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The following discussion should be read in conjunction with our condensed financial statements and accompanying notes in this quarterly report on Form 10-Q, and our audited financial statements with notes in our annual report on Form 10-K for the year ended August 31, 2022.
−Removed: Page 18 of 30
Lexaria’s patented DehydraTECH technology improves the delivery of bioactive compounds while promoting healthy ingestion methods, lowers overall dosing, and is highly effective in active molecule delivery available in a range of formats from oral ingestible to oral buccal/sublingual to topical products.
1 unchanged sentence
Applications of this technology extends across many categories beyond the primary pharmaceutical focus of the Company, from foods and beverages to cosmetic products and nutraceuticals.
+Added: Page 17 of 29
Our mission is to obtain FDA approval for a DehydraTECH-CBD drug for use on hypertension.
−Removed: Lexaria operates a federally licensed, in-house research laboratory and continues to build upon our intellectual property portfolio with 28 patents granted internationally and roughly 50 patents pending worldwide.
−Removed: Lexaria is advancing several R&D activities in both preclinical and future clinical programs.
−Removed: Our primary focus during the current year is on our investigations of CBD for the reduction of hypertension.
−Removed: In fiscal 2022 we completed three human studies on hypertension with the results of our fourth and largest hypertension study to date continuing to be released throughout fiscal 2023.
+Added: Lexaria operates a federally licensed, in-house research laboratory and continues to build upon our intellectual property portfolio with 34 patents granted internationally and many other patents pending worldwide.
+Added: Lexaria is advancing several R&D activities in both preclinical and future clinical programs, with our primary focus during the current year, being our investigations of CBD for the reduction of hypertension.
+Added: In fiscal 2022 we completed three human studies on hypertension with the results of our fourth and largest hypertension study to date culminating in the publication of six research articles.
The Company continues to engage in small R&D projects and B2B formulation for third parties who are evaluating our technology for use in their products.
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We continue to pursue patent protection in more than 40 countries around the world as vigorously as we are able, since the successful granting of more of those applications could lead to material increases in shareholder value.
−Removed: The Company currently has over 50 patent applications pending worldwide .
−Removed: The Company has patents issued in the United States, Australia, Europe, India, Mexico, and Japan.
−Removed: On December 29, 2022, Lexaria was granted its first patent in Canada, marking our 28 th patent to date as listed below:
+Added: The Company has patents issued in the United States, Australia, Europe, India, Mexico, Canada and Japan.
+Added: Since our last 10-Q quarterly report filing, we were advised of six additional paten issuances;
+Added: one in Japan, one in Australia, two in Canada and two in the US.
+Added: Our new US patents, protect the use of DehydraTECH enhanced cannabidiol for use in pharmaceutical compositions and methods for treating hypertension and DehydraTECH enhanced cannabidiol for use in general compositions and methods for treating hypertension.
+Added: Page 18 of 29
+Added: The issued patents of the Company as at the date of this quarterly report are disclosed in the following table:
Issued Patent #
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#18 Compositions and Methods for Enhanced Delivery of Antiviral Agents
+Added: AU 2021261261
+Added: US 11,666,544
+Added: #21 Compositions and Methods for Treating Hypertension
+Added: US 11,666,543
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1 unchanged sentence
Lexaria is advancing several R&D activities in both preclinical and clinical programs.
−Removed: Currently, our primary research program is the investigation of cannabidiol (CBD) for the reduction of hypertension leading to an application under the FDA for an Investigational New Drug (“IND”).
−Removed: Other programs include nicotine for oral pouches and nicotine replacement therapy, hormones, diabetes, dementia and others.
+Added: Currently, our primary research program is the investigation of cannabidiol (“CBD”) for the reduction of hypertension leading to an application under the FDA for an IND.
+Added: Other programs include DehydraTECH formulation development and testing with nicotine for oral pouches and prospective nicotine replacement therapy, human hormones, CBD for diabetes, dementia and others.
From time to time the Company will engage in contract R&D for third parties who are interested in evaluating DehydraTECH in their products.
−Removed: During the quarter ended February 28, 2023, Lexaria incurred $696,178 (Feb 2022- $275,686) in R&D expenditures.
+Added: During the quarter ended May 31, 2023, Lexaria incurred $1,640,648 (May 2022- $752,095) in R&D expenditures.
Specific R&D programs are in ongoing development and align to our financial ability to undertake each research phase for each API.
−Removed: Due to our expanding portfolio coverage, we continually examine accelerated timetable options for testing, research, and development of each API.
+Added: Due to our expanding patent portfolio coverage, we continually examine accelerated timetable options for testing, research, and development of each API.
Fiscal 2023 continues to highlight the direction of our research and development programs with confirmatory results from our ongoing programs.
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We continue working toward our IND filing which is anticipated to be in late fiscal 2023 or early 2024.
−Removed: We have begun the process of selecting our contract research organization (“CRO”) to perform the IND study which will be a Phase 1(b) study that we are designating HYPER-H23-1.
−Removed: We have begun certain manufacturing work associated with that study in advance of our IND filing and corresponding response from the FDA.
−Removed: Along with our CRO, we will soon begin certain administrative tasks associated with the IND study as we prepare for what we anticipate to be first-in-patient dosing during Q1 of our 2024 fiscal year.
+Added: We have selected InClin Inc.
+Added: as our contract research organization (“CRO”) to perform the IND study which will be a Phase 1(b) study that we are designating HYPER-H23-1.
+Added: We have completed manufacturing our IND drug product through our third-party contract manufacturer, in compliance with current Good Manufacturing Practice (“cGMP”) regulations as mandated by the FDA, which has been set down for stability testing.
+Added: We anticipate receiving the last of the results from the stability testing necessary for disclosure in our IND filing at the end of our fiscal fourth quarter following which we will be in a position to file our IND application.
+Added: Along with our CRO, we have begun certain administrative study start-up tasks associated with preparation to perform study HYPER-H23-1 when ready to be initiated following IND effectiveness.
The first results of our hypertension study HYPER-H21-4 were announced on October 27, 2022, with the primary safety and efficacy objectives being met.
−Removed: The study showed, among other things, a sustained drop in blood pressure in normally active hypertensive patients following multiple weeks of oral cannabidiol ("CBD") therapy, using Lexaria's patented DehydraTECH-CBD capsule formulation.
+Added: HYPER-H21-4 was a randomized, double-blinded, placebo-controlled, cross-over study that consisted of male and female volunteers between the ages of 40-70.
+Added: Sixty-six (66) people were ultimately dosed to completion of the study and, prior to enrollment, they had documented or measured:
+Added: elevated blood pressure (120/80 to 139/80 mmHg);
+Added: mild (stage 1) hypertension (140/90 to 159/99 mmHg);
+Added: moderate (stage 2) hypertension (160/100 to 179/109 mmHg).
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−Removed: On December 21, 2022 further results were released from this multi-week human clinical hypertension study, indicating superior cannabidiol ("CBD") blood absorption levels from our patented DehydraTECH-CBD™ relative to those of published, pharmaceutical-grade CBD industry.
−Removed: On February 21, 2023 the Company announced additional findings demonstrating a potentially novel mechanism of action in reducing blood pressure.
−Removed: These latest results from study HYPER-H21-4 imply that the antihypertensive effects of DehydraTECH-CBD may be explained, at least in part, by its interaction with the sympatho-chromaffin system via catestatin modulation.
−Removed: This suggests a potentially unique mechanistic benefit upon cardiovascular regulation with DehydraTECH-CBD treatment that has not previously been demonstrated, to our knowledge, with testing of CBD for blood pressure reduction.
−Removed: Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon as these findings become available.
+Added: All study participants received DehydraTECH-CBD every day for a 5-week duration in the dose-escalating 2.5 week increments noted above.
+Added: Upon cross-over and wash out, all 66 study participants also received the matching placebo for a 5-week duration following the study randomization schedule.
+Added: Thirty-three (33) of these patients had been diagnosed with hypertension but were not being treated with any antihypertensive medications, while 33 patients had been diagnosed with hypertension and were receiving commonly used antihypertensive therapies including angiotensin-converting enzyme (“ACE”) inhibitors with or without diuretics;
+Added: or alternatively, ACE inhibitors with calcium channel blockers.
+Added: The complete study protocol has and select findings from the study have already been published and is available at PubMed .
+Added: The initial study results showed a sustained drop in blood pressure in normally active hypertensive patients following multiple weeks of oral CBD therapy, using Lexaria’s patented DehydraTECH-CBD capsule formulation.
+Added: Lexaria is aware of only a handful of other published research studies, mostly in young, healthy, and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing;
+Added: none of which have been successful in achieving this.
+Added: DehydraTECH-CBD appears to reduce blood pressure more effectively than other oral CBD formulations.
+Added: Subsequent to the announcement of the initial results from HYPER-H21-4, the Company supplemented its findings with additional research results which appeared to demonstrate:
+Added: increased CBD blood absorption levels from our patented DehydraTECH-CBD™ relative to those of published, pharmaceutical-grade CBD industry peers;
+Added: a potentially novel mechanism of action in reducing blood pressure whereby the antihypertensive effects of DehydraTECH-CBD may be explained, at least in part, by its interaction with the sympatho-chromaffin system via catestatin modulation, thus suggesting a potentially unique mechanistic benefit upon cardiovascular regulation with DehydraTECH-CBD treatment;
+Added: significant reductions in several pro-inflammatory biomarkers known to be linked to cardiovascular disease (“CVD”) and a host of other conditions through evidenced reduction in blood-plasma levels of interleukin (“IL”) 8, 10, and 18 by ~19%, ~27%, and ~43%, respectively.
In March 2022, Lexaria initiated an animal study to determine if DehydraTECH-CBD evidences superior treatment of seizure activity when compared to Epidiolex®.
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Additional work has been completed in study program EPIL-A21-1 with the final study designed to establish an ED50 (i.e., the dose required to achieve seizure inhibition in 50% of the animals tested) for DehydraTECH-CBD in this animal model, where ED50 determination is a common performance metric in preclinical animal studies for developmental therapeutics.
−Removed: This ED50 study is designed to corroborate the experimental findings to date.
−Removed: Final results are expected to be released in the third quarter of fiscal 2023.
+Added: This ED50 study was designed to corroborate the experimental findings to-date and the final results confirmed that DehydraTECH-CBD was most effective at a dose of 75 mg/Kg as compared to the standard Epidiolex dosage of 100 mg/Kg.
+Added: Further testing would be required to validate these findings in humans, although these dose levels in animals converted to human equivalent doses would be expected to be in the 10-12 mg/Kg and 15-16 mg/Kg ranges respectively based on typical animal to human conversion practices.
On November 8, 2022 commencement of animal study program DEM-A22-1 was announced.
−Removed: The study is designed to determine whether DehydraTECH-CBD may offer therapeutic utility against diabetes and dementia respectively.
−Removed: We are expecting the results of this study program in Q4 of fiscal 2023.
−Removed: We announced the commencement of animal study program DIAB-A22-1 on November 8, 2022.
−Removed: On March 2, 2023 the Company announced that its diabetes animal model study has completed and produced at least three positive outcomes including weight loss in obese diabetic-conditioned animals, together with improved triglyceride and cholesterol levels.
−Removed: Additional study work is nearing completion with results expected in fourth fiscal quarter of 2023.
+Added: The study was designed to determine whether DehydraTECH-CBD may offer therapeutic utility against diabetes and dementia respectively.
+Added: This study had several unexpected complications that produced inconclusive results.
+Added: Should the Company choose to further pursue research in this area, it will likely be for a longer duration and may involve DehydraTECH-nicotine rather than DehydraTECH-CBD.
