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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Homology Medicines Inc | NASDAQ:FIXX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.9347 | 0.8911 | 0.9293 | 0 | 01:00:00 |
“We realized our goal to have three clinical programs underway this year by moving our gene editing candidate for PKU and gene therapy for Hunter syndrome into the clinic, both evaluating first-of-a-kind approaches for these diseases,” stated Arthur Tzianabos, Ph.D., President and CEO of Homology Medicines. “We have always planned to develop two solutions for people living with PKU, first with our ongoing pheNIX gene therapy trial in adults and now with our gene editing trial, which is focused initially on adults and then pediatric patients over time. In addition, our gene therapy program for patients with Hunter syndrome plans to evaluate a much needed one-time therapy designed to address both peripheral organ and cognitive manifestations of this disease with an I.V. infusion.”
Dr. Tzianabos added, “We continue to benefit from our internal commercial GMP manufacturing platform, as this fully integrated ‘plug and play’ capability has now delivered product for three successful INDs, including our first gene editing product candidate. Confidence in our AAVHSC technology and the team’s ability to develop genetic medicines builds as multiple programs have entered the clinic and is reflected in our recent commitment to expand our headquarters in support of continued growth and success.”Third Quarter 2021 and Recent Accomplishments
Third Quarter 2021 Financial Results
Upcoming Event
About Homology Medicines, Inc. Homology Medicines, Inc. is a clinical-stage genetic medicines company dedicated to transforming the lives of patients suffering from rare diseases by addressing the underlying cause of the disease. The Company’s clinical programs include HMI-102, an investigational gene therapy for adults with phenylketonuria (PKU); HMI-103, a gene editing candidate for PKU; and HMI-203, an investigational gene therapy for Hunter syndrome. Additional programs focus on metachromatic leukodystrophy (MLD), paroxysmal nocturnal hemoglobinuria (PNH) and other diseases. Homology’s proprietary platform is designed to utilize its family of 15 human hematopoietic stem cell-derived adeno-associated virus vectors (AAVHSCs) to precisely and efficiently deliver genetic medicines in vivo through a gene therapy or nuclease-free gene editing modality, as well as to deliver one-time gene therapy to produce antibodies throughout the body through the GTx-mAb platform. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a focus on rare diseases. Homology believes its initial clinical data and compelling preclinical data, scientific and product development expertise, internal manufacturing capabilities and broad intellectual property position the Company as a leader in genetic medicines. For more information, visit www.homologymedicines.com.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of our product candidates; our plans to name a development candidate in a new therapeutic area and potential thereof; plans and timing for the release of additional preclinical and clinical data; our beliefs regarding our manufacturing capabilities; our position as a leader in the development of genetic medicines; the sufficiency of our cash and cash equivalents to fund our operations; and our participation in upcoming presentations and conferences. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies and clinical trials, and on general economic conditions; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of our development efforts; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the capabilities of our manufacturing facility; risks relating to the regulatory approval process; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; failure to obtain U.S. or international marketing approval; ongoing regulatory obligations; effects of significant competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to attract, retain and motivate qualified personnel; the possibility of system failures or security breaches; risks relating to intellectual property and significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
- Financial Tables Follow -
HOMOLOGY MEDICINES, INC. | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(in thousands) | |||||||
(Unaudited) | |||||||
As of | |||||||
September 30, 2021 | December 31, 2020 | ||||||
Cash, cash equivalents and short-term investments | $ | 187,551 | $ | 217,431 | |||
Property and equipment, net | 32,697 | 37,002 | |||||
Right-of-use assets | 5,028 | 5,897 | |||||
Other assets | 5,540 | 3,407 | |||||
Total assets | $ | 230,816 | $ | 263,737 | |||
Accounts payable, accrued expenses and other liabilities | $ | 13,538 | $ | 14,525 | |||
Operating lease liabilities | 13,541 | 15,442 | |||||
Deferred revenue | 5,166 | 37,775 | |||||
Stockholders' equity | 198,571 | 195,995 | |||||
Total liabilities and stockholders' equity | $ | 230,816 | $ | 263,737 | |||
HOMOLOGY MEDICINES, INC. | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Collaboration revenue | $ | 1,677 | $ | 567 | $ | 33,169 | $ | 1,722 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 23,987 | 20,417 | 69,439 | 77,197 | ||||||||||||
General and administrative | 8,351 | 8,423 | 26,054 | 24,986 | ||||||||||||
Total operating expenses | 32,338 | 28,840 | 95,493 | 102,183 | ||||||||||||
Loss from operations | (30,661 | ) | (28,273 | ) | (62,324 | ) | (100,461 | ) | ||||||||
Other income: | ||||||||||||||||
Interest income | 53 | 41 | 143 | 1,558 | ||||||||||||
Total other income | 53 | 41 | 143 | 1,558 | ||||||||||||
Net loss | $ | (30,608 | ) | $ | (28,232 | ) | $ | (62,181 | ) | $ | (98,903 | ) | ||||
Net loss per share-basic and diluted | $ | (0.54 | ) | $ | (0.62 | ) | $ | (1.14 | ) | $ | (2.19 | ) | ||||
Weighted-average common shares outstanding-basic and diluted | 57,106,639 | 45,227,231 | 54,704,410 | 45,196,459 | ||||||||||||
Company ContactsTheresa McNeelyChief Communications Officer and Patient Advocatetmcneely@homologymedicines.com781-301-7277
Media Contact:Cara Mayfield Vice President, Patient Advocacy and Corporate Communications cmayfield@homologymedicines.com781-691-3510
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