Inozyme Pharma, Inc. Stock Price, News & Analysis

Inozyme Pharma has announced changes to its Scientific Advisory Board (SAB), welcoming three experts in vascular calcification and renal disease: W Charles O’Neill IV, Jouni Uitto, and Paul B. Yu. David Thompson, former Chief Scientific Officer, joins the SAB as well. The transition follows the departure of three members, aiming to strengthen the company's focus on rare diseases linked to mineralization abnormalities. The new appointees bring valuable expertise that will aid Inozyme in its research and development efforts.

Inozyme Pharma, Inc. (Nasdaq: INZY) received Orphan Drug Designation from the FDA for INZ-701, targeting ABCC6 deficiency. The company plans to initiate Phase 1/2 trials for both ENPP1 and ABCC6 deficiencies in 2021. As of December 31, 2020, cash reserves stood at $159.9 million, projected to fund operations into the second half of 2022. R&D expenses increased significantly to $46.5 million, driven by asset acquisitions and clinical preparations. The net loss reported was $56.4 million, translating to a loss of $5.11 per share.

Inozyme Pharma announces the feature of ENPP1 deficiency on The Balancing Act® to raise awareness about this rare, life-threatening disease with no approved treatments. The episode, airing on March 15 and March 24, 2021, will include personal stories from patients and medical professionals. The ENPP1 gene is vital for regulating mineralization and its deficiency can lead to severe health issues, especially in infants. Inozyme aims to develop therapies for these conditions, emphasizing the need for early diagnosis and proper treatment.

Inozyme Pharma (Nasdaq: INZY) announced the appointment of Dr. Deborah Wenkert as Senior Vice President and Chief Medical Officer, effective February 2, 2021. With over 20 years of experience in pediatric rheumatology and metabolic bone disorders, Dr. Wenkert will lead clinical development programs and scientific communications. She succeeds Dr. Pedro Huertas, who has left the position. Dr. Wenkert has previously held significant roles at PreciThera and Amgen, enhancing her qualifications for the new role as Inozyme advances its clinical trials for rare bone diseases, specifically ENPP1 and ABCC6 deficiencies.

Inozyme Pharma (Nasdaq: INZY) announced regulatory approvals for its investigational drug INZ-701, targeting ENPP1 deficiency. The U.S. FDA cleared its IND application, while the UK MHRA authorized its Clinical Trial Application for a Phase 1/2 trial. The company plans to enroll its first subject in H1 2021 and provide preliminary safety data in H2 2021. The trial aims to assess safety, tolerability, and pharmacokinetics of INZ-701, with a multi-center approach involving nine subjects across three dose cohorts.

Inozyme Pharma submitted a Clinical Trial Application for INZ-701 to treat ENPP1 deficiency, receiving both Rare Pediatric Disease and Fast Track Designations from the FDA. The company aims to initiate Phase 1/2 trials in H1 2021. Financially, Inozyme reported a net loss of $28.1 million for Q3 2020, increasing from $4.0 million in Q3 2019. R&D expenses surged to $25.2 million, attributed to a non-recurring acquisition and rising employee costs. Cash reserves stood at $171.7 million, expected to sustain operations into H2 2022.

Inozyme Pharma (Nasdaq: INZY) announced the appointment of Dr. Kevin B. Johnson as senior vice president of regulatory affairs. Dr. Johnson, who has over 25 years of experience in global regulatory strategies for rare diseases, will spearhead Inozyme's regulatory initiatives. His previous roles include senior vice president at Magenta Therapeutics and head of regulatory affairs at IMARA Inc., where he achieved key designations for orphan diseases. Inozyme focuses on developing treatments for rare metabolic diseases linked to mineralization disorders, particularly targeting ENPP1 and ABCC6 deficiencies.

Inozyme Pharma (Nasdaq: INZY) announced the appointment of Yves Sabbagh, Ph.D., as the new senior vice president and chief scientific officer, marking a significant leadership change. Dr. Sabbagh brings over 20 years of experience in rare genetic disorders and mineral metabolism. He will focus on expanding Inozyme's proprietary pipeline. The company also confirmed the retirement of former CSO David Thompson, who will transition to a senior advisor role. Inozyme plans to enhance its R&D capabilities with new laboratory space in Boston.

Inozyme Pharma reported its Q2 2020 financial results, highlighting an upsized IPO that raised $128.8 million in July 2020. The company submitted its first IND for INZ-701 for treating ENPP1 deficiency, but the FDA placed the clinical trial on hold pending toxicity study reports. They expect trials to begin in early 2021. Cash reserves increased to $63.9 million by June 30, 2020, bolstered by IPO proceeds. R&D expenses rose to $7.9 million, reflecting intensified development activities. The net loss amounted to $9.5 million for the quarter.