What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-27 compared with 2025-03-13 · 79 added, 65 removed, 174 unchanged (45% of the section changed)

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Accordingly, there remains a continued unmet need for the development of direct IT therapies for solid tumors that provide high local killing efficacy coupled with nontoxic systemic anti-cancer effects.

We believe we have created a product candidate with the necessary chemistry to overcome this local delivery challenge.

We believe we have created a product candidate, using our non-covalent conjugation chemistry, with the necessary physical properties to overcome this local delivery challenge.

Evidence shows the mechanism of tumor killing achieved by our drug candidate also leads to systemic immune activation and T-cell repertoire expansion in certain cancers.

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The drug is also used in breast and lung cancer.

In 2017, we initiated the IT-01 Study using INT230-6 in the United States under an IND authorized by the FDA and in Canada under a CTA approved by Health Canada.

The IT-01 Study tested the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers, and enrolled 110 patients in three arms:

(i) INT230-6 used as a monotherapy, (ii) INT230-6 in combination with Merck’s Keytruda® (pembrolizumab), and (iii) INT230-6 in combination with BMS Yervoy® (ipilimumab).

We completed enrollment of the IT-01 Study in June 2022, locked the database in February 2023 and finalized the clinical study report in September 2023.

Our Clinical Programs

In 2017, we initiated the IT-01 Study, a Phase 1/2 dose escalation study using INT230-6 in the United States under an IND authorized by the FDA and in Canada under a CTA approved by Health Canada.

The study tested the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers, and enrolled 110 patients in three arms:

(i) INT230-6 used as a monotherapy, (ii) INT230-6 in combination with Merck’s Keytruda® (pembrolizumab), and (iii) INT230-6 in combination with BMS’s Yervoy® (ipilimumab).

We completed enrollment of the IT-01 Study in June 2022, locked the IT-01 Study database in February 2023 and finalized the clinical study report in September 2023.

We delivered the combination-specific reports and other information to our partners in the fourth quarter of 2023.

In 2021, we initiated the INVINCIBLE 2 Study.

In 2021, we initiated the INVINCIBLE-2 Study, a Phase 2 randomized study that tested INT230-6 as a monotherapy treatment in early-stage breast cancer for patients not suitable for presurgical chemotherapy.

The study enrolled 91 subjects and the database was locked in November 2023.

The key endpoint was whether INT230-6 could reduce a patient’s cancer compared to no treatment (the current SOC) or a saline injection.

The key endpoint was whether INT230-6 could reduce a patient’s cancer compared to no treatment, which is the current SOC for the majority of patients with early-stage breast cancer, or a saline injection.

Substantial reduction of cancer presurgically in aggressive forms of cancer has been shown to correlate with delaying disease recurrence.

Other endpoints of the INVINCIBLE 2 Study were to understand the percentage of necrosis that can be achieved in tumors for a given dose, especially tumors larger than 2 centimeters in longest diameter, and whether either a local or whole body anti-cancer immune response could be induced.

The key endpoints of the INVINCIBLE 2 Study were to understand the percentage of necrosis that can be achieved in tumors of varying sizes for a given dose, especially for tumors larger than 2 centimeters in longest diameter.

We also sought to determine whether a local or whole-body anti-cancer immune response could be induced.

The INVINCIBLE-2 Study demonstrated a high order of necrosis in presurgical breast cancer tumors in the period from diagnosis to surgery, with some patients experiencing greater than 95% necrosis of the tumor.

Data from the INVINCIBLE-2 Study demonstrated that INT230-6 had a favorable safety profile.

An increase of certain types of immune cells (CD4+ and NK T-cells) in the tumor and blood was also shown.

There was also an increase in the T-cells repertoire relative to control.

In July 2024, we initiated and dosed our first patient in the INVINCIBLE-3 Study testing INT230-6 as a monotherapy compared to the SOC drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes.

This study has been authorized by the FDA, Health Canada, the European Medicines Authority, and Australia's Therapeutics Goods Administration.

The trial is enrolling and being conducted in eight countries:

the US, Australia, Canada, France, Germany, Italy, Poland, and Spain.

Up to 60 sarcoma-focused hospitals and other centers are expected to participate from these countries.

We plan to enroll 333 patients and expect to complete enrollment in the first half of 2026, with an endpoint of overall survival.

In October 2024, in collaboration with SAKK, we initiated and dosed our first patient in the INVINCIBLE-4 Study to treat patients with localized TNBC.

We plan to enroll 54 patients and expect to complete enrollment by the end of the first quarter of 2026, and the endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone.

