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Q32 Bio Inc.(QTTB) - 2023 Q2 - Quarterly Report
2023-08-14 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-38433 Homology Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) De ...
Q32 Bio Inc.(QTTB) - 2023 Q1 - Quarterly Report
2023-05-11 20:00
Financial Performance - Net loss for Q1 2023 was $28,844,000, compared to a net income of $92,105,000 in Q1 2022, reflecting a significant change in financial performance[13]. - Loss from operations for Q1 2023 was $27,511,000, compared to a loss of $37,618,000 in Q1 2022, indicating an improvement of about 27%[13]. - For the three months ended March 31, 2023, the company reported a net loss of $28.8 million compared to a net income of $92.1 million for the same period in 2022[20]. - The company incurred a loss from operations of $28.8 million during the three months ended March 31, 2023, and has an accumulated deficit of $458.0 million as of the same date[26]. - The accumulated deficit increased to $457,981,000 as of March 31, 2023, from $429,137,000 at the end of 2022[11]. Revenue and Expenses - Collaboration revenue for the three months ended March 31, 2023, was $802,000, consistent with the same period in 2022[13]. - Total operating expenses decreased to $28,313,000 in Q1 2023 from $38,420,000 in Q1 2022, representing a reduction of approximately 26%[13]. - Research and development expenses for Q1 2023 were $19,988,000, down from $24,273,000 in Q1 2022, a decrease of approximately 18%[13]. - General and administrative expenses also decreased to $8,325,000 in Q1 2023 from $14,147,000 in Q1 2022, a reduction of about 41%[13]. - The company did not generate any revenue from product sales and does not expect to do so in the foreseeable future[26]. Cash Flow and Liquidity - Cash and cash equivalents decreased to $39.5 million as of March 31, 2023, down from $248.4 million at the end of the same period in 2022[36]. - The company recorded a net cash used in operating activities of $26.1 million for the three months ended March 31, 2023, compared to $30.7 million for the same period in 2022[20]. - The company provided $31.4 million in net cash from investing activities during the three months ended March 31, 2023, compared to $168.3 million in the same period in 2022[20]. - As of March 31, 2023, the company believes its cash and cash equivalents will enable it to continue operations for at least one year[27]. - The company expects to incur additional operating losses and negative operating cash flows for the foreseeable future[26]. Stockholders' Equity and Investments - Total stockholders' equity decreased to $151,899,000 as of March 31, 2023, down from $177,978,000 at the end of 2022[11]. - The Company’s total short-term investments amounted to $110.571 million, with $31.297 million in commercial paper, $57.202 million in US Treasury securities, and $22.072 million in corporate debt securities[63]. - The company has filed a Registration Statement for the registration of up to $250.0 million of its common stock, with $75.0 million available for sale under an "at-the-market" offering[24]. - The company recorded a gain of $131.2 million on the sale of its manufacturing business, with cash received amounting to $130.0 million and a fair value of equity method investment at $31.2 million[80]. Lease and Operating Costs - Operating lease costs for the three months ended March 31, 2023, were $1.1 million, compared to $0.9 million for the same period in 2022[88]. - The company has a noncancelable operating lease for approximately 67,000 square feet, with an initial annual base rent of $39.50 per square foot, increasing by three percent annually[83]. - Total undiscounted lease payments amount to $43.646 million, with a present value of operating lease liabilities at $29.101 million[89]. - Cash paid for lease liabilities in Q1 2023 was $1.101 million, an increase from $0.877 million in Q1 2022[91]. Risks and Future Outlook - The company anticipates continued losses for the foreseeable future and will require additional capital to fund operations[6]. - The company is heavily dependent on the success of its product candidates, with no history of commercializing genetic medicine products, which poses significant risks[6]. - The company does not believe inflation has materially affected its financial condition as of March 31, 2023, but acknowledges potential future impacts on expenses[204]. Stock-Based Compensation - The Company recorded stock-based compensation expense of $2.369 million in Q1 2023, down from $4.051 million in Q1 2022[106]. - The Company expects to recognize $15.8 million of unrecognized compensation expense related to unvested share-based compensation over approximately 2.7 years[106]. - The fair value of stock options granted in Q1 2023 was estimated at $1.06 per share, compared to $1.78 in Q1 2022[101]. - The total intrinsic value of options exercised during Q1 2022 was insignificant, with no options exercised in Q1 2023[101]. Collaboration and Agreements - Under the Supply Agreement with OXB Solutions, the company is committed to purchase approximately $29.7 million worth of AAV-based products in 2023[117]. - The company recorded purchases from OXB Solutions of $4.9 million for drug substance and $1.2 million for process development services during the three months ended March 31, 2023[118]. - The exclusive right of first refusal (ROFR) granted to Pfizer for collaboration on HMI-102 and HMI-103 expired on May 9, 2023[111].
Q32 Bio Inc.(QTTB) - 2022 Q4 - Annual Report
2023-03-09 21:01
Clinical Trials and Product Development - The company has initiated a Phase 1 clinical trial for HMI-103, its lead gene editing candidate for classical PKU, with the first participant dosed in January 2023 and additional patients being screened across ten active sites[10]. - The HMI-103 trial is expected to enroll up to nine patients aged 18-55, with initial data anticipated by mid-2023, focusing on safety and serum phenylalanine changes[11]. - HMI-203, an investigational gene therapy for Hunter syndrome, is currently in a Phase 1 trial with initial data expected in the second half of 2023, targeting nine male patients aged 18-45[13]. - The company paused enrollment in the HMI-102 trial to prioritize the HMI-103 trial, despite observing biologic activity in the former[14]. - HMI-204 is an optimized gene therapy candidate for MLD, with IND-enabling studies completed and the company seeking a partner for advancement[86]. - The company has initiated a Phase 1 trial with HMI-103 for the treatment of classical PKU, with additional patients being screened across ten active clinical trial sites[36]. - The company plans to enroll younger patients in subsequent HMI-103 clinical trials if positive safety and efficacy results are established in adults[11]. - HMI-203 showed robust biodistribution and significant reductions in heparan sulfate GAG levels in multiple organs in preclinical studies[13]. Financial Overview and Capital Requirements - The company anticipates continued losses for the foreseeable future and will require additional capital to fund operations, which may impact its ability to commercialize product candidates[8]. - The company has raised approximately $721 million in aggregate net proceeds since its inception, including $130.0 million from the Oxford agreement[22]. - The company has incurred significant losses since inception and expects to continue incurring losses for the foreseeable future[8]. - The company requires additional capital to fund operations and may not be able to complete the development and commercialization of its product candidates if financing is not obtained[8]. Regulatory and Compliance Challenges - The regulatory approval processes for its product candidates are lengthy and unpredictable, posing a risk to the company's business[8]. - The FDA approval process for biological products requires extensive regulatory compliance, including preclinical and clinical trials, and submission of a Biologics License Application (BLA)[119]. - The company must navigate various regulatory requirements and may incur substantial time and financial resources in obtaining approvals[119]. - The FDA reviews Biologics License Applications (BLAs) to ensure products are safe, pure, potent, and effective, typically adding approximately two months to the review timeline[129]. - Orphan drug designation can be granted for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S., providing financial incentives such as grant funding and tax advantages[130]. Intellectual Property and Competitive Landscape - The company has a robust intellectual property portfolio with issued patents for its family of 15 AAVHSCs, which is considered a strategic asset[22]. - The company has exclusive worldwide rights to its technologies, including 15 issued composition of matter patents in the United States for its novel AAVHSCs[37]. - The company has entered into a license agreement with Caltech, paying an initial licensing fee of $100,000 and up to $7.2 million in milestone payments for the first licensed product[115]. - The company relies on a combination of patents, trade secrets, and confidentiality agreements to protect its intellectual property[106]. - The company faces competition from major pharmaceutical and biotechnology companies, academic institutions, and research institutions, with potential competitors including American Gene Technologies and BioMarin[103]. Manufacturing and Supply Chain - The company relies on third-party manufacturers, which increases the risk of supply issues that could delay development or commercialization efforts[8]. - The company closed a transaction with Oxford Biomedica Solutions, resulting in the transfer of assets primarily used for AAV vector manufacturing in exchange for 175,000 common equity units[18]. - The manufacturing strategy utilizes HEK293 cells, ensuring scalability and regulatory familiarity[99]. - The manufacturing capabilities established with Oxford are designed to support the pipeline programs while reducing costs and maintaining quality[37]. Gene Therapy and Technology Platforms - The company focuses on monogenic diseases, utilizing gene therapy and gene editing approaches to address these conditions[23]. - The proprietary AAVHSC platform enables nuclease-free gene editing, which is believed to provide improved safety and efficacy compared to traditional methods[31]. - The AAVHSC platform allows for high-efficiency gene editing without the use of nucleases, simplifying the manufacturing and delivery of therapeutic candidates[33]. - The AAVHSCs demonstrate gene integration efficiencies believed to be in therapeutic ranges, significantly higher than both nuclease-based and other AAV-based approaches[31]. - The AAVHSC technology allows for targeting multiple tissues, including the liver, CNS, and muscle, with a single intravenous administration[49]. Market and Treatment Landscape - The incidence of PKU in the U.S. is estimated at one in 12,707, translating to approximately 350 new cases annually[60]. - Current treatments for PKU, such as Kuvan and Palynziq, do not address the underlying genetic defect, with Kuvan sales at approximately $228 million and Palynziq at $255 million in 2022[64][67]. - The gene integration approach aims to restore PAH activity to 10% or more of normal levels, potentially normalizing serum Phe levels and improving patient quality of life[68]. - Approximately 80% of individuals lack pre-existing neutralizing antibodies against AAVHSCs, enhancing the potential patient pool for gene therapies[57]. - The company is focused on developing product candidates for monogenic diseases with significant unmet medical needs, particularly in the liver, CNS, and peripheral tissues[34].
