Immunome Inc.
For the period ended Jun 30, 2026. Filed Aug 11, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 11, 2026
IMNM$18.71+4.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001193125-26-219425
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001193125-26-344636
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 96 previous paragraphs and 105 current paragraphs.
64 unchanged; 21 reworded; 14 added; 11 removed; 0 previous and 6 current paragraphs rearranged.
Tables are not compared: 4 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 (14)
Current report
We have not generated any revenues from product sales and will not be able to do so unless and until we receive regulatory approval for our product candidates. If we are successful in obtaining regulatory approval for varegacestat, we expect to incur significant expenses related to developing our sales, marketing, market access, patient services and commercial operations functions.
Current report
Varegacestat also achieved all key secondary endpoints. The confirmed objective response rate, or ORR, based on RECIST v1.1 was 56% with varegacestat versus 9% with placebo (p<0.0001), as assessed by blinded independent central review. Varegacestat achieved a statistically significant improvement in change in worst pain intensity score at week 12, as assessed with the Gounder/Desmoid Tumor Research Foundation Desmoid Tumor Symptom/Impact scale. At week 12, patients treated with varegacestat experienced a mean change from baseline of -2.24 (standard error, or SE: 0.27), compared with +0.18 (SE: 0.27) for patients receiving placebo, for a treatment difference of -2.42 (SE: 0.37; p<0.0001). A clinically significant difference of more than 2 points was observed as early as the first evaluation at week 4. Varegacestat also achieved a statistically significant improvement in change in tumor volume at week 24, as assessed by blinded independent central review. In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% versus +11% with placebo, also as assessed by blinded independent central review. The Phase 3 data also show that varegacestat has a safety profile consistent with other GSI therapies.
Current report
Research and development expenses increased by $19.4 million, from $40.5 million for the three months ended June 30, 2025 to $59.9 million for the three months ended June 30, 2026.
Current report
The decrease for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was due primarily to the timing of IND-enabling activities, partially offset by an increase in clinical trial activities associated with our Phase 1 trial.
Current report
General and administrative expenses increased by $8.2 million, from $10.0 million for the three months ended June 30, 2025 to $18.3 million for the three months ended June 30, 2026. The increase was primarily related to increases in expenses related to commercialization readiness, as well as an increase in personnel-related costs including share-based compensation from an increase in headcount to support overall growth.
Current report
Comparison of the six months ended June 30, 2026 and 2025
Current report
Research and development expenses increased by $28.9 million, from $77.3 million for the six months ended June 30, 2025 to $106.3 million for the six months ended June 30, 2026.
Current report
The decrease for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due primarily to a decrease in clinical trial and manufacturing activities required to support our NDA filing in April 2026.
Current report
The increase for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due primarily to an increase in clinical trial and manufacturing activities associated with our Phase 1 trial.
Current report
The decrease for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due primarily to the timing of IND-enabling activities, partially offset by an increase in clinical trial activities associated with our Phase 1 trial.
Current report
The increase for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due primarily to an increase in clinical trial activities associated with our Phase 1 trial.
Current report
The increase for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due primarily to an increase in personnel related costs, including share-based compensation and allocated support costs, in support of our product candidates and discovery programs.
Current report
General and administrative expenses increased by $10.5 million, from $20.7 million for the six months ended June 30, 2025 to $31.2 million for the six months ended June 30, 2026. The increase was primarily related to increases in expenses related to commercialization readiness, as well as an increase in personnel-related costs including share-based compensation from an increase in headcount to support overall growth.
Current report
Interest income increased by $4.4 million from $6.1 million for the six months ended June 30, 2025 to $10.5 million for the six months ended June 30, 2026. The increase was primarily a result of higher cash, cash equivalent, and marketable securities balances, partially offset by lower interest rates during the six months ended June 30, 2026 compared to the six months ended June 30, 2025.
Removed paragraphs (11)
Previous report
Collaboration revenue
Previous report
Research and development expenses
Previous report
General and administrative expenses
Previous report
Interest income
Previous report
Collaboration revenue
Previous report
Research and development expenses
Previous report
Research and development expenses increased by $9.5 million, from $36.9 million for the three months ended March 31, 2025 to $46.4 million for the three months ended March 31, 2026.
Previous report
The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to IND-enabling and clinical trial activities associated with our planned Phase 1 trial.
Previous report
General and administrative expenses
Previous report
General and administrative expenses increased by $2.3 million, from $10.7 million for the three months ended March 31, 2025 to $13.0 million for the three months ended March 31, 2026. The increase was primarily a result of a $1.8 million increase in personnel-related costs from an increase in headcount, including a $1.0 million increase in share-based compensation.
Previous report
Interest income
Reworded paragraphs (21)
Previous wording
We are advancing a pipeline that includes four clinical assets and two preclinical assets. Varegacestat, formerly AL102, is an investigational, oral, once-daily gamma secretase inhibitor, or GSI. In December 2025, we announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors. We submitted a new drug application, or NDA, for varegacestat in April 2026, and we plan to submit a marketing authorization application, or MAA, with the European Medicines Agency, or EMA, by the end of 2026. IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugate, is currently under evaluation in a Phase 1 trial. In November 2025, we reported observed objective responses at multiple dose levels in B-cell lymphoma patients treated with IM-1021, and we plan to share initial lymphoma data in 2026. IM-3050 is a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT. In March 2026, we initiated the first site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors. IM-1617, a first-in-class ADC, received initial new drug, or IND, clearance in April 2026, and we plan to initiate a Phase 1 trial in the second quarter of 2026. Our preclinical assets include two solid tumor ADCs with anticipated 2026 IND submissions: IM-1340, and IM-1335.
Current wording
We are advancing a pipeline that includes four clinical assets and two preclinical assets. Varegacestat, formerly AL102, is an investigational, oral, once-daily gamma secretase inhibitor, or GSI. In December 2025, we announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors. We submitted a new drug application, or NDA, for varegacestat in April 2026, which has been accepted by the U.S. Food and Drug Administration, or FDA, and assigned a Prescription Drug User Fee Act, or PDUFA, target action date of April 28, 2027. Additionally, we plan to submit a marketing authorization application, or MAA, with the European Medicines Agency, or EMA, by the end of 2026. IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugate, is currently under evaluation in a Phase 1 trial. In November 2025, we reported observed objective responses at multiple dose levels in B-cell lymphoma patients treated with IM-1021, and we plan to share initial lymphoma data in 2026. In June 2026, we dosed the first participant in a Phase 1 trial of IM-1617, a potential first-in-class ADC, in patients with advanced solid tumors. IM-3050 is a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT. In July 2026, we dosed the first participant in a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors. Our preclinical assets include two solid tumor ADCs with anticipated 2026 IND submissions: IM-1340, and IM-1335.
Previous wording
Our lead clinical asset is varegacestat, an investigational, oral, once-daily GSI therapy under evaluation for the treatment of desmoid tumors. In December 2025, we reported positive Phase 3 RINGSIDE (Part B) topline results showing that the study met all primary and key secondary endpoints. Varegacestat achieved the primary endpoint of progression free survival, delivering an 84% reduction in the risk of disease progression or death versus placebo (HR=0.16, p<0.0001). The confirmed objective response rate, or ORR, based on RECIST v1.1 was 56% with varegacestat vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review. In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% vs. +11% with placebo, as assessed by blinded independent central review. In addition, the trial met all key secondary endpoints, with varegacestat achieving statistically significant improvements vs. placebo in landmark tumor volume reduction and worst pain intensity. The Phase 3 RINGSIDE topline and Phase 2 RINGSIDE data also show that varegacestat has a safety profile consistent with other GSI therapies. We acquired varegacestat from Ayala Pharmaceuticals, Inc., or Ayala, in March 2024. We submitted an NDA for varegacestat in April 2026, and we plan to submit an MAA with the EMA by the end of 2026.
