What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2021-11-12 compared with 2021-08-11 · 72 added, 67 removed, 154 unchanged (47% of the section changed)

9 unchanged sentences

Built on more than a decade of foundational science on extracellular tRNA synthetase biology and its effect on immune responses, we have built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets, such as neuropilin-2 (NRP2).

Our lead clinical product candidate, ATYR1923, a is a selective modulator of NRP2 that downregulates both the innate and adaptive immune responses in uncontrolled inflammatory disease states.

Our lead clinical product candidate, ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of NRP2 that downregulates innate and adaptive immune response in inflammatory disease states.

We are developing ATYR1923 as a potential disease-modifying therapy for patients with severe inflammatory lung diseases with high unmet medical need.

This includes interstitial lung diseases (ILD), a group of rare immune-mediated disorders that cause progressive fibrosis of the lung, and severe respiratory complications caused by COVID-19.

We selected pulmonary sarcoidosis as our first ILD indication and completed enrollment in a Phase 1b/2a multi-center clinical trial.

The study has been designed to evaluate the safety, tolerability, steroid-sparing effect and immunogenicity of multiple doses of ATYR1923 and to evaluate established clinical endpoints and certain biomarkers to assess preliminary clinical activity of ATYR1923.

In July 2021, we announced completion of the last patient visit and expect to report data in mid-September 2021.

The results of this study will guide future development of ATYR1923 in pulmonary sarcoidosis and provide insight for the potential of ATYR1923 in other ILD such as chronic hypersensitivity pneumonitis (CHP) and connective tissue disease related ILD (CTD-ILD).

We designed a Phase 1b/2a multiple-ascending dose, double-blind, placebo-controlled clinical trial in patients with pulmonary sarcoidosis, a major form of ILD, to evaluate the safety, tolerability, steroid-sparing effect and immunogenicity of ATYR1923 and to evaluate established clinical endpoints and certain biomarkers to assess preliminary clinical activity of ATYR1923.

In September 2021, we announced positive results and clinical proof-of-concept from the Phase 1b/2a clinical trial in 37 patients with pulmonary sarcoidosis.

ATYR1923 was safe and well-tolerated at all doses with no drug-related serious adverse events or signal of immunogenicity.

Additionally, the study demonstrated consistent dose response for ATYR1923 on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.

Based on the results of this study, we plan to meet with the U.S.

Food and Drug Administration (FDA) to present these data and our plans for subsequent clinical development and path to registration for ATYR1923 for pulmonary sarcoidosis, and we expect to initiate a registrational trial next year.

Based on the results of this study, we believe in the potential of ATYR1923 in other ILD, such as chronic hypersensitivity pneumonitis (CHP) and connective tissue disease related ILD (CTD-ILD).

In response to the COVID-19 pandemic, we conducted a Phase 2 study in patients with COVID-19 related severe respiratory complications.

The study was designed to evaluate the safety and preliminary efficacy of ATYR1923 as compared to placebo through the assessment of key clinical outcome measures.

In early 2021, we reported positive data which showed that the trial met its primary endpoint of safety, demonstrating that a single, intravenous (IV) dose of ATYR1923 was generally safe and well-tolerated in both the 1.0 and 3.0 mg/kg treatment groups, with no drug-related serious adverse events.

3.0 mg/kg treatment groups, with no drug-related serious adverse events.

The study also showed a signal of activity in the 3.0 mg/kg cohort.

In addition, patients treated with ATYR1923 demonstrated a trend of overall improvement in key biomarkers analyzed compared to placebo.

In addition, p atients treated with ATYR1923 demonstrated a trend of overall improvement in key biomarkers analyzed compared to placebo.

We plan on leveraging data from our ATYR1923 Phase 2 clinical trial in COVID-19 patients with severe respiratory complications for our mechanistic understanding of ATYR1923 and for its application in ILD.

5 unchanged sentences

In September 2020, Kyorin began dosing patients in a Phase 1 clinical trial of ATYR1923 (known as KRP-R120 in Japan) and completed the last subject visit in December 2020.

The Phase 1 clinical trial, which was conducted and funded by Kyorin, is a placebo-controlled clinical trial to evaluate the safety, pharmacokinetics (PK) and immunogenicity of ATYR1923 in 32 healthy Japanese male volunteers.

ATYR1923 was observed to be generally safe and well-tolerated with no drug-related serious adverse events and PK findings were consistent with previous studies of ATYR1923.

The Phase 1 clinical trial, which was conducted and funded by Kyorin, was a placebo-controlled clinical trial to evaluate the safety, pharmacokinetics (PK) and immunogenicity of ATYR1923 in 32 healthy Japanese male volunteers.

ATYR1923 was observed to be generally well-tolerated with no drug-related serious adverse events and PK findings were consistent with previous studies of ATYR1923.

We received an $8.0 million upfront payment in January 2020 and a $2.0 million milestone payment in January 2021 upon completion of enrollment in the Phase 1 clinical trial, and are eligible to receive up to an additional $165.0 million in the aggregate upon achievement of certain development, regulatory and sales milestones, as well as tiered royalties ranging from the mid-single digits to mid-teens on net sales in Japan.

2 unchanged sentences

ATYR2810 is a fully humanized monoclonal antibody that specifically and functionally blocks the interaction between NRP2 and one of its primary ligands, vascular endothelial growth factor (VEGF).

ATYR2810 is in preclinical development for the potential treatment of certain aggressive cancers where NRP2 is implicated.

NRP2 is highly expressed on certain tumors and increased NRP2 expression is associated with worse outcomes in many cancers, such as overall survival, metastasis and resistance to targeted therapies.

The role of NRP2 and VEGF signaling in the tumor microenvironment and its importance in the progression of certain aggressive cancers is becoming increasingly validated.

ATYR2810 is in preclinical development for the potential treatment of certain aggressive cancers where NRP2 is implicated and we plan to submit an IND application and initiate a Phase 1 clinical trial in 2022.

In March 2020, our subsidiary, Pangu BioPharma Limited (Pangu BioPharma), together with the Hong Kong University of Science and Technology (HKUST) was awarded a grant of approximately $750,000 to build a high-throughput platform for the development of bi-specific antibodies.

6 unchanged sentences

The impact of the COVID-19 pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.

Impacts to our business have included delayed enrollment of our Phase 1b/2a clinical trial in patients with pulmonary sarcoidosis and the discontinuation of some patients in that trial, temporary closures of portions of our facilities and those of our licensees and collaborators, disruptions or restrictions on our employee's ability to travel and delays in certain research and development activities.

Other potential impacts to our business include, but are not limited to disruptions to or delays in other clinical trials, third-party manufacturing supply and other operations, inflation, the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, interruptions or delays in the operations of the FDA or other regulatory authorities, and our ability to raise capital and conduct business development activities.

Impacts to our business have included delayed enrollment of our now completed Phase 1b/2a clinical trial in patients with pulmonary sarcoidosis and the discontinuation of some patients in that trial, temporary closures of portions of our facilities and those of our licensees and collaborators, disruptions or restrictions on our employee's ability to travel and delays in certain research and development activities.

Other potential impacts to our business include, but are not limited to disruptions to or delays in planned clinical trials, third-party manufacturing supply and other operations, inflation, the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, interruptions or delays in the operations of the FDA or other regulatory authorities, and our ability to raise capital and conduct business development activities.

Liquidity and Capital Resources

We have incurred losses and negative cash flows in each year from operations since our inception.

As of June 30, 2021, we had an accumulated deficit of $356.1 million and we expect to continue to incur net losses for the foreseeable future.

As of June 30, 2021, we had cash, cash equivalents and available-for-sale investments of $44.1 million.

We have incurred losses and negative cash flows from operations in each year since our inception.

As of September 30, 2021, we had an accumulated deficit of $363.7 million and we expect to continue to incur net losses for the foreseeable future.

As of September 30, 2021, we had cash, cash equivalents and available-for-sale investments of $116.4 million.

We believe that our current cash, cash equivalents and available-for-sale investments, will be sufficient to meet our anticipated cash requirements for a period of at least one year from the date of this Quarterly Report on Form 10-Q.

Sources of Liquidity

From our inception through June 30, 2021, we have financed our operations primarily through the sale of equity securities and convertible debt, venture debt, term loans and through license and collaboration agreement revenues.

From our inception through September 30, 2021, we have financed our operations primarily through the sale of equity securities and convertible debt, venture debt, term loans and through license and collaboration agreement revenues.

Sales of Equity Securities

In September 2021, we completed an underwritten follow-on public offering of 10,781,250 shares of our common stock, including the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $8.00 per share.

The total net proceeds from the offering were approximately $80.6 million, after deducting underwriting discounts, commissions and offering expenses payable by us.

In February 2020, we completed an underwritten follow-on public offering of 4,235,294 shares of our common stock at a price to the public of $4.25 per share.

In March 2020, the underwriters fully exercised their option to purchase additional shares resulting in the issuance of an additional 635,294 shares of common stock.

The total net proceeds from the offering were approximately $18.8 million, after deducting underwriting discounts, commissions and offering expenses payable by us.

In March 2021, we entered into a Capital on Demand TM Sales Agreement with JonesTrading Institutional Services LLC (JonesTrading) to create an at-the-market offering (ATM Offering Program) under which we may offer and sell shares of our common stock having an aggregate offering price of up to $25.0 million.

JonesTrading is entitled to a commission at a commission rate up to 3% of the gross proceeds.

For the nine months ended September 30, 2021, we sold an aggregate of 986,267 shares of common stock at an average price of $4.75 per share for net proceeds of $4.4 million under the JonesTrading ATM Offering Program.

In May 2019, we entered into a sales agreement with H.C.

Wainwright & Co., LLC (Wainwright) for an at-the-market offering (ATM Offering Program) under which we could offer and sell shares of our common stock having an aggregate offering price of up to $10.0 million.

In November 2020, we amended our sales agreement with Wainwright to increase the amount of the ATM Offering

Program to $20.0 million.

Wainwright & Co., LLC (Wainwright) for an ATM Offering Program under which we could offer and sell shares of our common stock having an aggregate offering price of up to $10.0 million.

In November 2020, we amended our sales agreement with Wainwright to increase the amount of the ATM Offering Program to $20.0 million.

Wainwright was entitled to a commission at a fixed commission rate equal to 3% of the gross proceeds.

In March 2021, the ATM Offering with Wainwright automatically terminated upon the issuance an d sale of all of the s hares having an aggregate offering price of $20.0 million .

In March 2021, the ATM Offering Program with Wainwright automatically terminated upon the issuance and sale of all of the shares having an aggregate offering price of $20.0 million.

Under the ATM Offering Program with Wainwright, during 2020, we sold an aggregate of 1,657,075 shares of common stock at an average price of $4.07 per share for net proceeds of $6.4 million.

Prior to the termination of the sales agreement with Wainwright, in 2021, we sold an aggregate of 1,988,254 shares of common stock at an average price of $4.99 per share for net proceeds of $9.6 million.

In February 2020, we completed an underwritten follow-on public offering of 4,235,294 shares of our common stock at a price to the public of $4.25 per share.

In March 2020, the underwriters fully exercised their over-allotment option for the issuance of an additional 635,294 shares of common stock.

The total gross proceeds from the underwritten follow-on public offering, including from the exercise of the over-allotment option, was approximately $20.7 million, before deducting underwriting discounts, commissions and offering expenses payable by us.

Additionally, in September 2020 , we entered into the Purchase Agreement with Aspire Capital, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $20.0 million of shares of our common stock at our request from time to time during the 30 month term of the Purchase Agreement.

Concurrently with entering into the Purchase Agreement, we also entered into a registration rights agreement with Aspire Capital, in which we agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act, registering the sale of the shares of our common stock that have been and may be issued to Aspire Capital under the Purchase Agreement.

For the six months ended June 30, 2021, we sold an aggregate of 3,000,000 shares of common stock at an average price of $5.09 per share for net proceeds of $15.2 million under this Purchase Agreement.

In March 2021, we entered into a Capital on Demand TM Sales Agreement with JonesTrading Institutional Services LLC (JonesTrading) to create an ATM Offering Program under which we may offer and sell shares of our common stock having an aggregate offering price of up to $25.0 million.

JonesTrading is entitled to a commission at a commission rate up to 3% of the gross proceeds.

For the six months ended June 30, 2021, we sold an aggregate of 293,830 shares of common stock at an average price of $4.72 per share for net proceeds of $1.3 million under the ATM Offering Program.

Additionally, in September 2020 , we entered into a common stock purchase agreement (Purchase Agreement) with Aspire Capital Fund, LLC (Aspire Capital), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $20.0 million of shares of our common stock at our request from time to time during the 30 month term of the Purchase Agreement.

Concurrently with entering into the Purchase Agreement, we also entered into a registration rights agreement with Aspire Capital, in which we agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act of 1933, as amended, for the resale of the shares of our common stock that have been and may be issued to Aspire Capital under the Purchase Agreement.

For the nine months ended September 30, 2021, we sold an aggregate of 3,000,000 shares of common stock at an average price of $5.09 per share for net proceeds of $15.2 million under this Purchase Agreement.

The following table sets forth a summary of the net cash flow activity for each of the periods indicated (in thousands):

Six Months Ended June 30,

Nine Months Ended September 30,

Net cash provided by (used in):

4 unchanged sentences

Operating activities.

Net cash used in operating activities for the six months ended June 30, 2021 was primarily related to our net loss of $17.5 million, adjusted for non-cash stock-based compensation expense of $0.8 million and net cash inflows from the changes in our operating assets and liabilities of $2.5 million.

Net cash provided by operating activities for the six months ended June 30, 2020 was primarily related to our net loss of $4.7 million, adjusted for non-cash stock-based compensation expense of $0.8 million and net cash outflows from the changes in our operating assets and liabilities of $1.4 million.

Net cash used in operating activities for the nine months ended September 30, 2021 and 2020 was $25.0 million and $9.9 million, respectively.

The fluctuation in net cash used in operating activities resulted primarily from our net loss adjusted for non-cash stock-based compensation expense and net cash inflows or outflows from the changes in our operating assets and liabilities.

Investing activities.

Net cash provided by (used in) investing activities for the six months ended June 30, 2021 and 2020 was $(27.4) million and $2.0 million, respectively.

Net cash provided by (used in) investing activities for the nine months ended September 30, 2021 and 2020 was $( 42.2 ) million and $ 3.7 million, respectively.

The fluctuation in net cash provided by or used in investing activities resulted primarily from the timing differences in investment purchases, sales and maturities, and the fluctuation of our portfolio mix between cash equivalents and investment holdings.

1 unchanged sentence

Financing activities.

Net cash provided by financing activities for the six months ended June 30, 2021 consisted primarily of $10.9 million proceeds from the issuance of common stock through the ATM Offering Program, net of offering costs and $15.2 million proceeds from the issuance of common stock through the Purchase Agreement, net of offering costs.

Net cash provided by financing activities for the six months ended June 30, 2020 consisted primarily of $18.8 million in proceeds from the issuance of common stock through an underwritten follow-on public offering in February 2020, net of offering costs, offset by a $4.0 million repayment on our term loans.

Net cash provided by financing activities for the nine months ended September 30, 2021 consisted primarily of $80.6 million in proceeds from the issuance of common stock in an underwritten follow-on public offering, net of offering costs, $15.2 million in proceeds from the issuance of common stock through the Purchase Agreement, net of offering costs and $14.1 million in proceeds from the issuance of common stock through the ATM Offering Programs, net of offering costs.

Net cash provided by financing activities for the nine months ended September 30, 2020 consisted primarily of $18.8 million in proceeds from the issuance of common stock in an underwritten follow-on public offering in February 2020, net of offering costs and $2.4 million in proceeds from the issuance of common stock through the Wainwright ATM Offering Program, net of offering costs, offset by a $6.0 million repayment on our term loans.

Funding Requirements

7 unchanged sentences

the type, number, scope progress, expansions, results, costs and timing of, our clinical trials and preclinical studies for our product candidates or other potential product candidates or indications which we are pursuing or may choose to pursue in the future;

delays of our current and planned clinical trials of ATYR1923 and any resulting cost increases as a result of the COVID-19 pandemic;

the costs, timing and outcome of regulatory review of our product candidates;

delays of our planned clinical trials of ATYR1923 and ATYR2810;

any resulting cost increases as a result of the COVID-19 pandemic;

the number and characteristics of product candidates that we pursue;

2 unchanged sentences

our ability to maintain existing and enter into new collaboration and licensing arrangements and the timing of any payments we may receive under such arrangements;

the costs, timing and outcome of regulatory review of our product candidates;

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

4 unchanged sentences

If we raise additional funds through collaborations, strategic partnerships or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, our other technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.

The incurrence of additional indebtedness would increase our fixed payment obligations and may require us to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

We may be unable to raise additional funds on acceptable terms or at all.

As a result of the COVID-19 pandemic and actions taken to slow its spread, the global credit and financial markets have experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, inflation, and uncertainty about economic stability.

As a result of the COVID-19 pandemic and actions taken to slow its spread, the global credit and financial markets have experienced extreme volatility and disruptions, includ ing severely diminished liquidity and credit availability, declines in consumer confidence, declines i n economic growth, increases in unemployment rates, inflation, and uncertainty about economic stability.

If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive.

3 unchanged sentences

These contracts generally provide for termination after a notice period, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments.

Our contractual obligations have not materially changed outside the ordinary course of our business during the three months and six months ended June 30, 2021, as compared to those disclosed in our 2020 Annual Report on Form 10-K for the fiscal year ended December 31, 2020.

Our contractual obligations have not materially changed outside the ordinary course of our business during the three months and nine months ended September 30, 2021, as compared to those disclosed in our 2020 Annual Report on Form 10-K for the fiscal year ended December 31, 2020.

Financial Operations Overview

4 unchanged sentences

was incorporated in the State of Delaware in September 2005.

The condensed consolidated financial statements include our accounts and our 98% majority-owned subsidiary in Hong Kong, Pangu BioPharma as of June 30, 2021.

The condensed consolidated financial statements include our accounts and our 98% majority-owned subsidiary in Hong Kong, Pangu BioPharma as of September 30, 2021.

All intercompany transactions and balances are eliminated in consolidation.

5 unchanged sentences

This achievement triggered a $2.0 million milestone payment, which we received in January 2021.

The Phase 1 trial, which was conducted and funded by Kyorin, is a placebo-controlled study to evaluate the safety, PK and immunogenicity of ATYR1923 in 32 healthy Japanese male volunteers.

The Phase 1 trial, which was conducted and funded by Kyorin, was a placebo-controlled study to evaluate the safety, PK and immunogenicity of ATYR1923 in 32 healthy Japanese male volunteers.

ATYR1923 was observed to be generally safe and well-tolerated with no drug-related serious adverse events and PK findings were consistent with previous studies of ATYR1923.

6 unchanged sentences

We received the $2.0 million from Kyorin in January 2021.

For the six months ended June 30, 2021, there were no activities that triggered additional license and collaboration agreement revenue.

Following the first anniversary of the effective date of the Kyorin Agreement, Kyorin had the right to terminate the agreement for any reason upon 90 days advance written notice.

Either party may terminate the Kyorin Agreement in the event that the other party breaches the agreement and fails to cure the breach, becomes insolvent or challenges certain of the intellectual property rights licensed under the agreement .

For the nine months ended September 30, 2021, there were no activities that triggered additional license and collaboration agreement revenue.

Kyorin has the right to terminate the agreement for any reason upon 90 days advance written notice.

In addition, either party may terminate the Kyorin Agreement in the event that the other party breaches the agreement and fails to cure the breach, becomes insolvent or challenges certain of the intellectual property rights licensed under the agreement .

Research and Development Expenses

8 unchanged sentences

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

We expect that the levels of our research and development expenses will increase in the current year and potentially future years and will consist primarily of costs related to our clinical development and manufacturing of ATYR1923 for patients with pulmonary sarcoidosis, including the costs associated with technology transfer to an additional CDMO of ATY1923, our preclinical development and manufacturing of ATYR2810 and other potential therapeutics based on tRNA synthetase biology and NRP2 biology.

We expect that the levels of our research and development expenses will increase in the current year and potentially future years and will consist primarily of costs related to our clinical development and manufacturing of ATYR1923 for patients with pulmonary sarcoidosis, including the costs associated with technology transfer to an additional CDMO of ATYR1923, our preclinical development, planned clinical development and manufacturing of ATYR2810 and other potential therapeutics based on tRNA synthetase biology and NRP2 biology.

We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates.

In particular, as a result of the COVID-19 pandemic, many clinical trial sites in our Phase 1b/2a clinical trial in patients with pulmonary sarcoidosis temporarily suspended dosing of previously-enrolled patients and/or enrollment of new patients and some patients discontinued from the trial which delayed completion of this clinical trial.

For instance, as a result of the COVID-19 pandemic, many clinical trial sites in our ATYR1923 Phase 1b/2a clinical trial in patients with pulmonary sarcoidosis temporarily suspended dosing of previously-enrolled patients and/or enrollment of new patients and some patients discontinued from the trial which delayed the results of this clinical trial.

At this time, due to the inherently unpredictable nature of preclinical and clinical development and given the early stage of our programs, we are unable to estimate with any certainty the costs we will incur or the timelines we will require in the continued development of our product candidates.

16 unchanged sentences

Results of Operations

Comparison of the Three Months Ended June 30, 2021 and 2020

The following table summarizes our results of operations for the three months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,

Comparison of the Three Months Ended September 30, 2021 and 2020

The following table summarizes our results of operations for the three months ended September 30, 2021 and 2020 (in thousands):

Three Months Ended September 30,

License and collaboration agreement revenues

3 unchanged sentences

License and collaboration agreement revenues.

Revenues for the three months ended June 30, 2020 consisted primarily from a collaboration agreement that was completed as of December 31, 2020.

Revenues for the three months ended September 30, 2020 consisted primarily from a collaboration agreement that was completed as of December 31, 2020.

Research and development expenses.

Research and development expenses were $7.7 million and $4.4 million for the three months ended June 30, 2021 and 2020, respectively.

The increase of $3.3 million was due primarily to a $3.5 million increase in manufacturing costs for ATYR1923 and a $0.8 million increase in research and development expenses related to ATYR1923 and ATYR2810 programs.

The increase was offset by a $1.0 million decrease in clinical trials costs.

Research and development expenses were $5.1 million and $4.6 million for the three months ended September 30, 2021 and 2020, respectively.

The increase was due primarily to a $0.5 increase in product development and manufacturing costs for ATYR1923, ATYR2810 and our discovery programs.

General and administrative expenses.

General and administrative expenses were $2.7 million and $2.1 million for the three months ended June 30, 2021 and 2020, respectively.

The increase of $0.6 million was due primarily to a $0.4 million increase in payroll related expenses and a $0.2 million increase in professional fees.

General and administrative expenses were $2.6 million and $2.0 million for the three months ended September 30, 2021 and 2020, respectively.

The increase of $0.5 million was due primarily to a $0.4 million increase in compensation related expenses, and a $0.1 million increase in professional fees.

Other income (expense), net.

Other income (expense), net was $0.1 million and $(0.1) million for the three months ended June 30, 2021 and 2020, respectively.

Other income (expense), net was $59,000 and $(88,000) for the three months ended September 30, 2021 and 2020, respectively.

The change was primarily a result of repayment of our term loans in November 2020.

Comparison of the Six Months Ended June 30, 2021 and 2020

The following table summarizes our results of operations for the six months ended June 30, 2021 and 2020 (in thousands):

Six Months Ended June 30,

Comparison of the Nine Months Ended September 30, 2021 and 2020

The following table summarizes our results of operations for the nine months ended September 30, 2021 and 2020 (in thousands):

Nine Months Ended September 30,

License and collaboration agreement revenues

3 unchanged sentences

License and collaboration agreement revenues.

Revenues for the six months ended June 30, 2020 consisted primarily of $8.0 million of license revenue under the Kyorin Agreement.

Revenues for the nine months ended September 30, 2020 consisted primarily of $8.0 million of license revenue under the Kyorin Agreement.

Research and development expenses.

Research and development expenses were $12.2 million and $8.0 million for the six months ended June 30, 2021 and 2020, respectively.

The increase of $4.2 million was due primarily to a $3.8 million increase in manufacturing costs for ATYR1923, a $1.3 million increase in research and development expenses related to ATYR1923 and ATYR2810 programs.

The increase was offset by a $1.0 million decrease on clinical trials costs.

Research and development expenses were $17.3 million and $12.6 million for the nine months ended September 30, 2021 and 2020, respectively.

The increase was due primarily to a $4.7 million increase in product development and manufacturing costs for ATYR1923, ATYR2810 and our discovery programs.

General and administrative expenses.

General and administrative expenses were $5.5 million and $4.7 million for the six months ended June 30, 2021 and 2020, respectively.

The increase of $0.7 million was due primarily to a $0.5 million increase in payroll related expenses and a $0.2 million increase in professional fees.

General and administrative expenses were $8.1 million and $6.8 million for the nine months ended September 30, 2021 and 2020, respectively.

The increase of $1.3 million was due primarily to a $1.0 million increase in compensation related expenses, and a $0.3 million increase in professional fees.

Other income (expense), net.

Other income (expense), net was $0.1 million and $(0.2) million for the six months ended June 30, 2021 and 2020, respectively.

Other income (expense), net was $0.2 million and $(0.3) million for the nine months ended September 30, 2021 and 2020, respectively.

The change was primarily a result of repayment of our term loans in November 2020.

6 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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis