9 unchanged sentences
Eledon Pharmaceuticals, Inc.
−Removed: (“Eledon” or the “Company”) is a clinical stage biopharmaceutical company focused on developing life-changing, targeted medicines for persons living with an autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (“ALS”) .
+Added: (“Eledon” or the “Company”) is a clinical stage biopharmaceutical company focused on discovering or acquiring, and then developing life-changing, targeted medicines for persons requiring an organ or cell-based transplant, living with autoimmune disease, or living with amyotrophic lateral sclerosis (“ALS”) .
The company’s lead compound in development is AT-1501, an IgG1, anti-CD40L antibody with high affinity for CD40 ligand (CD40L, also called CD154), a well-validated biological target with broad therapeutic potential.
AT-1501 is engineered to potentially both improve safety and provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other anti-CD40 approaches.
−Removed: The CD40L/CD40 pathway is widely recognized for its prominent role in immune regulation.
+Added: The CD40L/CD40 pathway is recognized for its prominent role in immune regulation.
CD40L is primarily expressed on activated CD4+ T cells, platelets and endothelial cells while the CD40 receptor is constitutively expressed on antigen presenting cells such as B cells, macrophages, and dendritic cells.
7 unchanged sentences
We have completed a single ascending dose Phase 1 study of AT-1501 in healthy volunteers and people with ALS.
−Removed: In this study, the doses of AT-1501 studied were well tolerated in healthy subjects and adults with ALS, and demonstrated a safety profile comparable to placebo.
+Added: In this study, the doses of AT-1501 studied were well tolerated in healthy subjects and adults with ALS.
AT-1501 demonstrated low anti-drug antibody responses that were not dose related, linear dose proportionality across the dose ranges, and a half-life of up to 26 days.
We plan to develop AT-1501 in up to four indications:
−Removed: prevention of kidney allograft rejection, prevention of islet cell allograft rejection, autoimmune nephritis, and ALS.
+Added: ALS, prevention of kidney allograft rejection, prevention of islet cell allograft rejection, and IgA Nephropathy.
We selected our indications based on preclinical and clinical data that was generated with either our molecule or historical anti-CD40L molecules.
1 unchanged sentence
In November 2020, we received clearance from Health Canada to proceed with the initiation of a Phase 2 clinical trial of AT-1501 in islet cell transplantation for the treatment of type 1 diabetes.
−Removed: Prior to our acquisition of Anelixis, we had been focused on developing medicines for patients with disorders of the ear, nose, and throat (“ENT”).
+Added: In July 2021, we received clearance from Health Canada to proceed with initiation of a Phase 1b clinical trial of AT-1501 in patients undergoing kidney transplantation.
+Added: Prior to our acquisition of Anelixis, we had focused on developing medicines for patients with disorders of the ear, nose, and throat (“ENT”).
In June 2020, we announced that our lead program did not achieve statistical significance for the primary efficacy endpoints in the treatment of acute otitis media.
−Removed: As a result of this failure to achieve the primary study endpoint, we suspended the clinical development of our legacy ENT assets while we assessed potential development strategies.
+Added: As a result of this failure to achieve the primary study endpoint, we suspended the clinical development of our legacy ENT assets while we assessed potential development
Following the June 2020 announcement, we significantly curtailed development expenses as we sought to identify strategic alternatives that would maximize stockholder value.
As a result of these activities, we acquired Anelixis and raised additional capital in September 2020, as described above .
+Added: Subsequent to our acquisition of Anelixis, we undertook a strategic review of the legacy ENT assets.
+Added: We concluded this review and determined that the best path forward was to terminate license agreements associated with these ENT assets and return the rights to the original license holders, which we did in July.
+Added: There was no financial impact to returning these assets.
+Added: Amyotrophic Lateral Sclerosis
+Added: ALS is a progressive, paralytic disorder characterized by degeneration of motor neurons in the brain and spinal cord.
+Added: In the U.S., the incidence is estimated at approximately 5,000 cases per year with a prevalence of approximately 30,000 cases overall.
+Added: Despite 2 approved drugs, in most cases, death from respiratory failure occurs approximately 2 to 5 years after diagnosis, with 50% of patients living ≥ 3 years from diagnosis and only 20% of patients living ≥ 5 years from diagnosis.
+Added: Neuroinflammation in ALS is characterized by the infiltration of lymphocytes and macrophages into the central nervous system, and the activation of microglia and reactive astrocytes.
+Added: Reactive astrocytes and microglia as well as infiltrating lymphocytes, dendritic cells, monocytes, macrophages and immune complexes have been identified in cerebrospinal fluid and neural tissues in both animal models of ALS and at autopsy in ALS patients.
+Added: While the exact pathogenic mechanism of ALS is still not fully understood, there is strong evidence indicating that this neuroinflammation plays an important role in the disease’s pathogenesis.
+Added: AT-1501 is designed to block CD40L binding to CD40, thereby potentially inhibiting neuroinflammatory pathways leading to disease progression in ALS.
+Added: In vitro proof-of-concept studies have shown that AT-1501 binds to CD40L in human cells and blocks CD40L binding on APCs and activated T cells.
+Added: The potential for therapeutic benefit of CD40L blockage in treating ALS has been demonstrated in a SOD1 mouse model of ALS, where a murine anti-CD40L antibody, MR1, prolonged survival and delayed the onset of neurological disease progression.
+Added: These clinical manifestations are believed to be due to reduced immune cell infiltration of macrophages into skeletal muscle and their destroying denervated nerves.
+Added: The plasticity of the nervous system to repair itself in the absence of this immune cell attack is believed to result in improved neuromuscular junction occupancy and improved muscle function.
+Added: Blocking CD40L signaling also prevents pro-inflammatory polarization of lymphocytes, reduced neuroinflammation and improved motor neuron survival in rodent ALS models.
+Added: In October 2020, we initiated a Phase 2a, open-label, multi-center study to evaluate the safety and tolerability of multiple doses of AT-1501 in adult subjects with ALS.
+Added: Approximately 54 subjects with ALS are planned to be enrolled into the study in the United States and Canada at up to 13 ALS treatment sites.
+Added: Ascending doses of AT-1501 will be administered as IV infusions to four sequentially enrolling cohorts.
+Added: The first two cohorts will consist of nine participants, and the last two cohorts of 18 participants, who will each receive six bi-weekly infusions of AT-1501 over a 12-week study period.
+Added: Blood samples for target engagement, and exploratory biomarkers for inflammation and neurodegeneration will be taken and analyzed.
+Added: Participant-focused clinical outcomes will also be assessed.
Kidney transplantation:
1 unchanged sentence
Kidney transplantation is the most common type of solid organ transplantation in the United States with an estimated 200,000 Americans living with a transplanted kidney.
−Removed: In 2019, an estimated 23,000 kidneys were transplanted, of which 10-15% were re-transplants in persons that had already received at least one other kidney.
+Added: In 2019, an estimated 23,000 kidneys were transplanted in the U.S., of which 10-15% were re-transplants in persons that had already received at least one other kidney.
Over 90,000 people in the U.S.
1 unchanged sentence
Calcineurin inhibitor (“CNI”s) are a critical component of many immunosuppressive regimens to prevent acute and long-term kidney transplant rejection.
−Removed: However, chronic exposure to certain CNIs including tacrolimus is associated with nephrotoxicity, cardiotoxicity, an increase in opportunistic infections, increased malignancies, and an increase in type 1 diabetes due to pancreatic Beta cell toxicity.
+Added: However, chronic exposure to certain CNIs, including tacrolimus, is associated with nephrotoxicity, cardiotoxicity, an increase in opportunistic infections, increased malignancies, and an increase in diabetes due to pancreatic Beta cell toxicity.
These liabilities may result in a requirement for reduced exposures to CNIs over long periods of time and a resulting decrease in the ability to prevent long-term rejection.
2 unchanged sentences
Several historical studies have described the effects of anti-CD40L antibodies in nonhuman primate models of kidney transplant and shown that even short courses of anti CD40L therapy can prevent both acute rejection and long-term rejection in nonhuman primates with durable efficacy.
+Added: In July 2021, we received clearance from Health Canada to proceed with initiation of a Phase 1b clinical trial of AT-1501 as a replacement for tacrolimus (a CNI), as an immunosuppressive regimen component in patients undergoing kidney transplantation.
Islet cell transplantation (“ICT”):
3 unchanged sentences
Impaired awareness of hypoglycemia for people with type 1 diabetes is associated with severe hypoglycemic events which can lead to significant symptoms and even death.
−Removed: Pancreatic islet cell transplantation is gaining attention as a therapeutic option for type 1 diabetes because it can restore physiological insulin secretion, minimize the risk of hypoglycemic unawareness, and reduce the risk of death due to severe hypoglycemia.
+Added: Pancreatic islet cell transplantation may be a therapeutic option for type 1 diabetes because it can restore physiological insulin secretion, minimize the risk of hypoglycemic unawareness, and reduce the risk of death due to severe hypoglycemia.
The advances made in this field over the past decade have improved patient outcomes, and the procedure has been evolving from an experimental treatment to a clinical treatment option.
4 unchanged sentences
AT-1501 seeks to address the challenges associated with current ICT immunosuppressive regimens using CNI-based therapies, by replacing the CNIs with AT-1501.
−Removed: CD40L blockade may abolish many effector mechanisms of inflammation, prevent and intervene in the progression of autoimmunity, and instill transplant tolerance.
+Added: CD40L blockade may abolish many effector mechanisms of inflammation, prevent and intervene in the progression of alloimmunity, and instill transplant tolerance.
Historical studies in nonhuman primate models of islet cell transplantation have demonstrated that treatment with anti-CD40L antibodies induces long term islet cell function and graft survival, even as a monotherapy.
−Removed: AT-1501 has shown pre-clinical, proof-of-concept efficacy in a non-human primate model of t ype 1 d iabetes, where animals undergoing ICT maintained glucose control and sustained levels of C-peptide with chronic AT-1501 treatment for up to a year.
−Removed: C ompared to combination immunosuppressive therapy including CNIs , AT-1501 monotherapy was more effective in preventing long term islet cell rejection, associated with better graft function, and showed an improved safety profile .
−Removed: Autoimmune Nephritis
−Removed: Autoimmune Nephritis refers to a group of autoimmune disorders associated with inflammation and eventual destruction of the kidney.
−Removed: These disorders include Lupus Nephritis (“LN”), focal segmental glomerulosclerosis (“FSGS”) and IgA Nephropathy (“IgAN”).
−Removed: Systemic lupus erythematosus, (“SLE”), is one of the largest autoimmune populations globally and up to an estimated 40 percent of people with SLE develop LN, which may lead to kidney dysfunction, dialysis and end stage renal disease.
−Removed: LN is an orphan disease with an estimated prevalence of between 65,000 and 120,000 persons in the United States.
−Removed: FSGS is also an orphan disease with an estimated prevalence of 40,000 people in the US and variable progression to end stage renal failure.
−Removed: FSGS results from renal podocyte injury associated with immune complex formation in the glomeruli.
−Removed: IgAN, also called Berger’s disease, is a type of glomerulonephritis that occurs when galactose-deficient IgA immune complexes build up in the kidneys, causing inflammation that ultimately damages kidney tissues.
+Added: AT-1501 has shown preclinical, proof-of-concept efficacy in a non-human primate model of type 1 diabetes, where animals undergoing ICT maintained glucose control and sustained levels of C-peptide with chronic AT-1501 treatment for up to a year.
+Added: Compared to combination immunosuppressive therapy including CNIs, AT-1501 monotherapy was more effective in preventing long term islet cell rejection, associated with better graft function, and showed an improved safety profile.
+Added: IgA Nephropathy
+Added: IgA Nephropathy (“IgAN”) is the leading cause of glomerulonephritis.
