MetaVia Inc.
For the period ended Mar 31, 2026. Filed May 14, 2026.
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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.
Mar 31, 2026 · Filed May 14, 2026
MTVA$1.43+31.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001104659-25-107726
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001104659-26-061166
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 79 previous paragraphs and 58 current paragraphs.
21 unchanged; 21 reworded; 15 added; 29 removed; 8 previous and 1 current paragraphs rearranged.
Tables are not compared: 32 previous and 10 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 (15)
Current report
Vanoglipel
Current report
We initiated a Phase 2a clinical trial in 2023 with the goal of establishing the mechanism of action and efficacy of vanoglipel in the treatment of MASH and to evaluate trends for T2DM. This is the first-in-human MASH clinical trial for vanoglipel. We are expecting to finalize the Clinical Study Report of the Phase 2a clinical trial in the first half of 2026. We are also currently working to schedule an end-of-Phase 2a meeting with the Food and Drug Administration.
Current report
We initiated a Phase 1 clinical trial in 2024 with the goal of establishing the safety and tolerability of DA-1726 while exploring the mechanism of action and efficacy of DA-1726 in the treatment of obesity. This is the first-in-human clinical trial for DA-
Current report
We started Part 3a and Part 3b of the Phase 1 clinical trial in April 2026. Part 3a will be a one-step titration with 16 mg for four weeks and 48 mg for 12 weeks. Part 3b will be a two-step titration with 16 mg for four weeks, 32 mg for four weeks and 64 mg for eight weeks. These titration studies are to see if it can remove any moderate adverse effects from the 48 mg dose level and to seek DA-1726 at a higher dose level of 64 mg. We expect dose-dependent exploratory weight loss and other early signals in the exploratory endpoints with potential for best-in-class safety and tolerability. The data readout for both Part 3a and Part 3b is planned for the fourth quarter of 2026.
Current report
Our total other income for thethree months ended March 31, 2026 was $0.2 million, consistent with the corresponding period in 2025.
Current report
Public offering
Current report
In January 2026, we closed on an underwritten public offering and received net proceeds of $7.1 million, pursuant to which we issued and sold, (i) 1,006,870 Class A Units, with each Class A Unit consisting of (A) one share of common stock, (B) 1.5 Series C Common Warrants to purchase 1.5 shares of common stock, and (C) 1.5 Series D Common Warrants to purchase 1.5 shares of common stock, at a price of $3.10 per Class A Unit, and (ii) 1,998,704 Class B Units, with each Class B Unit consisting of (A) one pre-funded warrant to purchase one share of common stock, (B) 1.5 Series C Common Warrants to purchase 1.5 shares of common stock, and (C) 1.5 Series D Common Warrants to purchase 1.5 shares of common stock, at a purchase price of $3.099 per Class B Unit. Each pre-funded warrant has an exercise price of $0.001 per share and is immediately exercisable and will expire when exercised in full. Each Series C Common Warrant and Series D Common Warrant has an exercise price of $3.10 per whole share of common stock, subject to certain adjustments, are immediately exercisable, and will expire on January 16, 2031 and January 16, 2028, respectively. Under the Series C Common Warrant and the Series D Common Warrant, we may not affect the exercise of any such warrants, and a holder will not be entitled to exercise any portion of any such warrants, which, upon giving effect to such exercise, would cause the aggregate number of shares of common stock beneficially owned by the holder (together with its affiliates) to exceed the beneficial ownership limitation contained therein.
Current report
The Series D Common Warrants are callable at our option following the release of a positive data readout for our Phase 1, Part 3 clinical trial for DA-1726 via a widely disseminated press release, subject to the satisfaction of certain conditions. The Series C and Series D Common Warrants are fixed priced and do not contain any variable pricing features or alternative exercise provisions.
Current report
As of March 31, 2026, 1,630,964 of the pre-funded warrants issued in the January 2026 underwritten public offering have been exercised for an equivalent number of shares of our common stock.
Current report
At the market offering
Current report
In November 2025, we entered into an At The Market Offering Agreement (the “ATM Sales Agreement”) with Ladenburg Thalmann & Co. Inc., as sales agent and/or principal (“Ladenburg”), pursuant to which we may offer and sell, from time to time through or to Ladenburg, shares of our common stock having an aggregate offering price of up to $2.3 million (the “ATM Program”). The offer and sale of the shares of common stock pursuant to the ATM Program is made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-278646) filed with the SEC on April 12, 2024, and declared effective by the SEC on April 23, 2024, as supplemented by a prospectus supplement to be filed with the SEC on November 6, 2025 pursuant to Rule 424(b) under the Securities Act.
