Second clinical candidate, ENTR-701, announced for the potential treatment of myotonic dystrophy type 1
On track to submit Investigational New Drug application to the
“In the first quarter of 2022, we continued to make significant progress in advancing our growing pipeline of EEV therapeutic candidates,” said
Recent Corporate Highlights
- Announced ENTR-701 as Entrada’s first clinical candidate for myotonic dystrophy type 1 (DM1) and second clinical candidate in its pipeline.
- Presented new data from Entrada’s Duchenne muscular dystrophy (DMD) and DM1 programs at TIDES USA 2022: Oligonucleotide & Peptide Therapeutics Conference in
May 2022 , including:- Preclinical non-human primate (NHP) data showing robust exon 44 skipping in NHP biceps for at least 12 weeks following a single intravenous (IV) infusion of ENTR-601-44, demonstrating durability of response. These data build on a previously reported NHP study indicating robust exon 44 skipping across different muscle groups at 7 days following a single IV infusion.
- Preclinical data indicating prolonged splicing correction in the tibialis anterior, triceps and quadriceps, and amelioration of myotonia in a DM1 mouse model following a single dose on ENTR-701.
- Presented new preclinical data from Entrada’s DM1 program at the 7th Annual
Oligonucleotide and Precision Therapeutics (OPT) Congress inMarch 2022 that further support continued development of ENTR-701. - Reported confirmatory preclinical data from Entrada’s DMD program at the
Muscular Dystrophy Association (MDA) Clinical and Scientific Conference inMarch 2022 .
Upcoming Scientific Meetings
Entrada plans to present at two additional scientific meetings in
American Society of Gene andCell Therapy (ASGCT) 25th Annual Meeting
Title: Development of Endosomal Escape Vehicles to Enhance the Intracellular Delivery of Oligonucleotides
Poster Number: M-95
Session: Oligonucleotide Therapeutics I
Presenter:Leo Ziqing Qian , PhD, Co-Founder & Vice President,Discovery Research of Entrada
Date & Time:Monday, May 16 from 5:30 –6:30 p.m. ET
Location: Virtual and in-person inWashington , D.C.
- CureDuchenne 2022
FUTURES Conference
Session:Exon Skipping and Read Through Agents Panel
Presenter:Nerissa Kreher , MD, Chief Medical Officer of Entrada
Date & Time:Monday, May 28 from 1:55 –3:10 p.m. ET
Location: Virtual and in-person inOrlando, FL
First Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were
Research & Development (R&D) Expenses: R&D expenses for the first quarter of 2022 were
General & Administrative (G&A) Expenses: G&A expenses for the first quarter of 2022 were
Net Loss: Net loss for the first quarter of 2022 was
About
For more information about Entrada, please visit our website, www.entradatx.com, and follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Entrada’s strategy, future operations, prospects and plans, objectives of management, the continued development of ENTR-601-44, including the Investigational New Drug (IND) application-enabling studies, the timing of Entrada’s planned regulatory filings regarding its development programs, expectations regarding the preclinical data of ENTR-601-44 and ENTR-701 and the related potential for development, the progression of early-stage oligonucleotide, antibody and enzyme-based programs into clinical development, the continued development and advancement of ENTR-601-44 for the treatment of DMD and ENTR-701 for the treatment of DM1, the potential therapeutic benefits of its EEV candidates, and the sufficiency of its cash resources, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Entrada may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies; the timing of and Entrada’s ability to submit and obtain regulatory clearance for IND applications and initiate clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether Entrada’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties associated with the impact of the ongoing COVID-19 pandemic on Entrada’s business and operations; as well as the risks and uncertainties identified in Entrada’s filings with the
ENTRADA THERAPEUTICS, INC. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) | |||||||
Three Months Ended | |||||||
2022 | 2021 | ||||||
Operating expenses: | |||||||
Research and development | $ | 15,718 | $ | 6,223 | |||
General and administrative | 6,433 | 2,170 | |||||
Total operating expenses | 22,151 | 8,393 | |||||
Loss from operations | (22,151 | ) | (8,393 | ) | |||
Other income: | |||||||
Interest and other income, net | 480 | 13 | |||||
Total other income, net | 480 | 13 | |||||
Net loss | $ | (21,671 | ) | $ | (8,380 | ) | |
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.69 | ) | $ | (6.67 | ) | |
Weighted-average common shares outstanding, basic and diluted | 31,246,916 | 1,256,487 |
ENTRADA THERAPEUTICS, INC. Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands) | |||||
2022 | 2021 | ||||
Cash and cash equivalents | $ | 84,640 | $ | 291,064 | |
Marketable securities | 179,262 | — | |||
Total assets | 316,702 | 305,833 | |||
Total liabilities | 39,311 | 7,115 | |||
Total stockholders’ equity | 277,391 | 298,718 |
Investor and Media Contact
VP, Corporate Communications and Investor Relations
kmacdonald@entradatx.com
Source:
2022 GlobeNewswire, Inc., source