Context Therapeutics Inc.

Previous 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.

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 dose escalation data for the CTIM-76 Phase 1 trial in the second quarter of 2026.

Previous 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.

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 dose escalation data for the CT-95 Phase 1 trial in the middle of 2026.

Previous 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.

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 complete necessary regulatory filings to support the initiation of a first-in-human trial for CT-202 in the second quarter of 2026.

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 $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.

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 $13.4 million for the six months ended June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $108.2 million.

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 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.

Current wording

In April 2021, we entered into a collaboration and licensing agreement with Integral Molecular, Inc. (“Integral”) (the “Integral License Agreement”) for the development of a CLDN6 BsAb for cancer therapy. On February 29, 2024, we further amended (the "Second Amendment") the Research Collaboration and License Agreement (the “Integral License Agreement”, as amended) with 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

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.

Current wording

As of June 30, 2025, we had cash and cash equivalents of $83.5 million, which we expect will be sufficient to fund the estimated duration of the dose escalation portions of our CTIM-76 and CT-95 Phase 1 trials, the estimated expenses to initiate patient enrollment in a first-in-human trial for CT-202, as well as 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

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.

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

Previous wording

Other (expense) income is primarily due to the recognition of foreign currency gains or losses as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

Current wording

Other income (expense) is primarily due to the recognition of foreign currency gains or losses as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

Previous 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:

Current wording

Research and development expenses increased by approximately $6.4 million for the three months ended June 30, 2025 as compared to the same period in 2024. The following table summarizes our research and development expenses for the three months ended June 30, 2025 as compared to the same period in 2024:

Previous 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.

Current wording

General and administrative expenses increased by approximately $0.2 million for the three months ended June 30, 2025 as compared to the same period in 2024. The increase was primarily driven by a $0.2 million increase in personnel-related costs, including share-based compensation, mainly due to higher headcount and compensation adjustments.

Previous 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.

Current wording

Interest income increased by approximately $0.1 million for the three months ended June 30, 2025 as compared to the same period in 2024, primarily due to higher cash and cash equivalent balances due to the sale of PIPE Shares and ATM Shares.

Previous 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.

Current wording

Other income was approximately $27,000 for the three months ended June 30, 2025, as compared to other expense of approximately $6,000 for the same period in 2024, primarily due to higher foreign currency gains as a result of exchange rate fluctuations on transactions denominated in a currency other than our functional currency.

Previous 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.

Current wording

CTIM-76 expenditures decreased by $0.7 million, primarily due to a decrease of $1.9 million in contract manufacturing, preclinical and diagnostic development costs, partially offset by an increase of $1.3 million in clinical costs as a result of our ongoing Phase 1 clinical trial. CT-95 expense of $2.3 million primarily represents approximately $1.5 million in clinical costs and $0.6 million in preclinical and diagnostic development expenses incurred. CT-95 was acquired from Link in July 2024. CT-202 expense of $4.1 million primarily represents $2.9 million in contract manufacturing costs and $1.2 million in preclinical expenses incurred. We entered into the BioAtla License Agreement in September 2024. Personnel-related costs, which include salaries, benefits and share-based compensation expense, increased by approximately $2.1 million, primarily due to higher headcount over the prior year period as well as termination benefits incurred related to certain employee departures.

Previous 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.

Current wording

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

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 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.

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 June 30, 2025, we have funded our operations through the sale of common stock, warrants, convertible debt, and convertible preferred stock. As of June 30, 2025, we had $83.5 million in cash and cash equivalents and an accumulated deficit of $108.2 million.

Previous wording

We expect our cash and cash equivalents at March 31, 2025 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. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.

Current wording

We expect our cash and cash equivalents at June 30, 2025 to fund the estimated duration of the dose escalation portions of our CTIM-76 and CT-95 Phase 1 trials, the estimated expenses to initiate patient enrollment in a first-in-human trial for CT-202, as well as our operations into 2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.

Previous 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.

Current wording

During the six months ended June 30, 2025, we used $10.9 million of cash in operating activities. Cash used in operating activities reflected our net loss of $13.4 million, partially offset by a change in our operating assets and liabilities of $1.8 million and non-cash share-based compensation expense of $0.7 million. The primary uses of cash were to fund our operations related to the development of our product candidates.

Previous 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.

Current wording

During the six months ended June 30, 2024, we used $7.7 million of cash in operating activities. Cash used in operating activities reflected our net loss of $5.9 million and a change in our operating assets and liabilities of $2.2 million, partially offset by non-cash share-based compensation expense of $0.4 million. The primary uses of cash were to fund our operations related to the development of CTIM-76.

Previous wording

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

Current wording

During the six months ended June 30, 2025, we used approximately $34,000 of cash in operating activities to purchase property and equipment.

Previous wording

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

Current wording

We did not have cash flows from investing activities during the six months ended June 30, 2024.

Previous wording

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.

Current wording

During the six months ended June 30, 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.

Previous 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.

Current wording

During the three and six months ended June 30, 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

Other exemptions and reduced reporting requirements under the JOBS Act include, without limitation, the requirements for providing an auditor’s attestation report on our system of internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, an exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements. We will remain an emerging growth company until the earlier to occur of (a) the last day of the fiscal year (i) following October 19, 2026, (ii) in which we have total annual gross revenues of at least $1.235 billion or (iii) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means that we have been required to file annual and quarterly reports under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), for a period of at least 12 months and have filed at least one annual report pursuant to the Exchange Act and (b) either (i) the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, or (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

Current wording

Accounting Oversight Board regarding mandatory audit firm rotation, and less extensive disclosure about our executive compensation arrangements. We will remain an emerging growth company until the earlier to occur of (a) the last day of the fiscal year (i) following October 19, 2026, (ii) in which we have total annual gross revenues of at least $1.235 billion or (iii) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means that we have been required to file annual and quarterly reports under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), for a period of at least 12 months and have filed at least one annual report pursuant to the Exchange Act and (b) either (i) the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, or (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.