Context Therapeutics Inc.
For the period ended Dec 31, 2024. Filed Mar 20, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 20, 2025
CNTX$0.19+3.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-21.
0001842952-24-000011
Item 7. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-20.
0001842952-25-000028
Item 7. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 104 previous paragraphs and 110 current paragraphs.
77 unchanged; 18 reworded; 15 added; 7 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 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 (15)
Current report
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.
Current report
On September 23, 2024, we entered into the BioAtla License Agreement with BioAtla, pursuant to which we obtained an exclusive, worldwide license to develop, manufacture and commercialize the BioAtla Asset, including BA3362 (renamed by the Company as CT-202), BioAtla’s Nectin-4 x CD3 TCE.
Current report
As partial consideration for the exclusive license under the BioAtla License Agreement, we made an upfront payment of $11.0 million, and BioAtla is eligible to receive up to $122.5 million in additional milestone payments based upon the achievement of specified pre-clinical, clinical, development and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales for products containing the BioAtla Assets, subject to standard reductions.
Current report
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 report
On July 9, 2024, we entered into the Asset Purchase Agreement pursuant to which we acquired CT-95 (formerly known as LNK-101), from Link, which succeeded to the assets of Link Immunotherapeutics Inc. The FDA previously cleared the IND application for CT-95.
Current report
Pursuant to the Asset Purchase Agreement, we purchased 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.
Current report
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 anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025. We expect to share initial data for the CT-95 Phase 1 trial in the middle of 2026.
Current report
On December 2, 2024, we entered into the ATM Sales Agreement with Agent. Pursuant to the terms of the ATM Sales Agreement, we may offer and sell ATM Shares having an aggregate offering amount of up to $75.0 million from time to time through the Agent. 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, the Company sold 14,705,882 shares of its common stock under the ATM Sales Agreement for net proceeds of approximately $14.5 million.
Current report
On May 1, 2024, we entered into the Purchase Agreement for the Private Placement of (i) 59,032,259 PIPE Shares at a purchase price of $1.55 per PIPE Share and (ii) Pre-Funded Warrants to purchase 5,482,741 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.
Current report
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
Percentage not meaningful
Current report
Other Expense
Current report
During the year ended December 31, 2024, financing activities provided $109.3 million, consisting of net proceeds of $94.8 million from the sale of common stock and Pre-Funded Warrants in the Private Placement, as well as net proceeds of $14.5 million from the sale of common stock under our ATM Sales Agreement.
Current report
Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct clinical studies and other research and development activities, acquired IPR&D, salaries, share-based compensation, and other operational costs related to our research and development activities.
Current report
Costs for certain development activities, such as the provision of services for product candidate development, clinical and preclinical development and related supply and manufacturing costs, are estimated based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although we do not expect our estimates to be materially different from amounts actually incurred, our estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary.
Removed paragraphs (7)
Previous report
We are a biopharmaceutical company advancing medicines for solid tumors.
Previous report
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 are in process, and we expect to submit an IND application to support human clinical trials to the FDA by the end of March 2024. We plan to initiate a Phase 1 trial to focus on CLDN6-positive gynecologic and testicular cancers upon receiving IND clearance from the FDA. We expect to have sufficient cash and cash equivalents to fund our operations into late 2024. We will require additional funding for our planned Phase 1 trial, other research and development expenditures, and general and administrative expenses.
Previous report
Acquired in-process research and development expense consists of initial up-front and development milestone payments incurred in connection with the acquisition or licensing of products or technologies that do not meet the definition of a business under Accounting Standards Codification Topic 805, Business Combinations. Acquired in-process research and development expense reflects the cash paid and/or the estimated fair value of the equity consideration given.
Previous report
Other Income
Previous report
Acquired in-process research and development expense ("IPR&D") of $0.5 million for the year ended December 31, 2022 reflects the expense recognized related to a development milestone achieved in 2022 under the Integral License Agreement for the development of our CLDN6 bsAb for solid tumors. There was no IPR&D expense recognized for the year ended December 31, 2023.
Previous report
During the year ended December 31, 2022, cash used in financing activities was $0.1 million, consisting of the payment of offering costs related to our December 2021 private placement.
