25 unchanged sentences
We hold worldwide development and commercialization rights, including through exclusive licenses, to all of our product candidates, which allows us to strategically maximize value from our product portfolio over time.
−Removed: We hold worldwide development and commercialization rights, including through exclusive licenses, to all of our product candidates, which allows us to strategically maximize value from our product portfolio over time.
Our patent portfolio includes patent protection for our upstream complement platform and each of our product candidates.
2 unchanged sentences
We do not have any products approved for sale, and we have not generated any revenue from product sales.
−Removed: We have incurred net losses each year since our inception.
−Removed: Our net losses were $31.3 million and $12.2 million for the three months ended June 30 , 2021 and 2020 , respectively .
−Removed: Our net losses were $ 57.4 million and $ 24.6 million for the six months ended June 30, 2021 and 2020, respectively.
−Removed: As of June 30 , 2021 , we had an accumulated deficit of $223.3 million and cash and cash equivalents and short-term investment s of $302.4 million .
+Added: We have incurred net losses each year since our
+Added: Our net losses were $35.6 million and $ 15.6 million for the three months ended September 30 , 2021 and 2020 , respectively .
+Added: Our net losses were $ 93.0 million and $ 40.2 million for the nine months ended September 30, 2021 and 2020, respectively.
+Added: As of September 30 , 2021 , we had an accumulated deficit of $258.9 million and cash and cash equivalents and short-term investment s of $271.4 million .
Initial Public Offering
4 unchanged sentences
The COVID-19 pandemic continues to rapidly evolve, and its ongoing impact is uncertain and subject to change.
−Removed: For instance, we have experienced shortages in clinical site staff and longer timelines for clinical site initiation.
+Added: For instance, we have experienced interruption in clinical trial activities, shortages in clinical site staff, longer timelines for clinical site initiation and temporary shortages in lab kits and supplies.
We will continue to monitor the COVID-19 situation closely.
29 unchanged sentences
We also expect to increase the size of our administrative function to support the growth of our business.
−Removed: Other Income, Net
−Removed: Other income, net, primarily consists of non-recurring income from research grants and interest income earned on our cash equivalents and short-term investments.
+Added: Other Income (Expense), Net
+Added: Other income (expense), net, primarily consists of non-recurring income from research grants and interest income earned on our cash equivalents and short-term investments.
Results of Operations
−Removed: Comparison of the Three Months Ended June 30, 2021 and 2020
+Added: Comparison of the Three Months Ended September 30, 2021 and 2020
The following tables summarize our results of operations for the periods presented.
Three Months Ended
+Added: September 30,
(in thousands)
4 unchanged sentences
Loss from operations
−Removed: Other income, net
+Added: Other income (expense), net
Net loss before taxes
3 unchanged sentences
Three Months Ended
+Added: September 30,
(in thousands)
10 unchanged sentences
Not meaningful
−Removed: Research and development expenses increased by $15.3 million, or 165%, for the three months ended June 30, 2021 compared to the same period in 2020.
−Removed: The increase was primarily due to an increase of $6.1 million in direct clinical outside services related to our multiple ongoing and planned clinical trials for ANX005, ANX007 and ANX009 as well as preclinical outside services to support pre-IND activities for our ANX105 and our small molecule program.
−Removed: Contract manufacturing expense increased by $2.7 million related to the production of ANX005 and ANX009 as well as pre-IND manufacturing activities for ANX105 and our small molecule program.
+Added: Research and development expenses increased by $15.8 million, or 134%, for the three months ended September 30, 2021 compared to the same period in 2020.
+Added: The increase was primarily due to an increase of $8.2 million in direct clinical outside services related to our multiple ongoing and planned clinical trials in GBS, warm autoimmune hemolytic anemia, Huntington’s Disease, amyotrophic lateral sclerosis and geographic atrophy as well as preclinical outside services to support pre-IND activities for ANX105 and our small molecule program, ANX1502.
+Added: Contract manufacturing expense increased by $2.3 million related to the production of ANX005, ANX007, and ANX009 as well as pre-IND manufacturing activities for ANX105 and ANX1502.
Compensation and personnel-related expenses increased by $3.6 million, including an increase of $1.8 million in stock-based compensation, due to an increase in headcount.
−Removed: Direct consulting and professional services costs increased by $1.3 million related to external research and development during the three months ended June 30, 2021.
+Added: Direct consulting and professional services costs increased by $0.5 million related to the support of multiple functions including clinical development, translational, regulatory and project management.
Facilities and depreciation costs increased by $1.2 million due to the commencement of our new office lease in Brisbane, California.
1 unchanged sentence
Three Months Ended
+Added: September 30,
(in thousands)
5 unchanged sentences
Not meaningful
−Removed: General and administrative expenses increased by $3.9 million, or 131%, for the three months ended June 30, 2021 compared to the same period in 2020.
+Added: General and administrative expenses increased by $4.3 million, or 113%, for the three months ended September 30, 2021 compared to the same period in 2020.
The increase was primarily due to an increase of $1.9 million in compensation and personnel-related expenses, including an increase of $1.2 million in stock-based compensation, due to an increase in headcount.
−Removed: Consulting and professional services for accounting, legal and audit fees, and directors and officers liability insurance increased by $0.8 million during the three months ended June 30, 2021.
+Added: Consulting and professional services for accounting, legal and audit fees, and directors and officers’ liability insurance increased by $1.8 million during the three months ended September 30, 2021.
Facilities and depreciation costs increased by $0.5 million due to the commencement of our new office lease in Brisbane, California.
−Removed: Comparison of the Six Months Ended June 30, 2021 and 2020
+Added: Comparison of the Nine Months Ended September 30, 2021 and 2020
The following tables summarize our results of operations for the periods presented.
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
(in thousands)
9 unchanged sentences
Research and Development Expenses
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
(in thousands)
10 unchanged sentences
Not meaningful
−Removed: Research and development expenses increased by $25.8 million, or 132%, for the six months ended June 30, 2021 compared to the same period in 2020.
−Removed: The increase was primarily due to an increase of $9.9 million in direct clinical outside services related to our multiple ongoing and planned clinical trials for ANX005, ANX007 and ANX009 as well as preclinical outside services to support pre-IND activities for our ANX105 and our small molecule program.
−Removed: Contract manufacturing expense increased by $4.9 million related to the production of ANX005 and ANX009 as well as pre-IND manufacturing activities for ANX105 and our small molecule program.
+Added: Research and development expenses increased by $41.6 million, or 133%, for the nine months ended September 30, 2021 compared to the same period in 2020.
+Added: The increase was primarily due to an increase of $18.1 million in direct clinical outside services related to our multiple ongoing and planned clinical trials in GBS, warm autoimmune hemolytic anemia, Huntington’s Disease, amyotrophic lateral sclerosis and geographic atrophy as well as preclinical outside services to support pre-IND activities for ANX105 and our small molecule program, ANX1502.
+Added: Contract manufacturing expense increased by $7.2 million related to the production of ANX005, ANX007, and ANX009 as well as pre-IND manufacturing activities for ANX105 and ANX1502.
Compensation and personnel-related expenses increased by $10.4 million, including an increase of $5.0 million in stock-based compensation, due to an increase in headcount.
−Removed: Direct consulting and professional services costs increased by $2.5 million related to external research and development during the six months ended June 30, 2021.
+Added: Direct consulting and professional services costs increased by $3.0 million related to the support of multiple functions including clinical development, translational, regulatory and project management.
Facilities and depreciation costs increased by $2.5 million due to the commencement of our new office lease in Brisbane, California.
General and Administrative Expenses
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
(in thousands)
5 unchanged sentences
Not meaningful
−Removed: General and administrative expenses increased by $7.1 million, or 137%, for the six months ended June 30, 2021 compared to the same period in 2020.
+Added: General and administrative expenses increased by $11.4 million, or 127%, for the nine months ended September 30, 2021 compared to the same period in 2020.
The increase was primarily due to an increase of $6.1 million in compensation and personnel-related expenses, including an increase of $4.0 million in stock-based compensation, due to an increase in headcount.
−Removed: Consulting and professional services for accounting, legal and audit fees, and directors and officers liability insurance increased by $2.1 million during the six months ended June 30, 2021.
+Added: Consulting and professional services for accounting, legal and audit fees and directors and officers’ liability insurance increased by $3.9 million during the nine months ended September 30, 2021.
Facilities and depreciation costs increased by $1.2 million due to the commencement of our new office lease in Brisbane, California.
3 unchanged sentences
We have funded our operations primarily through the sale of equity securities.
−Removed: From our inception through June 30, 2021, we have raised net cash proceeds of $233.9 million from private placements of our redeemable convertible preferred stock and $262.4 million from the IPO of our common stock.
−Removed: As of June 30, 2021, we had available cash and cash equivalents and short-term investments of $302.4 million and an accumulated deficit of $223.3 million.
+Added: From our inception through September 30, 2021, we have raised net cash proceeds of $233.9 million from private placements of our redeemable convertible preferred stock and $262.4 million from the IPO of our common stock.
+Added: As of September 30, 2021, we had available cash and cash equivalents and short-term investments of $271.4 million and an accumulated deficit of $258.9 million.
Historical Cash Flows
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
(in thousands)
−Removed: Cash used in operating activities
−Removed: Cash used in investing activities
−Removed: Cash provided by financing activities
−Removed: Net (decrease) increase in cash, cash equivalents and restricted cash
+Added: Net cash used in operating activities
+Added: Net cash used in investing activities
+Added: Net cash provided by financing activities
+Added: (Decrease) increase in cash, cash equivalents and restricted cash
Cash Flows from Operating Activities
−Removed: Cash used in operating activities for the six months ended June 30, 2021 was $48.1 million, which consisted of a net loss of $57.4 million, partially offset by $9.5 million in non-cash charges and a net change of $0.3 million in our net operating assets and liabilities.
−Removed: The non-cash charges consisted of stock-based compensation of $7.5 million, depreciation and amortization of $1.0 million, and accretion of discount on available-for sale securities of $0.5 million, and reduction in the carrying amount of right-of-use assets of $0.5 million.
−Removed: Cash used in operating activities for the six months ended June 30, 2020 was $20.2 million, which consisted of a net loss of $24.6 million, partially offset by $1.7 million in non-cash charges and a net change of $2.7 million in our net operating assets and liabilities.
+Added: Cash used in operating activities for the nine months ended September 30, 2021 was $77.8 million, which consisted of a net loss of $93.0 million, partially offset by $15.4 million in non-cash charges and a net change of $0.2 million in our operating assets and liabilities.
+Added: The non-cash charges consisted of stock-based compensation of $11.9 million, depreciation and amortization of $1.6 million, accretion of discount on available-for-sale securities of $0.9 million, and reduction in the carrying amount of right-of-use assets of $0.9 million.
+Added: Cash used in operating activities for the nine months ended September 30, 2020 was $33.8 million, which consisted of a net loss of $40.2 million, partially offset by $3.3 million in non-cash charges and a net change of $3.1 million in our operating assets and liabilities.
The non-cash charges consisted of stock-based compensation of $2.9 million and depreciation and amortization of $0.4 million.
Cash Flows from Investing Activities
−Removed: Cash used in investing activities for the six months ended June 30, 2021 was $120.7 million, which consisted of $159.6 million of purchases of available-for-sale securities, $33.0 million of maturities of available-for-sale securities, and $6.0 million of proceeds from sale of available-for-sale securities.
−Removed: Cash used in investing activities for the six months ended June 30, 2020 was related to immaterial purchase of property and equipment.
+Added: Cash used in investing activities for the nine months ended September 30, 2021 was $121.9 million, which consisted of $191.1 million of purchases of available-for-sale securities and $0.8 million of purchase of property and equipment, partially offset by $62.0 million of proceeds from maturities of available-for-sale securities and $8.0 million of proceeds from sale of available-for-sale securities.
+Added: Cash used in investing activities for the nine months ended September 30, 2020 was $0.3 million, related to purchase of property and equipment.
Cash Flows from Financing Activities
−Removed: Cash provided by financing activities for the six months ended June 30, 2021 was $0.9 million, related to proceeds from exercise of common stock options and employee stock purchase plan purchases.
−Removed: Cash provided by financing activities for the six months ended June 30, 2020 was $101.1 million, which consisted of gross proceeds received from sale and issuance of our Series D redeemable convertible preferred stock of approximately $102.0 million and proceeds of $0.5 million from a Paycheck Protection Program loan, partially offset by payments for deferred offering costs of $0.9 million and repayments of $0.5 million of the Paycheck Protection Program loan.
+Added: Cash provided by financing activities for the nine months ended September 30, 2021 was $0.8 million, related to $1.2 million of proceeds from the exercise of common stock options and employee stock purchase plan purchases, partially offset by $0.4 million of deferred offering costs.
+Added: Cash provided by financing activities for the nine months ended September 30, 2020 was $360.9 million, which consisted of the net proceeds of $262.4 million from the IPO, net of underwriting discounts and expenses, the net proceeds received from sale and issuance of our Series D redeemable convertible preferred stock of approximately $96.8 million, and proceeds of $0.5 million from the Paycheck Protection Program loan, partially offset by repayment of the $0.5 million Paycheck Protection Program loan.
Funding Requirements
17 unchanged sentences
the timing, receipt and amount of sales of any future approved products.
−Removed: Based upon our current operating plan, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements through 2023.
+Added: Based upon our current operating plan, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into 2024.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.
13 unchanged sentences
As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
−Removed: As of June 30, 2021, we retained our eligibility as a smaller reporting company as well as an emerging growth company.
−Removed: Because (i) the aggregate worldwide market value of our voting common stock held by non-affiliates (or “public float”) exceeded $700 million on June 30, 2021, (ii) we will have been subject to the reporting requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, for at least twelve calendar months, (iii) we have previously filed an annual report under Section 13(a) or 15(d) of the Exchange Act and (iv) we will not be eligible for smaller reporting company status because we exceed the public float and revenue threshold for such status, we will qualify as a “large accelerated filer” under Rule 12b-2 of the Exchange Act as of the end of the current fiscal year.
+Added: As of September 30, 2021, we retained our eligibility as a smaller reporting company as well as an emerging growth company.
+Added: Because (i) the aggregate worldwide market value of our voting common stock held by non-affiliates, or public float, exceeded $700 million on June 30, 2021, (ii) we will have been subject to the reporting requirements of Section 13(a) or 15(d) of the Exchange Act for at least twelve calendar months, (iii) we have previously filed an annual report under Section 13(a) or 15(d) of the Exchange Act and (iv) we will not be eligible for smaller reporting company status because we exceed the public float and revenue threshold for such status, we will qualify as a “large accelerated filer” under Rule 12b-2 of the Exchange Act as of the end of the current fiscal year.
As a large accelerated filer, we will no longer qualify as an emerging growth company.
23 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.