36 unchanged sentences
limited trading volume for our stock, concentration of ownership of our stock, and other risks detailed herein and from time to time in our SEC reports, and
−Removed: the impact resulting from the outbreak of COVID-19, which has delayed and may continue to delay our clinical trial and development efforts, as well as the impact that COVID-19 has on the volatility of the capital market and our
−Removed: ability to access the capital market.
+Added: the impact resulting from a pandemic or the reemergence of COVID-19, which delayed our clinical trial and development efforts, as well as the impact that such a pandemic has on the volatility of the capital market and our ability to
+Added: access the capital market.
We caution investors that actual results or business conditions may differ materially from those projected or suggested in forward-looking statements as a result of various factors including, but not limited to,
17 unchanged sentences
to establish and implement clinical development programs that add value to our business in the shortest period of time possible and to seek strategic partners when one of our programs becomes advanced and requires significant additional
−Removed: Our lead galectin-3 inhibitor is belapectin (GR-MD-02), which has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis and in clinical studies to decrease portal hypertension and prevent
−Removed: its complication:
+Added: Our lead galectin-3 inhibitor is belapectin (GR-MD-02), which has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis and in clinical studies to decrease portal hypertension and
+Added: prevent its complication:
the development of esophageal varices.
12 unchanged sentences
Research and development
−Removed: We generally categorize research and development expenses as either direct external expenses, comprised of amounts paid to third party vendors for services, or all other research and development expenses, comprised
−Removed: of employee payroll and general overhead allocable to research and development.
−Removed: We consider a clinical program to have begun upon acceptance by the FDA, or similar agency outside of the United States, to commence a clinical trial in humans, at
−Removed: which time we begin tracking expenditures by the product candidate.
−Removed: Clinical program expenses comprise payments to vendors related to preparation for, and conduct of, all phases of the clinical trial, including costs for drug manufacture,
−Removed: patient dosing and monitoring, data collection and management, oversight of the trials and reports of results.
−Removed: Pre-clinical expenses comprise all research and development amounts incurred before human trials begin and for additional toxicology
−Removed: studies to support advanced development, including payments to vendors for services related to product experiments and discovery, toxicology, pharmacology, metabolism and efficacy studies, as well as manufacturing process development for a drug
+Added: We generally categorize research and development expenses as either direct external expenses, comprised of amounts paid to third party vendors for services, or all other research and development expenses,
+Added: comprised of employee payroll and general overhead allocable to research and development.
+Added: We consider a clinical program to have begun upon acceptance by the FDA, or similar agency outside of the United States, to commence a clinical trial in
+Added: humans, at which time we begin tracking expenditures by the product candidate.
+Added: Clinical program expenses comprise payments to vendors related to preparation for, and conduct of, all phases of the clinical trial, including costs for drug
+Added: manufacture, patient dosing and monitoring, data collection and management, oversight of the trials and reports of results.
+Added: Pre-clinical expenses comprise all research and development amounts incurred before human trials begin and for
+Added: additional toxicology studies to support advanced development, including payments to vendors for services related to product experiments and discovery, toxicology, pharmacology, metabolism and efficacy studies, as well as manufacturing process
+Added: development for a drug candidate.
We have two product candidates, belapectin and GM-CT-01;
7 unchanged sentences
Payroll and other including stock-based compensation
−Removed: Clinical programs expenses increased in the year ended December 31, 2022 over the year ended December 31, 2021 primarily due to costs related to our the NAVIGATE clinical trial activities and preparations and some
−Removed: preclinical activities incurred in support of the planned clinical program such as development and reproductive toxicity studies, clinical supplies and other supportive activities.
−Removed: Payroll and other costs increased primarily due to additional
−Removed: employees being hired in research and development.
+Added: Clinical programs expenses decreased in the year ended December 31, 2023 over the year ended December 31, 2022 primarily due to costs related to our the NAVIGATE clinical trial activities and a decrease in costs
+Added: related to contract manufacturing of belapectin.
+Added: Pre-clinical activities increased due to activities incurred in support of the clinical program such as development and reproductive toxicity studies, clinical supplies and other supportive
+Added: Payroll and other costs increased primarily due to additional employees being hired in research and development.
