Homology Medicines Reports Third Quarter 2022 Financial Results and Recent Highlights - Yahoo Finance

- On Track for Updates connected 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 familial medicines company, announced contiguous fiscal results for the 3rd 4th ended September 30, 2022, and highlighted caller accomplishments.

“We stay connected way to supply an update from our pheEDIT and juMPStart objective trials, including tract initiations and enrollment status, by the extremity of this year,” said Albert Seymour, Ph.D., President and Chief Executive Officer of Homology Medicines. “With our caller pipeline prioritization, which included devoting resources to our ongoing objective trials and prime preclinical programs, Homology extended its currency runway into the 4th fourth of 2024 done cardinal milestones crossed each programs. We proceed to advancement HMI-104, our pb GTx-mAb improvement candidate, done IND-enabling studies and judge that our optimized in vivo cistron therapy improvement campaigner for MLD, which has demonstrated the quality to transverse the blood-brain-barrier pursuing a azygous I.V. medication successful preclinical studies, is differentiated from different approaches and makes it an charismatic programme for america to partner. Our enactment to bring first-in-class familial medicine candidates guardant for patients is ongoing, and we look guardant to sharing our continued progress.”

Third Quarter 2022 and Recent Highlights

• Announced a pipeline prioritization, which included shifting resources from the pheNIX cistron therapy proceedings evaluating HMI-102 for phenylketonuria (PKU) and pausing enrollment to absorption connected generating information from the pheEDIT objective proceedings that is evaluating in vivo gene editing campaigner HMI-103 for PKU. The mechanics of enactment of this cistron editing campaigner has the imaginable to dainty adults and yet pediatric patients.

• Continued to beforehand the juMPStart objective proceedings evaluating in vivo cistron therapy campaigner HMI-203 for MPS II, oregon Hunter syndrome. Homology remains connected way to supply an update connected enrollment and tract presumption for this proceedings and the pheEDIT proceedings by the extremity of this year.

• Continued to beforehand IND-enabling studies of HMI-104, a C5 antibody improvement campaigner for paroxysmal nocturnal hemoglobinuria (PNH), which utilizes the Company’s GTx-mAb level that has the imaginable to code larger marketplace indications.

• Announced volition to spouse the optimized in vivo cistron therapy campaigner HMI-204 for metachromatic leukodystrophy (MLD), which demonstrated the quality to transverse the blood-brain-barrier arsenic good arsenic scope the cardinal tense strategy and cardinal peripheral organs progressive successful MLD pursuing a azygous I.V. administration.

• Presented plan of the pheEDIT cistron editing proceedings for HMI-103 and supporting preclinical data, arsenic good arsenic information that demonstrated the usage of next-generation sequencing methods that tin pb to improved AAVHSC vector design, which were featured astatine the American Society of Human Genetics Meeting.

• Promoted Albert Seymour, Ph.D., to Chief Executive Officer of Homology and to the Board of Directors, succeeding Arthur Tzianabos, Ph.D., who served arsenic CEO and Board subordinate since 2016 and who was appointed Chair of the Board successful conjunction with this transition.

• Announced peer-reviewed work successful Scientific Reports, a Nature journal, connected the usage of long-read sequencing methods that could beryllium applied to further qualify Homology’s AAVHSCs and optimize vector design.

• Spoke alongside manufacture leaders connected panels focused connected innovations successful cistron editing and AAV manufacturing during the Cell & Gene Meeting connected the Mesa.

Third Quarter 2022 Financial Results

• As of September 30, 2022, Homology had astir $201.1 cardinal successful cash, currency equivalents and short-term investments. Based connected existent projections, Homology expects currency resources to money operations into the 4th fourth of 2024.

• Net nonaccomplishment for the 4th ended September 30, 2022 was $(33.7) cardinal oregon $(0.59) per share, compared to a nett nonaccomplishment of $(30.6) cardinal oregon $(0.54) per stock for the 4th ended September 30, 2021.

• Collaboration revenues for the 4th ended September 30, 2022 were $0.8 million, compared to $1.7 cardinal for the 4th ended September 30, 2021. Collaboration gross successful each play included deferred gross recognized nether Homology’s banal acquisition statement with Pfizer. Collaboration revenues for the 3rd 4th 2021 besides included the designation of deferred gross and reimbursement of R&D expenses nether the Company’s erstwhile collaboration with Novartis.

• Total operating expenses for the 4th ended September 30, 2022 were $33.7 million, compared to $32.3 cardinal for the 4th ended September 30, 2021, and consisted of probe and improvement expenses and wide and administrative expenses.

• Research and improvement expenses for the 4th ended September 30, 2022 were $25.9 million, compared to $24.0 cardinal for the 4th ended September 30, 2021. Research and improvement expenses accrued chiefly owed to accrued improvement costs for our ongoing HMI-103 and HMI-203 clinical-stage programs and earlier-stage programs. Partially offsetting these increases were little employee-related costs arsenic a effect of transferring employees to Oxford Biomedica Solutions, the AAV Innovation and Manufacturing Business that Homology established with Oxford Biomedica successful the archetypal 4th of 2022 successful bid to leverage its in-house manufacturing capabilities portion establishing a 20% involvement and preferred lawsuit presumption successful the caller business.

• General and administrative expenses for the 4th ended September 30, 2022 were $7.8 million, compared to $8.4 cardinal for the 4th ended September 30, 2021. General and administrative expenses decreased chiefly arsenic a effect of finance, quality resources, IT and ineligible services provided by the Company to OXB Solutions nether the transitional services statement that provided for these services to beryllium reimbursed, arsenic good arsenic decreased depreciation disbursal arsenic the Company’s leasehold improvements were transferred to Oxford Biomedica Solutions. Partially offsetting these decreases was an summation successful audit and ineligible fees.

Upcoming Events

• Stifel 2022 Healthcare Conference: November 15, 2022 astatine 4:10 p.m. ET – Fireside Chat

About Homology Medicines, Inc.
Homology Medicines, Inc. is simply a clinical-stage familial medicines institution dedicated to transforming the lives of patients suffering from uncommon diseases by addressing the underlying origin of the disease. The Company’s objective programs see HMI-102, an investigational cistron therapy for adults with phenylketonuria (PKU); HMI-103, a cistron editing campaigner for PKU; and HMI-203, an investigational cistron therapy for Hunter syndrome. Additional programs absorption connected metachromatic leukodystrophy (MLD), paroxysmal nocturnal hemoglobinuria (PNH) and different diseases. Homology’s proprietary level is designed to utilize its household of 15 quality hematopoietic stem cell-derived adeno-associated microorganism (AAVHSCs) vectors to precisely and efficiently present familial medicines in vivo done a cistron therapy oregon nuclease-free cistron editing modality, arsenic good arsenic to present one-time cistron therapy to nutrient antibodies passim the assemblage done the GTx-mAb platform. Homology has a absorption squad with a palmy way grounds of discovering, processing and commercializing therapeutics with a absorption connected uncommon diseases. Homology believes its archetypal objective information and compelling preclinical data, technological and merchandise improvement expertise and wide intelligence spot presumption the Company arsenic a person successful familial medicines. For much information, sojourn www.homologymedicines.com.

Forward-Looking Statements
This property merchandise contains forward-looking statements wrong the meaning of the Private Securities Litigation Reform Act of 1995. We mean specified forward-looking statements to beryllium covered by the harmless harbor provisions for forward-looking statements contained successful Section 27A of the Securities Act of 1933, arsenic amended and Section 21E of the Securities Exchange Act of 1934, arsenic amended. All statements contained successful this property merchandise that bash not subordinate to matters of humanities information should beryllium considered forward-looking statements, including without regulation statements regarding: our expectations surrounding the potential, safety, efficacy, and regulatory and objective advancement of our merchandise candidates; the imaginable of our cistron therapy and cistron editing platforms, including our GTx-mAb platform; our plans and timing for the merchandise of further preclinical and objective data; our presumption arsenic a person successful the improvement of familial medicines; the sufficiency of our currency and currency equivalents to money our operations; our plans to prosecute successful aboriginal collaborations and strategical partnerships; and our information successful upcoming presentations and conferences. The words “believe,” “may,” “will,” “estimate,” “potential,” “continue,” “anticipate,” “intend,” “expect,” “could,” “would,” “project,” “plan,” “target,” and akin expressions are intended to place forward-looking statements, though not each forward-looking statements usage these words oregon expressions. These statements are neither promises nor guarantees, but impact known and chartless risks, uncertainties and different important factors that whitethorn origin our existent results, show oregon achievements to beryllium materially antithetic from immoderate aboriginal results, show oregon achievements expressed oregon implied by the forward-looking statements, including, but not constricted to, the following: the interaction of the COVID-19 pandemic connected our concern and operations, including our preclinical studies and objective trials, and connected wide economical conditions; we person and expect to proceed to incur important losses; our request for further funding, which whitethorn not beryllium available; nonaccomplishment to place further merchandise candidates and make oregon commercialize marketable products; the aboriginal signifier of our improvement efforts; imaginable unforeseen events during objective trials could origin delays oregon different adverse consequences; risks relating to the regulatory support process; interim, topline and preliminary information whitethorn alteration arsenic much diligent information go available, and are taxable to audit and verification procedures that could effect successful worldly changes successful the last data; our merchandise candidates whitethorn origin superior adverse broadside effects; inability to support our collaborations, oregon the nonaccomplishment of these collaborations; our reliance connected 3rd parties, including for the manufacture of materials for our probe programs, preclinical and objective studies; nonaccomplishment to get U.S. oregon planetary selling approval; ongoing regulatory obligations; effects of important competition; unfavorable pricing regulations, third-party reimbursement practices oregon healthcare betterment initiatives; merchandise liability lawsuits; securities people enactment litigation; nonaccomplishment to attract, clasp and motivate qualified personnel; the anticipation of strategy failures oregon information breaches; risks relating to intelligence spot and important costs incurred arsenic a effect of operating arsenic a nationalist company. These and different important factors discussed nether the caption “Risk Factors” successful our Quarterly Report connected Form 10-Q for the 4th ended September 30, 2022 and our different filings with the Securities and Exchange Commission could origin existent results to disagree materially from those indicated by the forward-looking statements made successful this property release. Any specified forward-looking statements correspond management’s estimates arsenic of the day of this property release. While we whitethorn elite to update specified forward-looking statements astatine immoderate constituent successful the future, we disclaim immoderate work to bash so, adjacent if consequent events origin our views to change.

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