15 unchanged sentences
Recent Business Update
+Added: On November 7, 2024, we announced the successful completion of its End-of-Phase 2 Meeting with the U.S.
+Added: Food and Drug Administration (the “FDA”) and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity.
+Added: The interaction with the FDA included an extensive review of the preclinical and clinical data generated to date, including data from six completed clinical trials of pemvidutide.
+Added: The planned registrational program will include four Phase 3, randomized, double-blind, placebo-controlled, parallel-group trials, each evaluating treatment with pemvidutide over a 60-week period.
+Added: The Phase 3 program is expected to enroll approximately 5,000 subjects across the four trials.
+Added: The safety and efficacy of pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg will be evaluated with the intention of obtaining approval for all three doses.
+Added: The Phase 3 program is designed to leverage the key attributes of pemvidutide, including the effects of balanced GLP-1/glucagon dual agonism in subjects with overweight and obesity.
+Added: On September 30, 2024, we announced the completion of patient enrollment in IMPACT, our Phase 2b biopsy-driven trial evaluating Pemvidutide in MASH, and expect top-line efficacy data in the second quarter of 2025.
+Added: On September 10, 2024, we presented results of MRI-based body composition sub-study from our 48-week MOMENTUM Phase 2 obesity trial of pemvidutide in subjects with overweight and obesity at the 60 th annual meeting of the European Association for the Study of Diabetes.
+Added: In an MRI sub-study of 67 subjects from the MOMENTUM Phase 2 obesity trial, 50 of whom were treated with pemvidutide for 48 weeks, the lean loss ratio, defined as the change in lean mass compared to the change in total mass, was 21.9%.
+Added: Lean mass preservation was greater in subjects aged 60 years and older, in whom the lean loss ratio was only 19.9%.
+Added: In addition to lean mass preservation, there was a preferential reduction of visceral adipose tissue (VAT), the adipose tissue associated with cardiovascular risk.
+Added: At the 2.4mg dose of pemvidutide, VAT was reduced by 28.3% at week 48 compared to a 19.5% loss in subcutaneous adipose tissue.
On June 23, 2024, we presented the full results of the body composition analysis from our 48-week MOMENTUM Phase 2 obesity trial of pemvidutide at the American Diabetes Association’s 84 th Annual Scientific Sessions.
9 unchanged sentences
Results of Operations
−Removed: Comparison of the three months ended June 30, 2024 and 2023
−Removed: The following table summarizes our results of operations for the three months ended June 30, 2024 and 2023 (in thousands):
−Removed: Three Months Ended June 30,
+Added: Comparison of the three months ended September 30, 2024 and 2023
+Added: The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023 (in thousands):
+Added: Three Months Ended September 30,
Increase (Decrease)
11 unchanged sentences
Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects.
−Removed: We recently closed out one of the remaining such contracts, and any revenues reported during the three months ended June 30, 2024 and 2023 were for the final indirect rate adjustments.
+Added: We recently closed out one of the remaining such contracts, and the revenue reported during the three months ended September 30, 2023 was primarily from the final indirect rate adjustments.
Research and development expenses
Research and development expenses consisted primarily of expenses related to product candidate development.
−Removed: Research and development expenses for the three months ended June 30, 2024 and 2023 are summarized as follows:
−Removed: Three Months Ended June 30,
+Added: Research and development expenses for the three months ended September 30, 2024 and 2023 are summarized as follows:
+Added: Three Months Ended September 30,
Product candidates
2 unchanged sentences
Total research and development expenses
−Removed: The increase in research and development expenses for pemvidutide was primarily due to an $8.7 million increase related to the ramp up of the IMPACT Phase 2b trial in MASH, a $0.2 million increase for other clinical analysis and a $1.5 million increase in net manufacturing expenses for production of Good Manufacturing Practice drug substance materials.
−Removed: These increases were partially offset by a $1.9 million reduction in expense associated with the MOMENTUM Phase 2 trial in obesity, which was ongoing during the three months ended June 30, 2023 and wound down in the year ended December 31, 2023, and a $0.3 million reduction in expenses associated with Phase 1 safety trial which was substantially completed in 2023.
+Added: The increase in research and development expenses for pemvidutide was primarily due to a $5.9 million increase related to the ramp up of the IMPACT Phase 2b trial in MASH and a $0.7 million increase for other nonclinical studies.
+Added: These increases were partially offset by a $2.7 million reduction in expense associated with the MOMENTUM Phase 2 trial in obesity, which was ongoing during the three months ended September 30, 2023 and wound down in the year ended December 31, 2023, and a $2.0 million decrease in net manufacturing expenses for production of Good Manufacturing Practice drug substance materials.
The decrease in research and development expenses for HepTcell was primarily due to the winddown and completion of the in-life portion of the Phase 2 trial in 2023.
−Removed: The research and development expenses for the three months ended June 30, 2024 were due to program winddown activities.
+Added: The research and development expenses for the three months ended September 30, 2024 were due to program winddown activities.
In the coming months, we expect to have some additional wrap up costs as we finalize these activities.
−Removed: The increase in other non-project specific research and development expenses was primarily due to a $0.5 million initial cost for a new research and discovery project.
+Added: The increase in other non-project specific research and development expenses was primarily due to a $0.8 million initial cost for additional research and discovery projects.
General and administrative expenses
−Removed: General and administrative expenses increased by $0.8 million, or 18%, for the three months ended June 30, 2024, as compared to the three months ended June 30, 2023, primarily due to a $1.3 million increase in stock compensation and other labor related expense, including the $1.0 million incremental stock-based compensation expense because of modifications of stock awards (see Note 8).
+Added: General and administrative expenses increased by $0.5 million, or 10%, for the three months ended September 30, 2024, as compared to the three months ended September 30, 2023, primarily due to a $0.4 million increase in professional fees.
Total other income (expense), net
−Removed: Total other income (expense), net increased by $0.2 million, or 8%, for the three months ended June 30, 2024, as compared to the three months ended June 30, 2023.
+Added: Total other income (expense), net increased by $0.1 million, or 3%, for the three months ended September 30, 2024, as compared to the three months ended September 30, 2023.
The net increase is primarily due to a $0.1 million increase in interest income earned on our cash equivalents and short-term investments.
−Removed: Comparison of the six months ended June 30, 2024 and 2023
−Removed: The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):
−Removed: Six Months Ended June 30,
+Added: Comparison of the nine months ended September 30, 2024 and 2023
+Added: The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):
+Added: Nine Months Ended September 30,
Increase (Decrease)
11 unchanged sentences
Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects.
−Removed: We recently closed out one of the remaining such contracts, and any revenues reported during the six months ended June 30, 2024 and 2023 were for the final indirect rate adjustments.
+Added: We recently closed out one of the remaining such contracts, and the revenue reported during the nine months ended September 30, 2023 was primarily from the final indirect rate adjustments.
Research and development expenses
Research and development expenses consisted primarily of expenses related to product candidate development.
−Removed: Research and development expenses for the six months ended June 30, 2024 and 2023 are summarized as follows:
−Removed: Six Months Ended June 30,
+Added: Research and development expenses for the nine months ended September 30, 2024 and 2023 are summarized as follows:
+Added: Nine Months Ended September 30,
Product candidates
2 unchanged sentences
Total research and development expenses
−Removed: The increase in research and development expenses for pemvidutide was primarily due to a $16.3 million increase related to the ramp up of the IMPACT Phase 2b trial in MASH, a $0.7 million increase for other clinical analysis, a $2.3 million increase in net manufacturing expenses for production of Good Manufacturing Practice drug substance materials, and a $1.1 million increase in nonclinical studies.
−Removed: These increases were partially offset by a $5.7 million reduction in expense associated with the MOMENTUM Phase 2 trial in obesity, which was ongoing during the six months ended June 30, 2023 and wound down in the year ended December 31, 2023, and a $1.7 million reduction in expenses associated with the metabolic dysfunction-associated steatotic liver disease (“MASLD”) trials and a $0.7 million reduction in expenses associated with Phase 1 safety trials, both of which were substantially completed in 2023.
+Added: The increase in research and development expenses for pemvidutide was primarily due to a $22.7 million increase related to the ramp up of the IMPACT Phase 2b trial in MASH, a $1.3 million increase for other clinical analysis, and a $1.9 million increase in nonclinical studies.
+Added: These increases were partially offset by a $9.0 million reduction in expense associated with the MOMENTUM Phase 2 trial in obesity, which was ongoing during the nine months ended September 30, 2023 and wound down in the year ended December 31, 2023, and a $2.7 million reduction in expenses associated with Phase 1 safety trials, which was substantially completed in 2023.
The decrease in research and development expenses for HepTcell was primarily due to the winddown and completion of the in-life portion of the Phase 2 trial in 2023.
−Removed: The research and development expenses for the six months ended June 30, 2024 were due to program winddown activities.
+Added: The research and development expenses for the nine months ended September 30, 2024 were due to program winddown activities.
In the coming months, we expect to have some additional wrap up costs as we finalize these activities.
−Removed: The increase in other non-project specific research and development expenses was primarily due to a $0.9 million increase in stock compensation expense and a $0.5 million initial cost for a new research and discovery project.