Previous report
We accrue an expense for preclinical studies and clinical trial activities performed by our vendors based upon estimates of the proportion of work completed. We determine the estimates by reviewing contracts, vendor agreements and purchase orders, and through discussions with our internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. However, actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including our clinical development plan.
Reworded paragraphs (18)
Previous wording
Our preclinical program, CTIM-76, is a CLDN6 x anti-CD3 bsAb that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6.
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
On February 29, 2024, we amended the Integral License Agreement 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 Integral License Agreement 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 part of the Second Amendment, Integral’s right to receive certain future payments will be reduced as follows: aggregate development and regulatory milestone payments will be reduced from $55 million to $15 million, aggregate sales milestone payments will be reduced from $130 million to $12.5 million, and a tiered royalty of 8-12% that commenced at first commercial sale will be reduced to a flat royalty rate of 6% on net sales beginning no sooner than February 1, 2034. The Second Amendment also narrows the license grant from Integral to us to only cover CTIM-76, removes any further obligation of us to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and includes mutual releases by the parties.
Current wording
As part of the Second Amendment, Integral’s right to receive certain future payments was reduced as follows: aggregate development and regulatory milestone payments were reduced from $55 million to $15 million, aggregate sales milestone payments were reduced from $130 million to $12.5 million, and a tiered royalty of 8-12% that commenced at first commercial sale was reduced to a flat royalty rate of 6% on net sales beginning no sooner than February 1, 2034. The Second Amendment also narrowed the license grant from Integral to us to only cover CTIM-76, removed any further obligation of us to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and included mutual releases by the parties.
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 convertible debt, convertible preferred stock, common stock and warrants. Our net loss was $24.0 million for the year ended December 31, 2023. As of December 31, 2023, we had an accumulated deficit of $68.1 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 convertible debt, convertible preferred stock, common stock and warrants. Our net loss was $26.7 million for the year ended December 31, 2024. As of December 31, 2024, we had an accumulated deficit of $94.8 million.
Previous wording
•continue nonclinical studies and initiate clinical trials for CTIM-76 and for any additional product candidates that we may pursue;
Current wording
•continue nonclinical studies and initiate clinical trials for CTIM-76, CT-95, CT-202 and for any additional product candidates that we may pursue;
Previous wording
As of December 31, 2023, we had cash and cash equivalents of $14.4 million, which we expect will be sufficient to fund our operations into late 2024. We have concluded that there is substantial doubt about our ability to continue as a going concern for a period of at least 12 months from the issuance date of these consolidated financial statements. 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 December 31, 2024, we had cash and cash equivalents of $94.4 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
Acquired In-process Research and Development Expense
Current wording
•license payments and acquisitions of acquired in-process research and development assets that have no alternative future use;
Previous wording
Other 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 expense is primarily due to the recognition of foreign currency 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 $10.7 million for the year ended December 31, 2023 as compared to the same period in 2022. The following table summarizes our research and development expenses for the year ended December 31, 2023 as compared to the same period in 2022:
Current wording
Research and development expenses increased by approximately $4.9 million for the year ended December 31, 2024 as compared to 2023. The following table summarizes our research and development expenses for the year ended December 31, 2024 as compared to 2023:
Previous wording
The decrease in ONA-XR expenses of $2.8 million was primarily due to a decrease of $1.4 million in contract manufacturing costs and $1.1 million in clinical costs largely due to the decision in March 2023 to discontinue development of ONA-XR. CTIM-76 expenditures increased by $13.6 million, primarily due to an increase of $7.7 million in contract manufacturing costs and $5.4 million in preclinical costs as a result of ongoing IND-enabling studies. Personnel-related costs, which include salaries, benefits and stock-based compensation expense, decreased by approximately $0.2 million, primarily due to lower headcount over the prior year period.
Current wording
The decrease in ONA-XR expenses of $1.9 million was due to the decision in March 2023 to discontinue development of ONA-XR and focus on the development of CTIM-76. CTIM-76 expenditures decreased by $9.0 million, primarily due to decreases of $6.1 million in contract manufacturing costs mainly due to the completion of manufacturing activities in early 2024 and $5.0 million in preclinical costs as a result of the completion of IND- enabling studies in early 2024. These decreases were partially offset by an increase of $2.0 million in clinical costs as a result of initiating our Phase 1 clinical trial. CT-95 expense of$4.9 million primarily represents consideration paid of $3.75 million to acquire the asset from Link in July 2024 and approximately$1.1 million in other expenses, the majority of which were$0.6 million of clinical start up costs. CT-202 expense of$11.2 million primarily represents the $11.0 million 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 $0.2 million, primarily due to lower average headcount over the prior year period.
