What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-10-21 compared with 2021-07-22 · 99 added, 85 removed, 130 unchanged (59% of the section changed)

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Significant changes since our most recent Annual Report on Form 10-K in the Critical Accounting Policies and Significant Estimates that we believe are important to understanding the assumptions and judgments underlying our financial statements.

Plus Therapeutics is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets.

Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases.

The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers.

We believe that this approach will produce drugs that provide unique benefits such as improved mechanism of action, better tumor targeting, improved pharmacokinetics and higher treatment doses to the tumor.

Benefits such as these may then improve the overall efficacy of drugs while reducing the side effects associated with more traditional drug delivery methods.

To support this goal, Plus Therapeutics has an established R&D and commercial scale manufacturing facility for nanoscale drug development in San Antonio, TX.

This facility is ideally suited to produce nanoliposomal drug candidates for research, development, clinical and, in conjunction with our partners, commercial use.

Plus Therapeutics’ lead investigational drug, Rhenium NanoLiposomes (RNL), is a patented radiotherapy for patients with recurrent glioblastoma (rGBM).

The RNL technology was a key part of the licensed radiotherapeutic portfolio that we acquired from NanoTx, Corp.

Plus Therapeutics is a U.S.

pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers.

Plus’ investigational drugs are intended for both adult and pediatric patients on a worldwide basis.

Plus Therapeutics’ headquarters and manufacturing facility are in Texas, in close proximity to world-class cancer institutions and researchers.

Our dedicated team of engineers, physicians, scientists, and other professionals are committed to advancing our novel radiotherapeutic technology for the benefit of cancer patients and healthcare providers.

Plus’ technology includes nanoliposome-encapsulated, BMEDA-chelated Rhenium-186 radiotherapeutics.

The nanoliposomes facilitate local and precise drug delivery and improved drug retention at the target site while Rhenium-186 releases high-energy beta particles for treatment and gamma photons for imaging.

This radiotherapeutic platform, combined with advances in surgery, nuclear medicine, and radiation oncology, affords us the opportunity to treat multiple types of cancer.

Our current pipeline is focused on treating rare and central nervous system tumors with significant unmet medical needs.

Plus Therapeutics’ lead investigational drug, Rhenium-186 NanoLiposome ( 186 RNL), is a patented radiotherapy potentially useful for patients with recurrent glioblastoma (GBM).

The RNL technology was part of a licensed radiotherapeutic portfolio that we acquired from NanoTx, Corp.

(“NanoTx”) on May 7, 2020.

The licensed radiolabeled nanoliposome platform can be applied toward several cancer targets, and has an active $3M award from NIH/NCI which will financially support the continued clinical development of RNL for recurrent glioblastoma through the completion of a Phase 2 clinical trial and enrollment of up to 55 patients.

The licensed radiotherapeutic can be applied toward several cancer targets, and has an active $3.0 million award from U.S.

National Institutes of Health/National Cancer Institute which will provide financial support for the continued clinical development of 186 RNL for recurrent glioblastoma through the completion of a Phase 2 clinical trial and enrollment of up to 55 patients.

Plus Therapeutics is currently conducting a clinical trial for ReSPECT GBM for Recurrent Glioblastoma and anticipates beginning a clinical trial for ReSPECT-LM Clinical Trial for Leptomeningeal Metastases in the fourth quarter of 2021 :

ReSPECT-GBM Clinical Trial for Recurrent Glioblastoma

186 RNL is a novel injectable radiotherapy designed to deliver targeted high dose radiation directly into brain tumors in a safe, effective, and convenient manner to optimize patient outcomes.

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RNL is given during a single 3- to 4-day in-patient hospital visit, while EBRT requires out-patient visits 5 days a week for approximately 4-6 weeks.

186 RNL is currently being evaluated for the treatment of recurrent glioblastoma in the Phase 1 multi-center ReSPECT-GBM dose-finding clinical trial.

ReSPECT-GBM is evaluating the safety, tolerability, and distribution of 186 RNL for the treatment of recurrent glioblastoma.

Thus far, 186 RNL has demonstrated safety and potential efficacy signals in patients with adequate dosing and tumor coverage with multiple patients surviving greater than 30 months, compared to a median survival of approximately 9 months with the current standard of care.

