Entero Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 13, 2024.
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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.
Sep 30, 2024 · Filed Nov 13, 2024
GRDX$4.92+5.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-10-21.
0001410578-24-001685
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0001410578-24-001914
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 103 previous paragraphs and 107 current paragraphs.
73 unchanged; 23 reworded; 11 added; 6 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 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 (11)
Current report
Binding Term Sheet
Current report
On November 8, 2024, we entered into a binding term sheet (the “Binding Term Sheet”) with Journey Therapeutics, Inc. (“Journey”), a life sciences company. Pursuant to the Binding Term Sheet, we will acquire 100% of the outstanding equity interests of Journey in return for 99% of our fully-diluted equity (the “Acquisition”).
Current report
Following the close of the Acquisition, it is anticipated that Henry Ji, M.D., Ph.D., the Chief Executive Officer of Journey, will assume the roles of Chief Executive Officer and Chairman of the Board of Entero. Further, following the close of the Acquisition, the Board will be of a size to be determined jointly by Entero and Journey, with one to two members of the post-closing Board to be designated by Entero.
Current report
We anticipate adopting an equity incentive plan (the “Equity Plan”) for up to 15% of the outstanding shares of Common Stock of Entero at the time of the close of the Acquisition. We will also create an employee stock purchase plan for up to 1% of the outstanding shares of Common Stock of Entero at the time of the close of the Acquisition (the “ESPP”). The creation and adoption of the Equity Plan and the ESPP are subject to obtaining requisite Company stockholder, Board and committee approvals.
Current report
The Acquisition is subject to a number of conditions, including the completion of customary due diligence, negotiation of the definitive agreement, as well as approvals by our Board and our stockholders. Such definitive agreement will include a number of customary provisions, including without limitation, representations and warranties of Journey and Entero, restrictive covenants appliable to Journey and Entero and indemnification provisions. The Acquisition is also conditioned upon the completion of an equity financing providing net proceeds of at least $5.0 million, the effectiveness of a Form S-4 Registration Statement with regard to the Acquisition, to be filed with the SEC, and the shares of Common Stock of the combined company being approved for initial listing on Nasdaq.
Current report
Under the Binding Term Sheet, Journey and Entero are subject to an exclusivity period that is a minimum of 30 days, and such exclusivity shall continue after the 30-day period until a party delivers a notice of termination of exclusivity (the “Exclusivity Period”). During the Exclusivity Period, both parties are restricted from soliciting, negotiating or entering into any agreements with third parties for the sale of their respective businesses or material assets.
Current report
The approximately $0.8 million decrease in total research and development expenses was primarily attributable to a decrease of $0.5 million related to the September 2023 up-front payment to Sanofi per the executed license agreement for Capeserod, as well as a $0.2 million decrease in clinical trial related expenses and a $0.1 million decrease in personnel costs.
Current report
General and administrative expenses for the three months ended September 30, 2024 totaled approximately $1.7 million, a decrease of approximately $0.7 million, or 30% over the approximately $2.4 million recorded for the three months ended September 30, 2023.
Current report
Consolidated Results of Operations for the Nine Months Ended September 30, 2024 and 2023
Current report
Research and development expenses for the nine months ended September 30, 2024 totaled approximately $0.9 million, a decrease of approximately $2.8 million, or 76%, over the approximately $3.7 million recorded for the nine months ended September 30, 2023.
Current report
General and administrative expenses for the nine months ended September 30, 2024 totaled approximately $13.5 million, an increase of approximately $5.6 million, or 70% over the approximately $7.9 million recorded for the nine months ended September 30, 2023.
Removed paragraphs (6)
Previous report
General and administrative expenses for the three months ended June 30, 2024 totaled approximately $3.2 million, an increase of approximately $0.4 million, or 13% over the approximately $2.8 million recorded for the three months ended June 30, 2023.
Previous report
Income tax expense
Previous report
Income tax expense for the three months ended June 30, 2024 and 2023 was $4.3 million and $0, respectively. The income tax expense of $4.3 million recorded for the three months ended June 30, 2024 represents an increase in our valuation allowance related to the reclassification of the IMGX in-process research & development (“IPR&D”) assets to held for sale.
Previous report
Consolidated Results of Operations for the Six Months Ended June 30, 2024 and 2023
Previous report
Research and development expenses for the six months ended June 30, 2024 totaled approximately $0.7 million, a decrease of approximately $2.0 million, or 75%, over the approximately $2.7 million recorded for the six months ended June 30, 2023.
