VivoSim Labs, INC.
For the period ended Jun 30, 2025. Filed Aug 12, 2025.
View on SEC.govAbout this filing
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.
Jun 30, 2025 · Filed Aug 12, 2025
VIVS$0.14+0.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-12-31; filed 2025-02-19.
0000950170-25-022778
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0000950170-25-107284
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 76 previous paragraphs and 54 current paragraphs.
25 unchanged; 21 reworded; 8 added; 26 removed; 4 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 4 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 (8)
Current report
We are a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. We offer partners liver and intestinal toxicology insights using our new approach methodologies ("NAM") models. We anticipate accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA") announcement on April 10, 2025 to refine animal testing requirements in favor of these non-animal NAM methods. We will also offer bespoke services in the areas of investigational toxicology, mechanism of drug action elucidation, and other applications of these complex human tissue models.
Current report
In March 2025, we sold our FXR program for $10.0 million, with $9.0 million paid at closing and $1.0 million held in escrow for a period of 15 months, with future milestones of up to $50.0 million in the aggregate to be paid if the lead asset, FXR314, hits key development, regulatory and commercial milestones.
Current report
Effective April 24, 2025, we changed our corporate name to VivoSim Labs, Inc. by filing a Certificate of Amendment to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware. We changed our name to reflect our new business model, which includes the use of other longstanding assets of the Company, intestinal and liver tox models and expertise, and our IP portfolio for 3D bioprinting.
Current report
We continue to advance our Preclinical IBD Program, with the goal of having a product candidate ready for an Investigational New Drug (“IND Application”) with the FDA by December 2026.
Current report
We are now offering liver toxicology predictive screening and research services as well as working on predicting and studying the intestinal side effect profiles of drugs that are therapeutic candidates of pharmaceutical and biotech companies at all stages of drug development. Our services offer the potential benefit of reducing the significant risk and cost of bringing therapeutics to market through the regulatory process. It is estimated that less than 10% of drug candidates entering clinical trials are approved, with a portion of the failures due to unexpected liver toxicity or intestinal intolerability. In addition, even approved drugs are occasionally withdrawn after liver toxicity is determined to be caused by the drug in a phenomenon called drug induced liver injury. We presented findings at the May 2025 Digestive Disease Week scientific conference showing that our liver toxicology platform had a best-in-class predictive power. Our liver predictive power was shown to be 87.5% for a set of challenging liver toxicity cases – inclusive of classic cases of “liver tox misses” drugs with unforeseen liver toxicity found in clinical trials or drugs that were withdrawn from the market after liver toxicity issues emerged later. The platform identified correctly that 87.5% of the known liver-toxic drugs could be seen as liver toxic using NAMkind™ liver. This is known as the sensitivity of the platform, which at 87.5% is a world’s best. Importantly, the specificity was 100%, meaning that none of the compounds tested that are not liver toxic were incorrectly identified as having liver toxicity issues by the platform.
Current report
For the three months ended June 30, 2025 and 2024, cost of revenues was zero and less than $0.1 million, respectively. Cost of revenue is related to the Company's former Mosaic division which ended operations during the third quarter of fiscal 2025.
Current report
Going forward, we intend to offer partners liver and intestinal toxicology insights using NAM models. We plan to work with pharmaceutical and biotech companies at all stages of drug development to reduce the significant risk and cost of bringing therapeutics to market through the regulatory process. We will also offer bespoke services in the areas of investigational toxicology, mechanism of drug action elucidation, and other applications of these complex human tissue models.
Current report
In the event that the aggregate market value of our common stock held by non-affiliates (“public float”) is less than $75.0 million, the amount we can raise through primary public offerings of securities, including sales under the Sales Agreement, in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of our public float. As of the date of filing of this Quarterly Report, our public float was less than $75.0 million, and therefore we are limited to an aggregate of one-third of our public float in the amount we could raise through primary public offerings of securities in any twelve-month period using shelf registration statements, with such public float recalculated at the time of sale. If our public float meets or exceeds $75.0 million at any time, we will no longer be subject to the restrictions set forth in General Instruction I.B.6 of Form S-3.
Removed paragraphs (26)
Previous report
We are a clinical stage biotechnology company that is focused on developing FXR314 in inflammatory bowel disease (“IBD”), including ulcerative colitis (“UC”), based on demonstration of clinical promise in three-dimensional (“3D”) human tissues as well as strong preclinical data. FXR is a mediator of gastrointestinal and liver diseases. FXR agonism has been tested in a variety of preclinical models of IBD. FXR314 is the lead compound in our established FXR program containing two clinically tested compounds (including FXR314) and over 2,000 discovery or preclinical compounds. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in UC.
