What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-12 compared with 2025-11-06 · 88 added, 141 removed, 125 unchanged (65% of the section changed)

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These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

We are a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients.

We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies, or ADCs.

We believe that the pursuit of novel or underexplored targets will be central to the next generation of transformative therapies.

Our goal is to establish a broad pipeline of preclinical and clinical assets and develop these assets into approved products for commercialization.

We are advancing a pipeline that includes three clinical assets and three preclinical assets.

Varegacestat, formerly AL102, is an investigational gamma secretase inhibitor, or GSI, currently under evaluation in a Phase 3 clinical trial for the treatment of desmoid tumors.

IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugate, is currently under evaluation in a Phase 1 trial with the first patient dosed in February 2025.

IM-3050, a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT, received IND clearance in April 2025 and we plan to initiate a Phase 1 trial in early 2026 after delivery of third-party diagnostic radiotracer supply.

Our preclinical assets include three solid tumor ADC drug candidates:

IM-1617, IM-1340, and IM-1335, all of which are advancing towards 2026 IND submissions.

In addition, we have multiple ADCs currently undergoing lead optimization in advance of future development decisions.

Currently, our internal discovery efforts center on designing ADCs against novel or underexplored targets.

We believe that pursuing differentiated targets provides a path to significant clinical benefit and meaningful market opportunities.

This strategy is supported by HC74, the differentiated, novel topoisomerase 1 inhibitor, or TOP1i, payload we purchased from Zentalis Pharmaceuticals, Inc., or Zentalis, in October 2024.

We have efforts underway to develop additional linkers and payloads and believe that a broad toolbox of linkers and payloads supports our mission to design and develop a diverse pipeline of ADCs.

We are a biotechnology company committed to the development of first-in-class and best-in-class targeted oncology therapies.

Our goal is to establish a broad portfolio of differentiated clinical assets to improve the lives of cancer patients.

Key to that strategy is our deep expertise in the discovery, design, development, manufacturing, and ultimately commercialization of antibody-drug conjugates and other oncology therapeutics.

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.

Our pipeline also includes numerous early-stage ADCs produced by our internal discovery efforts, providing opportunities for additional IND submissions in 2027 and beyond.

Our approach to discovery centers on designing ADCs against novel or underexplored targets, which we believe provides a path to significant clinical benefit and meaningful market opportunities.

HC74, our differentiated, novel topoisomerase 1, or TOP1, inhibitor payload, supports this strategy, and we have efforts underway to develop additional linkers and payloads with favorable safety and efficacy profiles.

We believe that combining novel targets with a broad toolbox of linkers and payloads supports our mission to design and develop a diverse pipeline of ADCs that address unmet medical need.

Our current programs

Varegacestat (formerly AL102)

Our lead clinical asset is varegacestat, an oral, once daily GSI that is being evaluated for the treatment of desmoid tumors.

In the Phase 2 RINGSIDE study Part A, varegacestat demonstrated objective response rates, or ORR, of 75% of evaluable patients and 64% in the intent-to-treat population;

median reduction in tumor volume of 88%;

and an 85% reduction in T2 imaging, which is suggestive of a reduction in cellularity.

The Phase 2 data also show a safety profile consistent with the GSI class.

Varegacestat received Orphan Drug Designation from the European Medicines Agency, or EMA, in July 2025, and previously received this designation from the U.S.

Food and Drug Administration, or FDA, in November 2023.

Enrollment in a Phase 3 registrational trial was completed in February 2024, and we expect to report topline data from this trial in the second half of 2025.

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.

IM-1021 (Solid Tumor and B-Cell Lymphoma ADC)

IM-1021 is a ROR1 ADC that incorporates HC74, our proprietary TOP1i payload.

ROR1 is expressed in both hematologic malignancies and solid tumors with limited normal tissue expression, and previous ADCs targeting ROR1 have demonstrated clinical activity.

In preclinical studies, IM-1021 showed sustained tumor regression in preclinical models, including a mouse model of triple-negative breast cancer, or TNBC, and a mouse model of mantle cell lymphoma, or MCL.

ROR1 is expressed in both hematologic malignancies and solid tumors with limited normal tissue expression.