Previous report
General and administrative expenses for the six months ended June 30, 2024 totaled approximately $11.8 million, an increase of approximately $6.3 million, or 114% over the approximately $5.5 million recorded for the six months ended June 30, 2023.
Reworded paragraphs (23)
Previous wording
References in this report to “Entero,” “First Wave,” “AzurRx,” “Company,” “we,” “us,” “our,”or similar references mean Entero Therapeutics, Inc. and its subsidiaries on a consolidated basis. References to“AzurRx SAS”refer to Entero’s former wholly owned subsidiary through which we previously conducted our European operations. References to “FWB” refer to First Wave Bio, Inc. and references to “IMGX” refer to ImmunogenX, Inc., Entero’s wholly-owned subsidiaries. References to the“SEC”* refer to the U.S. Securities and Exchange Commission.*
Current wording
References in this report to “Entero,” “First Wave,” “AzurRx,” “Company,” “we,” “us,” “our,”or similar references mean Entero Therapeutics, Inc. and its subsidiaries on a consolidated basis. References to“AzurRx SAS”refer to Entero’s former wholly owned subsidiary through which we previously conducted our European operations. References to “FWB” refer to First Wave Bio, Inc. and references to “IMGX” refer to ImmunogenX, LLC, Entero’s wholly-owned subsidiaries. References to the“SEC”* refer to the U.S. Securities and Exchange Commission.*
Previous wording
We have initiated a plan to dispose of certain assets and liabilities of IMGX, including Latiglutenase and CypCel, within 12 months of the date of the Merger with IMGX. As of June 30, 2024, these were reclassified as assets and liabilities held for sale and due to the short period of time since the close of the Merger, are reported at their fair value less cost to sell. We determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on our operations and financial statements.
Current wording
We have initiated a plan to dispose of certain assets and liabilities of IMGX, including Latiglutenase and CypCel, within 12 months of the date of the Merger with IMGX. As of September 30, 2024, these were classified as assets and liabilities held for sale and due to the short period of time since the close of the Merger, are reported at their fair value less cost to sell. We determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on our operations and financial statements.
Previous wording
On August 7, 2024, we notified the Staff of Nasdaq that, as the result of the resignations of two of our directors, we were no longer in compliance with Nasdaq Rule 5605(c)(2) (the “Audit Committee Rule”), which requires a Nasdaq-listed company to have an audit committee of the Board comprised of at least three independent directors meeting the eligibility requirements of the Audit Committee Rule. On August 8, 2024, our Board, having determined that both individuals meet the eligibility requirements of the Audit Committee Rule, appointed Chaitan Khosla and Alastair Riddell to the audit committee of the Board (the “Audit Committee”) to fill the vacancies on the Audit Committee created by the aforementioned resignations. Additionally, the Board appointed the existing Audit Committee member, Edward J. Borkowski, as chair of the Audit Committee. As a result of the appointments, the Audit Committee now has three members, as required by the Audit Committee Rule.
Current wording
On August 7, 2024, we notified the Staff of Nasdaq that, as the result of the resignations of two of our directors, we were no longer in compliance with Nasdaq Rule 5605(c)(2) (the “Audit Committee Rule”), which requires a Nasdaq-listed company to have an audit committee of the Board comprised of at least three independent directors meeting the eligibility requirements of the Audit Committee Rule. On August 8, 2024, our Board, having determined that both individuals meet the eligibility requirements of the Audit Committee Rule, appointed Chaitan Khosla and Alastair Riddell to the audit committee of the Board (the “Audit Committee”) to fill the vacancies on the Audit Committee created by the aforementioned resignations. Additionally, the Board appointed the existing Audit Committee member, Edward J. Borkowski, as chair of the Audit Committee. As a result of the appointments, the Audit Committee once again had three members, as required by the Audit Committee Rule.
Previous wording
On September 6, 2024, we received a letter from the Staff of Nasdaq indicating that, based upon the closing bid price of our Common Stock for the last 30 consecutive business days, we are not currently in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Notice”. The Notice has no immediate effect on the continued listing status of our common stock on The Nasdaq Capital Market, and, therefore, our listing remains fully effective. We are provided a compliance period of 180 calendar days from the date of the Notice, or until March 5, 2025, to regain compliance with the minimum closing bid requirement, pursuant to Nasdaq Listing Rule 5810(c)(3)(A). If at any time before March 5, 2025, the closing bid price of our common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, subject to Nasdaq’s discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H), Nasdaq will provide written notification that we have achieved compliance with the minimum bid price requirement, and the matter would be resolved. If we do not regain compliance during the compliance period ending March 5, 2025, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we meet the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and notifies Nasdaq of its intent to cure the deficiency.
