Rallybio Corp
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
RLYB$15.75+0.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0001739410-25-000061
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001739410-25-000112
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 139 previous paragraphs and 151 current paragraphs.
100 unchanged; 27 reworded; 16 added; 11 removed; 1 previous and 8 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (16)
Current report
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 report
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 report
▪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 report
This decrease was partially offset by:
Current report
▪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 report
Revenue
Current report
Collaboration and license revenue was $0.4 million for the six months ended June 30, 2025, compared to $0.3 million for the six months ended June 30, 2024.
Current report
Research and development expenses were $11.8 million for the six months ended June 30, 2025, compared to $25.9 million for the six months ended June 30, 2024. The decrease of $14.1 million in 2025 as compared to 2024 was primarily due to:
Current report
▪a $2.5 million decrease in RLYB116 development costs, primarily related to a decrease in manufacturing and other related development costs;
Current report
▪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 report
▪a $1.6 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 the severance expense recognized in the second quarter of 2025 in connection with the workforce reduction, effective May 2, 2025.
Current report
General and administrative expenses were $8.4 million for the six months ended June 30, 2025, compared to $11.2 million for the six months ended June 30, 2024. The decrease of $2.9 million in 2025 as compared to 2024 was primarily due to:
Current report
▪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 report
▪a $0.7 million decrease primarily related to professional fees and other related general and administrative expenses.
Current report
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 report
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.
Removed paragraphs (11)
Previous report
We are developing therapies that address diseases of complement dysregulation, including paroxysmal nocturnal hemoglobinuria ("PNH"), antiphospholipid syndrome ("APS") and generalized myasthenia gravis ("gMG"). RLYB116 is a novel, potentially long-acting, subcutaneously injected inhibitor of C5 in development for the treatment of patients with complement-related diseases. RLYB114 is a pegylated C5 inhibitor in development for complement-mediated ophthalmic disorders.
Previous report
Metabolic Disorders
Previous report
We have a collaboration with Recursion Pharmaceuticals, Inc. ("Recursion") through its acquisition of Exscientia Limited ("Exscientia") in 2024 that is focused on the discovery of a small molecule targeting an ENPP1 inhibitor for the treatment of HPP. HPP is a rare, genetic disease characterized by mutations in the ALPL gene. The ALPL gene provides instructions for making an enzyme called tissue-nonspecific alkaline phosphatase, which plays an important role in the growth and development of bones and teeth. We believe that a small molecule inhibitor of ENPP1 has the potential to bring meaningful benefit to HPP patients. In 2024, we presented data at the American Society for Bone and Mineral Research from an early lead ENPP1 inhibitor, REV101, in a mouse model of later-onset HPP demonstrating a 30% reduction in inorganic pyrophosphate ("PPi"), a key biomarker that is elevated in HPP and contributes to poor bone mineralization. Together with Recursion, we also advanced REV102, an ENPP1 inhibitor for the treatment of patients HPP to position the molecule for additional preclinical development activities in 2025.
Previous report
Operating Expenses
Previous report
General and Administrative Expenses
Previous report
Total Other Income, Net
Previous report
Operating Expenses
Previous report
General and Administrative Expenses
Previous report
▪a $2.3 million decrease in payroll and personnel-related costs, primarily related to the workforce reduction, effective March 6, 2024, in addition to lower ongoing headcount in 2025 as compared to 2024; and
Previous report
Total Other Income, Net
Previous report
▪the progress, timing and costs of the development by us or third parties of companion diagnostics, if required, for any of our product candidates, including design, manufacturing and regulatory approval;
Reworded paragraphs (27)
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 broad pipeline of promising product candidates aimed at addressing diseases with unmet medical need in the areas of complement dysregulation, hematology, and metabolic disorders. Our lead program, RLYB116, is a differentiated complement component 5 (“C5”) inhibitor with the potential to treat diseases of complement dysregulation. We also have two programs in preclinical development, including REV102, an Ectonucleotide Pyrophosphatase/ Phosphodiesterase 1 ("ENPP1") inhibitor for the treatment of patients with hypophosphatasia ("HPP"), and RLYB332, a long-acting matriptase-2 ("MTP-2") antibody for the treatment of diseases of iron overload. We plan to initiate a confirmatory pharmacokinetic ("PK") and pharmacodynamic ("PD") study of RLYB116 in healthy volunteers in the second quarter of 2025 with data expected in the third and fourth quarters of 2025. In April 2025, we announced the discontinuation of the RLYB212 program for the prevention of fetal and neonatal alloimmune thrombocytopenia ("FNAIT"). Our decision to discontinue RLYB212 development was 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.
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. 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.
Previous 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
Current 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.
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 PNH, gMG and APS. 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. We plan to initiate a RLYB116 confirmatory clinical PK/PD trial in the second quarter of 2025 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 will include 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
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.
Previous wording
As of March 31, 2025, we had cash, cash equivalents and marketable securities of $54.5 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 first half of 2027. This estimate and our expectation to advance the preclinical and clinical development of RLYB116, REV102 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 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.”
Previous wording
We have incurred significant operating losses since inception, including net losses of $9.4 million and $19.0 million for three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $302.5 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 $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:
Previous wording
▪seek regulatory approvals for RLYB116 and any other product candidates, as well as for any related companion diagnostic, if required;
Current wording
▪seek regulatory approvals for RLYB116 and any other product candidates;
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 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.
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
Previous wording
We do not allocate employee costs, costs associated with our facilities, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources and third-party consultants primarily to conduct our research and development activities as well as for managing our process development, manufacturing and clinical development activities.
Current wording
We do not allocate employee costs, facility costs, including depreciation, or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources and third-party consultants primarily to conduct our research and development activities as well as for managing our process development, manufacturing and clinical development activities.
Previous wording
The Company recognizes its pro-rata share of losses in the joint venture with Recursion (as successor in interest to Exscientia) on its 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 it does 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 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.
Previous wording
Collaboration and license revenue was $0.2 million during the three months ended March 31, 2025. There was no collaboration and license revenue during the three months ended March 31, 2024. The increase of $0.2 million in 2025 as compared to 2024 was related to our entrance into the J&J Collaboration Agreement in the second quarter of 2024 and the recognition of revenue related to the collaboration performance obligations.
Current wording
Collaboration and license revenue was $0.2 million for the three months ended June 30, 2025, compared to $0.3 million for the three months ended June 30, 2024.
Previous wording
Research and development expenses were $5.7 million for the three months ended March 31, 2025, compared to $12.9 million for the three months ended March 31, 2024. The decrease of $7.2 million in 2025 as compared to 2024 was primarily due to:
Current wording
Research and development expenses were $6.1 million for the three months ended June 30, 2025, compared to $12.9 million for the three months ended June 30, 2024. The decrease of $6.9 million in 2025 as compared to 2024 was primarily due to:
Previous wording
▪a $0.7 million decrease in costs related to the development of RLYB116, primarily related to a decrease in manufacturing and other related development costs;
Current wording
▪a $1.9 million decrease in RLYB116 development costs, primarily related to a decrease in manufacturing and other related development costs;
Previous wording
▪a $0.8 million decrease in costs related to the development of other program candidates, primarily related to RLYB332; and
Current wording
▪a $0.5 million decrease in costs related to the development of other program candidates, primarily related to RLYB332 manufacturing costs; and
Previous wording
▪a $2.6 million decrease in payroll and personnel-related expenses, primarily related to the workforce reduction, effective March 6, 2024.
Current 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.
Previous wording
General and administrative expenses were $4.2 million for the three months ended March 31, 2025, compared to $6.9 million for the three months ended March 31, 2024. The decrease of $2.7 million in 2025 as compared to 2024 was primarily due to:
Current wording
General and administrative expenses were $4.2 million for the three months ended June 30, 2025, compared to $4.4 million for the three months ended June 30, 2024. The decrease of $0.2 million in 2025 as compared to 2024 was primarily due to:
Previous wording
▪a $0.4 million decrease in other related general and administrative expenses.
Current wording
▪a $0.4 million decrease primarily related to professional fees and other related general and administrative expenses.
Previous wording
Total other income, net, for the three months ended March 31, 2025 was $0.8 million compared to $1.4 million for the three months ended March 31, 2024. The decrease in total other income of $0.6 million was primarily due 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 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.
Previous wording
Loss on investment in joint venture for the three months ended March 31, 2025 was $0.6 million compared to $0.7 million for the three months ended March 31, 2024. The decrease in loss on investment in joint venture of $0.1 million was primarily due to a decrease in joint venture development costs.
Current wording
Loss on investment in joint venture for the three months ended June 30, 2025 was $0.3 million compared to $0.5 million for the three months ended June 30, 2024. The decrease in loss on investment in joint venture of $0.2 million was primarily due to a decrease in joint venture development costs.
Previous wording
▪a $3.2 million decrease in costs related to the development of RLYB212, primarily related to a decrease in clinical development costs, manufacturing costs and other related development costs;
Current 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;
Previous wording
As of March 31, 2025, we had $54.5 million of cash, cash equivalents and marketable securities.
Current wording
As of June 30, 2025, we had $45.7 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 first half of 2027. This estimate and our expectation to advance the development of RLYB116, REV102 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 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.
Previous wording
▪the cost and timing of the manufacture and supply of non-clinical and clinical trial material for RLYB116, REV102 and our other product candidates;
Current wording
▪the cost and timing of the manufacture and supply of non-clinical and clinical trial material for RLYB116 and our other product candidates;
Previous wording
▪our ability to maintain our collaborations with Recursion and AbCellera on favorable terms and establish any new collaborations;
Current wording
▪our ability to maintain our collaboration with AbCellera on favorable terms and establish any new collaborations;
Previous wording
During the three months ended March 31, 2025, net cash used in operating activities was $10.2 million as compared to $15.5 million for the three months ended March 31, 2024. The decrease in net cash used in operating activities for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was primarily related to a decrease in research and development and general and administrative activities and changes in working capital.
Current 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.
Previous wording
Net cash provided by investing activities was $11.1 million for the three months ended March 31, 2025 as compared to $10.3 million of net cash provided by investing activities for the three months ended March 31, 2024. The increase of $0.8 million in net cash provided by investing activities was primarily related to proceeds of $18.0 million from maturities of highly-rated debt securities, partially offset by purchases of highly-rated debt securities of $5.9 million during the three months ended March 31, 2025, as compared to proceeds from maturities of highly-rated debt securities of $21.8 million, partially offset by purchases of highly-rated debt securities of $10.7 million during the three months ended March 31, 2024.
Current 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.
Previous wording
There was no cash provided by financing activities during the three months ended March 31, 2025 or 2024.
Current 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.
Previous wording
There have been no other material changes in our contractual obligations and commitments during the three months ended March 31, 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 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.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
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
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
Comparison of the Six Months Ended June 30, 2025 and 2024
Current report — wording carried from elsewhere
The following table summarizes our results of operations:
Current report — wording carried from elsewhere
The following table summarizes our research and development costs for each of the periods presented:
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
Loss On Investment In Joint Venture
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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.