Mereo BioPharma Group plc
For the period ended Sep 30, 2025. Filed Nov 10, 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.
Sep 30, 2025 · Filed Nov 10, 2025
MREO$0.28+0.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001193125-25-178489
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001193125-25-274272
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 115 previous paragraphs and 118 current paragraphs.
68 unchanged; 35 reworded; 14 added; 11 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 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 (14)
Current report
Research and development expenses (“R&D expenses”)
Current report
Other income
Current report
Other income of $0.3 million for the nine months ended September 30, 2025 comprised amounts received from āshibio in connection with the out-licensing of vantictumab, which was acquired in connection with the merger between the Company and Mereo BioPharma 5, Inc.
Current report
Foreign currency transaction gain/(loss),net
Current report
The net foreign exchange gain for the three months ended September 30, 2025 was $1.9 million, compared to a loss of $6.4 million for the three months ended September 30, 2024. This change primarily reflects the impact of a strengthening in the value of U.S. dollars when translating U.S. dollar balances into our functional currency of pound sterling in the three months ended September 30, 2025, compared to a weakening of U.S. dollars in the three months ended September 30, 2024.
Current report
Comparison of nine months ended September 30, 2025 and 2024
Current report
R&D expenses
Current report
General and administrative expenses decreased by $1.2 million, from $20.0 million in the nine months ended September 30, 2024 to $18.8 million in the nine months ended September 30, 2025. The decrease was primarily due to lower professional fees.
Current report
Other income
Current report
Other income of $0.3 million for the nine months ended September 30, 2025 comprised amounts received from āshibio in connection with the out-licensing of vantictumab, which was acquired in connection with the merger between the Company and Mereo BioPharma 5, Inc.
Current report
Foreign currency transaction loss
Current report
Net cash used in operating activities for the nine months ended September 30, 2025 was $23.3 million, a decrease of $0.1 million from $23.4 million in the nine months ended September 30, 2024. This decrease is principally due to:
Current report
a)
Removed paragraphs (11)
Previous report
Recent Developments
Previous report
On July 9, 2025, we and our collaboration partner Ultragenyx announced that the randomized, placebo-controlled Phase 3 portion of the Orbit study evaluating setrusumab in pediatric and young adult patients with OI is progressing toward a final analysis consistent with the original plan, around the end of 2025. The Data Monitoring Committee met and informed Ultragenyx that setrusumab demonstrates an acceptable safety profile and Ultragenyx and the Company should continue the study to final analysis. In addition, the Cosmic study evaluating setrusumab in young pediatric patients aged 2 to <7 years old will also proceed to final analysis around the end of 2025.
Previous report
Research and development (“R&D”) expenses
Previous report
General and administrative expenses decreased by $2.4 million, from $7.9 million in the three months ended June 30, 2024 to $5.5 million in the three months ended June 30, 2025. The decrease was primarily due to the recognition of a $1.9 million reduction in expenses in the three months ended June 30, 2025 for amounts received from our depository to reimburse certain expenses incurred by us in respect of our ADR program as well as lower professional fees.
Previous report
Foreign currency transaction (loss)/gain
Previous report
The net foreign exchange loss for the three months ended June 30, 2025 was $5.3 million, compared to a gain of less than $0.1 million for the three months ended June 30, 2024. This change primarily reflects (i) the impact of a weakening in the value of U.S. dollars when translating U.S. dollar balances into our functional currency of pound sterling in the three months ended June 30, 2025, compared to a strengthening of U.S. dollars in the three months ended June 30, 2024, and (ii) higher U.S. dollar balances following the underwritten registered direct offering in June 2024.
Previous report
Comparison of six months ended June 30, 2025 and 2024
Previous report
Revenue
Previous report
Cost of revenue
Previous report
Research and development (“R&D”) expenses
Previous report
Foreign currency transaction (loss)/gain
Reworded paragraphs (35)
Previous wording
We are a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. We have developed a portfolio of late-stage clinical product candidates. Our two rare disease product candidates are setrusumab for the treatment of OI and alvelestat for the treatment of severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). Setrusumab has received orphan designation for OI from the European Commission ("EC") and the U.S. Food and Drug Administration ("FDA"), PRIME designation from the European Medicines Agency ("EMA") and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received orphan designation for AATD from the EC and the FDA, and Fast Track designation for the treatment of AATD-LD from the FDA.
Current wording
We are a biopharmaceutical company focused on the development of innovative therapeutics for rare diseases. We have developed a portfolio of late-stage clinical product candidates. Our two rare disease product candidates are setrusumab for the treatment of OI and alvelestat for the treatment of severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD). Setrusumab has received orphan designation for OI from the European Commission ("EC") and the U.S. Food and Drug Administration ("FDA"), PRIME designation from the European Medicines Agency ("EMA") and has Breakthrough Therapy designation and rare pediatric disease designation from the FDA. Alvelestat has received orphan designation for AATD from the EC and the FDA, and Fast Track designation for the treatment of AATD-LD from the FDA. We also have an early stage rare disease program, vantictumab, for the treatment of a second bone disease, autosomal dominant osteopetrosis type 2. The global development of vantictumab is being funded and led by our partner, āshibio, Inc. ("āshibio"), and we retain the European commercial rights.
Previous wording
Our strategy is to selectively acquire and develop product candidates for rare diseases that have already received significant investment from large pharmaceutical and biotechnology companies and that have substantial pre-clinical, clinical and manufacturing data packages. Since our formation in March 2015, we have successfully executed on this strategy by acquiring six clinical-stage product candidates of which four were in rare diseases and oncology. Four of our six clinical-stage product candidates were acquired from large pharmaceutical companies and two were acquired in our merger with OncoMed Pharmaceuticals Inc in 2019. We have successfully completed large, randomized Phase 2 clinical trials for four of our product candidates and the Phase 1b portion of a Phase 1b/2 for a fifth product candidate.
Current wording
Our strategy is to selectively acquire and develop product candidates for rare diseases that have already received significant investment from large pharmaceutical and biotechnology companies and that have substantial pre-clinical, clinical and manufacturing data packages. Since our formation in March 2015, we have successfully executed on this strategy by acquiring six clinical-stage product candidates of which four were in rare diseases and oncology. Four of our six clinical-stage product candidates were acquired from large pharmaceutical companies and two were acquired in our merger with Mereo BioPharma 5, Inc. (formerly OncoMed Pharmaceuticals, Inc.) in 2019. We have successfully completed large, randomized Phase 2 clinical trials for four of our product candidates and the Phase 1b portion of a Phase 1b/2 for a fifth product candidate.
Previous wording
Total R&D expenses increased by $0.4 million, from $4.9 million in the three months ended June 30, 2024 to $5.4 million in the three months ended June 30, 2025.
Current wording
Total R&D expenses increased by $1.1 million, from $3.2 million in the three months ended September 30, 2024 to $4.3 million in the three months ended September 30, 2025.
Previous wording
The increase was primarily due to increases of $2.2 million in R&D expenses for setrusumab offset by decreases of $1.5 million and $0.2 million in R&D expenses for alvelestat and etigilimab, respectively.
Current wording
The increase was primarily due to increases of $0.9 million in R&D expenses for setrusumab and $0.5 million for alvelestat, partially offset by a reduction of $0.2 million in R&D expenses for etigilimab.
Previous wording
The decrease in program expenses for alvelestat was primarily due to the completion of the drug formulation and manufacturing activities undertaken in preparation for the Phase 3 study in the six months ended June 30, 2024.
Current wording
The increase in program expenses for alvelestat was primarily due to activities undertaken in preparation for the Phase 3 study, including drug product and packaging, in the three months ended September 30, 2025.
Previous wording
General and administrative expenses decreased by $1.0 million, from $13.8 million in the six months ended June 30, 2024 to $12.8 million in the six months ended June 30, 2025. The decrease was primarily due to lower professional fees.
Current wording
General and administrative expenses decreased by $0.2 million, from $6.2 million in the three months ended September 30, 2024 to $6.0 million in the three months ended September 30, 2025. The decrease was primarily due to lower professional fees.
Previous wording
General and administrative expenses also includes $1.2 million in the three months ended June 30, 2025 of pre-commercial activities to lay the foundation for the commercial launch of setrusumab in Europe, including those to support pricing and reimbursement by HTA authorities and payor decision-makers in Europe.
Current wording
General and administrative expenses also includes $0.8 million in the three months ended September 30, 2025 of pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, if approved, including those to support pricing and reimbursement by HTA authorities and payor decision-makers in Europe.
Previous wording
Interest income increased by less than $0.1 million, from $0.6 million in the three months ended June 30, 2024 to $0.6 million in the three months ended June 30, 2025, principally due to a higher cash and cash equivalents balance as a result of receiving the net proceeds of $46.2 million from the underwritten registered direct offering in June 2024, offset by lower interest rates earned.
Current wording
Interest income decreased by $0.5 million, from $1.0 million in the three months ended September 30, 2024 to $0.5 million in the three months ended September 30, 2025, principally due to a combination of lower interest rates earned and lower average cash and cash equivalents balances in the three months ended September 30, 2025 compared to the three months ended September 30, 2024. These lower balances were the result of having received the net proceeds of $46.2 million from the underwritten registered direct offering in June 2024.
Previous wording
Interest expense decreased by $0.3 million, from $0.3 million in the three months ended June 30, 2024 to less than $0.1 million in the three months ended June 30, 2025. The decrease was principally due to the conversion of convertible loan notes in February 2025, following which the Company had no significant remaining interest-bearing liabilities.
Current wording
Interest expense decreased by $0.3 million, from $0.4 million in the three months ended September 30, 2024 to less than $0.1 million in the three months ended September 30, 2025. The decrease was principally due to the conversion of convertible loan notes in February 2025, following which the Company had no significant remaining interest-bearing liabilities.
Previous wording
The total change in fair value of warrants in the three months ended June 30, 2025 was an unrealized loss of $0.1 million, compared to an unrealized loss of $0.1 million in the three months ended June 30, 2024, both of which were primarily due to the impact of decreases in the price of the Company’s ADSs on the value of the warrant liabilities.
Current wording
The total change in fair value of warrants in the three months ended September 30, 2025 was an unrealized gain of $0.2 million, compared to an unrealized loss of $0.1 million in the three months ended September 30, 2024. The unrealized gain in the three months ended September 30, 2025 was primarily due to the impact of decreases in the price of the Company’s ADSs on the value of the warrant liabilities, while the unrealized loss in the three months ended September 30, 2024 was primarily due to increases in the price of ADSs.
Previous wording
The benefit from research and development tax credit increased by $0.4 million, from $0.4 million in the three months ended June 30, 2024 to $0.7 million in the three months ended June 30, 2025. This increase reflects a higher level of qualifying expenditure in the three months ended June 30, 2025. The income tax benefit represents eligible cash rebates paid or receivable from the tax authorities in the jurisdictions within which we operate for eligible types of research and development activities and associated expenditure.
Current wording
The benefit from research and development tax credit increased by $0.2 million, from $0.2 million in the three months ended September 30, 2024 to $0.4 million in the three months ended September 30, 2025. This increase reflects a higher level of qualifying expenditure in the three months ended September 30, 2025. The income tax benefit represents eligible cash rebates paid or receivable from the tax authorities in the jurisdictions within which the Company operates for eligible types of research and development activities and associated expenditure.
Previous wording
The foreign currency translation adjustment for the three months ended June 30, 2025 was a gain of $6.6 million, compared to a gain of less than $0.1 million in the three months ended June 30, 2024. This change primarily reflects the impact of a greater weakening in the value of U.S. dollars when translating U.S. dollar balances into our functional currency of pound sterling in the three months ended June 30, 2025, compared to a lesser weakening of U.S. dollars in the three months ended June 30, 2024 .
Current wording
The foreign currency translation adjustment for the three months ended September 30, 2025 was a loss of $2.3 million, compared to a gain of $7.2 million in the three months ended September 30, 2024. This change primarily reflects the impact of a strengthening in the value of U.S. dollars when translating pound sterling functional currency balances into our presentational currency of U.S. dollars in the three months ended September 30, 2025, compared to a weakening of U.S. dollars in the three months ended September 30, 2024.
Previous wording
The following table sets forth Mereo’s results of operations for the six months ended June 30, 2025 and 2024.
Current wording
The following table sets forth Mereo’s results of operations for the nine months ended September 30, 2025 and 2024.
Previous wording
Revenue of $0.5 million for the three months ended June 30, 2025 comprised a one-time milestone payment of $0.5 million resulting from the achievement of a clinical milestone on leflutrozole by ReproNovo pursuant to the ReproNovo Licensing Agreement. No revenue was recognized for the three months ended June 30, 2024.
Current wording
Revenue of $0.5 million for the nine months ended September 30, 2025 comprised a one-time milestone payment of $0.5 million resulting from the achievement of a clinical milestone on leflutrozole received from ReproNovo pursuant to the ReproNovo Licensing Agreement. No revenue was recognized for the nine months ended September 30, 2024.
Previous wording
Cost of revenue for the three months ended June 30, 2025 was $0.1 million and represents amounts payable pursuant to the 2015 asset purchase agreement with Novartis for leflutrozole, under which the Company pays a percentage of proceeds resulting from milestone revenue received, subject to certain deductions and other amounts. No cost of revenue was recognized for the three months ended June 30, 2024.
Current wording
Cost of revenue for the nine months ended September 30, 2025 was $0.1 million and represents amounts paid pursuant to the 2015 asset purchase agreement with Novartis for leflutrozole, under which the Company pays a percentage of proceeds resulting from milestone revenue received, subject to certain deductions and other amounts. No cost of revenue was recognized for the nine months ended September 30, 2024.
Previous wording
The following table sets forth our R&D expenses by product development program for the six months ended June 30, 2025 and 2024.
Current wording
The following table sets forth our R&D expenses by product development program for the nine months ended September 30, 2025 and 2024.
Previous wording
Total R&D expenses increased by $0.4 million, from $8.9 million in the six months ended June 30, 2024 to $9.3 million in the six months ended June 30, 2025.
Current wording
Total R&D expenses increased by $1.5 million, from $12.1 million in the nine months ended September 30, 2024 to $13.6 million in the nine months ended September 30, 2025.
Previous wording
The increase was primarily due to an increase of $3.6 million in R&D expenses for setrusumab, offset by decreases of $2.8 million and $0.4 million in R&D expenses for alvelestat and etigilimab, respectively.
Current wording
The increase was primarily due to an increase of $4.4 million in R&D expenses for setrusumab, partially offset by decreases of $2.3 million and $0.6 million in R&D expenses for alvelestat and etigilimab, respectively.
Previous wording
The decrease in program expenses for alvelestat was primarily due to the completion of the drug formulation and manufacturing activities undertaken in preparation for the Phase 3 study in the three months ended June 30, 2024.
Current wording
The decrease in program expenses for alvelestat was primarily due to the completion of activities undertaken in preparation for the Phase 3 study, including drug formulation and manufacturing, in the nine months ended September 30, 2024.
Previous wording
General and administrative expenses also includes $2.3 million in the six months ended June 30, 2025 of pre-commercial activities to lay the foundation for the commercial launch of setrusumab in Europe, including those to support pricing and reimbursement by HTA authorities and payor decision-makers in Europe.
Current wording
General and administrative expenses also includes $3.2 million in the nine months ended September 30, 2025 of pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, if approved, including those to support pricing and reimbursement by HTA authorities and payor decision-makers in Europe.
Previous wording
Interest income increased by $0.1 million, from $1.2 million in the six months ended June 30, 2024 to $1.2 million in the six months ended June 30, 2025, principally due to a higher cash and cash equivalents balance as a result of receiving the net proceeds of $46.2 million from the underwritten registered direct offering in June 2024, offset by lower interest rates earned.
Current wording
Interest income decreased by $0.4 million, from $2.2 million in the nine months ended September 30, 2024 to $1.8 million in the nine months ended September 30, 2025, principally due to a combination of lower interest rates earned and lower average cash and cash equivalents balances in the three months ended September 30, 2025 compared to the three months ended September 30, 2024. These lower balances were the result of having received the net proceeds of $46.2 million from the underwritten registered direct offering in June 2024.
Previous wording
Interest expense decreased by $0.4 million, from $0.6 million in the six months ended June 30, 2024 to $0.2 million in the six months ended June 30, 2025. The decrease was principally due to the conversion of convertible loan notes in February 2025, following which the Company had no significant remaining interest-bearing liabilities.
Current wording
Interest expense decreased by $0.8 million, from $1.0 million in the nine months ended September 30, 2024 to $0.2 million in the nine months ended September 30, 2025. The decrease was principally due to the conversion of convertible loan notes in February 2025, following which the Company had no significant remaining interest-bearing liabilities.
Previous wording
The total change in fair value of warrants in the six months ended June 30, 2025 was an unrealized gain of $0.3 million, compared to an unrealized loss of $0.5 million in the six months ended June 30, 2024. The unrealized gain in the six months ended June 30, 2025 was primarily due to the impact of a decrease in the price of the Company’s ADSs on the value of the warrant liabilities, whereas in the six months ended June 30, 2024, the unrealized loss was primarily due to an increase in the ADS price in the period.
Current wording
The total change in fair value of warrants in the nine months ended September 30, 2025 was an unrealized gain of $0.5 million, compared to an unrealized loss of $0.6 million in the nine months ended September 30, 2024. The unrealized gain in the nine months ended September 30, 2025 was primarily due to the impact of decreases in the price of the Company’s ADSs on the value of the warrant liabilities, while the unrealized loss in the nine months ended September 30, 2024 was primarily due to increases in the price of ADSs.
Previous wording
The net foreign exchange loss for the six months ended June 30, 2025 was $8.1 million, compared to a gain of $0.6 million for the six months ended June 30, 2024. This change primarily reflects (i) the impact of a weakening in the value of U.S. dollars when translating U.S. dollar balances into our functional currency of pound sterling in the six months ended June 30, 2025, compared to a strengthening of U.S. dollars in the six months ended June 30, 2024, and (ii) higher U.S. dollar balances following the underwritten registered direct offering in June 2024.
Current wording
The net foreign exchange loss for the nine months ended September 30, 2025 was $6.2 million, compared to a loss of $5.8 million for the nine months ended September 30, 2024. This change primarily reflects the impact of a greater weakening in the value of U.S. dollars when translating U.S. dollar balances into our functional currency of pound sterling in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.
Previous wording
The benefit from research and development tax credit increased by $0.1 million, from $0.8 million in the six months ended June 30, 2024 to $0.9 million in the six months ended June 30, 2025. This increase reflects a combination of a higher level of qualifying expenditure in the six months ended June 30, 2025. The income tax benefit represents eligible cash rebates paid or receivable from the tax authorities in the jurisdictions within which we operate for eligible types of research and development activities and associated expenditure.
Current wording
The benefit from research and development tax credit increased by $0.3 million, from $1.1 million in the nine months ended September 30, 2024 to $1.4 million in the nine months ended September 30, 2025. This increase reflects a higher level of qualifying expenditure in the nine months ended September 30, 2025. The income tax benefit represents eligible cash rebates paid or receivable from the tax authorities in the jurisdictions within which the Company operates for eligible types of research and development activities and associated expenditure.
Previous wording
The foreign currency translation adjustment for the six months ended June 30, 2025 was a gain of $10.2 million, compared to a loss of $0.8 million in the six months ended June 30, 2024. This change primarily reflects the impact of a significant weakening in the value of U.S. dollars when translating U.S. dollar balances into our functional currency of pound sterling in the six months ended June 30, 2025, compared to a slight strengthening of U.S. dollars in the six months ended June 30, 2024.
Current wording
The foreign currency translation adjustment for the nine months ended September 30, 2025 was a gain of $7.9 million, compared to a gain of $6.4 million in the nine months ended September 30, 2024. This change primarily reflects the impact of a greater weakening in the value of U.S. dollars when translating pound sterling functional currency balances into our presentational currency of U.S. dollars in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.
Previous wording
In addition, we enter into contracts in the ordinary course of business with CROs, CMOs, and other vendors, including Ultragenyx for the manufacture of setrusumab as described in our 2024 Annual Report in “Item 1. Business—Material Agreements—Agreements with Ultragenyx for Setrusumab”, to assist in the performance of its research and development activities and other services and products for operating purposes. The contracts with CROs generally provide for termination on notice, and therefore are cancelable contracts. We have manufacturing commitments with CMOs of $0.7 million and $0.5 million as of June 30, 2025 and December 31, 2024, respectively.
Current wording
In addition, we enter into contracts in the ordinary course of business with CROs, CMOs, and other vendors, including Ultragenyx for the manufacture of setrusumab as described in our 2024 Annual Report in “Item 1. Business—Material Agreements—Agreements with Ultragenyx for Setrusumab”, to assist in the performance of its research and development activities and other services and products for operating purposes. The contracts with CROs generally provide for termination on notice, and therefore are cancelable contracts. We have manufacturing commitments with CMOs of $0.1 million and $0.5 million as of September 30, 2025 and December 31, 2024, respectively.
Previous wording
Comparison of the six months ended June 30, 2025 and 2024
Current wording
Comparison of the nine months ended September 30, 2025 and 2024
Previous wording
The table below summarizes our cash flows (used in) from operating, investing and financing activities for the six months ended June 30, 2025 and 2024.
Current wording
The table below summarizes our cash flows (used in)/provided by operating, investing and financing activities for the nine months ended September 30, 2025 and 2024.
Previous wording
Revenue of $0.5 million for the six months ended June 30, 2025 comprised a one-time milestone payment of $0.5 million resulting from the achievement of a clinical milestone on leflutrozole by ReproNovo pursuant to the ReproNovo Licensing Agreement. No revenue was recognized for the six months ended June 30, 2024.
Current wording
receipt of a $0.5 million one-time milestone payment in the nine months ended September 30, 2025 for the achievement of a clinical milestone on leflutrozole in the six months ended June 30, 2025, net of $0.1 million paid to Novartis.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2025 was $16.0 million, an increase of $0.1 million from $15.9 million in the six months ended June 30, 2024. This increase is principally due to receipt of $2.0 million from a claim on our Directors and Officers insurance policy to reimburse us for certain legal and professional costs incurred in prior years in the six months ended June 30, 2024 with no similar amounts recognized in the six months ended June 30, 2025. This increase was offset by receipt of $1.1 million in R&D tax credits in the six months ended June 30, 2025 and approximately $0.8 million in lower other net cash operating expense.
Current wording
These decreases were offset by receipt of $2.0 million from a claim on our Directors and Officers insurance policy to reimburse us for certain legal and professional costs incurred in prior years in the nine months ended September 30, 2024 with no similar amounts recognized in the nine months ended September 30, 2025 and higher net cash operating payments of approximately $1.6 million.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2025 was $0.3 million, a decrease of $0.4 million from $0.7 million in the six months ended June 30, 2024. The decrease is principally due to lower payments to acquire intangible assets in the six months ended June 30, 2025.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2025 was less than $0.1 million, a decrease of $0.7 million from $0.7 million in the nine months ended September 30, 2024. The decrease is principally due to lower payments to acquire intangible assets and proceeds from out-licensing of vantictumab in the nine months ended September 30, 2025.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2025 was $0.3 million, a decrease of $46.5 million from $46.8 million in the six months ended June 30, 2024. The decrease principally represents the net proceeds of $46.2 million from the underwritten registered direct offering in the six months ended June 30, 2024 with no similar amounts recognized in the six months ended June 30, 2025.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2025 was $0.3 million, a decrease of $45.9 million from $46.2 million in the nine months ended September 30, 2024. The decrease primarily represents the net proceeds of $46.2 million from the underwritten registered direct offering in the nine months ended September 30, 2024 with no similar financing activities in the nine months ended September 30, 2025.
Previous wording
As of June 30, 2025, we had an accumulated deficit of $486.6 million. We expect to continue to report significant operating losses for the foreseeable future as we continue our research and development efforts and seek to obtain regulatory approval of our product candidates and any future products we develop.
Current wording
As of September 30, 2025, we had an accumulated deficit of $493.7 million. We expect to continue to report significant operating losses for the foreseeable future as we continue our research and development efforts and seek to obtain regulatory approval of our product candidates and any future product candidates we develop.
Previous wording
the performance of our collaborators and partners under the existing agreements on setrusumab, leflutrozole and navicixizumab;
Current wording
the performance of our collaborators and partners under the existing agreements on setrusumab, vantictumab, leflutrozole and navicixizumab;
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
receipt of $3.3 million in R&D tax credits in the nine months ended September 30, 2025; and
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Cost of revenue for the six months ended June 30, 2025 was $0.1 million and represents amounts payable pursuant to the 2015 asset purchase agreement with Novartis for leflutrozole, under which the Company pays a percentage of proceeds resulting from milestone revenue received, subject to certain deductions and other amounts. No cost of revenue was recognized for the six months ended June 30, 2024.