UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 7, 2024
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (857) 520-9158
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02 Results of Operations and Financial Condition
On May 7, 2024, Entrada Therapeutics, Inc. announced its financial results for the quarter ended March 31, 2024 and other corporate updates. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits.
The following exhibit relating to Item 2.02 of this Form 8-K shall be deemed to be furnished and not filed:
99.1 | |||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | ||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Entrada Therapeutics, Inc. | ||||||||
| Date: May 7, 2024 | /s/ Dipal Doshi | |||||||
| Dipal Doshi | ||||||||
| Chief Executive Officer | ||||||||
Entrada Therapeutics Reports First Quarter 2024 Financial Results
– Initiated dosing of the fourth and final cohort of Phase 1 clinical trial of ENTR-601-44 for the potential treatment of DMD with data readout on track for October of 2024 –
– Achieved $75 million milestone payment from Vertex for the clinical advancement of its Phase 1/2 clinical trial of VX-670 for DM1 –
– Cash runway expected through the second quarter of 2026 with $327 million in cash, cash equivalents and marketable securities as of March 31, 2024 –
Boston, May 7, 2024 -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. The Company today reported financial results for the first quarter ended March 31, 2024, and highlighted recent business updates.
“The first quarter of 2024 was a period of significant clinical progress for Entrada. We initiated dosing for the fourth and final cohort of our Phase 1 clinical trial of ENTR-601-44 for DMD and our partner Vertex announced that enrollment and dosing are underway in their global Phase 1/2 clinical trial of VX-670 for DM1,” said Dipal Doshi, Chief Executive Officer of Entrada Therapeutics. “With two neuromuscular programs from Entrada's development pipeline now in the clinic and a cash runway expected through the second quarter of 2026, we believe we are well positioned to execute on several important clinical milestones across our pipeline of intracellular therapeutic candidates in 2024 and beyond.”
Recent Corporate Highlights
•The Company completed dosing for the first three cohorts and has initiated dosing for the fourth and final cohort of its Phase 1 clinical trial, ENTR-601-44-101, for the potential treatment of individuals with Duchenne muscular dystrophy (DMD) who are exon 44 skipping amenable. Entrada expects to report data from the clinical trial in October of 2024.
•The Company is on track to submit regulatory applications in the fourth quarter of 2024 to initiate independent global Phase 2 clinical development studies for ENTR-601-44 in patients with DMD who are exon 44 skipping amenable and ENTR-601-45 in patients with DMD who are exon 45 skipping amenable.
•Vertex announced that its U.S. Investigational New Drug Application (IND) for the Phase 1/2 clinical trial of VX-670 in people with myotonic dystrophy type 1 (DM1) has cleared, as have the Clinical Trial Applications (CTAs) in Canada, the U.K. and the EU, and the Clinical Trials Notification (CTN) in Australia. Vertex further noted that enrollment and dosing are underway.
•In March 2024, Entrada achieved a milestone under its global collaboration with Vertex related to the clinical advancement of Vertex’s Phase 1/2 clinical trial of VX-670, which triggered a $75 million payment. The Company expects to receive this payment in the second quarter of 2024. The Company is eligible to receive up to
$485 million, inclusive of milestones achieved to date, for the successful achievement of certain research, development, regulatory and commercial milestones, and tiered royalties on future net sales for any products that may result from this collaboration agreement.
First Quarter 2024 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $327.4 million as of March 31, 2024, compared to $352.0 million as of December 31, 2023. Entrada anticipates that its cash, cash equivalents and marketable securities as of March 31, 2024, together with ongoing research support from Vertex and the clinical advancement milestone expected to be received in the second quarter of 2024, will be sufficient to extend its cash runway through the second quarter of 2026, supporting the Company's expansion and continued development of EEV therapeutic candidates targeting DMD and advance EEV-therapeutic candidates in indications beyond neuromuscular disease.
Collaboration Revenue: Collaboration revenue was $59.1 million for the first quarter of 2024, compared to $25.3 million for the same period in 2023. The increase was primarily a result of the clinical advancement milestone achieved in the first quarter of 2024.
