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Investor releaseQuarter not tagged2026-08-05Entrada Therapeutics Reports Second Quarter 2026 Financial Results
GlobeNewswire
Entrada Therapeutics Reports Second Quarter 2026 Financial Results
-- Company to report ELEVATE-44-201 data from Cohort 1 open-label period by year-end 2026 -- -- ELEVATE-44-201 Cohort 2 enrollment complete with data expected in Q1 2027 -- -- Company to report ELEVATE-45-201 Cohort 1 data in October 2026 -- -- ELEVATE-45-201 Cohort 2 dosing ongoing at the increased dose of 10 mg/kg with data expected in H1 2027 -- -- Vertex to report VX-670 Phase 1/2 data in people living with DM1 in H2 2026 -- BOSTON, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the second quarter ended June 30, 2026, and highlighted recent business updates. “With multiple data readouts ahead in 2026, we are well positioned to deliver on important clinical milestones and further demonstrate the potential of our DMD franchise,” said Dipal Doshi, Chief Executive Officer of Entrada Therapeutics. “We are entering a catalyst-rich period with several near-term clinical data readouts including ELEVATE-45-201 Cohort 1 in October 2026, ELEVATE-44-201 Cohort 1 open-label period by year-end 2026 and ELEVATE-44-201 Cohort 2 data in the first quarter of 2027. These data are expected to further characterize the safety, tolerability and emerging functional profile of ENTR-601-44 and ENTR-601-45. Together, with the continued progress of VX-670 through our collaboration with Vertex on DM1, these milestones have the potential to further strengthen the clinical and strategic value of our pipeline as we work to bring transformative new treatment options to people living with serious neuromuscular diseases.” Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S., complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Enrollment complete for Cohort 2 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory participants living with DMD who are amenable to exon 44 skipping. Previously announced data from Cohort 1 achieved the primary objective of favorable safety and tolerability, with no discontinuations and no serious adverse events. Cohort 1 data also demonstrated early functional benefits in Time to Rise (TTR) and Time to Rise veloci…Read full documentShow less
-- Company to report ELEVATE-44-201 data from Cohort 1 open-label period by year-end 2026 -- -- ELEVATE-44-201 Cohort 2 enrollment complete with data expected in Q1 2027 -- -- Company to report ELEVATE-45-201 Cohort 1 data in October 2026 -- -- ELEVATE-45-201 Cohort 2 dosing ongoing at the increased dose of 10 mg/kg with data expected in H1 2027 -- -- Vertex to report VX-670 Phase 1/2 data in people living with DM1 in H2 2026 -- BOSTON, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the second quarter ended June 30, 2026, and highlighted recent business updates. “With multiple data readouts ahead in 2026, we are well positioned to deliver on important clinical milestones and further demonstrate the potential of our DMD franchise,” said Dipal Doshi, Chief Executive Officer of Entrada Therapeutics. “We are entering a catalyst-rich period with several near-term clinical data readouts including ELEVATE-45-201 Cohort 1 in October 2026, ELEVATE-44-201 Cohort 1 open-label period by year-end 2026 and ELEVATE-44-201 Cohort 2 data in the first quarter of 2027. These data are expected to further characterize the safety, tolerability and emerging functional profile of ENTR-601-44 and ENTR-601-45. Together, with the continued progress of VX-670 through our collaboration with Vertex on DM1, these milestones have the potential to further strengthen the clinical and strategic value of our pipeline as we work to bring transformative new treatment options to people living with serious neuromuscular diseases.” Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S., complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Enrollment complete for Cohort 2 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory participants living with DMD who are amenable to exon 44 skipping. Previously announced data from Cohort 1 achieved the primary objective of favorable safety and tolerability, with no discontinuations and no serious adverse events. Cohort 1 data also demonstrated early functional benefits in Time to Rise (TTR) and Time to Rise velocity versus placebo. A Long-Term Extension (LTE) platform study protocol (ENTR-DMD-202) was accepted by U.K. and European authorities. ENTR-DMD-202 will enable study participants continued access to ENTR-601-44 and provide for the collection of longer-term safety and efficacy data, including functional measures. The Company is on track to report data from the Cohort 1 (6 mg/kg) open-label period of the study by year-end 2026. The open-label period of the study will assess longer-term safety, continued changes in TTR and other functional measures that are normally assessed in DMD clinical studies. Additional data from Cohort 2 MAD (12 mg/kg) is expected in the first quarter of 2027 and data from Cohort 3 (up to 18 mg/kg) will follow, if needed. ELEVATE-44-102: Based on a review of safety, pharmacokinetic and pharmacodynamic data from Cohort 1 of the ELEVATE-44-201 study in the U.K. and EU, the Company plans to re-engage with the FDA to discuss increasing the planned starting dose in this clinical study. The Company will provide an update on clinical study design and timing following interactions with the FDA. ELEVATE-45-201: The Company has completed enrollment and dosing of Cohort 1 of the global Phase 1/2 MAD clinical study of ENTR-601-45 in ambulatory participants living with DMD who are amenable to exon 45 skipping. An independent Data Monitoring Committee (DMC) reviewed all available safety and PK data from the eight participants enrolled in Cohort 1 and recommended initiation of Cohort 2 at the increased dose of 10 mg/kg without any protocol modification. All participants from Cohort 1 have transitioned into the open-label, Phase 2 portion of the study. Cohort 2 dosing at 10 mg/kg is ongoing. The Company expects to report data from the Cohort 1 MAD (5 mg/kg) in October 2026, data from the Cohort 2 MAD (10 mg/kg) in the first half of 2027, and data from Cohort 3 (up to 15 mg/kg) will follow, if needed. ELEVATE-50-201: The Company received regulatory authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate a Phase 1/2 MAD clinical study of ENTR-601-50 in ambulatory participants living with DMD who are amenable to exon 50 skipping. The Company expects to submit additional global regulatory applications following a review of data from the ongoing studies of its lead programs. ENTR-601-51: The Company has completed Clinical Trial Authorization (CTA)-enabling studies for people living with DMD who are amenable to exon 51 skipping, which is the largest sub-population of exon-skipping amenable patients. The Company expects to submit global regulatory applications following a review of data from the ongoing studies of its lead programs. VX-670: Vertex has completed enrollment and continues dosing in the MAD portion of the GALILEO global Phase 1/2 clinical trial of VX-670 in people with DM1. The study is assessing safety and preliminary efficacy, including change from baseline in the splicing index and other endpoints evaluating muscle function and strength. Vertex is on track to complete dosing and report results in the second half of 2026. Expanding Preclinical Pipeline: The Company has generated compelling preclinical data from programs focused on ocular and metabolic diseases. The pipeline includes the advancement of two novel oligonucleotide-based programs for the potential treatment of inherited retinal diseases, where there exists high unmet need. The Company announced its first ocular candidate, ENTR-801, for the potential treatment of Usher syndrome type 2A (USH2A) and plans to announce a second clinical candidate in ocular disease in the second half of 2026. The Company will provide additional details on its clinical development strategy at that time. Upcoming Investor Conferences Cantor Global Healthcare Conference, New York, NY on September 9, 2026 Second Quarter 2026 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $223.0 million as of June 30, 2026, compared to $295.7 million as of December 31, 2025. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of June 30, 2026 will be sufficient to fund its operations into the third quarter of 2027. Collaboration Revenue: Collaboration revenue was $0.9 million for the second quarter of 2026, compared to $2.0 million for the same period in 2025. Research & Development (R&D) Expenses: R&D expenses were $35.4 million for the second quarter of 2026, compared to $37.9 million for the same period in 2025. The decrease was primarily driven by lower personnel and facility costs, partially offset by additional expenses incurred related to the Company’s DMD programs. General & Administrative (G&A) Expenses: G&A expenses were $10.5 million for the second quarter of 2026, compared to $10.9 million for the same period in 2025. The decrease was primarily driven by lower professional services costs. Net Loss: Net loss was $42.8 million for the second quarter of 2026, compared to $43.1 million for the same period in 2025. Patients and Their Care PartnersPatients and their care partners are a critical part of our community, and we are committed to keeping them informed and connected. To receive community updates in real time and read today’s quarterly update, please visit Community Updates on our corporate website. About Entrada TherapeuticsEntrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy who are exon 44, 45, 50 and 51 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 StatementsThis press release contains express and implied 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, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, the timing and achievement of anticipated clinical, regulatory and development milestones, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-44, including the potential of the open-label period of the study to assess longer-term safety and additional functional measures, the potential of the LTE study and its ability to enable continued access to ENTR-601-44 for study participants and provide for the collection of longer-term safety and efficacy data, including functional measures, the timing of data from the Cohort 1 open-label period by year-end 2026 and Cohort 2 in the first quarter of 2027 with data from Cohort 3 to follow, if needed, expectations regarding the initiation of the planned ELEVATE-44-102 study in the U.S., including Entrada’s plans to re-engage with the FDA to discuss increasing the planned starting dose for the study and to provide an update on the clinical study design and timing following such planned interactions, the ability to recruit for and complete the global Phase 1/2 clinical studies of ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, the potential therapeutic benefits of Entrada’s EEV product candidates, including the potential for ENTR-601-44 to be a transformative treatment option, expectations regarding Entrada's Phase 1/2 MAD clinical study of ENTR-601-45, including the timing of data from Cohort 1 in October 2026 and Cohort 2 in the first half of 2027, with Cohort 3 to follow, if needed, expectations regarding regulatory filings and authorizations and the timing of initiation of the planned clinical studies of ENTR-601-50 and ENTR-601-51, including Entrada’s evaluation of the optimal timing for initiating such studies, the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including but not limited to ocular disease, expectations regarding the timing of announcement of a second clinical candidate for ocular disease and Entrada’s clinical development strategy therefore in the second half of 2026, and the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the treatment of DMD and ENTR-801 for the potential treatment of Usher syndrome type 2A and the partnered product candidate VX-670 for the potential treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, including the timing of Vertex completing dosing and reporting results from the MAD portion of the global Phase 1/2 study of the VX-670 program in the second half of 2026, the ability to continue to expand and develop additional therapeutic programs and modalities, including further exon skipping programs, and the sufficiency of its cash resources for at least twelve months from the date of issuance of the condensed consolidated financial statements for the six months ended June 30, 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 studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; 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. Investor ContactDoug SnowHead of Investor [email protected] Patient Advocacy ContactSarah FriedhoffHead of Patient [email protected] Media ContactMegan Prock McGrathCTD Comms, [email protected]