There was also an increase of certain types of immune cells (CD4+ and NK T-cells) in the tumor and blood.

Additionally, there was an increase in the T-cells repertoire relative to control.

In July 2024, we initiated and dosed our first patient in the INVINCIBLE-3 Study, a Phase 3 open-label, randomized study testing INT230-6 as a monotherapy compared to the SOC drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes.

This 333-patient study with an endpoint of overall survival has been authorized by the FDA, Health Canada, the European Medicines Authority, and Australia's Therapeutic Goods Administration.

In March 2025, we paused new site activations and patient enrollments due to funding constraints.

Prior to this pause, the trial had enrolled 21 patients.

We will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations to reduce ongoing costs during this pause.

Once sufficient funding is obtained, we plan to restart site activations and patient enrollment in the INVINCIBLE-3 Study.

In October 2024, in collaboration with the Swiss Cancer Group, formerly the Swiss Cancer Group for Clinical Cancer Research (SAKK), we initiated and dosed our first patient in the INVINCIBLE-4 Study, a Phase 2 study to treat

patients with localized TNBC.

The endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone.

In September 2025, we paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in Cohort A due to some patients in Cohort A experiencing localized skin irritation near the tumor site.

In March 2026, a protocol amendment was submitted to the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6.

Full approval to resume enrollment was granted on March 26, 2026, and we plan to resume enrollment in the second quarter of 2026.

We are currently targeting to complete enrollment by the end of 2027 and will likely add resources to help sites enroll new patients.

In the event we are unable to obtain sufficient additional funding, we may have to delay the completion of the INVINCIBLE-4 Study until such funding is obtained.

We have also successfully developed Phase 3 quality analytical methods for the three INT230-6 components and successfully manufactured a large-scale batch of INT230-6.

In a meeting with the FDA in the fourth quarter of 2023, we agreed on a CMC plan for Phase 3 and product registration for our three key ingredients and INT230-6.

If we successfully

execute the agreed upon plan, and expect that the CMC portion of an NDA should be acceptable to the FDA for product approval and registration (subject to final NDA review).

If we successfully execute the agreed upon plan, and expect that the CMC portion of an NDA should be acceptable to the FDA for product approval and registration (subject to final NDA review).

Since our inception in 2012, our operations have included business planning, hiring personnel, raising capital, building our intellectual property portfolio, and performing both research and development on our product candidates.

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As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the issuances of equity, debt financing, or other capital sources, which may include collaborations with other companies or other strategic transactions.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financing, or other capital sources, which may include collaborations with other companies or other strategic transactions.

We may not be able to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.

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General and Administrative Expenses

• Salaries and Benefits Related Costs include employee-related expenses such as salaries and related benefits for employees engaged in fund raising, management, and corporate administration functions.

• Salaries and Benefits Related Costs include employee-related expenses such as salaries, bonuses and related benefits for employees engaged in fund raising, management, and corporate administration functions.

• Legal Fees include expenses for corporate, patent and trademark fees with outside law firms.

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Treasury bills.

We incurred interest expense on our convertible notes through June 29, 2023.

Accrued interest was converted into Common Stock upon commencement of our IPO.

Results of Operations

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Interest income 180 314 (134)

Interest expense - (305) 305

Loss on debt extinguishment - (2,262) 2,262

Other income, net 186 3 183

Net loss $ (11,606) $ (16,268) $ 4,662

Preferred stock deemed dividend - (1,324) 1,324

Net loss attributable to common stockholders $ (16,268) $ (11,862) $ (4,406)

Years Ended December 31,

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Legal fees 451 728 (277)

Accounting fees 349 404 (55)

Audit fees 310 349 (39)

Consulting 609 768 (159)

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Year Ended December 31, 2025 Compared to Year Ended December 31, 2024

Research and development expenses increased $5.7 million or 119%, and were primarily due to the following:

• Salaries and benefits related costs increased $0.5 million due to two new employee hires in late 2023 and two additional employee hires in early 2024.

• Clinical trial expenses increased $5.1 million, primarily due to an increase of $5.6 million in the INVINCIBLE-3 Study in 2024, in which we enrolled our first patient in the third quarter of 2024, and to a lesser extent, an increase of $0.5 million in the INVINCIBLE-4 Study, in which we enrolled and dosed our first patient in the fourth quarter of 2024.

These increases were partially offset by a decrease of $1.1 million in our IT-01 Study due to the completion of enrollment in this study in mid-2022 and the completion of study-related costs in 2023.

• Contract manufacturing decreased by $0.3 million in 2024, as there were fewer INT230-6 batches manufactured compared to 2023.

• Stock-based compensation increased due to new option awards granted to new employees, and additional option awards granted to employees in 2024, compared to minimal option awards granted in 2023.

General and administrative expenses increased $2.6 million or 72%, and were primarily due to the following:

• Salaries and benefits related costs increased by $0.3 million primarily due to the hiring of our new chief financial officer in the fourth quarter of 2023.

• Insurance increased by $0.3 million due to the additional directors and officers insurance as a publicly held company.

• Legal fees increased $0.3 million primarily due to the higher public company reporting-related costs incurred over the full 2024 calendar year, compared to the partial year of public company-related costs subsequent to the completion of our IPO in mid-2023.

• Accounting fees decreased slightly by $0.1 million primarily due lower annual audit fees compared to higher fees incurred in the year of our IPO.

• Consulting increased $0.3 million primarily due to higher board fees and investor relation expenses subsequent to the completion of our IPO in mid-2023.

• Stock-based compensation increased due to new option awards granted our new chief financial officer, and additional option awards granted to employees in 2024, compared to minimal option awards granted in 2023.

Interest income was relatively unchanged in 2024.

Interest expense incurred in 2023 was due to convertible notes outstanding in 2023, which converted to Common Stock at the time of our IPO.

In addition, at the time of conversion, we also recognized a $2.3 million loss on debt conversion.

At the time of our IPO, a preferred stock deemed dividend of $1.3 million was recognized, representing the value that was transferred to the Series B and C preferred stockholders upon triggering of anti-dilution provisions.

Research and development expenses decreased $3.7 million or 35%, and were primarily due to the following:

• Clinical trial expenses decreased $2.8 million, primarily due to lower INVINCIBLE-3 Study costs.

In March 2025, we paused new site activations and patient enrollments in the INVINCIBLE-3 Study, due to funding constraints.

Prior to this pause, the trial had enrolled 21 patients.

We will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and once sufficient funding is obtained, we plan to restart site activations and patient enrollment.

• Contract manufacturing costs declined by $0.6 million, as there were no new manufacturing batches of INT230-6 in 2025.

• Salaries and benefits related costs increased due to an estimated bonus accrual of $0.3 million in 2025 compared to zero in 2024, which was partially offset by a decrease of $0.1 million due to a minor reduction in employee headcount in 2025.

• Stock-based compensation decreased due to lower fair value per share of option awards granted to employees in 2025.

General and administrative expenses decreased $0.9 million or 15%, and were primarily due to the following:

• Salaries and benefits related costs increased due to an estimated bonus accrual of $0.5 million in 2025 compared to zero in 2024.

• Insurance decreased by $0.2 million due to the favorable directors and officers insurance renewal terms obtained in 2025 compared to the prior policy year.

• Legal, accounting, consulting and other expenses decreased as a result of cost saving from the integration of new systems and other cost-efficient activities in the administrative areas.

• Stock-based compensation decreased due to lower fair value per share of option awards granted to employees in 2025.

Interest income in 2025 and 2024 related to interest earned on cash and investment balances.

Liquidity and Capital Resources

Our financial statements have been prepared assuming we will continue as a going concern.

We have incurred losses from operations and negative cash flows that raise substantial doubt about our ability to continue as a going concern.

We have incurred losses from operations and negative cash flows from operations that raise substantial doubt about our ability to continue as a going concern.

We have financed our operations primarily through an initial investment from our founder, the issuance and sale of convertible debt notes, and private and public equity financings.

Since our inception, we have not generated any revenue from product sales and have incurred significant operating losses.

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The sale of equity and convertible debt securities may result in dilution to our stockholders.

Additional capital may not be

available on reasonable terms, or at all.

Additional capital may not be available on reasonable terms, or at all.

If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, scale back or discontinue the development of our product candidates.

On July 3, 2024, we filed a universal shelf registration statement on Form S-3, which was declared effective by the SEC on July 11, 2024, on which we registered for sale up to $150 million of any combination of our Common Stock , preferred stock, debt securities, warrants, and/or units from time to time and at prices and on terms that we may determine, which included up to $15 million of Common Stock that we may issue and sell from time to time, through H.C.

Wainwright & Co., LLC (“Wainwright”) acting as our sales agent, pursuant to the sales agreement that we entered into with Wainwright on July 3, 2024 for our “at-the-market” equity program (the “ATM Agreement”).

On November 20, 2024, we filed a prospectus supplement to reduce the maximum we may sell and issue under the ATM Agreement to $7.0 million of Common Stock , not including shares previously sold under the ATM Agreement.

For the year ended December 31, 2024, we issued 51,820 shares of Common Stock under the Sales Agreement for net proceeds of $0.2 million.

On March 23, 2026, we filed a prospectus supplement to adjust the maximum the Company may sell and issue under the ATM Sales Agreement to $60.0 million of our common stock, not including the shares previously sold under the ATM Sales Agreement.

Since inception through March 22, 2026, we have issued 1,297,655 shares of common stock under the ATM Sales Agreement for net proceeds of $11.5 million.

On October 30, 2025, the Company entered into a Securities Purchase Agreement with an institutional investor, pursuant to which the Company issued and sold in a registered direct offering by the Company directly to the investor 200,000 shares of common stock at a price of $20.00 per share, for aggregate gross proceeds of $4.0 million before deducting the placement agent’s fees and related offering expenses.

On June 11, 2025, we entered into an underwriting agreement (the “Underwriting Agreement”) with ThinkEquity LLC (the “Underwriter”) relating to the issuance and sale of an aggregate of 267,000 shares (the “Firm Shares”) of our common stock to the Underwriter at a price to the public of $7.50 per share (the “June 2025 Offering”).

Pursuant to the terms of the Underwriting Agreement, we granted to the Underwriter a 45-day option to purchase up to an additional 40,050 shares of common stock in the June 2025 Offering (the “Option Shares” and together with the Firm Shares, the “Shares”).

The Underwriter exercised its option in full to purchase the 40,050 Option Shares at the public offering price on June 12, 2025.

The June 2025 Offering, including the exercise of the Underwriter’s over-allotment option, closed on June 13, 2025.

All of the Shares were sold by us.

Pursuant to the Underwriting Agreement, we also agreed to issue to the Underwriter and/or its designees warrants to purchase up to 15,352 shares of common stock (the “Representative’s Warrants”), which equals 5% of the Shares purchased in the June 2025 Offering, such warrants to be exercisable as set forth in the Representative’s Warrant Agreement.

The net proceeds from the June 2025 Offering, including the exercise of the Underwriter’s over-allotment option, were approximately $1.8 million after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

On April 24, 2025, we commenced a best efforts public offering (the “April 2025 Offering”) of an aggregate of (i) 125,333 shares (the “Shares”) of the our common stock, (ii) 125,333 Series B-1 Common Warrants (the “Series B-1 Common Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-1 Common Warrant Shares”), (iii) 125,333 Series B-2 Common Warrants (the “Series B-2 Common Warrants” and together with the Series B-1 Warrants, the “Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-2 Common Warrant Shares” and together with the Series B-1 Common Warrant Shares, the “Warrant Shares”).

In connection with the April 2025 Offering, we entered into a Securities Purchase Agreement on April 24, 2025 with certain institutional investors participating in the April 2025 Offering.

The April 2025 Offering closed on April 28, 2025.

Each Share was sold together with one Series B-1 Common Warrant to purchase one share of common stock and one Series B-2 Common Warrant to purchase one share of common stock.

The combined offering price for each Share and accompanying Warrants was $18.75.

Each Warrant has an exercise price of $21.25 and was immediately exercisable upon issuance.

The Series B-1 Common Warrants will expire on the five-year anniversary of the date of issuance, and the Series B-2 Common Warrants will expire on the eighteen-month anniversary of the date of issuance.

We raised an aggregate of $2.35 million in the April 2025 Offering, and net proceeds of the April 2025 Offering, after deducting the fees and expenses were approximately $1.9 million.

On November 21, 2024, we entered into a Securities Purchase Agreement with a single healthcare focused institutional investor (the “Investor”), pursuant to which we agreed to issue and sell, in a registered direct offering directly to the Investor, 49,484 shares of common stock to the Investor, at a price of $60.625 per share, for aggregate gross proceeds of approximately $3.0 million before deducting the placement agents’ fees and related offering expenses.

In a concurrent private placement, we agreed to issue to the Investor common stock warrants to purchase up to 49,484 shares (the “Common Warrants”) at an exercise price of $73.75 per share.

Each Common Warrant will be exercisable six months from the issuance date and will expire five and one-half years from the issuance date.

We have financed our operations primarily through an initial investment from our founder, the issuance and sale of convertible debt notes, private equity financings, and the IPO, after which shares of our Common Stock began trading on Nasdaq under the symbol “INTS” on June 30, 2023.

Each Common Warrant is exercisable six months from the issuance date and will expire five and one-half years from the issuance date.

