Mereo BioPharma Group plc
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
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, 2026 · Filed Nov 9, 2026
MREO$0.30+4.3%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001193125-26-343533
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001193125-26-452745
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 117 previous paragraphs and 114 current paragraphs.
68 unchanged; 35 reworded; 10 added; 12 removed; 2 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 (10)
Current report
Revenue of $0.8 million for the three months ended September 30, 2026 comprised the portion of the $1.0 million option fee pursuant to the Sentynl Agreement recognized based on an estimate of progress towards satisfaction of the performance obligation. No revenue was recognized for the three months ended September 30, 2025.
Current report
Other income
Current report
Other income of $0.3 million for the three months ended September 30, 2025 comprised amounts received from āshibio, Inc. (“āshibio”) in connection with the out-licensing of vantictumab.
Current report
Foreign currency transaction gain, net
Current report
Comparison of nine months ended September 30, 2026 and 2025
Current report
The decrease was primarily due to reductions of $2.4 million in R&D expenses for setrusumab and $2.3 million for alvelestat.
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.
Current report
$1.0 million under the option and license agreement with Sentynl for alvelestat in 2026.
Current report
Comparison of the nine months ended September 30, 2026 and 2025
Removed paragraphs (12)
Previous report
Recent Events
Previous report
Setrusumab (BPS-804/UX143) for the Treatment of Osteogenesis Imperfecta (OI)
Previous report
In December 2025 we, and our partner Ultragenyx, announced that the Phase 3 Orbit and Cosmic studies for our lead program setrusumab in OI did not achieve their primary endpoint of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic).
Previous report
In January 2026, topline safety and efficacy data from both studies were presented and included data on bone mineral density, vertebral fractures, and patient reported outcomes on pain and physical function. We believe the data across two global Phase 3 studies suggest that setrusumab has a meaningful effect on bone disease in OI. We will continue to engage regulatory agencies to determine the necessary data to support a regulatory filing and if there is a potential path forward for setrusumab.
Previous report
Alvelestat (MPH-966) for the Treatment of Severe Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD)
Previous report
On August 11, 2026, we entered into an Option and License Agreement (the "Sentynl Agreement") with Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company, for the U.S. commercial and global manufacturing rights to alvelestat for AATD-LD. Alvelestat is a neutrophil elastase inhibitor being readied for Phase 3 and, if approved, would be the first oral treatment for this rare, progressive genetic lung disease affecting an estimated 75,000 people in North America and 110,000 in Europe.
Previous report
Under the terms of the Sentynl Agreement, we will receive a non-refundable option fee and, on option exercise, we are eligible to receive $40 million in upfront and R&D payments, up to $435 million in potential milestones, and double-digit tiered royalties on U.S. sales of alvelestat. We will lead the global Phase 3 study and regulatory interactions until the study is completed. During the option period, we and Sentynl will collaborate to advance manufacturing and refine the Phase 3 study design.
Previous report
Foreign currency transaction loss, net
Previous report
Comparison of six months ended June 30, 2026 and 2025
Previous report
Cost of revenue
Previous report
The decrease was primarily due to reductions of $1.9 million in R&D expenses for alvelestat and $0.8 million for setrusumab.
Previous report
Comparison of the six months ended June 30, 2026 and 2025
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 late-stage rare disease product candidates are setrusumab for the treatment of OI and alvelestat for the treatment of severe 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, ADO2. The global development of vantictumab is being funded and led by our partner, āshibio, Inc. (“āshibio”), and we retain the European commercial rights.
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 late-stage rare disease product candidates are setrusumab for the treatment of OI and alvelestat for the treatment of severe 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, ADO2.
Previous wording
Total R&D expenses decreased by $3.6 million, from $5.4 million in the three months ended June 30, 2025 to $1.8 million in the three months ended June 30, 2026.
Current wording
Total R&D expenses decreased by $2.2 million, from $4.3 million in the three months ended September 30, 2025 to $2.1 million in the three months ended September 30, 2026.
Previous wording
The decrease was primarily due to reductions of $2.6 million in R&D expenses for setrusumab and $1.0 million for alvelestat.
Current wording
The decrease was primarily due to reductions of $1.6 million in R&D expenses for setrusumab and $0.4 million for alvelestat.
Previous wording
The decrease in program expenses for alvelestat was primarily due to the completion of activities undertaken in preparation for the potential Phase 3 study during 2025.
Current wording
The decrease in program expenses for alvelestat was primarily due to the completion of activities undertaken in 2025 in preparation for a potential Phase 3 study.
Previous wording
General and administrative expenses decreased by $3.5 million, from $12.8 million in the six months ended June 30, 2025 to $9.2 million in the six months ended June 30, 2026. The decrease was primarily due to delays to investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, and other realized cost savings.
Current wording
General and administrative expenses decreased by $1.1 million, from $6.0 million in the three months ended September 30, 2025 to $4.9 million in the three months ended September 30, 2026. The decrease was primarily due to reductions in investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, and other realized net cost savings.
Previous wording
Interest income decreased by $0.3 million, from $0.6 million in the three months ended June 30, 2025 to $0.3 million in the three months ended June 30, 2026, principally due to a combination of lower interest rates earned and lower average cash and cash equivalents balances in the three months ended June 30, 2026 compared to the three months ended June 30, 2025.
Current wording
Interest income decreased by $0.3 million, from $0.5 million in the three months ended September 30, 2025 to $0.2 million in the three months ended September 30, 2026, 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, 2026 compared to the three months ended September 30, 2025.
Previous wording
The total change in fair value of warrants in the three months ended June 30, 2026 was an unrealized gain of less than $0.1 million, compared to an unrealized loss of $0.1 million in the three months ended June 30, 2025. The unrealized gain in the three months ended June 30, 2026 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 June 30, 2025 was primarily due to the impact of increases 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, 2026 was an unrealized loss of less than $0.1 million, compared to an unrealized gain of $0.2 million in the three months ended September 30, 2025. The unrealized loss in the three months ended September 30, 2026 was primarily due to the impact of a negligible increase in the price of the Company’s ADSs on the value of the warrant liabilities while the unrealized gain in the three months ended September 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.
Previous wording
The net foreign exchange loss for the three months ended June 30, 2026 was $0.4 million, compared to a loss of $5.3 million for the three months ended June 30, 2025. This change primarily reflects the impact of a slight 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, 2026, compared to a more significant weakening of U.S. dollars in the three months ended June 30, 2025.
Current wording
The net foreign exchange gain for the three months ended September 30, 2026 was less than $0.1 million, compared to a gain of $1.9 million for the three months ended September 30, 2025. This change primarily reflects the impact of a negligible movement 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, 2026, compared to a strengthening of U.S. dollars in the three months ended September 30, 2025.
Previous wording
The benefit from research and development tax credit decreased by $0.6 million, from $0.7 million in the three months ended June 30, 2025 to $0.1 million in the three months ended June 30, 2026. This decrease reflects a lower level of qualifying expenditure in the three months ended June 30, 2026 than in the three months ended June 30, 2025.
Current wording
The benefit from research and development tax credit decreased by $0.3 million, from $0.4 million in the three months ended September 30, 2025 to $0.1 million in the three months ended September 30, 2026. This decrease reflects a lower level of qualifying expenditure in the three months ended September 30, 2026 than in the three months ended September 30, 2025.
Previous wording
Other comprehensive income– Foreign currency translation adjustments
Current wording
Other comprehensive income/(loss)– Foreign currency translation adjustments
Previous wording
The foreign currency translation adjustment for the three months ended June 30, 2026 was a gain of $0.3 million, compared to a gain of $6.6 million in the three months ended June 30, 2025. This change primarily reflects the impact of a slight 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 three months ended June 30, 2026, compared to a more significant weakening of U.S. dollars in the three months ended June 30, 2025.
Current wording
The foreign currency translation adjustment for the three months ended September 30, 2026 was a gain of less than $0.1 million, compared to a loss of $2.3 million in the three months ended September 30, 2025. This change primarily reflects the impact of a negligible movement 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, 2026, compared to a strengthening of U.S. dollars in the three months ended September 30, 2025.
Previous wording
The following table sets forth Mereo’s results of operations for the six months ended June 30, 2026 and 2025.
Current wording
The following table sets forth Mereo’s results of operations for the nine months ended September 30, 2026 and 2025.
Previous wording
No revenue was recognized for the three months ended June 30, 2026. 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.
Current wording
Revenue of $0.8 million for the nine months ended September 30, 2026 comprised the portion of the $1.0 million option fee pursuant to the Sentynl Agreement recognized based on an estimate of progress towards satisfaction of the performance obligation. 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 by ReproNovo pursuant to the ReproNovo Licensing Agreement.
Previous wording
No cost of revenue was recognized for the three months ended June 30, 2026. 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.
Current wording
No cost of revenue was recognized for the nine months ended September 30, 2026. Cost of revenue for the nine months ended September 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.
Previous wording
The following table sets forth our R&D expenses by product development program for the six months ended June 30, 2026 and 2025.
Current wording
The following table sets forth our R&D expenses by product development program for the nine months ended September 30, 2026 and 2025.
Previous wording
Total R&D expenses decreased by $2.7 million, from $9.3 million in the six months ended June 30, 2025 to $6.6 million in the six months ended June 30, 2026.
Current wording
Total R&D expenses decreased by $4.9 million, from $13.6 million in the nine months ended September 30, 2025 to $8.6 million in the nine months ended September 30, 2026.
Previous wording
The decrease in program expenses for setrusumab was primarily driven by reductions of, and delays to, investment in manufacturing and ongoing activities, including medical affairs activities in Europe during the six months ended June 30, 2026, partially offset by an expense of $2.3 million for our share of certain costs related to the cancellation of manufacturing slots by Ultragenyx.
Current wording
The decrease in program expenses for setrusumab was primarily driven by reductions of, and delays to, investment in manufacturing and ongoing activities, including medical affairs activities in Europe during the nine months ended September 30, 2026, partially offset by an expense of $2.3 million for our share of certain costs related to the cancellation of manufacturing slots by Ultragenyx.
Previous wording
The decrease in program expenses for alvelestat was primarily due to the completion of activities undertaken in preparation for the potential Phase 3 study in the six months ended June 30, 2025.
Current wording
The decrease in program expenses for alvelestat was primarily due to the completion of activities undertaken in preparation for a potential Phase 3 study in the nine months ended September 30, 2025.
Previous wording
General and administrative expenses decreased by $0.3 million, from $5.5 million in the three months ended June 30, 2025 to $5.2 million in the three months ended June 30, 2026. The decrease was primarily due to reductions of approximately $2.2 million driven by delays to investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, and other realized cost savings. These decreases were partially offset by 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, whereas the corresponding amount in the current year was recognized in the three months ended March 31, 2026.
Current wording
General and administrative expenses decreased by $4.6 million, from $18.8 million in the nine months ended September 30, 2025 to $14.2 million in the nine months ended September 30, 2026. The decrease was primarily due to reductions in investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe, and other realized net cost savings.
Previous wording
Interest income decreased by $0.6 million, from $1.2 million in the six months ended June 30, 2025 to $0.6 million in the six months ended June 30, 2026, principally due to a combination of lower interest rates earned and lower average cash and cash equivalents balances in the six months ended June 30, 2026 compared to the six months ended June 30, 2025.
Current wording
Interest income decreased by $0.9 million, from $1.8 million in the nine months ended September 30, 2025 to $0.8 million in the nine months ended September 30, 2026, principally due to a combination of lower interest rates earned and lower average cash and cash equivalents balances in the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.
Previous wording
Interest expense decreased by $0.2 million, from $0.2 million in the six months ended June 30, 2025 to less than $0.1 million in the six months ended June 30, 2026. 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 $0.2 million, from $0.2 million in the nine months ended September 30, 2025 to less than $0.1 million in the nine months ended September 30, 2026. 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 the fair value of warrants in the six months ended June 30, 2026 was an unrealized gain of less than $0.1 million, compared to an unrealized gain of $0.3 million in the six months ended June 30, 2025. The unrealized gain in both periods was 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 the fair value of warrants in the nine months ended September 30, 2026 was an unrealized gain of less than $0.1 million, compared to an unrealized gain of $0.5 million in the nine months ended September 30, 2025. The unrealized gain in both periods was primarily due to the impact of decreases in the price of the Company’s ADSs on the value of the warrant liabilities.
Previous wording
The net foreign exchange gain for the six months ended June 30, 2026 was $1.3 million, compared to a loss of $8.1 million for the six months ended June 30, 2025. 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 six months ended June 30, 2026, compared to a significant weakening of U.S. dollars in the six months ended June 30, 2025.
Current wording
The net foreign exchange gain for the nine months ended September 30, 2026 was $1.3 million, compared to a loss of $6.2 million for the nine months ended September 30, 2025. This change primarily reflects the impact of a strengthening in the value of
Previous wording
The benefit from research and development tax credit decreased by $0.7 million, from $0.9 million in the six months ended June 30, 2025 to $0.2 million in the six months ended June 30, 2026. This decrease reflects a lower level of qualifying expenditure in the six months ended June 30, 2026 than in the six months ended June 30, 2025.
Current wording
The benefit from research and development tax credit decreased by $1.1 million, from $1.4 million in the nine months ended September 30, 2025 to $0.3 million in the nine months ended September 30, 2026. This decrease reflects a significantly lower level of qualifying expenditure in the nine months ended September 30, 2026 than in the nine months ended September 30, 2025.
Previous wording
The foreign currency translation adjustment for the six months ended June 30, 2026 was a loss of $1.5 million, compared to a gain of $10.2 million in the six months ended June 30, 2025. 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 six months ended June 30, 2026, compared to a significant weakening of U.S. dollars in the six months ended June 30, 2025.
Current wording
The foreign currency translation adjustment for the nine months ended September 30, 2026 was a loss of $1.4 million, compared to a gain of $7.9 million in the nine months ended September 30, 2025. 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 nine months ended September 30, 2026, compared to a significant weakening of U.S. dollars in the nine months ended September 30, 2025.
Previous wording
Under the current business plan and cash flow forecasts, and in consideration of our ongoing research and development efforts and our general corporate funding requirements, we anticipate that our current on-hand cash resources will extend into late 2027. However, we will need additional external funding to complete our development plans and potentially commercialize selected rare disease products. We plan to fund our operations through cash on hand and a combination of non-dilutive funding sources, public or private equity or debt financing or other sources.
Current wording
Under the current business plan and cash flow forecasts, and in consideration of our ongoing research and development efforts and our general corporate funding requirements, we anticipate that our current on-hand cash resources will extend into late 2027. However, we will need additional external funding or may need to implement measures to conserve cash resources to complete our development plans and potentially commercialize selected rare disease products. We plan to fund our operations through cash on hand and a combination of non-dilutive funding sources, including partnering income, public or private equity or debt financing, or other sources.
Previous wording
$4.0 million under the license and collaboration agreement with Feng Biosciences, Inc. (formerly OncXerna Therapeutics, Inc.) for navicixizumab in 2020 and a further milestone payment of $2.0 million in 2022; and
Current wording
$4.0 million under the license and collaboration agreement with Feng Biosciences, Inc. (formerly OncXerna Therapeutics, Inc.) for navicixizumab in 2020 and a further milestone payment of $2.0 million in 2022;
Previous wording
$1.0 million under the global license agreement with ReproNovo SA for leflutrozole in 2023 and a further milestone payment of $0.5 million in 2025.
Current wording
$1.0 million under the global license agreement with ReproNovo SA for leflutrozole in 2023 and a further milestone payment of $0.5 million in 2025; and
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 2025 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 no manufacturing commitments with CMOs as of June 30, 2026 and December 31, 2025.
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 2025 Annual Report in “Item 1. Business—Material Agreements—Agreements with Ultragenyx for Setrusumab”, to assist in the performance of our 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 no manufacturing commitments with CMOs as of September 30, 2026 and December 31, 2025.
Previous wording
The table below summarizes our cash flows (used in)/provided by operating, investing and financing activities for the six months ended June 30, 2026 and 2025.
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, 2026 and 2025.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2026 was $10.4 million, a decrease of $5.6 million from $16.0 million in the six months ended June 30, 2025. This decrease is principally due to lower cash bonus payments of approximately $2.0 million and lower net operating cash flows of approximately $4.7 million, reflecting reduced R&D and General and administrative expenses in the period. These decreases were partially offset by receipt of $1.1 million in R&D tax credits in the six months ended June 30, 2025 with no similar amount received in the six months ended June 30, 2026.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2026 was $14.4 million, a decrease of $8.9 million from $23.3 million in the nine months ended September 30, 2025. This decrease is principally due to lower cash bonus payments of approximately $2.0 million, receipt of a $1.0 million option fee pursuant to the Sentynl Agreement and lower net operating cash flows of approximately $7.7 million, reflecting reduced R&D and General and administrative expenses in the period. These decreases were partially offset by receipt of $1.8 million in additional in R&D tax credits in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2026.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2026 and 2025 were $0.3 million. These cash flows primarily relate to payments to acquire intangible assets in both periods.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2026 was $0.3 million, an increase of $0.3 million from less than $0.1 million in the nine months ended September 30, 2025. These cash flows primarily relate to payments to acquire intangible assets in both periods, net of the proceeds from the partial out-licensing of vantictumab in the nine months ended September 30, 2025.
Previous wording
Net cash used in financing activities for the six months ended June 30, 2026 was less than $0.1 million, compared to net cash provided by financing activities of $0.3 million in the six months ended June 30, 2025. The decrease primarily represents the $0.5 million received upon exercise of the 2020 Novartis Warrants in the six months ended June 30, 2025, net of transaction costs.
Current wording
Net cash used in financing activities for the nine months ended September 30, 2026 was less than $0.1 million, compared to net cash provided by financing activities of $0.3 million in the nine months ended September 30, 2025. The decrease primarily represents the $0.5 million received upon exercise of the 2020 Novartis Warrants in the nine months ended September 30, 2025, net of transaction costs.
Previous wording
As of June 30, 2026, we had an accumulated deficit of $514.5 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.
Current wording
As of September 30, 2026, we had an accumulated deficit of $520.4 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
potentially establish a sales, marketing, and distribution infrastructure and scale-up manufacturing capabilities to commercialize or co-commercialize any product candidates for which we may obtain regulatory approval and chose to commercialize directly;
Current wording
potentially establish a sales, marketing, and distribution infrastructure and scale-up manufacturing capabilities to commercialize or co-commercialize any product candidates for which we may obtain regulatory approval and choose to commercialize directly;
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
U.S. dollars when translating U.S. dollar balances into our functional currency of pound sterling in the nine months ended September 30, 2026, compared to a significant weakening of U.S. dollars in the nine months ended September 30, 2025.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
No revenue was recognized for six months ended June 30, 2026. 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.
Previous report — wording carried elsewhere
No cost of revenue was recognized for the six months ended June 30, 2026. 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.