Current wording
Our lead product candidate is varegacestat, an investigational, oral, once-daily GSI therapy under evaluation for the treatment of desmoid tumors. In December 2025, we reported positive Phase 3 RINGSIDE (Part B) topline results and, in May 2026, detailed efficacy and safety results were presented at the 2026 American Society of Clinical Oncology Annual Meeting. Varegacestat achieved the primary endpoint of progression-free survival, delivering an 84% reduction in the risk of disease progression or death versus placebo, with a hazard ratio, or HR, of 0.16 (p<0.0001).
Previous wording
IM-1617 is a potential first-in-class ADC that targets an undisclosed receptor that is preferentially expressed in a broad array of solid tumors, including colorectal cancer, or CRC, non-small cell lung cancer, or NSCLC, and breast and ovarian cancers. The target is a receptor tyrosine kinase that promotes tumor cell survival and mediates immune cell exclusion, providing potential for a secondary mechanism of action. We received IND clearance for this program in April 2026 and plan to initiate a Phase 1 trial in the second quarter of 2026.
Current wording
IM-1617 is a potential first-in-class ADC that targets an undisclosed receptor that is preferentially expressed in a broad array of solid tumors, including colorectal cancer, or CRC, non-small cell lung cancer, or NSCLC, and breast and ovarian cancers. The target is a receptor tyrosine kinase that promotes tumor cell survival and mediates immune cell exclusion, providing potential for a secondary mechanism of action. In June 2026, we dosed the first participant in a Phase 1 clinical trial of IM-1617. We expect the study to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and breast cancer.
Previous wording
IM-3050 is a FAP-targeted lutetium-177, Lu-177 or 177Lu, RLT product candidate for the treatment of solid tumors. FAP is a cell surface protease that serves as a tumor-specific marker due to its broad expression on cancer associated fibroblasts, the most common tumor stromal cell. FAP is expressed in 75% of solid tumors. IM-3050 is designed to deliver radioactive 177Lu directly to FAP-expressing cells, where the “bystander” effect of the radiation may damage or kill nearby tumor cells. We believe this RLT approach could overcome the limitations, such as poor internalization and low expression on tumor cells, that make FAP an unsuitable target for ADCs. In vivo data show single dose antitumor activity and tolerability. In March 2026, we initiated the first site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors.
Current wording
IM-3050 is a FAP-targeted lutetium-177, Lu-177 or 177Lu, RLT product candidate for the treatment of solid tumors. FAP is a cell surface protease that serves as a tumor-specific marker due to its broad expression on cancer associated fibroblasts, the most common tumor stromal cell. FAP is expressed in 75% of solid tumors. IM-3050 is designed to deliver radioactive 177Lu directly to FAP-expressing cells, where the “bystander” effect of the radiation may damage or kill nearby tumor cells. We believe this RLT approach could overcome the limitations, such as poor internalization and low expression on tumor cells, that make FAP an unsuitable target for ADCs. In vivo data show single dose antitumor activity and tolerability. In July 2026, we dosed the first participant in a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors.
Previous wording
We have not generated any revenue from product sales and do not expect to do so for the foreseeable future. To date, we have generated our revenue through a Collaboration and Option Agreement, or the Collaboration Agreement, with AbbVie Global Enterprises Ltd., or AbbVie, which terminated in accordance with its terms in July 2025. Revenue recognized under the Collaboration Agreement consisted of payments received from AbbVie and was recognized over the performance period. No further collaboration revenue will be recognized under the Collaboration Agreement.
Current wording
To date, we have only generated revenue through a Collaboration and Option Agreement, or the Collaboration Agreement, with AbbVie Global Enterprises Ltd., or AbbVie, which terminated in accordance with its terms in July 2025. Revenue recognized under the Collaboration Agreement consisted of payments received from AbbVie and was recognized over the performance period. No further collaboration revenue will be recognized under the Collaboration Agreement.
Previous wording
The decrease for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to a decrease in clinical trial activities following the readout of topline data for our Phase 3 trial in December 2025.
Current wording
The decrease for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was due primarily to a decrease in clinical trial and manufacturing activities required to support our NDA filing in April 2026.
Previous wording
The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to an increase in clinical trial activities associated with our Phase 1 trial.
Current wording
The increase for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was due primarily to an increase in clinical trial and manufacturing activities associated with our Phase 1 trial.
Previous wording
The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to an increase in activities associated with our planned Phase 1 trial.
Current wording
The increase for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was due primarily to an increase in activities associated with our Phase 1 trial.
Previous wording
The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to an increase in personnel related costs, including share-based compensation, in support of our product candidates and discovery programs.
Current wording
The increase for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 was due primarily to an increase in personnel related costs, including share-based compensation and allocated support costs, in support of our product candidates and discovery programs.
Previous wording
Interest income increased by $2.5 million from $3.0 million for the three months ended March 31, 2025 to $5.5 million for the three months ended March 31, 2026. The increase was primarily a result of higher cash and cash equivalent balances, partially offset by lower interest rates during the three months ended March 31, 2026 compared to the three months ended March 31, 2025.
Current wording
Interest income increased by $1.9 million from $3.1 million for the three months ended June 30, 2025 to $5.0 million for the three months ended June 30, 2026. The increase was primarily a result of higher cash, cash equivalent, and marketable securities balances, partially offset by lower interest rates during the three months ended June 30, 2026 compared to the three months ended June 30, 2025.
Previous wording
To date, we have not generated any revenue from the commercial sale of productsand do not expect to generate revenue from commercial sales unless and until we receive marketing approval for one or more of our product candidates. Since inception, we have incurred significant operating losses and negative cash flows from operations. Our net losses were $53.8 million and $41.6 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had cash and cash equivalents of $582.7 million and an accumulated deficit of $782.0 million.
Current wording
To date, we have not generated any revenue from the commercial sale of productsand do not expect to generate revenue from commercial sales unless and until we receive marketing approval for one or more of our product candidates. Since inception, we have incurred significant operating losses and negative cash flows from operations. Our net losses were $73.1 million and $43.4 million for the three months ended June 30, 2026 and 2025, respectively, and $127.0 million and $85.0 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had cash and cash equivalents of $217.7 million, marketable securities of $302.3 million and an accumulated deficit of $855.1 million.
Previous wording
In May 2024, we entered into an “at the market” sales agreement, or the 2024 ATM Agreement, with TD Securities (USA) LLC, or TD Cowen, as sales agent, pursuant to which we may offer and sell from time to time shares of our common stock having an aggregate offering price of up to $200.0 million, or the ATM Shares. We have agreed to pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from any ATM Shares sold through the 2024 ATM Agreement. As of March 31, 2026, we had sold an aggregate of 6,655,587 shares of common stock under the 2024 ATM Agreement for gross proceeds of $65.9 million and net proceeds of approximately $64.5 million, with approximately $134.1 million remaining available for future offerings. No shares of common stock were sold under the 2024 ATM Agreement during the three months ended March 31, 2026 and 2025.
Current wording
In May 2024, we entered into an “at the market” sales agreement, or the 2024 ATM Agreement, with TD Securities (USA) LLC, or TD Cowen, as sales agent, pursuant to which we may offer and sell from time to time shares of our common stock having an aggregate offering price of up to $200.0 million, or the ATM Shares. We have agreed to pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from any ATM Shares sold through the 2024 ATM Agreement. As of June 30, 2026, we had sold an aggregate of 6,655,587 shares of common stock under the 2024 ATM Agreement for gross proceeds of $65.9 million and net proceeds of approximately $64.5 million, with approximately $134.1 million remaining available for future offerings. No shares of common stock were sold under the 2024 ATM Agreement during the six months ended June 30, 2026.
Previous wording
The following table summarizes our sources and uses of cash for the three months ended March 31, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our sources and uses of cash for the six months ended June 30, 2026 and 2025 (in thousands):
Previous wording
Net cash used in operating activities for the three months ended March 31, 2026 was $58.6 million, consisting primarily of our net loss of $53.8 million and a net change in operating assets and liabilities of $13.6 million, partially offset by noncash charges of $8.8 million. The noncash charges primarily consisted of $8.0 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in accounts payable of $1.4 million, an increase in prepaid expenses and other assets of $5.1 million, and a decrease in accrued expenses and other current liabilities of $9.7 million.
Current wording
Net cash used in operating activities for the six months ended June 30, 2026 was $120.3 million, consisting primarily of our net loss of $127.0 million and a net change in operating assets and liabilities of $11.7 million, partially offset by noncash charges of $18.3 million. The noncash charges primarily consisted of $16.8 million of share-based compensation. The change in operating assets and liabilities primarily consisted of an increase in prepaid expenses and other assets of $12.0 million, partially offset by an increase in accounts payable of $2.6 million.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2025 was $53.1 million, consisting primarily of our net loss of $41.6 million and a net change in operating assets and liabilities of $17.0 million, partially offset by noncash charges of $5.6 million. The noncash charges primarily consisted of $5.7 million of share-based compensation. The change in operating assets and liabilities primarily consisted of a decrease in accrued expenses and other current liabilities of $8.5 million, a decrease in accounts payable of $3.8 million, a decrease in deferred revenue of $2.9 million and an increase in prepaid expenses and other assets of $1.7 million.
Current wording
Net cash used in operating activities for the six months ended June 30, 2025 was $102.5 million, consisting primarily of our net loss of $85.0 million and a net change in operating assets and liabilities of $28.8 million, partially offset by noncash charges of $11.4 million. The noncash charges primarily consisted of $11.1 million of share-based compensation. The change in operating assets and liabilities primarily consisted of a decrease in accrued expenses and other current liabilities of $7.9 million, a decrease in accounts payable of $8.8 million, a decrease in deferred revenue of $6.9 million and an increase in prepaid expenses and other assets of $5.3 million.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2026 was $12.0 million, consisting of $9.0 million in payments related to in-process research and development (IPR&D) assets included in accrued expenses and other current liabilities as of December 31, 2025, and $3.0 million of purchases of property and equipment.
Current wording
Net cash used in investing activities for the six months ended June 30, 2026 was $316.4 million, consisting of $302.2 million of purchases of marketable securities, $9.0 million in payments related to in-process research and development (IPR&D) assets included in accrued expenses and other current liabilities as of December 31, 2025, and $5.2 million of purchases of property and equipment.
Previous wording
Net cash provided by investing activities for the three months ended March 31, 2025 was $5.1 million, consisting of $15.0 million from maturities of marketable securities, partially offset by $6.2 million of upfront and milestone payments related to IPR&D assets and $3.7 million of purchases of property and equipment.
Current wording
Net cash used in investing activities for the six months ended June 30, 2025 was $59.1 million, consisting of $123.3 million of purchases of marketable securities, $6.2 million of purchases of IPR&D assets and $4.6 million of purchases of property and equipment, partially offset by $75.0 million from maturities of marketable securities.