Previous ADCs targeting ROR1 have demonstrated clinical activity.

We believe that IM-1021 may provide improved therapeutic index as compared to other ROR1-targeted ADCs in development.

The Phase 1 clinical trial is ongoing, with objective responses observed in patients with B-cell lymphomas at multiple dose levels.

We expect to present initial data for IM-1021 in 2026.

The Phase 1 clinical trial is ongoing, with objective responses observed in participants with B-cell lymphomas at multiple dose levels.

We expect to present initial lymphoma data for IM-1021 in 2026.

IM-3050 (FAP Radioligand Therapy)

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In vivo data show single dose antitumor activity and tolerability.

We received IND clearance for this program in April 2025 and plan to initiate a Phase 1 trial in early 2026 after delivery of third-party diagnostic radiotracer supply.

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 (Solid Tumor ADC)

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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.

IND-enabling work for IM-1617 is ongoing.

We received IND clearance for this program in April 2026 and plan to initiate a Phase 1 trial in the second quarter of 2026.

IM-1340 (Solid Tumor ADC)

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It has a unique expression profile that spans neuroendocrine tumors, or NETs, and other carcinomas, including lung and prostate tumors, with limited expression in normal tissue.

IND-enabling work for IM-1340 is ongoing.

IND-enabling work for IM-1340 is ongoing and we expect to submit an IND for this program to the FDA in mid-2026.

IM-1335 (Solid Tumor ADC)

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We identified limitations that we expect contributed to the failure of the prior ADC against this target, and we believe that IM-1335 overcomes these limitations.

IND-enabling work for IM-1335 is ongoing.

IND-enabling work for IM-1335 is ongoing and we expect to submit an IND for this program to the FDA in late 2026.

Other Programs and Platforms

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No further collaboration revenue will be recognized under the Collaboration Agreement.

In-process research and development expenses

Intangible assets acquired in an asset acquisition for use in research and development activities which have no alternative future use are expensed as in-process research and development, or IPR&D, expense on the acquisition date.

Research and development expenses

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The prepaid amounts are expensed as the benefits are consumed.

Research and development activities are central to our business model.

Research and development activities are central to our business model and may vary substantially from year to year and quarter to quarter depending on the stage of product development.

For example, product candidates in later stages of clinical development generally have higher costs than those in earlier stages of development, primarily due to the size and cost of later-stage clinical trials compared to early development activities.

We expect that our research and development expenses will increase substantially in connection with the continuation of our activities and new agreements.

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General and administrative expenses also include legal fees relating to intellectual property and corporate matters, professional fees for accounting, auditing, tax and consulting services, insurance costs, travel, direct and allocated facility related expenses and other operating costs.

We anticipate that our general and administrative expenses will increase in the future to support increased and progressed research and development activities and to operate as a public company.

We anticipate that our general and administrative expenses will increase in the future to support increased and progressed research and development activities, activities to prepare for the potential commercialization of varegacestat, and increased activities and costs to operate as a public company.

Interest income

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Results of operations

Comparison of the three months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the periods presented (in thousands):

Three Months Ended September 30,

Collaboration revenue

Operating expenses:

In-process research and development

Research and development (1)

General and administrative (1)

Total operating expenses

Loss from operations

Interest income

(1) Amounts include non-cash share-based compensation expense as follows (in thousands):

Three Months Ended September 30,

Research and development

General and administrative

Total share-based compensation expense

Collaboration revenue

There was no collaboration revenue for the three months ended September 30, 2025.

Collaboration revenue for the three months ended September 30, 2024 of $2.9 million was related to certain research and development activities under the Collaboration Agreement with AbbVie.

As of June 30, 2025, we had recognized all revenue and costs associated with our performance obligation under the agreement.

In-process research and development expense

There was no IPR&D expense for the three months ended September 30, 2025.

IPR&D expense for the three months ended September 30, 2024 was related to the write-off of IPR&D assets that were determined to have no alternative future use.

Research and development expenses

Research and development expenses increased by $12.0 million, from $37.2 million for the three months ended September 30, 2024 to $49.2 million for the three months ended September 30, 2025.

The table below summarizes the components of our research and development expenses for the periods presented (in thousands):

Three Months Ended September 30,

Varegacestat (1)

Other product candidates (4)

Indirect research and development (5)

(1) The increase for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was due primarily to increases in consulting and manufacturing activities to support our Phase 3 trial and a potential future NDA submission.

(2) The decrease for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was due primarily to the timing of outsourced research, manufacturing and IND-enabling activities, partially offset by an increase in clinical trial activities as we initiated our Phase 1 trial in February 2025.

(3) The decrease for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was due primarily to the timing of outsourced research, manufacturing and IND-enabling activities, partially offset by an increase in clinical trial start up activities as we prepare to initiate our Phase 1 trial.

We received IND clearance for this program in April 2025.

(4) The increase for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was due primarily to increased manufacturing activities for our product candidates, partially offset by reductions in professional and contract laboratory services due to the replacement of certain outsourced services with internal resources.

(5) The increase for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was due primarily to an increase in personnel and personnel-related costs in support of our product candidates and discovery programs.

General and administrative expenses

General and administrative expenses increased by $1.4 million, from $9.5 million for the three months ended September 30, 2024 to $10.9 million for the three months ended September 30, 2025.

The increase was primarily a result of a $1.6 million increase in personnel-related costs from an increase in headcount, including a $0.8 million increase in share-based compensation, which was partially offset by decreases in other general operating costs.

Interest income

Interest income decreased by $0.7 million from $3.4 million for the three months ended September 30, 2024 to $2.7 million for the three months ended September 30, 2025.

The decrease was primarily a result of lower interest rates during the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

Comparison of the nine months ended September 30, 2025 and 2024

Comparison of the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the periods presented (in thousands):

Nine Months Ended September 30,

Three Months Ended March 31,

Collaboration revenue

Operating expenses:

In-process research and development

Research and development (1)

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(1) Amounts include non-cash share-based compensation expense as follows (in thousands):

Nine Months Ended September 30,

Three Months Ended March 31,

Research and development

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Collaboration revenue

Collaboration revenue increased by $0.6 million, from $6.3 million for the nine months ended September 30, 2024 to $6.9 million for the nine months ended September 30, 2025.

The increase was primarily due to an increase in certain research and development activities allocated to AbbVie during the nine months ended September 30, 2025 compared to the same period in 2024.

There was no collaboration revenue for the three months ended March 31, 2026.

Collaboration revenue for the three months ended March 31, 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.

In-process research and development expenses

There was no IPR&D expense for the nine months ended September 30, 2025.

IPR&D expense for the nine months ended September 30, 2024 primarily related to the write-off of IPR&D assets that were acquired from Zentalis, Ayala and others and determined to have no alternative future use.

Research and development expenses

Research and development expenses increased by $44.9 million, from $81.7 million for the nine months ended September 30, 2024 to $126.5 million for the nine months ended September 30, 2025.

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.

The table below summarizes the components of our research and development expenses for the periods presented (in thousands).

Nine Months Ended September 30,

For the three months ended March 31, 2026, we revised the presentation of our research and development expenses in the table below to align with how management evaluates our research programs and expenses.

Prior period amounts have been reclassified to conform to the current year presentation.

Three Months Ended March 31,

Direct research and development

Varegacestat (1)

Other product candidates (4)

Indirect research and development (6)

(1) The increase for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to clinical trial activities, as well as manufacturing and consulting activities associated with our Phase 3 trial and in preparation for potential a future NDA submission

(2) The decrease for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to the timing of outsourced research, manufacturing and IND-enabling activities, partially offset by an increase in clinical trial activities as we initiated our Phase 1 trial in February 2025.

(3) The decrease for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to the timing of outsourced research, manufacturing and IND-enabling activities.

We received IND clearance for this program in April 2025.

(4) The increase for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to increased manufacturing activities for our product candidates, partially offset by reductions in professional and contract laboratory services due to the replacement of certain outsourced services with internal resources.

(5) The increase for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was due primarily to an increase in personnel and personnel-related costs in support of our product candidates and discovery programs.

(1) 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.

(2) 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.

(3) 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.

(4) 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.

(5) The increase for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due primarily to increased IND-enabling activities for our product candidates.

(6) 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.

General and administrative expenses

General and administrative expenses increased by $9.2 million, from $22.5 million for the nine months ended September 30, 2024 to $31.7 million for the nine months ended September 30, 2025.

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.

Interest income

Interest income decreased by $1.4 million from $10.1 million for the nine months ended September 30, 2024 to $8.8 million for the nine months ended September 30, 2025.

The decrease was primarily a result of lower interest rates during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.

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.

Liquidity and capital resources

Sources of liquidity

Since our inception in 2006, we have devoted substantially all our resources to research and development, raising capital, building our management team, building our intellectual property portfolio and entering and executing on collaborations and strategic transactions.

To date, we have financed our operations primarily through sales of our equity securities.

To date, we have not generated any revenue from commercial sale of products and do not expect to generate revenue from commercial sales for the foreseeable future.

We have devoted substantially all our resources to research and development programs and to general and administrative costs to support our operations, raising capital, building our management team, building our intellectual property portfolio and entering and executing on collaborations and strategic transactions.

To date, we have not generated any revenue from the commercial sale of products and 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 $57.5 million and $47.1 million for the three months ended September 30, 2025 and 2024, respectively, and $142.5 million and $212.7 million for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had cash and cash equivalents of $272.6 million and an accumulated deficit of $658.3 million.

In January 2025, we issued 22,258,064 shares of our common stock at $7.75 per share for net proceeds of $161.7 million, after deducting underwriting discounts and commissions and offering expenses payable by us, or the 2025 Financing.

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.

In January 2025, we issued and sold 22,258,064 shares of our common stock at $7.75 per share in a public offering for net proceeds of $161.7 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

In December 2025, we issued and sold 21,418,750 shares of our common stock at $21.50 per share in a public offering for net proceeds of $432.4 million, after deducting underwriting discounts and commissions and offering expenses payable by us.

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.

During the three and nine months ended September 30, 2025, the Company sold 4,625,156 shares of common stock in two transactions under the 2024 ATM Agreement for gross proceeds of $45.9 million and net proceeds of approximately $44.9 million.

As of September 30, 2025, 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.

The following table summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024 (in thousands):

Nine Months Ended September 30,

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.

The following table summarizes our sources and uses of cash for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Cash used in operating activities

Cash provided by (used in) investing activities

Cash provided by financing activities

Net increase in cash and cash equivalents and restricted cash

Cash (used in) provided by investing activities

Cash (used in) provided by financing activities

Net (decrease) increase in cash and cash equivalents and restricted cash

Operating activities

Net cash used in operating activities for the nine months ended September 30, 2025 was $143.0 million, consisting primarily of our net loss of $142.5 million and a net change in operating assets and liabilities of $18.5 million, partially offset by noncash charges of $18.0 million.

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 a decrease in accounts payable of $6.9 million, a decrease in deferred revenue of $6.9 million, an increase in prepaid expenses and other assets of $3.4 million and a decrease in accrued expenses and other current liabilities of $1.2 million.

Net cash used in operating activities for the nine months ended September 30, 2024 was $68.7 million, consisting primarily of our net loss of $212.7 million, partially offset by noncash charges of $134.4 million and a net change in operating assets and liabilities of $9.6 million.

The noncash charges primarily consisted of $125.0 million of in-process research and development assets acquired without alternative future use and $10.3 million of share-based compensation.

The change in operating assets and liabilities primarily consisted of an increase in accrued expenses and other current liabilities of $13.5 million and a decrease in prepaid expenses and other assets of $2.3 million, partially offset by a decrease in deferred revenue of $6.3 million.

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.

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.

Investing activities

Net cash provided by investing activities for the nine months ended September 30, 2025 was $64.8 million, consisting of $200.0 million from maturities of marketable securities, partially offset by $123.3 million of purchases of marketable securities, $6.2 million of purchases of IPR&D assets and $5.7 million of purchases of property and equipment.

Net cash used in investing activities for the nine months ended September 30, 2024 was $94.8 million, consisting primarily of $112.7 million of purchases of marketable securities, $46.1 million of purchases of IPR&D assets and $6.0 million of purchases of property and equipment, partially offset by $70.0 million from maturities of marketable securities.

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.

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.

Financing activities

Net cash provided by financing activities for the nine months ended September 30, 2025 was $207.6 million, consisting of gross proceeds of $172.5 million from the 2025 Financing, $45.9 from the 2024 ATM Agreement, and $0.8 million from the exercise of options, partially offset by offering costs of $11.7 million from the 2025 Financing and 2024 ATM Agreement.

Net cash provided by financing activities for the nine months ended September 30, 2024 was $220.4 million, consisting of gross proceeds of $230.0 million from a follow-on public offering we completed in February 2024, or the 2024 Financing, and $5.3 million from the exercise of options and common stock warrants, partially offset by offering costs of $14.8 million from our 2024 Financing and 2024 ATM Agreement.

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.

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.

Funding requirements

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, advance the clinical development of IM-1021 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 clinical development services, non-clinical research, strategic transactions, manufacturing, legal and other regulatory compliance expenses, compensation and related expenses, risk management and general overhead costs.

We expect that our existing cash and cash equivalents as of September 30, 2025 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.

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.

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.

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• the scope, progress, results and costs of discovery, preclinical development, manufacturing and clinical trials for programs and product candidates that we currently own and those that we may discover or acquire rights to in the future;

• the extent to which we acquire or in-license products, intellectual property and other technologies and the terms on which we acquire or in-license those assets;

• the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights, and defending intellectual property-related claims and the success of our intellectual property portfolio;

• the costs, timing and outcome of regulatory review of the programs and product candidates we may develop;

• the costs of future activities, including product sales, medical affairs, marketing, manufacturing, distribution, coverage and reimbursement for any programs or product candidates for which we receive regulatory approval;

• the extent to which we acquire or in-license products, intellectual property and other technologies and the terms on which we acquire or in-license those assets;

• the success of our existing and any future license agreements, collaborations and other strategic transactions and the achievement of milestones or occurrence of other developments that trigger payments to or from us under any such agreements and transactions;

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Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, including pursuant to the 2024 ATM Agreement, debt financings, collaborations, strategic alliances and licensing arrangements.

As a result of the war between Russia and Ukraine, conflicts in the Middle East, trade wars, bank failures, inflationary pressures on the economy and monetary policy responses taken by government agencies and other macroeconomic and political factors, the global credit and financial markets have experienced extreme volatility, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth and uncertainty about economic stability.

As a result of wars, conflicts, trade wars, bank failures, inflationary pressures on the economy and monetary policy responses taken by government agencies and other macroeconomic and geopolitical factors, the global credit and financial markets have experienced extreme volatility, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth and uncertainty about economic stability.

There can be no assurance that deterioration in credit and financial markets and confidence in economic conditions will not occur.

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See Note 2, Summary of significant accounting policies , to our condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for more information regarding recently issued accounting pronouncements.

We currently qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies, including reduced disclosure about our executive compensation arrangements, exemption from the requirements to hold non-binding advisory votes on executive compensation and golden parachute payments and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.

We may choose to take advantage of some, but not all, of the available exemptions.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards.

This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.

Therefore, the reported results of operations contained in our financial statements may not be directly comparable to those of other public companies.

As of June 30, 2025, the market value of our common stock held by non-affiliates exceeded $700.0 million.

As a result, we will no longer be an emerging growth company effective as of December 31, 2025 or a smaller reporting company beginning with our Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2026.

Based on recent SEC guidance, we will, however, continue to be a non-accelerated filer through at least our fiscal year ending December 31, 2026.

As a result of this transition, we will be subject to certain disclosure and compliance requirements that apply to other public companies that did not previously apply to us due to our status as an emerging growth company and smaller reporting company.

These requirements include, but are not limited to:

the requirement that we provide more detailed disclosures regarding executive compensation;

and the requirement that we hold a non-binding advisory vote on executive compensation and obtain shareholder approval of any golden parachute payments not previously approved.

We will not, however, be subject to the requirement that our independent registered public accounting firm attest to the effectiveness of our internal control over financial reporting under Section 404 while we are a non-accelerated filer.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis