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Item 2. Management’s Discussion and Analysis

2024-08-08 compared with 2024-05-09 · 69 added, 32 removed, 84 unchanged (55% of the section changed)

15 unchanged sentences

Recent Business Update

On March 27, 2024, the Company announced results of the body composition analysis from its 48-week MOMENTUM Phase 2 obesity trial of pemvidutide.

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.

The body composition analysis showed that 78.1% of weight loss was derived from adipose tissue and only 21.9% from lean mass.

Historically, lean mass loss has been shown to be approximately 25% from diet and exercise programs.

As announced on November 30, 2023, the trial enrolled 391 subjects with obesity or overweight with at least one co-morbidity and without diabetes.

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Approximately 75% of subjects were female.

The body composition analysis showed that 74.5% of weight loss was derived from adipose tissue and only 25.5% from lean mass, comparable to the effects historically associated with weight loss from diet and exercise programs.

On March 27, 2024, we announced that the overall response in the Phase 2 trial was deemed to be insufficient to warrant further advancement in clinical trials.

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Results of Operations

Comparison of the three months ended March 31, 2024 and 2023:

Three Months Ended March 31,

Comparison of the three months ended June 30, 2024 and 2023

The following table summarizes our results of operations for the three months ended June 30, 2024 and 2023 (in thousands):

Three Months Ended June 30,

Increase (Decrease)

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We have not generated any revenues from the sale of any products to date.

Our revenue in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects.

We recently closed out one of the remaining such contracts and any revenue reported during the three months ended March 31, 2024 and 2023 were for the final indirect rate adjustments.

Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects.

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.

Research and development expenses

Research and development expenses consisted primarily of expenses related to product candidate development.

Research and development expenses for the three months ended March 31, 2024 and 2023 are summarized as follows:

Three Months Ended March 31,

Research and development expenses for the three months ended June 30, 2024 and 2023 are summarized as follows:

Three Months Ended June 30,

Product candidates

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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.

These increases were partially offset by a $3.8 million reduction in expense associated with the MOMENTUM Phase 2 trial in obesity, which was ongoing during the three months ended March 31, 2023 and wound down in the year ended December 31, 2023, and a $1.5 million reduction in expenses associated with the metabolic dysfunction-associated steatotic liver disease (“MASLD”) trials and a $0.6 million reduction in expenses associated with Phase 1 safety trials, both of which were substantially completed by March 31, 2023.

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.

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.

The research and development expenses for the three months ended March 31, 2024 was due to program winddown activities.

The research and development expenses for the three months ended June 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.

The increase in other non-project specific research and development expenses was primarily due to a $0.5 million increase in stock compensation expense.

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.

General and administrative expenses

General and administrative expenses increased by $0.8 million, or 17%, for the three months ended March 31, 2024, as compared to the three months ended March 31, 2023.

The increase is due primarily to a $0.6 million increase in stock compensation and other labor related expense and a $0.1 million increase in professional fees.

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).

Total other income (expense), net

Total other income (expense), net increased by $0.7 million, or 42%, for the three months ended March 31, 2024, as compared to the three months ended March 31, 2023.

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.

The net increase is primarily due to a $0.3 million increase in interest income earned on our cash equivalents and short-term investments.

Comparison of the six months ended June 30, 2024 and 2023

The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):

Six Months Ended June 30,

Increase (Decrease)

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense):

Interest expense

Interest income

Other income (expense), net

Total other income (expense), net

We have not generated any revenues from the sale of any products to date.

Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects.

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.

Research and development expenses

Research and development expenses consisted primarily of expenses related to product candidate development.

Research and development expenses for the six months ended June 30, 2024 and 2023 are summarized as follows:

Six Months Ended June 30,

Product candidates

Increase (Decrease)

Non-project costs

Total research and development expenses

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.

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.

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.

The research and development expenses for the six months ended June 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.

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.

General and administrative expenses

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).

Total other income (expense), net

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.

The net increase is primarily due to a $1.1 million increase in interest income earned on our cash equivalents and short-term investments.

Liquidity and Capital Resources

Our primary sources of cash during the three months ended March 31, 2024 were from equity transactions, interest and dividends from our money market funds and short-term investments, and proceeds from maturity of our short-term investments.

Our cash, cash equivalents, restricted cash and short-term investments were $182.1 million as of March 31, 2024.

We believe, based on the operating cash requirements and capital expenditures expected for 2024 and 2025, our cash on hand as of March 31, 2024, together with expected cash receipts from our R&D incentives, are sufficient to fund operations for at least a twelve-month period from the issuance date of our March 31, 2024 consolidated financial statements.

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.

Our cash, cash equivalents, restricted cash, and short-term investments were $164.9 million as of June 30, 2024.

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.

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.

As of March 31, 2024, we had an accumulated deficit of $490.7 million.

As of June 30, 2024, we had an accumulated deficit of $515.4 million.

In addition, we have not generated positive cash flows from operations.

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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.

Since inception through March 31, 2024, the Company has sold 20,454,516 shares of

common stock under the 2023 Agreement resulting in approximately $86.6 million in proceeds.

During the three months ended March 31, 2024, we did not sell any shares of common stock under the 2023 Agreement, and as of March 31, 2024, $60.6 million remained available to be sold under the 2023 Shelf.

The following table provides information regarding our cash flows for the three months ended March 31, 2024 and 2023:

Three Months Ended March 31,

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.

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.

The following table provides information regarding our cash flows for the six months ended June 30, 2024 and 2023:

Six Months Ended June 30,

(in thousands)

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Operating Activities

Net cash used in operating activities was $16.4 million for the three months ended March 31, 2024 compared to $19.4 million during the three months ended March 31, 2023.

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.

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.

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Investing Activities

Net cash used in investing activities was $39.5 million, for the three months ended March 31, 2024 compared to $13.3 million net cash provided by during the three months ended March 31, 2023.

The cash used in investing activities during the three months ended March 31, 2024 was primarily due to purchase of $53.5 million of short-term investments, partially offset by $14.0 million proceeds from sale and maturities of short-term investments.

The cash provided by investing activities during the three months ended March 31, 2023 was primarily due to $34.6 million proceeds from sale and maturities of short-term investments, partially offset by $21.2 million purchase of short-term investments.

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.

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.

The net cash provided by investing

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.

Financing Activities

Net cash used in financing activities during each of the three months ended March 31, 2024 and 2023 was $0.3 million.

The net cash used in financing activities during the three months ended March 31, 2024 was primarily due to $0.6 million net payment for tax withholding obligations related to share-based compensation, partially offset by $0.2 million in proceeds from proceeds from employee stock purchase plan and $0.2 million proceeds from exercise of stock warrants.

The net cash used by financing activities during the three months ended March 31, 2023 was primarily due to $0.5 million payment for tax withholding obligations related to share-based compensation, partially offset by $0.1 million in proceeds from proceeds from employee stock purchase plan and $0.1 million proceeds from exercise of stock options.

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.

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.

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.

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.

As of March 31, 2024, we had $79.0 million of cash, cash equivalents and restricted cash and $103.0 million of short-term investments.

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 March 31, 2024 financial statements.

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.

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.

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis