Context Therapeutics Inc

Previous wording

We are a biopharmaceutical company advancing medicines for solid tumors.

Current wording

We are a biopharmaceutical company advancing medicines for solid tumors that is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics. Product candidates include CTIM-76, a CLDN6 x CD3 bispecific antibody, and CT-95, an MSLN x CD3 bispecific antibody.

Previous wording

Our clinical stage program, CTIM-76, is an anti-CLDN6 bsAb 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 Investigational New Drug ("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 the enrollment of the first patient in the dose escalation portion of the clinical trial in mid-2024.

Current 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. IND-enabling studies on CTIM-76 have been completed. On May 2, 2024, we announced the FDA cleared our Investigational New Drug (“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 in the third quarter of 2024.

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, and the Private Placement closed on May 6, 2024. We expect placement offering expenses will be approximately $5.2 million.

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 “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.

Previous wording

Net proceeds from the Private Placement are expected to be used to fund the research and development of CTIM-76 and for working capital and general corporate purposes. We also expect that the net proceeds, together with our cash and cash equivalents at March 31, 2024, will extend our cash runway through the estimated duration of our planned CTIM-76 Phase 1 clinical trial, as well as into 2028.

Current wording

Net proceeds from the Private Placement are expected to be used to fund the research and development of CTIM-76 and CT-95, as well as for working capital and general corporate purposes. We expect to have sufficient cash and cash equivalents to fund the estimated duration of our CTIM-76 Phase 1 trial and the dose escalation portion of our CT-95 Phase 1 trial, as well as our operations into 2028.

Previous wording

In addition, pursuant to a registration rights agreement dated May 1, 2024 (the “Registration Rights Agreement”), we agreed to file a registration statement on or before May 31, 2024 (subject to certain exceptions) for purposes of registering the resale of the Shares (including the Warrant Shares) (the “Registration Statement”), to use our reasonable best efforts to have such Registration Statement declared effective within the time period set forth in the Registration Rights Agreement, and 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.

Current wording

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 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 $3.7 million for the three months ended March 31, 2024. As of March 31, 2024, we had an accumulated deficit of $71.7 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 $5.9 million for the six months ended June 30, 2024. As of June 30, 2024, we had an accumulated deficit of $74.0 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, and for any additional product candidates that we may pursue;

Previous wording

As of March 31, 2024, we had cash and cash equivalents of $10.1 million, which, together with the proceeds from our recent Private Placement, we expect will be sufficient to fund our operations into 2028. 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, 2024, we had cash and cash equivalents of $101.5 million, which we expect will be sufficient to fund our operations into 2028. 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

Research and development expenses decreased by approximately $2.6 million for the three months ended March 31, 2024 as compared to the same period in 2023. The following table summarizes our research and development expenses for the three months ended March 31, 2024 as compared to the same period in 2023:

Current wording

Research and development expenses decreased by approximately $2.1 million for the three months ended June 30, 2024 as compared to the same period in 2023. The following table summarizes our research and development expenses for the three months ended June 30, 2024 as compared to the same period in 2023:

Previous wording

General and administrative expenses decreased by approximately $0.3 million for the three months ended March 31, 2024 as compared to the same period in 2023. The decrease was primarily driven by decreases in insurance expense of $0.1 million, in professional fees of $0.1 million, and in compensation and share-based compensation costs of $0.1 million.

Current wording

General and administrative expenses decreased by approximately $0.1 million for the three months ended June 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 $0.2 million and insurance expense of $0.1 million, partially offset by an increase in professional fees of $0.1 million.

Previous wording

Interest income decreased by approximately $0.2 million for the three months ended March 31, 2024 as compared to the same period in 2023 primarily due to lower interest income earned on cash and cash equivalent balances.

Current wording

Interest income increased by approximately $0.5 million for the three months ended June 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 wording

The decrease in ONA-XR expense of $2.1 million was primarily 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 $0.2 million, primarily due to a decrease of $0.7 million in contract manufacturing costs, partially offset by an increase of $0.5 million in preclinical, regulatory, and clinical costs as a result of IND-enabling studies and preparing to initiate our planned Phase 1 clinical trial. Personnel-related costs, which include salaries, benefits and stock-based compensation expense deceased by approximately $0.3 million, primarily due to lower headcount over the prior year period.

Current 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 $2.2 million, primarily due to a decrease of $3.2 million in preclinical and contract manufacturing costs, partially offset by an increase of $0.9 million in clinical and regulatory costs as a result of preparing to initiate our planned Phase 1 clinical trial. Personnel-related costs, which include salaries, benefits and stock-based compensation expense, decreased by approximately $0.5 million, primarily due to lower 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, 2024, we have funded our operations through the sale of convertible debt, convertible preferred stock, common stock and warrants. As of March 31, 2024, we had $10.1 million in cash and cash equivalents and an accumulated deficit of $71.7 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 convfor several years, if at all. Since our inception through June 30, 2024, we have funded our operations through the sale of common stock, warrants, convertible debt, and convertible preferred stock. As of June 30, 2024, we had $101.5 million in cash and cash equivalents and an accumulated deficit of $74.0 million.

Previous wording

We also expect that the net proceeds from our Private Placement, together with our cash and cash equivalents at March 31, 2024, will extend our cash runway through the estimated duration of our planned CTIM-76 Phase 1 clinical trial, as well as into 2028. 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, 2024 to fund the estimated duration of our CTIM-76 Phase 1 trial and the dose escalation portion of our CT-95 Phase 1 trial, as well as our operations into 2028. 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, 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 our product candidate.

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, 2023, we used $5.7 million of cash in operating activities. Cash used in operating activities reflected our net loss of $6.3 million, partially offset by non-cash share-based compensation of $0.3 million and a 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 product candidates.

Current wording

During the six months ended June 30, 2023, we used $10.4 million of cash in operating activities. Cash used in operating activities reflected our net loss of $11.3 million, partially offset by non-cash share-based compensation expense of $0.6 million and a 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 product candidates.

Previous wording

During the three months ended March 31, 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 and six months ended June 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.