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C4 Therapeutics Inc

For the period ended Sep 30, 2024. Filed Oct 31, 2024.

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.

Sep 30, 2024 · Filed Oct 31, 2024

CCCC$3.10+5.1%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 2024-06-30; filed 2024-08-01.

0001628280-24-033882

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

Current report: 10-Q

Period ended 2024-09-30; filed 2024-10-31.

0001628280-24-044411

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 112 previous paragraphs and 112 current paragraphs.

73 unchanged; 32 reworded; 6 added; 6 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 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 (6)

Current report

The $3.5 million increase in research and development expense in the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 is primarily driven by:

Current report

•a $4.3 million increase in preclinical expenses as a result of the progress made on our collaboration programs; and

Current report

•a $2.6 million increase in clinical expenses due to continued progress on our cemsidomide and CFT1946 programs.

Current report

These amounts were partially offset by a $2.4 million increase in clinical expenses as a result of continued progress on our cemsidomide and CFT1946 programs.
Removed paragraphs (6)

Previous report

•a $1.1 million decrease in clinical expenses due to the closeout of our C4T8634 program; and

Previous report

•a $1.0 million decrease in intellectual property and other expenses.

Previous report

The $12.7 million decrease in research and development expense in the six months ended June 30, 2024 as compared to the six months ended June 30, 2024 is primarily driven by:

Previous report

•a $1.8 million decrease in intellectual property and other expenses; and
Reworded paragraphs (32)

Previous wording

Our other most advanced product candidate, CFT1946, is an orally bioavailable BiDAC degrader designed to be potent and selective against BRAF V600X mutant targets to treat melanoma, non-small cell lung cancer, or NSCLC, colorectal cancer, or CRC, and other malignancies that harbor this mutation. In January 2023, we initiated a first-in-human Phase 1/2 clinical trial of CFT1946 for the treatment of BRAF V600X mutant solid tumors including NSCLC, colorectal cancer and melanoma. In January 2024, we shared pharmacokinetic and pharmacodynamic data from the first two dose escalation cohorts of the ongoing Phase 1/2 trial, demonstrating dose proportional exposure and oral bioavailability, which was associated with BRAF degradation. We continue to progress the ongoing Phase 1/2 clinical trial of CFT1946.

Current wording

Our other most advanced product candidate, CFT1946, is an orally bioavailable BiDAC degrader designed to be potent and selective against BRAF V600X mutant targets to treat melanoma, non-small cell lung cancer, or NSCLC, colorectal cancer, or CRC, and other malignancies that harbor this mutation. In January 2023, we initiated a first-in-human Phase 1/2 clinical trial of CFT1946 for the treatment of BRAF V600X mutant solid tumors including NSCLC, colorectal cancer and melanoma. In September 2024, we presented initial monotherapy CFT1946 data demonstrating proof of mechanism and early evidence of proof of concept in BRAF V600 mutant solid tumors at the European Society for Medical Oncology (ESMO) Congress 2024. We continue to progress the ongoing Phase 1/2 clinical trial of CFT1946.

Previous wording

Additionally, we are developing CFT8919, an orally bioavailable, allosteric, mutant-selective BiDAC degrader of epidermal growth factor receptor, or EGFR, with an L858R mutation in NSCLC. In May 2023, we entered into an exclusive licensing agreement for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan, with Betta Pharmaceuticals, Co., Ltd, or Betta Pharma. Additionally in June 2023, the FDA cleared the investigational new drug, or IND, application for CFT8919 and, in December 2023, Betta Pharma received clinical trial application clearance for CFT8919 from China's National Medical Product Administration. We expect to initiate clinical trial activities outside Greater China following the completion of Betta Pharma's Phase 1 dose escalation trial in Greater China.

Current wording

Additionally, we are developing CFT8919, an orally bioavailable, allosteric, mutant-selective BiDAC degrader of epidermal growth factor receptor, or EGFR, with an L858R mutation in NSCLC. In May 2023, we entered into an exclusive licensing agreement for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan, with Betta Pharmaceuticals, Co., Ltd, or Betta Pharma. Additionally, the FDA cleared the investigational new drug, or IND, application for CFT8919 and Betta Pharma received clinical trial application clearance for CFT8919 from China's National Medical Product Administration. We expect to initiate clinical trial activities outside Greater China following the completion of Betta Pharma's Phase 1 dose escalation trial in Greater China.

Previous wording

Beyond these initial product candidates, we are further diversifying our pipeline by developing new degraders against both clinically validated and currently undruggable targets for our own proprietary programs, as well as for programs we are developing in collaboration with MKDG, Merck, Biogen and Roche.

Current wording

Beyond these initial product candidates, we are further diversifying our pipeline by developing new degraders against both clinically validated and currently undruggable targets for our own proprietary programs, as well as for programs we are developing in collaboration with MKDG, Merck, and Roche.

