What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-11-15 compared with 2021-05-13 · 164 added, 401 removed, 348 unchanged (62% of the section changed)

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Except as may be required under applicable securities laws, we undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this report or to reflect the occurrence of unanticipated events.

You should review the factors and risks we describe under “Risk Factors” in this report on Form 10-K for the year ended June 30, 2020 and in our other filings with the Securities and Exchange Commission, available at www.sec.gov.

You should review the factors and risks we describe under “Risk Factors” in our report on Form 10-K for the year ended June 30, 2021 and in our other filings with the Securities and Exchange Commission, available at www.sec.gov.

Actual results may differ materially from any forward-looking statement.

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The ultimate impact of the COVID-19 pandemic on our operations 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, new information which may emerge concerning the duration and severity of the COVID-19 pandemic, and any additional preventative and protective actions that governments, or us, may determine are needed.

To date, the COVID-19 pandemic has not caused significant disruption to our Phase 2 clinical studies.

Each of our ongoing Phase 2 clinical studies is being conducted at a single site which has reduced the risk of disruption.

Patient visits are currently taking place on schedule at the MD Anderson Cancer Center study being conducted in Houston, Texas while patient enrollment and patient treatment for our Phase 2 study being conducted at Sun Yat-sen University Cancer Center in China has been completed.

All patients in the China study are currently in the follow-up period of the Phase 2 study.

In addition, thus far, any disruptions to patient treatments have been within allowances under each study protocol.

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

Regarding the VAL-083 study arm of the Global Coalition for Adaptive Research (“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.

The COVID-19 pandemic did not cause significant disruption to our Phase 2 clinical studies.

Each of our now-completed Phase 2 clinical studies was conducted at respective single sites which reduced the risk of study disruption.

Any disruptions to patient treatments for our Phase 2 studies were within allowances under each study protocol.

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.

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.

The current delays could have an impact on our REM-001 program timeline.

We have cash available to fund planned operations into the second quarter of calendar 2022.

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.

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Kintara Therapeutics, Inc.

(formerly DelMar Pharmaceuticals, Inc.) is a clinical stage, biopharmaceutical company focused on the development and commercialization of new cancer therapies.

On June 9, 2020, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), by and among Adgero Acquisition Corp., our wholly-owned subsidiary incorporated in the State of Delaware (“Merger Sub”), and Adgero Biopharmaceuticals Holdings, Inc., a Delaware corporation (“ Adgero ”).

is a clinical stage, biopharmaceutical company focused on the development and commercialization of new cancer therapies.

On June 10 , 2020, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) dated as of June 9, 2020 , by and among Adgero Acquisition Corp., our wholly-owned subsidiary incorporated in the State of Delaware (“Merger Sub”), and Adgero Biopharmaceuticals Holdings, Inc., a Delaware corporation (“Adgero”).

On August 19, 2020, upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub merged with and into Adgero (the “Merger”), the separate corporate existence of Merger Sub ceased , and Adgero continued its existence under Delaware law as the surviving corporation in the Merger and became our direct, wholly-owned subsidiary.

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We are also the parent company to Callco and Exchangeco which are British Columbia, Canada corporations.

Callco and Exchangeco were formed to facilitate the Reverse Acquisition.

References to “we”, “us”, and “our”, refer to Kintara and our wholly-owned subsidiaries, Del Mar (BC), Adgero, Callco and Exchangeco.

Callco and Exchangeco were formed to facilitate the Reverse Acquisition that occurred in 2013.

References to “we”, “us”, and “our”, refer to Kintara and our wholly-owned subsidiaries, Del Mar (BC), Adgero, Adgero Bio, Callco, and Exchangeco.

We are dedicated to the development of novel cancer therapies for patients with unmet medical needs.

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Recent Highlights

On April 10, 2021 at the American Association for Cancer Research (“AACR”) Annual Meeting we announced positive data updates from our ongoing Phase 2 clinical studies in newly-diagnosed first-line, newly-diagnosed adjuvant, and recurrent GBM.

On February 17, 2021 we announced the final patient was enrolled in the recurrent arm of our ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (“MD Anderson”).

The recurrent arm of the study addresses patients suffering from GBM who have been pre-treated with temozolomide (“TMZ”) prior to disease recurrence.

On January 13, 2021, we announced the initiation of patient recruitment for the VAL-083 study arm of the GCAR registrational Phase 2/3 clinical trial for GBM.

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

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

newly-diagnosed methylated MGMT;

newly-diagnosed unmethylated MGMT;

and recurrent.

Private Placement of Series C Preferred Stock

In conjunction with the closing of the Merger, and through a series of three private placement closings, we issued a total of 25,028 shares of Series C Convertible Preferred Stock (the “Series C Stock”) at a purchase price of $1,000 per share for total aggregate gross proceeds of approximately $25,000, or net proceeds of approximately $21,598.

Each closing of the private placement was priced at-the-market under the rules of the Nasdaq Stock Market.

The Series C Stock was issued in three series (C-1, C-2, and C-3) at conversion prices equal to $1.16, $1.214 and $1.15, respectively.

As result, we issued a total of 25,028 shares of Series C Stock, which are convertible into an aggregate of 21,516,484 shares of common stock.

The Series C Stock will be entitled to receive dividends, payable in shares of common stock at a rate of 10%, 15%, 20% and 25% of the number of shares of common stock issuable upon conversion of the Series C Stock, on the 12 th , 24 th , 36 th and 48 th month, anniversary of the initial closing of the private placement which occurred on August 19, 2020;

provided, that the holder of such shares has not converted the shares of Series C Stock prior to the applicable dividend rate.

In connection with the private placement, we entered into a Placement Agency Agreement (the “Placement Agency Agreement”), with Aegis Capital Corp., which acted as our exclusive placement agent (the “Placement Agent”) for the private placement.

Pursuant to the terms of the Placement Agency Agreement, in connection with the three closings of the private placement, we paid the Placement Agent an aggregate cash fee of $2 ,50 3 , a non-accountable expense allowance of approximately $65 1 a nd issued to the Placement Agent, or its designees, warrants to purchase 2,504 shares of Series C Stock (the “Placement Agent Warrants”).

The Placement Agent Warrants have an exercise price of $1,000 per share, provide for a cashless exercise feature and are exercisable for a period of four years from the date of the initial closing of the private placement.

The Series C Stock issuable upon exercise of the Placement Agent Warrants will be convertible into shares of common stock and will be entitled to the same dividend rights as the outstanding Series C Stock.

In addition, and as compensation for advisory services rendered in connection with the Merger, we issued 57 2 shares of common stock to the Placement Agent.

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

Hoffman, our current Chairman, will succeed Saiid Zarrabian as President and Chief Executive Officer.

Hoffman will continue in his capacity as our Chairman and Mr.

Zarrabian will transition to heading up our strategic partnerships initiative and will remain a member of the Board of Directors.

On September 23, 2021, we entered into securities purchase agreements with certain institutional investors pursuant to which, on September 28, 2021, we issued an aggregate of 7,200,000 shares of common stock, pre-funded warrants to purchase 4,800,000 shares of common stock and warrants to purchase 12,000,000 shares of common stock for approximately $15 million in gross proceeds, before placement agent fees and other offering expenses payable by us.

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

(calendar quarters)

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

Commenced Enrollment – GCAR GBM AGILE Registration Study

American Association for Cancer Research Posters – Provided Data Updates for Phase 2 GBM Studies

Top Line Results – Phase 2 Recurrent GBM Study

Top Line Results – Phase 2 Adjuvant GBM Study

Q4 2021/Q1 2022

Enroll first patient – CMBC lead-in study

First Half 2022

Graduation from Stage 1 to Stage 2 in the GCAR GBM AGILE Registration Study

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)

Product Pipeline

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As part of our business strategy, we leverage and build upon these prior NCI investments and data from more than 40 NCI Phase 1 and Phase 2 clinical studies, which includes an estimated 1,200 patient safety database.

Prior studies of VAL-083 have shown increased median overall survival benefits versus radiation alone validating the positive tumor affecting properties of VAL-083.

Our research has highlighted the opportunities afforded by VAL-083’s unique mechanism of action and its potential to address unmet medical needs in a well-defined and acknowledged biomarker selected population within the larger GBM population.

Historically, we have focused our development efforts on patients whose tumors exhibit biological features that make them resistant to, or unlikely to respond to, currently available therapies as identified by the National Comprehensive Cancer Network (“NCCN”).

For example, our research demonstrating VAL-083’s activity in GBM independent of the O6-methyl guanine methyltransferase (“MGMT”) methylation status has allowed us to focus our Phase 2 study patient selection based on this important biomarker and thus improve the probability of success in our current and future clinical studies.

We are currently conducting two open-label, biomarker-driven, Phase 2 studies in MGMT-unmethylated GBM.

MGMT is a DNA-repair enzyme that is associated with resistance to TMZ, the current standard-of-care chemotherapy used in the treatment of GBM.

Greater than 60% of GBM patients have MGMT-unmethylated tumors and exhibit a high expression of MGMT, which is correlated with TMZ treatment failure and poor patient outcomes as indicated in the NCCN guidelines for GBM treatment published in September 2017.

Our research demonstrates that VAL-083’s anti-tumor activity is independent of MGMT expression.

In our current Phase 2 studies we are using MGMT as a biomarker to identify patients for treatment with VAL-083 in three distinct GBM patient populations:

MGMT-unmethylated GBM, currently comprising two ongoing, separate Phase 2 clinical studies for:

GBM patients in two study arms at MD Anderson:

as adjuvant therapy immediately following concomitant TMZ treatment with chemoradiation in newly-diagnosed GBM patients;

in Avastin ® -naïve recurrent GBM patients;

As first-line therapy in newly-diagnosed GBM patients at Sun Yat-sen University Cancer Center (“SYSUCC”).

On June 4, 2020, we accepted an invitation from GCAR to include VAL-083 in GCAR’s GBM AGILE Study, an adaptive clinical study platform for patients with GBM.

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:

In GBM, we are part of the GBM AGILE Study which is a registrational Phase 2/3 clinical study for GBM.

The study is a revolutionary, patient centered, adaptive platform study for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM.

VAL-083 is currently the only therapeutic agent being evaluated in all three GBM patient subtypes in this study:

newly-diagnosed methylated MGMT;

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and recurrent.

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

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design.

The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously.

With its innovative design and efficient operational infrastructure, we believe data from the GBM AGILE Study can be used as the foundation for an NDA and biologics license application submissions and registrations to the U.S.

Food and Drug Administration (“FDA”) and other health authorities.

GCAR is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative and complex trials including master protocols and platform trials.

GCAR is the sponsor of GBM AGILE.

Key strategic partners for the GBM AGILE trial effort include the National Brain Tumor Society (“NBTS”), National Foundation for Cancer Research, and Asian Fund for Cancer Research.

We have also undertaken research in ovarian cancer.

We have also completed two open-label, biomarker-driven, Phase 2 studies in MGMT-unmethylated GBM.

MGMT is a DNA-repair enzyme that is associated with resistance to TMZ, the current standard-of-care chemotherapy used in the treatment of GBM.

Greater than 60% of GBM patients have MGMT-unmethylated tumors and exhibit a high expression of MGMT which is correlated with TMZ treatment failure and poor patient outcomes as indicated in the current National Comprehensive Cancer Network (“ NCCN ”) guidelines for GBM treatment.

Our research demonstrates that VAL-083’s anti-tumor activity is independent of MGMT expression.

In our completed Phase 2 studies we used MGMT as a biomarker to identify patients for treatment with VAL-083 in three distinct GBM patient populations .

In addition, we have undertaken research in ovarian cancer.

Ovarian cancer is the fifth most common cancer in women and is the leading cause of death among women diagnosed with gynecological malignancies.

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The FDA granted orphan drug designation for the use of VAL-083 in the treatment of ovarian cancer.

In addition to our clinical development activities in the United States, pursuant to our collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co.

(“Guangxi Wuzhou Pharmaceutical Company”), we have provided Guangxi Wuzhou Pharmaceutical Company certain commercial rights to VAL-083 in China where it is approved as a chemotherapy for the treatment of chronic myelogenous leukemia (“CML”) and lung cancer.

Guangxi Wuzhou Pharmaceutical Company is the only manufacturer presently licensed by the China Food and Drug Administration (“CFDA”) to produce the product for the China market.

We have a broad patent portfolio to protect our intellectual property.

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The FDA has also granted Orphan Drug description to VAL-083 for the treatment of medulloblastoma and ovarian cancer.

Our corporate development strategy is to advance VAL-083 on an indication-by-indication basis, and then to consider out-licensing when it has matured enough to warrant proper licensing valuations.

In addition to VAL-083’s applicability to multiple solid tumor indications, we are also constantly evaluating licensing, or acquiring additional product candidates, in order to establish a product pipeline and to position us for long-term sustainability and growth of shareholder value.

We believe the experience of our clinical development team will position us to efficiently develop possible drug candidates that we may acquire, or license, in the future.

We intend to continue to evaluate options for our strategic direction.

These options may include raising additional capital, the acquisition of another company and/or complementary assets, our sale, or another type of strategic partnership.

MGMT-unmethylated GBM

GBM is the most common and the most lethal form of glioma.

According to the Central Brain Tumor Registry of the United States, GBM occurs with an incidence of 3.20 per 100,000 person-years.

Approximately 13,000 new cases of GBM were diagnosed in the United States and 16,000 in Europe during 2017.

Within the GBM patient population, over 60% of patients are unmethylated with respect to their MGMT status.

Measurement of MGMT (O6-methyl guanine methyltransferase) methylation status has become routine in clinical practice as a biomarker that correlates with resistance to the standard-of-care chemotherapy with TMZ (Temodar ® ), and patient outcomes in GBM.

Over 60% of GBM patients’ tumors are characterized as “MGMT-unmethylated” and exhibit a high expression of MGMT, a naturally occurring DNA-repair enzyme, the activity of which nullifies the chemotherapeutic activity of TMZ.

The lack of specific therapies for MGMT-unmethylated GBM is a significant unmet medical need.

Importantly, the 2017 update to the NCCN guidelines states that the treatment benefit of TMZ is likely to be lower in GBM patients with an unmethylated MGMT promoter.

We have demonstrated that VAL-083’s anti-tumor mechanism is active independent from the MGMT status in vitro .

We believe this distinct mechanism of action suggests the potential of VAL-083 as a replacement for the current standard-of-care chemotherapy, temozolomide, in both MGMT methylated and MGMT-unmethylated GBM.

We have utilized MGMT-methylation status to identify GBM patients who are unlikely to respond to TMZ and have included only MGMT-unmethylated patients in our current Phase 2 clinical studies of VAL-083.

We have recently received approval to treat newly-diagnosed methylated, newly-diagnosed unmethylated, and recurrent GBM patients as part of our treatment arm in the GCAR GBM AGILE study.

We believe that our research, highlights the opportunity for VAL-083 as a potential new standard-of-care in the treatment of both MGMT methylated and MGMT-unmethylated GBM.

VAL-083 Clinical Studies

On June 4, 2020, we accepted an invitation from GCAR to include VAL-083 in GCAR’s GBM AGILE Study, an adaptive clinical study platform for patients with GBM.

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:

newly-diagnosed methylated MGMT;

newly-diagnosed unmethylated MGMT;

and recurrent.

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.

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

and Canada with potential to increase this total to 65 clinical study centers worldwide.

GBM AGILE is an international, innovative platform study designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design.

The study, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously.

With its innovative design and efficient operational infrastructure, we believe data from the GBM AGILE Study can be used as the foundation for a New Drug Application (“NDA”) and biologics license application submissions and registrations to the U.S.

Food and Drug Administration (“FDA”) and other health authorities.

GCAR is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative and complex studies including master protocols and platform studies.

GCAR is the sponsor of GBM AGILE.

Key strategic partners for the GBM AGILE study effort include the National Brain Tumor Society (“NBTS”), National Foundation for Cancer Research, and Asian Fund for Cancer Research.

Phase 2 Study in Newly-Diagnosed MGMT-unmethylated GBM

In September 2017, we initiated a single arm, biomarker driven, open-label Phase 2 study in newly-diagnosed MGMT-unmethylated GBM patients at SYSUCC in Guangzhou, China.

The study is being conducted under our collaboration agreement with Guangxi Wuzhou Pharmaceutical Company.

In this Phase 2 study, VAL-083 is being combined with radiotherapy as a potential replacement for standard-of-care chemoradiation with temozolomide in patients with MGMT-unmethylated GBM.

The goals of the study are to confirm the safety of the three-day VAL-083 dosing regimen in combination with radiotherapy and to investigate efficacy outcomes of the combination of VAL-083 and radiotherapy in MGMT-unmethylated GBM patients.

In September 2017, we initiated a single arm, biomarker driven, open-label Phase 2 study in newly-diagnosed MGMT-unmethylated GBM patients at Sun Yat-sen University Cancer Center (“SYSUCC”) in Guangzhou, China.

The study was conducted under our collaboration agreement with Guangxi Wuzhou Pharmaceutical Company.

In this Phase 2 study, VAL-083 was combined with radiotherapy as a potential replacement for standard-of-care chemoradiation with temozolomide in patients with MGMT-unmethylated GBM.

The goals of the study were to confirm the safety of the three-day VAL-083 dosing regimen in combination with radiotherapy and to investigate efficacy outcomes of the combination of VAL-083 and radiotherapy in MGMT-unmethylated GBM patients.

We have completed enrollment of this study with a total of 29 newly-diagnosed, MGMT-unmethylated GBM patients and we have also completed treatment of the patients on this study.

The efficacy endpoints of the study include tumor response, as assessed by the Response Assessment in NeuroOncology (“RANO”), and progression-free survival (“PFS”), progression-free survival at six months (“PFS6”), and overall survival (“OS”), compared to historical results in the target population.

The study is being conducted in two parts:

The study was conducted in two parts:

(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 will be studied in up to 20 additional patients at the target dose, as determined by the dose-confirmation part of the study, administered concurrently with XRT.

Assessments of safety and tolerability will be used to support further clinical development of VAL-083 in combination with radiotherapy.

Pharmacokinetic assessments of VAL-083 in plasma and cerebral spinal fluid (“CSF”) will be used to correlate drug exposure in the central nervous system with patient outcomes.

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.

Assessments of safety and tolerability were used to support further clinical development of VAL-083 in combination with radiotherapy.

Pharmacokinetic assessments of VAL-083 in plasma and cerebral spinal fluid (“CSF”) were used to correlate drug exposure in the central nervous system with patient outcomes.

Dose-confirming cohorts studying 20, 30, and 40 mg/m 2 /day x three every 21 days have been completed.

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This study is fully enrolled at 29 patients.

On April 10, 2021 at the virtual AACR Annual Meeting, we provided an update on patient data as follows:

For the 29 patients as of the March 11, 2021 cut-off date, median PFS with VAL-083 is currently 9.3 months (95% confidence interval (“CI”) 6.4-12.0 months).

On April 10, 2021, at the virtual AACR Annual Meeting, we provided top-line results on patient data as follows:

For the 29 patients as of the March 11, 2021 cut-off date, median PFS with VAL-083 was 9.3 months (95% confidence interval (“CI”) 6.4-12.0 months).

Additionally, for the 25 patients initially receiving the treatment dose that is being carried forward into the GBM AGILE pivotal Phase 3 study of 30 mg/m 2 /day on days 1, 2 and 3 of a 21-day cycle, median PFS was reported to be 8.7 months (CI 6.4-12.5 months);

While this is not a head-to-head study, this PFS data compares favorably to historical TMZ control data.

Published data from Hegi et al.

For the 29 patients as of the March 11, 2021 cut-off date, median overall survival (“mOS”) with VAL-083 was 19.6 months (CI 14.0-22.4 months).

Additionally, for the 25 patients initially receiving the treatment dose that is being carried forward into the GBM AGILE pivotal Phase 3 study of 30 mg/m 2 /day on days 1, 2 and 3 of a 21-day cycle, mOS was reported to be 19.1 months (CI 12.0-22.3 months).

While this was not a head-to-head study, this PFS and mOS data compares favorably to historical TMZ control data of 5.3 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) indicates that MGMT-unmethylated patients receiving the current standard of care have a median PFS of 5.3 months and 6.9 months, respectively.

(2017 – NeuroOncology), 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.

Phase 2 Study in MGMT-unmethylated GBM in Collaboration with University of Texas MD Anderson Cancer Center

In February 2017, we initiated a biomarker driven, open-label, single-arm Phase 2 study in collaboration with MD Anderson This biomarker-driven study (testing for MGMT methylation status) has been amended to enroll up to 83 patients (35 with a starting dose of 40 mg/m 2 /day and 48 with a starting dose of 30 mg/m 2 /day) to determine the potential of VAL-083 treatment to improve overall survival in GBM patients whose tumors have recurred following treatment with temozolomide.

In February 2017, we initiated a biomarker driven, open-label, single-arm Phase 2 study in collaboration with MD Anderson for recurrent GBM patients.

This biomarker-driven study (testing for MGMT methylation status) has been completed.

The study enrolled a total of 89 patients with 35 patients (35 efficacy evaluable) initially receiving a dose of VAL-083 at 40 mg/m 2 /day, and 54 patients (48 efficacy evaluable) initially receiving the treatment dose of 30 mg/m 2 /day on days 1, 2 and 3 of a 21-day cycle.

This 30 mg dose corresponds to the dose being studied in the currently enrolling VAL-083 study arm of the GBM AGILE study.

The study was designed to determine the potential of VAL-083 treatment to improve overall survival in GBM patients whose tumors have recurred following treatment with temozolomide.

These patients will not have been treated previously with Avastin ® .

In addition, this study has been amended to add an adjuvant patient arm.

This arm will include up to 36 patients previously treated with TMZ in combination with radiation who, rather than being treated with additional cycles of TMZ, will begin treatment with VAL-083.