Current wording
On September 6, 2024, we received a letter from the Staff of Nasdaq indicating that, based upon the closing bid price of our Common Stock for the last 30 consecutive business days, we are not currently in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Notice”. The Notice has no immediate effect on the continued listing status of our common stock on The Nasdaq Capital Market, and, therefore, our listing remains fully effective. We are provided a compliance period of 180 calendar days from the date of the Notice, or until March 5, 2025, to regain compliance with the minimum closing bid requirement, pursuant to Nasdaq Listing Rule 5810(c)(3)(A). If at any time before March 5, 2025, the closing bid price of our common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, subject to Nasdaq’s discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H), Nasdaq will provide written notification that we have achieved compliance with the minimum bid price requirement, and the matter would be resolved. If we do not regain compliance during the compliance period ending March 5, 2025, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we meet the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and notify Nasdaq of our intent to cure the deficiency.
Previous wording
As of December 31, 2023, we had 9 employees, which increased to 15 employees in March 2024 following the IMGX Merger. In connection with certain cost reduction measures we have taken, on July 16, 2024, we reduced our headcount to 11 employees, and Dr. Syage agreed to reduce his annual base salary to $66,560, effective July 1, 2024. On August 1, 2024, in order to further reduce costs and conserve resources, we approved the termination of all non-essential employees and determined to vacate our Boca Raton office.
Current wording
As of December 31, 2023, we had 9 employees, which increased to 15 employees in March 2024 following the IMGX Merger. In connection with certain cost reduction measures we have taken, on July 16, 2024, we reduced our headcount to 11 employees, and Dr. Syage agreed to reduce his annual base salary to $66,560, effective July 1, 2024. On August 1, 2024, in order to further reduce costs and conserve resources, we approved the termination of all non-essential employees and are considering vacating the Boca Raton office.
Previous wording
As of June 30, 2024, we had cash and cash equivalents of approximately $0.7 million and had sustained cumulative losses attributable to common stockholders of approximately $187.6 million. Subsequent to June 30, 2024, the Company raised aggregate gross proceeds of approximately $1.9 million from a July 2024 inducement offering. Based on our cash on hand at June 30, 2024, together with proceeds from the July 2024 exercise of warrants, we anticipate having sufficient cash to fund planned operations into November 2024. We believe that we will need to raise substantial additional capital in the near term to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support our working capital needs and business activities. The acceleration or reduction of cash outflows by management can significantly impact the timing for the need to raise additional capital to complete development of our products. In order to manage our operating costs, we have reduced headcount and paused development activities, and we are exploring strategic alternatives for the purpose of maximizing value of all of our stakeholders of the Company. We have been, and expect to continue to, explore various potential strategies available to us including but not limited to raising capital, restructuring our indebtedness and identifying and evaluating potential strategic alternatives but there can be no assurance that these efforts will be successful, that we will be able to raise necessary capital on acceptable terms, reach agreement with our lenders, or that the strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We are evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transactions. However, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that we will make any cash distributions to our stockholders. Any failure in these efforts could force us to delay, limit or terminate our operations, make reductions in our workforce, discontinue our research and development programs, liquidate all or a portion of our assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.
Current wording
As of September 30, 2024, we had cash and cash equivalents of approximately $0.4 million and had sustained cumulative losses attributable to common stockholders of approximately $190.1 million. Based on our cash on hand at September 30, 2024, we anticipate having sufficient cash to fund planned operations into December 2024. We believe that we will need to raise substantial additional capital in the near term to fund our continuing operations, satisfy existing and future obligations and liabilities, and otherwise support our working capital needs and business activities. The acceleration or reduction of cash outflows by management can significantly impact the timing for the need to raise additional capital to complete development of our products. In order to manage our operating costs, we have reduced headcount and paused development activities, and we are exploring strategic alternatives for the purpose of maximizing value of all of our stakeholders of the Company. We have been, and expect to continue to, explore various potential strategies available to us, including but not limited to raising capital, restructuring our indebtedness and identifying and evaluating potential strategic alternatives but there can be no assurance that these efforts will be successful, that we will be able to raise necessary capital on acceptable terms, reach agreement with our lenders, or that the strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We are evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transactions. As discussed above, in November 2024, we entered into a binding term sheet with Journey Therapeutics, Inc. pursuant to which we will acquire 100% of the outstanding equity interests of Journey in return for 99% of our fully-diluted equity, subject to a number of conditions. See Management’s Discussion and Analysis of Financial Condition and Results of Operations – Recent Developments. However, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that we will make any cash distributions to our stockholders. Any failure in these efforts could force us to delay, limit or terminate our operations, make reductions in our workforce, discontinue our research and development programs, liquidate all or a portion of our assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.
