Disc Medicine, Inc.

Previous wording

We have completed two Phase 2 clinical trials of bitopertin: BEACON, an open-label, parallel-dose clinical trial in EPP and XLP patients conducted at sites in Australia, and AURORA, a randomized, double-blind, placebo-controlled clinical trial in EPP patients conducted at sites in the United States. In both trials, bitopertin significantly reduced the toxic metabolite, protoporphyrin IX, or PPIX, and was associated with improvements in measures of time spent in sunlight and quality of life. In addition, bitopertin was generally well-tolerated. All participants in AURORA and BEACON were eligible to participate in HELIOS, an ongoing open-label, long-term extension study of bitopertin in EPP and XLP patients. Interim data from HELIOS, presented in June 2025 and June 2026, demonstrated that longer term treatment of bitopertin was associated with sustained reductions in PPIX, as well as improvements in quality of life and liver biomarkers. Bitopertin is also currently being studied in APOLLO, a Phase 3, randomized, double-blind, placebo-controlled, clinical trial of bitopertin in EPP and XLP patients that we initiated in May 2025. In September 2025 we submitted a New Drug Application, or NDA, for accelerated approval of bitopertin in EPP and XLP in the United States based on our Phase 2 data. The FDA accepted our NDA for review in November 2025 and in February 2026 issued a complete response letter, or CRL. The FDA concluded that the AURORA and BEACON trials did not show evidence of association between percent change in PPIX and sunlight exposure-based endpoints as measured in the trials, resulting in uncertainty regarding whether bitopertin’s effect on PPIX is reasonably likely to predict clinical benefit, despite the strong mechanistic and biological plausibility supporting the use of the PPIX biomarker in protoporphyria. In our Type A meeting during the second quarter of 2026, the FDA indicated that results of the ongoing Phase 3 APOLLO trial, if successful, could serve as the basis for a response to the CRL and could potentially support a traditional approval. We completed enrollment in APOLLO (n=183) in the first quarter of 2026 and expect to report topline data in the fourth quarter of 2026. If successful, we plan to submit a response to the CRL and would then anticipate an FDA decision on our NDA by mid-2027.

Current wording

In September 2025 we submitted a New Drug Application, or NDA, for accelerated approval of bitopertin in EPP and XLP in the United States based on our Phase 2 data. The U.S. Food and Drug Administration, or the FDA, accepted our NDA for review in November 2025 and in February 2026 issued a complete response letter, or CRL. The FDA concluded that the AURORA and BEACON trials did not show evidence of association between percent change in PPIX and sunlight exposure-based endpoints as measured in the trials, resulting in uncertainty regarding whether bitopertin’s effect on PPIX is reasonably likely to predict clinical benefit, despite the strong mechanistic and biological plausibility supporting the use of the PPIX biomarker in protoporphyria. In our Type A meeting during the second quarter of 2026, the FDA indicated that results of the Phase 3 APOLLO trial, if successful, could serve as the basis for a response to the CRL and could potentially support a traditional approval. With the positive topline results from APOLLO, we plan to engage with the FDA and resubmit an NDA by the end of 2026, with an FDA decision anticipated by mid-2027.

Previous wording

Selcodebart is the lead product candidate in our iron homeostasis portfolio and was licensed from AbbVie Deutschland GmbH & Co. KG, or AbbVie. Selcodebart is designed to suppress hepcidin production and increase serum iron levels. We completed a Phase 1 clinical trial in healthy volunteers in the United States in June 2022, with results showing an acceptable tolerability profile and evidence of target engagement, iron mobilization and augmented erythropoiesis. We initiated a Phase 1b/2 clinical trial in June 2022 in patients with anemia of MF, with results from the Phase 1b portion of this clinical trial showing substantial and sustained reductions in hepcidin levels and increases in iron alongside strong hematologic responses across patient types and an acceptable tolerability profile. We initiated RALLY-MF, the open-label Phase 2 portion of this clinical trial, in December 2024 and reported initial data in December 2025 and interim data in June 2026, with results demonstrating meaningful overall anemia responses across all patient subgroups, regardless of baseline transfusion status and independent of concomitant Janus Kinase, or JAK, inhibitor therapy use. We expect to share additional data in the fourth quarter of 2026. If positive, we expect to hold an end-of-Phase 2 meeting with the FDA for selcodebart in anemia of MF by the end of 2026. We also initiated RALLY-IBD, a Phase 2 clinical trial of selcodebart in patients with IBD and anemia in the first quarter of 2026, with initial data anticipated in 2027, and we are planning exploratory studies in additional patient populations with anemia of chronic disease. We are also developing a preclinical anti-hemojuvelin, or HJV, monoclonal antibody, DISC-0998, which also targets hepcidin suppression and was licensed from AbbVie. DISC-0998 is designed to increase serum iron levels and has an extended serum half-life as compared to selcodebart. We believe this profile may be desirable in certain subsets of patients with anemia associated with inflammatory diseases.