Previous wording
General and administrative expenses decreased by $0.5 million from $7.8 million for the year ended December 31, 2022 to $7.3 million for the year ended December 31, 2023. The decrease was primarily driven by a decrease in insurance expense of $0.7 million and other administrative costs of $0.1 million, partially offset by an increase in spending on professional fees of $0.3 million.
Current wording
General and administrative expenses decreased by $0.1 million from $7.3 million for the year ended December 31, 2023 to $7.2 million for the year ended December 31, 2024. The decrease was primarily driven by a decrease in insurance expense of $0.2 million and salaries, benefits and stock-based compensation expense of $0.1 million. These decreases were partially offset by an increase in other administrative costs of $0.2 million.
Previous wording
Interest income increased by approximately $0.6 million for the year ended December 31, 2023 as compared to 2022, primarily due to higher interest income earned on cash and cash equivalent balances.
Current wording
Interest income increased by approximately $2.0 million for the year ended December 31, 2024 as compared to 2023, primarily due to higher interest income earned on cash and cash equivalent balances due to the Private Placement and other sales of common stock.
Previous wording
Other expense increased by approximately $54,000 for the year ended December 31, 2023 as compared to 2022 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 decreased by approximately $0.1 million for the year ended December 31, 2024 as compared to 2023 primarily due to lower 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 December 31, 2023, we have funded our operations through the sale of convertible debt, convertible preferred stock, common stock and warrants. As of December 31, 2023, we had $14.4 million in cash and cash equivalents and an accumulated deficit of $68.1 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 December 31, 2024, we have funded our operations through the sale of convertible debt, convertible preferred stock, common stock and warrants. As of December 31, 2024, we had $94.4 million in cash and cash equivalents and an accumulated deficit of $94.8 million.
Previous wording
While we expect our existing cash and cash equivalents will be sufficient to fund our operations into late 2024, we have concluded that there is substantial doubt about our ability to continue as a going concern for a period of at least 12 months from the issuance date of these consolidated financial statements. 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 December 31, 2024 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.
Previous wording
During the year ended December 31, 2022, we used $13.5 million of cash in operating activities. Cash used in operating activities reflected our net loss of $14.8 million, partially offset by non-cash share-based compensation of $1.0 million, in-process research and development charges of $0.5 million, and a net change in our operating assets and liabilities of $0.3 million. The primary uses of cash were to fund our operations related to the development of our current and former product candidates.
Current wording
During the year ended December 31, 2024, we used $14.6 million of cash in operating activities. Cash used in operating activities reflected our net loss of $26.7 million and a net change in our operating assets and liabilities of $3.5 million, partially offset by in-process research and development charges of $14.8 million and non-cash share-based compensation of $0.8 million. The primary uses of cash were to fund our operations related to the development of our product candidates.
Previous wording
During the year ended December 31, 2022, cash used in investing activities was primarily attributable to the payment of a development milestone of $0.5 million under the Integral License Agreement for the development of CTIM-76. In addition, we used approximately $37,000 of cash to purchase property and equipment.
Current wording
During the year ended December 31, 2024, cash used in investing activities was primarily attributable to a payment of $11.0 million under the BioAtla License Agreement for the development of CT-202 and a one-time payment of $3.75 million made to Link to acquire the assets associated with CT-95.
Previous wording
We make estimates of our prepaid/accrued expenses as of each balance sheet date in our consolidated financial statements based upon facts and circumstances known at that time. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the prepaid/accrual accordingly. Nonrefundable advance payments for goods and services, including fees for clinical trial expenses, process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed, or services are performed.
Current wording
Nonrefundable advance payments for goods and services, including fees for clinical trial expenses, process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Acquired In-Process Research and Development Expenses
Previous report — wording carried elsewhere
Research and development expenses consist primarily of costs incurred in connection with the development of our current and former product candidates. We expense research and development costs as incurred.