+Added: The increase in other non-project specific research and development expenses was primarily due to a $1.2 million increase in stock compensation expense and a $1.3 million initial cost for additional research and discovery projects.
General and administrative expenses
−Removed: General and administrative expenses increased by $1.6 million, or 17%, for the six months ended June 30, 2024, as compared to the six months ended June 30, 2023, primarily due to a $2.0 million increase in stock compensation and other labor related expense, including the $1.0 million incremental stock-based compensation expense because of modifications of stock awards (see Note 8).
+Added: General and administrative expenses increased by $2.1 million, or 15%, for the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023, primarily due to a $2.1 million increase in stock compensation and other labor-related expense, including the $1.0 million incremental stock-based compensation expense because of modifications of stock awards (see Note 8).
Total other income (expense), net
−Removed: Total other income (expense), net increased by $0.9 million, or 24%, for the six months ended June 30, 2024, as compared to the six months ended June 30, 2023.
−Removed: The net increase is primarily due to a $1.1 million increase in interest income earned on our cash equivalents and short-term investments.
+Added: Total other income (expense), net increased by $0.9 million, or 17%, for the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023.
+Added: The net increase is primarily due to a $1.1 million increase in interest income earned on our cash equivalents and short-term investments, partially offset by a $0.2 million increase in foreign currency exchange losses.
Liquidity and Capital Resources
−Removed: Our primary sources of cash during the six months ended June 30, 2024 were from equity transactions, interest and dividends from our money market funds and short-term investments, and proceeds from maturities of our short-term investments.
−Removed: Our cash, cash equivalents, restricted cash, and short-term investments were $164.9 million as of June 30, 2024.
−Removed: We believe, based on the operating cash requirements and capital expenditures expected for 2024 and 2025, our cash on hand as of June 30, 2024, together with expected cash receipts from our R&D incentives, is sufficient to fund operations for at least a twelve-month period from the issuance date of our June 30, 2024 consolidated financial statements.
+Added: Our primary sources of cash during the nine months ended September 30, 2024 were from equity transactions, interest and dividends from our money market funds and short-term investments, and proceeds from maturities of our short-term investments.
+Added: Our cash, cash equivalents, restricted cash, and short-term investments were $139.4 million as of September 30, 2024.
+Added: We believe, based on the operating cash requirements and capital expenditures expected for 2024 and 2025, our cash on hand as of September 30, 2024, together with expected cash receipts from our R&D incentives, is sufficient to fund operations for at least a twelve-month period from the issuance date of our September 30, 2024 consolidated financial statements.
We have not generated any revenues from the sale of any products to date, and there is no assurance of any future revenues from product sales.
We have incurred significant losses since we commenced operations.
−Removed: As of June 30, 2024, we had an accumulated deficit of $515.4 million.
+Added: As of September 30, 2024, we had an accumulated deficit of $538.2 million.
In addition, we have not generated positive cash flows from operations.
5 unchanged sentences
On February 28, 2023, we filed a shelf registration statement on Form S-3ASR, which was declared effective immediately.
−Removed: This shelf registration allows us to offer and sell any amount of our common stock, preferred stock, debt securities, warrants, rights and units (the “2023 Shelf”) for a period of 3 years from effectiveness.
+Added: This shelf registration allows us to offer and sell any amount of our common stock, preferred stock, debt securities, warrants, rights and units (the “2023 Shelf”) for a period of 3 years from effectiveness or until such determination that we no longer qualify as a well-known seasoned issuer.
At-the-Market Offerings
On February 28, 2023, we entered into the 2023 Agreement with Sales Agents with respect to an at-the-market offerings program under which we may offer and sell, from time to time at our sole discretion, the Shares through the Sales Agents from the 2023 Shelf.
−Removed: Since inception through June 30, 2024, we have sold 20,454,516 shares of common stock under the 2023 Agreement, resulting in approximately $86.6 million in net proceeds.
−Removed: During the six months ended June 30, 2024, we did not sell any shares of common stock under the 2023 Agreement, and as of June 30, 2024, $60.6 million remained available to be sold under the 2023 Shelf.
−Removed: The following table provides information regarding our cash flows for the six months ended June 30, 2024 and 2023:
−Removed: Six Months Ended June 30,
+Added: Since inception through September 30, 2024, we have sold 20,454,516 shares of common stock under the 2023 Agreement, resulting in approximately $86.6 million in net proceeds.
+Added: During the nine months ended September 30, 2024, we did not sell any shares of common stock under the 2023 Agreement, and as of September 30, 2024, $60.6 million remained available to be sold under the 2023 Shelf.
