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FIXX Homology Medicines

Homology Medicines, Inc. operates as a technology platform to design and develop treatments to address rare diseases at the genetic level. It develops genetic medicines by translating proprietary, next generation gene editing and gene therapy technologies into novel treatments for patients with rare diseases. The company was founded by Saswati Chatterjee in 2015 and is headquartered in Bedford, MA.

FIXX stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

6 May 21
9 May 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
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Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 105.69M 105.69M 105.69M 105.69M 105.69M 105.69M
Cash burn (monthly) 37.67M 3.25M 370.33K 7.91M 9.94M 8.19M
Cash used (since last report) 48M 4.14M 471.91K 10.08M 12.67M 10.44M
Cash remaining 57.69M 101.55M 105.22M 95.61M 93.02M 95.25M
Runway (months of cash) 1.5 31.3 284.1 12.1 9.4 11.6

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
7 Apr 21 Kelly Timothy P Employee Stock Option Common Stock Grant Aquire A No No 7.18 10,000 71.8K 10,000
1 Mar 21 Kelly Timothy P Common Stock Sell Aquire S No Yes 11.1622 6,232 69.56K 0
1 Mar 21 Kelly Timothy P Common Stock Option exercise Aquire M No No 2.8947 2,000 5.79K 6,232
1 Mar 21 Kelly Timothy P Common Stock Option exercise Aquire M No No 6.6314 2,000 13.26K 4,232
1 Mar 21 Kelly Timothy P Employee Stock Options Common Stock Option exercise Dispose M No No 2.8947 2,000 5.79K 32,001
1 Mar 21 Kelly Timothy P Employee Stock Options Common Stock Option exercise Dispose M No No 6.6314 2,000 13.26K 41,500
8 Feb 21 Smith W Bradford Common Stock Sell Dispose S No Yes 14.2537 13,500 192.42K 0
8 Feb 21 Smith W Bradford Common Stock Option exercise Aquire M No No 0.64 13,500 8.64K 13,500
8 Feb 21 Smith W Bradford Employee Stock Option Common Stock Option exercise Dispose M No No 0.64 13,500 8.64K 101,904
5 Feb 21 Tzianabos Arthur RSU Common Stock Grant Aquire A No No 0 42,000 0 42,000

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

78.5% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 106 105 +1.0%
Opened positions 19 24 -20.8%
Closed positions 18 21 -14.3%
Increased positions 33 26 +26.9%
Reduced positions 33 38 -13.2%
13F shares
Current Prev Q Change
Total value 511.99M 623.01M -17.8%
Total shares 39.65M 34.04M +16.5%
Total puts 227.4K 148K +53.6%
Total calls 28.8K 94.3K -69.5%
Total put/call ratio 7.9 1.6 +403.1%
Largest owners
Shares Value Change
PFE Pfizer 5M $48.05M NEW
5AM Ventures IV 4.54M $51.21M NEW
5AM Venture Management 4.54M $51.21M -18.1%
JPM JPMorgan Chase & Co. 3.44M $38.86M +16.7%
Temasek 3.22M $36.36M 0.0%
BLK Blackrock 2.76M $31.2M +0.8%
Wellington Management 2.14M $24.2M +42.2%
TROW T. Rowe Price 1.99M $22.43M -19.6%
BLVGF Bellevue 1.74M $19.61M 0.0%
Vanguard 1.52M $17.18M +5.3%
Largest transactions
Shares Bought/sold Change
PFE Pfizer 5M +5M NEW
5AM Ventures IV 4.54M +4.54M NEW
RTW Investments 0 -2.52M EXIT
5AM Venture Management 4.54M -1M -18.1%
Citadel Advisors 974.01K +946.08K +3386.8%
FMR 930.31K -837.7K -47.4%
Wellington Management 2.14M +636.16K +42.2%
JPM JPMorgan Chase & Co. 3.44M +492.61K +16.7%
TROW T. Rowe Price 1.99M -482.83K -19.6%
Cormorant Asset Management 0 -470.9K EXIT

