Docoh
Loading...

GLTO Galecto

Galecto is a clinical stage biotechnology company committed to the development of novel small molecule therapeutics directed at biological targets which are at the heart of fibrosis, inflammation, and cancer. Galecto was founded by leading fibrosis-focused scientists and biotech executives and is built on more than 10 years of research into galectin and fibrosis modulators. The Company's team has developed a deep understanding of the galectin family of proteins and the LOXL2 enzyme, and how both influence multiple biological pathways of these complex, often devastating, diseases.

Company profile

Ticker
GLTO
Exchange
Website
Employees
Incorporated
Location
Fiscal year end
Former names
Galecto Inc.
SEC CIK
IRS number
371957007

GLTO stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

4 May 21
27 Jul 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 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
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from Galecto earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Cash on hand (at last report) 74.45M 74.45M 74.45M
Cash burn (monthly) 29.8M 4.52M 4.72M
Cash used (since last report) 115.99M 17.59M 18.36M
Cash remaining -41.54M 56.86M 56.09M
Runway (months of cash) -1.4 12.6 11.9

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
28 Jun 21 Bertil Lindmark Common Stock Buy Aquire P No No 5.26 2,000 10.52K 2,000
24 Jun 21 Hans T. Schambye Common Stock Buy Aquire P No No 5.11 3,000 15.33K 42,928
23 Jun 21 Freve Jonathan Common Stock Buy Aquire P No No 4.74 2,000 9.48K 2,000
23 Jun 21 Garrett Winslow Common Stock Buy Aquire P No No 4.8 2,000 9.6K 2,000
15 Jun 21 Garrett Winslow Stock Option Common Stock Grant Aquire A No No 5.61 120,000 673.2K 120,000

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

38.0% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 5 0 NEW
Opened positions 5 0 NEW
Closed positions 0 0
Increased positions 0 0
Reduced positions 0 0
13F shares
Current Prev Q Change
Total value 95.63M 0 NEW
Total shares 9.59M 0 NEW
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
Orbimed Advisors 2.77M $41.57M NEW
Novo Holdings A/S 2.5M $0 NEW
Cormorant Asset Management 2.15M $26.91M NEW
HBM Healthcare Investments 1.31M $16.36M NEW
Soleus Private Equity Fund I 863.05K $10.8M NEW
Largest transactions
Shares Bought/sold Change
Orbimed Advisors 2.77M +2.77M NEW
Novo Holdings A/S 2.5M +2.5M NEW
Cormorant Asset Management 2.15M +2.15M NEW
HBM Healthcare Investments 1.31M +1.31M NEW
Soleus Private Equity Fund I 863.05K +863.05K NEW

Financial report summary

?
Risks
  • We have incurred significant net losses since inception and we expect to continue to incur significant net losses for the foreseeable future.
  • We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs, future commercialization efforts or other operations.
  • The amount of our future losses is uncertain and our operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
  • We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
  • Our business is highly dependent on the success of our lead product candidate, GB0139, as well as GB1211, GB2064 and any other product candidates that we advance into the clinic. All of our product candidates may require significant additional preclinical and clinical development before we may be able to seek regulatory approval for and launch a product commercially.
  • Clinical development involves a lengthy, complex and expensive process, with an uncertain outcome, and the results of preclinical studies and early-stage clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials.
  • We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of GB0139 or any of our other product candidates in development.
  • Our ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in our preclinical studies and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of any of our product candidates.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • The design or execution of our ongoing and future clinical trials may not support marketing approval or commercialization.
  • We have obtained orphan drug designation for GB0139; however, we may be unable to maintain this designation or obtain orphan drug designation for our other product candidates, and we may not be able to realize the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.
  • Breakthrough Therapy designation and Fast Track designation by the FDA, neither of which has been obtained, even if granted for any of our current or future product candidates, may not lead to a faster development or regulatory review process, and such designations do not increase the likelihood that any of our product candidates will receive marketing approval in the United States.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • We may not be successful in our efforts to identify or discover additional product candidates in the future.
  • Due to our limited resources and access to capital, we must make decisions on the allocation of resources to certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business.
  • If product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit commercialization of our product candidates.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • We have identified a material weakness in our internal control over financial reporting. If our remediation of this material weakness is not effective, or if we experience additional material weaknesses or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations.
  • Even if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.
  • Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell any products for which we obtain regulatory approval, we may not be able to generate product revenue.
  • Our relationships with healthcare providers, physicians, prescribers, purchasers, third-party payors, charitable organizations and patients will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Even if we receive regulatory approval of any product candidates, we will be subject to ongoing post-marketing 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.
  • Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
  • Inadequate funding for the FDA, the SEC and other government agencies 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.
  • EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the European member states.
  • We may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations.
  • Legal, political and economic uncertainty surrounding the exit of the U.K. from the EU may be a source of instability in international markets, create significant currency fluctuations, adversely affect our operations in the U.K. and pose additional risks to our business, revenue, financial condition, and results of operations.
  • Additional laws and regulations governing international operations, and the complexity associated with maintaining geographically diverse operations, could negatively impact or restrict our operations and ability to grow.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
  • Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
  • We may enter into license or other collaboration agreements in the future that may impose certain obligations on us. If we fail to comply with our obligations under such future agreements with third parties, we could lose license rights that may be important to our future business.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be negatively impacted, and our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement may be costly and time consuming to defend, and could prevent or delay our product discovery, development and commercialization efforts.
  • Third parties may assert that we are employing their proprietary technology without authorization.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • Others may claim an ownership interest in our intellectual property, which could expose us to litigation and have a significant adverse effect on our prospects.
  • We may not be successful in obtaining or maintaining necessary rights to develop any future product candidates on acceptable terms.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, or challenging the patent rights of others, which could be expensive, time-consuming and unsuccessful.
  • 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.
  • Any patents, if issued, covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
  • Changes in patent law in the United States and in other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We have limited foreign intellectual property rights and may not be able to protect and enforce our intellectual property rights throughout the world.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
  • If we do not obtain patent term extension and data exclusivity or similar non-U.S. legislation extending the term of protection covering any product candidates we may develop, 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 in our markets of interest and our business may be adversely affected.
  • We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.
  • We contract with third parties for the manufacture of our product candidates for preclinical development, clinical testing, and expect to continue to do so for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • We may in the future seek to enter into collaborations with third parties for the development and commercialization of our product candidates, and our future collaborations will be important to our business. If we are unable to enter into collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • The global pandemic of the novel coronavirus disease, COVID-19, has, and may continue to, adversely impact our business, including our preclinical studies and clinical trials.
  • The study of GB0139 in the University of Edinburgh’s STOPCOVID program for COVID-19 is at an early stage and subject to many risks. A COVID-19 product candidate may be unable to receive approval in a timely manner, if at all, and GB0139 may never be approved for the treatment of COVID-19.
  • The regulatory pathway for COVID-19 treatments is continually evolving, and may result in unexpected or unforeseen challenges.
  • We may encounter difficulties in managing our growth, which could adversely affect our operations.
  • If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to develop current product candidates or identify and develop new product candidates will be impaired, could result in loss of markets or market share and could make us less competitive.
  • We may be unable to adequately protect our information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure.
  • We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from any such serious disaster.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • The increasing use of social media platforms presents new risks and challenges.
  • The estimates of market opportunity and forecasts of market growth included in this Annual Report on Form 10-K or that we may otherwise provide may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • Our employees, independent contractors, consultants, commercial partners, collaborators and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We use and generate materials that may expose us to material liability.
  • Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our products.
  • Changes in U.S. tax law could adversely affect our financial condition and results of operations.
  • Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could expose us to greater than anticipated tax liabilities.
  • Our corporate structure and intercompany arrangements are subject to the tax laws of various jurisdictions, and we could be obligated to pay additional taxes, which would harm our results of operations.
  • Our ability to use our net operating loss carryforwards and certain tax credit carryforwards may be subject to limitation.
  • The price of our stock may be volatile, and you could lose all or part of your investment.
  • We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our stock.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • We are an emerging growth company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors.
  • We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • A significant portion of our total outstanding shares are eligible to 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 doing well.
  • We have broad discretion in the use of our existing cash and cash equivalents and may not use them effectively.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control, which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
  • Our amended and restated bylaws will designate certain courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to litigate disputes with us in a different judicial forum.
  • Our issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
Management Discussion
  • Research and development expenses were $10.0 million for the three months ended March 31, 2021, compared to $4.7 million for the three months ended March 31, 2020. The increase of $5.3 million was primarily related to an increase in clinical trial-related expenses of $2.3 million chemistry, manufacturing and control, or CMC, activities of $2.0 million and clinical consulting expenses of $0.2 million, as well as an increase in personnel costs of $0.4 million and non-cash stock-based compensation of $0.4 million.
  • General and administrative expenses were $3.6 million for the three months ended March 31, 2021, compared to $1.1 million for the three months ended March 31, 2020. The increase of $2.5 million was primarily related to an increase in consultant costs of $0.6 million, insurance costs of $0.5 million and personnel costs of $0.4 million as well as non-cash stock-based compensation of $0.6 million and other general and administrative costs of $0.4 million.
  • Other income (expense), net was $0.2 million for both the three months ended March 31, 2021 and 2020.  
Content analysis
?
Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. sophomore Avg