On July 3, 2024, we filed a universal shelf registration statement on Form S-3, which was declared effective by the SEC on July 11, 2024, on which we registered for sale up to $150 million of any combination of our c ommon stock , preferred stock, debt securities, warrants, and/or units from time to time and at prices and on terms that we may determine, which included up to $15 million of c ommon stock that we may issue and sell from time to time, through H.C.

As of December 31, 2025, our cash and cash equivalents were approximately $11.9 million.

Based on our balances in cash and cash equivalents, we project to have sufficient cash to fund our current operating plan through the end of the first quarter of 2025.

Based on our balances in cash and cash equivalents, we project to have sufficient cash to fund our current operating plan into the second quarter of 2027.

Accordingly, we will need to obtain substantial additional funding to continue our operations.

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Net cash used in operating activities $ (9,233) $ (15,220)

Net cash provided by (used in) investing activities 6,354 (6,023)

Net cash provided by investing activities — 6,354

Net cash provided by financing activities 18,564 2,900

Net (decrease) increase in cash and cash equivalents $ (5,966) $ 7,244

Net increase (decrease) in cash and cash equivalents $ 9,331 $ (5,966)

Operating Activities

Our cash used in operating activities for the year ended December 31, 2024 was $15.2 million, comprising of (i) our net loss of $16.3 million, as adjusted for $3.1 million in non-cash expenses (including $3.1 million for non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $2.1 million.

Our cash used in operating activities for the year ended December 31, 2023 was $7.2 million, comprising of (i) our net loss of $10.5 million, as adjusted for $4.0 million in non-cash expenses (including $2.3 million for the conversion of convertible notes into shares of Common Stock , and $1.4 million non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $0.6 million.

Our cash used in operating activities for the year ended December 31, 2025 was $9.2 million, comprising of (i) our net loss of $11.6 million, as adjusted for $2.0 million in non-cash expenses (primarily $2.0 million for non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $0.3 million.

Our cash used in operating activities for the year ended December 31, 2024 was $15.2 million, comprising of (i) our net loss of $16.3 million, as adjusted for $3.1 million in non-cash expenses (primarily $3.1 million non-cash stock based compensation), and (ii) net changes in operating assets and liabilities of $2.1 million.

Investing Activities

Our cash provided in investing activities during the year ended December 31, 2024 totaled approximately $6.4 million and was primarily due to net redemptions of marketable debt securities (net of purchases of marketable debt securities).

Our cash used in investing activities during the year ended December 31, 2023 totaled approximately $6.0 million and was primarily due to net purchases of marketable debt securities (net of redemptions of marketable debt securities).

There were no investing activities during the year ended December 31, 2025.

Our cash provided by investing activities during the year ended December 31, 2024 totaled approximately $6.4 million and was primarily due to net redemptions of marketable debt securities (net of purchases of marketable debt securities).

Financing Activities

Our cash provided by financing activities during the year ended December 31, 2024 was $2.9 million, primarily comprising of net proceeds of $2.4 million from our registered direct offering in 2023, net proceeds of $0.2 million from issuances of Common Stock from our ATM, and $0.3 million in proceeds from exercises of options and warrants.

Our cash provided by financing activities during the year ended December 31, 2023 was $20.5 million, primarily comprising of net proceeds of $20.2 million from our IPO in 2023, and $0.2 million from the sale of convertible notes prior to the IPO.

Our cash provided by financing activities during the year ended December 31, 2025 was $18.6 million, primarily comprising of (i) $1.9 million in net proceeds received from the issuance of common stock and warrants in the April 2025 Offering, (ii) $1.8 million in net proceeds received from the issuance of common stock in the June 2025 Offering, (iii) $3.6 million in net proceeds received from the issuance of common stock in the October 2025 Offering, and (iv) $11.2 million in net proceeds received from the issuance of common stock under the ATM Sales Agreement.

Our cash provided by financing activities during the year ended December 31, 2024 was $2.9 million, primarily comprising of net proceeds of $2.4 million from our registered direct offering, net proceeds of $0.2 million from issuances of Common Stock from our ATM, and $0.3 million in proceeds from exercises of options and warrants.

Off-Balance Sheet Arrangements

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We estimate the grant date fair value and the resulting stock-based compensation expense using the Black-Scholes option-pricing model.

The grant date fair value of the stock-based awards is recognized on a straight-line basis over the requisite service periods, which are generally the vesting period of the respective awards.

The grant date fair

value of the stock-based awards is recognized on a straight-line basis over the requisite service periods, which are generally the vesting period of the respective awards.

Forfeitures are accounted for as they occur.

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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-K

Item 7. Management’s Discussion and Analysis