Financial report summary

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Risks
  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future. If we are unable to achieve and sustain profitability, the market value of our common stock will likely decline. We may never achieve or maintain profitability.
  • We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • We have a limited operating history and no history of commercializing genetic medicine products, which may make it difficult to evaluate the prospects for our future viability.
  • We may not be successful in our efforts to identify additional product candidates.
  • We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
  • We may be required to make significant payments in connection with our license agreements with each of the City of Hope and the California Institute of Technology.
  • Risks Related to Discovery, Development, Clinical Testing, Manufacturing and Regulatory Approval
  • We intend to identify and develop product candidates based on our novel genetic medicines platform, which makes it difficult to predict the time and cost of product candidate development. No products that utilize gene editing technology have been approved in the United States or in Europe, and there have only been a limited number of human clinical trials involving a gene editing product candidate. Moreover, none of those trials has involved our nuclease-free gene editing technology.
  • Because gene therapy and gene editing are novel and the regulatory landscape that governs any product candidates we may develop is uncertain and continues to change, we cannot predict the time and cost of obtaining regulatory approval, if we receive it at all, for any product candidates we may develop.
  • Clinical trials are expensive, time-consuming, difficult to design and implement, and involve an uncertain outcome.
  • Adverse public perception of genetic medicine, and gene editing in particular, may negatively impact regulatory approval of, or demand for, our potential products.
  • A Fast Track Designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.
  • We have received orphan drug designation for HMI-102 and HMI-202, and we intend to seek orphan drug designation for our other product candidates, but any orphan drug designations we receive may not confer marketing exclusivity or other expected benefits.
  • We have received rare pediatric disease designation for HMI-202, and we may seek rare pediatric disease designation for our other product candidates, however, there is no guarantee that we will obtain such designation, and even if we do, there is no guarantee that FDA approval will result in a priority review voucher.
  • We and our contract manufacturers are subject to significant regulation with respect to manufacturing our products. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and have limited capacity.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Even if we obtain FDA approval for HMI-102, HMI-103, HMI-202, HMI-203 or any other product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential.
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • Potential product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we may develop.
  • Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
  • Our employees and independent contractors, including principal investigators, CROs, consultants, vendors, and any third parties we may engage in connection with development and commercialization may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • Our business and operations would suffer in the event of system failures.
  • Initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time 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.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • We are subject to environmental, health and safety laws and regulations, and we may become exposed to liability and substantial expenses in connection with environmental compliance or remediation activities.
  • We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize any product candidates we may develop.
  • Even if HMI-102, HMI-103, HMI-202, HMI-203 or any other product candidate receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
  • If we obtain approval to commercialize any products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
  • Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • Risks Related to Our Dependence on Third Parties
  • We currently contract with third parties for the manufacture of certain materials for our research programs, preclinical and clinical studies. This reliance on third parties increases the risk that we will not have sufficient quantities of such materials, product candidates, or any medicines that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost or in compliance with regulatory requirements, which could delay, prevent, or impair our development or commercialization efforts.
  • We intend to continue to rely on third parties to conduct, supervise and monitor our clinical trials. If those third parties do not successfully carry out their contractual duties, or if they perform in an unsatisfactory manner, it may harm our business.
  • We may collaborate with third parties for the development and commercialization of HMI-102, HMI-103, HMI-202, HMI-203 or any other product candidate. We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize HMI-102, HMI-103, HMI-202, HMI-203 or any other product candidate successfully, if at all.
  • If we fail to comply with our obligations in the agreements under which we in-license or acquire development or commercialization rights to products, technology or data from third parties, including those for HMI-102, we could lose such rights that are important to our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for our technology and products or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
  • Third parties may assert claims against us alleging infringement of their patents and proprietary rights, or we may need to become involved in lawsuits to defend or enforce our patents, either of which could result in substantial costs or loss of productivity, delay or prevent the development and commercialization of our product candidates, prohibit our use of proprietary technology or sale of products or put our patents and other proprietary rights at risk.
  • Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We enjoy only limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world.
  • If we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be materially harmed.
  • Our reliance on third parties may require us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed, and confidentiality agreements with employees and third parties may not adequately prevent disclosure of trade secrets and protect other proprietary information.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • We may need to license additional intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
  • Risks Related to Employee Matters and Managing Growth and Other Risks Related to Our Business
  • The COVID-19 pandemic caused by the novel strain of coronavirus could adversely impact our business, including our preclinical studies and clinical trials.
  • Our future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters public health emergencies and other natural catastrophic events, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Risks Related to Our Common Stock
  • Our executive officers and directors and their respective affiliates, if they choose to act together, will continue to have the ability to control or significantly influence all matters submitted to stockholders for approval.
  • A significant portion of our total outstanding shares are eligible, or will soon become eligible, to be sold into the market, which could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • Provisions in our restated certificate of incorporation and amended and restated bylaws and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our certificate of incorporation designates the Court of Chancery of the State of Delaware, subject to certain exceptions, as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders and our bylaws designate the federal district courts of the United States as the exclusive forum for actions arising under the Securities Act of 1933, as amended, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Our ability to use net operating losses and research and development credits to offset future taxable income or income tax liabilities may be subject to certain limitations.
  • The market price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
  • We could be subject to securities class action litigation.
  • We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.
Management Discussion
  • Collaboration revenue for the three months ended March 31, 2021 was $29.3 million, compared to $0.6 million for the three months ended March 31, 2020. Collaboration revenue includes the recognition of deferred revenue and reimbursements incurred under the collaboration and license agreement with Novartis, for which Novartis gave written notice of termination on February 26, 2021. As a result, we recognized approximately $28.5 million as collaboration revenue upon receipt of the termination notice. The remaining balance of deferred revenue pursuant to the collaboration and license agreement with Novartis will be recognized as the Company continues to perform the remaining activities under the collaboration and license agreement during the notice period, which ends on August 26, 2021. In addition, we recognized collaboration revenue of $0.8 million related to the Stock Purchase Agreement with Pfizer.
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