidates, complete preclinical studies and clinical trials, finance our business development strategy, seek regulatory approval for the commercialization of our product candidates and commercialize our products, if approved. Our expenses will increase substantially over time if and as we:

Current wording

We have incurred significant operating losses since inception, including net losses of $11.5 million and $46.7 million for the three and nine months ended September 30, 2024, respectively. In connection with the JV Sale, we received a total of $20.0 million in the third quarter of 2025 which resulted in net income of $16.0 million for the three months ended September 30, 2025 and a net loss of $3.1 million for the nine months ended September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $296.1 million. These losses have resulted primarily from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. We have not commercialized any products and have never generated revenue from the commercialization of any product. We expect to incur significant additional operating losses in the foreseeable future as we advance our programs through preclinical and clinical development, expand our research and development activities, acquire and develop new product candidates, complete preclinical studies and clinical trials, finance our business development strategy, seek regulatory approval for the commercialization of our product candidates and commercialize our products, if approved. Our expenses will increase substantially over time if and as we:

Previous wording

▪advance our discovery and preclinical development activities for our product candidates;

Current wording

▪advance discovery and preclinical development activities for our product candidates;

Previous wording

The Company determined there were performance obligations as follows:

Current wording

We determined there were performance obligations as follows:

Previous wording

In April 2024, we also entered into the JJDC Securities Purchase Agreement. Under the terms of the JJDC Securities Purchase Agreement, JJDC made an equity investment purchasing 3,636,363 shares of common stock with a par value of $0.0001 per share for a share purchase price of $1.82 per share which includes a 10% premium 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. We determined the J&J Collaboration Agreement and JJDC Securities Purchase Agreement represented combined agreements. In accordance with ASC 606 and Accounting Standards Codification Topic

Current wording

In April 2024, we also entered into the JJDC Securities Purchase Agreement. Under the terms of the JJDC Securities Purchase Agreement, JJDC made an equity investment purchasing 3,636,363 shares of common stock with a par value of $0.0001 per share for a share purchase price of $1.82 per share which includes a 10% premium 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. We determined the J&J Collaboration Agreement and JJDC Securities Purchase Agreement represented combined agreements. In accordance with ASC 606 and Accounting Standards Codification 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 the two year expected performance period.

Previous wording

Total other income, net, includes interest income earned on cash, cash equivalents and marketable securities, and income and expense items.

Current wording

Total other income, net, includes interest income earned on cash, cash equivalents and marketable securities, and income and expense items, including income related to the proceeds from the JV Sale.

Previous wording

We recognize the pro-rata share of losses in the joint venture with Recursion (as successor in interest to Exscientia) on the condensed consolidated statements of operations and comprehensive loss within the loss on investment in joint venture line item, with a corresponding change to the joint venture investment asset on the condensed consolidated balance sheets for equity method investments for which we do not have a controlling interest in.

Current wording

We recognize the pro-rata share of losses in the joint venture with Recursion (as successor in interest to Exscientia) on the condensed consolidated statements of operations and comprehensive income (loss) within the loss on investment in joint venture line item, with a corresponding change to the joint venture investment asset on the condensed consolidated balance sheets for equity method investments for which we do not have a controlling interest in. In July 2025, we sold our interest in REV102 to Recursion.

Previous wording

▪a $5.5 million decrease in RLYB212 development costs, primarily related to a decrease in clinical development costs, manufacturing costs and other related development costs as a result of our discontinuation of the FNAIT program in April 2025;

Current wording

▪a $4.0 million decrease in RLYB212 development costs, primarily related to a decrease in clinical development costs and other related development costs as a result of our discontinuation of the FNAIT program in April 2025;

Previous wording

▪a $0.5 million decrease in costs related to the development of other program candidates, primarily related to RLYB332 manufacturing costs; and

Current wording

▪a $0.4 million decrease in costs related to the development of other program candidates, primarily related to RLYB332 manufacturing costs; and

Previous wording

▪a $0.2 million increase in payroll and personnel-related costs, primarily related to the severance expense recognized in the second quarter of 2025 in connection with the workforce reduction, effective May 2, 2025; offset by a decrease in payroll and personnel-related expenses due to lower ongoing headcount during the three months ended June 30, 2025 as compared to the same period in 2024.

Current wording

▪a $0.9 million decrease in payroll and personnel-related expenses, primarily due to lower ongoing headcount during the three months ended September 30, 2025 as compared to the same period in 2024.

Previous wording

▪a $2.5 million decrease in RLYB116 development costs, primarily related to a decrease in manufacturing and other related development costs;

Current wording

▪a $1.2 million increase in RLYB116 development costs, primarily related to an increase in clinical development costs and other related development costs.

Previous wording

Total other income, net, for the three months ended June 30, 2025 was $0.6 million compared to $1.3 million for the three months ended June 30, 2024. The decrease in total other income of $0.6 million was primarily related to a decrease in interest income from marketable securities due to a lower excess cash balance.

Current wording

Total other income, net, for the three months ended September 30, 2025 was $22.9 million compared to $1.2 million for the three months ended September 30, 2024. The increase in total other income of $21.7 million was primarily related to an increase in other income related to the JV Sale; offset by a decrease in interest income from marketable securities due to a lower excess cash balance.

Previous wording

▪an $8.7 million decrease in RLYB212 development costs, primarily related to a decrease in clinical development costs, manufacturing costs and other related development costs;

Current wording

▪a $12.6 million decrease in RLYB212 development costs, primarily related to a decrease in clinical development costs, manufacturing costs and other related development costs;

Previous wording

▪a $1.9 million decrease in RLYB116 development costs, primarily related to a decrease in manufacturing and other related development costs;

Current wording

▪a $1.4 million decrease in RLYB116 development costs, primarily related to a decrease in manufacturing and other related development costs; offset by an increase in clinical development costs;

Previous wording

▪a $1.3 million decrease in costs related to the development of other program candidates, primarily related to manufacturing and preclinical costs for RLYB332; and

Current wording

▪a $1.6 million decrease in costs related to the development of other program candidates, primarily related to manufacturing and preclinical costs for RLYB332; and

Previous wording

▪a $1.0 million increase in payroll and personnel-related expenses, primarily related to the severance expense recognized in the second quarter of 2025 in connection with the workforce reduction, effective May 2, 2025; offset by a decrease in payroll and personnel-related expenses due to lower ongoing headcount during the three months ended June 30, 2025 as compared to the same period in 2024.

Current wording

▪a $2.4 million decrease in payroll and personnel-related expenses, primarily related to lower ongoing headcount during the nine months ended September 30, 2025 as compared to the same period in 2024; offset by an increase in payroll and personnel-related expenses due to the severance expense recognized in the second quarter of 2025 in connection with the workforce reduction, effective May 2, 2025.

Previous wording

▪a $2.2 million decrease in payroll and personnel-related costs, primarily related to lower ongoing headcount during the six months ended June 30, 2025 as compared to the same period in 2024; offset by an increase in payroll and personnel-related costs due to severance expense recognized in the second quarter of 2025 in connection with the workforce reduction, effective May 2, 2025; and

Current wording

▪a $3.3 million decrease in payroll and personnel-related expenses, primarily related to lower ongoing headcount during the nine months ended September 30, 2025 as compared to the same period in 2024; offset by an increase in payroll and personnel-related expenses due to severance expense recognized in the second quarter of 2025 in connection with the workforce reduction, effective May 2, 2025; and

Previous wording

Total other income, net, for the six months ended June 30, 2025 was $1.5 million compared to $2.7 million for the six months ended June 30, 2024. The decrease in total other income of $1.3 million was primarily related to a decrease in interest income from marketable securities due to a lower excess cash balance.

Current wording

Total other income, net, for the nine months ended September 30, 2025 was $24.4 million compared to $4.0 million for the nine months ended September 30, 2024. The increase in total other income of $20.4 million was primarily related to an increase in other income related to the JV Sale; offset by a decrease in interest income from marketable securities due to a lower excess cash balance.

Previous wording

Loss on investment in joint venture for the six months ended June 30, 2025 was $0.9 million compared to $1.2 million for the six months ended June 30, 2024. The decrease in loss on investment in joint venture of $0.3 million was primarily due to a decrease in joint venture development costs.

Current wording

Loss on investment in joint venture for the nine months ended September 30, 2025 was $0.9 million compared to $1.8 million for the nine months ended September 30, 2024. The change was primarily due to the sale of our interest in REV102 in July 2025.

Previous wording

In August 2022, we filed a Registration Statement on Form S-3 (the “Shelf”) with the SEC in relation to the registration and potential future issuance of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $300.0 million. The Shelf was declared effective on August 15, 2022. Pursuant to General Instruction I.B.6 to Form S-3 (“Instruction I.B.6”), a company with a public float of less than $75 million measured at certain time periods may not issue securities under Registration Statements on Form S-3 in excess of one-third of its public float in a 12-month period. We are subject to the limitations of Instruction I.B.6, which may limit the amount of funds we can raise using the Shelf or any other Registration Statement on Form S-3. In connection with the Shelf, we also simultaneously entered into a Sales Agreement with TD Securities (USA) LLC (f/k/a Cowen and Company, LLC) ("TD Cowen"), which was amended on March 13, 2025 (as amended, the "Sales Agreement"). In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $9.55 million from time to time at prices through TD Cowen acting as our agent. Pursuant to the Sales Agreement, sales of our common stock, if any, will be made in sales deemed to be “at the market offerings” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"). Under the Sales Agreement, TD Cowen will be entitled to compensation equal to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of June 30, 2025, we had not sold any shares of common stock pursuant to the Sales Agreement.

Current wording

In August 2022, we filed a Registration Statement on Form S-3 (the “Shelf”) with the SEC in relation to the registration and potential future issuance of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $300.0 million. The Shelf was declared effective on August 15, 2022. Pursuant to General Instruction I.B.6 to Form S-3 (“Instruction I.B.6”), a company with a public float of less than $75.0 million measured at certain time periods may not issue securities under Registration Statements on Form S-3 in excess of one-third of its public float in a 12-month period. We are subject to the limitations of Instruction I.B.6, which may limit the amount of funds we can raise using the Shelf or any other Registration Statement on Form S-3. In connection with the Shelf, we also simultaneously entered into a Sales Agreement with TD Securities (USA) LLC (f/k/a Cowen and Company, LLC) ("TD Cowen"), which was amended on March 13, 2025 (as amended, the "Sales Agreement"). In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $9.55 million from time to time at prices through TD Cowen acting as our agent. Pursuant to the Sales Agreement, sales of our common stock, if any, will be made in sales deemed to be “at the market offerings” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"). Under the Sales Agreement, TD Cowen will be entitled to compensation equal to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of September 30, 2025, we had not sold any shares of common stock pursuant to the Sales Agreement.

Previous wording

In April 2024, we entered into the JJDC Securities Purchase Agreement, pursuant to which we sold to JJDC in an unregistered offering, 3,636,363 shares of our 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. We agreed, among other things, to file with the SEC a registration statement covering the resale of the shares within 120 days following the closing of the offering. We filed this registration statement on May 10, 2024.

Current wording

In April 2024, we entered into the JJDC Securities Purchase Agreement, pursuant to which we sold to JJDC in an unregistered offering, 3,636,363 shares of our common stock at a price of $1.82 per share, which represented a 10% premium on our closing stock price on April 9, 2024, for aggregate gross proceeds of approximately $6.6 million, before deducting offering expenses. We agreed, among other things, to file with the SEC a registration statement covering the resale of the shares within 120 days following the closing of the offering. We filed this registration statement on May 10, 2024.

Previous wording

In July 2025, we announced that we had entered into the ENPP1 Purchase Agreement to sell our interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with HPP, to Buyer (a subsidiary of our joint venture partner, Recursion). In connection with the sale, we received an upfront equity payment of $7.5 million. In addition, we are 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. We are 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.

Current wording

In July 2025, we announced that we had entered into the ENPP1 Purchase Agreement to sell our interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with HPP, to Buyer (a subsidiary of our joint venture partner, Recursion). In connection with the JV Sale, we received a total of $20.0 million in the third quarter of 2025 including $7.5 million from an upfront payment and $12.5 million from a milestone payment related to the initiation of additional preclinical studies. We are 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 REV-I. We may also be eligible to receive certain payments in the event of Recursion’s sale of the REV102 program.

