What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-12 compared with 2025-08-14 · 70 added, 90 removed, 395 unchanged (29% of the section changed)

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This Quarterly Report on Form 10-Q for the three-month

period ended June 30, 2025 contains “forward-looking statements” within the meaning of the Securities Act of 1933, as amended

(the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

period ended September 30, 2025 contains “forward-looking statements” within the meaning of the Securities Act of 1933, as

amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

forward-looking statements contain information about our expectations, beliefs or intentions regarding our product development and commercialization

efforts, business, financial condition, results of operations, strategies or prospects, and other similar matters.

These forward-looking

statements contain information about our expectations, beliefs or intentions regarding our product development and commercialization efforts,

business, financial condition, results of operations, strategies or prospects, and other similar matters.

These forward-looking statements

are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties,

statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties,

risks and changes in circumstances that are difficult to predict.

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Our net losses were

$11.1 million and $5.9 million for the six months ended June 30, 2024 and June 30, 2025, respectively.

As of June 30, 2025, we had

an accumulated deficit of $107.1 million.

We expect that our operating expenses will increase significantly as we advance our product

candidates through pre-clinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization;

$15.2 million and $11.9 million for the nine months ended September 30, 2024 and September 30, 2025, respectively.

As of September

30, 2025, we had an accumulated deficit of $113.2 million.

We expect that our operating expenses will increase significantly as

we advance our product candidates through pre-clinical and clinical development, seek regulatory approval, and prepare for and, if approved,

proceed to commercialization;

acquire, discover, validate and develop additional product candidates;

obtain, maintain, protect and enforce our intellectual property

obtain, maintain, protect and enforce

our intellectual property portfolio;

and hire additional personnel.

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Recent Developments

On June 11, 2025, we issued 300,000 shares of

common stock, upon conversion of 3,000 shares of our Series B-2 Preferred Stock.

In June 2025, we issued 277,000 shares of common

stock, upon conversion of shares of our Series A-3 Preferred Stock related to exercise of Tranche A warrants.

During the six months ended June 30, 2025, the Company sold 2,009,616

shares of common stock pursuant to a sales agreement, with Guggenheim Securities, LLC, at an average price of $6.07 per share and paid

$379,000 in commissions, resulting in net proceeds to the Company of approximately $12.2 million.

Reverse Stock Split

On June 18, 2025, the Company filed the Charter

Amendment with the Secretary of State of the State of Delaware to effectuate a reverse stock split.

The Company’s common stock began

trading on a split-adjusted basis at the opening of trading on the Nasdaq Capital Market on June 20, 2025.

When the reverse stock split

became effective, every 10 shares of common stock were automatically reclassified and combined into one share of common stock.

No fractional

shares were issued as a result of the split.

Stockholders who would otherwise be entitled to receive a fractional share will instead automatically

have their fractional interests rounded up to the next whole share, after aggregating all the fractional interests of a holder resulting

from the split.

The split affects all stockholders uniformly and will not change any stockholder’s percentage ownership interest

or any stockholder’s proportionate voting power, except for immaterial changes that may result from the treatment of fractional

The split did not change the number of authorized shares of common stock or the par value per share of the common stock.

As a result of the reverse stock split, proportionate

adjustments were made to the per share exercise prices of, and the number of shares underlying, the Company’s outstanding stock

options, as well as to the number of shares available for future awards granted under the Company’s stock incentive plans.

proportionate adjustments were made to the per share exercise prices of, and the number of shares underlying, outstanding warrants to

purchase shares of the Company’s common stock.

Further, a proportionate adjustment was made to the per share conversion price of

the Company’s series A-2 prime preferred stock, pursuant to its terms.

Following the reverse stock split we had 12,768,239 shares

of our common stock outstanding, which excludes approximately 49,000 shares of our common stock that were issued for rounding up fractional

shares resulting from the reverse stock split.

The reverse stock Split is retroactively reflected in the Company’s condensed consolidated

balance sheets, condensed consolidated statements of operations, condensed consolidated statements of changes in shareholders’ equity

and loss per share data.

