Entrada Therapeutics, Inc.

Previous wording

Based on positive preclinical data and data from the Phase 1 clinical trial, the Company is on track to submit regulatory applications in the fourth quarter of 2024 to initiate separate global Phase 2 clinical trials for ENTR-601-44 in patients with Duchenne who are exon 44 skipping amenable and for ENTR-601-45 in patients with Duchenne who are exon 45 skipping amenable, subject to regulatory feedback. In addition, we plan to submit regulatory applications in 2025 to initiate a global Phase 2 clinical trial for our third Duchenne candidate, ENTR-601-50, in patients who are exon 50 skipping amenable, subject to regulatory feedback.

Current wording

•Based on the positive preclinical data observed to date, we are on track to initiate a clinical study of our third Duchenne product candidate, ENTR-601-50, in patients who are exon 50 skipping amenable, in the fourth quarter of 2025.

Previous wording

We are a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines which engage intracellular targets that have long been considered inaccessible. The Company’s Endosomal Escape Vehicle ("EEV™")-therapeutics are designed to enable the efficient delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through our proprietary, highly versatile and modular EEV platform ("EEV Platform"), we are building a robust development portfolio of therapeutic candidates. On June 24, 2024, we reported positive preliminary data in healthy volunteers from a Phase 1 clinical trial, ENTR-601-44-101, for our first drug candidate. Our Vertex partnered candidate, VX-670, is in an ongoing global Phase 1/2 clinical trial and announced in November 2024 completion of the Phase 1 SAD portion of the study and initiation of the Phase 2 MAD portion to evaluate both safety and efficacy. We expect to initiate additional regulatory filings by the end of 2024. We believe that the potential success of our early programs can translate into the efficient development of additional therapeutic candidates and allow us to build portfolios in neuromuscular disease and beyond.

Current wording

•Our Vertex partnered candidate, VX-670, is in an ongoing global Phase 1/2 clinical trial, and in November 2024, Vertex announced completion of the Phase 1 SAD portion of the study and initiation of the Phase 2 MAD portion to evaluate both safety and efficacy.

Previous wording

Since inception, we have incurred significant net losses. As of September 30, 2024, we had an accumulated deficit of $130.5 million. Other than the recognition of revenue related to collaboration payments, we expect to continue to generate operating losses and negative operating cash flows for the foreseeable future as we advance our platform and therapeutic candidates. We will not generate any revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more therapeutic candidates, if ever. If we obtain regulatory approval for any therapeutic candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution.

Current wording

Since inception, we have incurred significant net losses. As of March 31, 2025, we had an accumulated deficit of $146.7 million. Other than the recognition of revenue related to collaboration payments, we expect to continue to generate operating losses and negative operating cash flows for the foreseeable future as we advance our platform and therapeutic candidates. We will not generate any revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more therapeutic candidates, if ever. If we obtain regulatory approval for any therapeutic candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution.

Previous wording

As of September 30, 2024, we had cash, cash equivalents and marketable securities of $449.3 million. Based on our current operating plans, we believe that our cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund our operations into 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources.” To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.

Current wording

As of March 31, 2025, we had cash, cash equivalents and marketable securities of $382.5 million. Based on our current operating plans, we believe that our cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund our operations into the second quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources.” To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.

Previous wording

•our ability to hire and retain key research and development personnel;

Current wording

•our ability to hire and retain key research and development personnel to meet our strategic goals;

Previous wording

Research and development expenses were $31.3 million for the three months ended September 30, 2024, compared to $22.2 million for the three months ended September 30, 2023. The increase of $9.1 million in research and development expenses was primarily attributable to:

Current wording

Research and development expenses were $32.1 million for the three months ended March 31, 2025, compared to $28.6 million for the three months ended March 31, 2024. The increase of $3.5 million in research and development expenses was primarily attributable to:

Previous wording

•an increase of $4.5 million in internal costs driven by increased headcount in our research and development function, inclusive of stock-based compensation expense of $2.1 million and $1.6 million for the three months ended September 30, 2024 and 2023, respectively.

Current wording

•an increase of $2.9 million in personnel related costs driven by increased headcount in our research and development function, inclusive of stock-based compensation expense of $2.4 million and $1.6 million for the three months ended March 31, 2025 and 2024, respectively; and

Previous wording

We expect that our research and development expenses will increase as we advance ENTR-601-44 / ENTR-601-45 through clinical trials, and ENTR-601-50 through preclinical development and into clinical trials, perform research activities under the Vertex Agreement and continue to perform discovery work for future product candidates.

Current wording

We expect that our research and development expenses will increase as we advance ENTR-601-44 and ENTR-601-45 through clinical trials, and ENTR-601-50 and ENTR-601-51 through preclinical development and into clinical trials, and continue to perform discovery work for future product candidates.

Previous wording

General and administrative expenses for the three months ended September 30, 2024 were $10.0 million, compared to $7.5 million for the three months ended September 30, 2023. The increase of $2.5 million was primarily attributable to an increase in personnel costs as the headcount in our general and administrative function increased. Our general and administrative personnel costs are inclusive of stock-based compensation expense of $2.7 million and$1.8 millionfor the three months ended September 30, 2024 and 2023, respectively.