Previous wording

As of June 30, 2025, we had $45.7 million of cash, cash equivalents and marketable securities.

Current wording

As of September 30, 2025, we had $59.3 million of cash, cash equivalents and marketable securities.

Previous wording

We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into the middle of 2027. This estimate and our expectation to advance the development of RLYB116 and any other product candidates are based on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect, or our clinical trials may be more expensive, time consuming or difficult to design or implement than we currently anticipate. We expect to incur significant expenses and operating losses in the foreseeable future as we advance our product candidates through clinical development, seek regulatory approval and pursue commercialization of any approved product candidates.

Current wording

We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through 2027. This estimate and our expectation to advance the development of RLYB116 and any other product candidates are based on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect, or our clinical trials may be more expensive, time consuming or difficult to design or implement than we currently anticipate. We expect to incur significant expenses and operating losses in the foreseeable future as we advance our product candidates through clinical development, seek regulatory approval and pursue commercialization of any approved product candidates.

Previous wording

During the six months ended June 30, 2025, net cash used in operating activities was $18.6 million as compared to $25.9 million for the six months ended June 30, 2024. The decrease in net cash used in operating activities for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 was primarily related to a decrease in research and development and general and administrative activities, in addition to changes in working capital.

Current wording

During the nine months ended September 30, 2025, net cash used in operating activities was $25.1 million as compared to $39.4 million for the nine months ended September 30, 2024. The decrease in net cash used in operating activities for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was primarily related to a decrease in research and development and general and administrative activities, in addition to changes in working capital.

Previous wording

Net cash provided by investing activities was $14.1 million for the six months ended June 30, 2025 as compared to $12.9 million of net cash provided by investing activities for the six months ended June 30, 2024. The increase of $1.3 million in net cash provided by investing activities was primarily related to proceeds of $25.5 million from maturities of highly-rated debt securities, partially offset by purchases of highly-rated debt securities of $9.9 million during the six months ended June 30, 2025, as compared to proceeds from maturities of highly-rated debt securities of $44.3 million, partially offset by purchases of highly-rated debt securities of $29.9 million during the six months ended June 30, 2024.

Current wording

Net cash provided by investing activities was $43.3 million for the nine months ended September 30, 2025 as compared to $35.1 million of net cash provided by investing activities for the nine months ended September 30, 2024. The increase of $8.3 million in net cash provided by investing activities was primarily related to proceeds of $35.5 million from maturities of highly-rated debt securities, in addition to an increase of $18.5 million primarily related to the JV Sale, partially offset by purchases of highly-rated debt securities of $10.6 million during the nine months ended September 30, 2025, as compared to proceeds from maturities of highly-rated debt securities of $68.7 million, partially offset by purchases of highly-rated debt securities of $31.6 million during the nine months ended September 30, 2024.

Previous wording

Net cash provided by financing activities during the six months ended June 30, 2025 was $10 thousand, representing proceeds from the issuance of common stock under the stock purchase plan. Net cash provided by financing activities during the six months ended June 30, 2024 was $5.2 million, representing proceeds from the issuance of common stock pursuant to the JJDC Securities Purchase Agreement, after deducting offering costs and accounting for the total consideration allocation related to the J&J Collaboration Agreement of $1.2 million.

Current wording

Net cash provided by financing activities during the nine months ended September 30, 2025 was $10 thousand, representing proceeds from the issuance of common stock under the stock purchase plan. Net cash provided by financing activities during the nine months ended September 30, 2024 was $5.2 million, representing proceeds from the issuance of common stock pursuant to the JJDC Securities Purchase Agreement, after deducting offering costs and accounting for the total consideration allocation related to the J&J Collaboration Agreement of $1.2 million.

Previous wording

There have been no other material changes in our contractual obligations and commitments during the six months ended June 30, 2025 from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations” in our Annual Report.

Current wording

There have been no other material changes in our contractual obligations and commitments during the nine months ended September 30, 2025 from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations” in our Annual Report.