Entrada Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results
- Cash runway extended through Q2 2026 with $352 million in cash, cash equivalents, and marketable securities.
- Completed dosing for third cohort of Phase 1 clinical trial of ENTR-601-44 for potential DMD treatment with data readout expected in H2 2024.
- Regulatory applications anticipated in Q4 2024 for global Phase 2 clinical development of ENTR-601-44 and ENTR-601-45 in DMD patients.
- Company reported financial results for Q4 and full year ending December 31, 2023, with significant cash position increase and collaboration revenue.
- Appointment of key executives to strengthen operational capabilities and leadership team.
- Net loss decreased significantly in Q4 and full year of 2023 compared to the same periods in 2022.
- Increase in R&D and G&A expenses due to clinical trial initiation, platform investment, and higher personnel costs.
- Net loss reported for Q4 and full year of 2023, indicating ongoing financial challenges despite positive cash position and revenue growth.
Insights
The financial performance of Entrada Therapeutics, Inc. showcases a significant improvement in their cash position, with a year-over-year increase from $188.7 million to $352 million. This robust liquidity is attributed to the proceeds from the Vertex Agreement, which is a strategic collaboration that has also contributed to the company's collaboration revenue of $129.0 million for the full year of 2023. Such a partnership can be a strong indicator of Entrada's potential for growth and innovation, particularly in the biopharmaceutical sector where cash flow is critical for sustaining long-term research and development (R&D) activities.
The company's projected cash runway through the second quarter of 2026 implies a substantial buffer for operational and capital expenditures, reducing the immediate risk of dilutive financing. However, investors should monitor the burn rate closely, as increased R&D expenses, up from $66.6 million to $99.9 million, reflect the company's investment in advancing its clinical trials. While this increase is a natural progression for a clinical-stage company, it is essential to evaluate the success of these trials in terms of their potential market impact and revenue generation to justify the R&D expenses.
Furthermore, the decrease in net loss from $94.6 million to $6.7 million annually signals improved operational efficiency or successful cost management strategies. This is a positive development for stakeholders, as it might indicate a trajectory towards profitability, a critical milestone for companies in the biopharmaceutical industry.
The advancement of Entrada's pipeline, particularly the ENTR-601-44 and ENTR-601-45 for the treatment of Duchenne muscular dystrophy (DMD), represents a significant step in addressing a substantial unmet medical need. DMD is a rare genetic disorder characterized by progressive muscle degeneration and current treatment options are limited. The development of therapeutics that are 'exon skipping amenable' targets a specific mutation approach that can potentially restore the production of dystrophin, a protein crucial for muscle function. The successful completion of dosing in the Phase 1 clinical trial and the expected regulatory applications for Phase 2 trials are critical milestones that could have a profound impact on patient outcomes and, consequently, the company's valuation.
The collaboration with Vertex Pharmaceuticals and the initiation of a Phase 1/2 clinical trial for VX-670 in patients with myotonic dystrophy type 1 (DM1) also highlights Entrada's strategic partnerships in exploring treatments for other rare diseases. DM1 is another area with significant unmet needs and advancements in treatment could lead to considerable market opportunities. The clearances from Health Canada and MHRA for VX-670's Clinical Trial Applications underscore the global scope of Entrada's research initiatives and their potential to penetrate international markets.
Entrada Therapeutics is operating within the high-stakes biopharmaceutical industry, where the path to drug approval is fraught with regulatory hurdles and clinical risks. The company's focus on rare diseases like DMD and DM1 positions it in a niche market with less competition and the possibility of orphan drug designation, which can provide benefits such as market exclusivity, tax credits and fee waivers. The anticipated regulatory submissions for global Phase 2 clinical development suggest that Entrada is progressing towards later stages of the drug development process, which can be a significant value driver for the company's stock.
However, the market's reaction to such developments will depend on the perceived efficacy and safety of the drug candidates, as well as the competitive landscape. Positive data readouts can lead to stock price appreciation, while any setbacks could have adverse effects. Investors typically weigh the risks of clinical trial outcomes against the potential for high returns in the biopharmaceutical sector. As such, Entrada's progress and strategic collaborations could be seen as a positive indicator of the company's trajectory and potential for future profitability.
– Cash runway extended through the second quarter of 2026 –
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– Completed dosing for third cohort of Phase 1 clinical trial of ENTR-601-44 for the potential treatment of DMD with data readout on track for the second half of 2024 –
– Regulatory applications expected in the fourth quarter of 2024 for the global Phase 2 clinical development of ENTR-601-44 and ENTR-601-45 in people living with DMD –
BOSTON, March 13, 2024 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year ending December 31, 2023, and highlighted recent business updates.
