Kintara Therapeutics Inc
For the period ended Mar 31, 2024. Filed May 14, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 14, 2024
HURA$1.63+1.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2023-12-31; filed 2024-02-14.
0000950170-24-015204
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-03-31; filed 2024-05-14.
0000950170-24-059694
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 106 previous paragraphs and 114 current paragraphs.
77 unchanged; 24 reworded; 13 added; 4 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 8 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
On April 3, 2024, we announced that we had entered into a definitive merger agreement (the “Merger Agreement”) with Kayak Mergeco, Inc., our wholly-owned subsidiary, and TuHURA Biosciences, Inc. (“TuHURA”), pursuant to which Merger Sub will merge with and into TuHURA, with TuHURA surviving the merger and becoming our direct, wholly-owned subsidiary (the “Merger”). Pursuant to the terms of the Merger, shareholders of TuHURA will receive shares of our common stock. Our existing stockholders will receive contingent value rights (“CVR”), entitling them to receive shares of our common stock upon achievement of enrollment of a minimum of 10 patients in the REM-001 Study, with such patients each completing 8 weeks of follow-up on or before December 31, 2025. Under the terms of the Merger Agreement, on a pro forma basis, our stockholders post-merger are expected to collectively own approximately 2.85%, or approximately 5.45% including the shares underlying the CVR, of the common stock of the post-merger combined company on a fully-diluted basis. The transaction is expected to close in the third calendar quarter of 2024 and remains subject to stockholder and regulatory approval.
Current report
Merger Agreement
Current report
On April 2, 2024, we entered into the Merger Agreement with Merger Sub and TuHURA pursuant to which Merger Sub will merge with and into TuHURA, with TuHURA surviving the Merger and becoming our direct, wholly-owned subsidiary. Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (i) each then-outstanding share of TuHURA common stock, par value $0.001 per share (the “TuHURA Common Stock”) (other than any shares held in treasury and Dissenting Shares (as defined in the Merger Agreement)) will be converted into shares of our common stock equal to the Exchange Ratio, as such term is defined in the Merger Agreement, (ii) each then-outstanding TuHURA stock option will be assumed and converted into an option to purchase shares of our common stock, subject to certain adjustments as set forth in the Merger Agreement, and (iii) each then-outstanding warrant to purchase shares of TuHURA Common Stock (the “TuHURA Warrants”) will be assumed and converted into and exchangeable for a warrant of like tenor entitling the holder to purchase shares of our common stock, subject to certain adjustments as set forth in the Merger Agreement. In addition to the foregoing, the Merger Agreement provides that, at the closing of the Merger, our corporate name will be changed to “TuHURA Biosciences, Inc.” Our existing stockholders will receive contingent value rights (“CVR”), entitling them to receive shares of our common stock upon achievement of enrollment of a minimum of 10 patients in the REM-001 Study, with such patients each completing 8 weeks of follow-up on or before December 31, 2025.
Current report
Under the terms of the Merger Agreement, on a pro forma basis, our stockholders are expected to collectively own approximately 2.85%, or approximately 5.45% including the shares underlying the CVR, of the common stock of the post-merger combined company on a pro forma fully diluted basis. TuHURA stockholders are expected to collectively own approximately 97.15%, or 94.55% assuming the distribution of the CVR shares, of the common stock of the combined company on a pro forma fully diluted basis.
Current report
The transaction is expected to close in the third calendar quarter of 2024 and remains subject to stockholder and regulatory approval.
Current report
Compensation Matters
Current report
On April 2, 2024, the Board approved a one-time special bonus to Mr. Hoffman in the amount of $327 for his service as the our Chief Executive Officer.
Current report
On April 2, 2024, the Board agreed to (i) resume payment of fees earned by non-employee directors for serving on the Board and (ii) pay an aggregate of $93 in accrued fees to such directors.
Current report
For the nine months ended
Current report
For the nine months ended
Current report
Comparison of the nine months ended March 31, 2024, and March 31, 2023
Current report
Nine months ended March 31, 2024, compared to the nine months ended March 31, 2023
Current report
the consummation of the Merger, subject to stockholder approval;
Removed paragraphs (4)
Previous report
For the six months ended
Previous report
For the six months ended
Previous report
Comparison of the six months ended December 31, 2023, and December 31, 2022
Previous report
Six months ended December 31, 2023, compared to the six months ended December 31, 2022
Reworded paragraphs (24)
Previous wording
In December 2023, we announced that our Board of Directors has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value.