The seventh dose escalation cohort of this trial has been completed.

Recently, the ReSPECT-GBM trial data safety and monitoring board (DSMB) recommended that we proceed to the eighth dosing cohort which provides for a 40% increase in both drug volume and radiation dose.

Thus far, treatment emergent serious adverse events have not been observed.

By infusing the 186 RNL drug directly into the tumor, bypassing the blood-brain barrier, normal brain and external tissues may be spared from radiation damage.

We believe that radiation in the form of high energy electrons may be effective against glioblastoma if an adequate dose can be effectively delivered.

For comparison, current EBRT protocols for recurrent glioblastoma typically recommend a total maximum dose of about 35 Gy.

In contrast, thus far, we have been able to deliver up to 740 Gy of absorbed radiation to tumor issue without significant toxicities.

Recurrent glioblastoma (GBM) affects approximately 12,000 patients annually in the U.S.

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Current approved therapies are associated with significant side effects, which limit dosing and prolonged use.

By infusing the RNL drug directly into the tumor, bypassing the blood-brain barrier, normal brain and external tissues may be spared from radiation damage.

We believe that radiation in the form of high energy electrons may be effective against glioblastoma if an adequate dose can be effectively delivered.

For comparison, current EBRT protocols for recurrent glioblastoma typically recommend a total maximum dose of about 35 Gy.

In contrast, thus far RNL is able to deliver up to 740 Gy of absorbed radiation to tumor tissue.

RNL is currently being evaluated for the treatment of recurrent glioblastoma in the Phase 1 multi-center ReSPECT™ dose-finding clinical trial.

ReSPECT is evaluating the safety, tolerability, and distribution of RNL for the treatment of recurrent glioblastoma.

Thus far, RNL has demonstrated early potential efficacy signals in patients with adequate dosing and tumor coverage with multiple patients surviving greater than 30 months, compared to a median survival of approximately 9 months with the current standard of care.

The seventh dose escalation cohort of this trial has been completed.

Recently, the ReSPECT trial data safety and monitoring board (DSMB) recommended that we proceed to the eight dosing cohort which provides for a 40% increase in both drug volume and radiation dose.

Thus far, treatment emergent serious adverse events have not been observed.

In September 2020, the FDA granted both Orphan Drug designation and Fast Track designations to 186 RNL for the treatment of patients with glioblastoma.

Based on substantial preclinical work completed and published, RNL is thought to have potential clinical benefits in other difficult to treat cancers.

We are in the process of developing additional indications utilizing RNL for leptomeningeal metastases and pediatric brain cancer.

ReSPECT-LM Clinical Trial for Leptomeningeal Metastases

Based on substantial preclinical work completed and published, 186 RNL is thought to have potential clinical benefits in other difficult to treat cancers for example leptomeningeal metastases and pediatric brain cancer.

The ReSPECT-LM Phase 1 clinical trial builds upon preclinical studies in which tolerance to doses of 186 RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity.

Furthermore, treatment led to marked reduction in tumor burden in both C6 and MDA-231 LM models.

In October 2021, the Federal Drug Administration (FDA) announced clearance for the Company to proceed with the Investigational New Drug (IND) application for 186 RNL for the treatment of leptomeningeal metastases (LM).

The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186 RNL (ReSPECT-LM) in the fourth quarter of 2021.

The ReSPECT-LM multi-center, sequential cohort, open-label, dose escalation study will evaluate the safety, tolerability, and distribution of 186 RNL via intrathecal infusion to the ventricle of patients with LM after standard surgical, radiation, and/or chemotherapy treatment.

The primary endpoint of the study is the incidence and severity of adverse events and dose limiting toxicities.

LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord.

The incidence of LM is growing and occurs in approximately 5% of people with late-stage cancer, or 110,000 people in the U.S.

It is usually terminal with an average 1-year survival of just 7%.

LM occurs with cancers that are most likely to spread to the central nervous system.

The most common cancers to include the leptomeninges are breast cancer, lung cancer, and melanomas .

Future potential Trials

We are in the process of developing additional indications utilizing 186 RNL such as for pediatric brain cancer.