+Added: The following table provides information regarding our cash flows for the nine months ended September 30, 2024 and 2023:
+Added: Nine Months Ended September 30,
(in thousands)
6 unchanged sentences
Operating Activities
−Removed: Net cash used in operating activities was $34.5 million for the six months ended June 30, 2024 compared to $38.8 million during the six months ended June 30, 2023.
+Added: Net cash used in operating activities was $61.6 million for the nine months ended September 30, 2024 compared to $59.3 million during the nine months ended September 30, 2023.
The primary uses of cash from our operating activities include payments for labor and labor-related costs, professional fees, research and development costs associated with our clinical trials, and other general corporate expenditures.
−Removed: The decrease in cash used in operations of $4.3 million year over year is due to changes in working capital accounts of $15.5 million, partially offset by an increase in net loss as adjusted for non-cash items of $11.2 million.
+Added: The increase in cash used in operations of $2.3 million year over year is due to changes in working capital accounts of $11.1 million, offset by an increase in net loss as adjusted for non-cash items of $13.4 million.
Investing Activities
−Removed: Net cash used in investing activities was $43.2 million for the six months ended June 30, 2024 compared to $17.3 million net cash provided by during the six months ended June 30, 2023.
−Removed: The net cash used in investing activities during the six months ended June 30, 2024 was primarily due to purchases of $76.7 million of short-term investments, partially offset by $33.5 million proceeds from sales and maturities of short-term investments.
−Removed: The net cash provided by investing
−Removed: activities during the six months ended June 30, 2023 was primarily due to $60.6 million proceeds from sales and maturities of short-term investments, partially offset by $43.2 million purchases of short-term investments.
+Added: Net cash used in investing activities was $42.0 million for the nine months ended September 30, 2024 compared to $21.7 million net cash provided by during the nine months ended September 30, 2023.
+Added: The net cash used in investing activities during the nine months ended September 30, 2024 was primarily due to purchases of $102.5 million of short-term investments, partially offset by $60.5 million proceeds from sales and maturities of short-term investments.
+Added: The net cash provided by investing activities during the nine months ended September 30, 2023 was primarily due to $76.5 million proceeds from sales and maturities of short-term investments, partially offset by $54.8 million purchases of short-term investments.
Financing Activities
−Removed: Net cash used in financing activities during the six months ended June 30, 2024 was $0.3 million compared to $12.8 million cash provided by financing activities during the six months ended June 30, 2023.
−Removed: The net cash used in financing activities during the six months ended June 30, 2024 was primarily due to $0.8 million net payments for tax withholding obligations related to share-based compensation, partially offset by $0.2 million in proceeds from the employee stock purchase plan, $0.2 million proceeds from exercises of stock options, and $0.2 million proceeds from exercises of stock warrants.
−Removed: The net cash provided by financing activities during the six months ended June 30, 2023 was primarily the result of the receipt of $13.2 million in net proceeds from the issuance of common stock from our at-the-market offerings program, partially offset by $0.5 million net payments for tax withholding obligations related to share-based compensation.
+Added: Net cash used in financing activities during the nine months ended September 30, 2024 was negligible compared to $13.4 million cash provided by financing activities during the nine months ended September 30, 2023.
+Added: The net cash used in financing activities during the nine months ended September 30, 2024 was primarily due to $0.8 million net payments for tax withholding obligations related to share-based compensation, partially offset by $0.3 million in proceeds from the employee stock purchase plan, $0.3 million proceeds from exercises of stock options, and $0.2 million proceeds from exercises of stock warrants.
+Added: The net cash provided by financing activities during the nine months ended September 30, 2023 was primarily the result of the receipt of $13.7 million in net proceeds from the issuance of common stock from our at-the-market offerings program, partially offset by $0.5 million net payments for tax withholding obligations related to share-based compensation.
Current Resources
We have financed our operations to date principally through our equity offerings and proceeds from issuances of our preferred stock, common stock, and warrants.
−Removed: As of June 30, 2024, we had $57.2 million of cash, cash equivalents, and restricted cash, and $107.8 million of short-term investments.
−Removed: Accordingly, management believes that we have sufficient capital to fund our plan of operations for at least a twelve-month period from the issuance date of our June 30, 2024 financial statements.
+Added: As of September 30, 2024, we had $31.5 million of cash, cash equivalents, and restricted cash, and $107.9 million of short-term investments.
+Added: Accordingly, management believes that we have sufficient capital to fund our plan of operations for at least a twelve-month period from the issuance date of our September 30, 2024 financial statements.
However, in order to address our capital needs in the long-term, including our planned clinical trials, we must continue to actively pursue additional equity or debt financing, government funding, and monetization of our existing programs through partnership arrangements or sales to third parties.
8 unchanged sentences
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.