Current wording

General and administrative expenses for the three months ended March 31, 2025 were $10.3 million, compared to $9.4 million for the three months ended March 31, 2024. The increase of $0.9 million was primarily attributable to an increase in personnel costs as the headcount in our general and administrative function increased. Our general and administrative personnel costs are inclusive of stock-based compensation expense of $2.7 million and$2.1 millionfor the three months ended March 31, 2025 and 2024, respectively.

Previous wording

Total interest and other income, net was$5.8 million for thethree months ended September 30, 2024, compared to$4.1 million of interest and other income for thethree months ended September 30, 2023; this increase is primarily driven by higher interest income from investments in debt securities due to an overall increase in interest rates and also an increase in the amount of marketable securities held.

Current wording

Total interest and other income, net was$4.4 million for thethree months ended March 31, 2025, compared to$4.2 million of interest and other income for thethree months ended March 31, 2024. The increase was primarily driven by higher interest income from investments in debt securities due to us having more cash available to invest into debt securities.

Previous wording

The Company recorded an income tax benefit of $1.9 million for the three months ended September 30, 2024 and an income tax benefit of $17.4 million for the three months ended September 30, 2023. For both periods, the income tax benefit recorded was driven largely by the application of ASC 740 interim reporting guidance to the projected current tax liabilities for tax years 2024 and 2023.

Current wording

The Company recorded no income tax provision for the three months ended March 31, 2025 and an income tax provision of $1.8 million for the three months ended March 31, 2024. Forthree months ended March 31, 2024, the income tax provision recorded was driven largely by the $75 million clinical advancement milestone achieved in the first quarter of 2024.

Previous wording

Since our inception in 2016, we have incurred significant operating losses. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $130.5 million and $195.0 million, respectively. We expect to generate significant operating losses and negative operating cash flows for the foreseeable future as we advance our EEV Platform and therapeutic candidates. Since our inception, we have raised over $850.0 million of gross proceeds from sales of stock to leading biotechnology investors and from the Vertex Agreement. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $449.3 million.

Current wording

Since our inception in 2016, we have incurred significant operating losses. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $146.7 million and $129.3 million, respectively. We expect to generate significant operating losses and negative operating cash flows for the foreseeable future as we advance our EEV Platform and therapeutic candidates. Since our inception, we have raised over $850.0 million of gross proceeds from sales of stock to leading biotechnology investors and from the Vertex Agreement. As of March 31, 2025, we had cash, cash equivalents and marketable securities of $382.5 million.

Previous wording

In September 2023, we entered into a sales agreement (the "Sales Agreement") with Cowen and Company, LLC (the "Sales Agent") under which we may, from time to time, issue and sell shares of our common stock having aggregate sales proceeds of up to $150.0 million, in a series of one or more ATM equity offerings (the "2023 ATM Program"). The Sales Agent is not required to sell any specific share amounts but acts as the Company’s sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. Pursuant to the Sales Agreement, shares will be sold pursuant to our shelf registration statement on Form S-3 (File No. 333-268099) filed with the SEC on November 1, 2022, including the base prospectus contained therein, as declared effective by the SEC on November 7, 2022 (the "Shelf Registration Statement"). The Company’s common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. As of September 30, 2024 we have not sold any shares of common stock under the 2023 ATM Program.

Current wording

In September 2023, we entered into a sales agreement (the "Sales Agreement") with Cowen and Company, LLC (the "Sales Agent") under which we may, from time to time, issue and sell shares of our common stock having aggregate sales proceeds of up to $150.0 million, in a series of one or more ATM equity offerings (the "2023 ATM Program"). The Sales Agent is not required to sell any specific share amounts but acts as the Company’s sales agent, using commercially reasonable efforts consistent with its normal trading and sales practices. Pursuant to the Sales Agreement, shares will be sold pursuant to our shelf registration statement on Form S-3 (File No. 333-268099) filed with the SEC on November 1, 2022, including the base prospectus contained therein, as declared effective by the SEC on November 7, 2022. Our common stock will be sold at prevailing market prices at the time of the sale, and as a result, prices may vary. As of March 31, 2025 we have not sold any shares of common stock under the 2023 ATM Program.

Previous wording

In June 2024, the Company entered into a securities purchase agreement with a limited number of investors relating to a registered direct offering (the “June 2024 Offering”) of 3,367,003 shares of the Company’s common stock at a purchase price of $14.85 per share and, in lieu of common stock to certain investors who so chose, pre-funded warrants (the “Pre-Funded Warrants”) to purchase 3,367,003 shares of Common Stock at a purchase price of $14.8499 per Pre-Funded Warrant, which represents the price per share at which the shares of common stock were sold to the investors in the June 2024 Offering, minus $0.0001, which is the exercise price of each Pre-Funded Warrant. The June 2024 Offering was made pursuant to the shelf registration statement on Form S-3 (File No. 333-268099) previously filed by the Company with the Securities and Exchange Commission (the “SEC”) on November 1, 2022 and declared effective by the SEC on November 7, 2022. The aggregate net proceeds from the sale of common stock and Pre-Funded Warrants in the June 2024 Offering were approximately $99.6 million, after deducting offering expenses payable by the Company. The Company will receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.