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+Added: We announced the commencement of animal study program DIAB-A22-1 on November 8, 2022.
+Added: On March 2, 2023 the Company announced that its diabetes animal model study had completed and produced at least three positive outcomes including weight loss in obese diabetic-conditioned animals, together with improved triglyceride and cholesterol levels.
+Added: Subsequent to the quarter ended May 31, 2023, the Company announced further results indicating that the blood glucose levels were lowered and kidney function improved in the obese diabetic-conditioned animals treated with DehydraTECH-CBD.
+Added: Lexaria’s animal study HOR-A22-1, being a pharmacokinetic study performed in twenty female Sprague-Dawley rats in order to evaluate the ability of DehydraTECH™ to enhance the delivery characteristics of orally administered estradiol, was successfully completed during the third fiscal quarter, and showed enhancement in the oral delivery of the estrogen hormone estradiol.
+Added: The DehydraTECH-estradiol formulation achieved an average peak concentration in the bloodstream (or “Cmax”) of 5.65ng/mL that was roughly nine times (900%) higher than that achieved with the control formulation at only 0.63 ng/mL.
+Added: As well, the study revealed that levels of the estrone metabolite were also significantly higher comparing an average Cmax of 6.49 ng/mL with the DehydraTECH formulation to only 0.302 ng/mL achieved with the control, representing greater than a twenty-fold (2,000%) improvement in delivery.
On November 1, 2022, the Company announced that independent review board approval had been received for human clinical nicotine study NIC-H22-1.
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or Zyn brand manufactured by Swedish Match.
−Removed: The study had earlier faced certain time extensions due to manufacturing and logistics issues which have since been resolved.
−Removed: Dosing continued during the second and into the third fiscal quarter of 2023.
−Removed: At the date of this report, the study is nearing completion.
−Removed: Results are anticipated to be released in the fourth quarter of 2023.
+Added: The primary study objectives are to determine the quantity of nicotine in blood at various time points and vital-sign data collection including blood pressure, heart rate and respiratory rate.
+Added: Subjective evaluations related to throat burn, user experience, gastrointestinal experience and more are also being conducted.
+Added: At the date of this report, dosing in the study has been completed with sample and data analyses underway at varying stages and the results from the study anticipated to be released in the fourth quarter of 2023.
Off-Balance Sheet Arrangements
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We believe that understanding the basis and nature of the estimates, judgments and assumptions involved with the following aspects of our financial statements is critical to an understanding of our financials.
−Removed: We considered the impact of the COVID-19 pandemic on the assumptions and estimates used and determined that there were no material adverse impacts on the financial statements for the period ending February 28, 2023.
+Added: We considered the impact of the COVID-19 pandemic on the assumptions and estimates used and determined that there were no material adverse impacts on the financial statements for the nine-months ended May 31, 2023.
For a discussion of our critical accounting estimates, please read Note 4.
1 unchanged sentence
There have been no material changes to the critical accounting estimates as previously disclosed in our 2022 Form 10-K.
−Removed: Page 22 of 30
Funding Requirements
−Removed: We anticipate that our expenditures will increase in connection with our ongoing R&D program, specifically with respect to our animal and human clinical trials of our DehydraTECH formulations for the purposes of treating hypertension, dementia and diabetes.
+Added: We anticipate that our expenditures will increase in connection with our ongoing R&D program, specifically with respect to our animal and human clinical trials of our DehydraTECH formulations for the purposes of treating hypertension and diabetes.
As we move forward with our IND application with the FDA, we anticipate that our expenditures will further increase and accordingly, we expect to incur increased operating losses and negative cash flows for the foreseeable future.
−Removed: Through February 28, 2023, we have funded our operations primarily through the proceeds from the sale of common stock.
−Removed: The Company has consistently incurred recurring losses and negative cash flows from operations, including net losses of $3,079,944 and $3,452,155 for the six months ended February 28, 2023 and 2022, respectively.
+Added: Through May 31, 2023, we have funded our operations primarily through the proceeds from the sale of common stock.
+Added: The Company has consistently incurred recurring losses and negative cash flows from operations, including net losses of $5,463,510 and $5,870,492 for the nine-months ended May 31, 2023, and 2022, respectively.
+Added: Page 22 of 29
The continuation of Lexaria as a going concern depends on raising additional capital and/or attaining and maintaining profitable operations.
The accompanying financial statements do not include any adjustment relating to the recovery and classification of recorded asset amounts or the amount and classification of liabilities that might be necessary should our Company discontinue operations.
−Removed: The recurring losses from operations and net capital deficiency do raise doubt about the Company’s ability to continue as a going concern within one year following the date that these consolidated financial statements are issued.
−Removed: Page 23 of 30
+Added: The recurring losses from operations and net capital deficiency raise substantial doubt about the Company’s ability to continue as a going concern within one year following the date that these consolidated financial statements are issued.
On August 12, 2022, we entered into an At-The-Market (“ATM”) Offering equity distribution agreement with Maxim Group LLC, (“Maxim”), pursuant to which we may offer and sell shares of our common stock with an aggregate offering price of up to $5,925,000.
−Removed: The equity distribution agreement entitles Maxim to a sales commission equal to 3.0% of the gross sales price per share of all shares sold under the ATM.
−Removed: As of the issuance date of these consolidated interim financial statements, we expect our approximately $3.3m cash at February 28, 2023, along with funds anticipated from both our ATM and brokered financing will be sufficient to fund our R&D programs, operating expenses and capital expenditure requirements through the forthcoming 12 months from the issuance date of this report.
−Removed: Results of Operations for the Period Ended February 28, 2023 and 2022
−Removed: Our net loss for the six months ended for the respective items are summarized as follows:
−Removed: Six Months Ended February 28,
+Added: The sales agreement entitles Maxim to a sales commission equal to 3.0% of the gross sales price per share of all shares sold under the ATM.
+Added: On May 11, 2023, the Company entered into share purchase agreements for the purposes of completing a $2 million best efforts financing with Maxim resulting in the issuance of 2,106,000 common shares and warrants to purchase common shares.
+Added: We have performed a review of our cash flow forecast and have concluded that funds on hand, combined with those expected from executed license agreements, will be sufficient to meet the Company’s financial obligations for the twelve-month period following the filing of these consolidated financial statements on Form 10-Q.
+Added: Results of Operations for the Period Ended May 31, 2023, and 2022
+Added: Our net loss for the nine-months ended for the respective items are summarized as follows:
+Added: Nine-Months Ended May 31,
Research and development
2 unchanged sentences
Other general and administrative
−Removed: Fees from intellectual property licensing increased by $64k and B2B sales increased by $12.8k with other sales slightly higher by $15k year- over year.
+Added: $ (5,463,510 )
+Added: $ (5,870,492 )
+Added: Fees from intellectual property licensing increased by $88,775 while B2B sales decreased by $67,430 with other sales higher by $64,049 year-over year.
Research and Development
−Removed: Expenditures on R&D increased by $791k year-over-year for the period ended February 28, 2023, as the Company continues with applied research and development programs in our pharmaceutical division with our primary focus being on DehydraTECH-CBD to treat hypertension.
−Removed: Consulting Fees and Salaries
−Removed: In the six months ended February 28, 2023 consulting fees and salaries decreased by $547k primarily due to the prior years’ recognition of stock-based compensation costs recorded for contractors ($287K) and employees ($121K), and the payment of management bonuses in the second quarter of 2022.
+Added: Expenditures on R&D increased by $1,679,828 year-over year for the period ended May 31, 2023, as the company continues with applied research and development programs in our pharmaceutical division with our primary focus being on FDA approval for a DehydraTECH-CBD drug to treat hypertension.
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+Added: Consulting Fees and Salaries
+Added: In the nine-months ended May 31, 2023, consulting fees and salaries decreased by $642,783 primarily due to the prior years’ recognition of stock-based compensation costs recorded for contractors and employees ($358,970), and the charges of salaries to research and development ($305,283), due to increased clinical development activity.
Legal and Professional Fees
−Removed: Our legal and professional fees decreased by $168k during the period compared to the same prior year period.
+Added: Our legal and professional fees decreased by $75,163 during the period compared to the same prior year period.
Previous year expenditures were higher due to increased patent and trademark filings and the utilization of additional legal advisory services.
General and Administrative
−Removed: Our other general and administrative expenses decreased overall by $363k during the period ended February 28, 2023, over the same period last year.
−Removed: Advertising and promotion was down by $140k in the current period with a slight decrease in investor relations ($35k) offset by an increase in office expenses ($34k).
−Removed: Unrealized losses on marketable securities were less in the current year ($80k vs $281k).
+Added: Our other general and administrative expenses decreased overall by $1,284,378 during the period ended May 31, 2023, over the same period last year.
+Added: Advertising and promotion were down by $474,642 in the current period with a slight decrease in investor relations ($68,457).
+Added: There was an increase of $ 40,871 in office expenses and unrealized losses on marketable securities were considerably lower in the current year ($77,775 vs $823,916).
Liquidity and Financial Condition
3 unchanged sentences
Net Working Capital
+Added: Nine-Months Ended
Cash flows used in operating activities
7 unchanged sentences
Operating Activities
−Removed: Net cash used in operating activities increased by $30k for the period compared with cash used during the same period in 2022.
−Removed: This difference was largely due to decreased stock-based compensation ($79k vs $409k), unrealized losses on marketable securities ($80k vs $281k) and an increased reduction in prepaid expenses balance in the current six months ended of $257k vs $97k in the prior year.
−Removed: Investing Activities
−Removed: Net cash used in investing activities decreased by $25k over 2022 due to decreased spending on acquisitions of equipment.
+Added: Net cash used in operating activities increased approximately $557,000 for the period compared with cash used during the same period in 2022.
+Added: The increase relates primarily to a lower unrealized loss on marketable securities ($746,141), combined with lower non-cash expenses related to shares issued for services rendered ($600,000) and stock-based compensation ($358,970);
+Added: partially offset by increased accounts payable and accrued liabilities ($815,786), and a lower net loss ($406,982).
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+Added: Investing Activities
+Added: Net cash used in investing activities decreased by $29,422 over 2022 due to decreased spending on acquisitions of equipment and intellectual property.
Financing Activities
−Removed: The change in net cash used in financing activities in the prior year relate to the reduction of the lease liability.
+Added: The $1,744,814 increase in cash from financing activities relates to common shares issued in the ATM Offering and common share/warrant units sold.
Liquidity and Capital Resources
−Removed: We have incurred net losses of approximately $7.4m and $4.2m respectively in the past two fiscal years.
+Added: We have incurred net losses of approximately $7.4 million and $4.2 million respectively in the past two fiscal years.
We expect to continue to incur significant expenditures for R&D and operational activities resulting in net losses in the upcoming 12 months and beyond.
3 unchanged sentences
To achieve this objective, we will require substantial funding in the future.
−Removed: On August 12, 2022, we entered into an equity distribution agreement with Maxim , pursuant to which we may offer and sell shares of our common stock with an aggregate offering price of up to $5,925,000 under an ATM.
−Removed: The equity distribution agreement provides that Maxim will be entitled to a sales commission equal to 3.0% of the gross sales price per share of all shares sold under the ATM.
−Removed: As of April 1, 2023 we have sold 34,652 shares into the market through the ATM for gross proceeds of $114,546.
−Removed: During the first half of fiscal 2023 we did not sell any shares.
−Removed: Subsequent to the six months ended February 28, 2023, we issued 34,652 shares of our common stock in a series of sales under the ATM at an average price of $3.30 per share and gross proceeds of $114,456.
−Removed: As of April 14, 2023, $5,810,544 in shares of our common stock remain eligible for sale under the ATM.
+Added: On August 12, 2022, we entered an equity distribution agreement with Maxim, under the agreement we may offer and sell shares of our common stock with an aggregate offering price of up to $5,925,000 under an ATM.
+Added: The sales agreement provides that Maxim will be entitled to a sales commission equal to 3.0% of the gross sale price per share of all shares sold under the ATM.
+Added: As of July 14, 2023, we have sold 34,652 shares into the market through the ATM for gross proceeds of $114,546.
+Added: Based on the current equity value of the Company’s shares, the Company’s revised ability to use the ATM is limited to $1,965,533.
+Added: Pursuant to the terms of the Company’s May 11, 2023, financing described below, the Company’s ability to use its ATM is currently on hold.
+Added: On May 11, 2023, the Company entered into share purchase agreements for the purposes of completing a $2 million best efforts financing with Maxim resulting in the issuance of 2,106,000 common shares and warrants to purchase common shares.
We may also offer securities in response to market conditions or other circumstances if we believe such a plan of financing is required to advance the Company’s business plans.
6 unchanged sentences
If we do so we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
−Removed: The Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern.
−Removed: As of February 28, 2023, the Company had cash on hand of approximately $3.3m to settle $223k in current liabilities.
−Removed: The Company believes this is sufficient to fund our expected R&D and operating expenditures for twelve months following the date of filing this report.
−Removed: We anticipate making few if any material capital expenditures in fiscal 2023 as we believe our current facilities and equipment are sufficient for the forthcoming twelve months following the date of filing this report.
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+Added: The Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern.
+Added: As of May 31, 2023, the Company had cash on hand of approximately $3,163,906 to settle $1,055,904 in current liabilities.
+Added: We have performed a review of our cash flow forecast and have concluded that funds on hand, combined with those expected from executed license agreements, will be sufficient to meet the Company’s financial obligations for the twelve-month period following the filing of these consolidated financial statements on Form 10-Q.
Impact of COVID-19
4 unchanged sentences
Management’s Report on Disclosure Controls and Procedures
−Removed: We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our President and Chief Executive Officer (Principal Executive Officer) and our Chief Financial Officer (Principal Financial and Accounting Officer) to allow for timely decisions regarding required disclosure.
−Removed: As of February 28, 2023, the fiscal quarter covered by this report, we carried out an evaluation, under the supervision and with the participation of our CEO and CFO, of the effectiveness of the design and operation of our disclosure controls and procedures.
−Removed: Based on the foregoing, our CEO and CFO concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of February 28, 2023.
+Added: We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our President (Principal Executive Officer) and our Chief Executive Officer (currently acting as the Principal Financial and Accounting Officer) to allow for timely decisions regarding required disclosure.
+Added: As of May 31, 2023, the fiscal quarter covered by this report, we carried out an evaluation, under the supervision and with the participation of our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures.
+Added: Based on the foregoing, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of May 31, 2023.
Inherent limitations on Effectiveness of Controls
6 unchanged sentences
Changes in Internal Control over Financial Reporting
−Removed: During the quarter ended February 28, 2023, our controls and controls processes remained consistent with August 31, 2022.
−Removed: There have been no changes in our internal controls over financial reporting that occurred during the quarter ended February 28, 2023, that have materially or are reasonably likely to materially affect our internal controls over financial reporting.
−Removed: Our control processes are designed to include remote workers.
−Removed: The advent of the COVID-19 pandemic has not materially impacted our internal controls over financial reporting other than increasing requirements for social distancing and some additional remote working requirements for staff.
+Added: During the quarter ended May 31, 2023, our controls and controls processes remained consistent with August 31, 2022.
+Added: There have been no changes in our internal controls over financial reporting that occurred during the quarter ended May 31, 2023, that have materially or are reasonably likely to materially affect our internal controls over financial reporting.
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1 unchanged sentence
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.