Current report
Pursuant to the ATM Sales Agreement, Ladenburg may sell the shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act. We are not obligated to make any sales of the shares under the ATM Sales Agreement. The offering of shares pursuant to the ATM Sales Agreement will terminate upon the termination of the ATM Sales Agreement by Ladenburg or us, as permitted therein. We are obligated to pay Ladenburg an aggregate sales agent commission of 3.0% of the gross sales price of the shares sold pursuant to the ATM Sales Agreement. We will also reimburse Ladenburg for certain specified expenses in connection with entering into the ATM Sales Agreement, which contains customary representations and warranties and conditions to the placements of the shares pursuant thereto.
Current report
In March 2026, we sold 216,625 shares of common stock under the ATM Program and received net proceeds of $0.3 million, net of sales agent commission and related offering expenses. As of March 31, 2026, we have $0.8 million remaining under the ATM Program in which we may offer and sell shares of our common stock.
Current report
There were no cash flows used in or provided by investing activities for three months ended March 31, 2026 and 2025.
Current report
Net cash provided by financing activities for the three months ended March 31, 2026 was $7.7 million and primarily attributable to gross proceeds of (i) $9.3 million from an underwritten public offering in January 2026 and (ii) $0.3 million from the sale of common stock under the ATM Sales Agreement. Partially offsetting these gross proceeds was an aggregate payment of $1.9 million in issuance costs in connection with the sale of common stock and warrants under an underwritten public offering and under an at the market offering agreement. Net cash used in financing activities for the three months ended March 31, 2025 was less than $0.1 million, related to the payment of employee withholding taxes related to shares withheld from the issuance of vested restricted stock units.
Removed paragraphs (29)
Previous report
Vanoglipel (DA-1241)
Previous report
We are currently finalizing the Clinical Study Report on a Phase 2a clinical trial in the United States (“U.S.”). MASH Phase 2a is a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical trial to establish safety and an early signal of efficacy in MASH as a next-generation competitive oral agent while we follow the trend for T2DM.
Previous report
In December 2024, we announced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. Part 1 of this Phase 2a trial is exploring Vanoglipel (DA-1241), a novel GPR119 agonist compared to placebo, while Part 2 is investigating the efficacy of Vanoglipel (DA-1241) in combination with sitagliptin, a DPP-4 inhibitor.
Previous report
We are currently conducting a Phase 1 trial in the U.S. The Phase 1 trial, a first-in-human trial, is a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects.
Previous report
In September 2024, we announced positive top-line data from the single ascending dose Part 1 of our Phase 1 trial evaluating DA-1726. In April 2025, we announced positive top-line data from the multiple ascending dose (“MAD”) Part 2 study of our Phase 1 trial.
Previous report
In June 2025, we began enrollment for a higher-dose MAD cohort to assess the maximum tolerated dose and fully realize DA-1726's potential, as higher doses may also show a similar profile, while potentially demonstrating increased weight reduction. We dosed the first patient in the 48 mg, MAD cohort of our Phase 1 clinical trial of DA-1726 in July 2025 and we extended the clinical trial for this 48 mg, MAD cohort to 8 weeks from 4 weeks to further explore the non-titrated maximum tolerated dose, explore safety and other primary, secondary and exploratory endpoints over a longer treatment duration, and evaluate longer-term early efficacy. Also, in August 2025, we administered the fifth dose for the first patient in the 48 mg, MAD cohort of our Phase 1 clinical trial of DA-1726. Top-line data of the 48 mg, MAD cohort is expected in the fourth quarter of 2025.
Previous report
In November 2025, we presented new Phase 1 and pre-clinical data on DA-1726 in two poster presentations at ObesityWeek® 2025.
Previous report
Research and development expenses
Previous report
R&D expenses consist primarily of costs incurred in connection with the development of our product candidates. These expenses include:
Previous report
Direct costs
Previous report
Indirect costs
Previous report
We recognize external development costs based on an evaluation of the progress toward completion of specific tasks using information provided to us by our service providers. This process involves reviewing contracts and purchase orders, communicating with our clinical research staff to identify services that have been performed on our behalf, and estimating the level of service provided and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered, or the services rendered.
Previous report
Our direct R&D expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research laboratories and outside consultants in connection with our clinical development, quality assurance and quality control processes, manufacturing, and clinical development activities. Our direct research and development expenses also include fees incurred under third-party license agreements, including the Shared Services Agreement with Dong-A ST (related party). We utilize our employee and infrastructure resources across multiple research and development projects. We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We utilize internal resources to manage CRO and CMO activities. These employees work across multiple programs. Our direct R&D expenses consist of (i) expenses attributable to our product candidates and (ii) certain other R&D expenses, including clinical, non-clinical and preclinical services or other R&D expenses that are not attributable to a single product candidate. Our indirect R&D expenses consist of (i) employment-related expenses for compensation and benefits, which are internal costs and (ii) consulting expenses.
Previous report
Clinical development activities are central to our business model. We do not believe that our historical costs are indicative of the future costs associated with these programs, nor do they represent the costs of future programs we may initiate. Product candidates in later stages of clinical development generally have higher development costs than those inpreclinical development or inearlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We have some control over the timing of these expenses, but costs may be difficult to control once clinical trials have commenced.
Previous report
The successful development and commercialization of our product candidates are highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates. Additionally, because of the risks inherent in novel treatment discovery and development, we cannot reasonably estimate or know:
Previous report
A change in the outcome of any of these variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate.
Previous report
Our total other income for thethree months ended September 30, 2025 was $0.1 million, a decrease of $0.5 million, compared to the three months ended September 30, 2024. This decrease was primarily attributable to (i) $0.2 million in lower interest income, net, due to lower cash balances and lower interest rates and (ii) approximately $0.4 million related to the change in fair value of warrant liabilities. We recorded a loss of $0.1 million from the change in fair value of warrant liabilities during the three months ended September 30, 2025 compared to a gain of $0.3 million from the change in fair value of warrant liabilities during the three months ended September 30, 2024.
Previous report
Nine months ended September 30, 2025 compared to nine months ended September 30, 2024
Previous report
Our total operating expenses and loss from operations for the nine months ended September 30, 2025 were $11.7 million, a decrease of $11.6 million, or 49.8%, compared to the nine months ended September 30, 2024. This decrease was attributable to lower R&D and general and administrative expenses for the nine months ended September 30, 2025. Our R&D expenses were $6.6 million for the nine months ended September 30, 2025, a decrease of $10.9 million, or 62.5%, compared to the nine months ended September 30, 2024. Ourgeneral and administrative expenses were $5.1 million for the nine months ended September 30, 2025, a decrease of $0.6 million, or 11.0%, compared to the nine months ended September 30, 2024.
Previous report
The $0.6 million decrease ingeneral and administrative expenses was primarily attributable to (i) $0.9 million in lower consulting expenditures and (ii) $0.2 million in lower other general and administrative expenses. These decreases were partially offset by (i) $0.4 million in higher legal and professional fees and (ii) $0.1 million in higher employee compensation and benefits.
Previous report
Total other income
Previous report
Our total other income for thenine months ended September 30, 2025 was $0.6 million, a decrease of $0.2 million, compared to the nine months ended September 30, 2024. This was attributable to $0.3 million in lower interest income, net, due to lower cash balances and lower interest rates, partially offset by a $0.1 million increase in gain from change in fair value of warrant liabilities. We recorded a gain of $0.2 million and $0.1 million from the change in fair value of warrant liabilities during the nine months ended September 30, 2025 and 2024, respectively.
Previous report
Provision for income taxes
Previous report
Net loss
Previous report
of the banks in which the deposits are held and which qualify for FDIC insurance protection in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.
Previous report
Private Placement
Previous report
In May 2025, we closed on a private placement offering with Dong-A ST, a related party, and Dong-A Socio Holdings Co., Ltd., an affiliate company of Dong-A ST, and received gross proceeds of $10.0 million, before deducting the placement agent’s fees and related offering expenses. The private placement was comprised of (i) 9,479,345 shares of our common stock at a price of $0.71 per share and (ii) 4,605,162 pre-funded warrants to purchase up to an equivalent number of shares of our common stock at a price of $0.709 per pre-funded warrant. The pre-funded warrants had an exercise price of $0.001 per pre-funded warrant. For additional information, see “Note 6. Stockholders’ equity” to the condensed consolidated financial statements included elsewhere in this Report.
Previous report
Net cash used in investing activities, related to the purchase of property and equipment, was less than $0.1 million for the nine months ended September 30, 2025 and 2024.
Previous report
Net cash provided by financing activities was $9.1 million for the nine months ended September 30, 2025, which primarily consisted of gross proceeds of $10.0 million from an equity offering in May 2025, net of payment of issuance cost of $0.9 million. Net cash provided by financing activities of $18.5 million for the nine months ended September 30, 2024, which primarily consisted of gross proceeds of $20.0 million from an equity offering in June 2024, net of payment of issuance cost of $1.5 million.
Reworded paragraphs (21)
Previous wording
The following discussion of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and related notes included elsewhere in this Report and the audited financial statements and related notes for the fiscal year ended December 31, 2024 included in our 2024 Form 10-K. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under Part II, Item 1A. Risk Factors, elsewhere in this Report.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Report and the audited financial statements and related notes included in our 2025 Form 10-K. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under Part II, Item 1A. Risk Factors, elsewhere in this Report.
Previous wording
We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. MetaVia has two ongoing programs focused primarily on the treatment ofmetabolic dysfunction-associated steatohepatitis (“MASH”) and obesity.
Current wording
We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. We have two ongoing programs focused primarily on the treatment ofmetabolic dysfunction-associated steatohepatitis (“MASH”) and obesity.
Previous wording
While we primarily focus our financial resources and management’s attention on the development of Vanoglipel (DA-1241) and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases on which we are not planning to advance development and have, or continue to consider for, out-licensing and divestiture opportunities.
Current wording
While we primarily focus our financial resources and management’s attention on the development of vanoglipel and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases on which we are not planning to advance development and have, or continue to consider for, out-licensing and divestiture opportunities.
Previous wording
We are currently working to schedule an end-of-Phase 2 meeting with the Food and Drug Administration (“FDA”). For additional information on Vanoglipel (DA-1241), including an overview of the top-line 16-week results from the two-part Phase 2a clinical trial, see “Part I, Item 1. Business, Our Pipeline, Vanoglipel (DA-1241) Treatment of MASH” in our 2024 Form 10-K.
Current wording
For additional information on vanoglipel, including an overview of the top-line 16-week results from the two-part Phase 2a clinical trial, see “Part I, Item 1. Business, Our Pipeline, vanoglipel (DA-1241) Treatment of MASH” in our 2025 Form 10-K.
Previous wording
For additional information on DA-1726, see “Part I, Item 1. Business, Our Pipeline, DA-1726 Treatment of Obesity” in our 2024 Form 10-K, and our Current Reports on Form 8-K dated April 15, 2025, April 22, 2025, July 9, 2025, and August 6, 2025.
Current wording
For additional information on DA-1726, see “Part I, Item 1. Business, Our Pipeline, DA-1726 Treatment of Obesity” in our 2025 Form 10-K, and our Current Reports on Form 8-Ks dated January 5, 2026, March 18, 2026, April 10, 2026, and May 11, 2026.
Previous wording
Except for the following disclosure and the financial amounts for the presented periods in this Report (see financial amounts in the below results of operations and the condensed consolidated balance sheets included elsewhere in this Report), there have been no material changes to our key operating information since December 31, 2024. Refer to our 2024 Form 10-K for a complete discussion of our key operating information.
Current wording
Our key operating information is described in “Key operating information” within “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” inour 2025 Form 10-K. There have been no material changes to our key operating information.
Previous wording
Our total operating expenses and loss from operations for the three months ended September 30, 2025 were $3.5 million, a decrease of $2.8 million, or 44.5%, compared to the three months ended September 30, 2024. This decrease was mainly attributable to lower R&D for the three months ended September 30, 2025. Our R&D expenses were $1.9 million for the three months ended September 30, 2025, a decrease of $2.6 million, or 57.6%, compared to the three months ended September 30, 2024. Ourgeneral and administrative expenses were $1.6 million for the three months ended September 30, 2025, a decrease of $0.2 million, or 10.4%, compared to the three months ended September 30, 2024.
Current wording
Our total operating expenses and loss from operations for the three months ended March 31, 2026 were $4.0 million, an increase of approximately $0.1 million, or 3.6%, compared to the corresponding period in 2025. This increase was mainly attributable to higher general and administrative (“G&A”) expensesfor the three months ended March 31, 2026, partially offset by lower R&D expenses. Our R&D expenses were $2.1 million for the three months ended March 31, 2026, a decrease of $0.2 million, or 9.7%, compared to the corresponding period in 2025. Our G&A expenses were $1.9 million for the three months ended March 31, 2026, an increase of approximately $0.4 million, or 23.4%, compared to the corresponding period in 2025.
Previous wording
The $2.6 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for Vanoglipel (DA-1241) and decreased activities related to the Phase 1 trial for DA-1726 as compared to the three months ended September 30, 2024. Specifically, the decrease in R&D expenses was primarily attributable to (i) $2.4 million in lower direct R&D expenses related to Vanoglipel (DA-1241) product development and (ii) $0.4 million in lower direct R&D expenses related to DA-1726 product development. These decreases were partially offset by (i) $0.1 million in higher direct other R&D costs and (ii) $0.1 million in higher indirect consulting expenses. Included in direct R&D costs (credits) were expenses totaling $0.2 million and $0.7 million for the three months ended September 30, 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party).
Current wording
The $0.2 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for vanoglipel during the three months ended March 31, 2026 as compared to the corresponding period in 2025. Specifically, the decrease in R&D expenses was primarily attributable to (i) $0.1 million in lower direct R&D expenses related to vanoglipel product development and (ii) $0.1 million in lower indirect employee compensation and benefits costs. Included in direct R&D costs were expenses totaling $0.7 million and $1.1 million for the three months ended March 31, 2026 and 2025, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party).
Previous wording
The $0.2 million decrease ingeneral and administrative expenses was primarily attributable to (i) $0.1 million in lower consulting expenditures, (ii) $0.1 million in lower employee compensation and benefits, and (iii) $0.1 million in lower other general and administrative expenses. These decreases were partially offset by $0.1 million in higher legal and professional fees.
Current wording
The approximately $0.4 million increase in G&A expenses was primarily attributable to (i) approximately $0.1 million in higher consulting expenditures, (ii) approximately $0.1 million in higher franchise tax expenses, and (iii) $0.1 million in higher legal and professional fees.
Previous wording
Our effective tax rate for thethree months ended September 30, 2025 and 2024 was zero percent as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.
Current wording
Our provision for income taxes and effective tax rate for thethree months ended March 31, 2026 and 2025 were zero as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.
Previous wording
For the three months ended September 30, 2025, we had a net loss of $3.4 million, or $0.14 per share of basic and diluted common stock, compared to a net loss of $5.7 million, or $0.55 per share of basic and diluted common stock for the three months ended September 30, 2024, primarily due to the factors described above.
Current wording
For the three months ended March 31, 2026, we had a net loss of $3.8 million, or $0.79 per share of basic and diluted common stock, compared to a net loss of $3.7 million, or $3.93 per share of basic and diluted common stock forthe corresponding period in 2025, primarily due to the factors described above.
Previous wording
As reflected in the condensed consolidated financial statements, we had $14.3 million in cash as of September 30, 2025. We believe that our existing cash will be sufficient to fund our operations into 2026. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $146.9 million as of September 30, 2025. We have incurred a net loss of $11.0 million and net cash used in operating activities of $10.8 million for the nine months ended September 30, 2025. Due in large part to the ongoing clinical trials, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern within one year from the issuance of these condensed consolidated financial statements.
Current wording
cash used in operating activities of $4.3 million for the three months ended March 31, 2026. Due in large part to the ongoing clinical trials, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern within one year from the issuance of these unaudited condensed consolidated financial statements.
Previous wording
We plan to continue to fund our operations from equity offerings, debt financing, exercise of existing warrants, or other sources, potentially including collaborations, out-licensing and other similar arrangements. However, there can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the Series B warrants issued in June 2024 will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.
Current wording
We plan to continue to fund our operations from equity offerings, debt financing, exercise of existing warrants, or other sources, potentially including collaborations, out-licensing and other similar arrangements. However, there can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the warrants issued in previously consummated offerings will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.
Previous wording
The determination as to whether we can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our condensed consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.
Current wording
The determination as to whether we can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our unaudited condensed consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.
Previous wording
Our primary use of cash is to fund our R&D activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity and convertible securities. As of September 30, 2025, we had cash totaling $14.3 million. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250 thousand per bank. Our cash balance includes liquid insured deposits, which are obligations
Current wording
Our primary use of cash is to fund our R&D activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity and convertible securities. As of March 31, 2026, we had cash and cash equivalents totaling $13.7 million. We maintain cash and cash equivalents at a financial institution that at times may exceed the Federal Deposit Insurance Corporation insured limits of $0.25 million per bank. To date, we have not experienced any losses related to these funds. Our cash equivalents consist principally of bank money market accounts and these securities are carried at cost, which approximates market value.
Previous wording
The principal use of cash in operating activities is to fund our current expenditures in support of our R&D activities. Financing activities currently represent the principal source of our cash flow.
Current wording
The principal use of cash in operating activities is to fund our current expenditures in support of our R&D activities. Financing activities currently represent the principal source of our cash flow. The following table reflects the major categories of cash flows (in thousands).
Previous wording
Net cash used in operating activities was $10.8 million for the nine months ended September 30, 2025 and consisted of net loss of $11.0 million, partially offset by non-cash charges totaling $0.2 million, which was primarily related to stock-based compensation and change in fair value of warrant liabilities. Net cash used in operating activities was $19.2 million for the nine months ended September 30, 2024 and consisted of net loss of $22.4 million, partially offset by net cash provided by changes in operating assets and liabilities of $2.9 million and non-cash charges totaling $0.3 million, which was primarily related to stock-based compensation and change in fair value of warrant liabilities.
Current wording
Net cash used in operating activities for the three months ended March 31, 2026 was approximately $4.3 million and primarily attributable to net loss of $3.8 million and net cash used in changes in operating assets and liabilities of $0.4 million. Net cash used in operating activities for the three months ended March 31, 2025 was $4.8 million and primarily attributable to net loss of $3.7 million and net cash used in changes in operating assets and liabilities of $1.2 million, partially offset by non-cash charges totaling $0.1 million, which was primarily related to stock-based compensation and change in fair value of warrant liabilities.
Previous wording
For additional details, see the condensed consolidated statements of cash flows in the condensed consolidated financial statements included elsewhere in this Report.
Current wording
For additional details, see the unaudited condensed consolidated statements of cash flows in the unaudited condensed consolidated financial statements included elsewhere in this Report.
Previous wording
Our condensed consolidated financial statements included in this Report have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
Current wording
Our unaudited condensed consolidated financial statements included in this Report have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”).
Previous wording
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in our condensed consolidated financial statements relate to accrued expenses and the fair value of
Current wording
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in our unaudited condensed consolidated financial statements relate to accrued expenses and the fair value of stock-based compensation and warrants. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.
Previous wording
Information regarding (i) adoption of new accounting standards and (ii) accounting standards issued but not yet adopted is included in “Note 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies” to the condensed consolidated financial statements included in this Report.
Current wording
Information regarding (i) adoption of new accounting standards and (ii) accounting standards issued but not yet adopted is included in “Note 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies” to the unaudited condensed consolidated financial statements included in this Report.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
As reflected in the unaudited condensed consolidated financial statements, we had $13.7 million in cash and cash equivalents as of March 31, 2026. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $152.7 million as of March 31, 2026. We have incurred a net loss of $3.8 million and net
Rearranged previous paragraphs (8)
Previous report — wording carried elsewhere
The following table summarizes our results of operations (in thousands, except share and per share amounts):
Previous report — wording carried elsewhere
Total operating expenses and loss from operations
Previous report — wording carried elsewhere
The following table summarizes our R&D expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report — wording carried elsewhere
The $10.9 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for Vanoglipel (DA-1241) and decreased activities related to the Phase 1 trial for DA-1726 as compared to the nine months ended September 30, 2024. Specifically, the decrease in R&D expenses was primarily attributable to (i) $7.6 million in lower direct R&D expenses related to Vanoglipel (DA-1241) product development, (ii) $3.3 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.1 million in lower direct other R&D costs. These decreases were partially offset by $0.1 million in higher indirect employee compensation and benefits cost and $0.1 million in higher indirect consulting expenses. Included in direct R&D costs were expenses totaling $2.6 million and $4.3 million for the nine months ended September 30, 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party).
Previous report — wording carried elsewhere
Our effective tax rate for thenine months ended September 30, 2025 and 2024 was zero percent as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.
Previous report — wording carried elsewhere
For the nine months ended September 30, 2025, we had a net loss of $11.0 million, or $0.63 per share of basic and diluted common stock, compared to a net loss of $22.4 million, or $3.24 per share of basic and diluted common stock for the nine months ended September 30, 2024, primarily due to the factors described above.
Previous report — wording carried elsewhere
The following table reflects the major categories of cash flows (in thousands).
Previous report — wording carried elsewhere
stock-based compensation and warrants. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.