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Solid Biosciences (SLDB)

Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne. Disease-focused and founded by a family directly impacted by Duchenne, its mandate is simple yet comprehensive - work to address the disease at its core by correcting the underlying mutation that causes Duchenne with its lead gene therapy candidate, SGT-001.

Company profile

Ticker
SLDB
Exchange
Website
CEO
Ilan Ganot
Employees
Incorporated
Location
Fiscal year end
Former names
Solid Biosciences, LLC
SEC CIK
Subsidiaries
Solid Biosciences UK Limited • Solid Biosciences Securities Corporation ...

SLDB stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

11 Aug 22
3 Oct 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 56.38M 56.38M 56.38M 56.38M 56.38M 56.38M
Cash burn (monthly) 25.13M 12.2M 8.46M 7.29M 5.29M 6.86M
Cash used (since last report) 78.55M 38.13M 26.44M 22.77M 16.54M 21.45M
Cash remaining -22.17M 18.26M 29.94M 33.61M 39.84M 34.93M
Runway (months of cash) -0.9 1.5 3.5 4.6 7.5 5.1

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
3 Jul 22 Smith Ian F Common Stock Option exercise Acquire M No No 0 24,313 0 318,896
3 Jul 22 Smith Ian F RSU Common Stock Option exercise Dispose M No No 0 24,313 0 48,624
7 Jun 22 Freed Martin I Director Stock Option Common Stock Grant Acquire A No No 0.625 51,000 31.88K 51,000
7 Jun 22 Huffines Robert Luther Director Stock Option Common Stock Grant Acquire A No No 0.625 51,000 31.88K 51,000
7 Jun 22 Clare Kahn Stock Option Common Stock Grant Acquire A No No 0.625 40,000 25K 40,000
7 Jun 22 Clare Kahn Director Stock Option Common Stock Grant Acquire A No No 0.625 51,000 31.88K 51,000
7 Jun 22 Georgia Keresty Director Stock Option Common Stock Grant Acquire A No No 0.625 51,000 31.88K 51,000
70.8% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 70 79 -11.4%
Opened positions 17 11 +54.5%
Closed positions 26 16 +62.5%
Increased positions 11 14 -21.4%
Reduced positions 23 35 -34.3%
13F shares Current Prev Q Change
Total value 116.6M 153.7M -24.1%
Total shares 79.99M 85.06M -6.0%
Total puts 18.9K 14.9K +26.8%
Total calls 34.8K 38K -8.4%
Total put/call ratio 0.5 0.4 +38.5%
Largest owners Shares Value Change
Perceptive Advisors 13.41M $8.26M 0.0%
Ra Capital Management 12.37M $7.61M 0.0%
Bain Capital Life Sciences Investors 7.93M $4.88M 0.0%
BCLS SB Investco 7.93M $43.69M 0.0%
RARE Ultragenyx Pharmaceutical 7.83M $26.84M 0.0%
Boxer Capital 5.34M $3.29M 0.0%
Suvretta Capital Management 5.07M $3.12M -29.9%
Artal 3M $1.85M 0.0%
K2 Principal Fund 2.91M $1.79M NEW
BLK Blackrock 2.87M $1.77M -50.7%
Largest transactions Shares Bought/sold Change
BLK Blackrock 2.87M -2.95M -50.7%
K2 Principal Fund 2.91M +2.91M NEW
EcoR1 Capital 0 -2.57M EXIT
Suvretta Capital Management 5.07M -2.16M -29.9%
Laurion Capital Management 1.16M +1.16M NEW
STT State Street 339.74K -736.2K -68.4%
Millennium Management 689K +677.05K +5663.8%
Ikarian Capital 0 -521.16K EXIT
Vanguard 2.59M +475.83K +22.5%
Geode Capital Management 627.34K -420.72K -40.1%

Financial report summary

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Risks
  • We have never generated revenue from product sales and do not expect to do so for the next several years, if ever.
  • Our limited operating history may make it difficult for our stockholders to evaluate the success of our business to date and to assess our future viability.
  • SGT-001 and SGT-003 are gene transfer candidates based on novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval. To our knowledge, only a limited number of gene transfer products have been approved for commercialization in the United States and the European Union.
  • We have never completed a clinical trial, and may be unable to do so for any product candidates we may develop, including SGT-001 and SGT-003.
  • Success in preclinical studies or early clinical trials, including our IGNITE DMD clinical trial, may not be indicative of results obtained in later trials.
  • Even if we obtain regulatory approval for a product candidate, our product candidates will remain subject to regulatory oversight.
  • Even if we obtain and maintain approval for SGT-001, SGT-003 or our other product candidates from the FDA, we may never obtain approval for our product candidates outside of the United States, which would limit our market opportunities and adversely affect our business.
  • Regulatory requirements governing gene therapy products are periodically updated and may continue to change in the future.
  • We may not be able to benefit from orphan drug designation for SGT-001 or any of our product candidates.
  • We may seek a breakthrough therapy designation for SGT-001, SGT-003 or our other product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.
  • Accelerated approval by the FDA, even if granted for SGT-001, SGT-003 or our other product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • A potential regenerative medicine advanced therapy designation by the FDA for our product candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • The FDA has granted Rare Pediatric Disease Designation to SGT-001; however, a BLA for SGT-001 may not meet the eligibility criteria for a priority review voucher upon approval.
  • We may seek priority review designation for SGT-001, SGT-003 or our other product candidates, but we might not receive such designation, and even if we do, such designation may not lead to a faster development or regulatory review or approval process.
  • Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We may fail to capitalize on other potential product candidates that may represent a greater commercial opportunity or for which there is a greater likelihood of success.
  • We may not be successful in finding strategic collaborators for continuing development of SGT-001, SGT-003 or our other product candidates or successfully commercializing or competing in the market for certain indications.
  • We expect to utilize third parties to conduct our product manufacturing for the foreseeable future. Therefore, we are subject to the risk that these third parties may not perform satisfactorily or meet regulatory requirements.
  • If we are unable to establish sales, distribution and marketing capabilities or enter into agreements with third parties to market and sell SGT-001, SGT-003 and our other product candidates, we will be unable to generate any product revenue.
  • If we are unable to establish medical affairs capabilities, we will be unable to establish an educated market of physicians to administer SGT-001, SGT-003 or our other product candidates.
  • If the market opportunities for SGT-001 are smaller than we believe they are, our revenue prospects may be adversely affected and our business may suffer.
  • The commercial success of any of our product candidates, including SGT-001, if approved, will depend upon market acceptance by physicians, patients, third-party payors and others in the medical community.
  • Any contamination in our manufacturing process, shortages of materials or failure of any of our key suppliers to deliver necessary components could result in interruption in the supply of our product candidates and delays in our clinical development or commercialization schedules.
  • The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate product revenue.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
  • If we obtain approval to commercialize SGT-001, SGT-003 and our other product candidates outside of the United States, in particular in the European Union, a variety of risks associated with international operations could materially adversely affect our business.
  • If we engage in future acquisitions or strategic collaborations, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
  • Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
  • If we are unable to manage growth in the scale and complexity of our operations, our performance may suffer.
  • Our employees may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • Enacted and future 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 relationships with customers, physicians and third-party payors will be subject, directly or indirectly, to federal and state health care fraud and abuse laws, false claims laws, health information privacy and security laws, and other health care laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Our internal computer systems, or those of our collaborators, contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development.
  • We heavily rely on certain in-licensed patents and other intellectual property rights in connection with our development of SGT-001, SGT-003 and our other product candidates and may be required to acquire or license additional patents or other intellectual property rights to continue to develop and commercialize SGT-001, SGT-003 and our other product candidates.
  • If we are unable to obtain and maintain patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be adversely affected.
  • We may not be able to file, prosecute, maintain, enforce, defend or license all patents that are necessary to our business.
  • Our licensed patents, and any patents we may own in the future, may be challenged, narrowed, invalidated or held unenforceable.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Some intellectual property that we have in-licensed may have been discovered through government-funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for U.S. manufacturing. Compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • If we do not obtain patent term extension for patents relating to SGT-001, SGT-003 or our other product candidates, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition and our business may be adversely affected.
  • Intellectual property rights and regulatory exclusivity rights do not necessarily address all potential threats.
  • If approved, our product candidates that are licensed and regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • Our executive officers, directors and principal stockholders maintain the ability to control or significantly influence all matters submitted to our stockholders for approval.
  • A significant number of our total outstanding shares may be sold into the market in the near future, which could cause the market price of our common stock to drop significantly, even if our business is performing well.
  • The price of our common stock has been, and in the future is likely to be, volatile and fluctuate substantially, which could result in substantial losses for holders of our common stock.
  • An active trading market for our common stock may not be sustained.
  • We are an “emerging growth company,” and a “smaller reporting company” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
  • We incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, is the only sole source of gain for an investment in our common stock.
  • Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for such disputes with us or our directors, officers or employees.
Management Discussion
  • Collaboration revenue for the year ended December 31, 2021 was $13.6 million, compared to no collaboration revenue for the year ended December 31, 2020. The increase in collaboration revenue was related to research services and cost reimbursement received under the Collaboration Agreement with Ultragenyx, which we entered into in the fourth quarter of 2020.
  • Research and development costs for the year ended December 31, 2021 were $58.7 million, compared to $64.9 million for the year ended December 31, 2020. The decrease of $6.1 million in research and development costs was due to a decrease in SGT-001 research and development costs of $6.7 million primarily due to the impacts of COVID-19, and a decrease of SGT-003 and other product candidates costs of $2.2 million primarily due to license fees incurred in 2020 in conjunction with the Ultragenyx Collaboration agreement. This was partially offset by an increase in unallocated expenses of $2.7 million primarily driven by personnel related expenses from an increase in headcount in 2021.
  • General and administrative expenses were $27.1 million for the year ended December 31, 2021, compared to $21.6 million for the year ended December 31, 2020. The increase of $5.5 million was due to an increase in personnel related expenses of $4.1 million due to the increase in headcount in 2021 and an increase in consulting fees of $1.4 million.