Q32 Bio Inc.(QTTB) - 2022 Q3 - Quarterly Report
2022-11-10 21:01
Financial Performance - Total current assets increased to $213,204,000 as of September 30, 2022, compared to $191,909,000 as of December 31, 2021, representing a growth of 11.5%[17] - Collaboration revenue for the three months ended September 30, 2022, was $802,000, a decrease of 52.2% from $1,677,000 in the same period of 2021[19] - The net loss for the three months ended September 30, 2022, was $33,726,000, compared to a net loss of $30,608,000 for the same period in 2021, reflecting a 10.3% increase in losses[19] - The company reported a comprehensive loss of $34,142,000 for the three months ended September 30, 2022, compared to a comprehensive loss of $30,615,000 for the same period in 2021[23] - For the nine months ended September 30, 2022, the company recorded a net income of $29.3 million, primarily due to a gain from the transaction with Oxford Biomedica[38] - The company reported a net cash used in operating activities of $86.5 million for the nine months ended September 30, 2022, compared to $79.3 million for the same period in 2021[30] - The company expects to incur additional operating losses and negative operating cash flows for the foreseeable future[38] - The company has not generated any revenue from product sales and does not expect to do so in the near future[38] Assets and Liabilities - Cash and cash equivalents decreased to $43,162,000 as of September 30, 2022, from $108,382,000 as of December 31, 2021, indicating a decline of 60.2%[17] - Total liabilities increased to $53,590,000 as of September 30, 2022, compared to $42,070,000 as of December 31, 2021, marking a rise of 27.4%[17] - Stockholders' equity rose to $209,061,000 as of September 30, 2022, from $169,651,000 as of December 31, 2021, an increase of 23.2%[17] - As of September 30, 2022, the company had an accumulated deficit of $394.8 million[38] - The company’s total financial assets amounted to $201.074 million as of September 30, 2022, including cash equivalents of $43.162 million and short-term investments of $157.912 million[76] Revenue and Expenses - Total operating expenses for the nine months ended September 30, 2022, were $101,193,000, up 5.8% from $95,493,000 in the same period of 2021[19] - The company’s stock-based compensation expense for the nine months ended September 30, 2022, was $9.965 million, compared to $12.582 million in 2021[30] - The Company reported operating lease costs of $2.826 million for the nine months ended September 30, 2022, compared to $1.869 million for the same period in 2021, reflecting a year-over-year increase of approximately 51.1%[94] - Research and development expenses for the three months ended September 30, 2022, increased by $1.87 million to $25.85 million compared to $23.99 million in 2021[191] - General and administrative expenses decreased by $541,000 to $7.81 million for the three months ended September 30, 2022[191] Investments and Financing - The company completed a transaction with Oxford Biomedica, receiving $130 million in upfront cash and retaining a 20% ownership interest in the new company[35] - The Company recorded a gain of $131.249 million on the sale of its manufacturing business, with cash received amounting to $130 million and a fair value of equity method investment at $31.223 million[86] - The company has raised approximately $721 million since its inception in 2015, including $130.0 million from the Oxford transaction[158] - The company has $148.4 million of common stock available for sale under its at-the-market offerings as of September 30, 2022[37] - The company entered into a sales agreement in March 2020 to issue and sell common stock with an aggregate value of up to $150 million under the ATM program[215] Clinical Development - The Company is developing multiple clinical-stage product candidates, including HMI-103 for PKU, HMI-203 for MPS II, and HMI-104 for PNH, utilizing its proprietary AAVHSC platform[131] - HMI-103 is currently in a Phase 1 clinical trial, with enrollment expected to include up to nine patients aged 18-55 diagnosed with classical PKU[135] - HMI-203 has received orphan drug designation from both the EMA and FDA, with a Phase 1 trial expected to enroll up to nine male patients aged 18-45 diagnosed with Hunter syndrome[138] - The Company paused enrollment in the HMI-102 trial to focus resources on the HMI-103 trial, despite observing biologic activity in the HMI-102 trial[141] - The Company is actively seeking a partner to advance the preclinical development of HMI-204, an optimized gene therapy candidate for MLD[146] Legal and Compliance - The Company believes the claims in a pending securities class action lawsuit lack merit and has filed motions to transfer venue and dismiss the case[95]
Q32 Bio Inc.(QTTB) - 2022 Q2 - Quarterly Report
2022-08-15 20:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-38433 Homology Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) (S ...
Q32 Bio Inc.(QTTB) - 2022 Q1 - Quarterly Report
2022-05-16 20:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-38433 Homology Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) D ...
Q32 Bio Inc.(QTTB) - 2021 Q4 - Annual Report
2022-03-23 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38433 Homology Medicines, Inc. (Exact name of Registrant as specified in its Charter) | Delaware | 47-3468154 | | --- | --- | | (Sta ...
Q32 Bio Inc.(QTTB) - 2021 Q3 - Quarterly Report
2021-11-15 12:01
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The unaudited financial statements show decreased assets and a significantly reduced net loss for the nine-month period Condensed Consolidated Balance Sheet Data (in thousands) | Metric | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $95,829 | $217,431 | | Total Assets | $230,816 | $263,737 | | Total Liabilities | $32,245 | $67,742 | | Total Stockholders' Equity | $198,571 | $195,995 | Condensed Consolidated Statements of Operations Data (in thousands) | Metric | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $1,677 | $567 | $33,169 | $1,722 | | Research and Development | $23,987 | $20,417 | $69,439 | $77,197 | | General and Administrative | $8,351 | $8,423 | $26,054 | $24,986 | | Net Loss | $(30,608) | $(28,232) | $(62,181) | $(98,903) | | Net Loss per Share | $(0.54) | $(0.62) | $(1.14) | $(2.19) | - For the nine months ended September 30, 2021, net cash used in operating activities was **$79.3 million**, while net cash provided by financing activities was **$52.2 million**[29](index=29&type=chunk) - The company's collaboration agreement with Novartis was terminated, resulting in the recognition of approximately **$26.9 million** in collaboration revenue[102](index=102&type=chunk)[103](index=103&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This analysis covers financial results, clinical program progress, the impact of the Novartis collaboration, and the company's liquidity position [Overview](index=27&type=section&id=Overview) - Homology Medicines is a clinical-stage company using its proprietary AAVHSC platform for in vivo gene therapy and nuclease-free gene editing[114](index=114&type=chunk) - Key clinical programs include HMI-102 for PKU gene therapy, HMI-103 for PKU gene editing, and HMI-203 for Hunter syndrome gene therapy[114](index=114&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - The company operates a 25,000-square-foot GMP manufacturing facility and has produced GMP material at the 500-liter scale[116](index=116&type=chunk) - The collaboration and license agreement with Novartis was terminated, with Homology regaining worldwide exclusive rights to the remaining ophthalmic target[127](index=127&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Comparison of Nine Months Ended September 30, 2021 and 2020 (in thousands) | Metric | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $33,169 | $1,722 | $31,447 | | Research and Development Expenses | $69,439 | $77,197 | $(7,758) | | General and Administrative Expenses | $26,054 | $24,986 | $1,068 | | Net Loss | $(62,181) | $(98,903) | $36,722 | - Collaboration revenue for the nine months ended Sep 30, 2021, increased to **$33.2 million**, primarily due to recognizing **$28.5 million** upon Novartis's termination notice[168](index=168&type=chunk) - Research and development expenses for the nine months ended Sep 30, 2021, decreased by **$7.8 million**, mainly due to a **$12.7 million** reduction in HMI-102 external costs[169](index=169&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2021, the company had **$187.6 million** in cash, cash equivalents, and short-term investments[179](index=179&type=chunk) - Management believes existing cash will fund operations and capital expenditures into the **first quarter of 2023**[189](index=189&type=chunk) - In April 2021, the company completed a follow-on public offering, raising net proceeds of approximately **$49.7 million**[177](index=177&type=chunk) - Net cash used in operating activities for the nine months ended September 30, 2021, was **$79.3 million**, driven by the net loss and a decrease in deferred revenue[181](index=181&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and investments, with no outstanding debt as of September 30, 2021 - The company's primary market risk is interest rate sensitivity related to its **$187.6 million** in cash, cash equivalents, and short-term investments[196](index=196&type=chunk) - The company had **no debt outstanding** as of September 30, 2021[196](index=196&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls during the quarter - Based on an evaluation as of the end of the period, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective**[198](index=198&type=chunk) - There were **no material changes** in internal control over financial reporting during the quarter[199](index=199&type=chunk) [PART II. OTHER INFORMATION](index=44&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is **not party to any material legal proceedings**[201](index=201&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks related to its history of losses, capital needs, dependence on lead candidates, and uncertainties in development and regulation [Financial and Capital Risks](index=44&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - The company has a history of significant losses, with an accumulated deficit of approximately **$390.5 million** as of September 30, 2021[203](index=203&type=chunk) - Additional capital is required to fund operations, and failure to obtain financing could prevent the development and commercialization of product candidates[207](index=207&type=chunk) - The business is heavily dependent on the success of **HMI-102**, its most advanced product candidate[217](index=217&type=chunk) [Discovery, Development, and Regulatory Risks](index=48&type=section&id=Risks%20Related%20to%20Discovery%2C%20Development%2C%20Clinical%20Testing%2C%20Manufacturing%20and%20Regulatory%20Approval) - The company's novel genetic medicines platform makes it difficult to predict development timelines and costs[225](index=225&type=chunk) - The regulatory landscape for gene therapy and gene editing is uncertain and evolving, which could delay or prevent approval[227](index=227&type=chunk) - Clinical trials are expensive and time-consuming, and delays in patient enrollment for rare diseases could adversely affect development[233](index=233&type=chunk)[259](index=259&type=chunk) - Product candidates may cause serious adverse events, which could lead to trial halts or denial of regulatory approval[262](index=262&type=chunk) [Commercialization Risks](index=69&type=section&id=Risks%20Related%20to%20Commercialization) - The company faces significant competition from major pharmaceutical and biotechnology companies with greater financial resources[305](index=305&type=chunk)[309](index=309&type=chunk) - Successful commercialization depends on obtaining adequate coverage and reimbursement from payors, which is uncertain[311](index=311&type=chunk)[312](index=312&type=chunk) - The company lacks infrastructure for sales, marketing, and distribution and must build these capabilities or collaborate with third parties[321](index=321&type=chunk) [Intellectual Property Risks](index=76&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - Success depends on obtaining and maintaining patent protection for its technology, but the patent position of biotech companies is highly uncertain[352](index=352&type=chunk)[355](index=355&type=chunk) - The company may face third-party claims of patent infringement, which could result in substantial costs or delay development[357](index=357&type=chunk) - Changes in U.S. patent laws, such as the transition to a "first-to-file" system, could diminish the value of patents[365](index=365&type=chunk)[366](index=366&type=chunk) [General Business and Employee Risks](index=85&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth%20and%20Other%20Risks%20Related%20to%20Our%20Business) - The **COVID-19 pandemic** could adversely impact business operations, including clinical trial enrollment and supply chain[386](index=386&type=chunk)[387](index=387&type=chunk) - Future success is highly dependent on the ability to attract and retain key executive, scientific, and clinical personnel[390](index=390&type=chunk)[391](index=391&type=chunk) - As an "emerging growth company," the company is subject to reduced disclosure requirements, which may make its stock less attractive to investors[396](index=396&type=chunk) [Other Information](index=93&type=section&id=Item%205.%20Other%20Information) The company amended its lease to expand its corporate headquarters and extend the lease term to June 30, 2030 - On November 9, 2021, the company amended its lease for its corporate headquarters, expanding the premises by approximately **23,011 square feet**[416](index=416&type=chunk)[417](index=417&type=chunk) - The amendment extends the lease term for the existing premises from February 28, 2027, to **June 30, 2030**[417](index=417&type=chunk) [Exhibits](index=94&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate documents and officer certifications - Lists exhibits filed with the report, including corporate governance documents, the amended lease agreement, and officer certifications[421](index=421&type=chunk)
Q32 Bio Inc.(QTTB) - 2021 Q2 - Quarterly Report
2021-08-12 20:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-38433 Homology Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) Dela ...
Q32 Bio Inc.(QTTB) - 2021 Q1 - Quarterly Report
2021-05-06 20:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-38433 Homology Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) Del ...