Odyssey Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 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 4, 2026
ODTX$19.23+1.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-335822
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001193125-26-446208
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 153 previous paragraphs and 150 current paragraphs.
106 unchanged; 34 reworded; 9 added; 10 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 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 (9)
Current report
a $2.2 million increase in internal personnel-related expenses, primarily due to increased stock-based compensation from awards granted upon the IPO and higher headcount; and
Current report
a $0.2 million decrease in facility-related costs, primarily due to lower depreciation expense following the disposal of fixed assets.
Current report
General and administrative expenses increased by $1.1 million, from $10.2 million during the three months ended September 30, 2025 to $11.2 million for the three months ended September 30, 2026. This increase was primarily attributable to:
Current report
a $1.2 million decrease in facility-related costs, primarily due to the loss on disposal of fixed assets recognized in the third quarter of 2025.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
Research and development expenses increased by $15.3 million, from $95.3 million for the nine months ended September 30, 2025 to $110.7 million for the nine months ended September 30, 2026. This increase was primarily attributable to:
Current report
General and administrative expenses decreased by $2.2 million, from $31.3 million during the nine months ended September 30, 2025 to $29.1 million for the nine months ended September 30, 2026. This decrease was primarily attributable to:
Current report
a $1.4 million decrease in facility-related costs, primarily due to losses on disposal of fixed assets recognized in 2025.
Current report
Nine months ended September 30, 2026 and 2025
Removed paragraphs (10)
Previous report
These increases were partially offset by:
Previous report
a $1.1 million decrease in internal personnel-related expenses, primarily due to a lower headcount.
Previous report
General and administrative expenses decreased by $2.7 million, from $13.2 million during the three months ended June 30, 2025 to $10.5 million for the three months ended June 30, 2026. This decrease was primarily attributable to:
Previous report
This decrease was partially offset by:
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
Research and development expenses decreased by $0.5 million, from $69.0 million for the six months ended June 30, 2025 to $68.5 million for the six months ended June 30, 2026. This decrease was primarily attributable to:
Previous report
General and administrative expenses decreased by $3.3 million, from $21.2 million during the six months ended June 30, 2025 to $17.9 million for the six months ended June 30, 2026. This decrease was primarily attributable to:
Previous report
a $0.1 million decrease in facility-related costs due to higher fixed asset disposals in the first half of 2025;
Previous report
Prior to the completion of our IPO and concurrent private placement in May 2026, we raised aggregate gross proceeds of approximately $726.5 million from the sale of our securities. In May 2026, we raised aggregate net proceeds of $278.2 million upon completion of our IPO and concurrent private placement, after deducting underwriter discounts and commissions, placement agent fees and other estimated offering expenses. Additionally, in June 2026, we raised aggregate net proceeds of $10.0 million upon the sale of our common stock pursuant to the underwriters' exercise of their option to purchase shares, after deducting underwriter discounts and commissions.
Previous report
Six months ended June 30, 2026 and 2025
Reworded paragraphs (34)
Previous wording
Our most advanced programs include OD-001, an oral small-molecule scaffolding inhibitor of receptor-interacting protein kinase 2, or RIPK2, and OD-002, an oral small-molecule inhibitor of solute carrier family 15 member 4, or SLC15A4. OD-001 has achieved proof-of-concept in a phase 2a trial for the treatment of ulcerative colitis, or UC, one of the two main types of inflammatory bowel disease, or IBD, and OD-002 is currently in IND-enabling studies. These programs have the potential to yield treatments for inflammatory and autoimmune diseases that have large, addressable patient populations globally and a lack of effective treatments, including IBD, systemic lupus erythematosus, and other disorders characterized either by the chronic overactivation of the type I interferon pathway, referred to as interferonopathies, or by pathogenic autoreactive B cells. In addition to our most advanced programs, we have a portfolio of wholly owned preclinical programs that include, but are not limited to, a regulatory T cells-specific tumor necrosis factor receptor 2 agonist, a bispecific antagonist of thymic stromal lymphopoietin and interleukin-33, and an interleukin-1 receptor-associated kinase 4 scaffolding inhibitor. We also have an interferon regulatory factor 5, or IRF5, inhibitor in preclinical development which we are collaborating on with Terray Therapeutics, Inc., or Terray.
Current wording
Our most advanced programs include OD-001, an oral small-molecule scaffolding inhibitor of receptor-interacting protein kinase 2, or RIPK2, and OD-002, an oral small-molecule inhibitor of solute carrier family 15 member 4, or SLC15A4. OD-001 has achieved proof-of-concept and we have completed OD-001 induction treatment in a phase 2a trial for the treatment of ulcerative colitis, or UC, one of the two main types of inflammatory bowel disease, or IBD. We have completed IND-enabling studies for OD-002, our second most advanced program, and expect to progress that program into clinical development. These programs have the potential to yield treatments for inflammatory and autoimmune diseases that have large, addressable patient populations globally and a lack of effective treatments, including IBD, systemic lupus erythematosus, and other disorders characterized either by the chronic overactivation of the type I interferon pathway, referred to as interferonopathies, or by pathogenic autoreactive B cells. In addition to our most advanced programs, we have a portfolio of wholly owned preclinical programs that include, but are not limited to, OD-003, a regulatory T cell-specific tumor necrosis factor receptor 2 agonist, OD-004, a bispecific antagonist of thymic stromal lymphopoietin and interleukin-33, and an interleukin-1 receptor-associated kinase 4 scaffolding inhibitor. We also have an interferon regulatory factor 5, or IRF5, inhibitor in preclinical development, which we are collaborating on with Terray Therapeutics, Inc., or Terray.
Previous wording
We have incurred significant operating losses and negative cash flows since our inception. Our net loss was $91.1 million and $79.7 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $659.2 million and cash, cash equivalents, and marketable securities of $433.1 million. Since our inception, we have financed our operations primarily through the sale of shares of our convertible preferred stock, the proceeds from research collaborations and license agreements, and through the sale of our common stock as part of our IPO and concurrent private placement completed in May 2026.
Current wording
We have incurred significant operating losses and negative cash flows since our inception. Our net loss was $144.1 million and $115.1 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $712.2 million and cash, cash equivalents, and marketable securities of $387.0 million. Since our inception, we have financed our operations primarily through the sale of shares of our convertible preferred stock, the proceeds from research collaborations and license agreements, and through the sale of our common stock as part of our IPO and concurrent private placement completed in May 2026.
Previous wording
We did not have any revenue for the three and six months ended June 30, 2026. For the three and six months ended June 30, 2025 our revenue consisted of collaboration revenue earned under the Material Transfer and Evaluation Agreement, dated December 20, 2022, or the Pfizer MTA, with Pfizer Inc., or Pfizer, which expired by its terms in 2025, and revenue earned under the Strategic Collaboration, Option and License Agreement, dated March 29, 2024, or the J&J Agreement, with Janssen Pharmaceutica NV, a Johnson & Johnson company, or J&J. For additional information about our revenue recognition policy related to our collaboration agreements, refer to Note 4 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Current wording
We did not have any revenue for the three and nine months ended September 30, 2026. For the three and nine months ended September 30, 2025 our revenue consisted of collaboration revenue earned under the Material Transfer and Evaluation Agreement, dated December 20, 2022, or the Pfizer MTA, with Pfizer Inc., or Pfizer, which expired by its terms in 2025, and revenue earned under the Strategic Collaboration, Option and License Agreement, dated March 29, 2024, or the J&J Agreement, with Janssen Pharmaceutica NV, a Johnson & Johnson company, or J&J. For additional information about our revenue recognition policy related to our collaboration agreements, refer to Note 4 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Previous wording
Collaboration revenue decreased by $1.0 million, from $1.0 million for the three months ended June 30, 2025 compared to zero for the three months ended June 30, 2026. The decrease is related to the Company fulfilling all of its current obligations under the J&J Agreement and the expiration of the Pfizer MTA during the year ended December 31, 2025.
Current wording
Collaboration revenue decreased by $0.1 million, from $0.1 million for the three months ended September 30, 2025 compared to zero for the three months ended September 30, 2026. The decrease is related to the Company fulfilling all of its current obligations under the J&J Agreement and the expiration of the Pfizer MTA during the year ended December 31, 2025.