Investor releaseQuarter not tagged2026-05-07Entrada shares dive as Duchenne results disappoint
BioPharma Dive
Entrada shares dive as Duchenne results disappoint
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Entrada Therapeutics lost more than half its value Thursday after the company reported early data for an experimental Duchenne muscular dystrophy treatment that fell short of analyst expectations. The company said results from the Phase 1/2 study were positive, with the RNA-based therapy showing favorable safety and tolerability. Researchers also saw indications that the medicine, dubbed ENTR-601-44, could help patients with the muscle-weakening disease rise off the floor faster than those on placebo. But investors zeroed in on how much the treatment could increase production of dystrophin, a protein that is critical for muscle protection and doesn’t appear at adequate levels in Duchenne patients. The study showed an increase of 2.36%, compared with analyst expectations of 10% or more. Shares of the company have subsequently tumbled 55%. Investors hoping for signs that Entrada’s medicine will be able to rival similar drugs that are further along were likely disappointed by the results released Thursday. Avidity Biosciences, which was scooped up by Novartis in a $12 billion deal that closed in February, reported last year a 25% increase in dystrophin production for its experimental “del-zota” therapy and made plans to seek approval. Entrada will now need to look to higher doses of its drug to compete, and the time needed to conduct the research “will augment first-to-market advantages for del-zota,” assuming Novartis succeeds in the regulatory process, William Blair analyst Myles Minter wrote in a note to clients. Even so, Minter found the time-to-rise data for ENTR-601-44 “intriguing.” Duchenne muscular dystrophy is caused by mutations in a gene that stifle production of the vital dystrophin protein, causing progressive muscle weakening that can eventually affect breathing and weaken the heart. The disease, which affects about 41,000 people in the U.S. and Europe, usually arises in childhood and mostly affects males. Entrada’s drug, like del-zota, is designed to treat a subset of Duchenne patients with mutations involving “exon 44,” a specific part of a defunct gene. The therapy is designed to “skip” this section and help the body produce a shorter, still-functional form of dystrophin. Development of the medicine h…Read full documentShow less
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Entrada Therapeutics lost more than half its value Thursday after the company reported early data for an experimental Duchenne muscular dystrophy treatment that fell short of analyst expectations. The company said results from the Phase 1/2 study were positive, with the RNA-based therapy showing favorable safety and tolerability. Researchers also saw indications that the medicine, dubbed ENTR-601-44, could help patients with the muscle-weakening disease rise off the floor faster than those on placebo. But investors zeroed in on how much the treatment could increase production of dystrophin, a protein that is critical for muscle protection and doesn’t appear at adequate levels in Duchenne patients. The study showed an increase of 2.36%, compared with analyst expectations of 10% or more. Shares of the company have subsequently tumbled 55%. Investors hoping for signs that Entrada’s medicine will be able to rival similar drugs that are further along were likely disappointed by the results released Thursday. Avidity Biosciences, which was scooped up by Novartis in a $12 billion deal that closed in February, reported last year a 25% increase in dystrophin production for its experimental “del-zota” therapy and made plans to seek approval. Entrada will now need to look to higher doses of its drug to compete, and the time needed to conduct the research “will augment first-to-market advantages for del-zota,” assuming Novartis succeeds in the regulatory process, William Blair analyst Myles Minter wrote in a note to clients. Even so, Minter found the time-to-rise data for ENTR-601-44 “intriguing.” Duchenne muscular dystrophy is caused by mutations in a gene that stifle production of the vital dystrophin protein, causing progressive muscle weakening that can eventually affect breathing and weaken the heart. The disease, which affects about 41,000 people in the U.S. and Europe, usually arises in childhood and mostly affects males. Entrada’s drug, like del-zota, is designed to treat a subset of Duchenne patients with mutations involving “exon 44,” a specific part of a defunct gene. The therapy is designed to “skip” this section and help the body produce a shorter, still-functional form of dystrophin. Development of the medicine has been bumpy. The Food and Drug Administration in 2022 halted the company’s plans to begin human trials in the U.S. — a hold that lasted until February 2025. Participants in the study released Thursday, known as ELEVATE-44-201, received the treatment at sites in the U.K. and European Union. Recommended Reading Arvinas, Entrada cut staff; Merck builds US hub for Keytruda
Investor releaseQuarter not tagged2026-05-07Entrada Therapeutics Reports First Quarter 2026 Financial Results
GlobeNewswire
Entrada Therapeutics Reports First Quarter 2026 Financial Results
-- Announced positive ELEVATE-44-201 Cohort 1 topline results in Duchenne muscular dystrophy showing favorable safety, tolerability and early functional benefit -- -- Company on track to report ELEVATE-45-201 Cohort 1 data in mid-2026, as well as ELEVATE-44-201 open-label period and Cohort 2 data by year-end 2026 -- -- Cash runway expected into Q3 2027 with $255 million in cash, cash equivalents and marketable securities as of March 31, 2026 -- -- Entrada to host investor webcast and conference call today, Thursday, May 7, at 8:30 a.m. ET -- BOSTON, May 07, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the first quarter ended March 31, 2026, and highlighted recent business updates. “With the recently announced positive data from Cohort 1 of our ELEVATE-44-201 clinical study, this year has already delivered a significant clinical inflection point. Establishing that ENTR-601-44 demonstrated not only favorable safety and tolerability, but early and differentiated functional benefits at 6 mg/kg, is a clear milestone for the program as well as Entrada’s neuromuscular pipeline,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “With cash runway into the third quarter of 2027, we are well positioned to achieve additional clinical inflection points throughout the year, including data from the first participant cohort of the ELEVATE-45-201 study, as well as the open-label and second cohort of the ELEVATE-44-201 study. The Company is also carefully evaluating the optimal timing for initiating the planned clinical studies of ENTR-601-50 and ENTR-601-51.” Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S., complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Announced positive topline results from Cohort 1 in the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory participants living with DMD who are amenable to exon 44 skipping. Study participants in Cohort 1 received three doses of 6 mg/kg of ENTR-601-44, the lead investigational product in Entrada’s DMD franchise, or placebo. Topline results demonstrated meaningf…Read full documentShow less
-- Announced positive ELEVATE-44-201 Cohort 1 topline results in Duchenne muscular dystrophy showing favorable safety, tolerability and early functional benefit -- -- Company on track to report ELEVATE-45-201 Cohort 1 data in mid-2026, as well as ELEVATE-44-201 open-label period and Cohort 2 data by year-end 2026 -- -- Cash runway expected into Q3 2027 with $255 million in cash, cash equivalents and marketable securities as of March 31, 2026 -- -- Entrada to host investor webcast and conference call today, Thursday, May 7, at 8:30 a.m. ET -- BOSTON, May 07, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the first quarter ended March 31, 2026, and highlighted recent business updates. “With the recently announced positive data from Cohort 1 of our ELEVATE-44-201 clinical study, this year has already delivered a significant clinical inflection point. Establishing that ENTR-601-44 demonstrated not only favorable safety and tolerability, but early and differentiated functional benefits at 6 mg/kg, is a clear milestone for the program as well as Entrada’s neuromuscular pipeline,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “With cash runway into the third quarter of 2027, we are well positioned to achieve additional clinical inflection points throughout the year, including data from the first participant cohort of the ELEVATE-45-201 study, as well as the open-label and second cohort of the ELEVATE-44-201 study. The Company is also carefully evaluating the optimal timing for initiating the planned clinical studies of ENTR-601-50 and ENTR-601-51.” Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S., complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Announced positive topline results from Cohort 1 in the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory participants living with DMD who are amenable to exon 44 skipping. Study participants in Cohort 1 received three doses of 6 mg/kg of ENTR-601-44, the lead investigational product in Entrada’s DMD franchise, or placebo. Topline results demonstrated meaningful and potentially differentiated early functional benefits including statistically significant improvement in Time to Rise (TTR) velocity in the majority of participants treated with ENTR-601-44. Results also demonstrated a favorable safety and tolerability profile, all adverse events (AEs) were mild or moderate, there were no reported serious adverse events (SAEs), and no AEs leading to discontinuation from the study. Plasma markers for kidney function were normal. The Company is on track to report data from the Cohort 1 open-label period and Cohort 2 (12 mg/kg) MAD by year-end 2026, with data from Cohort 3 MAD (up to 18 mg/kg) to follow. ELEVATE-44-102: The Company believes this clinical study, in the underserved adult patient population with advanced disease, would be best to initiate at the highest advisable starting dose. Following a review of safety, pharmacokinetic and pharmacodynamic data from Cohort 1 of the ELEVATE-44-201 study in the U.K. and EU, the Company plans to re-engage with the FDA to discuss increasing the planned doses in this clinical study. As such, the Company will provide an update on clinical study design and timing following interactions with the FDA. ELEVATE-45-201: Completed enrollment and initiated dosing in Cohort 1 of the global Phase 1/2 MAD clinical study of ENTR-601-45 in ambulatory participants living with DMD who are amenable to exon 45 skipping. The Company is on track to report data from Cohort 1 (5 mg/kg) in mid-2026, with data from Cohort 2 and Cohort 3 (up to 10 mg/kg and 15 mg/kg, respectively) to follow. ELEVATE-50-201: The Company received regulatory authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate a Phase 1/2 MAD clinical study of ENTR-601-50 in ambulatory participants living with DMD who are amenable to exon 50 skipping. The Company expects to submit additional regulatory applications and obtain authorization in the EU following a review of data from the ongoing studies of its lead programs. ENTR-601-51: The Company has completed Clinical Trial Authorization (CTA)-enabling studies for people living with DMD who are amenable to exon 51 skipping, which is applicable to the largest sub-population of exon skipping amenable patients. The Company expects to submit regulatory applications and obtain authorization following a review of data from the ongoing studies of its lead programs. VX-670: Vertex continues to enroll and dose the MAD portion of the GALILEO global Phase 1/2 clinical study of VX-670 in people with DM1. The study assesses both safety and efficacy and Vertex is on track to share results during the second half of 2026. Expanding Preclinical Pipeline: The Company has generated compelling preclinical data from programs focused on ocular and metabolic diseases. The pipeline includes the advancement of two novel oligonucleotide-based programs for the potential treatment of inherited retinal diseases, where there exists high unmet need. The first ocular candidate, ENTR-801, for the potential treatment of Usher syndrome type 2A (USH2A) was announced in December 2025. The Company plans to announce a second clinical candidate in ocular disease in the second half of 2026 and will provide additional details on its clinical development strategy at that time. Upcoming Investor Conferences H.C. Wainwright 4th Annual BioConnect Investor Conference, New York, NY on May 19, 2026 2026 Jefferies Global Healthcare Conference, New York, NY on June 3, 2026 Goldman Sachs 47th Annual Global Healthcare Conference 2026, Miami Beach, FL on June 8, 2026 Investor Webcast and Conference Call Information Entrada Therapeutics will host an investor webcast and conference call today, Thursday, May 7, 2026, at 8:30 a.m. ET to discuss financial results for the first quarter ended March 31, 2026, recent business updates and topline results from Cohort 1 of the Phase 1/2 ELEVATE-44-201 study. The webcast can be accessed by visiting the Investor Relations section of the Company’s website at www.entradatx.com. Analysts planning to participate during the Q&A portion of the live call can join the conference call at the audio-conferencing link here. The webcast will be archived and available for replay on the Entrada Therapeutics website for 90 days following the call. Patients and Their Care Partners Patients and their care partners are a critical part of our community, and we are committed to keeping them informed and connected. To receive community updates in real time and read today’s update, please visit Community Updates on our corporate website. First Quarter 2026 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $254.9 million as of March 31, 2026, compared to $295.7 million as of December 31, 2025. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund its operations into the third quarter of 2027. Collaboration Revenue: Collaboration revenue was $0.9 million for the first quarter of 2026, compared to $20.6 million for the same period in 2025. This decrease is primarily attributable to the substantial completion of the collaboration research plan activities associated with VX-670 during the first quarter of 2025. Research & Development (R&D) Expenses: R&D expenses were $33.1 million for the first quarter of 2026, compared to $32.1 million for the same period in 2025. The increase was primarily driven by additional costs incurred related to the Company’s DMD programs. General & Administrative (G&A) Expenses: G&A expenses were $10.1 million for the first quarter of 2026, compared to $10.3 million for the same period in 2025. The decrease was primarily driven by fewer professional services costs incurred. Net Loss: Net loss was $39.7 million for the first quarter of 2026, compared to $17.3 million for the same period in 2025. About Entrada Therapeutics Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy who are exon 44, 45, 50 and 51 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 express and implied 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, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-44, including the timing of data from the Cohort 1 open-label period and Cohort 2 by year-end 2026 with data from Cohort 3 to follow, expectations regarding the initiation of the planned ELEVATE-44-102 study in the U.S., including plans to re-engage with the FDA to discuss increasing planned doses, the ability to recruit for and complete the global Phase 2 clinical studies of ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, the potential therapeutic benefits of Entrada’s EEV product candidates, including the potential for ENTR-601-44 to be a transformative treatment option, the potential of TTR velocity data observed in Cohort 1 to predict early functional benefit, the potential for a deepening of functional responses, continued functional benefit and higher dystrophin levels with increase in plasma exposure during the Cohort 1 open-label Phase 2 portion of the study, the potential for further enhanced muscle function and a meaningful increase in dystrophin in Cohort 2, expectations regarding Entrada's Phase 1/2 MAD clinical study of ENTR-601-45, including the timing of data from Cohort 1 in mid-2026, with data from Cohort 2 and Cohort 3 to follow, expectations regarding regulatory filings in the EU for the planned Phase 1/2 MAD clinical study of ENTR-601-50, expectations regarding regulatory filings for the ENTR-601-51 program, the potential therapeutic benefits of Entrada’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including but not limited to ocular disease, expectations regarding the timing of nomination of a second clinical candidate for ocular disease in the second half of 2026, and the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the treatment of DMD and ENTR-801 for the potential treatment of Usher syndrome type 2A and the partnered product candidate VX-670 for the potential treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, including the timing of results from the MAD portion of the global Phase 1/2 study of the VX-670 program in the second half of 2026, the ability to continue to expand and develop additional therapeutic programs and modalities, including further exon skipping programs, and the sufficiency of its cash resources into the third quarter of 2027, 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 studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; 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. Investor Contact Karla MacDonald Chief Corporate Affairs Officer [email protected] Patient Advocacy Contact Sarah Friedhoff Head of Patient Advocacy [email protected] Media Contact Megan Prock McGrath CTD Comms, LLC [email protected]
Investor releaseQuarter not tagged2026-02-26Entrada Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Entrada Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
– Company on track to report ELEVATE-44-201 data from Cohort 1 in Q2 2026 and Cohort 2 by year-end 2026 – – Company on track to report ELEVATE-45-201 data from Cohort 1 in mid-2026 – – Independent Data Monitoring Committee recommended initiation of Cohort 2 at the increased dose of 12 mg/kg in the ELEVATE-44-201 study – – Cash runway expected into Q3 2027 with $296 million in cash, cash equivalents and marketable securities as of December 31, 2025 – BOSTON, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the fourth quarter and full year ended December 31, 2025, and highlighted recent business updates. “We have started 2026 with strong momentum, including a positive DMC recommendation to initiate the second cohort of ELEVATE-44-201 at the increased dose of 12 mg/kg. In the coming months, we will share multiple clinical readouts, including data from the first patient cohorts of the ELEVATE-44-201 and ELEVATE-45-201 studies, as well as the second patient cohort of the ELEVATE-44-201 study later in the year. We strongly believe these results continue to derisk our entire neuromuscular portfolio,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We are also advancing our growing development portfolio of genetic medicines, with the nomination of ENTR-801 for the potential treatment of Usher syndrome type 2A and the planned nomination of a second clinical candidate in inherited retinal diseases expected later this year. With a cash runway into the third quarter of 2027, we believe we are well-positioned to continue expanding our unique pipeline of intracellular therapeutics.” Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. In 2026, the Company expects to have four clinical-stage programs in its DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51), complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Completed dosing of Cohort 1 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. An independent Data Monitoring Commi…Read full documentShow less
– Company on track to report ELEVATE-44-201 data from Cohort 1 in Q2 2026 and Cohort 2 by year-end 2026 – – Company on track to report ELEVATE-45-201 data from Cohort 1 in mid-2026 – – Independent Data Monitoring Committee recommended initiation of Cohort 2 at the increased dose of 12 mg/kg in the ELEVATE-44-201 study – – Cash runway expected into Q3 2027 with $296 million in cash, cash equivalents and marketable securities as of December 31, 2025 – BOSTON, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the fourth quarter and full year ended December 31, 2025, and highlighted recent business updates. “We have started 2026 with strong momentum, including a positive DMC recommendation to initiate the second cohort of ELEVATE-44-201 at the increased dose of 12 mg/kg. In the coming months, we will share multiple clinical readouts, including data from the first patient cohorts of the ELEVATE-44-201 and ELEVATE-45-201 studies, as well as the second patient cohort of the ELEVATE-44-201 study later in the year. We strongly believe these results continue to derisk our entire neuromuscular portfolio,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We are also advancing our growing development portfolio of genetic medicines, with the nomination of ENTR-801 for the potential treatment of Usher syndrome type 2A and the planned nomination of a second clinical candidate in inherited retinal diseases expected later this year. With a cash runway into the third quarter of 2027, we believe we are well-positioned to continue expanding our unique pipeline of intracellular therapeutics.” Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. In 2026, the Company expects to have four clinical-stage programs in its DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51), complementing the ongoing clinical progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Completed dosing of Cohort 1 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. An independent Data Monitoring Committee (DMC) has reviewed the data to date from the eight patients enrolled in Cohort 1 and recommended the initiation of Cohort 2 at the increased dose of 12 mg/kg without any protocol modification. All participants from Cohort 1 have transitioned into the open label, Phase 2 portion of the study. The Company is on track to report data from Cohort 1 (6 mg/kg) in the second quarter of 2026, data from Cohort 2 (12 mg/kg) by year-end 2026, and data from Cohort 3 (up to 18 mg/kg) to follow. Entrada intends to open an expansion cohort later in the year to increase the number of participants treated in the ELEVATE-44-201 study, as this study has been designed to support an accelerated approval in the U.S. In December 2025, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to ENTR-601-44. ELEVATE-44-102: The Company believes this clinical study, in the underserved adult patient population with advanced disease, would be best to initiate at the highest advisable starting dose. Following a review of safety, pharmacokinetic and pharmacodynamic data from the ELEVATE-44-201 study in the U.K. and EU in Q2 2026, the Company plans to re-engage with the FDA to discuss increasing the planned doses in this clinical study. As such, the Company will provide an update on clinical study design and timing following interactions with the FDA. ELEVATE-45-201: Initiated patient dosing in the global Phase 1/2 MAD clinical study of ENTR-601-45 in ambulatory patients living with DMD who are amenable to exon 45 skipping. The Company is on track to report data from Cohort 1 (5 mg/kg) in mid-2026, with data from Cohort 2 and Cohort 3 (up to 10 mg/kg and 15 mg/kg, respectively) to follow. ELEVATE-50-201: The Company received regulatory authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate a Phase 1/2 MAD clinical study of ENTR-601-50 in ambulatory patients living with DMD who are amenable to exon 50 skipping. The Company expects to submit regulatory applications and obtain authorization in the EU for ENTR-601-50 by year-end 2026. ENTR-601-51: The Company expects to submit global regulatory applications for ENTR-601-51 in 2026. VX-670: Vertex continues to enroll and dose the MAD portion of the GALILEO global Phase 1/2 clinical study of VX-670 in people with DM1. The study assesses both safety and efficacy and is on track to complete enrollment and dosing in mid-2026. Expanding Preclinical Pipeline: The Company has generated compelling preclinical data from programs focused on ocular and metabolic diseases. The pipeline includes the advancement of two novel oligonucleotide-based programs for the potential treatment of inherited retinal diseases, where there exists high unmet need. The first ocular candidate, ENTR-801, for the potential treatment of Usher syndrome type 2A (USH2A) was announced in December 2025. The Company plans to announce a second clinical candidate in ocular disease in the second half of 2026. Upcoming Investor Conference TD Cowen’s 46th Annual Health Care Conference, Boston, MA on March 3, 2026 Fourth Quarter and Full Year 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $295.7 million as of December 31, 2025, compared to $420.0 million as of December 31, 2024. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of December 31, 2025 will be sufficient to fund its operations into the third quarter of 2027. Collaboration Revenue: Collaboration revenue was $1.3 million for the fourth quarter of 2025 and $25.4 million for the full year of 2025, compared to $37.4 million and $210.8 million for the same periods in 2024. This decrease is primarily attributable to the substantial completion of the collaboration research plan activities associated with VX-670 during the first quarter of 2025. Research & Development (R&D) Expenses: R&D expenses were $34.0 million for the fourth quarter and $142.3 million for the full year of 2025, compared to $33.4 million and $125.3 million for the same periods in 2024. The increase was primarily driven by additional costs incurred related to the Company’s DMD programs, as well as higher personnel costs (including non-cash, stock-based compensation). General & Administrative (G&A) Expenses: G&A expenses were $9.6 million for the fourth quarter and $41.1 million for the full year of 2025, compared to $9.9 million and $38.5 million for the same periods in 2024. The annual increase was primarily due to higher personnel costs (including non-cash, stock-based compensation). Net Income (loss): Net loss was $(39.2) million for the fourth quarter of 2025 and $(143.8) million for the full year of 2025, compared to a net income of $1.1 million and $65.6 million for the same periods in 2024. About Entrada Therapeutics Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. The Company’s lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy who are exon 44, 45, 50 and 51 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 express and implied 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, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-44, including the timing of data from Cohort 1 in the second quarter of 2026, data from Cohort 2 by end of 2026 and data from Cohort 3 to follow, expectations regarding the initiation of the planned ELEVATE-44-102 study in the U.S., including plans to re-engage with the FDA to discuss increasing planned doses, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-45, including the timing of data from Cohort 1 in mid-2026, with data from Cohort 2 and Cohort 3 to follow, expectations regarding the timing of regulatory filings in the EU for the planned Phase 1/2 MAD clinical study of ENTR-601-50 by year-end 2026, expectations regarding the timing of global regulatory filings and clearance for the planned clinical study of ENTR-601-51 in 2026, the ability to recruit for and complete global Phase 2 clinical studies of ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, the potential therapeutic benefits of Entrada’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including but not limited to ocular disease, expectations regarding the timing of nomination of a second clinical candidate for ocular disease in the second half of 2026, the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the potential treatment of DMD and ENTR-801 for the potential treatment of Usher syndrome type 2A and the partnered product candidate VX-670 for the potential treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, including completion of enrollment and dosing of the MAD portion of the global Phase 1/2 study of the VX-670 program in mid-2026, the ability to continue to expand and develop additional therapeutic programs and modalities, including further exon skipping programs, and the sufficiency of its cash resources into the third quarter of 2027, 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 studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; 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. Investor Contact Karla MacDonald Chief Corporate Affairs Officer [email protected] Patient Advocacy Contact Sarah Friedhoff Head of Patient Advocacy [email protected] Media Contact Megan Prock McGrath CTD Comms, LLC [email protected]
Investor releaseQuarter not tagged2026-02-26Arcutis Biotherapeutics, Inc. (ARQT) Surpasses Q4 Earnings and Revenue Estimates
Zacks
Arcutis Biotherapeutics, Inc. (ARQT) Surpasses Q4 Earnings and Revenue Estimates
Arcutis Biotherapeutics, Inc. (ARQT) came out with quarterly earnings of $0.13 per share, beating the Zacks Consensus Estimate of $0.03 per share. This compares to a loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +290.39%. A quarter ago, it was expected that this company would post a loss of $0.1 per share when it actually produced earnings of $0.06, delivering a surprise of +160%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Arcutis Biotherapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $129.5 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 11.93%. This compares to year-ago revenues of $71.36 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Arcutis Biotherapeutics shares have lost about 7.1% since the beginning of the year versus the S&P 500's gain of 0.7%. While Arcutis Biotherapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Arcutis Biotherapeutics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near fu…Read full documentShow less
Arcutis Biotherapeutics, Inc. (ARQT) came out with quarterly earnings of $0.13 per share, beating the Zacks Consensus Estimate of $0.03 per share. This compares to a loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +290.39%. A quarter ago, it was expected that this company would post a loss of $0.1 per share when it actually produced earnings of $0.06, delivering a surprise of +160%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Arcutis Biotherapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $129.5 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 11.93%. This compares to year-ago revenues of $71.36 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Arcutis Biotherapeutics shares have lost about 7.1% since the beginning of the year versus the S&P 500's gain of 0.7%. While Arcutis Biotherapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Arcutis Biotherapeutics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.02 on $94.6 million in revenues for the coming quarter and $0.38 on $470.02 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Entrada Therapeutics, Inc. (TRDA), has yet to report results for the quarter ended December 2025. This company is expected to post quarterly loss of $1.32 per share in its upcoming report, which represents a year-over-year change of -4500%. The consensus EPS estimate for the quarter has been revised 1.5% lower over the last 30 days to the current level. Entrada Therapeutics, Inc.'s revenues are expected to be $1.29 million, down 96.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Arcutis Biotherapeutics, Inc. (ARQT) : Free Stock Analysis Report Entrada Therapeutics, Inc. (TRDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-02-19Earnings Preview: Entrada Therapeutics, Inc. (TRDA) Q4 Earnings Expected to Decline
Zacks
Earnings Preview: Entrada Therapeutics, Inc. (TRDA) Q4 Earnings Expected to Decline
Entrada Therapeutics, Inc. (TRDA) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended December 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $1.32 per share in its upcoming report, which represents a year-over-year change of -4500%. Revenues are expected to be $1.29 million, down 96.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.52% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnin…Read full documentShow less
Entrada Therapeutics, Inc. (TRDA) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended December 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $1.32 per share in its upcoming report, which represents a year-over-year change of -4500%. Revenues are expected to be $1.29 million, down 96.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.52% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Entrada Therapeutics, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -59.09%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Entrada Therapeutics will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Entrada Therapeutics would post a loss of$1.04 per share when it actually produced a loss of -$1.06, delivering a surprise of -1.92%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Entrada Therapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Kura Oncology (KURA), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report loss per share of $0.72 for the quarter ended December 2025. This estimate points to a year-over-year change of -227.3%. Revenues for the quarter are expected to be $29.81 million, down 44.7% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Kura Oncology has been revised 552.4% down to the current level. Nevertheless, the company now has an Earnings ESP of -13.29%, reflecting a lower Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that Kura Oncology will beat the consensus EPS estimate. Over the last four quarters, the company surpassed EPS estimates just once. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Entrada Therapeutics, Inc. (TRDA) : Free Stock Analysis Report Kura Oncology, Inc. (KURA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2025-11-06Entrada Therapeutics Reports Third Quarter 2025 Financial Results
GlobeNewswire
Entrada Therapeutics Reports Third Quarter 2025 Financial Results
-- Company on track to report ELEVATE-44-201 data from first patient cohort in Q2 2026 -- -- First patient dosed in ELEVATE-45-201 and the Company is on track to report data from the first patient cohort in mid-2026 -- -- Filed for regulatory authorization in U.K. to initiate ELEVATE-50-201, a global Phase 1/2 MAD clinical study of ENTR-601-50 -- -- Expected cash runway extended into Q3 2027 with $327 million in cash, cash equivalents and marketable securities as of September 30, 2025 -- BOSTON, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the third quarter ended September 30, 2025, and highlighted recent business updates. “This year, we have strategically positioned Entrada to significantly advance what we believe to be best-in-class therapies for people living with Duchenne muscular dystrophy and their families. We expect 2026 to be a data-rich year, with multiple potential value-creating inflection points across our growing Duchenne franchise,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “The unmet medical need in Duchenne is profound, with the community calling for therapies that are both safe and effective. We look forward to delivering data from the first patient cohort of ELEVATE-44-201 in the second quarter of 2026 and ELEVATE-45-201 in mid-2026. With an expected cash runway extended into the third quarter of 2027, we believe we are well-positioned to advance and expand our unique pipeline of intracellular therapeutics.” Third Quarter and Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. By year-end, the Company expects to have three clinical-stage programs in its DMD franchise (ENTR-601-44, ENTR-601-45 and ENTR-601-50), complementing the ongoing progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Completed enrollment of Cohort 1 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. An independent Data Monitoring Committee (DMC) has reviewed initial data from the eight patients enrolled in Cohort 1 of the blinded, placebo-controlled MAD portion of…Read full documentShow less
-- Company on track to report ELEVATE-44-201 data from first patient cohort in Q2 2026 -- -- First patient dosed in ELEVATE-45-201 and the Company is on track to report data from the first patient cohort in mid-2026 -- -- Filed for regulatory authorization in U.K. to initiate ELEVATE-50-201, a global Phase 1/2 MAD clinical study of ENTR-601-50 -- -- Expected cash runway extended into Q3 2027 with $327 million in cash, cash equivalents and marketable securities as of September 30, 2025 -- BOSTON, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the third quarter ended September 30, 2025, and highlighted recent business updates. “This year, we have strategically positioned Entrada to significantly advance what we believe to be best-in-class therapies for people living with Duchenne muscular dystrophy and their families. We expect 2026 to be a data-rich year, with multiple potential value-creating inflection points across our growing Duchenne franchise,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “The unmet medical need in Duchenne is profound, with the community calling for therapies that are both safe and effective. We look forward to delivering data from the first patient cohort of ELEVATE-44-201 in the second quarter of 2026 and ELEVATE-45-201 in mid-2026. With an expected cash runway extended into the third quarter of 2027, we believe we are well-positioned to advance and expand our unique pipeline of intracellular therapeutics.” Third Quarter and Recent Corporate Highlights Clinical-Stage Development Pipeline: Entrada continues to advance multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. By year-end, the Company expects to have three clinical-stage programs in its DMD franchise (ENTR-601-44, ENTR-601-45 and ENTR-601-50), complementing the ongoing progress of its myotonic dystrophy type 1 (DM1) partnership (VX-670) with Vertex. ELEVATE-44-201: Completed enrollment of Cohort 1 of the global Phase 1/2 multiple ascending dose (MAD) portion of the clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. An independent Data Monitoring Committee (DMC) has reviewed initial data from the eight patients enrolled in Cohort 1 of the blinded, placebo-controlled MAD portion of the study and supports continuation without any protocol modifications. The Company is on track to report data from Cohort 1 (6 mg/kg) in the second quarter of 2026, with data from Cohort 2 and Cohort 3 (up to 12 mg/kg and 18 mg/kg) to follow. ELEVATE-44-102: The Company expects to initiate a Phase 1b MAD clinical study of ENTR-601-44 in ambulatory and non-ambulatory adults living with DMD in the U.S. in the first half of 2026. ELEVATE-45-201: First patient dosed in the global Phase 1/2 MAD clinical study of ENTR-601-45 in ambulatory patients living with DMD who are amenable to exon 45 skipping. The Company is on track to report data from Cohort 1 (5 mg/kg) in mid-2026, with data from Cohort 2 and Cohort 3 (up to 10 mg/kg and 15 mg/kg) to follow. ELEVATE-50-201: The Company filed for regulatory authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate a global Phase 1/2 MAD clinical study of ENTR-601-50 in ambulatory patients living with DMD who are amenable to exon 50 skipping. The Company expects to submit regulatory applications in the EU for ENTR-601-50 in the second half of 2026 and initiate the study by the end of 2026. ENTR-601-51: The Company expects to submit global regulatory applications for ENTR-601-51 in 2026. VX-670: Vertex continues to enroll and dose the MAD portion of the global Phase 1/2 clinical trial of VX-670 in people living with DM1, which will assess both safety and efficacy. Vertex is on track to complete enrollment and dosing in the trial in the first half of 2026. Expanding Preclinical Pipeline: The Company has generated positive preclinical data from programs focused on ocular and metabolic diseases, which include new moieties. The Company has advanced two ocular programs into lead optimization, with the first clinical candidate nomination expected by year-end 2025. Upcoming Investor Conferences Jefferies Global Healthcare Conference in London, U.K. on November 18. Evercore Healthcare Conference in Miami, Florida on December 3. Third Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $326.8 million as of September 30, 2025, compared to $420.0 million as of December 31, 2024. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund its operations into the third quarter of 2027. Collaboration Revenue: Collaboration revenue was $1.6 million for the third quarter of 2025, compared to $19.6 million for the same period in 2024. This decrease is primarily attributable to the substantial completion of the collaboration research plan activities associated with VX-670. Research & Development (R&D) Expenses: R&D expenses were $38.4 million for the third quarter of 2025, compared to $31.3 million for the same period in 2024. The increase was primarily driven by additional costs incurred related to the Company’s DMD programs, as well as higher personnel costs (including non-cash, stock-based compensation). General & Administrative (G&A) Expenses: G&A expenses were $10.3 million for the third quarter of 2025, compared to $10.0 million for the same period in 2024. The increase was primarily due to higher personnel costs (including non-cash, stock-based compensation). Net Income (loss): Net loss was $(44.1) million for the third quarter of 2025, compared to a net loss of $(14.0) million for the same period in 2024. 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- and protein-based programs for the potential treatment of neuromuscular and ocular 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, 50 and 51 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 express and implied 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, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-44, including the timing of data from Cohort 1 in the second quarter of 2026, expectations regarding initiation of the planned ELEVATE-44-102 study in the U.S. in the first half of 2026, expectations regarding the timing of regulatory filings in the EU for the planned Phase 2 clinical study for ENTR-601-50 in the second half of 2026 and initiation by the end of 2026, pending clearance, expectations regarding the timing of global regulatory filings for the planned Phase 2 clinical study for ENTR-601-51 in 2026, the ability to recruit for and complete global Phase 2 clinical studies for ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, the potential therapeutic benefits of Entrada’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including the potential for ENTR-601-44 to be a transformative treatment option, the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the potential treatment of DMD and the partnered product candidate VX-670 for the potential treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, the ability to continue to expand and develop additional therapeutic programs, including further exon skipping programs, and the sufficiency of its cash resources into the third quarter of 2027, 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 studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; 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. Investor Contact Karla MacDonald Chief Corporate Affairs Officer [email protected] Patient Advocacy Contact Sarah Friedhoff Head of Patient Advocacy [email protected] Media Contact Megan Prock McGrath CTD Comms, LLC [email protected]
Investor releaseQuarter not tagged2025-08-07Entrada Therapeutics Second Quarter 2025 Earnings: Misses Expectations
Simply Wall St.
Entrada Therapeutics Second Quarter 2025 Earnings: Misses Expectations
Revenue: US$1.95m (down 98% from 2Q 2024). Net loss: US$43.1m (down by 178% from US$55.0m profit in 2Q 2024). US$1.04 loss per share (down from US$1.61 profit in 2Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 76%. Earnings per share (EPS) also missed analyst estimates by 23%. Looking ahead, revenue is expected to decline by 81% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 18%. Performance of the American Biotechs industry. The company's shares are up 1.2% from a week ago. What about risks? Every company has them, and we've spotted 2 warning signs for Entrada Therapeutics (of which 1 is a bit unpleasant!) you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-08-06Entrada Therapeutics Reports Second Quarter 2025 Financial Results
GlobeNewswire
Entrada Therapeutics Reports Second Quarter 2025 Financial Results
-- First patient dosed in ELEVATE-44-201 with data from first patient cohort anticipated in H1 2026 -- -- Initiated ELEVATE-45-201 and on track to dose the first patient in Q3 2025 -- -- Multiple clinical trial sites in U.K. and EU activated for ELEVATE-44-201 and ELEVATE-45-201 -- -- Leadership team expanded with the additions of Navid Khan, PhD, as Senior Vice President of Medical Affairs and Kiran Patki, MD, MSc, FFPM, as Senior Vice President of Clinical Development -- -- Cash runway expected into Q2 2027 with $354 million in cash, cash equivalents and marketable securities as of June 30, 2025 -- BOSTON, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the second quarter ended June 30, 2025, and highlighted recent business updates. “Now, more than ever, patients living with Duchenne muscular dystrophy need safer and efficacious therapeutic options. We are pleased that we achieved a key clinical milestone with the dosing of the first patient in our ELEVATE-44-201 clinical study and expect to report data from the first patient cohort during the first half of 2026. ELEVATE-45-201 sites have also been activated, and we remain on track to dose the first patient in the third quarter of this year, making it the most advanced clinical study of a conjugated exon skipping therapy for individuals amenable to exon 45 skipping. These two programs provide the potential for multiple clinical data readouts across our growing Duchenne franchise in 2026,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. Mr. Doshi continued, “This important progress, coupled with the upcoming regulatory submissions to initiate ELEVATE-50 later this year and ELEVATE-51 in 2026, continue to drive clinical momentum for large Duchenne patient populations with profound unmet need. In parallel, we are strategically strengthening our organization with key hires to support our expanding pipeline while remaining committed to financial discipline.” Second Quarter and Recent Corporate Highlights Clinical-Stage Development Pipeline: Since January 2025, Entrada has advanced multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. These programs include: ELEVATE-44-201: First patient dosed in the global Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44…Read full documentShow less
-- First patient dosed in ELEVATE-44-201 with data from first patient cohort anticipated in H1 2026 -- -- Initiated ELEVATE-45-201 and on track to dose the first patient in Q3 2025 -- -- Multiple clinical trial sites in U.K. and EU activated for ELEVATE-44-201 and ELEVATE-45-201 -- -- Leadership team expanded with the additions of Navid Khan, PhD, as Senior Vice President of Medical Affairs and Kiran Patki, MD, MSc, FFPM, as Senior Vice President of Clinical Development -- -- Cash runway expected into Q2 2027 with $354 million in cash, cash equivalents and marketable securities as of June 30, 2025 -- BOSTON, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the second quarter ended June 30, 2025, and highlighted recent business updates. “Now, more than ever, patients living with Duchenne muscular dystrophy need safer and efficacious therapeutic options. We are pleased that we achieved a key clinical milestone with the dosing of the first patient in our ELEVATE-44-201 clinical study and expect to report data from the first patient cohort during the first half of 2026. ELEVATE-45-201 sites have also been activated, and we remain on track to dose the first patient in the third quarter of this year, making it the most advanced clinical study of a conjugated exon skipping therapy for individuals amenable to exon 45 skipping. These two programs provide the potential for multiple clinical data readouts across our growing Duchenne franchise in 2026,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. Mr. Doshi continued, “This important progress, coupled with the upcoming regulatory submissions to initiate ELEVATE-50 later this year and ELEVATE-51 in 2026, continue to drive clinical momentum for large Duchenne patient populations with profound unmet need. In parallel, we are strategically strengthening our organization with key hires to support our expanding pipeline while remaining committed to financial discipline.” Second Quarter and Recent Corporate Highlights Clinical-Stage Development Pipeline: Since January 2025, Entrada has advanced multiple clinical programs in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. These programs include: ELEVATE-44-201: First patient dosed in the global Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. Multiple clinical trial sites in the U.K. and EU are activated and screening patients. The Company expects to report data from Cohort 1 (6 mg/kg patient dose) in the first half of 2026, with data from Cohort 2 and Cohort 3 (up to 18 mg/kg) to follow. ELEVATE-44-102: Planned Phase 1b MAD clinical study of ENTR-601-44 in ambulatory and non-ambulatory adults living with DMD. The study will run in the U.S. and is on track to initiate in the first half of 2026. ELEVATE-45-201: Initiated a global Phase 1/2 MAD clinical study of ENTR-601-45 in ambulatory patients living with DMD who are amenable to exon 45 skipping. The study received authorization in the U.K. (March 2025) and EU (May 2025). Multiple clinical study sites are activated, and the study is on track to dose the first patient in the third quarter of 2025. The Company expects to report data from Cohort 1 (5 mg/kg) in mid-2026, with data from Cohort 2 and Cohort 3 (up to 15 mg/kg) to follow. ENTR-601-50 and ENTR-601-51: The Company expects to submit global regulatory applications for ENTR-601-50 in the fourth quarter of 2025 and for ENTR-601-51 in 2026. VX-670: Vertex continues to enroll and dose the MAD portion of the global Phase 1/2 clinical trial of VX-670 in people living with myotonic dystrophy type 1 (DM1), which will assess both safety and efficacy. Vertex is on track to complete enrollment and dosing in the trial in the first half of 2026. Preclinical Pipeline: The Company has generated positive preclinical data from programs outside of its neuromuscular franchise, which include new moieties. Advanced two inherited retinal disease programs into lead optimization with the first clinical candidate nomination expected by year-end 2025. Significant progress in additional neuromuscular and metabolic disease programs. Organizational Evolution: To support its accelerated clinical growth and other strategic priorities, the Company has enhanced the organization as follows: Appointed Navid Khan, PhD, to the newly created role of Senior Vice President of Medical Affairs in August 2025. Dr. Khan has extensive expertise in directing medical affairs for pre-commercial and commercial therapies for neuromuscular disorders, including DMD. Expanded its Clinical Development leadership with the appointment of Kiran Patki, MD, MSc, FFPM, as Senior Vice President of Clinical Development in July 2025. Dr. Patki brings deep expertise in rare diseases including early- and late-stage clinical development, and has a proven track record of securing product regulatory approvals. Appointed Maha Radhakrishnan, MD, to the Company’s Board of Directors in June 2025. Dr. Radhakrishnan brings extensive experience in global drug development and commercialization, having served in executive medical roles at numerous global biopharmaceutical companies. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $354.0 million as of June 30, 2025, compared to $420.0 million as of December 31, 2024. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund its operations into the second quarter of 2027. Collaboration Revenue: Collaboration revenue was $2.0 million for the second quarter of 2025, compared to $94.7 million for the same period in 2024. This decrease is primarily attributable to the substantial completion of the collaboration research plan activities associated with VX-670. Research & Development (R&D) Expenses: R&D expenses were $37.9 million for the second quarter of 2025, compared to $32.0 million for the same period in 2024. The increase was primarily driven by additional costs incurred related to the Company’s DMD programs, as well as higher personnel costs (including non-cash, stock-based compensation). General & Administrative (G&A) Expenses: G&A expenses were $10.9 million for the second quarter of 2025, compared to $9.2 million for the same period in 2024. The increase was primarily due to higher personnel costs (including non-cash, stock-based compensation). Net Income (loss): Net loss was $(43.1) million for the second quarter of 2025, compared to net income of $55.0 million for the same period in 2024. 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- and protein-based programs for the potential treatment of neuromuscular and ocular 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, 50 and 51 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 express and implied 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, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding Entrada’s Phase 1/2 MAD clinical study of ENTR-601-44 in the U.K. and EU, including the release of data from the ELEVATE-44-201 study from the first patient cohort in the first half of 2026, expectations regarding Entrada’s planned Phase 1/2 MAD clinical study of ENTR-601-45 in the U.K. and EU, including its initiation in the U.K. and EU and dosing of the first patient in the third quarter of 2025 and the release of data from the first patient cohort in mid-2026, the ability to recruit for and complete the ELEVATE-44-102 study in the U.S., including its initiation in the U.S. in the first half of 2026, the ability to recruit for and complete global Phase 2 clinical studies for ENTR-601-44, ENTR-601-45 and ENTR-601-50, expectations regarding the timing of global regulatory filings for the planned Phase 2 clinical studies for ENTR-601-50 in the fourth quarter of 2025 and for ENTR-601-51 in 2026, expectations regarding the timing of candidate nomination for a retinal disease program in 2025, the potential therapeutic benefits of Entrada’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including the potential for ENTR-601-44 to be a safe and transformative treatment option, the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the potential treatment of DMD and the partnered product candidate VX-670 for the potential treatment of DM1, expectations regarding the anticipated contributions from recent key hires to the Company’s operations and progress, expectations regarding the progress and success of Entrada’s collaboration with Vertex, the ability to continue to expand and develop additional therapeutic programs, including further exon skipping programs, and the sufficiency of its cash resources into the second quarter of 2027, 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 studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; 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. Investor Contact Karla MacDonald Chief Corporate Affairs Officer [email protected] Patient Advocacy Contact Sarah Friedhoff Head of Patient Advocacy [email protected] Media Contact Megan Prock McGrath CTD Comms, LLC [email protected]
Investor releaseQuarter not tagged2025-05-11Analysts Are Upgrading Entrada Therapeutics, Inc. (NASDAQ:TRDA) After Its Latest Results
Simply Wall St.
Analysts Are Upgrading Entrada Therapeutics, Inc. (NASDAQ:TRDA) After Its Latest Results
Entrada Therapeutics, Inc. (NASDAQ:TRDA) just released its quarterly report and things are looking bullish. The results were impressive, with revenues of US$21m exceeding analyst forecasts by 102%, and statutory losses of US$0.42 were likewise much smaller than the analysts had forecast. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Entrada Therapeutics after the latest results. We've discovered 1 warning sign about Entrada Therapeutics. View them for free. Taking into account the latest results, the five analysts covering Entrada Therapeutics provided consensus estimates of US$39.7m revenue in 2025, which would reflect a substantial 77% decline over the past 12 months. Earnings are expected to tip over into lossmaking territory, with the analysts forecasting statutory losses of -US$2.96 per share in 2025. Before this latest report, the consensus had been expecting revenues of US$36.7m and US$3.50 per share in losses. So it seems there's been a definite increase in optimism about Entrada Therapeutics' future following the latest consensus numbers, with a notable improvement in the loss per share forecasts in particular. View our latest analysis for Entrada Therapeutics The consensus price target fell 7.9%, to US$24.33, suggesting that the analysts remain pessimistic on the company, despite the improved earnings and revenue outlook. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. There are some variant perceptions on Entrada Therapeutics, with the most bullish analyst valuing it at US$30.00 and the most bearish at US$20.00 per share. This shows there is still a bit of diversity in estimates, but analysts don't appear to be totally split on the stock as though it might be a success or failure situation. These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the Entrada Therapeutics' past performance and to peers in the same industry. We would highlight that revenue is expected to reverse, with a forecast 86% annu…Read full documentShow less
Entrada Therapeutics, Inc. (NASDAQ:TRDA) just released its quarterly report and things are looking bullish. The results were impressive, with revenues of US$21m exceeding analyst forecasts by 102%, and statutory losses of US$0.42 were likewise much smaller than the analysts had forecast. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Entrada Therapeutics after the latest results. We've discovered 1 warning sign about Entrada Therapeutics. View them for free. Taking into account the latest results, the five analysts covering Entrada Therapeutics provided consensus estimates of US$39.7m revenue in 2025, which would reflect a substantial 77% decline over the past 12 months. Earnings are expected to tip over into lossmaking territory, with the analysts forecasting statutory losses of -US$2.96 per share in 2025. Before this latest report, the consensus had been expecting revenues of US$36.7m and US$3.50 per share in losses. So it seems there's been a definite increase in optimism about Entrada Therapeutics' future following the latest consensus numbers, with a notable improvement in the loss per share forecasts in particular. View our latest analysis for Entrada Therapeutics The consensus price target fell 7.9%, to US$24.33, suggesting that the analysts remain pessimistic on the company, despite the improved earnings and revenue outlook. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. There are some variant perceptions on Entrada Therapeutics, with the most bullish analyst valuing it at US$30.00 and the most bearish at US$20.00 per share. This shows there is still a bit of diversity in estimates, but analysts don't appear to be totally split on the stock as though it might be a success or failure situation. These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the Entrada Therapeutics' past performance and to peers in the same industry. We would highlight that revenue is expected to reverse, with a forecast 86% annualised decline to the end of 2025. That is a notable change from historical growth of 89% over the last three years. Compare this with our data, which suggests that other companies in the same industry are, in aggregate, expected to see their revenue grow 18% per year. So although its revenues are forecast to shrink, this cloud does not come with a silver lining - Entrada Therapeutics is expected to lag the wider industry. The most important thing to take away is that the analysts reconfirmed their loss per share estimates for next year. Fortunately, they also upgraded their revenue estimates, although our data indicates it is expected to perform worse than the wider industry. Furthermore, the analysts also cut their price targets, suggesting that the latest news has led to greater pessimism about the intrinsic value of the business. With that in mind, we wouldn't be too quick to come to a conclusion on Entrada Therapeutics. Long-term earnings power is much more important than next year's profits. We have estimates - from multiple Entrada Therapeutics analysts - going out to 2027, and you can see them free on our platform here. Before you take the next step you should know about the 1 warning sign for Entrada Therapeutics that we have uncovered. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-05-08Entrada Therapeutics Reports First Quarter 2025 Financial Results
GlobeNewswire
Entrada Therapeutics Reports First Quarter 2025 Financial Results
– Receives regulatory authorization in the EU for ELEVATE-44-201, a Phase 1/2 MAD clinical study of ENTR-601-44 in patients living with Duchenne muscular dystrophy who are amenable to exon 44 skipping – – Company remains on track to initiate ELEVATE-44-201 and ELEVATE-45-201 in Q2 and Q3 2025, respectively – – Cash runway expected into Q2 2027 with $383 million in cash, cash equivalents and marketable securities as of March 31, 2025 – BOSTON, May 08, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the first quarter ended March 31, 2025, and highlighted recent business updates. “We are excited to announce the first European Union regulatory clearance within our Duchenne franchise, with the authorization to initiate the ELEVATE-44-201 patient study across multiple countries. The first quarter of 2025 has been highly productive, with clearances granted for the first two of our novel exon skipping Duchenne programs, ENTR-601-44 and ENTR-601-45,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We expect to quickly advance three distinct Duchenne programs – for people who are exon 44, 45 and 50 skip amenable – into global clinical development by the end of this year. In parallel, our partnered program with Vertex for myotonic dystrophy type 1, VX-670, continues to progress in the clinic. This increased clinical momentum, combined with a cash runway expected into Q2 2027 and our ongoing commitment to financial discipline, positions us strongly despite the challenging macroeconomic environment.” Recent Corporate Highlights In May 2025, the ELEVATE-44-201 study received authorization from the Health Authorities and Ethics Committees of multiple countries under the European Union Clinical Trial Regulation (EU-CTR). The recent EU authorization of ELEVATE-44-201 builds upon the Company’s significant clinical momentum. Since January 2025, Entrada has received authorization to initiate clinical studies in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. These authorizations include: ELEVATE-44-201: A global Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. The study will run in the U.K. and EU and is on track to initiate in the second quarter of 2025. ELEVATE-44-102: A Phas…Read full documentShow less
– Receives regulatory authorization in the EU for ELEVATE-44-201, a Phase 1/2 MAD clinical study of ENTR-601-44 in patients living with Duchenne muscular dystrophy who are amenable to exon 44 skipping – – Company remains on track to initiate ELEVATE-44-201 and ELEVATE-45-201 in Q2 and Q3 2025, respectively – – Cash runway expected into Q2 2027 with $383 million in cash, cash equivalents and marketable securities as of March 31, 2025 – BOSTON, May 08, 2025 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) today reported financial results for the first quarter ended March 31, 2025, and highlighted recent business updates. “We are excited to announce the first European Union regulatory clearance within our Duchenne franchise, with the authorization to initiate the ELEVATE-44-201 patient study across multiple countries. The first quarter of 2025 has been highly productive, with clearances granted for the first two of our novel exon skipping Duchenne programs, ENTR-601-44 and ENTR-601-45,” said Dipal Doshi, Chief Executive Officer at Entrada Therapeutics. “We expect to quickly advance three distinct Duchenne programs – for people who are exon 44, 45 and 50 skip amenable – into global clinical development by the end of this year. In parallel, our partnered program with Vertex for myotonic dystrophy type 1, VX-670, continues to progress in the clinic. This increased clinical momentum, combined with a cash runway expected into Q2 2027 and our ongoing commitment to financial discipline, positions us strongly despite the challenging macroeconomic environment.” Recent Corporate Highlights In May 2025, the ELEVATE-44-201 study received authorization from the Health Authorities and Ethics Committees of multiple countries under the European Union Clinical Trial Regulation (EU-CTR). The recent EU authorization of ELEVATE-44-201 builds upon the Company’s significant clinical momentum. Since January 2025, Entrada has received authorization to initiate clinical studies in people living with Duchenne muscular dystrophy (DMD) in the U.K., EU and U.S. These authorizations include: ELEVATE-44-201: A global Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44 in ambulatory patients living with DMD who are amenable to exon 44 skipping. The study will run in the U.K. and EU and is on track to initiate in the second quarter of 2025. ELEVATE-44-102: A Phase 1b MAD clinical study of ENTR-601-44 in ambulatory and non-ambulatory adults living with DMD. The study will run in the U.S. and is on track to initiate in the first half of 2026. ELEVATE-45-201: A global Phase 1/2 MAD clinical study of ENTR-601-45 in ambulatory patients living with DMD who are amenable to exon 45 skipping. The study has been authorized to start in the U.K., and the Company has submitted for regulatory authorization in the EU. The study is on track to initiate in the third quarter of 2025. The Company remains on track to submit global regulatory applications for ENTR-601-50 in the second half of 2025 and for ENTR-601-51 in 2026. Vertex continues to enroll and dose the MAD portion of the global Phase 1/2 clinical trial of VX-670 in people with myotonic dystrophy type 1 (DM1), which will assess both safety and efficacy. In April 2025, Entrada initiated a strategic plan to focus the Company’s resources on its expanding portfolio of DMD clinical candidates (ENTR-601-44, -45, -50 and -51), key preclinical programs, including ocular, and maturing platform investments. Activities include enhanced hiring efforts to support planned global clinical study execution in DMD, as well as focused reductions in select research areas, which reduced the Company’s workforce by approximately 20%. Upcoming Investor Conferences H.C. Wainwright 3rd Annual BioConnect Investor Conference in New York, NY on May 20, 2025. Jefferies Global Healthcare Conference in New York, NY on June 4, 2025. Goldman Sachs 46th Annual Global Healthcare Conference 2025 in Miami Beach, FL on June 9, 2025. First Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $382.5 million as of March 31, 2025, compared to $420.0 million as of December 31, 2024. The decrease was primarily driven by cash used to fund operations. Based on current operating plans, the Company believes that its cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund its operations into the second quarter of 2027. Collaboration Revenue: Collaboration revenue was $20.6 million for the first quarter of 2025, compared to $59.1 million for the same period in 2024. Research & Development (R&D) Expenses: R&D expenses were $32.1 million for the first quarter of 2025, compared to $28.6 million for the same period in 2024. The increase was primarily driven by additional costs incurred related to our Duchenne programs, as well as higher personnel costs (including non-cash, stock-based compensation). General & Administrative (G&A) Expenses: G&A expenses were $10.3 million for the first quarter of 2025, compared to $9.4 million for the same period in 2024. The increase was primarily due to higher personnel costs (including non-cash, stock-based compensation). Net Income (loss): Net loss was $(17.3) million for the first quarter of 2025, compared to net income of $23.5 million for the same period in 2024. 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- and protein-based programs for the potential treatment of neuromuscular and ocular 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, 50 and 51 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 express and implied 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, the validation and differentiation of Entrada’s approach and EEV platform and its ability to provide a potential treatment for patients, expectations regarding Entrada’s planned 1/2 MAD clinical study of ENTR-601-44 in the U.K. and EU, including its initiation in the U.K. and EU in the second quarter of 2025, expectations regarding Entrada’s planned 1/2 MAD clinical study of ENTR-601-45 in the U.K. and EU, including its initiation in the U.K. in the third quarter of 2025, the ability to recruit for and complete the ELEVATE-44-102 study in the U.S., including its initiation in the U.S. in the first half of 2026, the ability to recruit for and complete global Phase 2 clinical studies for ENTR-601-44, ENTR-601-45, ENTR-601-50 and ENTR-601-51, expectations regarding the timing of global regulatory filings for the planned Phase 2 clinical studies for ENTR-601-50 in the second half of 2025 and for ENTR-601-51 in 2026, the potential therapeutic benefits of Entrada’s EEV product candidates and the ability to advance therapeutic candidates in indications beyond neuromuscular disease, including the potential for ENTR-601-44 to be a transformative treatment option, the continued development and advancement of ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51 for the treatment of DMD and the partnered product candidate VX-670 for the treatment of DM1, expectations regarding the progress and success of Entrada’s collaboration with Vertex, the ability to continue to expand and develop additional therapeutic programs, including further exon skipping programs, and the sufficiency of its cash resources into the second half of 2027, 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 studies; uncertainties as to the availability and timing of results from preclinical and clinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance and initiate clinical studies; whether results from preclinical studies or clinical studies will be predictive of the results of later preclinical studies and clinical studies; the risk that the costs and charges associated with the Company’s new strategic plan may be greater than anticipated or incurred in different periods than anticipated; the risk that the Company’s efforts in connection with the new strategic plan may adversely affect the Company’s internal programs and the Company’s ability to recruit and retain skilled and motivated personnel, and may be distracting to employees and management; the risk that the Company’s efforts in connection with the new strategic plan may negatively impact the Company’s business operations and reputation; the risk that the Company’s efforts in connection with the new strategic plan may not generate their intended benefits to the extent or as quickly as anticipated; 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. Investor and Media Contact Karla MacDonald Chief Corporate Affairs Officer [email protected]
Investor releaseQuarter not tagged2025-05-01Eton Pharmaceuticals, Inc. (ETON) Earnings Expected to Grow: What to Know Ahead of Q1 Release
Zacks
Eton Pharmaceuticals, Inc. (ETON) Earnings Expected to Grow: What to Know Ahead of Q1 Release
Eton Pharmaceuticals, Inc. (ETON) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly earnings of $0.09 per share in its upcoming report, which represents a year-over-year change of +400%. Revenues are expected to be $16.2 million, up 103.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 75% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an…Read full documentShow less
Eton Pharmaceuticals, Inc. (ETON) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly earnings of $0.09 per share in its upcoming report, which represents a year-over-year change of +400%. Revenues are expected to be $16.2 million, up 103.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 75% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Eton Pharmaceuticals, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +52.94%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Eton Pharmaceuticals will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Eton Pharmaceuticals would post a loss of $0.02 per share when it actually produced a loss of $0.02, delivering no surprise. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Eton Pharmaceuticals appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Entrada Therapeutics, Inc. (TRDA) is soon expected to post loss of $0.78 per share for the quarter ended March 2025. This estimate indicates a year-over-year change of -214.7%. This quarter's revenue is expected to be $9.72 million, down 83.6% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Entrada Therapeutics has remained unchanged. Nevertheless, the company now has an Earnings ESP of -18.71%, reflecting a lower Most Accurate Estimate. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Entrada Therapeutics will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Eton Pharmaceuticals, Inc. (ETON) : Free Stock Analysis Report Entrada Therapeutics, Inc. (TRDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

