FORWARD LOOKING STATEMENTSThis Quarterly Report on Form10-Qof Magenta Therapeutics, Inc. (the "Company") contains or incorporatesstatements that constitute forward-looking statements within the meaning of thefederal securities laws. Any express or implied statements that do not relate tohistorical or current facts or matters are forward-looking statements. In somecases, you can identify forward-looking statements by terminology such as "may,""will," "could," "should," "expects," "intends," "plans," "anticipates,""believes," "estimates," "predicts," "projects," "seeks," "endeavor,""potential," "continue" or the negative of these terms or other comparableterminology. Forward-looking statements appear in a number of places in thisQuarterly Report on Form10-Qand include, but are not limited to, statements about: the initiation, timing and success of clinical trials of MGTA-145, MGTA-117 and any other product candidates; the outcomes of our preclinical studies; our ability to commence and enroll patients in our clinical trials at the pace that we project; whether the results of our trials will be sufficient to support domestic or foreign regulatory approvals for MGTA-145, MGTA-117 or any other product candidates we may develop; our ability to establish clinical programs moving forward in multiple indications, with a rapidly advancing portfolio and sustainable platform; regulatory actions with respect to our product candidates or our competitors' products and product candidates our ability to obtain, including on an expedited basis, and maintain regulatory approval of MGTA-145, MGTA-117 or any other product candidates we may develop; the level of expenses related to any of our product candidates or clinical development programs; our expectation that our existing capital resources will be sufficient to enable us to fund our planned development of MGTA-145, MGTA-117 and any other product candidates we may identify and pursue; the benefits of the use of MGTA-145, MGTA-117 or any other product candidate, if approved; our ability to successfully commercialize MGTA-145, MGTA-117 or any other product candidates we may identify and pursue, if approved; our ability to successfully find collaborators for E478 or any of our current and future programs and product candidates; the rate and degree of market acceptance of MGTA-145, MGTA-117 or any other product candidates we may identify and pursue; our ability to obtain orphan drug designation for any of our product candidates we may identify and pursue; our expectations regarding government and third-party payor coverage and reimbursement; our ability to manufacture MGTA-145, MGTA-117 or any other product candidate in conformity with the U.S. Food and Drug Administration's requirements and to scale up manufacturing of our product candidates to commercial scale, if approved; our ability to successfully build a specialty sales force and commercial infrastructure; our ability to compete with companies currently producing or engaged in the clinical development of treatments for the disease indications that we pursue and treatment modalities that we develop; our reliance on third parties to conduct our clinical trials; our reliance on third-party contract manufacturers to manufacture and supply our product candidates for us; our ability to retain and recruit key personnel; our ability to obtain and maintain intellectual property protection for MGTA-145, MGTA-117 or any other product candidates we may identify and pursue; 18
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We expense research and development costs to operations as incurred. Advancepayments for goods or services to be received in the future for use in researchand development activities are recorded as prepaid expenses. The prepaid amountsare expensed as the related goods are delivered or the services are performed.Our direct research and development expenses are tracked on aprogram-by-programbasis and consist primarily of external costs, such as fees paid to consultants,central laboratories, contractors, CMOs and CROs in connection with ourpreclinical and clinical development activities. We do not allocate employeecosts, costs associated with our platform technology or facility expenses,including depreciation or other indirect costs, to specific product developmentprograms because these costs are deployed across multiple product developmentprograms and, as such, are not separately classified.The successful development and commercialization of our product candidates ishighly uncertain. This is due to the numerous risks and uncertainties, includingthe following:
A change in the outcome of any of these variables with respect to thedevelopment of any of our product candidates would significantly change thecosts and timing associated with the development of that product candidate. Wemay never succeed in obtaining regulatory approval for any of our productcandidates.Research and development activities are central to our business model. Productcandidates in later stages of clinical development generally have higherdevelopment costs than those in earlier stages of clinical development,primarily due to the increased size and duration of later-stage clinical trials.We expect research and development costs to increase significantly for theforeseeable future as our product candidate development programs progress.However, we do not believe that it is possible at this time to accuratelyproject total program-specific expenses through commercialization. There arenumerous factors associated with the successful commercialization of any of ourproduct candidates, including future trial design and various regulatoryrequirements, many of which cannot be determined with accuracy at this timebased on our stage of development. Additionally, future commercial andregulatory factors beyond our control will impact our clinical developmentprograms and plans.
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Accordingly, we believe the policies set forth above are critical to fullyunderstanding and evaluating our financial condition and results of operations.If actual results or events differ materially from the estimates, judgments andassumptions used by us in applying these policies, our reported financialcondition and results of operations could be materially affected.Results of OperationsComparison of the Three Months Ended September 30, 2021 and 2020The following table summarizes our results of operations for the three monthsended September 30, 2021 and 2020:
Operating expenses:Research and development $ 10,795 $ 11,786 $ (991 )General and administrative
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Direct research and development expenses by program:Conditioning
Unallocated expenses:Personnel related (including stock-based compensation) 4,886 3,704 1,182Consultant (including stock-based compensation)
Expenses related to our conditioning program decreased primarily due to adecrease in manufacturing costs as we completed our GMP manufacturing activitiesto support the submission of an IND and future clinical trials. Expenses relatedto our cell therapy program decreased primarily due to the discontinuance ofenrollment in our Phase 2 trial in inherited metabolic diseases in June 2020.The increase in personnel related costs was due primarily to an increase inheadcount in our research and development function and an increase instock-based compensation. Personnel related costs for the three months endedSeptember 30, 2021 and 2020 included stock-based compensation expense of$1.3 million and $0.7 million, respectively. The increase in facility relatedand other was primarily due to higher operating costs related to our Cambridge,Massachusetts facility.General and Administrative Expenses
Personnel related (including stock-based compensation) $ 4,213 $ 3,539 $ 674Professional and consultant
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Table of ContentsComparison of the Nine Months Ended September 30, 2021 and 2020The following table summarizes our results of operations for the nine monthsended September 30, 2021 and 2020:
Operating expenses:Research and development $ 33,652 $ 38,359 $ (4,707 )General and administrative 20,900 21,278 (378 )
Interest and other income, net 2,708 2,869 (161 )
Research and Development Expenses
Direct research and development expenses by program:Conditioning
Unallocated expenses:Personnel related (including stock-based compensation) 14,193 11,120 3,073Consultant (including stock-based compensation)
Expenses related to our conditioning program decreased primarily due to adecrease in manufacturing costs as we completed our GMP manufacturing activitiesto support the submission of an IND and future clinical trials. Expenses relatedto our cell therapy program decreased primarily due to the discontinuance ofenrollment in our Phase 2 trial in inherited metabolic diseases in June 2020.The increase in personnel related costs was due primarily to an increase inheadcount in our research and development function and an increase instock-based compensation. Personnel related costs for the nine months endedSeptember 30, 2021 and 2020 included stock-based compensation expense of$3.2 million and $2.2 million, respectively. The increase in facility relatedand other was primarily due to higher operating costs related to our Cambridge,Massachusetts facility.General and Administrative Expenses
Personnel related (including stock-based compensation) $ 10,508 $ 11,097 $ (589 )Professional and consultant
The decrease in professional and consultant costs was primarily due to lowerpatent related costs. The increase in facility related and other was primarilydue to higher operating costs related to our Cambridge, Massachusetts facilityand higher directors and officers' insurance.
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Net increase in cash, cash equivalents and restricted cash $ 99,387 $ 76,609
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