Recurrent Study Arm

On April 10, 2021 at the virtual AACR Annual Meeting, we provided an update on patient data as follows:

For patients in the fully-enrolled recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 89 patients have been enrolled as of the data cut-off of March 12, 2021 with 35 patients (35 efficacy evaluable) having received an initial dose of 40 mg/m 2 /day and 54 (48 efficacy evaluable) having received the planned Phase 3 initial dose of 30 mg/m 2 /day (on days 1, 2 and 3 of a 21-day cycle).

The median overall survival (“mOS”) for the 83 efficacy evaluable patients who have completed at least one cycle of treatment was 7.5 months (CI 6.0-9.0 months).

For the 48 efficacy evaluable patients initially receiving the intended treatment dose that is being carried forward in the GBM AGILE pivotal study (30 mg/m 2 /day on days 1, 2 and 3 of a 21-day cycle), mOS is currently 7.9 months (CI 5.9-9.9 months) as of the March 12, 2021 cut-off date.

While this is not a head-to-head study, historically, lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months as indicated by published data from Wick et al.

On July 1, 2021 we reported topline 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 5.9-9.9 months);

For the 83 efficacy evaluable patients who have completed at least one cycle of treatment mOS was 7.5 months (CI 6.1-9.0 months).

While this was not a head-to-head study, historically, lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months as indicated by published data from Wick et al.

(2017 – New England Journal of Medicine).

It is important for this GBM patient population, which has been heavily pre-treated with temozolomide, to be able to be treated with multiple cycles of VAL-083 without significant hematological toxicities.

We believe the modified dose of VAL-083, in addition to the change in patient eligibility platelet counts, should help provide for enhanced patient safety.

We believe a positive outcome from this study will help support approval of VAL-083 for the treatment of MGMT-unmethylated recurrent GBM.

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 April 10, 2021 at the virtual AACR Annual Meeting, we provided an update on patient data as follows:

As of the data cut-off date of March 12, 2021, for the 33 efficacy evaluable patients (of a planned up to 36 patients) median PFS is currently 10.0 months (CI 8.2-10.8).

While this is not a head-to-head study, this PFS data compares favorably to historical TMZ control data of 5.3 months and 6.9 months as indicated by published data from Hegi et al.

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

PFS for the 36 efficacy evaluable patients is 10.0 months (95% CI 8.2-10.8);

mOS for the 36 efficacy evaluable patients is 16.5 months (CI 13.3-19.3 months).

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

(2017 – NeuroOncology), respectively.

As noted above, patients in the recurrent arm of the MD Anderson clinical study have been heavily pre-treated with temozolomide.

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).

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Safety Across Studies

Consistent with prior studies, myelosuppression is the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting at MD Anderson.

In the 30 mg/m 2 /day starting dose cohort (the dose being studied in the GBM AGILE Study) seven subjects have experienced a serious adverse event (“SAE”) possibly related to VAL-083 in the recurrent group and one patient has experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.

In the newly-diagnosed study being conducted at SYSUCC, three subjects have experienced an SAE possibly related to VAL-083.

Consistent with prior studies, myelosuppression was the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting at MD Anderson.

In the 30 mg/m 2 /day starting dose cohort (the dose being studied in the GBM AGILE Study) five subjects have experienced a serious adverse event (“SAE”) possibly related to VAL-083 in the recurrent group and one patient has experienced a possible drug-related SAE in the newly-diagnosed adjuvant group as of the relevant data cut-off dates.

In the newly-diagnosed first-line study being conducted at SYSUCC, three subjects have experienced an SAE possibly related to VAL-083.

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) were shown to be generally safe and well-tolerated.

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Their primary function is to provide support and protection for neurons in the CNS.

GBM is the most common and the most lethal form of glioma.

According to the Central Brain Tumor Registry of the United States, GBM occurs with an incidence of 3.20 per 100,000 person-years.

Approximately 13,000 new cases of GBM were diagnosed in the United States and 16,000 in Europe during 2017.

Common symptoms of GBM include headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly.

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The overall median survival in newly diagnosed GBM patients with best available treatments is less than 15 months, and two-year and five-year survival rates are approximately 30% and 10%, respectively.

In September 2017, the NCCN updated treatment guidelines for GBM.

Median overall survival in newly-diagnosed, unmethylated GBM patients is 12.2 months.

The recommended treatment regimen for GBM includes surgical resection to remove as much of the tumor as possible (“debulking”) followed by radiotherapy with concomitant and adjuvant chemotherapy with temozolomide with or without tumor treating fields (“TTF”).

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We believe clinical data indicates that REM-001 Therapy holds promise as a treatment to locally eliminate, or slow the growth of, treated cutaneous cancerous tumors in this difficult-to-treat patient population.

In 2012, Adgero acquired certain assets and regulatory filings, including REM-001 Therapy developed by Miravant Medical Technologies, and its wholly-owned subsidiaries (collectively, “Miravant”), and the associated technology, clinical data and intellectual property, from a creditor of Miravant.

The primary motivation behind the acquisition of the technology was to secure the rights to the REM-001 Therapy and its associated technology, proprietary processes and regulatory filings which have already undergone substantial clinical development which we believe will help expedite the process of gaining regulatory approval to market our REM-001 Therapy.

Miravant initiated commercial development of REM-001 and its associated device components in the 1990s.

This led to late-stage clinical studies in CMBC and also in an aspect of “wet” age-related macular degeneration (“AMD”).

Of these two indications, AMD represented a much larger market, and in 1998, for what we believe were primarily business reasons, Miravant discontinued its CMBC program and, together with, or through its corporate partners, ultimately focused its REM-001 development efforts on AMD.

In 2004, Miravant submitted an NDA to the FDA for the use of REM-001 to treat an aspect of AMD.

The FDA reviewed this submission and granted Miravant an approvable letter for REM-001 in the treatment of AMD, with final approval contingent on, among other things, the successful completion of a Phase 3 study.

Miravant ceased operations in 2006 prior to completing this study.

While Miravant did not pursue the CMBC indication through to approval, it did compile substantial clinical data in the four Miravant CMBC Studies.

The first two of these studies were Phase 2/3 studies that treated 68 CMBC patients who, for the most part, previously failed radiation therapy, and were then treated with REM-001 Therapy.

Miravant compiled both safety and efficacy data for these two studies.

At the time Miravant discontinued its CMBC program, REM-001 Therapy was also being tested in two additional Phase 2 or 3 clinical studies that treated a total of 81 CMBC patients.

Our review of internal Miravant records indicates that data was collected in all four studies generally in accordance with Good Clinical Practice and the data was analyzed for safety, and reports were filed with the FDA.

Our review also indicates that Miravant never conducted an efficacy analysis of the 81 patients in the last two studies which were not yet complete when Miravant discontinued its CMBC program.

Based on our analysis of both the 81 CMBC patients, and data collected from the initial 68 patients, we believe REM-001 Therapy provided promising safety and efficacy in CMBC patients and that, taken together, these results provide strong support for REM-001 Therapy as a potential therapy for this disease.

Furthermore, we believe the approvable letter previously granted to Miravant with respect to its NDA for REM-001 in an aspect of AMD may indicate that many of the elements required for approval have already been completed for REM-001.

Numerous approaches have been utilized to treat CMBC patients, including various forms of chemotherapy, radiation therapy, surgical excision, hyperthermia, cryotherapy, electro-chemotherapy, topical drugs, and intra-lesional chemotherapy injections.

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it can be highly directed to the tumor site, has minimal systemic effects or normal tissue toxicities, can be used in conjunction with other therapies, and can be periodically repeated.

As a result of our review, we submitted questions to the FDA under a Type C format to review the technology and results and determine the anticipated requirements for regulatory approval.

On March 3, 2017, we received FDA’s written response to these questions.

As a result of our review of the historical data, we submitted questions to the FDA under a Type C format to review the technology and results and determine the anticipated requirements for regulatory approval.

On March 3, 2017, we received the FDA’s written response to these questions.

Based on that response, we believe our plans to manufacture REM-001 by revising the prior quality standards to meet the currently recommended regulatory standards will be acceptable.

The FDA also indicated our plans for utilizing light delivery devices that have been shown to be functionally equivalent to the devices used by Miravant will be acceptable.

The FDA also indicated our plans for utilizing light delivery devices that have been shown to be functionally equivalent to the devices used previously will be acceptable.

In October 2017, we held a Type B face-to-face guidance meeting with the FDA that was primarily focused on the design of a Phase 3 study in CMBC.

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In these interactions, the FDA provided guidance on a number of clinical parameters it would like us to measure in the planned clinical study, and on the associated CMC and device plans.

Based on the FDA’s responses, we plan to conduct an initial open-label 15 patient study in CMBC to confirm the planned dose and optimized trial design followed by a Phase 3 clinical study to test the safety and efficacy of REM-001 Therapy for marketing approval.

Based on the FDA’s responses, we intend to conduct an initial open-label, 15-patient study in CMBC to confirm the planned dose and optimized study design followed by a Phase 3 clinical study to test the safety and efficacy of REM-001 Therapy for marketing approval.

In June 2018, we submitted to the FDA a Phase 3 protocol and statistical analysis plan incorporating feedback received from FDA at the October 2017 meeting.

We have also undertaken extensive discussions with clinical research organizations to carry out this study and have received detailed proposals from five of these organizations.

We have also undertaken extensive discussions with clinical research organizations to carry out this study.

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 .

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Following this designation, we contacted clinical experts in BCCNS and related indications to seek their guidance on the most appropriate clinical pathway for REM-001 Therapy in these indications.

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 also 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.

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 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.

On July 17, 2020, we received notification that that grant had been awarded.

REM-001 Regulatory Filings

The initial investigational new drug (“IND”) filing for REM-001 Therapy was IND 39,940 which was filed in June 1992 with the FDA’s Division of Oncology and Pulmonary Drug Products.

This IND is now under the purview of the FDA’s Division of Oncology Products.

All CMBC studies were conducted under this IND.

Miravant kept this IND in place but in 2005 they placed it on inactive status since they had focused their REM-001 development efforts on ophthalmology.

In 2012, following St Cloud’s foreclosure action on Miravant and our subsequent purchase of the Miravant assets, St.

Cloud transferred ownership of this IND to us.

This transfer was formally recognized by the FDA with a Change of Sponsor letter dated December 14, 2012.

Our interactions with the FDA for CMBC are under the auspices of this IND.

It is our expectation, based on input from regulatory consultants, that clinical development in CMBC, non-CMBC cutaneous metastatic cancer and BCCNS basal cell nevus syndrome would be conducted under this IND.

Recent FDA approvals in locally advanced basal cell cancers, which included patients with BCCNS, have been under the purview of the FDA’s Division of Oncology Products.

As part of our purchase agreement with St.

Cloud, sponsorship of two other INDs was transferred to us.

On February 25, 2013, the FDA’s Division of Dermatology and Dental Products notified us with a Change of Sponsor letter that it recognized us as the sponsor of IND 50,116.

On May 8, 2013 the FDA’s Division of Transplant and Ophthalmology Products notified us with a Change of Sponsor letter that it recognized Adgero as the sponsor of IND 49,648.

At this time, we do not anticipate any of our planned, or contemplated, clinical development activities would be under either of these INDs.

REM-001 Therapy

Our REM-001 Therapy product consists of three parts, the DD series laser light source (or equivalent), the ML2-0400 light delivery device (or equivalent) and the drug REM-001.

Pursuant to the Miravant oncology IND, the FDA previously approved all three components to be used together in certain Miravant CMBC Studies.

In use, the drug REM-001 is first administered by intravenous infusion and allowed to distribute within the body and be taken up by the tumors.

Tumors are then illuminated with light using the light delivery device, which is attached to the laser light source, so that the accumulated drug REM-001 can be activated for the desired clinical effect.

Our analysis of clinical data collected in the Miravant CMBC Studies shows that REM-001 Therapy provides a stronger reaction in tumor tissues than in healthy tissues, which was a goal with REM-001’s formulation.

Our REM-001 Therapy product consists of three parts:

the DD series laser light source (or equivalent), the ML2-0400 light delivery device (or equivalent) and the drug REM-001.

In use, REM-001 is first administered by intravenous infusion and allowed to distribute within the body and be taken up by the tumors.

Tumors are then illuminated with light using the light delivery device, which is attached to the laser light source, so that the accumulated REM-001 can be activated for the desired clinical effect.

Our plan is to use new lasers that are functionally equivalent to the Miravant DD2, the laser used in certain prior Miravant clinical studies, for CMBC.

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Based on our interactions with the FDA, we believe that use of such new functionally equivalent lasers will be acceptable to the FDA.

The light delivery devices we plan to use in our CMBC program are the same basic design developed and used previously by Miravant in its clinical studies.

The light delivery devices we plan to use in our CMBC program are the same basic design developed and as used previously by Miravant in its clinical studies.

In the case of cutaneous treatment, such as with CMBC, the light delivery device consists of an optical fiber which has a modified end to allow it to deliver a uniform light treatment field to the tumor.

Our plan is to have clinical light delivery devices built by a contract medical device manufacturer using the basic Miravant design and tested to the same performance specifications as used previously.

The REM-001 Drug

REM-001 is a light activated photosensitizer drug used in PDT.

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Therapeutic drugs that produce such an immune response are known as immunotherapies.

Optically activated drugs that induce such a response are known as photoimmunetherapies.

We believe that immunotherapies are promising areas of cancer treatment and are being developed as either monotherapies or in combination with other treatments.

REM-001 has been shown to induce apoptosis and, in treating an aspect of AMD, to have anti-angiogenesis properties.

REM-001 is a second-generation photosensitizer drug designed with the following attributes to overcome several of the shortcomings of earlier, first generation photosensitizer drugs:

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PDT carries what we believe is an inherent safety advantage since it uses photosensitizer compounds that are largely inactive except when they are being illuminated by intense light at specific wavelengths.

Nevertheless, drug molecules, including photosensitizer molecules, can carry safety or toxicology risks on their own.

REM-001 has previously undergone preclinical and clinical studies throughout its development cycle and has undergone certain tests typically required for FDA drug approval.

REM-001 has been safely administered to over 1,100 patients in prior clinical studies.

Most significantly, REM-001 has been previously reviewed by the FDA as part of the NDA submitted by Miravant for the use of REM-001 to treat an aspect of AMD, a non-CMBC indication.

Following that review, the FDA granted an approvable letter for REM-001 in an aspect of AMD in 2004, with final approval contingent on, among other things, the successful completion of a Phase 3 study.

While not definitive, we believe this letter, along with feedback we received from FDA meetings, indicates that it is unlikely that there will be significant safety or toxicology issues associated with REM-001 that would ultimately prevent marketing approval.

Based on our review of the clinical data of the Miravant CMBC Studies, we believe pain was the most common treatment-related adverse event experienced by patients in these studies.

The second most common safety issue experienced with REM-001 was a transient photosensitivity, meaning extended exposure in bright light and direct sunlight should be avoided.

Transient photosensitivity occurs with all photosensitizers to some degree.

We believe this issue can be addressed by minimizing one’s exposure to bright light and sunlight for two to four weeks after treatment.

In general, the potentially treatment-related adverse events observed in these CMBC studies were expected in nature (pain, edema, skin photosensitivity) and severity, and mostly resolved during the course of the studies.

Current and Experimental Treatments for CMBC

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Clinical Results in CMBC

While we have not conducted any clinical studies, we have undertaken an analysis of the Phase 1 and four Phase 2 and/or Phase 3 CMBC clinical studies done previously with REM-001 Therapy by Miravant (the “Miravant CMBC Studies”) and have concluded that, in these studies, REM-001 Therapy provided higher tumor response rates than are generally seen with alternative CMBC treatments but this program was discontinued in 1998.

Our review of Miravant’s records further indicates that, following this decision, Miravant continued to monitor patients in the CMBC studies and collected data as required by protocol, but they conducted no further treatment of CMBC patients with REM-001 Therapy.

We believe that Miravant primarily chose to discontinue this program in order to focus its REM-001 development efforts on an aspect of “wet” AMD.

Phase 1 Clinical Study

A Phase 1 dose escalation clinical study was initially conducted by Miravant to establish the REM-001 dosimetry to be used in subsequent safety and efficacy studies.

The study was initiated in 1993 and enrolled 22 patients with a variety of types of cutaneous cancer lesions.

Of these, 213 cutaneous cancer lesions were treated using escalating REM-001 drug and light doses.

This study used earlier generation light delivery devices than those used in later studies but these devices provided equivalent light output to those units used in later studies.

In these studies, REM-001 drug doses ranged from 0.1 mg/kg to 1.2 mg/kg, light doses ranged from 100 to 200 J/cm 2 and treatment time-points ranged from 24 to 72 hours.

This study indicated that a drug dose in excess of 0.8 mg/kg and a light dose of 200 J/cm 2 administered at 24 hours provided a high overall response rate when delivered in a variety of cutaneous cancer lesions.

The previously tested dose of 1.2mg/kg was then tested further in a second Phase 1 trial, where it was administered to 27 cutaneous tumor lesions and provided a 66% complete response rate and a 90% overall response rate.

Based on these results, this dosimetry was used in subsequent CMBC studies, including the Miravant CMBC Studies described below.

Phase 2/3 Studies

Miravant conducted four Phase 2/3 studies with REM-001 Therapy for the treatment of CMBC as summarized below.

These studies all used the same dosimetry as described above and most of the patients had been previously treated with radiation therapy and chemotherapy.

The light delivery devices used in these studies were the ML1-0400 or the functionally equivalent ML2-0400.

The laser light source used in three of the studies was the Miravant DD2 laser and one study used the KTP model laser manufactured by LaserScope.

Each study was conducted under Miravant’s REM-001 cancer Investigational New Drug Application (“IND”) using Good Clinical Practices with safety and efficacy data collected accordingly.

In connection with our acquisition of the Miravant assets, ownership of that IND has been transferred to us.

The table below summarizes the Miravant CMBC Studies.

Studies CA008, CA009 and CA019 required that the patients enrolled had received prior radiation therapy.

Study CA013 did not have this specific inclusion requirement but our review of the data indicates that at least 50 of the 56 patients in CA013 had received prior radiation therapy.

A second difference across the studies is that studies CA008, CA009 and CA019 had a 24-week follow-up period while study CA013 had a 52-week follow-up period.

Also, in studies CA008 and CA009 two tumor lesions on each patient were randomly selected as controls and did not receive light activation.

CA013 was conducted in Europe by a corporate partner of Miravant.

Beyond these differences and those device differences noted above, we believe there were no other substantive differences between the studies and that all studies enrolled similar patients.

Table of Phase 2 and/or 3 Miravant CMBC Studies

SnET2 is now called REM-001.)

Open-Label Randomized No Treatment

Concurrent Controlled Study of Single Dose

Tin Ethyl Etiopurpurin (SnET2) Photodynamic

Therapy (PDT) in Patients with Advanced

Breast Cancer Who Have Failed Radiation

Therapy for the Management of Cutaneous

Metastatic Breast Carcinoma

(24 Week Follow Up)

Open-Label Randomized No Treatment

Concurrent Controlled Study of Single Dose

Tin Ethyl Etiopurpurin (SnET2) Photodynamic

Therapy (PDT) in Patients with Advanced

Breast Cancer Who Have Failed Radiation

Therapy for the Management of Cutaneous

Metastatic Breast Carcinoma

(24 Week Follow Up)

Multinational, Open-Label Study of

Single Dose Tin Ethyl Etiopurpurin (SnET2)

Photodynamic Therapy (PDT) in Patients

with Advanced Breast Cancer for the

Management of Cutaneous Metastases

of Breast Carcinoma (52 Week Follow Up)

Open-Label Study of Single Dose Tin

Ethyl Etiopurpurin (SnET2) Photodynamic

Therapy (PDT) in Patients with Advanced

Breast Cancer Who Have Failed Radiation

Therapy for the Management of Cutaneous

Metastatic Breast Carcinoma

(24 Week Follow Up)

The primary endpoints for studies CA008 and CA009 were objective tumor response rate, quality-of-life change, device performance and patient safety.

Our review of the tumor response rate and quality-of-life endpoints indicated they were defined as follows:

Tumor Response:

Measured as paired response difference, as calculated by the percentage of a patient’s evaluable lesions that respond minus the percentage of the patient’s control lesions that respond with this difference averaged over all treated patients.

Quality of Life Change:

Measured using the Dermatologic Life Quality Index (DLQI, A.Y.

Finlay and O.K.

Khan, “Dermatology Life Quality Index (DLQI—a simple practical measure for routine clinical use”.

Clinical and Experimental Dermatology 1994;

210-2 16) with change measured from baseline measurements.

The following table shows the results of these two endpoints for studies CA008 and CA009 as calculated by Miravant.

In some cases, patients dropped out of the study before lesion responses could be assessed or they did not complete their quality of life questionnaires.

The Eligible Patients column in this and the following tables refers to the number of patients in each case for which sufficient data is available to calculate the relevant endpoint.

Tumor Response as Measured by

Paired Response Endpoint

24 Week Quality of Life

The FDA typically requires a p value of 0.05 or less for approval.

Based on the above results, it appears that the Paired Response endpoint achieved statistical significance in both the CA008 and CA009 studies.

However, it is our understanding that FDA questions the strength of this data, in part due to the small number of patients involved as well as the fact that each patient had only two control lesions.

Following discussions with the FDA, an endpoint called Clinical Success was added as an additional measure of tumor response.

This was defined as follows:

Clinical Success:

Clinical success is determined by a two-step process.

First, for each patient, clinical success occurs when the fraction of evaluable lesions that respond minus the fraction of evaluable lesions that progress is greater than 0.5.

Second, for the entire study, an average rate of clinical success is determined, simply by taking the ratio of individual patients who are clinical successes to the total number of eligible patients.

Note this endpoint does not involve the control lesions or any other control, so a p-value is not appropriate since p-values refer to the difference between a treated and a control group.

In such uncontrolled settings, the statistical measure commonly used by regulatory agencies instead of a p-value is the confidence interval, which is provided in the charts below.

The clinical success rates for studies CA008 and CA009 as calculated by Miravant are provided in the following table:

Tumor Response as

Measured by Clinical Success

No significant device failures were observed in either study.

Secondary endpoints in CA008 and CA009 were patient disease burden, duration of response and patient pain assessment.

Miravant’s analysis indicated, for patients for which data was available, there was a treatment benefit in disease burden (p = 0.0017 for CA008, p = 0.0020 for CA009) and duration of response (p < 0.001 for CA008, not significant in CA009) when comparing treated and control lesions.

In terms of pain, there was no significant change in pain in CA008 and a treatment related increase in pain at 4 Weeks post-treatment in CA009.

Treatment related pain, particularly during the first month after treatment, was the most commonly reported adverse event and was often treated with analgesics.

Studies CA013 and CA019 used similar endpoints with one notable exception.

Tumor Response as Measured by Paired Response was not possible in these studies since this measurement relies on control lesions and CA013 and CA019 did not include controls.

Miravant did not conduct an efficacy analysis of these two studies but we have conducted an analysis of the Quality of Life and Clinical Success endpoints used in the pivotal CA008 and CA009 studies.

Results from that analysis are shown in the following table:

Clinical Success

24 Week Quality of Life Change

We have not attempted any further analysis of the endpoints included in these two studies.

The most common adverse events seen in these four studies (CA008, CA009, CA013, CA019) were pain and photosensitivity, both of which are expected with this therapy.

In the four studies there were a total of 17 serious adverse events (SAE’s) that were judged by investigators to be possibly, probably or definitely related to treatment.

None of these were classified by the investigator as life threatening and none resulted in death.

Of the 17 SAE’s, eight were related to necrosis of the treated lesions, three were related to treatment field infection, 4 were treatment related pain, one was a photosensitivity skin reaction and one was an allergic reaction.

We believe that the data from these studies show that REM-001 Therapy is promising for the treatment of CMBC.

However, because there are no approved therapies for CMBC, we have no basis for comparing these results to existing therapies.

Based on the FDA’s March 3, 2017 response, we believe the FDA will view these results as supportive data and our plan is to conduct an initial open-label 15 patient study in CMBC to confirm planned dose and optimized trial design, followed by a pivotal Phase 3 study to support an NDA.

The figure below shows the results of our initial preliminary analysis of Miravant clinical data and depicts the percentage of evaluable lesions in each Miravant CMBC Study for which there was a complete response;

i.e., where all visible clinical evidence of the tumor is gone after treatment with REM-001 Therapy.

We have undertaken an analysis of the Phase 1 and four Phase 2 and/or Phase 3 CMBC clinical studies done previously with REM-001 Therapy, and have concluded that, in these studies, REM-001 Therapy provided higher tumor response rates than are generally seen with alternative CMBC treatments.

Clinical Development Plans

Our plan is to conduct an initial open-label, 15 patient study in CMBC to confirm planned dose and optimized trial design followed by a Phase 3 clinical study in CMBC.

Our plan is to conduct an initial open-label, 15-patient study in CMBC to confirm planned dose and optimized study design followed by a Phase 3 clinical study in CMBC.

In June 2018, we submitted to the FDA a Phase 3 protocol and statistical analysis plan incorporating feedback received from the FDA at our October 2017 meeting.

At this time, we estimate the necessary pivotal study design will be a Phase 3 multi-center study that would enroll approximately 100-150 CMBC patients who have received prior radiation therapy and chemotherapy.

This study design incorporates input from the FDA with the goal of gaining expedited development and review through one or more of the FDA’s expedited programs.

Following our meeting with the FDA, we undertook further analysis of the original Miravant study data and concluded that the data may support use of a lower dose than Miravant used in its original study design.

This planned study design incorporates input from the FDA with the goal of gaining expedited development and review through one or more of the FDA’s expedited programs.

Following our meeting with the FDA, we undertook further analysis of the original study data and concluded that the data may support use of a lower dose than used in the original study design.

Use of such a lower dose may have potential benefits including faster post-treatment healing and response assessment, and lower drug exposure.

Based on this analysis and discussions with regulatory and clinical consultants, including prior FDA employees or consultants, and clinical research organizations, we plan to add a preliminary confirmatory element to our Phase 3 study, or, if it provides a faster pathway, we may formally structure this as a standalone Phase 2 study.

This confirmatory element anticipates treating up to 15 patients at a lower dose than used by Miravant .

Patients treated in this confirmatory phase will not be included in the pivotal study efficacy population but their results should provide an indication that a lower dose may be as effective as the original Miravant dose and they may be used to provide a further preliminary confirmation of the potential of REM-001 Therapy in CMBC and if the results are sufficiently compelling, we may use them as guidance for the use of a slightly lowered dose in the pivotal study.

This confirmatory phase was included in the protocol submitted to FDA in June 2018 and we have not received comment on this from FDA although based on guidance from our regulatory consultants we believe the FDA will be supportive of this design.

Based on this analysis and discussions with regulatory and clinical consultants, including prior FDA employees or consultants, and clinical research organizations, we plan to treat up to 15 patients at a lower dose than used historically, in an initial open-label study.

This data may be used to provide further preliminary confirmation of the potential of REM-001 Therapy in CMBC and if the results are sufficiently compelling, we may use them as guidance for the use of a slightly lowered dose in the pivotal study.

This confirmatory phase was included in the protocol submitted to the FDA in June 2018.

We have not received comment on this from the FDA although based on guidance from our regulatory consultants we believe the FDA will be supportive of this design.

If approved, the FDA grants five years of data exclusivity for a new chemical entity (“NCE”).

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Outstanding Securities

As of May 11, 2021, we had 32,618 shares of common stock issued and outstanding, outstanding warrants to purchase 7,021 shares of common stock, warrants to purchase 2,449 shares of our Series C Preferred Stock that upon exercise are convertible into 2,104 shares of common stock, outstanding stock options to purchase 6,528 shares of common stock, 20,092 outstanding shares of Series C Preferred Stock that are convertible into 17,296 shares of common stock.

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.

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 March 31, 2021 and June 30, 2020 is the US$.

Our functional currency at September 30, 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

(in thousands, except per share data)

Research and development

General and administrative

Other (income) loss

Foreign exchange

Amortization of deferred loan costs

Interest expense

Interest income

Net loss for the period

Series A Preferred cash dividend

Series B Preferred stock dividend

Net loss for the period attributable to common

Basic and fully diluted weighted average number of

Basic and fully diluted loss per share

For the nine months ended

September 30,

(in thousands, except per share data)

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Amortization of deferred loan costs

Interest expense

Interest income

Interest, net

Net loss for the period

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Series B Preferred stock dividend

Series C Preferred stock dividend

Net loss for the period attributable to common

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For the three months ended

(in thousands)

Research and development - GAAP

non-cash, share-based compensation

Research and development net of non-cash,

share-based, compensation expense –

General and administrative - GAAP

non-cash, share-based compensation

General and administrative net of non-cash,

share-based, compensation expense –

For the nine months ended

September 30,

(in thousands)

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Results of Operations

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

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

Three months ended

September 30,

(in thousands)

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General and administrative

In-process research and development

Other income (loss)

1 unchanged sentence

Amortization of deferred loan costs

Interest expense

Interest income

Interest, net

Research and Development

Research and development expenses increased to $3,843 for the three months ended March 31, 2021 from $899 for the three months ended March 31, 2020.

The increase was largely attributable to higher clinical development, non-cash, share-based compensation expenses, and personnel costs incurred during the three months ended March 31, 2021 compared to the three months ended March 31, 2020.

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 patient enrollment, were incurred during the three months ended March 31, 2021 but were not incurred during the three months ended March 31, 2020.

In addition, with the acquisition of the REM-001 technology as part of the Adgero merger that closed in August 2020, costs relating to clinical development and drug manufacturing activity have been incurred in the current quarter and not in the corresponding quarter of the prior period.

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.

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 prior quarter.

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 March 31, 2021 compared to the three months ended March 31, 2020, due to the recognition of compensation expense for stock options granted in September 2020.

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.

General and Administrative

General and administrative expenses were $2,762 for the three months ended March 31, 2021 compared to $1,077 for the three months ended March 31, 2020.

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

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.

Office and sundry expenses have increased in the three months ended March 31, 2021 compared to the three months ended March 31, 2020 largely due to higher directors’ and officers’ liability insurance.

Preferred Share Dividends

For each of the three months ended March 31, 2021 and 2020, we recorded $2 related to the 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.

During the three months ended March 31, 2021, we issued 3 (2020 – 4) shares of common stock as a dividend on the Series B Preferred stock and recognized $6 (2020 - $1) as a direct increase in accumulated deficit.

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

Nine months ended

(in thousands)

Research and development

General and administrative

In-process research and development

Other (income) loss

Foreign exchange

Amortization of deferred loan costs

Interest expense

Interest income

Research and Development

Research and development expenses increased to $7,784 for the nine months ended March 31, 2021 from $2,332 for the nine months ended March 31, 2020.

The increase was largely attributable to higher clinical development, non-cash, share-based compensation expenses, and personnel costs incurred during the nine months ended March 31, 2021 compared to the nine months ended March 31, 2020.

Clinical development costs have increased in the current period compared to the prior period largely due to the start-up and patient enrollment costs related to the GCAR GBM AGILE Study.

Patient recruitment commenced in January 2021 so there were costs incurred in order to prepare the study for commencement as well as patient recruitment and enrollment.

In addition, with the acquisition of the REM-001 technology as part of the Adgero merger, costs relating to clinical development and drug manufacturing activity have been incurred during the nine months ended March 31, 2021 that were not incurred during the nine months ended March 31, 2020.

We expect our research and development costs to be higher in fiscal year 2021 than fiscal year 2020 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 nine months ended March 31, 2021 compared to the nine months ended March 31, 2020, due to the recognition of compensation expense for stock options granted in September 2020.

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

General and Administrative

General and administrative expenses were $7,091 for the nine months ended March 31, 2021 compared to $3,045 for the nine months ended March 31, 2020.

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

In addition, non-cash, share-based compensation expense increased due to the issuance of warrants for professional services.

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

Office and sundry increased in the nine months ended March 31, 2021 compared to the nine months ended March 31, 2020 due primarily to costs of higher directors’ and officers’ liability insurance.

Professional fees increased during the nine months ended March 31, 2021 compared to the nine months ended March 31, 2020 primarily due to higher legal and accounting fees in the current period.

Merger costs of $500 relate to expenditures with respect to the Adgero transaction and have been expensed.

Acquired In-Process Research and Development Expense

We acquired in-process research and development assets in connection with our merger with Adgero.

As the acquired in-process research and development assets were deemed to have no current or alternative future use, an expense of $16,094 was recognized in the condensed consolidated interim statements of operations for the nine month period ended March 31, 2021.

Preferred Share Dividends

For each of the nine months ended March 31, 2021 and 2020, we recorded $6 related to the dividend payable to Valent on the Series A preferred stock.

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.

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

During the nine months ended March 31, 2021, we issued 10 (2020 – 12) shares of common stock as a dividend on the Series B Preferred stock and recognized $15 (2020 - $6) as a direct increase in accumulated deficit.

Liquidity and Capital Resources

Nine months ended March 31, 2021 compared to the nine months ended March 31, 2020

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

September 30,

(in thousands)

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Operating Activities

Net cash used in operating activities increased to $14,171 for the nine months ended March 31, 2021 from $5,350 for the nine months ended March 31, 2020.

During the nine months ended March 31, 2021 and 2020, we reported net losses of $31,566 and $5,303, respectively.

Partially offsetting the higher loss in the current period compared to the prior period was the recognition of $16,094 of acquired in-process research and development expense related to the Adgero merger.

Additional changes in adjustments to reconcile net loss to net cash used in operating activities for the nine months ended March 31, 2021 included stock option expense of $4,248 being recognized during the current period compared to $307 in the prior period.

The most significant change in working capital for the nine months ended March 31, 2021 was from a use of cash due to an increase prepaid expenses and deposits related primarily to a $2,600 payment to GCAR for study initiation and patient recruitment.

The most significant change in working capital for the nine months ended March 31, 2020 was cash used as a reduction in accounts payable and accrued liabilities of $659.

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.

Investing Activities

As part of the Adgero merger that closed on August 19, 2020, we acquired $969 in cash.

There were no investing activities during the nine months ended March 31, 2020.

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.

Financing Activities

During the nine months ended March 31, 2021, we received approximately $21,600 in net proceeds from the completion of a private placement of Series C Preferred stock and $4,399 from the cash exercise of stock purchase warrants.

Also, during the nine months ended March 31, 2021, we received proceeds from the NBTS Loan of $500.

During the nine months ended March 31, 2020, we received $6,583 in net proceeds from the completion of an underwritten public offering by us of common stock, pre-funded warrants, and common stock purchase warrants.

Additionally, we received $27 pursuant to the exercise of warrants in the current period.

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.

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 nine months ended March 31, 2021, we reported a loss of $31,566 and a negative cash flow from operations of $14,171.

We had an accumulated deficit of $104,489 and had cash and cash equivalents of $15,718 as of March 31, 2021.

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.

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

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Some of these estimates require judgments about matters that are inherently uncertain and therefore actual results may differ from those estimates.

A detailed presentation of all of our significant accounting policies and the estimates derived therefrom is included in Note 2 to our consolidated financial statements for the year ended June 30, 2020 contained in our Form 10-K.

While all of the significant accounting policies are important to our consolidated financial statements, the following accounting policies and the estimates derived therefrom are critical:

Warrants and shares issued for services

Stock options

Fair value of financial instruments

Accruals for research and development expenses and clinical trials

Warrants and shares issued for services

We have issued equity instruments for services provided by employees and nonemployees.

The equity instruments are valued at the fair value of the instrument granted.

Stock options

Fair value of financial instruments

We recognize compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the statement of operations over the service period based on a measurement of fair value for each stock-based award.

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 nine-months ended March 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 nine-months ended March 31, 2021 and 2020, we utilized the plain vanilla method to determine the expected life of stock options.

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.

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

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The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results, or updated estimates, differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised.

We have issued warrants for services provided by non-employees.

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.

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

Accruals for research and development expenses and clinical trials

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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 years ended June 30, 2020 and 2019, there were no material adjustments to our prior period estimates of accrued expenses for clinical trials.

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.

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