Current wording
In December 2023, we announced that our Board of Directors initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value.
Previous wording
On February 12, 2024, we announced the initiation of an open label 15-patient study in CMBC patients which is evaluating REM-001 (the “REM-001 Study”), a second-generation PDT photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (“bORR”) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24. The majority of the costs to run this study will be covered by the $2.0 million Small Business Innovation Research grant Kintara was awarded from the NIH.
Current wording
On February 12, 2024, we announced the initiation of an open label 15-patient study in CMBC patients which is evaluating REM-001 (the “REM-001 Study”), a second-generation PDT photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (“bORR”) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24. The majority of the costs to run this study will be covered by the $2,000 Small Business Innovation Research grant Kintara was awarded from the NIH.
Previous wording
On September 20, 2023, the Nasdaq Staff notified us that we did not comply with the Stockholders’ Equity Requirement (the “Notice”). Pursuant to the Notice, we submitted a plan to regain compliance and received an extension of 180 calendar days from the date of the Notice, or March 18, 2024, to evidence compliance and to maintain compliance through December 31, 2024. The Notice has no immediate effect on the listing of our common stock and our common stock continues to trade on The Nasdaq Capital Market under the symbol “KTRA,” subject to our compliance with the other continued listing requirements.
Current wording
On February 27, 2024, we announced that we received a letter from Nasdaq stating that we had regained compliance with Nasdaq’s minimum stockholders’ equity requirement. Our common stock continues to trade on The Nasdaq Capital Market under the symbol “KTRA,” subject to our compliance with Nasdaq’s continued listing requirements.
Previous wording
Effective July 1, 2023, we were awarded a $2.0 million grant from the National Institutes of Health (“NIH”) to be received over a two-year period as expenses are incurred. The grant from the NIH will fund the majority of expenses related to the REM-001 CMBC 15-patient clinical study.
Current wording
Effective July 1, 2023, we were awarded a $2,000 grant from the National Institutes of Health (“NIH”) to be received over a two-year period as expenses are incurred. The grant from the NIH will fund the majority of expenses related to the REM-001 CMBC 15-patient clinical study (the “REM-001 Study”). As a result of receiving the NIH grant, we re-initiated our REM-001 program and have opened enrollment at Memorial Sloan Kettering Cancer Center, where we have initiated treatment in a total of 2 patients as of May 14, 2024. We expect to complete enrollment of patients in the REM-001 Study in the third calendar quarter of 2024.
Previous wording
On October 19, 2022, we announced that the REM-001 program in CMBC was paused to conserve cash which will be used to support the funding of the GBM AGILE Study. Effective July 1, 2023, the Company was awarded a two-year $2,000 Small Business Innovation Research grant from the National Institutes of Health to support the clinical development of REM-001 for the treatment of CMBC. The grant will be received in tranches of approximately $1,250 for the period July 1, 2023, to June 30, 2024, and approximately $750 for the period July 1, 2024, to June 30, 2025. As a result of receiving the grant, we have re-initiated the REM-001 program and we expect to start enrolling patients in the REM-001 Study in the first quarter of calendar year 2024.
Current wording
On October 19, 2022, we announced that the REM-001 program in CMBC was paused to conserve cash which will be used to support the funding of the GBM AGILE Study. Effective July 1, 2023, we were awarded a two-year $2,000 Small Business Innovation Research grant from the National Institutes of Health to support the clinical development of REM-001 for the treatment of CMBC. The grant will be received in tranches of approximately $1,250 for the period July 1, 2023, to June 30, 2024, and approximately $750 for the period July 1, 2024, to June 30, 2025. As a result of receiving the grant, we re-initiated our REM-001 program and have opened enrollment at Memorial Sloan Kettering Cancer Center, where we have initiated treatment in a total of 2 patients as of May 14, 2024. We expect to complete enrollment of patients in the REM-001 Study in the third calendar quarter of 2024.
Previous wording
As of February 12, 2024, we had 39,038 shares of common stock issued and outstanding, outstanding warrants to purchase 700 shares of common stock, warrants to purchase 2,444 shares of our Series C Preferred Stock that upon exercise are convertible into 42 shares of common stock, outstanding stock options to purchase 237 shares of common stock, 66 restricted stock units, and 13,668 outstanding shares Series C Preferred Stock that are convertible into 235 shares of common stock. All common stock warrants, stock options, and restricted stock units are convertible, or exercisable into, one share of common stock. The Series C Preferred Stock (issued in three series) is convertible into shares of common stock at $58.00 per share (Series C-1), $60.70 per share (Series C-2) or $57.50 per share (Series C-3), respectively. The Series C Preferred stock purchase warrants are convertible into Series C Preferred Stock at $1,000 per share for either Series C-1, Series C-2, or Series C-3 Preferred Stock, as applicable.
Current wording
As of May 14, 2024, we had 55,305 shares of common stock issued and outstanding, outstanding warrants to purchase 693 shares of common stock, warrants to purchase 2,444 shares of our Series C Preferred Stock that upon exercise are convertible into 42 shares of common stock, outstanding stock options to purchase 222 shares of common stock, 66 restricted stock units, and 13,668 outstanding shares Series C Preferred Stock that are convertible into 235 shares of common stock. All common stock warrants, stock options, and restricted stock units are convertible, or exercisable into, one share of common stock. The Series C Preferred Stock (issued in three series) is convertible into shares of common stock at $58.00 per share (Series C-1), $60.70 per share (Series C-2) or $57.50 per share (Series C-3), respectively. The Series C Preferred stock purchase warrants are convertible into Series C Preferred Stock at $1,000 per share for either Series C-1, Series C-2, or Series C-3 Preferred Stock, as applicable.
Previous wording
The financial information reported herein has been prepared in accordance with accounting principles generally accepted in the United States. Our functional currency at December 31, 2023, and June 30, 2023, is the US$. The following tables represent selected financial information for us for the periods presented. All amounts in the remainder of this MD&A are expressed in thousands, except par value and per share amounts, unless otherwise noted.
Current wording
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, 2024, and June 30, 2023, is the US$. The following tables represent selected financial information for us for the periods presented.
Previous wording
Research and development expenses decreased to $111 for the three months ended December 31, 2023, from $2,059 for the three months ended December 31, 2022. The decrease was largely attributable to lower clinical development costs and lower non-cash, share-based compensation expenses incurred during the three months ended December 31, 2023, compared to the three months ended December 31, 2022.
Current wording
Research and development expenses decreased to $592 for the three months ended March 31, 2024, from $2,005 for the three months ended March 31, 2023. The decrease was largely attributable to lower clinical development costs and lower non-cash, share-based compensation expenses incurred during the three months ended March 31, 2024, compared to the three months ended March 31, 2023.
Previous wording
Clinical development costs have decreased in the current quarter compared to the same quarter in the prior fiscal year in part due to costs related to the GBM AGILE Study being lower in the three months ended December 31, 2023, compared to the three months ended December 31, 2022. In addition, on October 19, 2022, we announced that we had paused the REM-001 program in order to preserve cash for the development of VAL-083. On June 28, 2023, we announced the restart of the REM-001 program as a result of the awarding of a $2 million grant, however, REM-001 costs to restart the program are not expected to ramp up until the first calendar quarter of 2024. In addition, during the three months ended December 31, 2023, we received $198 (2022 - nil) in grant proceeds. Non-cash, share-based compensation expense decreased to $23 for the three months ended December 31, 2023, from $134 for the three months ended December 31, 2022.
Current wording
Clinical development costs have decreased in the current quarter compared to the same quarter in the prior fiscal year in part due to costs related to the GBM AGILE Study being lower in the three months ended March 31, 2024, compared to the three months ended March 31, 2023. In addition, on October 19, 2022, we announced that we had paused the REM-001 program in order to preserve cash for the development of VAL-083. On June 28, 2023, we announced the restart of the REM-001 program as a result of the awarding of a $2 ,000 grant, however, REM-001 costs to restart the program are not expected to ramp up until the second calendar quarter of 2024. In addition, during the three months ended March 31, 2024, we received $194 (2023 - nil) in grant proceeds. Non-cash, share-based compensation expense decreased to $63 for the three months ended March 31, 2024, from $115 for the three months ended March 31, 2023.