Content analysis

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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. junior Avg
New words: calendar, consecutive, delisted, delisting, Exhibit, formatted, inclusion, Inline, Linkbase, longitudinal, notifying, omicron, Page, regain, regained, Schema, split, Summary, Taxonomy, thereunto, undersigned, upfront, XBRL
Removed: asubstantial, commencing, dispose, home, hundred, relocate, remotely, supplying, tenant, twentieth

Patents

Utility
Recombinant Herpesvirales Vector
29 Sep 22
The invention described herein provides a recombinant replication-defective vims derived from Herpesvirales order, wherein the virus is characterized by a complete deletion of a gene encoding ICP27, or a functional equivalent gene thereof.
Utility
Combination Therapy for Treating Muscular Dystrophy
3 Feb 22
The invention described herein provides gene therapy vectors, such as adeno-associated virus (AAV) vectors, that co-express a functional protein (such as a miniaturized human micro-dystrophin gene product) and one or more additional coding sequences for an RNAi sequence (siRNA, shRNA, miRNA), an antisense sequence, a guide sequence for a gene editing enzyme (such as an sgRNA for CRISPR/Cas9, or a crRNA for CRISPR/Casl2a), and/or a micro RNA, and methods of using the vectors to treat subjects suffering from a muscular dystrophy such as DMD/BMD.
Utility
Multi-path Communication Device for Sharing Feedback Path for Digital Pre-distortion
15 Apr 20
The present invention, which relates to a multi-path communication device for sharing a feedback path for digital pre-distortion, includes: a DPD processing unit configured to output a plurality of pre-distorted signals by respectively pre-distorting a plurality of input signals, to output an nth control signal when an nth input signal is input, and to output an nth pre-distorted signal using an nth feedback signal input in response to the nth control signal; a power amplifying unit configured to amplify each of the plurality of pre-distorted signals and output a plurality of amplified signals; a signal combining unit configured to combine some of each of the plurality of amplified signals and output combined feedback signal; and a signal selection unit configured to select and output only the nth feedback signal from the combined feedback signal according to the input nth control signal, thereby preventing an increase in the size of a device and manufacturing cost thereof caused by a plurality of DPD feedback paths.
Utility
Distributed Antenna System-based on Time Sensitive Network
18 Mar 20
A TSN-based distributed antenna system including a headend unit, one or more TSN switches, and one or more remote units and a fronthaul transport network constituted by the headend unit, the TSN switch, and the remote unit is provided.
Utility
Apparatus and method for compensating optical transmission delay
2 Mar 20
The present invention provides a method of optical transmission delay compensation of a system including a main unit and a remote unit, wherein the main unit and the remote unit are connected to each other through an optical transmission line, including: receiving a reference signal, by the remote unit, generated by the main unit through the optical transmission line; analog converting the reference signal and performing analog processing on the reference signal; converting the analog-processed reference signal into an RF signal and radiating the RF signal; and measuring a delay time until the reference signal is generated and radiated as the RF signal.