Plus Therapeutics also has two other clinical stage drugs in our pipeline which are:

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Recent Developments

Recent Financings

At-the-Market Transaction

On October 23, 2020, we entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Canaccord Genuity LLC (“Canaccord”), pursuant to which we may issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $10,000,000 (the “ATM Shares”), depending on market demand, with Canaccord acting as an agent for sales.

Refer to “Liquidity and Capital Resources” section below for additional details on the Distribution Agreement.

During the year ended December 31, 2020, we issued 1,616,331 shares under the Distribution Agreement for net proceeds of approximately $3.2 million.

During the six months ended June 30, 2021, we issued 2,179,193 shares under the Distribution Agreement for net proceeds of $6.3 million .

As of June 30, 2021, there are no remaining shares that may be issued and sold under the Distribution Agreement.

Lincoln Park Purchase Agreement

On September 30, 2020, we entered into a purchase agreement (the “2020 Purchase Agreement”) and registration rights agreement pursuant to which Lincoln Park Capital Fund, LLC (“Lincoln Park”) has committed to purchase up to $25.0 million of our common stock.

On September 30, 2020, we entered into a purchase agreement (the “2020 Purchase Agreement”) and registration rights agreement (the “LPC Registration Rights Agreement”).

Under the 2020 Purchase Agreement Lincoln Park Capital Fund, LLC (“Lincoln Park”) has committed to purchase up to $25.0 million of our common stock.

Pursuant to the LPC Registration Rights Agreement, we have agreed to register any shares sold to Lincoln Park under the 2020 Purchase Agreement for resale by Lincoln Park .

Refer to “Liquidity and Capital Resources” section below for additional details on the 2020 Purchase Agreement.

During the year ended December 31, 2020, we issued 353,113 shares, excluding 180,701 shares issued as commitment fee, under the 2020 Purchase Agreement for net proceeds of approximately $0.7 million.

During the six months ended June 30, 2021 we issued 2,262,686 shares of our common stock under the 2020 Purchase Agreement for total proceeds of $6.0 million.

During the nine months ended September 30, 2021 we issued 5,535,186 shares of our common stock under the 2020 Purchase Agreement for total proceeds of $12.3 million.

COVID-19 Impact

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As the accessibility of vaccines against COVID-19 and the number of adults who have received a vaccine has increased, several of the restrictions have been eased or lifted entirely.

The Company considered the impacts of COVID-19 on the assumptions and estimates used to prepare its consolidated financial statements and determined that there were no material adverse impacts on the Company’s results of operations and financial position at June 30, 2021.

The full extent to which the COVID-19 pandemic will directly or indirectly impact its business, results of operations and financial condition, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as the economic impact on local, regional, national and international markets.

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The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer’s social security payments, net operating loss utilization and carryback periods, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property (QIP).

The CARES Act had no material impact on the Company’s income tax provision for the year ended December 31, 2020 or the six months ended June 30, 2021.

The Company continues to evaluate the impact of the CARES Act on its financial position, results of operations and cash flows.

The CARES Act had no material impact on the Company’s income tax provision for the year ended December 31, 2020 or the nine months ended September 30, 2021.

The programs under the CARES Act expired on September 6, 2021.

Results of Operations

Development revenues

Under our government contract with BARDA, we recognized a total of $0.2 million and $0.3 million in revenues for the three and six months ended June 30, 2020, respectively, and $0.2 million and $0.3 million in qualified expenditures for those periods.

Under our government contract with BARDA, we recognized a total of $0 and $0.3 million in revenues for the three and nine months ended September 30, 2020, respectively, and $0 and $0.3 million in qualified expenditures for those periods.

The BARDA contract was terminated in December 2019 and the close out process was completed in 2020.

There were no revenue or expenses recognized relating to the BARDA contract during the six months ended June 30, 2021, and we do not expect additional BARDA revenue in the near future.

There were no revenue or expenses recognized relating to the BARDA contract during the nine months ended September 30, 2021, and we do not expect additional BARDA revenue in the near future.

Research and development expenses

Research and development expenses include costs associated with the design, development, testing, and enhancement of our product candidates, payment of regulatory fees, laboratory supplies, pre-clinical studies, and clinical studies .

The following table summarizes the components of our research and development expenses for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes the components of our research and development expenses for the three and nine months ended September 30, 2021 and 20 20 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Research and development

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Total research and development expenses

The increase of $0.8 million and $1.0 million in research and development expenses for the three and six months ended June 30, 2021 as compared to the same periods in 2020 was due primarily to increased expenditures related to the development of RNL in compliance with current good manufacturing practices, or cGMP, requirements.

The increase of $1.2 million and $2.1 million in research and development expenses for the three and nine months ended September 30, 2021 as compared to the same periods in 2020 was due primarily to increased expenditures related to the development of RNL in compliance with current good manufacturing practices, or cGMP, requirements.

We expect aggregate research and development expenditures to increase in absolute dollars during the remainder of 2021 due to the expected costs of development of the RNL therapy acquired from NanoTx .

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General and administrative expenses include costs for administrative personnel, legal and other professional expenses, and general corporate expenses.

The following table summarizes the general and administrative expenses for the three and six months ended June 30, 2021 and 20 20 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes the general and administrative expenses for the three and nine months ended September 30, 2021 and 2020 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

General and administrative

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Total general and administrative expenses

General and administrative expenses remained consistent during the three months ended June 30, 2021 , as compared to the same period in 2020.

General and administrative expenses decreased by $0.2 million during the six months ended June 30, 2021 , as compared to the same period in 2020.

The decrease was primarily driven by a reduction of legal expenses of $0.6 million, offset by increases of $0.2 million of stock based compensation expenses, and $0.2 million of consulting and professional services expenses.

General and administrative expenses increase by approximately $0.9 million during the three months ended September 30, 2021 as compared to the same period in 2020.

The increase was primarily due to an increase of $0.6 million in legal and professional expenses, an increase of $0.1 million for stock-based compensation expenses, an increase of $0.1 million in insurance expenses and $0.1 million in personnel costs.

General and administrative expenses increased by $0.7 million during the nine months ended September 30, 2021 , as compared to the same period in 2020.

The increase was primarily driven by an increase of professional expenses of $0.5 million, and an increase of $0.2 million of stock based compensation expenses.

We expect general and administrative expenditures to remain consistent on a quarterly basis for the remainder of 2021 as compared with 2020.

Loss on disposal of property and equipment

Loss on disposal of property and equipment of $18,000 was due to the proceeds received for used property and equipment were lower than their carrying amount.

Stock-based compensation expense

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Such expense is recognized over the requisite service period.

The following table summarizes the components of our stock-based compensation expenses for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes the components of our stock-based compensation expenses for the three and nine months ended September 30, 2021 and 2020 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Research and development

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Total stock-based compensation

The increase in stock-based compensation expense for the three and six months ended June 30, 2021 as compared to the same periods in 2020 is primarily related to increased stock options grants in the three and six months ended June 30, 2021, as compared to the same periods in 2020 .

The increase in stock-based compensation expense for the three and nine months ended September 30, 2021 as compared to the same periods in 2020 is primarily related to increased stock options grants in the three and nine months ended September 30, 2021, as compared to the same periods in 2020 .

We expect to continue to grant stock options (which will result in an expense) to our employees, directors, and, as appropriate, to non-employee service providers.

In addition, previously-granted stock options will continue to vest in accordance with their original terms.

As of June 30, 2021, the total compensation cost related to non-vested stock options and stock awards not yet recognized for all our plans is approximately $1.7 million which is expected to be recognized as a result of vesting under service conditions over a weighted average period of 3.16 years.

As of September 30, 2021 , the total compensation cost related to non-vested stock options and stock awards not yet recognized for all our plans is approximately $ 1.5 million w hich is expected to be recognized as a result of vesting under service conditions over a weighted average period of 3.0 years.

Financing items

The following table summarizes interest income, interest expense, and other income and expense for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes interest income, interest expense, and other income and expense for the three and nine months ended September 30, 2021 and 2020 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Interest income

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Change in fair value of warrants

The decrease in interest expense for the three and six months ended June 30, 2021 as compared to the same periods in 2020 was primarily due to the repayment of debt principal of $5.0 million in April 2020.

The decrease in interest expense for the three and nine months ended September 30, 2021 as compared to the same periods in 2020 was primarily due to the repayment of debt principal of $5.0 million in April 2020.

The changes in fair value of our warrant liabilities are primarily due to fluctuations in the valuation inputs for the warrants.