Previous wording

Comparison of the three and six months ended June 30, 2024 and 2023

Current wording

Comparison of the three and nine months ended September 30, 2024 and 2023

Previous wording

Revenue from our collaboration and license agreements consisted of the following for the three and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

Revenue from our collaboration and license agreements consisted of the following for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

The $9.3 million increase in revenue in the three months ended June 30, 2024, as compared to the three months ended June 30, 2023 is primarily driven by the $8.0 million milestone earned under the Biogen Agreement for the accepted delivery of a development candidate in an undisclosed indication, a $1.9 million increase as a result of progress made on the MKDG Agreement signed in March 2024, and a $1.1 million increase as a result of the progress made on the Merck Agreement signed in December 2023.

Current wording

The $4.3 million increase in revenue in the three months ended September 30, 2024, as compared to the three months ended September 30, 2023 is primarily driven by the $8.0 million milestone earned under the Biogen Agreement for the accepted delivery of a development candidate in an undisclosed indication and a total of $6.9 million of revenue recognized related to the MKDG, Merck and Betta Pharma collaborations that had activities commence in 2024. This was offset by a $7.8 million decrease in revenue related to the Roche collaboration as a result of our September 2023 completion of research activities for a nominated target.

Previous wording

The $8.6 million increase in revenue in the six months ended in June 30, 2024, as compared to the six months ended June 30, 2023 is primarily driven by the $4.1 million increase from the milestone earned under the Biogen Agreement, a $1.9 million increase under the Roche Agreement as a result of continued progress towards the nominated targets, a $1.9 million increase as a result for the MKDG Agreement signed in March 2024, and a $1.7 million increase as a result of the Merck Agreement signed in December 2023.

Current wording

The $12.9 million increase in revenue in the nine months ended in September 30, 2024, as compared to the nine months ended September 30, 2023 is primarily driven by the $10.6 million increase from start of collaboration activities in 2024 for the MKDG, Merck, and Betta Pharma Agreements, and two milestones earned under the Biogen Agreement. This was offset by a $5.9 million decrease under the Roche Agreement as a result of our September 2023 completion of research activities for a nominated target.

Previous wording

The following table summarizes our research and development expense for the three and six months June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our research and development expense for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

•a $4.2 million decrease in personnel costs as a result of our restructuring activities;

Current wording

These amounts were partially offset by a $2.9 million decrease in personnel costs as a result of our restructuring activities in January 2024.

Previous wording

The $6.2 million decrease in research and development expense in the three months ended June 30, 2024 as compared to the three months ended June 30, 2023 is primarily driven by:

Current wording

The $9.2 million decrease in research and development expense in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 is primarily driven by:

Previous wording

•a $2.3 million decrease in personnel costs as a result of our restructuring activities;

Current wording

•a $7.1 million decrease in personnel costs as a result of our restructuring activities;

Previous wording

•a $1.5 million decrease in preclinical expenses as a result of prioritization of our business towards programs that are in clinical stages;

Current wording

•a $1.2 million decrease in preclinical expenses as a result of prioritization of our business towards programs that are in clinical stages.

Previous wording

The following table summarizes our general and administrative expense for the three and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our general and administrative expense for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

The $1.3 million decrease in general and administrative expense in the six months ended June 30, 2024 as compared to the six months ended June 30, 2024 is primarily driven by the $1.2 million decrease in professional fees and other expenses.

Current wording

The $1.2 million increase in general and administrative expense in the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 is primarily driven by a $0.9 million increase in personnel expenses related to our hiring of key personnel.

Previous wording

The $0.6 million decrease in general and administrative expense in the three months ended June 30, 2024 as compared to the three months ended June 30, 2023 is primarily driven by a $0.6 million decrease in professional fees and other expenses during the three months ended June 30, 2024.

Current wording

General and administrative expense in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 remained relatively flat as a result of an increase of $0.8 million for personnel expenses offset by a $0.7 million decrease in professional fees and other expenses.

Previous wording

The $2.4 million increase of restructuring expense in the six months ended June 30, 2024 compared to the six months ended June 30, 2023 is driven by the restructuring plan implemented in January 2024 to better align its workforce with the needs of its business and reduce operating costs that included a reduction in the Company's workforce by 30%.

Current wording

The $2.4 million increase of restructuring expense in the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 is driven by the restructuring plan implemented in January 2024 to better align the

Previous wording

The following table summarizes our other income (expense), net for the three and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our other income (expense), net for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

The $4.5 million increase in other income (expense), net in the six months ended June 30, 2024 as compared to the six months ended June 30, 2023 is primarily driven by a $3.3 million increase in interest and other income resulting from higher interest earned on our investments during the three months ended June 30, 2024, offset by a $1.2 million decrease in interest expense from long-term debt.

Current wording

The $1.8 million increase in other income (expense), net in the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 is primarily driven by a $1.0 million increase in interest and other income resulting from higher interest earned on our investments during the three months ended September 30, 2024 and a $0.6 million decrease in loss on extinguishment of long-term debt.

Previous wording

The $2.1 million increase in other income (expense), net in the three months ended June 30, 2024 as compared to the three months ended June 30, 2023 is primarily driven by a $1.5 million increase in interest and other income resulting from higher interest earned on our investments during the three months ended June 30, 2024, offset be a $0.6 million decrease in interest expense from long-term debt..

Current wording

The $6.3 million increase in other income (expense), net in the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 is primarily driven by a $4.3 million increase in interest and other income resulting from higher interest earned on our investments during the three months ended September 30, 2024 and a $1.4 million decrease in interest expense from long-term debt.

Previous wording

Since inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical programs and our product candidates through clinical development. We do not currently have any approved products and have never generated any revenue from product sales. To date, we have financed our operations primarily through the sale of preferred stock, public offerings of our common stock, private placements of our common stock, and through payments from collaboration partners. As of June 30, 2024, we had cash, cash equivalents and marketable securities of approximately $295.7 million.

Current wording

Since inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical programs and our product candidates through clinical development. We do not currently have any approved products and have never generated any revenue from product sales. To date, we have financed our operations primarily through the sale of preferred stock, public offerings of our common stock, private placements of our common stock, and through payments from collaboration partners. As of September 30, 2024, we had cash, cash equivalents and marketable securities of approximately $284.4 million.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 was driven primarily by the following uses of cash:

Current wording

Net cash used in operating activities for the nine months ended September 30, 2024 was driven primarily by the following uses of cash:

Previous wording

•$9.4 million change in accrued expenses and other current liabilities;

Current wording

•$5.2 million change in accrued expenses and other current liabilities;

Previous wording

•$5.1 million change in prepaid expenses and other current and long-term assets; and

Current wording

•$4.3 million change in prepaid expenses and other current and long-term assets; and

Previous wording

•$16.2 million change in deferred revenue due to the upfront payment related to the MKDG agreement and the allocated transaction price that remains unsatisfied related to the Betta Pharma License Agreement, partially offset by the recognition of revenue under our collaboration agreements;

Current wording

•$12.1 million change in deferred revenue due to the upfront payment related to the MKDG Agreement and the allocated transaction price that remains unsatisfied related to the Betta Pharma License Agreement, partially offset by the recognition of revenue under our collaboration agreements;

Previous wording

•$10.6 million change in accounts receivable, primarily a result of the Merck upfront payment; and

Current wording

•$1.5 million change in accounts receivable, primarily a result of the Merck upfront payment; and

Previous wording

•non-cash expenses of $13.7 million, which primarily consisted of stock-based compensation expense of $12.6 million.

Current wording

•non-cash expenses of $23.2 million, which primarily consisted of stock-based compensation expense of $21.4 million.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2024 was driven primarily by $64.9 million of purchases of marketable securities, net of maturities.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2024 was driven primarily by $64.8 million of purchases of marketable securities, net of maturities.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024 was driven primarily by:

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was driven primarily by:

Previous wording

•$14.1 million in net proceeds from our at-the-market equity program.

Current wording

•$24.4 million in net proceeds from our at-the-market equity program.

Previous wording

In November 2021, we filed an automatically effective registration statement on Form S-3, or the Registration Statement, with the SEC that registers the offering, issuance and sale of an unspecified amount of common stock, preferred stock, debt securities, warrants, and/or units of any combination thereof. Simultaneously, we entered into an equity distribution agreement with Cowen and Company, LLC, as sales agent, to provide for the issuance and sale by of up to $200.0 million of common stock from time to time in “at-the-market” offerings under the Registration Statement and related prospectus and any prospectus supplement filed with the Registration Statement, or the ATM Program. As of June 30, 2024, the Company has sold 13,686,743 shares of our common stock at an average purchase price of $5.42 under the ATM Program, resulting in net proceeds of $71.9 million.

Current wording

In November 2021, we filed an automatically effective registration statement on Form S-3, or the Registration Statement, with the SEC that registers the offering, issuance and sale of an unspecified amount of common stock, preferred stock, debt securities, warrants, and/or units of any combination thereof. Simultaneously, we entered into an equity distribution agreement with Cowen and Company, LLC, as sales agent, to provide for the issuance and sale by of up to $200.0 million of common stock from time to time in “at-the-market” offerings under the Registration Statement and related prospectus and any prospectus supplement filed with the Registration Statement, or the ATM Program. In February 2023, we filed a post-effective amendment to convert the automatic shelf registration statement into a conventional shelf registration statement and that registration statement became effective in May 2023. As of September 30, 2024, the Company has sold 15,318,264 shares of our common stock at an average purchase price of $5.54 under the ATM Program, resulting in net proceeds of $82.3 million.

Previous wording

During the six months ended June 30, 2024, except for the minimum rental commitments disclosed in Note 6, Leases, to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, there were no significant changes to our contractual obligations and commitments described under "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2023.

Current wording

During the nine months ended September 30, 2024, except for the minimum rental commitments disclosed in Note 6, Leases, to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, there were no significant changes to our contractual obligations and commitments described under "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2023.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Company's workforce with the needs of the business and reduce operating costs, which resulted in a reduction in the Company's workforce of 30%.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

•a $5.5 million decrease in preclinical expenses as a result of prioritization of our business towards programs that are in clinical stages;