Previous wording
Net cash used in financing activities for the three months ended March 31, 2026 was $0.1 million, consisting of $0.4 million in payments related to offering costs from the December 2025 financing accrued as of December 31, 2025, partially offset by $0.2 million from the exercise of options.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2026 was $0.9 million, consisting of $1.3 million from the exercise of options, partially offset by $0.4 million in payments related to offering costs from the December 2025 financing accrued as of December 31, 2025.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2025 was $162.2 million, consisting of gross proceeds of $172.5 million from the January 2025 financing and $0.2 million from the exercise of options, partially offset by offering costs of $10.5 million from the January 2025 financing.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2025 was $162.2 million, consisting of gross proceeds of $172.5 million from the January 2025 financing and $0.4 million from the exercise of options, partially offset by offering costs of $10.8 million from the January 2025 financing.
Previous wording
We expect our expenses to increase substantially in connection with our ongoing and future activities, particularly as we advance and expand our clinical development of varegacestat, seek regulatory approval for varegacestat, prepare for the commercialization of varegacestat, if approved, advance the clinical development of IM-1021, IM-3050, and IM-1617, continue the development of our other current product candidates and any future product candidates, and continue to pursue our business development strategy. We expect that our primary uses of capital will be for the potential commercial launch of varegacestat for the treatment of desmoid tumors, if approved, continued commercial development and manufacturing scale-up for varegacestat, continued clinical and preclinical development of other pipeline assets, as well as for working capital and other general corporate purposes including potential strategic transactions, legal and other regulatory compliance expenses, compensation and related expenses, risk management and general overhead costs.
Current wording
We expect our expenses to increase substantially in connection with our ongoing and future activities, particularly as we advance and expand our clinical development of varegacestat, seek regulatory approval for varegacestat, prepare for the commercialization of varegacestat, if approved, advance the clinical development of IM-1021, IM-1617, and IM-3050, continue the development of our other current product candidates and any future product candidates, and continue to pursue our business development strategy. We expect that our primary uses of capital will be for the potential commercial launch of varegacestat for the treatment of desmoid tumors, if approved, continued commercial development and manufacturing scale-up for varegacestat, continued clinical and preclinical development of other pipeline assets, as well as for working capital and other general corporate purposes including potential strategic transactions, legal and other regulatory compliance expenses, compensation and related expenses, risk management and general overhead costs.
Previous wording
We expect that our existing cash and cash equivalents as of March 31, 2026 will be sufficient to fund our current and planned operating expenses and capital expenditures for at least 12 months from the filing date of this Quarterly Report on Form 10-Q. We will need additional financing to support our continuing operations and pursue our research and development strategy and commercialization of varegacestat, if approved. We have based these estimates on assumptions that may prove to be imprecise, and we may exhaust our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development of our programs, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the research and development of our programs and product candidates.
Current wording
We expect that our existing cash, cash equivalents and marketable securities as of June 30, 2026 will be sufficient to fund our current and planned operating expenses and capital expenditures for at least 12 months from the filing date of this Quarterly Report on Form 10-Q. We will need additional financing to support our continuing operations and pursue our research and development strategy and commercialization of varegacestat, if approved. We have based these estimates on assumptions that may prove to be imprecise, and we may exhaust our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development of our programs, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the research and development of our programs and product candidates.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
We acquired varegacestat from Ayala Pharmaceuticals, Inc., or Ayala, in March 2024. We submitted an NDA for varegacestat in April 2026. In July 2026, the FDA accepted the NDA and assigned a PDUFA target action date of April 28, 2027. We plan to submit an MAA with the EMA by the end of 2026.
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the periods presented (in thousands):
Current report — wording carried from elsewhere
Amounts include non-cash share-based compensation expense as follows (in thousands):
Current report — wording carried from elsewhere
There was no collaboration revenue for the six months ended June 30, 2026. Collaboration revenue for the six months ended June 30, 2025 related to certain research and development activities allocated to AbbVie. As of June 30, 2025, we had recognized all revenue and costs associated with our performance obligation under the agreement.
Current report — wording carried from elsewhere
The table below summarizes the components of our research and development expenses for the periods presented (in thousands):
Current report — wording carried from elsewhere
The increase for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 was due primarily to increased IND-enabling activities for our product candidates.