General and Administrative Expense
2 unchanged sentences
General and administrative
−Removed: General and administrative expenses consist primarily of salaries including stock-based compensation, legal and accounting fees, insurance, investor relations, business development and other
−Removed: office related expenses.
−Removed: The primary reasons for the increase for the year ended December 31, 2022, as compared to the same period for 2021 are due to an increase in non-cash stock-based compensation of $399,000 partially offset by decreases in
−Removed: legal fees and insurance expense of $146,000 and $131,000, respectively.
+Added: General and administrative expenses consist primarily of salaries including stock-based compensation, legal and accounting fees, insurance, investor relations, business development and other office related
+Added: The primary reasons for the decrease for the year ended December 31, 2023, as compared to the same period for 2022 are due to a decrease in non-cash stock-based compensation of $624,000.
Other Income and Expense
−Removed: During the year ended December 31, 2022, other income and expense consisted of $52,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes
−Removed: payable and convertible line of credit of $1,033,000.
−Removed: During the year ended December 31, 2021, other income and expense consisted of $4,000 of interest income offset by amortization of the debt discount associated with warrants issued with a line
−Removed: of credit entered into in December 2017 of $174,000 which is classified as interest expense, and interest expense and amortization of debt discounts on convertible notes payable of $315,000.
+Added: During the year ended December 31, 2023, other income and expense consisted of $230,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and
+Added: convertible line of credit of $2,792,000 and change in fair value of derivatives of $432,000.
+Added: During the year ended December 31, 2022, other income and expense consisted of $52,000 of interest income and change in fair value of derivatives of $557,000 offset by interest expense and amortization of debt
+Added: discounts on convertible notes payable and convertible line of credit of $1,033,000.
Results of Operations from the Years Ended December 31, 2022 and 2021
3 unchanged sentences
Research and development
−Removed: We generally categorize research and development expenses as either direct external expenses, comprised of amounts paid to third party vendors for services, or all other research and development expenses, comprised
−Removed: of employee payroll and general overhead allocable to research and development.
−Removed: We consider a clinical program to have begun upon acceptance by the FDA, or similar agency outside of the United States, to commence a clinical trial in humans, at
−Removed: which time we begin tracking expenditures by the product candidate.
−Removed: Clinical program expenses comprise payments to vendors related to preparation for, and conduct of, all phases of the clinical trial, including costs for drug manufacture,
−Removed: patient dosing and monitoring, data collection and management, oversight of the trials and reports of results.
−Removed: Pre-clinical expenses comprise all research and development amounts incurred before human trials begin and for additional toxicology
−Removed: studies to support advanced development, including payments to vendors for services related to product experiments and discovery, toxicology, pharmacology, metabolism and efficacy studies, as well as manufacturing process development for a drug
+Added: We generally categorize research and development expenses as either direct external expenses, comprised of amounts paid to third party vendors for services, or all other research and development expenses,
+Added: comprised of employee payroll and general overhead allocable to research and development.
+Added: We consider a clinical program to have begun upon acceptance by the FDA, or similar agency outside of the United States, to commence a clinical trial in
+Added: humans, at which time we begin tracking expenditures by the product candidate.
+Added: Clinical program expenses comprise payments to vendors related to preparation for, and conduct of, all phases of the clinical trial, including costs for drug
+Added: manufacture, patient dosing and monitoring, data collection and management, oversight of the trials and reports of results.
+Added: Pre-clinical expenses comprise all research and development amounts incurred before human trials begin and for
+Added: additional toxicology studies to support advanced development, including payments to vendors for services related to product experiments and discovery, toxicology, pharmacology, metabolism and efficacy studies, as well as manufacturing process
+Added: development for a drug candidate.
We have two product candidates, belapectin and GM-CT-01;
7 unchanged sentences
Payroll and other including stock-based compensation
−Removed: Clinical programs expenses increased in the year ended December 31, 2021 over the year ended December 31, 2020 primarily due to costs related to our the NAVIGATE clinical trial activities and preparations and some
−Removed: preclinical activities incurred in support of the planned clinical program such as development and reproductive toxicity studies, clinical supplies and other supportive activities.
+Added: Clinical programs expenses increased in the year ended December 31, 2022 over the year ended December 31, 2021 primarily due to costs related to our the NAVIGATE clinical trial activities and preparations and
+Added: some preclinical activities incurred in support of the planned clinical program such as development and reproductive toxicity studies, clinical supplies and other supportive activities.
+Added: Payroll and other costs increased primarily due to
+Added: additional employees being hired in research and development.
General and Administrative Expense
2 unchanged sentences
General and administrative
−Removed: General and administrative expenses consist primarily of salaries including stock-based compensation, legal and accounting fees, insurance, investor relations, business development and other
−Removed: office related expenses.
−Removed: The primary reasons for the increase for the year ended December 31, 2021, as compared to the same period for 2020, are due to an increase in non-cash stock-based compensation of $373,000 and increase in insurance
−Removed: expense of $395,000.
+Added: General and administrative expenses consist primarily of salaries including stock-based compensation, legal and accounting fees, insurance, investor relations, business development and other office related
+Added: The primary reasons for the increase for the year ended December 31, 2022, as compared to the same period for 2021 are due to an increase in non-cash stock-based compensation of $399,000 partially offset by decreases in legal fees and
+Added: insurance expense of $146,000 and $131,000, respectively.
Other Income and Expense
−Removed: During the year ended December 31, 2021, other income and expense consisted of $4,000 of interest income offset by amortization of the debt discount associated with warrants issued with a line
−Removed: of credit entered into in December 2017 of $174,000 which is classified as interest expense, and interest expense and amortization of debt discounts on convertible notes payable of $315,000.
+Added: During the year ended December 31, 2022, other income and expense consisted of $52,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and convertible
+Added: line of credit of $1,033,000.
+Added: During the year ended December 31, 2021, other income and expense consisted of $4,000 of interest income offset by amortization of the debt discount associated with warrants issued with a line of credit entered
+Added: into in December 2017 of $174,000 which is classified as interest expense, and interest expense and amortization of debt discounts on convertible notes payable of $315,000.
Liquidity and Capital Resources
4 unchanged sentences
At December 31, 2023, the Company had $25.7 million of unrestricted
−Removed: cash and cash equivalents in addition to $50 million available under a line of credit provided by our chairman available to fund future operations.
−Removed: The Company believes there is sufficient cash to fund currently planned operations at least
−Removed: through December 31, 2024.
−Removed: We will require more cash to fund our operations after December 31, 2024 and believe we will be able to obtain additional financing.
−Removed: The currently planned operations include costs related to our adaptively designed
−Removed: NAVIGATE Phase 2b/3 clinical trial.
+Added: cash and cash equivalents in addition to $30 million available under two lines of credit provided by our chairman available to fund future operations.
+Added: The Company believes there is sufficient cash to fund currently planned operations through
+Added: March 31, 2025.
+Added: We will require more cash to fund our operations after March 31, 2025 and believe we will be able to obtain additional financing.
+Added: The currently planned operations include costs related to our adaptively designed NAVIGATE Phase
+Added: 2b/3 clinical trial.
However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.
1 unchanged sentence
Net cash used in operations increased by $1,909,000 to $32,965,000 for 2023, as compared to $31,056,000 for 2022.
−Removed: Cash operating expenses increased principally due to increased research and
−Removed: development activities primarily related to our NAVIGATE clinical trial and associated activities.
+Added: Cash operating expenses increased principally due to increased research and development activities
+Added: primarily related to our NAVIGATE clinical trial and associated activities.
There were no equipment purchases or other investing activities in 2023 or 2022.
Net cash provided by financing activities was $40,033,000 during 2023 as compared to $10,000,000 during 2022, due primarily to the transactions described below.
−Removed: In 2022, we received $10,000,000 in proceeds under a convertible line of credit provided by our chairman.
−Removed: In 2021, we received proceeds of $30,000,000 from three related-party convertible
−Removed: notes payable, $2,950,000 from the exercise of common stock warrants and $3,864,000 in net proceeds from issuance of common shares under our ATM.
+Added: In 2023, we received $30,000,000 in proceeds under a convertible line of credit provided by our chairman in addition to $10 million in proceeds from stock purchase warrants exercised by our chairman.
+Added: received proceeds of $10,000,000 under a convertible line of credit provided by our chairman.
2022 compared to 2021
Net cash used in operations increased by $6,748,000 to $31,056,000 for 2022, as compared to $24,308,000 for 2021.
−Removed: Cash operating expenses increased principally due to increased research and
−Removed: development activities primarily related to our NAVIGATE clinical trial and associated activities.
+Added: Cash operating expenses increased principally due to increased research and development activities
+Added: primarily related to our NAVIGATE clinical trial and associated activities.
There were no equipment purchases or other investing activities in 2022 or 2021.
Net cash provided by financing activities was $10,000,000 during 2022 as compared to $36,814,000 during 2021, due primarily to the transactions described below.
−Removed: In 2021, we received proceeds of $30,000,000 from three related-party convertible notes payable, $2,950,000 from the exercise of common stock warrants and $3,864,000 in net proceeds from
−Removed: issuance of common shares under our ATM.
−Removed: In 2020, we received proceeds of $44,000 from issuances of common stock through the At the Market issuances and received $219,000 from exercise of common stock options.
+Added: In 2022, we received $10,000,000 in proceeds under a convertible line of credit provided by our chairman.
+Added: In 2021, we received proceeds of $30,000,000 from three related-party convertible notes payable,
+Added: $2,950,000 from the exercise of common stock warrants and $3,864,000 in net proceeds from issuance of common shares under our ATM.
Operating leases
−Removed: Effective February 28, 2022, the Company entered into an amendment to its operating lease for office space in Norcross, GA for a term of thirty-eight months, beginning on March 1, 2022 and
−Removed: ending April 30, 2025 at an average rate of approximately $4,250 per month.
+Added: Effective February 28, 2022, the Company entered into an amendment to its operating lease for office space in Norcross, GA for a term of thirty-eight months, beginning on March 1, 2022 and ending April 30, 2025
+Added: at an average rate of approximately $4,250 per month.
The amended lease provided for free rent for the first six months of the lease and continues the security deposit of $6,000.
−Removed: In addition to base rental payments
−Removed: included in the contractual obligations table above, the Company is responsible for our pro-rata share of the operating expenses for the building.
+Added: In addition to base rental payments included in the contractual
+Added: obligations table above, the Company is responsible for our pro-rata share of the operating expenses for the building.
In October 2012, the Company entered into an operating lease for office and lab space for research and development activities in Natick, MA.
−Removed: The lease is for a period of one year, beginning on October 1, 2012, for
−Removed: a rate of $15,000 for the term, payable in equal monthly increments.
+Added: The lease is for a period of one year, beginning on October 1, 2012,
+Added: for a rate of $15,000 for the term, payable in equal monthly increments.
This lease was continued on a month-to-month basis from October 1, 2013.
20 unchanged sentences
As part of the process of preparing our consolidated financial statements, we are required to estimate accrued expenses.
−Removed: This process involves identifying services that third parties have performed on our behalf and estimating the level of service performed and the associated cost incurred on these services as of each balance sheet date in our
−Removed: consolidated financial statements.
+Added: This process involves
+Added: identifying services that third parties have performed on our behalf and estimating the level of service performed and the associated cost incurred on these services as of each balance sheet date in our consolidated financial statements.
Examples of estimated accrued expenses include professional service fees, such as those arising from the services of attorneys and accountants and accrued payroll expenses.
−Removed: In connection with these service
−Removed: fees, our estimates are most affected by our understanding of the status and timing of services provided relative to the actual services incurred by the service providers.
−Removed: In the event that we do not identify certain costs that have been
−Removed: incurred or we under- or over-estimate the level of services or costs of such services, our reported expenses for a reporting period could be understated or overstated.
−Removed: The date on which certain services commence, the level of services
−Removed: performed on or before a given date, and the cost of services are often subject to our judgment.