+Added: Disease manifestation and clinical presentation involves renal dysfunction characterized by proteinuria with a slow relentless course.
+Added: Approximately 30%-40% of patients ultimately reach end stage renal disease (ESRD).
+Added: The standard of care for ESRD is dialysis or kidney transplant, which represents a significant economic burden as well as a major impact on a patient’s quality of life.
With an estimated prevalence of approximately 140,000 persons in the United States, IgAN is one of the most common, orphan, kidney diseases.
There are currently no European Medicines Agency (“EMA”) or U.S.
−Removed: Food and Drug Administration (“FDA”) approved treatments for IgAN or FSGS, and only two approved by the FDA for LN, although immunosuppressants such as systemic steroids and CNIs are prescribed off-label.
−Removed: In historical preclinical animal models of lupus nephritis, anti-CD40L antibodies ameliorated disease progression, improved kidney function, reduced immune cell infiltrate into the kidney, and improved survival.
−Removed: Systemic biomarkers of SLE such as anti-dsDNA antibodies have also been reduced with anti-CD40L treatment in animal models.
−Removed: Similar data has been described in preclinical models of FSGS.
−Removed: FSGS models using historical anti-CD40L treatments have shown ameliorated kidney function as measured by a reduction in proteinuria and were associated with a decrease in immune cell infiltrate into the glomeruli.
−Removed: Amyotrophic Lateral Sclerosis
−Removed: ALS is a progressive, paralytic disorder characterized by degeneration of motor neurons in the brain and spinal cord.
−Removed: In the U.S., the incidence is estimated at approximately 5,000 cases per year with a prevalence of approximately 30,000 cases overall.
−Removed: Despite 2 approved drugs, in most cases, death from respiratory failure occurs approximately 2 to 5 years after diagnosis, with 50% of patients living ≥ 3 years from diagnosis and only 20% of patients living ≥ 5 years from diagnosis.
−Removed: Neuroinflammation in ALS is characterized by the infiltration of lymphocytes and macrophages into the central nervous system, and the activation of microglia and reactive astrocytes.
−Removed: Reactive astrocytes and microglia as well as infiltrating lymphocytes, dendritic cells, monocytes, macrophages and immune complexes have been identified in cerebrospinal fluid and neural tissues in both animal models of ALS and at autopsy in ALS patients.
−Removed: While the exact pathogenic mechanism of ALS is still not fully understood, there is strong evidence indicating that this neuroinflammation plays an important role in the disease’s pathogenesis.
−Removed: AT-1501 is designed to block CD40L binding to CD40, thereby potentially inhibiting neuroinflammatory pathways leading to disease progression in ALS.
−Removed: In vitro proof-of-concept studies have shown that AT-1501 binds to CD40L in human cells and blocks CD40L binding on APCs and activated T cells.
−Removed: The potential for therapeutic benefit of CD40L blockage in treating ALS has been demonstrated in a SOD1 mouse model of ALS, where a murine anti-CD40L antibody, MR1, prolonged survival and delayed the onset of neurological disease progression.
−Removed: These clinical manifestations are believed to be due to reduced immune cell infiltration of macrophages into skeletal muscle and their destroying denervated nerves.
−Removed: The plasticity of the nervous system to repair itself in the absence of this immune cell attack is believed to result in improved neuromuscular junction occupancy and improved muscle function.
−Removed: Blocking CD40L signaling also prevents pro-inflammatory polarization of lymphocytes, reduced neuroinflammation and improved motor neuron survival in rodent ALS models.
−Removed: In October 2020, we initiated a Phase 2 a , open-label, multi-center study to evaluate the safety and tolerability of multiple doses of AT-1501 in adult subjects with ALS.
−Removed: Approximately 54 subjects with ALS are planned to be enrolled into the study in the United States and Canada at up to 13 ALS treatment sites.
−Removed: A scending doses of AT-1501 will be administered as IV infusion s to four sequentially enrolling cohorts.
−Removed: The first two cohorts will consist of nine participants, and the last two cohorts of 18 participants, who will each receive six bi-weekly infusions of AT-1501 over a 12-week study period.
−Removed: Blood samples for target engagement , and exploratory biomarkers for inflammation and neurodegeneration will be taken and analyzed.
−Removed: Participant-focused clinical outcomes will also be assessed.
+Added: Food and Drug Administration (“FDA”) approved treatments for IgAN.
+Added: The pathophysiology of IgAN has been well characterized, and based on its mechanism of action, AT-1501 has the potential to impact the disease process both upstream, at the source of the immune complexes, and downstream in the kidney itself, where it may reduce inflammation in the glomeruli.
+Added: By disrupting multiple steps in the pathophysiology, AT-1501 has the potential to affect the clinical course of the disease and improve outcomes for patients.
+Added: The inhibition of CD40L has been shown to be effective in models of multiple glomerulonephritides, including lupus nephritis and focal segmental glomerulosclerosis.
COVID-19 Impact
17 unchanged sentences
Actual results may differ materially from these estimates under different assumptions or conditions.
−Removed: There have been no significant and material changes in our critical accounting policies and significant judgments and estimates during the six months ended June 30, 2021, as compared to those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020, filed by the Company with the SEC on March 31, 2021.
+Added: There have been no significant and material changes in our critical accounting policies and significant judgments and estimates during the nine months ended September 30, 2021, as compared to those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020, filed by the Company with the SEC on March 31, 2021.
RESULTS OF OPERATIONS
−Removed: Comparison of the Three Months Ended June 30, 2021 and 2020
−Removed: The following table provides comparative unaudited results of operations for the three months ended June 30, 2021 and 2020 (in thousands):
+Added: Comparison of the Three Months Ended September 30, 2021 and 2020
+Added: The following table provides comparative unaudited results of operations for the three months ended September 30, 2021 and 2020 (in thousands):
For the Three Months
−Removed: Ended June 30,
+Added: Ended September 30,
Operating expenses:
4 unchanged sentences
Loss from operations
−Removed: Other income (expense), net
+Added: Other income, net
Loss before income tax benefit
1 unchanged sentence
Research and Development Expenses
−Removed: Research and development expenses increased $3.4 million, to $4.2 million for the three months ended June 30, 2021, as compared to $832,000 for the three months ended June 30, 2020.
−Removed: The increase was primarily due to increases in costs related to the production of clinical trial materials and clinical costs as we advance our AT-1501 program of $842,000 and $921,000, respectively, an increase in consulting services of $443,000, as well as increases in personnel costs of $435,000, and stock-based compensation costs of $735,000 due to increased headcount.
−Removed: Additionally, general operating costs and travel-related costs increased $21,000 and $12,000, respectively.
+Added: Research and development expenses increased $7.0 million, to $7.7 million for the three months ended September 30, 2021, as compared to $0.6 million for the three months ended September 30, 2020.
+Added: The increase was primarily due to increases in costs related to the production of clinical trial materials and clinical costs of $3.2 million and $1.8 million, respectively, as we advance our AT-1501 program, an increase in consulting costs of $0.8 million, as well as increases in personnel costs of $0.7 million, and stock-based compensation costs of $0.5 million, due to increased headcount.
General and Administrative Expenses
−Removed: General and administrative expenses increased $2.5 million, to $3.7 million for the three months ended June 30, 2021, as compared to $832,000 for the three months ended June 30, 2020.
−Removed: The increase was primarily due to increases in stock-based compensation costs and personnel costs of $1.1 million and $750,000, respectively, due to increased headcount.
−Removed: The remaining increase of $650,000 was primarily due to legal fees and other professional costs associated with financing activities and higher insurance premiums, as well as general operating expenses.
+Added: General and administrative expenses decreased $0.9 million, to $2.8 million for the three months ended September 30, 2021, as compared to $3.7 million for the three months ended September 30, 2020.
+Added: The decrease was primarily due to $2.2 million of merger related expenses that were incurred in the three months ended September 30, 2020.
+Added: No merger related expenses were recorded for the three months ended September 30, 2021.
+Added: This was partially offset by an increase in stock-based compensation costs and personnel costs of $0.6 million and $0.3 million, respectively, due to increased headcount.
+Added: The remaining increase of $0.4 million was primarily due to an increase in legal fees and professional costs, higher insurance premiums, as well as higher general operating expenses.
Restructuring Expense
−Removed: On June 11, 2020, following the prior announcement of topline results of the Phase 2a Clinical Trial of OP0201 in Acute Otitis Media, the board of directors of the Company approved a reduction in force.
−Removed: The restructuring was completed on June 30, 2020.
−Removed: The Company incurred charges totaling $490,000 for the estimated cash payments related to employee separation costs, including severance and post-employment health benefits.
−Removed: No restructuring expenses were recorded for the period ended June 30, 2021.
−Removed: Other Income (Expense), Net
−Removed: The change in other income (expense), net was due to an increase in realized losses on foreign currency translation of $6,000 for the three months ended June 30, 2021.
+Added: On June 11, 2020, following the prior announcement of topline results of the Phase 2a Clinical Trial of OP0201 in acute otitis media, the Board of the Company approved a reduction in force.
+Added: Following the acquisition of Anelixis, the severance terms of certain terminated employees were modified.
+Added: Additionally, on September 3, 2020, the board of directors (the “Board”) of the Company accepted the resignation of Gregory Flesher as the Company’s Chief Executive Officer and a member of the Board.
+Added: Flesher’s resignation was effective as of the close of business on September 4, 2020.
+Added: The resignation of Mr.
+Added: Flesher was not the result of any dispute or disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
+Added: The Company incurred charges totaling $1.8 million for the estimated cash payments related to employee separation costs, including severance and post-employment health benefits for the three months ended September 30, 2020.
+Added: No restructuring expenses were recorded for the three months ended September 30, 2021.
+Added: Other Income, Net
+Added: The decrease in other income, net, was primarily due to a decrease in interest income for the three months ended September 30, 2021.
Income Tax Benefit
−Removed: The Company recognized an income tax benefit of $588,000 for the three months ended June 30, 2021 due to the current quarter change in deferred tax liabilities for acquired IPR&D related to the Anelixis acquisition.
−Removed: Comparison of the Six Months Ended June 30, 2021 and 2020
−Removed: The following table provides comparative unaudited results of operations for the six months ended June 30, 202 1 and 20 20 (in thousands):
−Removed: For the Six Months
−Removed: Ended June 30,
+Added: The Company recognized an income tax benefit of $0.7 million for the three months ended September 30, 2021 due to the current quarter change in deferred tax liabilities for acquired IPR&D related to the Anelixis acquisition.
+Added: Comparison of the Nine Months Ended September 30, 2021 and 2020
+Added: The following table provides comparative unaudited results of operations for the nine months ended September 30, 2021 and 2020 (in thousands):
+Added: For the Nine Months
+Added: Ended September 30,
Operating expenses:
9 unchanged sentences
Research and Development Expenses
−Removed: Research and development expenses increased $7.4 million, to $9.9 million for the six months ended June 30, 2021 as compared to $2.5 million for the six months ended June 30, 2020.
−Removed: The increase was primarily due to increases in production of clinical trial materials and clinical costs for AT-1501 of $3.1 million and $1.2 million, respectively, as well as increases in personnel costs of $835,000, stock-based compensation costs of $1.3 million, and consulting costs of $976,000.
−Removed: Additionally, general operating costs and travel-related costs increased $24,000 and $14,000, respectively.
+Added: Research and development expenses increased $14.5 million, to $17.6 million for the nine months ended September 30, 2021 as compared to $3.1 million for the nine months ended September 30, 2020.
+Added: The increase was primarily due to increases in production of clinical trial materials and clinical costs for AT-1501 of $6.3 million and $3.0 million, respectively, as well as increases in personnel costs of $1.6 million and stock-based compensation costs of $1.8 million, due to increased headcount, and consulting costs of $1.8 million .
