9 unchanged sentences
statements about accounting assumptions and estimates;
−Removed: expectations regarding liquidity and the sufficiency of cash to fund currently planned operations through at least September 30, 2021;
+Added: expectations regarding liquidity and the sufficiency of cash to fund currently planned operations through at least December 31, 2021;
our commitments and contingencies;
67 unchanged sentences
this study began enrolling patients in Q2-2020.
+Added: Recently the Company received a letter from FDA providing comments, asking questions and providing guidance on various aspects of the ongoing NASH-RX trial.
We endeavor to leverage our scientific and product development expertise as well as established relationships with outside sources to achieve cost-effective and efficient drug development.
42 unchanged sentences
The NASH CX trial top line data was reported in December 2017 and was published in Gastroenterology
−Removed: Based on recent FDA feedback, the NASH-RX
−Removed: trial is designed as an adaptive Phase 2b/3 trial for the prevention of varices in NASH patients with well compensated cirrhosis.
+Added: Based on FDA feedback, the NASH-RX
+Added: trial is an adaptive Phase 2b/3 trial for the prevention of varices in NASH patients with well compensated cirrhosis.
An interim efficacy analysis will be incorporated to confirm previous Phase 2 data, confirm an optimal dose and reaffirm efficacy, and the end of study endpoints will include development of varices and a composite clinical endpoint including progression to varices requiring treatment (large varices or varices with a red wale).
17 unchanged sentences
Investigator IND for that study submitted in September 2015.
−Removed: Early data was reported in
−Removed: February 2017 and studies with the 3 rd
+Added: Early data was reported in February 2017 and studies with the 3 rd
cohort were reported in September 2018.
195 unchanged sentences
Results of Operations
−Removed: Three and Six Months Ended June 30, 2020 Compared to Three and Six Months Ended June 30, 2019
+Added: Three and Nine Months Ended September 30, 2020 Compared to Three and Nine Months Ended September 30, 2019
Research and Development Expense.
Three Months Ended
−Removed: Six Months Ended
+Added: Nine Months Ended
2020 as Compared to 2019
+Added: September 30,
+Added: September 30,
(In thousands, except %)
6 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
+Added: September 30,
+Added: Nine Months Ended
+Added: September 30,
(in thousands)
3 unchanged sentences
Clinical programs expenses increased primarily due to costs related to our NASH-RX
−Removed: trial during the three and six month periods ended June 30, 2020 as compared to the same periods ended June 30, 2019.
−Removed: Other research and development expense increased primarily due to increased payroll related to the hiring of Dr.
+Added: trial during the three and nine month periods ended September 30, 2020 as compared to the same periods ended September 30, 2019.
+Added: Other research and development expense increased primarily due to increased payroll and non-cash
+Added: stock compensation expense related to the hiring of Dr.
Pol Boudes as Chief Medical Officer in March 2020.
6 unchanged sentences
2020 as Compared to 2019
−Removed: Ended June 30,
−Removed: Ended June 30,
+Added: Ended September 30,
+Added: Ended September 30,
(In thousands, except %)
1 unchanged sentence
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 expenses.
−Removed: The primary reasons for the decrease in general and administrative expenses for the three-months ended June 30, 2020 as compared to the same period in 2019 is due to a decrease in non-cash
−Removed: stock compensation expense of approximately $48,000.
−Removed: The primary reasons for the decrease in general and administrative expenses for the six-months
−Removed: ended June 30, 2020 as compared to the same period in 2019 is due to a decrease in non-cash
−Removed: stock compensation expense of approximately $101,000 and a decrease in legal expenses of $264,000 partially offset by an increase in insurance expense of $138,000.
+Added: The primary reasons for the decrease in general and administrative expenses for the three-months ended September 30, 2020 as compared to the same period in 2019 is due to a decrease in non-cash
+Added: stock compensation expense of approximately $70,000 and a decrease of approximately $67,000 in investor relations, business development and travel expenses due to less travel in 2020 due to the COVID-19
+Added: The primary reasons for the decrease in general and administrative expenses for the nine-months ended September 30, 2020 as compared to the same period in 2019 is due to a decrease in non-cash
+Added: stock compensation expense of approximately $171,000, a decrease in investor relations, business development and travel expenses of approximately $146,000 due to less travel in 2020 due to the COVID-19
+Added: pandemic, and a decrease in legal expenses of $281,000 partially offset by an increase in insurance expense of $211,000.
Liquidity and Capital Resources
Since our inception on July 10, 2000, we have financed our operations from proceeds of public and private offerings of debt and equity.
−Removed: As of June 30, 2020, we raised a net total of $197.4 million from these offerings.
+Added: As of September 30, 2020, we raised a net total of $197.4 million from these offerings.
We have operated at a loss since our inception and have had no significant revenues.
We anticipate that losses will continue for the foreseeable future.
−Removed: At June 30, 2020, the Company had $40.8 million of unrestricted cash and cash equivalents available to fund future operations.
+Added: At September 30, 2020, the Company had $32.6 million of unrestricted cash and cash equivalents available to fund future operations.
In December 2018, the Company announced the extension of its $10 million unsecured line of credit facility with stockholder and director, Richard E.
The Company has not drawn under the line of credit.
−Removed: The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through September 30, 2021.
−Removed: We will require more cash to fund our operations after September 30, 2021 and believe we will be able to obtain additional financing.
+Added: The Company believes there is sufficient cash, including availability of the line of credit, to fund currently planned operations at least through December 31, 2021.
+Added: We will require more cash to fund our operations after December 31, 2021 and believe we will be able to obtain additional financing.
The currently planned operations include costs related to a planned adaptively designed Phase 2b/3 clinical trial.
−Removed: The costs of the trial along with drug manufacturing and scientific support activities and general overhead during the first stage of the Phase 3 trial are currently estimated to be approximately $90 million.
−Removed: We will require additional funding in order to complete the trial.
+Added: Currently, we expect to require an additional approximately $40 million to cover costs of the trial to reach the planned interim analysis estimated to occur in the second quarter of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs.
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.
−Removed: Net cash used in operations increased by $1,361,000 to $6,975,000 for the six months ended June 30, 2020, as compared to $5,614,000 for the six months ended June 30, 2019.
+Added: Net cash used in operations increased by $8,098,000 to $15,187,000 for the nine months ended September 30, 2020, as compared to $7,089,000 for the nine months ended September 30, 2019.
Cash operating expenses increased principally due to our NASH-RX
clinical trial with belapectin.
−Removed: Net cash provided by financing activities for the six months ended June 30, 2020, of $263,000 represents proceeds of $219,000 from the exercise of common stock options and $44,000 in net proceeds from issuance of common shares under our ATM.
−Removed: Net cash provided by financing activities for the six months ended June 30, 2019, of $49,404,000 represents proceeds from the issuance of common stock from the stockholder rights offering of $44,889,000, from the ATM of $1,865,000 and $2,650,000 from the exercise of common stock options and warrants.
+Added: Net cash provided by financing activities for the nine months ended September 30, 2020, of $263,000 represents proceeds of $219,000 from the exercise of common stock options and $44,000 in net proceeds from issuance of common shares under our ATM.
+Added: Net cash provided by financing activities for the nine months ended September 30, 2019, of $49,173,000 represents proceeds from the issuance of common stock from the stockholder rights offering of $44,889,000, from the ATM of $2,028,000 and $2,650,000 from the exercise of common stock options and warrants offset partially by $394,000 paid in dividends on convertible preferred stock.
Sheet Arrangements
11 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.