Current wording

In June 2024, we entered into a securities purchase agreement with a limited number of investors relating to a registered direct offering (the “June 2024 Offering”) of 3,367,003 shares of our common stock at a purchase price of $14.85 per share and, in lieu of common stock to certain investors who so chose, pre-funded warrants (the “Pre-Funded Warrants”) to purchase 3,367,003 shares of common stock at a purchase price of $14.8499 per Pre-Funded Warrant, which represents the price per share at which the shares of common stock were sold to the investors in the June 2024 Offering, minus $0.0001, which is the exercise price of each Pre-Funded Warrant. The June 2024 Offering was made pursuant to the shelf registration statement on Form S-3 (File No. 333-268099) previously filed with the SEC on November 1, 2022 and declared effective by the SEC on November 7, 2022. The aggregate net proceeds from the sale of common stock and Pre-Funded Warrants in the June 2024 Offering were approximately $99.6 million, after deducting offering expenses payable by us. We will receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.

Previous wording

For thenine months ended September 30, 2023, net cash provided by operating activities was $143.8 million and consisted of our net income of $2.9 million, net cash provided by changes in our operating assets and liabilities of $133.4 million, primarily resulting from the upfront payment received in connection with the Vertex Agreement, adjustments for non-cash expenses relating to stock-based compensation expense of $9.3 million and depreciation expense of $2.0 million, and adjustments for non-cash income relating to accretion of premiums and discounts on marketable securities of $3.8 million.

Current wording

For thethree months ended March 31, 2025, net cash used in operating activities was $38.5 million and was driven by our net loss of $17.3 million, net cash used in changes in our operating assets and liabilities of $25.9 million, adjustments for non-cash expenses relating to stock-based compensation expense of $5.1 million and depreciation expense of $0.9 million, and adjustments for non-cash income relating to accretion of premiums and discounts of $1.3 million.

Previous wording

For thenine months ended September 30, 2024, net cash used in operating activities was $10.0 million and consisted of our net income of $64.5 million, net cash used in changes in our operating assets and liabilities of $83.0 million, adjustments for non-cash expenses relating to stock-based compensation expense of $13.2 million and depreciation expense of $2.8 million, and adjustments for non-cash income relating to accretion of premiums and discounts of $7.5 million.

Current wording

For thethree months ended March 31, 2024, net cash used in operating activities was $25.5 million and was driven by our net income of $23.5 million, net cash used in changes in our operating assets and liabilities of $51.6 million, adjustments for non-cash expenses relating to stock-based compensation expense of $3.7 million and depreciation expense of $0.9 million, and adjustments for non-cash income relating to accretion of premiums and discounts of $2.0 million.

Previous wording

Net cash used in investing activities was $81.2 million for thenine months ended September 30, 2024, consisting primarily of $373.2 million in purchases or marketable securities and $2.5 million of purchases of property and equipment, partially offset by $294.5 million from the maturities of marketable securities.

Current wording

Net cash provided by investing activities was $4.8 million for thethree months ended March 31, 2025, consisting primarily of $85.9 million from the maturities of marketable securities, partially offset by $80.0 million in purchases of marketable securities and $1.1 million of purchases of property and equipment.

Previous wording

Net cash used in investing activities was $157.4 million for thenine months ended September 30, 2023, consisting primarily of $318.7 million in purchases of marketable securities and $4.6 million from purchases of property and equipment, partially offset by $165.9 million from the maturities of marketable securities.

Current wording

Net cash provided by investing activities was $26.1 million for thethree months ended March 31, 2024, consisting primarily of $123.9 million from the maturities of marketable securities, partially offset by $96.9 million in purchases of marketable securities and $0.9 million of purchases of property and equipment.

Previous wording

Net cash provided by financing activities was $101.6 million for thenine months ended September 30, 2024, consisting of $99.6 million of proceeds from sales of our common stock and pre-funded warrants, $1.7 million in proceeds from stock option exercises and $0.3 million from the issuance of common stock under our employee stock purchase plan.

Current wording

Net cash provided by financing activities was $0.4 million for thethree months ended March 31, 2025, consisting of $0.4 million in proceeds from stock option exercises.

Previous wording

We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical and, if successful, the clinical development of our programs. In addition, we expect to incur additional costs associated with operating as a public company. Our operating expenses and future funding requirements are expected to increase substantially as we continue to advance our portfolio of programs. Based on our current operating plans, we believe that our cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund our operations into 2027. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Current wording

We expect to incur significant expenses and operating losses for the foreseeable future as we advance the preclinical and, if successful, the clinical development of our programs. In addition, we expect to incur additional costs associated with operating as a public company. Our operating expenses and future funding requirements are expected to increase substantially as we continue to advance our portfolio of programs. Based on our current operating plans, we believe that our cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund our operations into the second quarter of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Previous wording

•hiring additional personnel, including research and development, clinical and commercial personnel;

Current wording

•hiring additional personnel, including research and development, clinical and commercial personnel, to meet our strategic goals;