What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-08-16 compared with 2021-05-12 · 99 added, 83 removed, 189 unchanged (49% of the section changed)

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Our approach is to design rational precision therapies that treat the underlying cause of disease and improve the lives of patients.

Our most advanced program is CGT9486, a selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17.

Our most advanced program is bezuclastinib (also known as CGT9486), a selective tyrosine kinase inhibitor designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17.

In the vast majority of cases, KIT D816V is responsible for driving Systemic Mastocytosis (“SM”), a serious disease caused by unchecked proliferation of mast cells.

Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (“GIST”), a type of cancer with strong dependence on oncogenic KIT signaling.

CGT9486 is a highly selective and potent KIT inhibitor with the potential to provide a new treatment option for these patient populations.

CGT9486 has been administered to more than 50 advanced solid tumor and GIST patients in a Phase 1/2 clinical trial, with the vast majority of those patients living with advanced GIST.

Bezuclastinib is a highly selective and potent KIT inhibitor with the potential to provide a new treatment option for these patient populations.

Bezuclastinib has been administered to more than 50 advanced solid tumor and GIST patients in a Phase 1/2 clinical trial, with the vast majority of those patients living with advanced GIST.

GIST is a disease frequently driven by KIT mutations, and resistance to currently available therapeutics is frequently associated with the emergence of other KIT mutations.

Anti-tumor activity for CGT9486 was observed in both single agent and combination settings, including in combination with sunitinib, an approved treatment option for GIST patients.

Anti-tumor activity for bezuclastinib was observed in both single agent and combination settings, including in combination with sunitinib, an approved treatment option for GIST patients.

Clinical data from this trial have been presented at several scientific conferences, including most recently by Cogent at the 2020 annual CTOS meeting, and previously by Plexxikon Inc.

(“Plexxikon”), a member of the Daiichi Sankyo Group, at the 2018 annual American Society of Clinical Oncology (“ASCO”) meeting and the 2017 annual Connective Tissue Oncology Society (“CTOS”) meeting.

Within the group of 15 heavily pre-treated GIST patients who received the combination of CGT9486 and sunitinib, and who had not received prior treatment with CGT9486, the confirmed objective response rate (“ORR”) was twenty percent, including two partial responses and one complete response, while the estimated median progression free survival (“mPFS”) for this group was twelve months.

Four subjects continued to receive CGT9486 via individual patient INDs beyond the conclusion of the trial.

Based on these results, we are planning an FDA interaction to explore further clinical development of CGT9486 in combination with sunitinib in GIST patients, and plan to initiate an additional clinical study in GIST in the second half of 2021.

In addition to continuing the development of CGT9486 in GIST patients, we are pursuing development of the compound in patients living with Advanced Systemic Mastocytosis (“AdvSM”) and Non-Advanced Systemic Mastocytosis (“Non-AdvSM”).

Within the group of 15 heavily pre-treated GIST patients who received the combination of bezuclastinib and sunitinib, and who had not received prior treatment with bezuclastinib, the confirmed objective response rate (“ORR”) was twenty percent, including two partial responses and one complete response, while the estimated median progression free survival (“mPFS”) for this group was twelve months.

Four subjects continued to receive bezuclastinib via individual patient INDs beyond the conclusion of the trial.

Based on these results, we are planning an FDA interaction to explore further clinical development of bezuclastinib in GIST patients.

Food and Drug Administration (“FDA”) has granted orphan drug designation to bezuclastinib for the treatment of GIST.

Enrollment in a randomized clinical trial evaluating the safety, tolerability, and efficacy of bezuclastinib in combination with sunitinib in imatinib-resistance GIST patients is expected to begin in the second half of 2021.

In addition to continuing the development of bezuclastinib in GIST patients, we are pursuing development of the compound in patients living with Advanced Systemic Mastocytosis (“AdvSM”) and Non-Advanced Systemic Mastocytosis (“Non-AdvSM”).

The vast majority of AdvSM and Non-AdvSM patients have a KIT D816V mutation.

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Emerging clinical data for other kinase inhibitors with activity against KIT D816V have shown that the disease is highly sensitive to inhibition of the target.