Previous wording
Research and development expenses for the three months ended June 30, 2024 totaled approximately $0.2 million, a decrease of approximately $1.1 million, or 84%, over the approximately $1.3 million recorded for the three months ended June 30, 2023.
Current wording
Research and development expenses for the three months ended September 30, 2024 totaled approximately $0.2 million, a decrease of approximately $0.8 million, or 80%, over the approximately $1.0 million recorded for the three months ended September 30, 2023.
Previous wording
The approximately $0.4 million increase in total general and administrative expenses was primarily attributable to $0.8 million in share-based compensation for consultants, partially offset by a decrease of $0.3 million in public company costs and investor relations.
Current wording
The approximately $0.7 million decrease in total general and administrative expenses was primarily attributable to a decrease of $0.5 million in public company costs and investor relations and $0.1 million in share-based compensation.
Previous wording
Loss from discontinued operations for the six months ended June 30, 2024 of $1.3 million represents expenses related to the disposal group that was classified as held for sale as of June 30, 2024.
Current wording
Loss from discontinued operations for the three months ended September 30, 2024 of $0.7 million represents expenses related to the disposal group that was classified as held for sale as of September 30, 2024.
Previous wording
As a result of the factors above, our net loss for the three months ended June 30, 2024 totaled approximately $8.8 million, an increase of approximately $4.6 million, or 110%, over the net loss of approximately $4.2 million recorded for the three months ended June 30, 2023.
Current wording
As a result of the factors above, our net loss for the three months ended September 30, 2024 totaled approximately $2.6 million, a decrease of approximately $0.9 million, or 25%, over the net loss of approximately $3.4 million recorded for the three months ended September 30, 2023.
Previous wording
The decrease in research and development expenses of $2.0 million was primarily attributable to decreases of approximately $2.0 million in clinical related expenses primarily related to our Phase 2b Adrulipase SPAN clinical trial which occurred during the six months ended June 30, 2023.
Current wording
The decrease in research and development expenses of $2.8 million was primarily attributable to decreases of approximately $2.0 million in clinical related expenses primarily related to our Phase 2b Adrulipase SPAN clinical trial which occurred during the nine months ended September 30, 2023 and a decrease of $0.5 million related to the September 2023 up-front payment due to Sanofi per the executed license agreement for Capeserod.
Previous wording
The increase in general and administrative expenses of $6.3 million was primarily due to $4.0 million of non-cash expense recorded for financial advisor fees related to the IMGX acquisition, $1.5 million in share-based compensation for consultants, as well as an increase of $0.9 million in legal fees and professional fees related to the IMGX acquisition.
Current wording
The increase in general and administrative expenses of $5.6 million was primarily due to $4.0 million of non-cash expense recorded for financial advisor fees related to the IMGX acquisition, $1.5 million in share-based compensation for consultants, and an increase of $0.9 million in legal fees and professional fees related to the IMGX acquisition. The increase was partially offset by a decrease of $0.5 million in public company costs and investor relations.
Previous wording
Other expenses for the six months ended June 30, 2024 and 2023 were insignificant.
Current wording
Other expenses for the nine months ended September 30, 2024 and 2023 were insignificant.
Previous wording
A tax benefit of approximately $10.6 million was recorded in the six months ended June 30, 2024 due to the release of a portion of our valuation allowance in connection with the IMGX Merger of $14.9 million, partially offset by an increase in our valuation allowance of $4.3 million related to the reclassification of the IMGX IPR&D to held for sale.
Current wording
A tax benefit of approximately $10.6 million was recorded in the nine months ended September 30, 2024 due to the release of a portion of our valuation allowance in connection with the IMGX Merger of $14.9 million, partially offset by an increase in our valuation allowance of $4.3 million related to the reclassification of the IMGX IPR&D to held for sale.
Previous wording
Loss from discontinued operations for the three months ended June 30, 2024 and 2023 was $1.1 million and $0, respectively. The $1.1M of loss from discontinued operations recorded for the three months ended June 30, 2024 represents expenses related to the disposal group that was classified as held for sale as of June 30, 2024.
Current wording
Loss from discontinued operations for the nine months ended September 30, 2024 of $2.0 million represents expenses related to the disposal group that was classified as held for sale as of September 30, 2024.
Previous wording
As a result of the factors above, our net loss for the six months ended June 30, 2024 totaled approximately $3.2 million, a decrease of approximately $5.0 million, or 61%, over the approximately $8.3 million net loss recorded for the six months ended June 30, 2023.
Current wording
As a result of the factors above, our net loss for the nine months ended September 30, 2024 totaled approximately $5.8 million, a decrease of approximately $5.9 million, or 50%, over the approximately $11.7 million net loss recorded for the nine months ended September 30, 2023.
Previous wording
Cash Flows for the Six Months Ended June 30, 2024 and 2023
Current wording
Cash Flows for the Nine Months Ended September 30, 2024 and 2023
Previous wording
Net cash used in operating activities during the six months ended June 30, 2024 of approximately $7.2 million was primarily attributable to our non-cash change in deferred tax valuation allowance of $10.6 million and our net loss of $3.2 million, partially offset by other non-cash expenses totaling approximately $6.3 million, mainly related to stock issued to our financial advisors in connection with the IMGX acquisition of $4.0 million, common stock granted to consultants of $1.5 million, and stock-based compensation of $0.4 million, as well as a decrease in prepaid expenses of $0.7 million.
Current wording
Net cash used in operating activities during the nine months ended September 30, 2024 of approximately $9.0 million was primarily attributable to our non-cash change in deferred tax valuation allowance of $10.6 million and our net loss of $5.8 million, partially offset by other non-cash expenses totaling approximately $7.4 million, mainly related to stock issued to our financial advisors in connection with the IMGX acquisition of $4.0 million, common stock granted to consultants of $1.5 million, and stock-based compensation of $0.6 million, as well as a decrease in prepaid expenses of $0.9 million.
Previous wording
Net cash used in operating activities during the six months ended June 30, 2023 of approximately $5.6 million was primarily attributable to our net loss of approximately $8.2 million, partially offset by non-cash expenses of approximately $0.7 million, mainly related to stock-based compensation, as well as a decrease in prepaid expenses of $0.9 million and increases in accounts payable and accrued expense of approximately $1.0 million.
Current wording
Net cash used in operating activities during the nine months ended September 30, 2023 of approximately $8.9 million was primarily attributable to our net loss of approximately $11.7 million; partially offset by a decrease in prepaid expenses of approximately $1.3 million, non-cash expenses of approximately $1.0 million, mainly related to stock-based compensation and common stock issued to consultants; and a net increase in accrued expenses and accounts payable of approximately $0.4 million.
Previous wording
Net cash provided by investing activities during the six months ended June 30, 2024 of approximately $0.1 million was due to the net cash acquired in the acquisition of IMGX.
Current wording
Net cash provided by investing activities during the nine months ended September 30, 2024 of approximately $0.1 million was due to the net cash acquired in the acquisition of IMGX.
Previous wording
Net cash provided by financing activities of approximately $4.1 million for the six months ended June 30, 2024 was primarily due to net proceeds of approximately $4.5 million from the March 2024 and May 2024 registered direct offerings, partially offset by approximately $0.5 million of cash repayments of the note payable financing for corporate insurances.
Current wording
Net cash provided by financing activities of approximately $5.6 million for the nine months ended September 30, 2024 was primarily due to net proceeds of approximately $4.5 million from the March 2024 and May 2024 registered direct offerings and $1.7 million from the July Inducement offering, partially offset by approximately $0.6 million of cash repayments of the note payable financing for corporate insurances.
Previous wording
Net cash provided by financing activities of approximately $5.5 million for the six months ended June 30, 2023 was primarily due to the net proceeds of approximately $2.2 million from the exercise of warrants and $3.7 million from the March 2023 Offering, partially offset by approximately $0.4 million of cash repayments of the note payable financing for corporate insurances.
Current wording
Net cash provided by financing activities of approximately $10.9 million for the nine months ended September 30, 2023 was due to the net proceeds of approximately $5.9 million from the exercise of warrants, the net proceeds of approximately $5.5 million from the March 2023 and July 2023 offerings of our common stock, partially offset by repayments of approximately $0.6 million related to the note payable.
Previous wording
During the six months ended June 30, 2024, there were no material changes to matters discussed under the heading “Critical Accounting Policies and Significant Judgments and Estimates” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
During the nine months ended September 30, 2024, there were no material changes to matters discussed under the heading “Critical Accounting Policies and Significant Judgments and Estimates” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The approximately $1.1 million decrease in total research and development expenses was primarily attributable to a net decrease of approximately $1.0 million in clinical related expenses primarily due to our Phase 2b Adrulipase SPAN clinical trial which occurred during the three months ended June 30, 2023.