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Context Therapeutics Inc.

For the period ended Mar 31, 2025. Filed May 7, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 7, 2025

CNTX$0.19+3.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-09-30; filed 2024-11-06.

0001842952-24-000085

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-03-31; filed 2025-05-07.

0001842952-25-000048

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The 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 110 previous paragraphs and 109 current paragraphs.

71 unchanged; 25 reworded; 10 added; 10 removed; 4 previous and 3 current paragraphs rearranged.

Tables are not compared: 5 previous and 3 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 (10)

Current report

On May 1, 2025, we provided notice of termination without cause to Dr. Claudio Dansky Ullmann, our chief medical officer, to be effective as of May 10, 2025. On May 1, 2025, Dr. Karen Smith, one of our directors, was appointed interim chief medical officer and will serve in such role until Dr. Dansky Ullmann’s permanent replacement is identified.

Current report

On December 2, 2024, we entered into a Sales Agreement (the “ATM Sales Agreement”) with Leerink Partners LLC (the “Agent”). Pursuant to the terms of the ATM Sales Agreement, we may offer and sell shares of common stock having an aggregate offering amount of up to $75.0 million from time to time through the Agent (the “ATM Shares”). Sales of the ATM Shares may be made in sales deemed to be an “at-the-market offering” as defined in Rule 415 under the Securities Act. The Agent will be entitled to a commission from the Company of 3.0% of the gross proceeds from the sale of ATM Shares sold under the ATM Sales Agreement. On December 23, 2024, we sold 14,705,882 shares of our common stock under the ATM Sales Agreement for net proceeds of approximately $14.5 million.

Current report

During the three months ended March 31, 2025, we used approximately $34,000 of cash in operating activities to purchase property and equipment.

Current report

During the three months ended March 31, 2025, we used approximately $15,000 of cash in financing activities related to the payment of remaining offering costs from the sale of ATM Shares under our ATM Sales Agreement.
Removed paragraphs (10)

Previous report

In addition, pursuant to a registration rights agreement dated May 1, 2024 (the “Registration Rights Agreement”), we filed a registration statement for purposes of registering the resale of the Shares (including the Warrant Shares) (the “Registration Statement”), which was declared effective by the SEC on May 31, 2024. We agreed to use our reasonable best efforts to keep the Registration Statement effective until the date that all registrable securities covered by the Registration Statement (i) have been sold, thereunder or pursuant to Rule 144, or (ii) may be sold by a non-affiliate without volume or manner-of-sale restrictions pursuant to Rule 144 and without the requirement for us to be in compliance with the current public information requirement under Rule 144.

Previous report

On March 22, 2023, we announced a portfolio prioritization and capital allocation strategy, including discontinuing the development of ONA-XR and focusing on the development of CTIM-76. Based upon the challenging market conditions for emerging companies, the increasingly competitive landscape for breast cancer treatments, recent study findings, and other factors, we decided to cease development and explore strategic options for ONA-XR. As a result, we no longer primarily focus on female cancers.

Previous report

ONA-XR income of $17,363 for the three months ended September 30, 2023 was due to actual closeout costs incurred being less than the estimated close out costs recorded as of June 30, 2023, following our decision in March 2023 to discontinue the development of ONA-XR and focus on the development of CTIM-76. CTIM-76 expenditures decreased by $2.8 million, primarily due to a decrease of $3.5 million in contract manufacturing costs and preclinical costs, partially offset by an increase of $0.8 million in clinical costs as a result of initiating our Phase 1 clinical trial. CT-95 expense of $4.0 million primarily represents consideration paid of $3.75 million to acquire the asset from Link in July 2024 and approximately $0.2 million in other preclinical expenses incurred. CT-202 expense of $11.0 million primarily represents consideration paid under the BioAtla

Previous report

Comparison of the Nine Months Ended September 30, 2024 and 2023

Previous report

General and administrative expenses decreased by approximately $0.2 million for the nine months ended September 30, 2024 as compared to the same period in 2023. The decrease was primarily driven by decreases in compensation and share-based compensation costs of $0.3 million and insurance expense of $0.2 million. These decreases were partially offset by an increase in professional fees of $0.2 million in the nine months ended September 30, 2024.

Previous report

Comparison of the Nine Months Ended September 30, 2024 and 2023

Previous report

During the nine months ended September 30, 2024, cash used in investing activities was primarily attributable to a one-time payment of $3.75 million made to Link to acquire the assets associated with CT-95 and a payment of $11.0 million under the BioAtla License Agreement for the development of CT-202. In addition, we used $7,000 of cash to purchase property and equipment.

Previous report

During the nine months ended September 30, 2024, financing activities provided $94.8 million, consisting of net proceeds from the sale of common stock and Pre-Funded Warrants in the Private Placement.
Reworded paragraphs (25)

Previous wording

We are a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. We are building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a CLDN6 x CD3 bsAb, CT-95, an MSLN x CD3 bsAb, and CT-202, a Nectin-4 x CD3 bsAb.

Current wording

We are a clinical-stage biopharmaceutical company advancing TCE bispecific antibodies for solid tumors. We are building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a CLDN6 x CD3 TCE, CT-95, an MSLN x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE.

Previous wording

CTIM-76 is a CLDN6 x CD3 bispecific antibody that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors and absent from or expressed at low levels in healthy adult tissues. Investigational New Drug (“IND”)-enabling studies on CTIM-76 have been completed. On May 2, 2024, we announced the FDA cleared our IND application to support the initiation of a Phase 1 dose escalation and expansion trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. We anticipate dosing the first patient in the CTIM-76 Phase 1 trial by the end of 2024. We expect to share initial data for the CTIM-76 Phase 1 trial in the first half of 2026.

Current wording

CTIM-76 is a CLDN6 x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors and absent from or expressed at low levels in healthy adult tissues. IND-enabling studies on CTIM-76 have been completed. On May 2, 2024, we announced the FDA cleared our IND application to support the initiation of a Phase 1 dose escalation and expansion trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. We dosed the first patient in our CTIM-76 Phase 1 trial in January 2025. We expect to share initial data for the CTIM-76 Phase 1 trial in the first half of 2026.

Previous wording

CT-202 targets Nectin-4, which is highly and frequently overexpressed in a variety of cancers. Nectin-4 is a clinically-validated target for cancer therapy using a traditional antibody-drug conjugate, but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a Conditionally Active Biologic T cell engager that is designed to be preferentially active within the tumor microenvironment. We expect to file an IND application for CT-202 in the middle of 2026.

Current wording

CT-202 is a Nectin-4 x CD3 TCE that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate (“ADC”), but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment. We expect to file an IND application for CT-202 in the middle of 2026.

Previous wording

Pursuant to the Asset Purchase Agreement, we purchased all of the assets of Link associated with CT-95, including patent rights, know-how, regulatory filings, and inventory of drug substance and drug product (the “Transferred Assets”), on an “as is” and “where is” basis. CT-95 patents are currently being prosecuted and/or maintained in the United States, Europe, Canada, Australia and Taiwan. We also assumed certain liabilities relating to the Transferred Assets. In consideration of the purchase of the Transferred Assets, we made a one-time payment to Link of $3.75 million.

Current wording

Pursuant to the Asset Purchase Agreement, we purchased all of the assets of Link associated with CT-95, including patent rights, know-how, regulatory filings, and inventory of drug substance and drug product (the “Transferred Assets”), on an “as is” and “where is” basis. CT-95 patents are currently being prosecuted and/or maintained in the United States, Europe, Canada, Australia, Japan and Taiwan. We also assumed certain liabilities relating to the Transferred Assets. In consideration of the Transferred Assets, we made a one-time payment to Link of $3.75 million.

Previous wording

CT-95 is an MSLN x CD3 bispecific antibody that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately 30% of cancers. One challenge in developing MSLN-targeted therapies has been the presence of MSLN fragments, also referred to as shed MSLN, found in both blood and the tumor microenvironment that can serve as a decoy or sink for MSLN-targeting antibodies. CT-95 is a fully humanized bispecific T cell engager that has a relatively low affinity but high avidity for membrane-bound MSLN, minimizing the impact of the shed MSLN. CT-95 is being developed as a therapy for advanced cancers associated with MSLN expression, including ovarian, lung, pancreatic, and mesothelioma. We expect to dose the first patient in the CT-95 Phase 1 trial in the first quarter of 2025. We expect to share initial data for the CT-95 Phase 1 trial in the middle of 2026.