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In April, June, July and September 2020, we entered into revised warrant agreements with the holders of 3,447,500 Series U warrants and in September 2020, we entered into revised warrant agreements for 75,000 of warrants issued to H.C.

Wainwright & Co.,

LLC, as representatives of the underwriters, i n the form of Series U warrants .

Wainwright & Co., LLC, as representatives of the underwriters, in the form of Series U warrants .

In return for reducing the strike price of the warrants, the warrant holders agreed to amend the settlement provisions upon fundamental transactions.

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Short-term and long-term liquidity

The following is a summary of our key liquidity measures at June 30, 2021 and December 31, 2020 (in thousands):

As of June 30,

The following is a summary of our key liquidity measures at September 30, 2021 and December 31, 2020 (in thousands):

As of September 30,

As of December 31,

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Working capital

We incurred net losses of $5.5 million for the six months ended June 30, 2021.

We have an accumulated deficit of $ 439.0 million as of June 30, 2021.

Additionally, we used net cash of $5.4 million to fund our operating activities for the six months ended June 30, 2021.

We incurred net losses of $9.2 million for the nine months ended September 30, 2021.

We have an accumulated deficit of $442.8 million as of September 30, 2021.

Additionally, we used net cash of $7.7 million to fund our operating activities for the nine months ended September 30, 2021.

These factors raise substantial doubt about our ability to continue as a going concern.

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Our inability to raise additional cash would have a material and adverse impact on operations and would cause us to default on our loan .

On October 23, 2020, we entered into the Distribution Agreement with Canaccord, pursuant to which we could issue and sell, from time to time, ATM Shares, depending on market demand, with Canaccord acting as an agent for sales.

Sales of the ATM Shares were made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made directly on or through the NASDAQ Capital Market.

Canaccord used its commercially reasonable efforts to sell the ATM Shares we requested to be sold on our behalf, consistent with Canaccord’s normal trading and sales practices, under the terms and subject to the conditions set forth in the Distribution Agreement.

We had no obligation to sell any of the ATM Shares.

We could instruct Canaccord not to sell the ATM Shares if the sales could not be effected at or above the price we designated from time to time and we could suspend at any time sales pursuant to the Distribution Agreement.

During the year ended December 31, 2020, we issued 1,616,331 shares under the Distribution Agreement for net proceeds of approximately $3.2 million.

During the six months ended June 30, 2021, we issued 2,179,193 shares under the Distribution Agreement for net proceeds of $6.3 million.

As of June 30, 2021, there were no remaining shares to issue and sell under the Distribution Agreement.

During the nine months ended September 30, 2021, we issued 2,179,193 shares under the Distribution Agreement for net

proceeds of $6.3 million.

As of September 30, 2021, there were no remaining shares to issue and sell under the Distribution Agreement .

On September 30, 2020, we entered into the 2020 Purchase Agreement and a registration rights agreement with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $25.0 million of our common stock.

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During the year ended December 31, 2020, we issued 353,113 shares, excluding 180,701 shares issued as commitment fee, under the 2020 Purchase Agreement for net proceeds of approximately $0.7 million.

During the six months ended June 30, 2021, we issued 2,262,686 shares of our common stock under the 2020 Purchase Agreement for net proceeds of $6.0 million.

On March 29, 2020, we entered into the Ninth Amendment, pursuant to which, among other things, Oxford agreed to defer the start date of principal repayment from May 1, 2020 to May 1, 2021.

On September 3, 2021, we filed a prospectus, which became effective on September 10, 2021, for the offer and sale of up to 5,865,000 shares of our common stock by Lincoln Park under the 2020 Purchase Agreement.

Dur ing the nine months ended September 30, 2021, we issued 5,535,186 shares of our common stock under the 2020 Purchase Agreement for net proceeds of $12.3 million.

On March 29, 2020, we entered into the Ninth Amendment of the Loan and Security Agreement (the “Ninth Amendment”) which amended that certain Loan and Security Agreement (the “Loan and Security Agreement”), pursuant to which Oxford Finance, LLC (“Oxford”) funded an aggregate principal amount of $17.7 million (the “Term Loan”), subject to the terms and conditions set forth in the Loan and Security Agreement.

Under the Ninth Amendment, among other things, Oxford agreed to defer the start date of principal repayments under the Loan and Security Agreement from May 1, 2020 to May 1, 2021.

As we met the “Second I/O Extension Equity Event,” as defined in the Ninth Amendment, the principal repayment start date has been deferred to November 1, 2021.

In addition, on April 1, 2020, we made a $5.0 million paydown of principal upon execution of the Ninth Amendment.

In addition, on April 1, 2020, we made a $5.0 million paydown of principal under the Term Loan upon execution of the Ninth Amendment.

As a result of this Ninth Amendment, the term of the Term Loan has been extended from September 1, 2021 to September 1, 2024, with all other major terms remained consistent.

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Without additional capital, current working capital and cash generated from sales will not provide adequate funding for research and product development activities at their current levels.

If sufficient capital is not raised, we will at a minimum need to significantly reduce or curtail our

research and development and other operations, and this would negatively affect our ability to ac hieve corporate growth goals.

T here is likely to be continued market volatility due to the COVID-19 pandemic , risk of inflation or other events, which could cause our stock price to decline.

If sufficient capital is not raised, we will at a minimum need to significantly reduce or curtail our research and development and other operations, and this would negatively affect our ability to achieve corporate growth goals.

There is likely to be continued market volatility due to the COVID-19 pandemic, risk of inflation or other events, which could cause our stock price to decline.

This in turn will likely negatively impact our ability to raise funds through equity-related financings.

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Should we be unable to raise additional cash from outside sources or if we are unable to do so in a timely manner or on commercially reasonable terms, it would have a material adverse impact on our operations.

Cash (used in) provided by operating, investing, and financing activities for the six months ended June 30, 2021 and 2020 is summarized as follows (in thousands):

For the Six Months Ended June 30,

Cash (used in) provided by operating, investing, and financing activities for the nine months ended September 30, 2021 and 2020 is summarized as follows (in thousands):

For the Nine Months Ended September 30,

Net cash used in operating activities

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Operating activities

Net cash used in operating activities for the six months ended June 30, 2021 was $5.4 million compared to $2.9 million in the same period of 2020.

Our operational cash use increased during the six months ended June 30, 2021 as compared to the same period in 2020, due primarily to timing of cash payments made for operating assets and liabilities.

Net cash used in operating activities for the nine months ended September 30, 2021 was $7.7 million compared to $5.2 million in the same period of 2020.

Our operational cash use increased during the nine months ended September 30, 2021 as compared to the same period in 2020, due primarily to timing of cash payments made for operating assets and liabilities.

Investing activities

Net cash used in investing activities for the six months ended June 30, 2021 were related to purchases of fixed assets.

Net cash used in investing activities for the six months ended June 30, 2020 was primarily related to cash payments of $0.4 million made for in process research and development assets from NanoTx, and purchases of fixed assets.

Net cash used in investing activities for the nine months ended September 30, 2021 were related to purchases of fixed assets of $134,000, offset by proceeds of $50,000 from sale of property and equipment.

Net cash used in investing activities for the nine months

ended September 30, 2020 was primarily related to cash payments of $0.4 million made for in process research and development assets from NanoTx, and purchases of fixed assets.

Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2021 was primarily related to sales of common stock of $12.3 million, net of offering cost through the 2020 Purchase Agreement with Lincoln Park and the Distribution Agreement with Canaccord, as well as $2.0 million from exercise of warrants.

Net cash used for financing activities for the six months ended June 30, 2020 was primarily related to repayment of $5.3 million of the Term Loan in April 2020, and cash payments for our finance leases, offset by cash proceeds received from warrant exercises of $0.4 million.

Net cash provided by financing activities for the nine months ended September 30, 2021 was primarily related to sales of common stock of $18.6 million, net of offering cost through the 2020 Purchase Agreement with Lincoln Park and the Distribution Agreement with Canaccord, as well as $2.0 million from exercise of warrants.

Net cash used for financing activities for the nine months ended September 30, 2020 was primarily related to repayment of $5.3 million of the Term Loan in April 2020, and cash payments for our finance leases, offset by cash proceeds received from warrant exercises of $1.1 million.

Critical Accounting Policies and Significant Estimates

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We believe it is important for you to understand our most critical accounting policies.

Our critical accounting policies and estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and there have been no material changes during the six months ended June 30, 2021.

Quantitative and Qualitat ive Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk

Not applicable.

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