Previous wording
Research and development expenses increased by $6.0 million, from $30.2 million for three months ended June 30, 2025 to $36.2 million for the three months ended June 30, 2026. This increase was primarily attributable to:
Current wording
Research and development expenses increased by $15.8 million, from $26.3 million for three months ended September 30, 2025 to $42.1 million for the three months ended September 30, 2026. This increase was primarily attributable to:
Previous wording
a $6.2 million increase in external expenses associated with preclinical and clinical studies, primarily due to an increase in CRO expenses and chemistry, manufacturing, and controls activities primarily associated with our ongoing OD-001 phase 2a monotherapy trial;
Current wording
a $12.4 million increase in external expenses associated with preclinical and clinical studies, primarily due to an increase in CRO expenses associated with start-up activities for our planned OD-001 phase 2b monotherapy and phase 2a combination trials, as well as increased toxicology studies, external chemistry and chemistry, manufacturing, and controls activities supporting our pipeline programs;
Previous wording
a $0.5 million increase in research software, professional services and laboratory operations, primarily due to the increase in research reagents to support increased level of research activity across the discovery and toxicology programs; and
Current wording
a $1.4 million increase in research software, professional services and laboratory operations, primarily due to the increase in research reagents and laboratory supplies to support increased level of research activity across the discovery programs.
Previous wording
a $1.2 million increase in payroll and personnel-related expenses, primarily due to increased stock-based compensation from awards granted upon the IPO; and
Current wording
a $2.1 million increase in payroll and personnel-related expenses, primarily due to increased stock-based compensation from awards granted upon the IPO; and
Previous wording
a $0.1 million increase in other general and administrative expenses due to additional corporate insurance expenses.
Current wording
a $0.3 million increase in other general and administrative expenses, primarily due to additional corporate insurance expenses associated with operating as a public company.
Previous wording
The change in the fair value of contingent consideration resulted in expense of $8.7 million for the three months ended June 30, 2026, compared to income of $0.6 million for the three months ended June 30, 2025. The change was driven by updates to the assumptions used in estimating the fair value of the Rahko contingent consideration following the completion of our IPO in May 2026.
Current wording
The change in the fair value of contingent consideration resulted in expense of $3.3 million for the three months ended September 30, 2026, compared to expense of $1.9 million for the three months ended September 30, 2025. The change was driven by updates to the assumptions used in estimating the fair value of the Rahko contingent consideration, primarily due to an increase in the Company's market capitalization, following the completion of our IPO in May 2026.
Previous wording
Interest income increased by $1.9 million from $0.9 million for the three months ended June 30, 2025 to $2.8 million for the three months ended June 30, 2026. The increase is primarily attributed to additional cash invested in marketable securities and interest-bearing accounts during the first half of 2026, given the proceeds received from our IPO.
Current wording
Interest income increased by $1.7 million from $2.2 million for the three months ended September 30, 2025 to $3.9 million for the three months ended September 30, 2026. The increase is primarily attributed to additional cash invested in marketable securities and interest-bearing accounts during 2026, given the proceeds received from our IPO.
Previous wording
Other income (expense), net decreased by $0.1 million from expense of $0.4 million during the six months ended June 30, 2025 compared to expense of $0.3 million during the six months ended June 30, 2026. The decrease primarily relates to fluctuations in foreign currency gains and losses.
Current wording
Other income (expense), net decreased by $0.7 million from income of $0.5 million during the three months ended September 30, 2025 compared to expense of $0.2 million during the three months ended September 30, 2026. The decrease primarily relates to a refundable tax credit recognized in the third quarter of 2025 and higher investment advisory fees in 2026 resulting from our larger investment portfolio.
Previous wording
Collaboration revenue decreased by $2.9 million, from $2.9 million for the six months ended June 30, 2025 compared to zero for the six months ended June 30, 2026. The decrease is related to the Company fulfilling all of its current obligations under the J&J Agreement and the expiration of the Pfizer MTA during the year ended December 31, 2025.
Current wording
Collaboration revenue decreased by $3.0 million, from $3.0 million for the nine months ended September 30, 2025 compared to zero for the nine months ended September 30, 2026. The decrease is related to the Company fulfilling all of its current obligations under the J&J Agreement and the expiration of the Pfizer MTA during the year ended December 31, 2025.
Previous wording
a $9.3 million increase in external expenses associated with preclinical and clinical studies, primarily due to an increase in CRO expenses and chemistry, manufacturing, and controls activities primarily associated with our ongoing OD-001 phase 2a monotherapy trial.
Current wording
a $21.7 million increase in external expenses associated with preclinical and clinical studies, primarily due to an increase in CRO expenses associated with our OD-001 phase 2a monotherapy trial and start-up activities for our planned OD-001 phase 2b monotherapy and phase 2a combination trials, as well as increased toxicology studies and external chemistry supporting our pipeline programs; and
Previous wording
a $6.0 million decrease in facility related costs primarily related to an impairment of our San Diego lease right-of-use asset in the first quarter of 2025; and
Current wording
a $6.2 million decrease in facility-related costs, primarily related to an impairment of our San Diego lease right-of-use asset in the first quarter of 2025; and
Previous wording
a $3.8 million decrease in internal personnel-related expenses, primarily attributable to a lower headcount.
Current wording
a $1.6 million decrease in internal personnel-related expenses, primarily attributable to lower headcount, partially offset by increased stock-based compensation from awards granted upon the IPO.
Previous wording
a $4.0 million decrease in professional and consulting fees due to lower legal and accounting fees; and
Current wording
a $4.2 million decrease in professional and consulting fees due to lower legal and accounting fees; and
Previous wording
a $0.7 million increase in payroll and personnel-related expenses, primarily due to increased stock-based compensation from awards granted upon the IPO; and
Current wording
a $2.8 million increase in payroll and personnel-related expenses, primarily due to increased stock-based compensation from awards granted upon the IPO; and
Previous wording
a $0.1 million increase in other general and administrative expenses due to additional corporate insurance expenses.
Current wording
a $0.4 million increase in other general and administrative expenses, primarily due to additional corporate insurance expenses associated with operating as a public company.
Previous wording
The change in the fair value of contingent consideration resulted in expense of $8.8 million for the six months ended June 30, 2026, compared to income of $6.2 million for the six months ended June 30, 2025. The change was driven by updates to the assumptions management used in estimating the fair value of the Rahko contingent consideration following the completion of our IPO in May 2026.
Current wording
The change in the fair value of contingent consideration resulted in expense of $12.2 million for the nine months ended September 30, 2026, compared to income of $4.3 million for the nine months ended September 30, 2025. The change was driven by updates to the assumptions management used in estimating the fair value of the Rahko contingent consideration following the completion of our IPO in May 2026.
Previous wording
Interest income increased by $2.5 million from $2.0 million for the six months ended June 30, 2025 to $4.5 million for the six months ended June 30, 2026. The increase is primarily attributed to additional cash invested in marketable securities and interest-bearing accounts during the first half of 2026, reflecting proceeds received from the Series D convertible preferred stock financing completed in the second half of 2025 and our IPO in May 2026.
Current wording
Interest income increased by $4.2 million from $4.2 million for the nine months ended September 30, 2025 to $8.4 million for the nine months ended September 30, 2026. The increase is primarily attributed to additional cash invested in marketable securities and interest-bearing accounts during 2026, reflecting proceeds received from the Series D convertible preferred stock financing completed in the second half of 2025 and our IPO in May 2026.
Previous wording
Interest expense did not significantly fluctuate during the six months ended June 30, 2026 as compared to the six months ended June 30, 2025, and is attributable to interest on our finance leases for certain lab equipment.
Current wording
Interest expense did not significantly fluctuate during the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025, and is attributable to interest on our finance leases for certain lab equipment.
Previous wording
Other income (expense), net decreased by $0.1 million from expense of $0.2 million during the three months ended June 30, 2025 compared to expense of $0.1 million during the three months ended June 30, 2026. The decrease primarily relates to fluctuations in foreign currency gains and losses.
Current wording
Other income (expense), net decreased by $0.6 million from income of $0.1 million during the nine months ended September 30, 2025 compared to expense of $0.5 million during the nine months ended September 30, 2026. The decrease primarily relates to a non-recurring Australian tax refund recognized in 2025 and higher investment advisory fees and unrealized losses in 2026, partially offset by foreign currency gains.
Previous wording
Income tax provision did not significantly fluctuate during the six months ended June 30, 2026 as compared to the six months ended June 30, 2025.
Current wording
Income tax provision did not significantly fluctuate during the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025.
Previous wording
Since our inception, we have primarily funded our operations through the sale of shares of our convertible preferred stock, the proceeds from research collaborations and license agreements and through the sale of our common stock in our IPO and concurrent private placement completed in May 2026. We have not generated any revenue from product sales and have incurred significant annual operating losses and negative cash flows from our operations. We expect to incur significant expenses and operating losses in the foreseeable future as we advance the development of our product candidates. As of June 30, 2026, we had $433.1 million in cash, cash equivalents and marketable securities and an accumulated deficit of $659.2 million.
Current wording
Since our inception, we have primarily funded our operations through the sale of shares of our convertible preferred stock, the proceeds from research collaborations and license agreements and through the sale of our common stock in our IPO and concurrent private placement completed in May 2026. We have not generated any revenue from product sales and have incurred significant annual operating losses and negative cash flows from our operations. We expect to incur significant expenses and operating losses in the foreseeable future as we advance the development of our product candidates. As of September 30, 2026, we had $387.0 million in cash, cash equivalents and marketable securities and an accumulated deficit of $712.2 million.
Previous wording
As of June 30, 2026, we had cash and cash equivalents, and marketable securities of $433.1 million. Based upon our current operating plans, we believe that the net proceeds from our IPO and concurrent private placement completed in May 2026, together with our cash, cash equivalents and investments as of June 30, 2026, will be sufficient to fund our operations into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Current wording
As of September 30, 2026, we had cash and cash equivalents, and marketable securities of $387.0 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and investments as of September 30, 2026, will be sufficient to fund our operations into the second half of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2026 was $72.2 million, primarily consisting of our net loss of $91.1 million and net changes in operating assets and liabilities of $2.7 million, which were partially offset by adjustments to reconcile net loss to net cash used in operating activities of $21.6 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2026 was $117.1 million, primarily consisting of our net loss of $144.1 million and net changes in operating assets and liabilities of $8.0 million, which were partially offset by adjustments to reconcile net loss to net cash used in operating activities of $35.0 million.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2025 was $72.9 million, primarily consisting of our net loss of $79.7 million and net changes in operating assets and liabilities of $2.8 million, which were partially offset by adjustments to reconcile net loss to net cash used in operating activities of $9.7 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2025 was $104.1 million, primarily consisting of our net loss of $115.1 million and net changes in operating assets and liabilities of $8.0 million, which were partially offset by adjustments to reconcile net loss to net cash used in operating activities of $19.0 million.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2026 was $176.6 million, primarily consisting of $246.5 million of purchases of marketable securities, partially offset by $69.9 million of maturities of marketable securities.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2026 was $133.3 million, primarily consisting of $246.5 million of purchases of marketable securities, partially offset by $113.7 million of maturities of marketable securities.
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2025 was $57.4 million, primarily consisting of maturities of marketable securities of $58.3 million.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2025 was $115.5 million, primarily consisting of $185.8 million of purchases of marketable securities, partially offset by $71.0 million of maturities of marketable securities.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2026 was $289.3 million, primarily consisting of proceeds from our IPO and concurrent private placement, including the underwriters’ partial exercise of their option to purchase additional shares.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2026 was $289.5 million, primarily consisting of proceeds from our IPO and concurrent private placement, including the underwriters’ partial exercise of their option to purchase additional shares.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2025 was $118.9 million, primarily consisting of proceeds from the issuance of Series D convertible preferred stock.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2025 was $209.7 million, primarily consisting of proceeds from the issuance of Series D convertible preferred stock.
Previous wording
In September 2021, we entered into an operating lease agreement for our corporate headquarters located in Boston, Massachusetts, expiring in September 2029. We are also party to several operating leases for office and lab space, as well as finance leases for certain lab equipment. As of June 30, 2026, our non-cancellable lease obligations were $29.6 million and $0.6 million under our operating and finance leases, respectively, of which $7.5 million and $0.2 million related to operating and finance leases, respectively, are due within the next 12 months. Refer to Note 9 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for more information on our leases.
Current wording
In September 2021, we entered into an operating lease agreement for our corporate headquarters located in Boston, Massachusetts, expiring in September 2029. We are also party to several operating leases for office and lab space, as well as finance leases for certain lab equipment. As of September 30, 2026, our non-cancellable lease obligations were $27.7 million and $0.6 million under our operating and finance leases, respectively, of which $7.4 million and $0.2 million related to operating and finance leases, respectively, are due within the next 12 months. Refer to Note 9 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for more information on our leases.
Previous wording
During the six months ended June 30, 2026, there were no material changes to our critical accounting estimates and significant accounting policies described in our IPO Prospectus.
Current wording
During the nine months ended September 30, 2026, there were no material changes to our critical accounting estimates and significant accounting policies described in our IPO Prospectus.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
a $1.4 million increase in research software, professional services and laboratory operations, primarily due to the increase in research reagents and laboratory supplies to support increased level of research activity across the discovery programs.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
a $0.3 million increase in facility-related costs, primarily due to disposal of fixed assets.
Previous report — wording carried elsewhere
a $4.0 million decrease in professional and consulting fees due to lower legal and accounting fees.
Previous report — wording carried elsewhere
These decreases were partially offset by: