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Progenity, Inc. (Nasdaq: PROG) announced a definitive securities purchase agreement with healthcare investment funds, aiming to raise approximately $40 million through a private placement. This involves issuing units of 16,194,332 shares of common stock and corresponding warrants at a unit price of $2.47. The warrants, exercisable at $2.84, could yield an additional $46 million if exercised. The proceeds will support Progenity's operations, molecular testing R&D, and general corporate purposes. Closing is anticipated on June 14, 2021, pending customary conditions.
Progenity, Inc. (NASDAQ: PROG) announced a strategic transformation aimed at reducing annual operational capital requirements by approximately 70%, from over $180 million to around $50 million. This includes discontinuing genetic lab services and laying off about 374 employees (56% of its workforce), expected to save $130 million in SG&A. The company will focus on its R&D pipeline, particularly the Preecludia test, gastrointestinal health products, and oral biopharmaceuticals. Additionally, it seeks non-dilutive funding through strategic partnerships, while withdrawing its 2021 financial guidance.
Progenity, Inc. (Nasdaq: PROG) announced significant findings from a preclinical study of PGN-001, a locally delivered adalimumab drug substance, showing potential for treating colitis. The study revealed that PGN-001 effectively reduces TNF-α in colonic tissue with minimal systemic exposure. Conducted in swine, the study confirmed tolerability and pharmacokinetics while also indicating no adverse events. The results bolster Progenity's Targeted Therapeutics program, with further clinical studies underway. The potential market for these therapies is estimated at $15 billion.
Progenity, Inc. (Nasdaq: PROG) announced the appointment of Sean Lavin, M.D. as Vice President of Business Development, Strategy, and Investor Relations. Dr. Lavin aims to enhance shareholder value by focusing on biotech innovation and strategic outreach. He brings extensive experience from BTIG and Lazard Capital Markets. The company’s Preecludia™ test for preeclampsia and a targeted therapeutics program for inflammatory bowel diseases were highlighted as key innovations that could significantly impact patient care and medical practices.
Progenity, Inc. (Nasdaq: PROG) announced two presentations at the 2021 Digestive Disease Week® (DDW) Virtual Event concerning its Targeted Therapeutics program. One study evaluated PGN-600, a liquid tofacitinib product candidate, for treating intestinal inflammation. Results indicated intra-cecal delivery could achieve drug concentrations with lower doses and reduced systemic exposure. The second study introduced an investigational Drug Delivery System (DDS), designed for targeted treatment of ulcerative colitis, showing promising preclinical results for drug delivery within the gastrointestinal tract.
Progenity (Nasdaq: PROG) is raising awareness about preeclampsia on World Preeclampsia Day. This condition, a leading cause of maternal mortality, often goes unrecognized due to common symptoms, affecting nearly 30% of pregnant women in the U.S. To aid education, Progenity launched two resources aimed at enhancing discussions between patients and physicians.
Additionally, Progenity's Preecludia™ test, currently in final validation, aims to better assess preeclampsia risk, marking a significant advancement in diagnostic tools.
Progenity reports Q1 2021 revenues of $24.5 million, a 72% increase from the previous quarter. The Preecludia™ test shows promising pre-validation data with a sensitivity of 87.8% and a negative predictive value of 97.0%. The company has secured funding from the Crohn’s and Colitis Foundation to advance its oral DDS for IBD. Despite operational challenges, Progenity anticipates growth in its molecular testing business and aims for a commercial launch in H2 2021 targeting a $2-3 billion market.
Progenity announced promising preliminary results on its Drug Delivery System (DDS) and PGN-600 from two studies on May 12, 2021. The DDS demonstrated accurate targeting and safety in a clinical study involving healthy adults, showing effective delivery to the proximal colon. In a preclinical study, PGN-600 was well-tolerated in dogs, achieving significantly higher tofacitinib concentrations in colon tissue compared to standard formulations, with reduced systemic exposure. These findings suggest enhanced therapeutic efficacy for treating ulcerative colitis and Crohn’s disease.
Progenity, Inc. (Nasdaq: PROG) announced funding from the Crohn’s & Colitis Foundation’s IBD Ventures program for its innovative oral Drug Delivery System (DDS) aimed at treating inflammatory bowel disease (IBD). The DDS capsule is designed to enhance the efficacy of IBD treatments by delivering therapeutics directly to targeted areas in the gastrointestinal tract. This funding will support further development and clinical studies of the DDS and Progenity’s therapeutic candidates, including PGN-001 and PGN-600, intended to improve treatment outcomes for conditions like ulcerative colitis.
Progenity, Inc. (NASDAQ: PROG) will report its first quarter 2021 financial results on May 13, 2021, after market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide corporate updates. Progenity specializes in the development and commercialization of molecular testing products aimed at improving patient outcomes through precision medicine. The company uses a multi-omics approach in its testing and investigational device development, focusing on enhancing diagnostics and targeted therapies.
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