+Added: In connection with these service fees, our estimates are most affected
+Added: by our understanding of the status and timing of services provided relative to the actual services incurred by the service providers.
+Added: In the event that we do not identify certain costs that have been incurred or we under- or over-estimate the
+Added: level of services or costs of such services, our reported expenses for a reporting period could be understated or overstated.
+Added: The date on which certain services commence, the level of services performed on or before a given date, and the cost
+Added: of services are often subject to our judgment.
We make these judgments based upon the facts and circumstances known to us in accordance with accounting principles generally accepted in the U.S.
Research and Development Expenses.
−Removed: Research and development expenses, including personnel costs, allocated facility costs, lab supplies, outside services, contract laboratory costs related to manufacturing drug product, clinical trials and preclinical studies are charged to research and development expense as incurred.
−Removed: The Company accounts for nonrefundable advance
−Removed: payments for goods and services that will be used in future research and development activities as expense when the service has been performed or when the goods have been received.
−Removed: Our current NAVIGATE clinical trial is being supported by
−Removed: third-party contract research organizations, or CROs, and other vendors.
+Added: Research and development expenses, including personnel costs, allocated facility costs, lab supplies, outside
+Added: services, contract laboratory costs related to manufacturing drug product, clinical trials and preclinical studies are charged to research and development expense as incurred.
+Added: The Company accounts for nonrefundable advance payments for goods
+Added: and services that will be used in future research and development activities as expense when the service has been performed or when the goods have been received.
+Added: Our current NAVIGATE clinical trial is being supported by third-party contract
+Added: research organizations, or CROs, and other vendors.
We accrue expenses for clinical trial activities performed by CROs based upon the estimated amount of work completed on each trial.
−Removed: For clinical trial expenses and related
−Removed: expenses associated with the conduct of clinical trials, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites, and the duration for which the patients have been
−Removed: enrolled in the trial.
−Removed: We monitor patient enrollment levels and related activities to the extent possible through internal reviews, review of contractual terms and correspondence with CROs.
−Removed: We base our estimates on the best information
−Removed: available at the time.
−Removed: We monitor patient enrollment levels and related activities to the extent possible through discussions with CRO personnel and based our estimates of clinical trial costs on the best information available at the time.
−Removed: However, additional information may become available to us which will allow us to make a more accurate estimate in future periods.
−Removed: In that event, we may be required to record adjustments to research and development expenses in future periods
−Removed: when the actual level of activity becomes more certain.
+Added: For clinical trial expenses and related expenses associated
+Added: with the conduct of clinical trials, the significant factors used in estimating accruals include the number of patients enrolled, the number of active clinical sites, and the duration for which the patients have been enrolled in the trial.
+Added: monitor patient enrollment levels and related activities to the extent possible through internal reviews, review of contractual terms and correspondence with CROs.
+Added: We base our estimates on the best information available at the time.
+Added: patient enrollment levels and related activities to the extent possible through discussions with CRO personnel and based our estimates of clinical trial costs on the best information available at the time.
+Added: However, additional information may
+Added: become available to us which will allow us to make a more accurate estimate in future periods.
+Added: In that event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity
+Added: becomes more certain.
Stock-Based Compensation .
−Removed: Stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the service period, which generally represents the vesting period.
−Removed: For awards that have performance-based vesting conditions the Company recognizes the expense over the estimated period that the awards are
−Removed: expected to be earned.
−Removed: The Company generally uses the Black-Scholes option-pricing model to calculate the grant date fair value of stock options.
−Removed: The expense recognized over the service period is required to include an estimate of the awards
−Removed: that will be forfeited.
+Added: Stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the service
+Added: period, which generally represents the vesting period.
+Added: For awards that have performance-based vesting conditions the Company recognizes the expense over the estimated period that the awards are expected to be earned.
+Added: The Company generally uses
+Added: the Black-Scholes option-pricing model to calculate the grant date fair value of stock options.
+Added: The expense recognized over the service period is required to include an estimate of the awards that will be forfeited.
Quantitative and Qualitative Disclosures About Market Risk
4 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.