CGT9486 was specifically designed to selectively inhibit KIT mutations on exon 17, including KIT D816V, and we aim to expand the clinical development of this program to treat systemic mastocytosis patients.

The FDA has cleared our Investigational New Drug (“IND”) submission for a Phase 2 study in patients with AdvSM, which remains on track for initiation in the first half of 2021.

Subject to feedback from regulatory authorities, we expect to initiate a clinical trial in Non-AdvSM patients in the second half of 2021.

We expect to rapidly assess CGT9486 activity in mastocytosis patients by monitoring levels of serum tryptase, a relevant biomarker of disease activity which is elevated in these patients.

Worldwide rights to develop and commercialize CGT9486, as well as an additional selective KIT inhibitor, CGT0206, are exclusively licensed from Plexxikon.

Bezuclastinib was specifically designed to selectively inhibit KIT mutations on exon 17, including KIT D816V, and we have expanded the clinical development program to include clinical trials in SM patients.

The FDA has cleared our Investigational New Drug (“IND”) submission for a Phase 2 trial in patients with AdvSM, now known as APEX, which was initiated in the second quarter of 2021.

We expect to report preliminary data from patients treated in the APEX trial in the first half of 2022.

Following recent positive interactions with FDA, we remain on track and expect to initiate a clinical trial in Non-AdvSM patients, known as SUMMIT, in the second half of 2021.

By monitoring relevant biomarkers of disease activity, including levels of serum tryptase, we expect to rapidly assess bezuclastinib activity in SM patients.

Worldwide rights to develop and commercialize bezuclastinib, as well as an additional selective KIT inhibitor, CGT0206, are exclusively licensed from Plexxikon.

Under the terms of the license agreement, Plexxikon received an upfront payment and is eligible for additional development milestones and mid- to high- single-digit royalty payments.

Patents protecting CGT9486 include composition of matter claims which have issued in the US and other key territories and provide exclusivity through 2033 and potentially beyond through patent term extensions.

In addition to our small molecule efforts, we have developed proprietary technologies which enable cell therapy programs targeting cancers utilizing a patient's engineered T cells.

Our ACTR (“Antibody-Coupled T cell Receptor”) product candidates incorporate a novel chimeric receptor that are designed to enable a co-administered, tumor-specific antibody to direct T cell targeting toward tumor cells.

All ACTR clinical trials are closed to further enrollment.

We have completed all closeout activities for 3 of 4 ACTR clinical trials as of March 31, 2021 and we anticipate closing out the last ACTR clinical trial in the first half of 2021.

Patents protecting bezuclastinib include composition of matter claims which have issued in the US and other key territories and provide exclusivity through 2033 and potentially beyond through patent term extensions.

In addition to bezuclastinib, our research team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases.

Since our inception in 2014, we have focused significant efforts and financial resources on establishing and protecting our intellectual property portfolio, conducting research and development of our product candidates, manufacturing drug product material for use in preclinical studies and clinical trials, staffing our company, and raising capital.

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sale and have not generated any revenue from product sales.

To date, we have funded our operations primarily with proceeds from the sales of preferred stock, our public offerings of our common stock, private placements and payments received under our Collaboration Agreement with Seagen Inc., formerly Seattle Genetics .

On March 19, 2020, we entered into the LPC Purchase Agreement with LPC, pursuant to which we may elect to sell to LPC up to $25.0 million in shares of our common stock, subject to certain limitations and conditions set forth in the LPC Purchase Agreement.

Pursuant to the LPC Purchase Agreement, we issued 181,595 shares of common stock to LPC as a commitment fee.

In 2020, 2,412,870 registered common shares were sold to LPC under the LPC Purchase Agreement for proceeds of $25.0 million.

No additional shares may be or have been sold to LPC under the LPC Purchase Agreement.

To date, we have funded our operations primarily with proceeds from the sales of preferred stock, our public offerings of our common stock and private placements.

On July 6, 2020, we issued a contingent value right (“CVR”), which was distributed to stockholders of record as of the close of business on July 6, 2020, and prior to the issuance of any shares to acquire Kiq or sold to the PIPE investors.

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Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates.

Our net loss was $11.7 million for the three months ended March 31, 2021 compared to a net loss of $6.1 million for the three months ended March 31, 2020.

As of March 31, 2021, we had an accumulated deficit of $210.4 million.

Our net losses were $28.3 million for the six months ended June 30, 2021 compared to net losses of $13.5 million for the six months ended June 30, 2020.

As of June 30, 2021, we had an accumulated deficit of $227.0 million.

We expect to continue to incur significant expenses and operating losses for at least the next several years.

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continue additional clinical trials for our product candidates;

continue to discover and develop additional product candidates;

continue to discover and develop additional product candidates, including through the creation of our research team in Boulder, CO;

acquire or in-license other product candidates and technologies;

maintain, expand, and protect our intellectual property portfolio;

hire additional clinical, scientific, and commercial personnel;

hire additional research, clinical, scientific, and commercial personnel;

establish a commercial manufacturing source and secure supply chain capacity sufficient to provide commercial quantities of any product candidates for which we may obtain regulatory approval;

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establish a sales, marketing, and distribution infrastructure to commercialize any products for which we may obtain regulatory approval;

add operational, financial, and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts, as well as to support our transition to a public reporting company.

add operational, financial, and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates.

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Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability.

if we are able to generate product sales, we may not become profitable.

If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to red uce or terminate our operations.

As of March 31, 2021, we had cash and cash equivalents of $230.7 million.

We expect that our current cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into 2024.

Even if we are able to generate product sales, we may not become profitable.

As of June 30, 2021, we had cash and cash equivalents of $218.1 million.

Based on our current plans, we expect that our current cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into 2024.

The COVID-19 Pandemic

In March 2020, the World Health Organization declared the outbreak of a novel strain of coronavirus, or COVID-19, as a pandemic, which has spread throughout the United States and worldwide.

We could be materially and adversely affected by the risks, or the public perception of the risks, related to an epidemic, pandemic, outbreak, or other public health crisis, such as the recent outbreak of COVID-19.

We continue to monitor the global outbreak and spread of COVID-19 and have taken steps to identify and mitigate the adverse impacts on, and risks to, our business posed by its spread and actions taken by governmental and health authorities to address the COVID-19 pandemic.

We continue to monitor the pandemic and have taken steps to identify and mitigate the adverse impacts on, and risks to, our business posed by its spread and actions taken by governmental and health authorities to address the COVID-19 pandemic.

The spread of COVID-19 has caused us to modify our business practices, including implementing a work-from-home policy for all employees who are able to perform their duties remotely and restricting all nonessential travel, and we expect to continue to take actions as may be required or recommended by government authorities or as we determine are in the best interests of our employees, the patients we serve and other business partners in light of COVID-19.

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We expect that our revenue for the next several years will be derived primarily from any collaborations that we may enter into in the future.

In June 2015, we entered into the Collaboration Agreement with Seagen.

Pursuant to the terms of the Collaboration Agreement, we and Seagen agreed to jointly develop two product candidates incorporating our ACTR platform and Seagen’s antibodies.

On January 16, 2020 (the “Termination Date”), we and Seagen announced an agreement to terminate the ATTCK-17-01 Phase 1 clinical trial and other research activities under the collaboration (the “Termination Agreement”).

Pursuant to terms of the Termination Agreement, among other things, (i) Seagen paid us $5.75 million, (ii) Seagen surrendered, assigned and transferred to us all of its right, title and interest in the 207,961 shares of our common stock owned by Seagen, (iii) we will continue to be responsible for and pay all expenses for the wind-down of the ACTR-BCMA trial and (iv) Seagen paid all research and development costs incurred through the Termination Effective Date.

In addition, the exclusivity provisions in the Collaboration Agreement terminate and each party will be free to research, develop and commercialize their individual intellectual property (either by themselves or with third parties, subject to the intellectual property rights of the other party.

All performance obligations were completed and all remaining revenue was recognized under the Collaboration Agreement and Termination Agreement in 2020.

Operating Expenses

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the cost of manufacturing drug products for use in our preclinical studies and clinical trials, including under agreements with third parties, such as consultants, contractors and contract manufacturing organizations (“CMOs”);

employee-related expenses, inclu ding salaries, related benefits and stock-based compensation expense for employees engaged in research and development functions;

employee-related expenses, including salaries, related benefits and stock-based compensation expense for employees engaged in research and development functions;

laboratory supplies and animal care;

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payments made under third-party licensing agreements.

Our research and development costs include costs for the development of product candidates that were developed with Seagen, and for which we have received reimbursement as specified in our Collaboration Agreement.

We expense research and development costs as incurred.

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This is due to the numerous risks and uncertainties associated with product development and commercialization, including the following:

the timing and progress of preclinical and clinical development activities;

the timing and progress of our preclinical and clinical development activities;

the number and scope of preclinical and clinical programs we decide to pursue;

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our ability to establish new licensing or collaboration arrangements;

the future productivity of our research team in Boulder, CO and its ability to discover new product candidates and build our pipeline;

the successful completion of clinical trials with safety, tolerability, and efficacy profiles that are satisfactory to the U.S.

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Results of Operations

Comparison of the three months ended March 31, 2021 and 2020

The following table summarizes our results of operations for the three months ended March 31, 2021 and 2020:

Three Months Ended March 31,

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:

Three Months Ended June 30,

(in thousands)

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Collaboration Revenue

No collaboration revenue was recognized during the three months ended March 31, 2021.

Collaboration revenue recognized during the three months ended March 31, 2020 was $7.0 million.

We recognized revenue from the upfront payment we received as well as ongoing reimbursements of research and development costs from Seagen by applying the costs-to-cost method over the performance period.

On January 16, 2020, Cogent and Seagen announced an agreement to terminate the ATTCK-17-01 Phase 1 clinical trial and other research activities under the collaboration.

All performance obligations were completed and all remaining revenue was recognized under the Collaboration Agreement and Termination Agreement in 2020.

No collaboration revenue was recognized during the three months ended June 30, 2021.

Collaboration revenue recognized during the three months ended June 30, 2020 was $0.5 million related to our legacy assets.

All performance obligations were completed and all remaining revenue was recognized in 2020.

Research and Development Expenses

Research and development expenses were $8.2 million for the three months ended March 31, 2021, compared to $9.5 million for the three months ended March 31, 2020.

The decrease in research and development expense during the three months ended March 31, 2021 compared to the three months ended March 31, 2020 is driven by the conclusion of our legacy cell therapy clinical efforts and the reduction in force in March 2020.

These decreases are partially offset by increased costs associated with the development of CGT9486.

Research and development expenses were $12.4 million for the three months ended June 30, 2021, compared to $5.1 million for the three months ended June 30, 2020.

The increase in research and development expense during the three months ended June 30, 2021 compared to the three months ended June 30, 2020 is driven by the development of bezuclastinib .

Increases in headcount also resulted in increased salary and benefit costs.

General and Administrative Expenses

General and administrative expenses for the three months ended March 31, 2021 were $4.6 million, compared to $3.7 million for the three months ended March 31, 2020.

The increase in general and administrative expenses was primarily due to an increase of $0.5 million in stock-based compensation expense and facility costs which was partially offset by a decrease in salary expense due to the reduction in force in March 2020.

General and administrative expenses for the three months ended June 30, 2021 were $4.9 million, compared to $2.8 million for the three months ended June 30, 2020.

The increase in general and administrative expenses was primarily due to increases in headcount, resulting in increased salary and benefit costs.

Interest Income

Interest income for the three months ended March 31, 2021 was $0.1 million, compared to $0.1 million for the three months ended March 31, 2020.

Interest income for the three months ended June 30, 2021 and June 30, 2020 was $0.1 million, respectively.

The impact of higher average invested balances in the current year was offset by lower interest rates in the current year compared to the prior period.

Other I ncome

Other income, net was $0.6 million in the three months ended March 31, 2021.

Other income represents sublease income recognized resulting from the sublease of a portion of our leased office space.

No sublease income was recorded for the three months ended March 31, 2020.

Other income, net was $0.6 million in the three months ended June 30, 2021, compared to $0.1 million for the three months ended June 30, 2020.

Other income represents sublease income resulting from the sublease of a portion of our leased office space.

Change in Fair Value of CVR Liability

The change in fair value of CVR liability for the three months ended March 31, 2021, represents the remeasurement of the CVR liability as a result of changes in our stock price prior to issuance of the common stock issued in partial settlement of the CVR.

Liquidity and Capital Resources

There was no change in fair value of CVR liability for the three months ended June 30, 2021 as any settlement of the remaining liability will be a cash settlement.

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 :

Six Months Ended June 30,

(in thousands)

Collaboration revenue

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense):

Interest income

Change in fair value of CVR liability

Total other income (expense), net

Collaboration Revenue

No collaboration revenue was recognized during the six months ended June 30, 2021.

Collaboration revenue recognized during the six months ended June 30, 2020 was $7.6 million related to our legacy assets.

All performance obligations were completed and all remaining revenue was recognized in 2020.

Research and Development Expenses

Research and development expenses were $20.6 million for the six months ended June 30, 2021, compared to $14.6 million for the six months ended June 30, 2020.

The increase in research and development expense during the six months ended June 30, 2021 compared to the six months ended June 30, 2020 is driven by increased costs associated with the development of bezuclastinib .

Increases in headcount also resulted in increased salary and benefit costs.

General and Administrative Expenses

General and administrative expenses for the six months ended June 30, 2021 were $9.5 million, compared to $6.5 million for the six months ended June 30, 2020.

The increase in general and administrative expenses was primarily due to increases in headcount, resulting in increased salary and benefit costs.

Interest Income

Interest income for the six months ended June 30, 2021 was $0.2 million, compared to $0.1 million for the six months ended June 30, 2020.

The impact of higher average invested balances in the current year was partially offset by lower interest rates in the current year compared to the prior period.

Other income, net was $1.2 million in the six months ended June 30, 2021, compared to $0.1 million for the six months ended June 30, 2020.

Other income represents sublease income resulting from the sublease of a portion of our leased office space.

Change in Fair Value of CVR Liability

The change in fair value of CVR liability for the six months ended June 30, 2021, represents the remeasurement of the CVR liability as a result of changes in our stock price prior to issuance of the common stock issued in partial settlement of the CVR.

L iquidity and Capital Resources

We have incurred certain costs related to the COVID-19 outbreak as a result of taking necessary precautions for essential personnel to operate safely both in person as well as remotely.

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We have historically funded our operations primarily through the public offering and private placement of our securities and consideration received from our collaborative agreements.

In 2020, 2,412,870 shares were sold under the LPC Purchase Agreement for proceeds of $25.0 million.

No additional shares may be or have been sold to LPC under the terms of the LPC Purchase Agreement.

On July 9, 2020, we completed a PIPE and issued 118,638 Series A Preferred Stock to new and existing investors in exchange gross proceeds of $104.4 million, or net proceeds of $98.9 million, after deducting commissions and offering costs.

On December 4, 2020, we completed an underwritten public offering of 11,794,872 shares of our common stock at a public offering price of $9.75 per share (including the exercise in full by the underwriters of their 30-day option to purchase up to 1,538,461 additional shares of common stock), or net proceeds from the offering of $107.7 million, after deducting the underwriting discounts and commissions and offering expenses.

As of March 31, 2021, we had cash and cash equivalents of $230.7 million, which we expect will be sufficient to fund our operating expenses and capital expenditure requirements into 2024.

As of June 30, 2021, we had cash and cash equivalents of $218.1 million, which we believe will be sufficient to fund our operating expenses and capital expenditure requirements into 2024.

The following table summarizes our sources and uses of cash for each of the periods presented:

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

Cash used in operating activities

Cash used in investing activities

Cash provided by (used in) financing activities

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Operating Activities

During the three months ended March 31, 2021, operating activities used $11.4 million of cash, primarily resulting from our net loss of $11.7 million and from net cash used by changes in our operating assets and liabilities of $1.1 million, partially offset by net non-cash charges of $1.4 million.

Net cash used by changes in our operating assets and liabilities for the three months ended March 31, 2021 consisted primarily of a $2.4 million decrease in accounts payable and accrued expenses and other current liabilities, and a $0.5 million decrease in operating lease liabilities, partially offset by a $1.4 million decrease in prepaid expenses and other current assets and a $0.5 million decrease in the right-of-use asset.

During the three months ended March 31, 2020, operating activities used $7.9 million of cash, primarily resulting from our net loss of $6.1 million and from net cash used by changes in our operating assets and liabilities of $2.1 million, partially offset by net

non-cash charges of $0.3 million.

Net cash used by changes in our operating assets and liabilities for the three months ended March 31, 2020 consisted primarily of a $3.6 million decrease in accounts payable and accrued expenses and other current liabilities and a $0.5 million decrease in deferred revenue, partially offset by $2.0 million decrease in accounts receivable.

During the six months ended June 30, 2021, operating activities used $23.9 million of cash, primarily resulting from our net loss of $28.3 million, partially offset by net cash provided by changes in our operating assets and liabilities of $0.3 million and by net noncash charges of $4.1 million.

Net cash provided by changes in our operating assets and liabilities for the six months ended June 30, 2021 consisted primarily of a $2.9 million increase in accounts payable and accrued expenses and other current liabilities, and a $0.9 million decrease in the right-of-use asset, partially offset by a $0.5 million increase in prepaid expenses and other current assets, a $2.0 million increase in other assets and a $1.0 million decrease in the operating lease liability.

During the six months ended June 30, 2020, operating activities used $16.2 million of cash, primarily resulting from our net loss of $13.5 million and from net cash used in changes in our operating assets and liabilities of $4.1 million, partially offset by net noncash charges of $1.4 million.

Net cash used in changes in our operating assets and liabilities for the six months ended June 30, 2020 consisted primarily of a $4.1 million decrease in accounts payable and accrued expenses and other current liabilities, a $1.0 million decrease in deferred revenue and a $1.4 million increase in prepaid expenses and other current assets, partially offset by $2.0 million decrease in accounts receivable and a $0.4 million decrease in other assets.

Investing Activities

There were no investing activities for the three months ended March 31, 2021 and 2020, respectively.

During the six months ended June 30, 2021, net cash used in investing activities was $0.1 million, consisting of purchases of property and equipment.

There were no investing activities for the six months ended June 30, 2020.

Financing Activities

During the three months ended March 31, 2021, net cash used by financing activities was $0.1 million which consisted of the partial settlement of the CVR obligation.

During the three months ended March 31, 2020, net cash provided by financing activities was $0.1 million which consisted of the proceeds from the issuance of common stock upon stock option exercises and from the issuance of common stock under the Employee Stock Purchase Plan.

During the six months ended June 30, 2021, net cash used by financing activities was $0.1 million, which consisted of partial settlement of the CVR obligation.

During the six months ended June 30, 2020, net cash provided by financing activities was $0.1 million, which consisted of the proceeds from the issuance of common stock upon stock option exercises and from the issuance of common stock under the Employee Stock Purchase Plan.

Funding Requirements

We expect our expenses to increase in connection with our ongoing activities, particularly as we advance clinical development of our product candidates and preclinical activities.

We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the clinical development of our product candidates and conduct preclinical activities.

The timing and amount of our operating expenditures will depend largely on:

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adverse developments concerning our manufacturers;

our inability to obtain adequate product supply for any approved product or inability to do so at acceptable prices;

our inability to establish collaborations if needed;

our inability to obtain adequate product supply for any approved product or our inability to do so at acceptable prices;

our inability to establish collaborations, if desired or needed;

our failure to commercialize our product candidates;

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the impact of COVID-19 on the operations of key governmental agencies, such as the FDA, which may delay the development of our current product candidates or any future product candidates.

We believe that our existing cash and cash equivalents of $230.7 million as of March 31, 2021 will enable us to fund our operating expenses and capital expenditure requirements into 2024.

Based on our current plans, we believe that our existing cash and cash equivalents of $218.1 million as of June 30, 2021 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 exhaust our available capital resources sooner than we expect.

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Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances, and marketing, distribution, or licensing arrangements.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders.

Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures, or declaring dividends.

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

If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce, or terminate

our research, product development, or future commercialization efforts, or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce, or terminate our research, product development, or future commercialization efforts, or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

Critical Accounting Policies and Significant Judgments and Estimates

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We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies.

Quantitative and Qualitati ve Disclosures about Market Risk.

Quantitative and Qualitative Disclosures about Market Risk.

We are a smaller reporting company, as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended, for this reporting period and are not required to provide the information required under this item.

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