General and Administrative Expenses
−Removed: General and administrative expenses increased $4.1 million, to $7.1 million for the six months ended June 30, 2021, as compared to $3.0 million for the three months ended June 30, 2020.
−Removed: The increase was primarily due to increases in stock-based compensation costs and personnel costs of $1.9 million and $826,000, respectively, due to increased headcount.
−Removed: The remaining increase of $1.4 million was primarily due to legal fees and other professional costs associated with financing activities and higher insurance premiums and general operating expenses.
+Added: General and administrative expenses increased $3.2 million, to $9.9 million for the nine months ended September 30, 2021, as compared to $6.7 million for the nine months ended September 30, 2020.
+Added: The increase was primarily due to an increase in stock-based compensation costs and personnel costs of $2.5 million and $1.1 million, respectively, due to increased headcount, as well as legal and professional costs, higher insurance premiums and general operating expenses of $1.8 million.
+Added: This was partially offset by a decrease of merger related expenses of $2.2 million that were incurred in the nine months ended September 30, 2020.
Restructuring Expense
−Removed: On June 11, 2020, following the prior announcement of topline results of the Phase 2a Clinical Trial of OP0201 in Acute Otitis Media, the board of directors of the Company approved a reduction in force.
+Added: On June 11, 2020, following the prior announcement of topline results of the Phase 2a Clinical Trial of OP0201 in acute otitis media, the Board of the Company approved a reduction in force.
The restructuring was completed on June 30, 2020.
−Removed: The Company incurred charges totaling $490,000 for the estimated cash payments related to employee separation costs, including severance and post-employment health benefits.
−Removed: No restructuring expenses were recorded for the period ended June 30, 2021.
+Added: Following the acquisition of Anelixis, the severance terms of certain terminated employees were modified.
+Added: Additionally, on September 3, 2020, the Board of the Company accepted the resignation of Gregory Flesher as the Company’s Chief Executive Officer and a member of the Board.
+Added: Flesher’s resignation was effective as of the close of business on September 4, 2020.
+Added: The resignation of Mr.
+Added: Flesher was not the result of any dispute or disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
+Added: The Company incurred charges totaling $2.3 million for the estimated cash payments related to employee separation costs, including severance and post-employment health benefits.
+Added: No restructuring expenses were recorded for the nine months ended September 30, 2021.
Other Income, Net
−Removed: The change in other income, net was primarily related to a decrease in interest income of $17,000, an increase of $12,000 in realized losses on foreign currency translation, and an increase of $2,000 in value added tax (“VAT”) paid in Israel for the six months ended June 30, 2020.
+Added: The change in other income, net , was related to a de crease in interest income and an in crease in realized losses on foreign currency translation for the nine month s ended September 30, 20 20 .
Warrant Inducement Expense
1 unchanged sentence
Income Tax Benefit
−Removed: The Company recognized an income tax benefit of $1.1 million for the six months ended June 30, 2021 due to the year to date change in deferred tax liabilities for acquired IPR&D related to the Anelixis acquisition.
+Added: The Company recognized an income tax benefit of $1.8 million for the nine months ended September 30, 2021 due to the year to date change in deferred tax liabilities for acquired IPR&D related to the Anelixis acquisition.
LIQUIDITY AND CAPITAL RESOURCES
−Removed: As of June 30, 2021, we had cash and cash equivalents of $101.1 million, consisting of readily available cash in bank accounts.
+Added: As of September 30, 2021, we had cash and cash equivalents of $94.0 million, consisting of readily available cash in bank accounts.
While we believe our cash is not subject to excessive risk, we maintain significant amounts of cash at one or more financial institutions that are in excess of federally insured limits.
22 unchanged sentences
The following table provides a summary of our net cash flow activity (in thousands):
−Removed: For the Six Months
−Removed: Ended June 30,
+Added: For the Nine Months
+Added: Ended September 30,
Net cash used in operating activities
+Added: Net cash provided by investing activities
Net cash (used in) provided by financing activities
Net change in cash and cash equivalents
−Removed: Comparison of the Six Months Ended June 30, 2021 and 2020
−Removed: Net cash used in operating activities for the six months ended June 30, 2021 consisted primarily of our net loss of $15.9 million, partially offset by the net change in non-cash items consisting primarily of stock-based compensation, depreciation and amortization, and income tax benefits totaling $2.8 million.
−Removed: Additionally, cash used in operating activities for the six months ended June 30, 2021 reflected a net increase in cash from changes in operating assets and liabilities of $462,000, primarily due to an increase in our prepaid expenses and other assets of $53,000, an increase in our accounts payable and other accrued expenses of $609,000, and a decrease in operating lease liability of $94,000.
−Removed: Net cash used in operating activities for the six months ended June 30, 2020 consisted primarily of our net loss of $10.8 million, partially offset by non-cash items consisting primarily of stock-based compensation and depreciation and amortization totaling $726,000, as well as warrant inducement expense of $4.8 million.
−Removed: Additionally, cash used in operating activities for the six months ended June 30, 2020 reflected a net decrease in cash from changes in operating assets and liabilities of $10,000, due to a decrease in accounts payable and accrued expenses as well as a decrease in operating lease liability, offset by a decrease in prepaid expenses and other assets.
−Removed: There was no cash provided by or used in the Company’s investing activities for the six months ended June 30, 2021 and 2020.
−Removed: Net cash used in financing activities for the six months ended June 30, 2021 was comprised of $450,000 of offering costs accrued as of December 31, 2020 in connection with the sale of shares of common stock and paid during the six months ended June 30, 2021 .
−Removed: Net cash provided by financing activities for the six months ended June 30, 2020 was comprised of $5.2 million in net proceeds from the exercise of warrants by stockholders to purchase approximately 6.9 million shares of common stock.
+Added: Comparison of the Nine Months Ended September 30, 2021 and 2020
+Added: Net cash used in operating activities for the nine months ended September 30, 2021 consisted primarily of our net loss of $25.7 million, and a decrease in the deferred tax liability of $1.8 million, partially offset by non-cash items consisting of stock-based compensation of $5.9 million, and amortization of operating lease assets of $0.1 million.
+Added: Additionally, cash used in operating activities for the nine months ended September 30, 2021 reflected a net increase in cash from changes in operating assets and liabilities of $1.8 million.
+Added: The increase in cash from changes in operating assets and liabilities was primarily due to an increase in accounts payable and other accrued expenses of $2.0 million, partially offset by an increase in prepaid and other assets as well as an increase in operating lease assets, net of lease liabilities, totaling $0.2 million.
+Added: Net cash used in operating activities for the nine months ended September 30, 2020 consisted primarily of our net loss of $16.9 million, partially offset by non-cash items consisting primarily of stock-based compensation and depreciation and amortization totaling $1.7 million, as well as warrant inducement expense of $4.8 million.
+Added: Additionally, cash used in operating activities for the nine months ended September 30, 2020 reflected a net increase in cash from changes in operating assets and liabilities of $4.6 million, due to an increase in accounts payable and accrued expenses and a decrease in prepaid expenses and other asset, offset by a decrease in operating lease liability.
+Added: There was no cash provided by or used in the Company’s investing activities for the nine months ended September 30, 2021.
+Added: Net cash provided by investing activities for the nine months ended September 30, 2020 consisted of cash and cash equivalents received from the acquisition of Anelixis.
+Added: Net cash used in financing activities for the nine months ended September 30, 2021 was comprised of $0.5 million of offering costs accrued as of December 31, 2020 in connection with the sale of shares of common stock and paid during the nine months ended September 30, 2021 .
+Added: Net cash provided by financing activities for the nine months ended September 30, 2020 was primarily comprised of $95.2 million in net proceeds from the 2020 Purchase Agreement for the sale of 199,112 shares of Series X 1 preferred stock and $5.2 million in net proceeds from the exercise of warrants by stockholders to purchase approximately 0.4 million shares of common stock.
CONTRACTUAL OBLIGATIONS AND COMMITMENTS
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