- On Track for Updates on pheEDIT and juMPStart Programs by Year-End -
- Strong Financial Position with Cash Runway into Fourth Quarter 2024 -
- Promoted Albert Seymour, Ph.D., to Chief Executive Officer Driving Clinical Trials and Genetic Medicines Platform Forward for Patients -
BEDFORD, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today financial results for the third quarter ended September 30, 2022, and highlighted recent accomplishments.
“We remain on track to provide an update from our pheEDIT and juMPStart clinical trials, including site initiations and enrollment status, by the end of this year,” said Albert Seymour, Ph.D., President and Chief Executive Officer of Homology Medicines. “With our recent pipeline prioritization, which included devoting resources to our ongoing clinical trials and select preclinical programs, Homology extended its cash runway into the fourth quarter of 2024 through key milestones across all programs. We continue to progress HMI-104, our lead GTx-mAb development candidate, through IND-enabling studies and believe that our optimized in vivo gene therapy development candidate for MLD, which has demonstrated the ability to cross the blood-brain-barrier following a single I.V. administration in preclinical studies, is differentiated from other approaches and makes it an attractive program for us to partner. Our work to bring first-in-class genetic medicine candidates forward for patients is ongoing, and we look forward to sharing our continued progress.”
Third Quarter 2022 and Recent Highlights
Third Quarter 2022 Financial Results
Upcoming Events
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 (AAVHSCs) vectors 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 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. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. 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; the potential of our gene therapy and gene editing platforms, including our GTx-mAb platform; our plans and timing for the release of additional preclinical and clinical data; our position as a leader in the development of genetic medicines; the sufficiency of our cash and cash equivalents to fund our operations; our plans to engage in future collaborations and strategic partnerships; and our participation in upcoming presentations and conferences. The words “believe,” “may,” “will,” “estimate,” “potential,” “continue,” “anticipate,” “intend,” “expect,” “could,” “would,” “project,” “plan,” “target,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. 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 regulatory approval process; interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; 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, including for the manufacture of materials for our research programs, preclinical and clinical studies; 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; securities class action litigation; failure to attract, retain and motivate qualified personnel; the possibility of system failures or security breaches; risks relating to intellectual property and significant costs incurred 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, 2022 and our other filings with the Securities and Exchange Commission 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, 2022 December 31, 2021Cash, cash equivalents and short-term investments$201,074 $155,873Assets held for sale — 28,907Equity method investment 27,132 —Property and equipment, net 1,415 2,252Right-of-use assets 20,900 15,607Other assets 12,130 9,082Total assets$262,651 $211,721 Accounts payable, accrued expenses and other liabilities$21,805 $13,772Operating lease liabilities 29,827 23,934Deferred revenue 1,958 4,364Stockholders' equity 209,061 169,651Total liabilities and stockholders' equity$262,651 $211,721HOMOLOGY 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, 2022
2021
2022
2021
Collaboration revenue$802 $1,677 $2,406 $33,169 Operating expenses: Research and development 25,854 23,987 71,202 69,439 General and administrative 7,810 8,351 29,991 26,054 Total operating expenses 33,664 32,338 101,193 95,493 Loss from operations (32,862) (30,661) (98,787) (62,324)Other income: Gain on sale of business - — 131,249 — Interest income 1,269 53 1,775 143 Total other income 1,269 53 133,024 143 Income (loss) before income taxes (31,593) (30,608) 34,237 (62,181)Benefit from (provision for) income taxes 46 — (816) — Loss from equity method investment (2,179) — (4,131) — Net income (loss)$(33,726) $(30,608) $29,290 $(62,181)Net income (loss) per share-basic$(0.59) $(0.54) $0.51 $(1.14)Net income (loss) per share-diluted$(0.59) $(0.54) $0.51 $(1.14)Weighted-average common shares outstanding-basic 57,447,192 57,106,639 57,372,399 54,704,410 Weighted-average common shares outstanding-diluted 57,447,192 57,106,639 57,901,298 54,704,410
Company Contacts
Theresa McNeely
Chief Communications Officer
and Patient Advocate
tmcneely@homologymedicines.com
781-301-7277 Media Contact:
Cara Mayfield
Vice President, Patient Advocacy
and Corporate Communications
cmayfield@homologymedicines.com
781-691-3510