What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2022-02-11 compared with 2021-11-15 · 130 added, 84 removed, 428 unchanged (33% of the section changed)

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Access to the sites by our clinical monitors was limited during the COVID-19 pandemic but the recording of study data in both studies and patient treatments at both study sites was conducted per protocol.

Regarding the VAL-083 study arm of the GCAR registrational Phase 2/3 clinical trial that is currently being conducted at multiple sites in the United States, we have not experienced any significant impacts on patient enrollment or treatment.

Regarding the VAL-083 study arm of the Global Coalition for Adaptive Research (“GCAR”) glioblastoma multiforme (“GBM”) Adaptive Global Innovative Learning Environment (“AGILE”) registrational Phase 2/3 clinical study (the “GBM AGILE Study”) that is currently being conducted at multiple sites in the United States and Canada, we have not experienced any significant impacts on patient enrollment or treatment.

With respect to the REM-001 drug supply, we are currently experiencing some delays in contract manufacturing schedules and supplies which we attribute to COVID-19.

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Including net proceeds of approximately $13.

6 million received from a registered direct financing that closed on September 28, 2021, we estimate that we have cash available to fund planned operations for less than one year from the date of issuance of our September 30, 2021 condensed consolidated interim financial statements but cash is expected to fund planned operations through stage 1 of the GBM AGILE study, which could result in graduation to the final confirmatory stage, the potential NDA enabling portion of the study.

However, the COVID-19 pandemic has created significant economic uncertainty and volatility in the credit and capital markets.

T he COVID-19 pandemic has created significant economic uncertainty and volatility in the credit and capital markets.

The ultimate impact of the COVID-19 pandemic on our ability to raise additional capital is unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the COVID-19 outbreak and new information which may emerge concerning the severity of the COVID-19 pandemic.

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Recent Highlights

On February 3, 2022, we announced that the U.S.

Patent and Trademark Office had issued United States Patent No.

11,234,955 to VAL-083, covering a method of treating brain tumors including GBM, medulloblastoma, and cancer brain tumor stem cells that has O6-methyl guanine methyltransferase (“MGMT”)-driven drug resistance.

On January 18, 2022, GCAR announced that the GBM AGILE Study has screened over 1,000 patients and that enrollment rates for the study are 3 to 4 times greater than traditional GBM studies according to GCAR, with active sites averaging 0.75 to 1 patient per site per month.

Based on continued dialogue with GCAR in connection with the study, the Company has determined that it will not disclose graduation from stage 1 (safety and efficacy:

100-150 patients) to stage 2 (confirmatory:

50 additional patients).

As a result of the accelerated enrollment rate, the Company expects to announce top line data from the Kintara arm of the study around the end of calendar year 2023.

On January 12, 2022, we announced that the Luxembourg Institute of Health received a multiyear research grant to study and further elucidate the mechanism of action of VAL-083.

On December 3, 2021, we received a listing extension from the Staff of the Listing Qualifications Department of The Nasdaq Capital Market LLC (“Nasdaq”).

The extension granted us until June 1, 2022 to regain compliance with the $1.00 Minimum Bid Price requirement for continued listing on Nasdaq.

We can regain compliance if at any time during the compliance period the closing bid price of our common stock is at least $1.00 per share for a minimum of ten consecutive business days.

On November 30, 2021, we activated the first Canadian site for the VAL-083 treatment arm in the GBM AGILE Study which is a registrational Phase 2/3 clinical study.

On November 8, 2021, we positioned our management team for our next stage of development by announcing that Robert E.

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The warrants have an exercise price of $1.25 per share and expire on March 28, 2025.

We estimate that the financing will provide sufficient funding through stage 1 of our Global Coalition for Adaptive Research (“GCAR”) registrational Phase 2/3 clinical study for GBM, which could result in graduation to the final confirmatory stage, the potentially NDA enabling portion of this study.

On September 22, 2021, we reported positive topline data for the adjuvant arm of our open-label, Phase 2 clinical study of our lead compound, VAL-083, that was conducted at the MD Anderson Cancer Center (“MD Anderson”) in Houston, Texas.

The Phase 2 study was a two-arm, biomarker-driven study testing VAL-083 in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (“MGMT”) gene.

The adjuvant arm of the study investigated newly-diagnosed patients suffering from GBM receiving VAL-083 in place of standard-of-care temozolomide (“TMZ”) as adjuvant therapy following surgery and chemoradiation TMZ.

On August 17, 2021, we announced that 26 clinical sites in the United States had been activated for our GCAR registrational Phase 2/3 clinical study for GBM.

The study, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) Study, is a revolutionary, patient-centered, adaptive platform study for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM.

Targeted Clinical Milestones

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Below are our planned, or expected, milestones for the respective time periods noted:

reactivation of Investigational New Drug application

enroll first patient – CMBC fifteen patient confirmatory study leading into pivotal study

GCAR GBM AGILE registration study graduation from stage 1 (safety and efficacy:

100-150 patients) to stage 2 (confirmatory:

50 additional patients)

• VAL-083 - first site in Canada – GCAR GBM AGILE International Registrational Study ✓

• VAL-083 - first site in European Union – GCAR GBM AGILE International Registrational Study

• REM-001 - enroll first patient – CMBC fifteen patient confirmatory study leading into pivotal study

• REM-001 - topline results – CMBC fifteen patient confirmatory study leading into pivotal study

VAL-083 - topline results 12 months after last patient randomized - GCAR GBM AGILE International Registrational Study

Product Pipeline

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On October 21, 2020, we announced we had entered into a definitive agreement with GCAR and on January 13, 2021, we announced the initiation of patient recruitment for the VAL-083 study arm of the GBM AGILE Study.

We also announced that VAL-083 is the only therapeutic agent currently being evaluated in all three GBM patient subtypes in the GBM AGILE Study:

VAL-083 is currently being evaluated in all three GBM patient subtypes in the GBM AGILE Study:

newly-diagnosed methylated MGMT;

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The GBM AGILE Study employs a cost-efficient, adaptive study design with a stage 1 (Phase 2) learning and adapting phase and a stage 2 (Phase 3) expansion and confirmation phase.

On August 17, 2021, we announced that 26 clinical sites in the United States had been activated for our treatment arm in this study.

On January 10, 2022, we provided an update announcing that 31 clinical sites in the United States and Canada had been activated for our treatment arm in this study.

GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the U.S.

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(1) Dose-confirmation:

VAL-083 in cohorts (20, 30 and 40 mg/m 2 /day IV daily x 3 every 21 days) to assess safety and activity

when administered concurrently with x-ray therapy (“XRT”) to confirm the maximum tolerated dose (“MTD”), and (2) Expansion:

VAL-083 in cohorts (20, 30 and 40 mg/m 2 /day IV daily x 3 every 21 days) to assess safety and activity when administered concurrently with x-ray therapy (“XRT”) to confirm the maximum tolerated dose (“MTD”), and (2) Expansion:

VAL-083 was studied in 20 additional patients at the target dose, as determined by the dose-confirmation part of the study, administered concurrently with XRT.

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While this was not a head-to-head study, this PFS and mOS data compares favorably to historical TMZ control data of 5.0 months and 6.9 months PFS and 12.7 months and 16.0 months mOS as indicated by published data from Hegi et al.

(2005 - New England Journal of Medicine) and Tanguturi et al.

(2017 – NeuroOncology), respectively.

(2005 - New England Journal of Medicine), Tanguturi et al.

(2017 – NeuroOncology), and Alnahhas et al.

(2020 - Neurooncol Adv), respectively.

Multiple treatment cycles of VAL-083 at the 30 mg/m 2 /day dose in combination with standard radiation treatment (2 Gy/day, 5 days/week) was shown to be generally safe and well-tolerated.

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Recurrent Study Arm

On July 1, 2021 we reported topline patient data as follows:

On November 18, 2021, at the Society for Neuro-Oncology (“SNO”) Annual Meeting we reported patient data as follows:

mOS for the 48 efficacy evaluable patients initially receiving the treatment dose of 30 mg/m 2 /day was 8.0 months (95% CI 6.6-10.3 months);

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(2017 – New England Journal of Medicine).

All patients have completed treatment.

A detailed description of this study can be found at clinicatrials.gov, Identifier Number:

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These patients will have had initial cycles of temozolomide concomitant with radiation but will not have yet started subsequent cycles of TMZ (i.e., maintenance stage TMZ patients).

On September 22, 2021 we reported topline data as follows:

On November 18, 2021, at the SNO Annual Meeting we reported patient data as follows:

PFS for the 36 efficacy evaluable patients is 9.5 months (95% CI 8.2-10.8);

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(2005 - New England Journal of Medicine) and Tanguturi et al.

(2017 – NeuroOncology), respectively.

(2005 - New England Journal of Medicine), Tanguturi et al.

(2017 – NeuroOncology), and Alnahhas et al.

(2020 - Neurooncol Adv), respectively

Based on published data from our MD Anderson and SYSUCC clinical studies, we believe there is a significant opportunity to treat GBM patients in the pre-temozolomide maintenance stage (i.e., adjuvant).

We have previously reported that myelosuppression (thrombocytopenia and neutropenia) is the most common adverse event associated with VAL-083.

All patients have completed treatment.

A detailed description of this study can be found at clinicatrials.gov, Identifier Number:

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Since our May 2018 meeting, we have engaged a contract manufacturer who has manufactured the starting material for our API and manufactured two API lots under GMP.

We are currently planning to undertake GMP manufacturing of finished drug product for use

in the initial planned clinical study.

We are currently planning to undertake GMP manufacturing of finished drug product for use in the initial planned clinical study.

Drug substance and drug product manufacturing, and associated analytical methods, are currently being optimized for Phase 3.

We also believe REM-001 Therapy holds promise as a treatment for cutaneous metastatic cancers other than CMBC, as well as locally-advanced basal cell cancer such as often occurs in patients with Basal Cell Carcinoma Nevus Syndrome (“BCCNS”) and cutaneously recurrent basal cell cancer.

cutaneously recurrent basal cell cancer.

On January 16, 2018, the FDA granted our request that tin ethyl etiopurpurin (the active pharmaceutical ingredient in REM-001) be designated as an orphan drug for treatment of BCCNS.

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In addition, we believe REM-001 Therapy also holds promise for certain cardiovascular conditions, including de novo treatment of cardiovascular access sites in hemodialysis patients to ameliorate current high failure rates.

We hold an orphan drug designation that was initially awarded to Miravant for tin ethyl etiopurpurin for the prevention of access graft failure in hemodialysis patients.

We hold an orphan drug designation that was initially awarded to Miravant Medical Technologies, and its wholly-owned subsidiaries, (collectively “Miravant”) for tin ethyl etiopurpurin for the prevention of access graft failure in hemodialysis patients.

We have been working to further develop this indication, including engaging with a key opinion leader in this area and submitting an NIH grant proposal for late-stage preclinical research that we believe could lead directly to an IND and clinical study.

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Outstanding Securities

As of November 11, 2021, we had 48,535 shares of common stock issued and outstanding, outstanding warrants to purchase 19,152 shares of common stock, warrants to purchase 2,444 shares of our Series C Preferred Stock that upon exercise are convertible into 2,100 shares of common stock, outstanding stock options to purchase 10,328 shares of common stock, 17,747 outstanding shares of Series C Preferred Stock that are convertible into 15,267 shares of common stock.

As of February 9, 2022, we had 49,057 shares of common stock issued and outstanding, outstanding warrants to purchase 18,396 shares of common stock, warrants to purchase 2,444 shares of our Series C Preferred Stock that upon exercise are convertible into 2,100 shares of common stock, outstanding stock options to purchase 9,836 shares of common stock, 17 outstanding shares of Series C Preferred Stock that are convertible into 14,745 shares of common stock.

All common stock warrants and stock options are convertible, or exercisable into, one share of common stock.

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The financial information reported herein has been prepared in accordance with accounting principles generally accepted in the United States.

Our functional currency at September 30, 2021, and June 30, 2021, is the US$.

Our functional currency at December 31, 2021, and June 30, 2021, is the US$.

The following tables represent selected financial information for us for the periods presented.

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Selected Balance Sheet Data

September 30,

(in thousands)

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For the three months ended

September 30,

(in thousands, except per share data)

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General and administrative

In-process research and development

Other income (loss)

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Net loss for the period

Deemed dividend recognized on beneficial conversion

features of Series C Preferred stock issuance

Series A Preferred cash dividend

Series B Preferred stock dividend

Series C Preferred stock dividend

Net loss for the period attributable to common

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Basic and fully diluted loss per share

For the six months ended

(in thousands, except per share data)

Research and development

General and administrative

In-process research and development

Other income (loss)

Foreign exchange

Amortization of deferred loan costs

Interest, net

Net loss for the period

Deemed dividend recognized on beneficial conversion features of Series C Preferred stock issuance

Series A Preferred cash dividend

Series B Preferred stock dividend

Series C Preferred stock dividend

Net loss for the period attributable to common stockholders

Basic and fully diluted weighted average number of shares

Basic and fully diluted loss per share

Expenses, net of non-cash, share-based compensation expense – non-GAAP

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For the three months ended

September 30,

(in thousands)

Research and development - GAAP

non-cash, share-based compensation

Research and development net of non-cash,

share-based, compensation expense –

non-cash, share-based compensation expense

Research and development net of non-cash, share-based, compensation expense – Non-GAAP

General and administrative - GAAP

non-cash, share-based compensation

General and administrative net of non-cash,

share-based, compensation expense –

non-cash, share-based compensation expense

General and administrative net of non-cash, share-based, compensation expense – Non-GAAP

For the six months ended

(in thousands)

Research and development - GAAP

non-cash, share-based compensation expense

Research and development net of non-cash, share-based, compensation expense – Non-GAAP

General and administrative - GAAP

non-cash, share-based compensation expense

General and administrative net of non-cash, share-based, compensation expense – Non-GAAP

Results of Operations

Comparison of the three months ended September 30, 2021, and September 30, 2020

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

Three months ended

September 30,

(in thousands)

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General and administrative

Other income (loss)

Foreign exchange

Amortization of deferred loan costs

Interest, net

Research and Development

Research and development expenses increased to $3,902 for the three months ended December 31, 2021, from $2,584 for the three months ended December 31, 2020.

The increase was largely attributable to higher clinical development costs, including data compilation and assessment, partially offset by lower non-cash, share-based compensation expenses incurred during the three months ended December 31, 2021 compared to the three months ended December 31, 2020.

Clinical development costs have increased in the current quarter compared to the same quarter in the prior fiscal year largely due to costs related to the GCAR GBM AGILE Study.

Patient recruitment for this study commenced in January 2021 so ongoing study costs, including clinical site activation and patient enrollment, were incurred during the three months ended December 31, 2021, but were not incurred during the three months ended December 31, 2020.

However, during the three months ended December 31, 2020, we did incur certain GCAR GBM AGILE Study preparation and start-up costs but those costs were lower than the current period costs.

In addition, with the acquisition of the REM-001 technology as part of the Adgero transaction that closed in August 2020, more costs relating to clinical development and drug manufacturing activity have been incurred in the three months ended December 31, 2021, compared to the three months ended December 31, 2020.

We expect our research and development costs to be higher in fiscal year 2022 than fiscal year 2021 as our GCAR GBM AGILE Study continues and we incur costs related to the development of REM-001.

Non-cash, share-based compensation expense decreased for the three months ended December 31, 2021, compared to the three months ended December 31, 2020, due to the recognition of compensation expense for stock options granted in September 2020.

General and Administrative

General and administrative expenses were $1,993 for the three months ended December 31, 2021, compared to $2,794 for the three months ended December 31, 2020.

A significant portion of the decrease was a result of lower non-cash, share-based compensation expenses in the current three months compared to the same period in the prior fiscal year due to the recognition of compensation expense for stock options granted in September 2020.

Partially offsetting the lower non-cash, share-based compensation expenses was higher personnel costs due to the recognition of employee severance costs during the three months ended December 31, 2021, while no such costs were recognized during the three months ended December 31, 2020.

Preferred Share Dividends

During the three months ended December 31, 2021, we issued nil (2020 – 3) shares of common stock as a stock dividend on the Series B Preferred stock and recognized $nil (2020 - $4) as a direct increase in accumulated deficit.

For each of the three months ended December 31, 2021, and 2020, we recorded $2 related to the cash dividend payable to Valent on the Series A preferred stock.

The dividend has been recorded as a direct increase in accumulated deficit for both periods.

Comparison of the six months ended December 31, 2021, and December 31, 2020

Six months ended

(in thousands)

Research and development

General and administrative

In-process research and development

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Research and Development

Research and development expenses increased to $3,793 for the three months ended September 30, 2021, from $1,357 for the three months ended September 30, 2020.

The increase was largely attributable to higher clinical development costs, including data compilation and assessment, non-cash, share-based compensation expenses, and personnel costs incurred during the three months ended September 30, 2021 compared to the three months ended September 30, 2020.

Clinical development costs have increased in the current quarter compared to the prior quarter largely due to costs related to the GCAR GBM AGILE Study.

Patient recruitment for this study commenced in January 2021 so ongoing study costs, including clinical site activation and patient enrollment, were incurred during the three months ended September 30, 2021, but were not incurred during the three months ended September 30, 2020.

Research and development expenses increased to $7,695 for the six months ended December 31, 2021, from $3,941 for the six months ended December 31, 2020.

The increase was largely attributable to higher clinical development costs, including data compilation and assessment incurred during the six months ended December 31, 2021, compared to the six months ended December 31, 2020.

Clinical development costs have increased in the current quarter compared to the same period in the prior fiscal year largely due to costs related to the GCAR GBM AGILE Study.

Patient recruitment for this study commenced in January 2021 so ongoing study costs, including clinical site activation and patient enrollment, were incurred during the six months ended December 31, 2021, but were not incurred during the six months ended December 31, 2020.

However, during the three months ended December 31, 2020, we did incur certain GCAR GBM AGILE Study preparation and start-up costs but those costs were lower than in the current period.

In addition, with the acquisition of the REM-001 technology as part of the Adgero transaction that closed in August 2020, more costs relating to clinical development and drug manufacturing activity have been incurred in the current quarter compared to the same period in the prior fiscal year .

We expect our research and development costs to be higher in fiscal year 2022 than fiscal year 2021 as our GCAR GBM AGILE Study continues and we incur costs related to the development of REM-001.

Non-cash, share-based compensation expense increased for the three months ended September 30, 2021, compared to the three months ended September 30, 2020 due to the recognition of compensation expense for stock options granted in September 2021.

Personnel costs have increased in the current quarter compared to the prior quarter due to the addition of staff from the Adgero transaction.

Partially offsetting the increase in clinical development costs was a decrease in non-cash, share-based compensation expense decreased for the six months ended December 31, 2021, compared to the six months ended December 31, 2020, due to the recognition of compensation expense for stock options granted in September 2020.

General and Administrative

General and administrative expenses were $2,178 for the three months ended September 30, 2021, compared to $1,534 for the three months ended September 30, 2020.

A significant portion of the increase was due to higher non-cash, share-based compensation expenses, professional fees, and personnel costs in the current three months compared to the prior three months.

Non-cash, share-based compensation expense increased for the three months ended September 30, 2021, compared to the three months ended September 30, 2020, due to the recognition of compensation expense for stock options granted in September 2021.

Professional fees increased due to higher costs for legal and accounting in the current quarter than in the prior quarter.

Personnel costs have increased in the current quarter compared to the prior quarter due to the addition of staff from the Adgero transaction.

General and administrative expenses were $4,171 for the six months ended December 31, 2021, compared to $4,329 for the six months ended December 31, 2020.

We incurred lower non-cash, share-based compensation expenses in the current six months compared to the same period in the prior fiscal year due to the recognition of compensation expense for stock options granted in September 2020.

Partially offsetting the lower non-cash, share-based compensation expenses for the six months ended December 31, 2021, were higher personnel and professional fees.

Personnel costs increased due to the recognition of employee severance costs during the current period while professional fees were higher for the six months ended December 31, 2021, due to higher costs for legal and accounting.

Preferred Share Dividends

During the three months ended September 30, 2021 we issued 1,698 (2020 – nil) shares of common stock as a stock dividend on the Series C Preferred stock and recognized $2,462 (2020 - $nil) as a direct increase in accumulated deficit.

During the three months ended September 30, 2021 we issued nil (2020 – 4) shares of common stock as a stock dividend on the Series B Preferred stock and recognized $nil (2020 - $5) as a direct increase in accumulated deficit.

For each of the three months ended September 30, 2021, and 2020 we recorded $2 related to the cash dividend payable to Valent on the Series A preferred stock.

During the six months ended December 31, 2021, we issued 1,698 (2020 – nil) shares of common stock as a stock dividend on the Series C Preferred stock and recognized $2,462 (2020 - $nil) as a direct increase in accumulated deficit.

During the six months ended December 31, 2021, we issued nil (2020 – 7) shares of common stock as a stock dividend on the Series B Preferred stock and recognized $nil (2020 - $9) as a direct increase in accumulated deficit.

For each of the six months ended December 31, 2021, and 2020, we recorded $4 related to the cash dividend payable to Valent on the Series A preferred stock.

The dividend has been recorded as a direct increase in accumulated deficit for both periods.

Liquidity and Capital Resources

Three months ended September 30, 2021 compared to the three months ended September 30, 2020

September 30,

Six months ended December 31, 2021, compared to the six months ended December 31, 2020

(in thousands)

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Operating Activities

Net cash used in operating activities increased to $5,073 for the three months ended September 30, 2021, from $4,110 for the three months ended September 30, 2020.

During the three months ended September 30, 2021, and 2020, we reported net losses of $5,966 and $19,518, respectively.

While the loss in the prior period was larger than the current period, the prior period included a non-cash amount of $16,094 relating to the recognition of acquired in-process research and development expense related to the Adgero transaction.

Additional changes in adjustments to reconcile net loss to net cash used in operating activities for the three months ended September 30, 2021, included stock option expense of $811 being recognized during the current period compared to $405 in the prior period.

The most significant change in working capital for the three months ended September 30, 2021, was cash from an increase in accounts and accrued liabilities of $122.

The most significant change in working capital for the three months ended September 30, 2020, was cash used as a reduction in accounts payable and accrued liabilities of $914.

Net cash used in operating activities increased to $10,177 for the six months ended December 31, 2021, from $9,541 for the six months ended December 31, 2020.

During the six months ended December 31, 2021, and 2020, we reported net losses of $11,859 and $24,931, respectively.

While the loss in the prior period was larger than the current period, the same period in the prior fiscal year included a non-cash amount of $16,094 relating to the recognition of acquired in-process research and development expense related to the Adgero transaction.

Additional changes in adjustments to reconcile net loss to net cash used in operating activities for the six months ended December 31, 2021, included stock option expense of $1,641 being recognized during the current period compared to $2,530 in the same period in the prior fiscal year.

The most significant changes in working capital for the six months ended December 31, 2021, were from an increase in accounts payable and accrued liabilities of $677 and a decrease from a reduction in prepaid expenses, deposits and other of $678.

The most significant change in working capital for the six months ended December 31, 2020, was cash used as an increase in prepaid expenses, deposits and other of $2,784.

Investing Activities

There were no investing activities during the three months ended September 30, 2021.

During the three months ended September 30, 2020, we acquired $969 in cash as part of the Adgero transaction that closed on August 19, 2020.

There were no investing activities during the six months ended December 31, 2021 .

During the six months ended December 31 , 2020, we acquired $969 in cash a s part of the Adgero transaction that closed on August 19, 2020 .

Financing Activities

During the three months ended September 30, 2021, we received approximately $13,803 in net proceeds from the completion of a registered direct financing that closed on September 28, 2021, and $74 from the cash exercise of stock purchase warrants.

During the three months ended September 30, 2020, we received $21,598 in net proceeds from the completion of a private placement of Series C Preferred stock and $994 from the cash exercise of stock purchase warrants.

Also, during the three months ended September 30, 2020, we received proceeds from the NBTS Loan of $500.

During the six months ended December 31, 2021, we received $13,634 in net proceeds from the completion of a registered direct financing that closed on September 28, 2021, and $74 from the cash exercise of stock purchase warrants.

During the six months ended December 31, 2020, we received $21,638 in net proceeds from the completion of a private placement of Series C Preferred stock and $1,180 from the cash exercise of stock purchase warrants.

Also, during the six months ended December 31, 2020, we received proceeds from the NBTS Loan of $500.

Going Concern and Capital Expenditure Requirements

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The condensed consolidated interim financial statements have been prepared on a going concern basis, which assumes that we will continue our operations for the foreseeable future and contemplates the realization of assets and the settlement of liabilities in the normal course of business .

For the three months ended September 30, 2021, we reported a loss of $5,966 and a negative cash flow from operations of $5,073.

We had an accumulated deficit of 119,655 and had cash and cash equivalents of $19,339 as of September 30, 2021.

For the six months ended December 31, 2021, we reported a loss of $11,859 and a negative cash flow from operations of $10,177.

We had an accumulated deficit of $125,550 and had cash and cash equivalents of $14,064 as of December 31, 2021.

We are in the clinical stage and have not generated any revenues to-date.

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Prior to our adoption of ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), stock options granted to non-employee consultants were revalued at the end of each reporting period until vested using the Black-Scholes option-pricing model and the changes in their fair value were recorded as adjustments to expense over the related vesting period.

For the three months ended September 30, 2021, and 2020, the determination of grant-date fair value for stock option awards was estimated using the Black-Scholes model which includes variables such as the expected volatility of our share price, the anticipated exercise behavior of its grantee, interest rates, and dividend yields.

For the three months September 30, 2021, and 2020, we utilized the plain vanilla method to determine the expected life of stock options.

For the six months ended December 31, 2021, and 2020, the determination of grant-date fair value for stock option awards was estimated using the Black-Scholes model which includes variables such as the expected volatility of our share price, the anticipated exercise behavior of its grantee, interest rates, and dividend yields.

For the six months ended December 31, 2021, and 2020, we utilized the plain vanilla method to determine the expected life of stock options.

These variables are projected based on our historical data, experience, and other factors.

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The warrants issued for services have been valued at the fair value of the warrants issued.

For the three months ended September 30, 2021, and 2020, the determination of grant-date fair value for warrants issued for services was estimated using the Black-Scholes model which includes variables such as the expected volatility of our share price, interest rates, dividend yields, and the term of the warrant.

For the six months ended December 31, 2021, and 2020, the determination of grant-date fair value for warrants issued for services was estimated using the Black-Scholes model which includes variables such as the expected volatility of our share price, interest rates, dividend yields, and the term of the warrant.

We have also issued shares for services to non-employees which have been valued using the share price of our common stock.

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Our clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.

Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low for any particular period.

For three months ended September 30, 2021, and 2020, there were no material adjustments to our prior period estimates of accrued expenses for clinical trials.

particular period.

For six months ended December 31, 2021 , and 2020 , there were no material adjustments to our prior period estimates of accrued expenses for clinical trials.

Off-Balance Sheet Arrangements

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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