Current wording

CT-95 is an MSLN x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately 30% of cancers. We dosed the first patient in our CT-95 Phase 1 trial in April 2025. We expect to share initial data for the CT-95 Phase 1 trial in the middle of 2026.

Previous wording

On May 1, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) for the private placement (the “Private Placement”) of (i) 59,032,259 shares (the “Shares”) of our common stock at a purchase price of $1.55 per Share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase 5,482,741 shares of common stock (the “Warrant Shares”) at a purchase price of $1.549 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and remain exercisable until exercised in full. The aggregate gross proceeds for the Private Placement were approximately $100 million, before deducting offering expenses of $5.2 million, and the Private Placement closed on May 6, 2024. We expect to have sufficient cash and cash equivalents to fund the estimated duration of the dose escalation portions of our CTIM-76 and CT-95 Phase 1 trials, the estimated expenses through IND filing for CT-202, as well as our operations into 2027.

Current wording

On May 1, 2024, we entered into a securities purchase agreement (the “Purchase Agreement”) for the private placement (the “Private Placement”) of (i) 59,032,259 shares (the “PIPE Shares”) of our common stock at a purchase price of $1.55 per PIPE Share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase 5,482,741 shares of common stock (the “Warrant Shares”) at a purchase price of $1.549 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.001 per share of common stock, are immediately exercisable and remain exercisable until exercised in full. The aggregate gross proceeds for the Private Placement were approximately $100 million, before deducting offering expenses of $5.2 million, and the Private Placement closed on May 6, 2024.

Previous wording

On February 29, 2024, we amended the Research Collaboration and License Agreement (the “Integral License Agreement”) with Integral Molecular, Inc. (“Integral”) to reflect updated financial terms. In the course of our further due diligence review of CTIM-76, we determined that certain of the licensed rights under the Integral License Agreement may incorporate intellectual property rights currently held by a third party. Specifically, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain of the intellectual property included in CTIM-76. While we believe we will have reasonable defenses against any potential claim of infringement, we may not be successful in such efforts, and we also may not be able to obtain a license to such patent on commercially reasonable terms, or at all.

Current wording

On February 29, 2024, we amended the Research Collaboration and License Agreement (the “Integral License Agreement”) with Integral Molecular, Inc. (“Integral”) to reflect updated financial terms. In the course of our further due diligence review of CTIM-76, we determined that certain of the licensed rights under the Integral License Agreement may incorporate intellectual property rights currently held by a third party. Specifically, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain parts of the intellectual property included in CTIM-76. While we believe we will have reasonable defenses against any potential claim of infringement, we may not be successful in such efforts, and we also may not be able to obtain a license to such patent on commercially reasonable terms, or at all.

Previous wording

We were incorporated in April 2015 under the laws of the State of Delaware. Since inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development, organizing and staffing our company, business planning and raising capital. We operate as one business segment and have incurred recurring losses, the majority of which are attributable to research and development activities, and negative cash flows from operations. We have funded our operations primarily through the sale of common stock, warrants, convertible debt, and convertible preferred stock. Our net loss was $23.4 million for the nine months ended September 30, 2024. As of September 30, 2024, we had an accumulated deficit of $91.4 million.

Current wording

We were incorporated in April 2015 under the laws of the State of Delaware. Since inception, we have devoted substantially all of our resources to developing product and technology rights, conducting research and development, organizing and staffing our company, business planning and raising capital. We operate as one business segment and have incurred recurring losses, the majority of which are attributable to research and development activities, and negative cash flows from operations. We have funded our operations primarily through the sale of common stock, warrants, convertible debt, and convertible preferred stock. Our net loss was $4.6 million for the three months ended March 31, 2025. As of March 31, 2025, we had an accumulated deficit of $99.4 million.

Previous wording

As of September 30, 2024, we had cash and cash equivalents of $84.8 million, which we expect will be sufficient to fund our operations into 2027. If the Company is unable to obtain additional financing, the lack of liquidity could have a material adverse effect on the Company’s future prospects.

Current wording

As of March 31, 2025, we had cash and cash equivalents of $89.4 million, which we expect will be sufficient to fund our operations into 2027. If the Company is unable to obtain additional financing, the lack of liquidity could have a material adverse effect on the Company’s future prospects.

Previous wording

•license payments and acquisitions of IPR&D assets that have no alternative future use;

Current wording

•license payments and acquisitions of acquired in-process research and development assets that have no alternative future use;

Previous wording

We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, potential commercialization efforts and increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, legal support and accountants, among other expenses. Additionally, we will continue to incur significant costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and the SEC, insurance and investor relations costs. If any of our current or future product candidates obtain U.S. regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.

Current wording

We expect that our general and administrative expenses will increase in the future to support our continued research and development activities, potential commercialization efforts and increased costs of operating as a public company. These increases will likely include increased costs related to the hiring of additional personnel and fees to outside consultants, legal support and accountants, among other expenses. Additionally, we will continue to incur significant costs associated with being a public company, including expenses related to services associated with maintaining compliance with the requirements of Nasdaq and the SEC, insurance and investor relations costs. If any of our current or future product candidates obtain U.S.

Previous wording

Research and development expenses increased by approximately $12.3 million for the three months ended September 30, 2024 as compared to the same period in 2023. The following table summarizes our research and development expenses for the three months ended September 30, 2024 as compared to the same period in 2023:

Current wording

Research and development expenses increased by approximately $1.5 million for the three months ended March 31, 2025 as compared to the same period in 2024. The following table summarizes our research and development expenses for the three months ended March 31, 2025 as compared to the same period in 2024:

Previous wording

The decrease in ONA-XR expense of $1.9 million was due to the decision in March 2023 to discontinue the development of ONA-XR and focus on the development of CTIM-76. CTIM-76 expenditures decreased by $4.9 million, primarily due to a decrease of $6.8 million in preclinical and contract manufacturing costs, partially offset by an increase of $1.7 million in clinical and regulatory costs as a result of initiating our Phase 1 clinical trial. CT-95 expense of $4.0 million primarily represents consideration paid of $3.75 million to acquire the asset from Link in July 2024 and approximately $0.2 million in other preclinical expenses incurred. CT-202 expense of $11.0 million primarily represents consideration paid under the BioAtla License Agreement entered into in September 2024. Personnel-related costs, which include salaries, benefits and stock-based compensation expense, decreased by approximately $0.5 million, primarily due to lower average headcount over the prior year period.

Current wording

CTIM-76 expenditures decreased by $0.8 million, primarily due to a decrease of $1.4 million in contract manufacturing costs and preclinical costs, partially offset by an increase of $0.8 million in clinical costs as a result of initiating our Phase 1 clinical trial. CT-95 expense of $0.8 million primarily represents approximately $0.5 million in clinical costs and $0.2 million in preclinical expenses incurred. CT-95 was acquired from Link in July 2024. CT-202 expense of $1.0 million primarily represents $0.7 million in contract manufacturing costs and $0.3 million in preclinical expenses incurred. We entered into the BioAtla License Agreement in September 2024. Personnel-related costs, which include salaries, benefits and stock-based compensation expense, increased by approximately $0.5 million, primarily due to higher headcount over the prior year period.

Previous wording

License Agreement entered into in September 2024. Personnel-related costs, which include salaries, benefits and stock-based compensation expense, increased by approximately $0.1 million, primarily due to higher headcount over the prior year period.

Current wording

Other research and development expense increased by approximately $0.1 million, primarily due to higher allocated expenses as a result of higher headcount over the prior year period.

Previous wording

General and administrative expenses increased by approximately $0.2 million for the three months ended September 30, 2024 as compared to the same period in 2023. The increase was primarily driven by an increase in professional fees of $0.2 million for legal services incurred during the three months ended September 30, 2024.

Current wording

General and administrative expenses increased by approximately $0.2 million for the three months ended March 31, 2025 as compared to the same period in 2024. The increase was primarily driven by a $0.1 million increase in salaries and personnel related costs, mainly due to higher headcount and compensation adjustments. Professional fees also increased by approximately $0.1 million as compared to the same period in 2024.

Previous wording

Interest income increased by approximately $1.0 million for the three months ended September 30, 2024 as compared to the same period in 2023 primarily due to higher cash and cash equivalent balances due to the Private Placement.

Current wording

Interest income increased by approximately $0.8 million for the three months ended March 31, 2025 as compared to the same period in 2024, primarily due to higher cash and cash equivalent balances due to the Private Placement.

Previous wording

Other expense was $2,152 for the three months ended September 30, 2024 as compared to other income of $15,369 for the same period in 2023, primarily due to higher foreign currency losses as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

Current wording

Other expense was approximately $7,000 for the three months ended March 31, 2025, as compared to other income of approximately $3,000 for the same period in 2024, primarily due to higher foreign currency losses as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

Previous wording

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception through September 30, 2024, we have funded our operations through the sale of common stock, warrants, convertible debt, and convertible preferred stock. As of September 30, 2024, we had $84.8 million in cash and cash equivalents and an accumulated deficit of $91.4 million.

Current wording

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. Since our inception through March 31, 2025, we have funded our operations through the sale of common stock, warrants, convertible debt, and convertible preferred stock. As of March 31, 2025, we had $89.4 million in cash and cash equivalents and an accumulated deficit of $99.4 million.

Previous wording

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic transactions or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Current wording

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic transactions and/or marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic transactions or marketing, or distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Previous wording

During the nine months ended September 30, 2023, we used $13.8 million of cash in operating activities. Cash used in operating activities reflected our net loss of $17.2 million, partially offset by a change in our operating assets and liabilities of $2.5 million and non-cash share-based compensation expense of $0.8 million. The primary uses of cash were to fund our operations related to the development of our product candidates.

Current wording

During the three months ended March 31, 2025, we used $5.0 million of cash in operating activities. Cash used in operating activities reflected our net loss of $4.6 million and a change in our operating assets and liabilities of $0.8 million, partially offset by non-cash share-based compensation expense of $0.3 million. The primary uses of cash were to fund our operations related to the development of our product candidates.

Previous wording

During the nine months ended September 30, 2024, we used $9.6 million of cash in operating activities. Cash used in operating activities reflected our net loss of $23.4 million and a change in our operating assets and liabilities of $1.7 million, partially offset by in-process research and development charges of $14.8 million and non-cash share-based compensation expense of $0.6 million. The primary uses of cash were to fund our operations related to the development of our product candidates.

Current wording

During the three months ended March 31, 2024, we used $4.4 million of cash in operating activities. Cash used in operating activities reflected our net loss of $3.7 million and a change in our operating assets and liabilities of $0.9 million, partially offset by non-cash share-based compensation expense of $0.2 million. The primary uses of cash were to fund our operations related to the development of CTIM-76.

Previous wording

We did not have cash flows from investing activities during the nine months ended September 30, 2023.

Current wording

We did not have cash flows from investing activities during the three months ended March 31, 2024.

Previous wording

We did not have cash flows from financing activities during the nine months ended September 30, 2023.

Current wording

We did not have cash flows from financing activities during the three months ended March 31, 2024.

Previous wording

During the three and nine months ended September 30, 2024, there were no material changes to our critical accounting policies and estimates from those described in our Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 21, 2024.

Current wording

During the three months ended March 31, 2025, there were no material changes to our critical accounting policies and estimates from those described in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 20, 2025.

Previous wording

In April 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from complying with new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

Current wording

In April 2012, the Jumpstart Our Business Startups Act (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from complying with new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
Rearranged current paragraphs (3)

Current report — wording carried from elsewhere

We expect to have sufficient cash and cash equivalents to fund the estimated duration of the dose escalation portions of our CTIM-76 and CT-95 Phase 1 trials, the estimated expenses through IND filing for CT-202, as well as our operations into 2027.

Current report — wording carried from elsewhere

regulatory approval, we expect that we would incur significantly increased expenses associated with building a sales and marketing team.

Current report — wording carried from elsewhere

Comparison of the Three Months Ended March 31, 2025 and 2024
Rearranged previous paragraphs (4)

Previous report — wording carried elsewhere

The following table sets forth our results of operations for the nine months ended September 30, 2024 and 2023:

Previous report — wording carried elsewhere

Research and development expenses increased by approximately $7.7 million for the nine months ended September 30, 2024 as compared to the same period in 2023. The following table summarizes our research and development expenses for the nine months ended September 30, 2024 as compared to the same period in 2023:

Previous report — wording carried elsewhere

Interest income increased by approximately $1.3 million for the nine months ended September 30, 2024 as compared to the same period in 2023 primarily due to higher cash and cash equivalent balances due to the Private Placement.

Previous report — wording carried elsewhere

Other expense was $4,906 for the nine months ended September 30, 2024 as compared to other income of $5,830 for the same period in 2023, primarily due to higher foreign currency losses as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.