Current wording

Selcodebart is the lead product candidate in our iron homeostasis portfolio and was licensed from AbbVie Deutschland GmbH & Co. KG, or AbbVie. Selcodebart is designed to suppress hepcidin production and increase serum iron levels. We completed a Phase 1 clinical trial in healthy volunteers in the United States in June 2022, with results showing an acceptable tolerability profile and evidence of target engagement, iron mobilization and augmented erythropoiesis. We initiated a Phase 1b/2 clinical trial in June 2022 in patients with anemia of MF, with results from the Phase 1b portion of this clinical trial showing substantial and sustained reductions in hepcidin levels and increases in iron alongside strong hematologic responses across patient types and an acceptable tolerability profile. We initiated RALLY-MF, the open-label Phase 2 portion of this clinical trial, in December 2024 and reported initial data in December 2025 and interim data in June 2026, with results demonstrating meaningful overall anemia responses across all patient subgroups, regardless of baseline transfusion status and independent of concomitant Janus Kinase, or JAK, inhibitor therapy use. We expect to share additional data and hold an end-of-Phase 2 meeting with the FDA for selcodebart in anemia of MF by the end of 2026. We anticipate initiating a Phase 3 clinical program for selcodebart in anemia of MF in the first half of 2027, subject to the outcome of our end-of-Phase 2 meeting with the FDA. We also initiated RALLY-IBD, a Phase 2 clinical trial of selcodebart in patients with IBD and anemia in the first quarter of 2026, with initial data anticipated in 2027, and we are planning exploratory studies in additional patient populations with anemia of chronic disease. We are also developing a preclinical anti-hemojuvelin, or HJV, monoclonal antibody, DISC-0998, which also targets hepcidin suppression and was licensed from AbbVie. DISC-0998 is designed to increase serum iron levels and has an extended serum half-life as compared to selcodebart. We believe this profile may be desirable in certain subsets of patients with anemia associated with inflammatory diseases.

Previous wording

In addition, we are developing DISC-3405, a monoclonal antibody against Transmembrane Serine Protease 6, or TMPRSS6, that we licensed from Mabwell Therapeutics, Inc., or Mabwell. DISC-3405 is part of our iron homeostasis portfolio and is designed to induce hepcidin production and reduce serum iron levels. We initiated a Phase 1 clinical trial of DISC-3405 in healthy adult volunteers in October 2023 and presented interim data from the single-ascending dose, or SAD, portion of this clinical trial in June 2024. We presented data from the multiple ascending dose, or MAD, portion of this clinical trial in December 2024, and presented updated data from both the SAD and MAD portions of this clinical trial in June 2025, with results showing an acceptable tolerability profile and evidence of target engagement, including dose-related increases in serum hepcidin and corresponding reductions in serum iron across all dose levels. We are developing DISC-3405 for the treatment of PV, SCD, and other hematologic disorders. We initiated RESTORE-PV, an open-label Phase 2 clinical trial of DISC-3405 in patients with PV, in June 2025, with initial data expected in the third quarter of 2026. We also initiated a Phase 1b, open-label clinical trial of DISC-3405 in patients with SCD in October 2025, with initial data expected in the fourth quarter of 2026, and plan to explore the role of therapeutic iron restriction in other indications.

Current wording

In addition, we are developing DISC-3405, a monoclonal antibody against Transmembrane Serine Protease 6, or TMPRSS6, that we licensed from Mabwell Therapeutics, Inc., or Mabwell. DISC-3405 is part of our iron homeostasis portfolio and is designed to induce hepcidin production and reduce serum iron levels. We initiated a Phase 1 clinical trial of DISC-3405 in healthy adult volunteers in October 2023, with results showing an acceptable tolerability profile and evidence of target engagement, including dose-related increases in serum hepcidin and corresponding reductions in serum iron across all dose levels. We are developing DISC-3405 for the treatment of PV, SCD, and other hematologic disorders. We initiated RESTORE-PV, an open-label Phase 2 clinical trial of DISC-3405 in patients with PV, in June 2025, and reported initial efficacy data from Cohort A of this trial in September 2026, with results demonstrating that treatment with DISC-3405 increased hepcidin and lowered serum iron, translating to reduction in phlebotomy events, controlled hematocrit, and improved symptom burden in patients with PV. In this initial data, DISC-3405 was generally well-tolerated in participants in Cohort A and Cohort B, with adverse events that were consistent with underlying disease and a low rate of injection site reactions, which were mild and self-limited. We expect to report additional data from our RESTORE-PV clinical trial by the end of 2026 and topline data in 2027. If positive, and subject to engagement with the FDA, we anticipate initiating a Phase 3 clinical program for DISC-3405 in PV in 2027. We also initiated a Phase 1b, open-label clinical trial of DISC-3405 in patients with SCD in October 2025, with initial data expected in the fourth quarter of 2026, and plan to explore the role of therapeutic iron restriction in other indications.

Previous wording

As of June 30, 2026, we had cash, cash equivalents and marketable securities of $717.7 million. We believe that our cash, cash equivalents and marketable securities will be sufficient to fund our current operating and capital expenditure plans and our debt service obligations into 2029, without taking into account any potential net cash inflows from bitopertin or any other marketed product, if approved during such period. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See "Liquidity and Capital Resources" for additional details.

Current wording

As of September 30, 2026, we had cash, cash equivalents and marketable securities of $682.8 million. In October 2026, we completed an underwritten public offering of shares of our common stock for net proceeds of approximately $485.9 million, after deducting estimated offering expenses payable by us. We believe that our cash, cash equivalents and marketable securities, including the net proceeds of our October 2026 underwritten public offering, will be sufficient to fund our current operating and capital expenditure plans and our debt service obligations into 2030, without taking into account any potential net cash inflows from bitopertin or any other marketed product, if approved during such period. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See "Liquidity and Capital Resources" for additional details.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of the Three and Nine Months Ended September 30, 2026 and 2025

Previous wording

The following table summarizes our results of operations for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our results of operations for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

The following table summarizes our research and development expenses for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Research and development expenses were $46.9 million for the three months ended June 30, 2026, compared to $46.3 million for the three months ended June 30, 2025. The increase of $0.6 million was driven by increases of $7.7 million and $3.1 million related to selcodebart (DISC-0974) and DISC-3405, respectively, primarily related to clinical trial advancement and drug manufacturing activities. Personnel-related costs increased $5.9 million related to higher research and development headcount, including an increase of $3.1 million in stock-based compensation driven by awards granted under our equity compensation plans. These increases were partially offset by a decrease of $15.0 million in bitopertin development expenses primarily driven by a $10.0 million milestone payment and higher manufacturing costs incurred during the comparative period. Other research programs and expenses also decreased $1.1 million.

Current wording

Research and development expenses were $44.1 million for the three months ended September 30, 2026, compared to $50.3 million for the three months ended September 30, 2025. The decrease of $6.3 million was driven by a $7.0 million reduction in expenses related to DISC-3405, primarily related to a $10.0 million milestone payment incurred during the comparative period. There was also a decrease of $4.8 million in bitopertin development expenses, primarily related to drug manufacturing activities in the comparative period that did not recur in the current period. These decreases were partially offset by an increase in personnel related costs of $3.8 million related to higher research and development headcount, including an increase of $2.9 million in stock-based compensation driven by awards granted under our equity compensation plans. Selcodebart development expenses increased $1.1 million, primarily related to drug manufacturing activities. Other research programs and expenses also increased $0.8 million.

Previous wording

Research and development expenses were $92.8 million for the six months ended June 30, 2026, compared to $74.1 million for the six months ended June 30, 2025. The increase of $18.8 million was primarily due to an increase of $13.1 million in personnel-related costs related to higher research and development headcount, including an increase of $6.0 million in stock-based compensation driven by awards granted under our equity compensation plans. DISC-3405 development expenses increased $10.6 million primarily driven by increased clinical and manufacturing activities and a $5.0 million milestone payment triggered in the first quarter of 2026. Additionally, selcodebart (DISC-0974) development expenses increased $9.7 million primarily related to clinical trial advancement and drug manufacturing activities. These increases were partially offset by a decrease of $14.1 million in bitopertin development expenses primarily driven by a $10.0 million milestone payment and higher manufacturing costs incurred during the comparative period. Other research programs and expenses also decreased $0.5 million.

Current wording

Research and development expenses were $136.9 million for the nine months ended September 30, 2026, compared to $124.4 million for the nine months ended September 30, 2025. The increase of $12.5 million was primarily due to an increase of $16.8 million in personnel-related costs related to higher research and development headcount, including an increase of $8.8 million in stock-based compensation driven by awards granted under our equity compensation plans. Selcodebart development expenses increased $10.8 million primarily related to clinical trial advancement and drug manufacturing activities. DISC-3405 development expenses increased $3.5 million primarily driven by increased clinical trial and drug manufacturing activities of $8.5 million which were partially offset by lower milestone payments of $5.0 million. Bitopertin development expenses decreased $19.0 million primarily driven by a $10.0 million milestone payment and drug manufacturing activities in the comparative period that did not recur in the current period.

Previous wording

The following table summarizes our selling, general and administrative expenses for the three and six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our selling, general and administrative expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Selling, general and administrative expenses were $18.1 million for the three months ended June 30, 2026, compared to $15.1 million for the three months ended June 30, 2025. The increase of $3.1 million was primarily due to an increase of $3.9 million in personnel-related costs due to increased selling, general and administrative headcount, including an increase of $2.4 million in stock-based compensation driven by awards granted under our equity compensation plans. This increase was partially offset by a $1.2 million decrease in legal, consulting, and professional fees primarily related to changes in the timing and scope of commercialization activities.

Current wording

Selling, general and administrative expenses were $20.1 million for the three months ended September 30, 2026, compared to $17.4 million for the three months ended September 30, 2025. The increase of $2.7 million was primarily due to an increase of $2.3 million in personnel-related costs due to increased selling, general and administrative headcount, including an increase of $2.2 million in stock-based compensation driven by awards granted under our equity compensation plans.

Previous wording

Selling, general and administrative expenses were $41.8 million for the six months ended June 30, 2026, compared to $27.3 million for the six months ended June 30, 2025. The increase of $14.5 million was primarily due to an increase of $12.6 million in personnel-related costs due to increased selling, general and administrative headcount, including an increase of $5.1 million in stock-based compensation driven by awards granted under our equity compensation plans and an increase of $1.6 million related to an organizational restructuring. There were also increases of $1.0 million and $0.9 million in other expenses and legal, consulting, and professional fees, respectively, primarily related to developing our commercialization capabilities.

Current wording

Selling, general and administrative expenses were $61.8 million for the nine months ended September 30, 2026, compared to $44.6 million for the nine months ended September 30, 2025. The increase of $17.2 million was primarily due to an increase of $14.9 million in personnel-related costs due to increased selling, general and administrative headcount, including an increase of $7.4 million in stock-based compensation driven by awards granted under our equity compensation plans and an increase of $1.6 million related to an organizational restructuring. There were also increases of $1.1 million and $1.2 million in other expenses and legal, consulting, and professional fees, respectively, primarily related to developing our commercialization capabilities.

Previous wording

Other income (expense), net was $5.6 million and $11.7 million for the three and six months ended June 30, 2026, respectively, compared to $6.2 million and $12.2 million for the three and six months ended June 30, 2025, respectively. Other income (expense), net consists primarily of interest income from our cash, cash equivalents and marketable securities, partially offset by interest expense associated with our term loan.

Current wording

Other income (expense), net was $4.7 million and $16.4 million for the three and nine months ended September 30, 2026, respectively, compared to $5.5 million and $17.7 million for the three and nine months ended September 30, 2025, respectively. Other income (expense), net consists primarily of interest income from our cash, cash equivalents and marketable securities, partially offset by interest expense associated with our term loan.

Previous wording

Income tax expense was $0.1 million for both the three and six months ended June 30, 2026, compared to $0.1 million and $0.2 million for the three and six months ended June 30, 2025, respectively. This expense primarily relates to state income tax resulting from an increase in interest income.

Current wording

Income tax expense was $0.1 million and $0.2 million for the three and nine months ended September 30, 2026, respectively, compared to $0.1 million and $0.3 million for the three and nine months ended September 30, 2025, respectively. This expense primarily relates to state income tax resulting from interest income.

Previous wording

To date, we have funded our operations primarily with proceeds from the sale of our convertible preferred stock and common stock, the proceeds from the merger with Gemini, proceeds from various private and public sales of our equity securities and proceeds from borrowings under the Hercules Loan Agreement. Through June 30, 2026, we have received net proceeds of $144.5 million from sales of our Series Seed, Series A and Series B convertible preferred stock, $89.5 million from the merger with Gemini, $941.8 million from various private and public sales of our equity securities, and $57.6 million from net borrowings under the Hercules Loan Agreement. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $717.7 million.

Current wording

To date, we have funded our operations primarily with proceeds from the sale of our convertible preferred stock and common stock, the proceeds from the merger with Gemini, proceeds from various private and public sales of our equity securities and proceeds from borrowings under the Hercules Loan Agreement. Through September 30, 2026, we have received net proceeds of $144.5 million from sales of our Series Seed, Series A and Series B convertible preferred stock, $89.5 million from the merger with Gemini, $941.8 million from various private and public sales of our equity securities, and $57.6 million from net borrowings under the Hercules Loan Agreement. As of September 30, 2026, we had cash, cash equivalents and marketable securities of $682.8 million.

Previous wording

We have incurred significant operating losses since inception and, as of June 30, 2026, had an accumulated deficit of $633.2 million. In addition, we expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future. We believe that our cash, cash equivalents and marketable securities will be sufficient to fund our current operating and capital expenditure plans and our debt service obligations into 2029, without taking into account any potential net cash inflows from bitopertin or any other marketed product, if approved during such period. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We may also pursue additional cash resources through public or private equity offerings, collaborations or additional debt financing.

Current wording

We have incurred significant operating losses since inception and, as of September 30, 2026, had an accumulated deficit of $692.8 million. In addition, we expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future. We believe that our cash, cash equivalents and marketable securities, including the net proceeds of our October 2026 underwritten public offering, will be sufficient to fund our current operating and capital expenditure plans and our debt service obligations into 2030, without taking into account any potential net cash inflows from bitopertin or any other marketed product, if approved during such period. We have based these estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We may also pursue additional cash resources through public or private equity offerings, collaborations or additional debt financing.

Previous wording

During the six months ended June 30, 2025, net cash used in operating activities of $89.3 million was primarily due to our net loss of $89.3 million and the change in operating assets and liabilities of $11.2 million. These were partially offset by non-cash expenses of $11.2 million which included $14.8 million in stock-based compensation, reduced by $5.1 million from amortization and accretion of investment securities.

Current wording

During the nine months ended September 30, 2026, net cash used in operating activities of $146.6 million was primarily due to our net loss of $182.6 million. This was partially offset by non-cash expenses of $40.2 million, which included $40.5 million in stock-based compensation, and the change in operating assets and liabilities of $4.2 million.

Previous wording

During the six months ended June 30, 2026, net cash used in operating activities of $106.4 million was primarily due to our net loss of $123.0 million and the change in operating assets and liabilities of $8.6 million. These were partially offset by non-cash expenses of $25.2 million which included $25.9 million in stock-based compensation, reduced by $1.6 million from amortization and accretion of investment securities.

Current wording

During the nine months ended September 30, 2025, net cash used in operating activities of $137.1 million was primarily due to our net loss of $151.7 million and the change in operating assets and liabilities of $4.9 million. These were partially offset by non-cash expenses of $19.4 million which included $24.3 million in stock-based compensation, reduced by $6.9 million from amortization and accretion of investment securities.

Previous wording

During the six months ended June 30, 2026, net cash provided by investing activities was primarily due to maturities of marketable securities of $266.4 million, partially offset by purchases of marketable securities of $186.5 million.

Current wording

During the nine months ended September 30, 2026, net cash provided by investing activities was primarily due to maturities of marketable securities of $410.2 million, partially offset by purchases of marketable securities of $305.0 million.

Previous wording

During the six months ended June 30, 2025, net cash used in investing activities was primarily due to purchases of marketable securities of $405.9 million, partially offset by maturities of marketable securities of $185.8 million.

Current wording

During the nine months ended September 30, 2025, net cash used in investing activities was primarily due to purchases of marketable securities of $491.3 million, partially offset by maturities of marketable securities of $320.8 million.

Previous wording

During the six months ended June 30, 2026, net cash provided by financing activities of $34.0 million consisted primarily of net proceeds from the issuance of long-term debt of $30.0 million and proceeds from stock option exercises.

Current wording

During the nine months ended September 30, 2026, net cash provided by financing activities of $40.2 million consisted primarily of net proceeds from the issuance of long-term debt of $30.0 million and proceeds from stock option exercises of $9.1 million.

Previous wording

During the six months ended June 30, 2025, net cash provided by financing activities of $245.1 million consisted primarily of aggregate net proceeds of $243.4 million from our underwritten offering in January 2025.

Current wording

During the nine months ended September 30, 2025, net cash provided by financing activities of $256.7 million consisted primarily of aggregate net proceeds of $243.4 million and $9.8 million from our underwritten offering in January 2025 and sales of shares of common stock pursuant to our Controlled Equity Offering Sales Agreement, or the Cantor ATM Agreement, with Cantor Fitzgerald & Co., or Cantor, respectively.