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Progenity (Nasdaq: PROG) reported significant progress on its Preecludia preeclampsia rule-out test, demonstrating commercial readiness in a pre-validation study. Key systems, including laboratory processes and training, were verified for launch. Data from over 300 patient samples showed a sensitivity exceeding 87% and a negative predictive value above 97%, consistent with prior verification study results. The test aims to offer a superior alternative to conventional assessments, addressing the high maternal mortality associated with undiagnosed preeclampsia. A targeted commercial launch is expected in the second half of 2021.
Progenity has presented new data for its Preecludia preeclampsia rule-out test, showcasing 87.8% sensitivity and a 97.0% negative predictive value at the 2021 ACOG Annual Meeting. This breakthrough test targets the significant issue of diagnosing preeclampsia, which affects over 700,000 women annually in the U.S. The market opportunity is projected at $3 billion. Progenity aims to launch Preecludia in the second half of 2021 after completing clinical validation. The test could transform preeclampsia management, potentially improving patient outcomes and reducing healthcare costs.
On April 26, 2021, Progenity, a biotechnology company listed on Nasdaq under the symbol PROG, announced that two abstracts on its ingestible drug delivery technologies for gastrointestinal disorders were accepted for presentation at the Digestive Disease Week® (DDW) virtual meeting from May 21-23, 2021. The presentations include a focus on improving the efficacy and safety of treatments for intestinal inflammation and ulcerative colitis. Details on these findings will be available on Progenity's website after the conference.
Progenity, Inc. (Nasdaq: PROG) will present verification study data for its Preecludia™ rule-out test for preeclampsia at the ACOG Annual Clinical and Scientific Meeting from April 30 – May 2, 2021. The presentation, titled Performance of a novel multi-biomarker rule out preeclampsia test: a prospective verification study, will include contributions from noted authors such as Matthew Cooper, PhD. The virtual meeting will feature interactive ePosters, with the poster number being 999251. Details will be accessible on the Progenity website post-conference.
Progenity, Inc. (Nasdaq: PROG) has partnered with Ionis Pharmaceuticals to evaluate the safety and performance of its Oral Biotherapeutics Delivery System (OBDS) for oral delivery of antisense oligonucleotides. The OBDS is designed to enhance systemic drug delivery via an ingestible capsule. The collaboration aims to assess the OBDS in conjunction with Ionis' drugs in preclinical studies. Progenity is also working on its own oral therapeutics, including PGN-OB1 and PGN-OB2, expanding its pipeline into RNA-targeted biotherapeutics.
Progenity reported approximately 82,000 tests in Q4 2020, generating $14.3 million in revenue, down from $25.9 million in Q3. The company raised $118 million in December 2020 through equity offerings and private placements. Despite reduced test volumes due to COVID-19, Progenity maintained its 2021 revenue guidance. The company achieved key milestones in its innovation pipeline, including validation for its Preecludia™ test. However, it faced a net loss of $75.5 million for the quarter and a gross margin of -50.1%. The management emphasized efforts to stabilize and grow its core testing business.
Progenity, Inc. (NASDAQ: PROG) will release its fourth quarter and full year 2020 financial results on March 18, 2021, following market close. Management will hold a conference call at 4:30 p.m. ET to discuss the results and provide a corporate update. Investors can access the call by dialing 833-519-1237 (domestic) or 914-800-3810 (international) and entering the conference code 9677695. A live webcast and archived call will also be available on their website.
Progenity, Inc. (NASDAQ: PROG) announced a definitive securities purchase agreement with healthcare investment funds for a private placement, anticipated to generate gross proceeds of approximately $25 million. The deal involves issuing 4,370,629 shares of common stock and warrants at a price of $5.72 per unit. If exercised, these warrants could yield an additional $30 million. Progenity plans to use the net proceeds to support operations and invest in research and development initiatives. The placement is expected to close on February 25, 2021, pending customary conditions.
Progenity (Nasdaq: PROG) has initiated a clinical study to assess the safety and tolerability of its Drug Delivery System (DDS) capsule, aimed at treating ulcerative colitis. The study will use gamma scintigraphy to track the capsule's ability to deliver a payload accurately to the colon. Approximately 12 healthy volunteers will participate, with results expected in Q2 2021. The DDS technology aims to enhance drug delivery efficacy while minimizing side effects, potentially improving treatment outcomes for patients with GI diseases.
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