Previous wording
General and administrative expenses were $908 for the three months ended December 31, 2023, compared to $1,440 for the three months ended December 31, 2022. A significant portion of the decrease was a result of lower non-cash, share-based compensation expenses and a reduction in professional fees and personnel costs in the current three months compared to the same period in the prior fiscal year. Non-cash, share-based compensation expense decreased to $180 for the three months ended December 31, 2023, from $302 for the six months ended December 31, 2022, due to the recognition of higher compensation expense recognized during the three months ended December 31, 2022, for stock options granted in September 2021. Professional fees have decreased in the current quarter compared to the same quarter in the prior fiscal year largely due to a reduction in corporate activity. Personnel costs have decreased in the current quarter compared to the same quarter in the prior fiscal year largely due to a reduction in staff.
Current wording
General and administrative expenses were $1,493 for the three months ended March 31, 2024, compared to $1,297 for the three months ended March 31, 2023. A significant portion of the increase was a result of higher professional fees incurred in relation to the proposed transaction with TuHURA, offset by lower non-cash, share-based compensation expenses and a reduction in facilities, office and sundry, personnel, and travel costs in the current three months compared to the same period in the prior fiscal year. Non-cash, share-based compensation expense decreased to $144 for the three months ended March 31, 2024, from $339 for the three months ended March 31, 2023, due to the recognition of higher compensation expense recognized during the three months ended March 31, 2023, for stock options granted in September 2021. Facilities, office and sundry costs have decreased primarily due to a reduction in directors and officers insurance expense in the current quarter compared to the same quarter in the prior fiscal year. Additionally, personnel costs have decreased in the current quarter compared to the same quarter in the prior fiscal year due to a reduction in staff.
Previous wording
Research and development expenses decreased to $1,970 for the six months ended December 31, 2023, from $5,230 for the six months ended December 31, 2022. The decrease was largely attributable to lower clinical development costs and lower non-cash, share-based compensation expenses incurred during the six months ended December 31, 2023, compared to the six months ended December 31, 2022.
Current wording
Research and development expenses decreased to $2,562 for the nine months ended March 31, 2024, from $7,235 for the nine months ended March 31, 2023. The decrease was primarily attributable to lower clinical development costs and lower non-cash, share-based compensation expenses incurred during the nine months ended March 31, 2024, compared to the nine months ended March 31, 2023.
Previous wording
Clinical development costs have decreased in the current quarter compared to the same quarter in the prior fiscal year in part due to costs related to the GBM AGILE Study being lower in the six months ended December 31, 2023, compared to the six months ended December 31, 2022. In addition, on October 19, 2022, we announced that we had paused the REM-001 program in order to preserve cash for the development of VAL-083. On June 28, 2023, we announced the restart of the REM-001 program as a result of the awarding of a $2 million grant, however, REM-001 costs to restart the program are not expected to ramp up until the first calendar quarter of 2024. In addition, during the six months ended December 31, 2023, we received $210 (2022 - nil) in grant proceeds. Non-cash, share-based compensation expense decreased to $109 for the six months ended December 31, 2023, from $274 for the six months ended December 31, 2022.
Current wording
Clinical development costs have decreased in the current quarter compared to the same quarter in the prior fiscal year in part due to costs related to the GBM AGILE Study being lower in the nine months ended March 31, 2024, compared to the nine months ended March 31, 2023. In addition, on October 19, 2022, we announced that we had paused the REM-001 program in order to preserve cash for the development of VAL-083. On June 28, 2023, we announced the restart of the REM-001 program as a result of the awarding of a $2,000 grant, however, REM-001 costs to restart the program are not expected to ramp up until the second calendar quarter of 2024. In addition, during the nine months ended March 31, 2024, we received $404 (2023 - nil) in grant proceeds. Non-cash, share-based compensation expense decreased to $172 for the nine months ended March 31, 2024, from $389 for the nine months ended March 31, 2023.
Previous wording
General and administrative expenses were $2,011 for the six months ended December 31, 2023, compared to $2,915 for the six months ended December 31, 2022. A significant portion of the decrease was a result of lower non-cash, share-based compensation expenses and a reduction in personnel costs in the current six months compared to the same period in the prior fiscal year. Non-cash, share-based compensation expense decreased to $301 for the six months ended December 31, 2023, from $680 for the six months ended December 31, 2022, due to the recognition of higher compensation expense recognized during the six months ended December 31, 2022, for stock options granted in September 2021. Personnel costs have decreased in the current quarter compared to the same quarter in the prior fiscal year largely due to a reduction in staff.
Current wording
General and administrative expenses were $3,504 for the nine months ended March 31, 2024, compared to $4,212 for the nine months ended March 31, 2023. A significant portion of the increase was a result of higher professional fees incurred in relation to the proposed transaction with TuHURA, offset by lower non-cash, share-based compensation expenses and a reduction in facilities, office and sundry, personnel, and travel costs in the current nine months compared to the same period in the prior fiscal year. Non-cash, share-based compensation expense decreased to $445 for the nine months ended March 31, 2024, from $1,019 for the nine months ended March 31, 2023, due to the recognition of higher compensation expense recognized during the nine months ended March 31, 2023, for stock options granted in September 2021. Facilities, office and sundry costs have decreased primarily due to a reduction in directors and officers insurance expense in the current period compared to the same period in the prior fiscal year. Additionally, personnel costs have decreased in the current period compared to the same period in the prior fiscal year primarily due to a reduction in staff.
Previous wording
For each of the six months ended December 31, 2023, and 2022, we recorded $4 related to the cash dividend payable to Valent on the Series A Preferred Stock. In addition, for the six months ended December 31, 2023, we recorded $173 (2022 - $362) related to the stock dividend payable to investors on the Series C Preferred Stock. The dividends have been recorded as a direct increase in accumulated deficit for both periods.
Current wording
For each of the nine months ended March 31, 2024, and 2023, we recorded $6 related to the cash dividend payable to Valent on the Series A Preferred Stock. In addition, for the nine months ended March 31, 2024, we recorded $173 (2023 - $362) related to the stock dividend payable to investors on the Series C Preferred Stock. The dividends have been recorded as a direct increase in accumulated deficit for both periods.
Previous wording
Net cash used in operating activities was $3,434 for the six months ended December 31, 2023, compared to $8,530 for the six months ended December 31, 2022. During the six months ended December 31, 2023, and 2022, we reported net losses of $3,985 and $8,050, respectively. Adjustments to reconcile net loss to net cash used in operating activities for the six months ended December 31, 2023, included stock option expense of $325 being recognized during the current period compared to $954 in the same period in the prior fiscal year. In addition, during the six months ended December 31, 2023, non-cash expenses of $85 were incurred for restricted stock unit expense while no such items were incurred in the six months ended December 31, 2022. The most significant changes in working capital for the six months ended December 31, 2023, were related to the use of clinical trial deposit to settle clinical trial expenses of $961 and settlement of accounts payable and accrued liabilities of $1,062. The most significant changes in working capital for the six months ended December 31, 2022, was due to a payment of clinical trial deposit of $1,700 and settlement of accounts payable and accrued liabilities of $535.
Current wording
Net cash used in operating activities was $5,734 for the nine months ended March 31, 2024, compared to $10,357 for the nine months ended March 31, 2023. During the nine months ended March 31, 2024, and 2023, we reported net losses of $5,996 and $11,314, respectively. Adjustments to reconcile net loss to net cash used in operating activities for the nine months ended March 31, 2024, included stock option expense of $481 and restricted stock unit expense of $136 being recognized during the current period compared to $1,244 and $164, respectively, in the same period in the prior fiscal year. In addition, during the nine months ended March 31, 2023, non-cash amortization of $2,150 of the clinical trial deposit was recognized while no such items were incurred in the nine months ended March 31, 2024. The most significant changes in working capital for the nine months ended March 31, 2024, were related to the use of clinical trial deposit to settle clinical trial expenses of $879 and settlement of accounts payable and accrued liabilities of $1,541 The most significant changes in working capital for the nine months ended March 31, 2023, were due to a payment of clinical trial deposit of $1,700 and settlement of accounts payable and accrued liabilities of $646.
Previous wording
Net cash used in investing activities was $20 for the six months ended December 31, 2023, compared to $232 for the six months ended December 31, 2022, for the purchase of equipment.
Current wording
Net cash used in investing activities was $20 for the nine months ended March 31, 2024, compared to $232 for the nine months ended March 31, 2023, for the purchase of equipment.
Previous wording
Net cash received from financing activities was $2,577 for the six months ended December 31, 2023, compared to $1,856 for the six months ended December 31, 2022. During the six months ended December 31, 2023, we received $2,476 in net proceeds from sales of shares under our ATM Facility (as defined herein) with A.G.P./Alliance Global Partners (“AGP”), $105 in net proceeds from the sale of shares under the stock purchase agreement, dated as of August 2, 2022, (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to a maximum of $20,000 of shares of the Company’s common stock, and $210 in clinical grant funding. During the six months ended December 31, 2022, we received $1,860 in net proceeds from the sale of shares under the Lincoln Park Purchase Agreement.
Current wording
Net cash received from financing activities was $10,570 for the nine months ended March 31, 2024, compared to $1,854 for the nine months ended March 31, 2023. During the nine months ended March 31, 2024, we received $10,471 in net proceeds from sales of shares under our ATM Facility (as defined herein) with A.G.P./Alliance Global Partners (“AGP”), $105 in net proceeds from the sale of shares under the stock purchase agreement, dated as of August 2, 2022, (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to a maximum of $20,000 of shares of our common stock. During the nine months ended March 31, 2023, we received $1,860 in net proceeds from the sale of shares under the Lincoln Park Purchase Agreement.
Previous wording
For the six months ended December 31, 2023, we reported a loss of $3,985 and a negative cash flow from operations of $3,434. We had an accumulated deficit of $155,537 and had cash and cash equivalents of $658 as of December 31, 2023. We are in the clinical stage and have not generated any revenues to date. We do not have the prospect of achieving revenues until such time that our product candidate is commercialized, or partnered, which may not ever occur. On August 2, 2022, we entered into the Purchase Agreement under which we received approximately $2,008 in net proceeds as of December 31, 2023, for the issuance of an aggregate of 662 shares of common stock under the Purchase Agreement. On October 9, 2023, we received stockholder approval to issue 20% or more of our outstanding shares as of the date we entered into the Purchase Agreement with Lincoln Park. In addition, on June 28, 2023, we announced that we had been awarded approximately $2.0 million in grant funding for our REM-001 project.
Current wording
For the nine months ended March 31, 2024, we reported a loss of $5,996 and a negative cash flow from operations of $5,734. We had an accumulated deficit of $157,550 and had cash and cash equivalents of $6,351 as of March 31, 2024. We are in the clinical stage and have not generated any revenues to date. We do not have the prospect of achieving revenues until such time that our product candidate is commercialized, or partnered, which may not ever occur. On August 2, 2022, we entered into the Purchase Agreement under which we received approximately $2,008 in net proceeds as of March 31, 2024, for the issuance of an aggregate of 662 shares of common stock under the Purchase Agreement. On October 9, 2023, we received stockholder approval to issue 20% or more of our outstanding shares as of the date we entered into the Purchase Agreement with Lincoln Park. On February 22, 2024, we determined that we have concluded utilization of the equity facility pursuant to the terms of the Purchase Agreement. In addition, on June 28, 2023, we announced that we had been awarded approximately $2,000 in grant funding for our REM-001 project.
Previous wording
On September 19, 2023, we entered into a Sales Agreement, (the “Sales Agreement”) with AGP pursuant to which the Company may offer and sell, from time to time, through AGP, as sales agent and/or principal, shares of common stock having an aggregate offering price of up to $10.9 million (the “ATM Facility”). From October 31, 2023, until December 31, 2023, we raised $2,579 in net proceeds from the sale of 8,013 shares of our common stock under the ATM Facility. From January 1, 2024, to February 12, 2024, we raised an additional $6,108 in net proceeds from the sale of 28,870 shares of our common stock under the ATM Facility.
Current wording
On September 19, 2023, we entered into a Sales Agreement, (the “Sales Agreement”) with AGP pursuant to which we may offer and sell, from time to time, through AGP, as sales agent and/or principal, shares of common stock having an aggregate offering price of up to $10,900 (the “ATM Facility”). From October 31, 2023, until March 31, 2024, we raised $10,471 in net proceeds from the sale of 53,151 shares of our common stock under the ATM Facility. On February 22, 2024, we determined that we have concluded utilization of the ATM facility.
Previous wording
Consequently, management is pursuing various financing alternatives to fund our operations in the short and long term and so we can continue as a going concern. In addition, we have initiated a process to explore and review a range of strategic alternatives focused on maximizing shareholder value. Management plans to secure the necessary financing through potential additional proceeds from our Purchase Agreement with Lincoln Park, the ATM Facility, grant funding, and the issue of new equity and/or the entering into of strategic partnership arrangements. Our ability to raise additional capital is unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence. We may not be able to raise sufficient additional capital and may tailor our drug candidate development program based on the amount of funding we are able to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.
Current wording
Consequently, management is pursuing various financing alternatives to fund our operations in the short and long term and so we can continue as a going concern. In addition, we initiated a process to explore and review a range of strategic alternatives focused on maximizing shareholder value, and as a result, entered into the Merger Agreement for the proposed Merger with TuHURA. If we do not receive stockholder approval for the Merger or the Merger is not otherwise consummated, management intends to seek to secure the necessary financing through potential additional proceeds from grant funding and the issue of new equity and/or the entering into of strategic partnership arrangements or pursue additional strategic transactions. In addition, if the Merger is not completed, we may not have sufficient capital to continue to operate our business in the long term and may become insolvent and be required to seek the protection of the bankruptcy courts and, without additional funding or a strategic transaction, we would likely be delisted from The Nasdaq Capital Market. Our ability to raise additional capital is unknown and will depend on future developments, which are highly uncertain and cannot be predicted with confidence. We may not be able to raise sufficient additional capital and may tailor our drug candidate development program based on the amount of funding we are able to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.
Previous wording
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, or strategic collaborations. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our shares of capital stock. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights. Economic conditions may affect the availability of funds and activity in equity markets. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan, file for bankruptcy protection or pursue a dissolution of the Company and liquidation of all of our remaining assets. In such an event, the amount of cash available for distribution to our shareholders, if any, will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as we continue to fund our operations. We cannot provide assurance as to the amount of cash that will be available to distribute to shareholders, if any, after paying our debts and other obligations and setting aside funds for reserves, nor as to the timing of any such distribution, if any.
Current wording
Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, or strategic collaborations. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our shares of capital stock. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights. Economic conditions may affect the availability of funds and activity in equity markets. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to complete the proposed Merger with TuHURA or secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan, file for bankruptcy protection or pursue a dissolution of the Company and liquidation of all of our remaining assets. In such an event, the amount of cash available for distribution to our shareholders, if any, will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as we continue to fund our operations. We cannot provide assurance as to the amount of cash that will be available to distribute to shareholders, if any, after paying our debts and other obligations and setting aside funds for reserves, nor as to the timing of any such distribution, if any.
Previous wording
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 Accounting Standards Update 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 six months ended December 31, 2023, and 2022, the determination of grant-date fair value for stock option awards was estimated using the Black-Scholes model which includes variables such as the expected volatility of our share price, the anticipated exercise behavior of its grantee, interest rates, and dividend yields. For the six months ended December 31, 2023, and 2022, 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. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of actual forfeitures, using the accelerated attribution method. We recognize forfeitures as they occur. 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.
Current wording
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 Accounting Standards Update 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, 2024, and 2023, 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, 2024, and 2023, 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. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of actual forfeitures, using the accelerated attribution method. We recognize forfeitures as they occur. 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.
Previous wording
For the six months ended December 31, 2023, and 2022, we issued stock options to our officers. The determination of grant-date fair value for options granted 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 option.
Current wording
For the nine months ended March 31, 2024, and 2023, we issued stock options to our officers. The determination of grant-date fair value for options granted 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 option.
Previous wording
As part of the process of preparing our financial statements, we are required to estimate our expenses resulting from our obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. Our objective is to reflect the appropriate expenses in our financial statements by matching those expenses with the period in which services are performed and efforts are expended. We account for these expenses according to the timing of various aspects of the expenses. We determine accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of our accrued expenses as of each balance sheet date based on the facts and circumstances known to us at that time. Our clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low for any particular period. For the six months ended December 31, 2023, and 2022, there were no material adjustments to our prior period estimates of accrued expenses for clinical trials.
Current wording
As part of the process of preparing our financial statements, we are required to estimate our expenses resulting from our obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. Our objective is to reflect the appropriate expenses in our financial statements by matching those expenses with the period in which services are performed and efforts are expended. We account for these expenses according to the timing of various aspects of the expenses. We determine accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of our accrued expenses as of each balance sheet date based on the facts and circumstances known to us at that time. Our clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low for any particular period. For the nine months ended March 31, 2024, and 2023, there were no material adjustments to our prior period estimates of accrued expenses for clinical trials.
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Previous report — wording carried elsewhere
As a result of receiving the NIH grant, we re-initiated our REM-001 program and we expect to start enrolling patients in the REM-001 Study in the first quarter of calendar year 2024.