“We continue to make significant progress advancing our growing pipeline of intracellular therapeutics,” said Dipal Doshi, Chief Executive Officer of Entrada Therapeutics. “We have an exciting year ahead in 2024, with several important clinical milestones within our Duchenne franchise, including the expected fourth quarter submissions of Phase 2 regulatory applications for the global development of ENTR-601-44 and ENTR-601-45. Clinical momentum is also building in our collaboration with Vertex, with the initiation of a Phase 1/2 clinical trial of VX-670 in patients with DM1. With the extension of our cash runway through the second quarter of 2026, we believe we are well positioned to progress our Duchenne franchise and broader pipeline to create value for patients and shareholders.”
Recent Corporate Highlights
- Completed dosing for the first three cohorts 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 plans to announce data from the clinical trial in the second half of 2024. Additionally, the Company expects to submit regulatory applications in the fourth quarter of 2024 for the separate global Phase 2 clinical development of ENTR-601-44 in Duchenne patients who are exon 44 skipping amenable and ENTR-601-45 in Duchenne patients who are exon 45 skipping amenable.
- Vertex Pharmaceuticals announced it received clearances from Health Canada and Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom for Clinical Trial Applications for VX-670 for patients with myotonic dystrophy type 1 (DM1). Vertex initiated the Phase 1/2 clinical trial in patients with DM1 in Canada and will initiate the study in the UK near-term.
- In January 2024, Entrada announced the promotion of Nathan Dowden, previously Chief Operating Officer of Entrada Therapeutics, to President and Chief Operating Officer. Mr. Dowden has played a critical role in developing Entrada’s strategic and operational capabilities. In February 2024, the Company appointed Kevin Healy, PhD, as Senior Vice President of Regulatory Affairs. Mr. Healy has extensive expertise in the development and commercialization of therapies for serious and rare diseases and has led or participated in more than 30 formal meetings with the FDA, EMA, and other global health authorities. In March 2024, Entrada appointed Marie Rosenfeld as Senior Vice President of Clinical Operations and Data Management. Ms. Rosenfeld has more than 20 years of experience in R&D at large and medium-size pharmaceutical companies and contract research organizations, with a proven track record of securing product regulatory approvals.
Fourth Quarter and Full Year 2023 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were
Collaboration Revenue: Collaboration revenue was
Research & Development (R&D) Expenses: R&D expenses were
General & Administrative (G&A) Expenses: G&A expenses were
Net Income (Loss): Net loss was
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 United Kingdom 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 United Kingdom, expectations regarding the timing of data from its Phase 1 clinical trial for ENTR-601-44 in the second half of 2024, 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 Duchenne 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 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, 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 December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Collaboration revenue | $ | 41,848 | $ | — | $ | 129,013 | $ | — | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 28,291 | 15,685 | 99,884 | 66,609 | |||||||||||
| General and administrative | 8,652 | 9,894 | 32,291 | 30,639 | |||||||||||
| Total operating expenses | 36,943 | 25,579 | 132,175 | 97,248 | |||||||||||
| Income (loss) from operations | 4,905 | (25,579 | ) | (3,162 | ) | (97,248 | ) | ||||||||
| Other income: | |||||||||||||||
| Interest and other income | 4,292 | 950 | 15,218 | 2,632 | |||||||||||
| Total other income | 4,292 | 950 | 15,218 | 2,632 | |||||||||||
| Income (loss) before provision for income taxes | 9,197 | (24,629 | ) | 12,056 | (94,616 | ) | |||||||||
| Provision for income taxes | (18,741 | ) | — | (18,741 | ) | — | |||||||||
| Net loss | $ | (9,544 | ) | $ | (24,629 | ) | $ | (6,685 | ) | $ | (94,616 | ) | |||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.29 | ) | $ | (0.79 | ) | $ | (0.20 | ) | $ | (3.02 | ) | |||
| Weighted‑average common shares outstanding, basic and diluted | 33,368,901 | 31,351,770 | 33,050,319 | 31,293,312 | |||||||||||
| ENTRADA THERAPEUTICS, INC. Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands) | |||||
| December 31, 2023 | December 31, 2022 | ||||
| Cash, cash equivalents and marketable securities | $ | 351,969 | $ | 188,712 | |
| Total assets | 469,192 | 252,056 | |||
| Total liabilities | 226,832 | 39,502 | |||
| Total stockholders’ equity | 242,360 | 212,554 | |||
Investor and Media Contact
Karla MacDonald
Chief Corporate Affairs Officer
kmacdonald@entradatx.com
FAQ
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