Research & Development (R&D) Expenses: R&D expenses were $28.6 million for the first quarter of 2024, compared to $23.1 million for the same period in 2023. The increase was primarily due to the progression of the Company's ENTR-601-44 Phase 1 clinical trial, costs incurred for IND-enabling studies for ENTR-601-45 and ENTR-601-50 to support future clinical trials, additional platform investment, and higher personnel costs (including non-cash, stock-based compensation).
General & Administrative (G&A) Expenses: G&A expenses were $9.4 million for the first quarter of 2024, compared to $7.9 million for the same period in 2023. The increase was primarily due to higher personnel costs (including non-cash, stock-based compensation).
Net Income (Loss): Net income was $23.5 million for the first quarter of 2024, compared to a net loss of $(6.7) million for the same period in 2023.
About Entrada Therapeutics
Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. The Company’s Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.
For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Entrada’s strategy, future operations, prospects and plans, objectives of management, Entrada’s ability to continue to recruit for and complete its ongoing healthy volunteer trial for ENTR-601-44 in the UK with dosing complete through the third cohort, the ability of Entrada’s partner Vertex to recruit for and complete its Phase 1/2 clinical trial in patients with DM1 in Canada and to initiate a Phase 1/2 clinical trial in patients with DM1 in the US, the UK, the EU and Australia, expectations regarding the timing of data from its Phase 1 clinical trial for ENTR-601-44 in October of 2024, expectations regarding the submission of regulatory applications in the fourth quarter of 2024 for ENTR-601-44 in patients with DMD who are exon 44 skipping amenable and ENTR-601-45 in patients with DMD who are exon 45 skipping amenable, expectations regarding the therapeutic benefits of ENTR-601-44, the continued development and advancement of ENTR-601-44, ENTR-601-45 and ENTR-601-50 for the treatment of DMD and our partnered candidate VX-670 for the treatment of DM1, expectations regarding the expected timing, progress and success of our collaboration with Vertex, including the receipt of the $75 million milestone payment from Vertex and any future payments we may receive under our collaboration and license agreements, the ability to develop additional therapeutic programs, including further exon skipping programs, the potential therapeutic benefits of its EEV candidates, express and implied statements regarding any future payments Entrada may receive under the Vertex Agreement, and the sufficiency of its cash resources through the second quarter of 2026, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Entrada may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; the timing of and Entrada’s ability to submit and obtain regulatory clearance for IND or equivalent foreign applications and initiate or complete clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether Entrada’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Entrada’s filings with the Securities and Exchange Commission (SEC), including the Company’s most recent Form 10-K and in subsequent filings Entrada may make with the SEC. In addition, the forward-looking statements included in this press release represent Entrada’s views as of the date of this press release. Entrada anticipates that subsequent events and developments will cause its views to change. However, while Entrada may elect to update these forward-looking statements at some point
in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Entrada’s views as of any date subsequent to the date of this press release.
ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended March 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Collaboration revenue | $ | 59,120 | $ | 25,260 | |||||||
| Operating expenses: | |||||||||||
| Research and development | 28,608 | 23,102 | |||||||||
| General and administrative | 9,399 | 7,938 | |||||||||
| Total operating expenses | 38,007 | 31,040 | |||||||||
| Income (loss) from operations | 21,113 | (5,780) | |||||||||
| Other income: | |||||||||||
| Interest and other income | 4,214 | 2,657 | |||||||||
| Total other income | 4,214 | 2,657 | |||||||||
| Income (loss) before provision for income taxes | 25,327 | (3,123) | |||||||||
| Provision for income taxes | (1,831) | (3,551) | |||||||||
| Net income (loss) | $ | 23,496 | $ | (6,674) | |||||||
| Net income (loss) per share, basic | $ | 0.70 | $ | (0.21) | |||||||
| Net income (loss) per share, diluted | $ | 0.68 | $ | (0.21) | |||||||
ENTRADA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheet Data (Unaudited)
(In thousands)
March 31, 2024 | December 31, 2023 | ||||||||||
| Cash, cash equivalents and marketable securities | $ | 327,414 | $ | 351,969 | |||||||
| Total assets | 510,844 | 469,192 | |||||||||
| Total liabilities | 241,477 | 226,832 | |||||||||
| Total stockholders’ deficit | 269,367 | 242,360 | |||||||||
Investor and Media Contact
Karla MacDonald
Chief Corporate Affairs Officer
kmacdonald@entradatx.com