During the nine months ended September 30, 2025,

the Company sold 8,046,736 shares of common stock pursuant to a sales agreement, with Guggenheim Securities, LLC, at an average price

of $4.94 per share and paid $1.2 million in commissions, resulting in net proceeds to the Company of approximately $38.6 million.

On October 28, 2025,we announced an update from

its meeting with the U.S.

Food and Drug Administration (FDA) and timing of the resubmission of its New Drug Application (NDA) for Oxylanthanum

Carbonate (OLC) following receipt of a Complete Response Letter (CRL) on June 30, 2025.

The Type A FDA meeting was held to discuss the

resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor.

No other concerns have been identified to us, including pre-clinical, clinical, or safety data submitted as part of the NDA.

receipt of the official meeting minutes from the Type A meeting and engaging in discussions with its third-party manufacturing vendor,

we plan to resubmit the NDA for OLC by year-end

Components of Results of Operations

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Results of Operations

Comparison of the Three Months Ended June

Comparison of the Three Months Ended September

30, 2024 and 2025

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Three Months Ended

September 30,

Operating expenses:

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Research and development expenses decreased by

approximately $3.1 million, or 64%, from approximately $4.9 million for the three months ended June 30, 2024, to approximately $1.8 million

for the three months ended June 30, 2025.

The decrease in research and development expenses

was primarily due to a $3.1 million decrease in drug development costs, consulting and other costs of $93,000, and stock-based compensation

of $23,000, partially offset by an increase in labor costs of $86,000

approximately $81,000, or 3%, from approximately $3.1 million for the three months ended September 30, 2024, to approximately $3.0 million

for the three months ended September 30, 2025.

The decrease in research and development expenses was primarily due to a $235,000 decrease

in professional services and drug development costs, partially offset by increases in labor, travel, and other costs of $154,000.

General and Administrative Expenses

General and administrative expenses increased

by $2.7 million , or 106%, from approximately $2.5 million for the three months ended June 30, 2024, to approximately $5.2 million for

the three months ended June 30, 2025 primarily due to an increase of $2.2 million in marketing, consulting and other expenses related

to our commercial launch, increase of $417,000 in labor costs, increase of $201,000 of insurance, travel and other costs, partially offset

by a decrease of $47,000 in stock-based compensation.

by $1.2 million, or 37%, from approximately $3.2 million for the three months ended September 30, 2024, to approximately $4.4 million

for the three months ended September 30, 2025.

The increase in general and administrative expenses was primarily due to an increase of

$0.5 million in consulting and other professional services expenses as well as an increase of $0.6 million in labor and other costs.

Other Income (Expenses)

Other income (expenses) decreased $0.8 million,

or 165%, from $17.3 million in the three months ended June 30, 2024 to $0.5 million for the three months ended June 30, 2025 due primarily

to the change in fair value of our warrant liability of $16.4 million and a decrease in interest income of $307,000.

Comparison of the Six Months Ended June

or 38%, from $2.2 million in the three months ended September 30, 2024 to $1.3 million for the three months ended September 30, 2025.

was primarily due to the change in fair value of our warrant liability of $0.7 million.

Comparison of the Nine months ended September

30, 2024 and 2025

Six Months Ended

Nine months ended

September 30,

Operating expenses:

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Research and development expenses decreased by

approximately $7.7 million, or 66%, from approximately $11.7 million for the six months ended June 30, 2024 to approximately $3.9 million

for the six months ended June 30, 2025.

The decrease in research and development expenses was primarily due to an $8.1 million decrease

in drug development costs, partially offset by an increase in labor costs of $239,000, consulting and other costs of $110,000, and stock-based

compensation of $13,000.

approximately $7.9 million, or 53%, from approximately $14.7 million for the nine months ended September 30, 2024 to approximately

$6.9 million for the nine months ended September 30, 2025.

The decrease in research and development expenses was primarily due to an $8.2

million decrease in drug development costs, partially offset by an increase in labor costs of $0.4 million.

General and Administrative Expenses

General and administrative expenses increased

by $6.1 million, or 124%, from approximately $4.9 million for the six months ended June 30, 2024 to approximately $11.0 million for the

six months ended June 30, 2025 primarily due to an increase of $5.0 million in marketing, consulting and other expenses related to our

commercial launch, increase of $884,000 in labor costs, increase of $284,000 of insurance, travel and other costs, partially offset by

a decrease of $42,000 in stock-based compensation.

General and administrative expenses

increased by $7.3 million, or 90%, from approximately $8.1 million for the nine months ended September 30, 2024 to approximately

$15.4 million for the nine months ended September 30, 2025 primarily due to an increase of $5.4 million in consulting and

professional services expenses as well as an increase of $1.9 million in labor and other costs.

Other Income (Expenses)

Other income (expenses) increased by $2.8 million,

(income), or 65%, from $5.5 million expense in the six months ended June 30, 2024 to $9.0 million income for the six months ended June

30, 2025 due primarily to the change in fair value of our warrant liability of $3.7 million, partially offset by a decrease in interest

income of $151,000.

or 36%, from $7.7 million expense in the nine months ended September 30, 2024 to $10.4 million income for the nine months ended

September 30.

The increase was primarily due to the change in fair value of our warrant liability.

Liquidity and Capital Resources

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through or to Guggenheim Securities, LLC acting as sales agent or principal.

During the six months ended June 30, 2025, the Company sold

2,009,616 shares of common stock at an average price of $6.07 per share and paid $379,000 in commissions, resulting in net proceeds to

the Company of approximately $12.2 million.

During the nine months ended September 30, 2025, the Company

sold 8,046,736 shares of common stock pursuant to a sales agreement, with Guggenheim Securities, LLC, at an average price of $4.94 per

share and paid $1.2 million in commissions, resulting in net proceeds to the Company of approximately $38.6 million.

Future Funding Requirements

We have incurred net losses since our inception.

For the six months ended June 30, 2025, we had a net loss of $5.9 million, and we expect to incur substantial additional losses in future

As of June 30, 2025, we had an accumulated deficit of $107.1 million.

For the nine months ended September 30, 2025, we had a net loss of $11.9 million, and we expect to incur substantial additional losses

in future periods.

As of September 30, 2025, we had an accumulated deficit of $113.2 million.

We expect to continue incurring losses in the

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and uses of cash for each of the periods presented below (in thousands):

Six Months Ended

Nine months ended

September 30,

Net cash (used in) provided by:

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Financing activities

Net increase (decrease) in cash and cash equivalents

Net increase in cash and cash equivalents

Cash Flows from Operating Activities

Net cash used in operating activities was $23.3

million for the six months ended June 30, 2025.

million for the nine months ended September 30, 2025.

Cash used in operating activities was primarily due to the use of funds for development

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Net cash used in operating activities was $22.0

million for the six months ended June 30, 2024.

million for the nine months ended September 30, 2024.

Cash used in operating activities was primarily due to the use of funds for development

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Net cash used in investing activities was $24,000

for the six months ended June 30, 2025 and was due to the purchase of lab equipment.

for the nine months ended September 30, 2025 and was due to the purchase of lab equipment.

Net cash used in investing activities was $50,000

for the six months ended June 30, 2024 and was due to the purchase of furniture and fixtures for our corporate office.

for the nine months ended September 30, 2024 and was due to the purchase of furniture and fixtures for our corporate office.

Cash Flows from Financing Activities

Net cash provided by financing activities was

$13.5 million during the six months ended June 30, 2025 due primarily to the at the market public offering agreement we signed on November

Net cash provided by financing activities was $39.9 million during

the nine months ended September 30, 2025, due primarily to the at the market public offering agreement we signed on November 13, 2024.

Net cash provided by financing activities was

$44.9 million during the six months ended June 30, 2024 due primarily to the private placement financing agreement we signed on March

$44.7 million during the nine months ended September 30, 2024 due primarily to the private placement financing agreement we signed on

March 13, 2024.

Critical Accounting Policies, Significant Judgments and Use of Estimates

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warrant liabilities.

There have been no other material changes to our critical accounting policies and estimates during the six months

ended June 30, 2025 from those used for the year ended December 31, 2024.

There have been no other material changes to our critical accounting policies and estimates during the nine months

ended September 30, 2025 from those used for the year ended December 31, 2024.

The below policies represent our critical accounting policies.

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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