Previous report
Our current understanding of intestinal tissue models and IBD disease models leads us to believe that we can create models that provide greater insight into the biology of these diseases than are generally currently available. We are creating high fidelity disease models, leveraging our prior work including the work found in our peer-reviewed publication on bioprinted intestinal tissues (Madden et al. Bioprinted 3D Primary Human Intestinal Tissues Model Aspects of Native Physiology and ADME/Tox Functions. iScience. 2018 Apr 27;2:156-167. doi: 10.1016/j.isci.2018.03.015.) Our advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures.
Previous report
Using these disease models, we intend to identify and validate novel therapeutic targets. After finding therapeutic drug targets, we intend to focus on developing novel small molecule, antibody, or other therapeutic drug candidates to treat the disease, and advance these novel drug candidates towards an Investigational New Drug filing and potential future clinical trials.
Previous report
We expect to broaden our work into additional therapeutic areas over time and are currently exploring specific tissues for development. In our work to identify the areas of interest, we evaluate areas that might be better served with 3D disease models than currently available models as well as the potential commercial opportunity. In line with these plans, we are building upon both our external and in house scientific expertise, which will be essential to our drug development effort.
Previous report
Recent Developments
Previous report
Mosaic Cell Sciences Division
Previous report
In February 2024, we formed our Mosaic Cell Sciences division (“Mosaic”) to serve as a key source of certain of the primary human cells we utilize in our research and development efforts. Mosaic provided us with qualified human cells for use in its clinical research and development programs. In addition to supplying us with primary human cells, Mosaic offered human cells for sale to life science customers, both directly and through distribution partners, which we expected to offset costs and over time become a profit center that offset our overall R&D spending. However, Mosaic ended its operations during the third quarter of fiscal 2025 and any remaining saleable inventory was internally transferred to R&D at that time.
Previous report
Nasdaq Minimum Bid Notice
Previous report
On July 18, 2024, we received a written notice (the “Notice”) from the Listing Qualifications Staff (the "Staff") of the Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the closing bid price of our common stock for the last 30 consecutive business days, we no longer meet the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (“Rule 5550(a)(2)”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided an initial period of 180 calendar days, or until January 14, 2025, to regain compliance.
Previous report
On January 16, 2025, the Staff provided a notice to us (the “Nasdaq Notice”) that we had not regained compliance with Rule 5550(a)(2) and were not eligible for a second 180 calendar day compliance period as we did not comply with the requirements for initial listing on the Nasdaq Capital Market. The Nasdaq Notice further indicated that, unless we timely requested a hearing before a Hearings Panel (the “Panel”), the Company’s common stock would be subject to delisting. We timely requested a hearing, which automatically stayed any delisting or suspension action pending the hearing and the expiration of any extension period granted by the Panel following the hearing. In that regard, pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant a further extension not to exceed July 15, 2025. Following the hearing request, our common stock continues to be listed on the Nasdaq Capital Market under the symbol “ONVO.”
Previous report
We intend to present our plan to the Panel at the hearing on February 27, 2025, which compliance plan is expected to include conducting a reverse stock split if necessary to regain compliance with Rule 5550(a)(2). However, there can be no assurance that the Panel will grant a further extension or that we will ultimately regain compliance with all applicable requirements for continued listing on the Nasdaq Capital Market. We intend to monitor the closing bid price of our common stock and consider our available options if our common stock does not trade at a level likely to result in us regaining compliance with Rule 5550(a)(2) by January 14, 2025, including effecting a reverse stock split, which would be subject to the prior approval of our stockholders.
Previous report
At our 2024 annual meeting of our stockholders held on November 20, 2024, our stockholders approved an amendment to our Certificate of Incorporation, as amended, to effect, in the sole discretion of our Board of Directors (our “Board”) at any time on or before November 20, 2025, a reverse split of our common stock at a ratio to be determined by the Board within a range of 1-to-5 to 1-to-20 (or any number in between).
Previous report
There can be no assurance that we will be able to regain compliance with Nasdaq’s minimum bid price requirement or that we will maintain our compliance with the other listing requirements necessary for us to maintain the listing of our common stock on the Nasdaq Capital Market.
Previous report
For the three months ended December 31, 2024 and 2023, total cost of revenues was less than $0.1 million and zero, respectively, and is related to the sale of finished goods inventory by Mosaic.
Previous report
For the three months ended December 31, 2024, total research and development expenses were $1.8 million, an increase of $0.4 million, or approximately 24%, from the prior year period. Our operations for the three months ended December 31, 2024 as compared to the three months ended December 31, 2023 resulted in a $0.4 million increase in material related costs. Of the $0.4 million increase in material costs, $0.6 million was due to the write-off and transfer of Mosaic's inventory to R&D, which was offset by a $0.2 decrease in lab supplies costs. Our fiscal 2025 operations also resulted in a $0.1 million increase in consulting expenses, which was offset by a $0.1 million decrease in personnel related costs due to a lower headcount compared to the prior year period. Going forward, we intend to continue to advance the clinical drug development of FXR314 and our 3D models for target discovery and drug development.
Previous report
Comparison of the nine months ended December 31, 2024 and 2023
Previous report
Revenues
Previous report
For each of the nine months ended December 31, 2024 and 2023, total revenue was $0.1 million. Royalty revenue is related to sales-based royalties from licensing intellectual property. The decrease in royalty revenue year over year relates to a decrease in sales of royalty bearing products by the licensee in fiscal 2025. Going forward, we expect annual sales of royalty bearing products by the licensee to remain consistent with the sales in fiscal 2025. Product revenue is related to the sale of human cells developed by Mosaic. As Mosaic's commercial operations ended during the third quarter of fiscal 2025, there will be no product revenue going forward.
Previous report
Cost of Revenues
Previous report
For the nine months ended December 31, 2024 and 2023, total cost of revenues was less than $0.1 million and zero, respectively, and is related to the sale of finished goods inventory by Mosaic.
Previous report
Research and Development Expenses
Previous report
Selling, General and Administrative Expenses
Previous report
For the nine months ended December 31, 2024, total selling, general and administrative expenses were approximately $5.4 million, a decrease of $2.3 million, or approximately 29%, compared to the prior year period. There was a reduction in force event in fiscal 2024 and one of the affected employees was our former General Counsel who was an executive officer and a highly compensated employee. The reduction in force event resulted in significant severance expenses in fiscal 2024 and lower personnel costs in fiscal 2025. Our operations for the nine months ended December 31, 2024 as compared to the nine months ended December 31, 2023 resulted in a $1.2 million decrease in personnel related expenses which includes stock-based compensation, a $0.2 million decrease in consulting expenses, and a $0.9 million decrease in legal and other corporate costs, which includes a $0.4 million decrease in legal expenses, a $0.2 million decrease in audit and tax expense, and a $0.3 million decrease in investor relations expenses.
Previous report
Going forward, we intend to focus on clinical drug development of FXR314, the lead compound in our established FXR program. Our current clinical focus is in advancing FXR314 in IBD, including UC and CD. We plan to start a Phase 2a clinical trial in UC in the calendar year 2025. We released Phase 2 data for FXR314 for the treatment of metabolic function-associated steatohepatitis (“MASH”) in April 2024 that is supportive of ongoing development, and we believe FXR314 has a commercial opportunity in MASH, most likely in combination therapy. Additionally, we plan to leverage our proprietary technology platform to develop therapeutic drugs, focusing on IBD, including CD and UC, with a goal of broadening our work into additional therapeutic areas over time.
Previous report
On May 8, 2024, we priced a best efforts public offering (the “Offering”) of: (i) 1,562,500 shares of our common stock and accompanying common warrants (“Common Warrants”) to purchase up to 1,562,500 shares of common stock at a combined public offering price of $0.80 per share and accompanying Common Warrant to purchase one share of common stock and (ii) pre-funded warrants (“Pre-Funded Warrants”) to purchase 5,000,000 shares of common stock and accompanying Common Warrants to purchase up to 5,000,000 shares of common stock at a combined public offering price of $0.799 per Pre-Funded Warrant and accompanying Common Warrant to purchase one share of common stock. The closing of the Offering occurred on May 13, 2024. We received net proceeds of approximately $4.5 million from the Offering, after deducting the offering expenses payable by us including the placement agent fees.
Previous report
On October 25, 2024, we filed a registration statement on Form S-1 for a potential best efforts offering of shares of common stock and warrants to purchase shares of common stock. However, the specific number of shares of common stock and warrants to purchase shares of common stock to be offered, the price range for the offering and the closing date of the offering have yet to be determined, and there can be no assurances that the offering will be consummated. To the extent an offering under such registration statement is consummated, we expect to use the net proceeds for working capital and general corporate purposes, which could include capital expenditures, research and development expenditures, regulatory affairs expenditures, clinical trial expenditures, legal expenditures, including intellectual property protection and maintenance expenditures, acquisitions of new technologies and investments, business combinations and the repurchase of capital stock. Such offering, if consummated at all, will depend on a variety of factors, including, among other things, the SEC declaring the registration statement effective, market conditions and the trading price of our common stock, and such offering would be dilutive to our existing stockholders. See the risk factor under the heading “We may require substantial additional funding. Raising additional capital would cause dilution to our existing stockholders and may restrict our operations or require us to relinquish rights to our technologies or to a product candidate.” in the section titled “Risk Factors” under Part II, Item 1A in this Quarterly Report on Form 10-Q for additional considerations related to this potential offering.
Reworded paragraphs (21)
Previous wording
The following management’s discussion and analysis of financial condition and results of operations should be read in conjunction with our historical consolidated financial statements and the related notes thereto included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2024. This management’s discussion and analysis contains forward-looking statements, such as statements related to our plans, objectives, expectations and intentions. Any statements that are not statements of historical fact are forward-looking statements. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like, and/or future tense or conditional constructions such as “will,” “may,” “could,” “should,” or similar expressions, identify certain of these forward-looking statements. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to risks and uncertainties, including those described in this Quarterly Report on Form 10-Q, as well as the risk factors disclosed in our Annual Report on the Form 10-K for the fiscal year ended March 31, 2024, filed with the Securities and Exchange Commission on May 31, 2024, and discussed in the section titled “Risk Factors” under Part II, Item 1A in this Quarterly Report on Form 10-Q, that could cause our actual results or events to differ materially from those expressed or implied by such forward-looking statements. Unless the context otherwise requires, the terms “Organovo,” the “Company”, “we”, “us” and “our” in this Quarterly Report on Form 10-Q refer to Organovo Holdings, Inc. and its wholly owned subsidiary, Organovo, Inc.
Current wording
The following management’s discussion and analysis of financial condition and results of operations should be read in conjunction with our historical consolidated financial statements and the related notes thereto included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2025. This management’s discussion and analysis contains forward-looking statements, such as statements related to our plans, objectives, expectations and intentions. Any statements that are not statements of historical fact are forward-looking statements. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like, and/or future tense or conditional constructions such as “will,” “may,” “could,” “should,” or similar expressions, identify certain of these forward-looking statements. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to risks and uncertainties, including those described in this Quarterly Report on Form 10-Q, as well as the risk factors disclosed in our Annual Report on the Form 10-K for the fiscal year ended March 31, 2025, filed with the Securities and Exchange Commission on June 5, 2025, and discussed in the section titled “Risk Factors” under Part II, Item 1A in this Quarterly Report on Form 10-Q, that could cause our actual results or events to differ materially from those expressed or implied by such forward-looking statements. Unless the context otherwise requires, the terms "VivoSim", the “Company”, “we”, “us” and “our” in this Quarterly Report on Form 10-Q refer to VivoSim Labs, Inc. and its wholly owned subsidiaries, Organovo, Inc. and VivoSim Inc.
Previous wording
Our current clinical focus is in advancing FXR314 in IBD, including UC and Crohn’s disease (“CD”). We plan to start a Phase 2a clinical trial in UC in the calendar year 2025. We released Phase 2 data for FXR314 for the treatment of metabolic function-associated steatohepatitis ("MASH") in April 2024 that are supportive of ongoing development, and we believe FXR314 has a commercial opportunity in MASH, most likely in combination therapy. We are exploring the potential for combination therapies using FXR314 and currently approved mechanisms in preclinical animal studies and our IBD disease models.
Current wording
We also advance product candidates to treat inflammatory bowel disease ("IBD") discovered and developed using our complex human tissue intestinal models. Prior to March 2025, we were a clinical stage biotechnology company that was focused on developing FXR314 in IBD, including ulcerative colitis ("UC"), based on demonstration of clinical promise in 3D human tissues as well as strong preclinical data. Our clinical focus was in advancing FXR314 in IBD, including UC and Crohn’s disease ("CD"). We planned to start a Phase 2a clinical trial in UC in the calendar year 2025 and were also exploring the potential for combination therapies using FXR314 and approved mechanisms in preclinical animal studies and our IBD disease models. We have also advanced a second program since 2023, a novel drug that will be a new chemical entity (“NCE”) to an undisclosed target discovered in our intestinal models to have activity for UC and CD. This drug program (the “Preclinical IBD Program”) has now left the in-silico phase in recent quarters, and has moved to medicinal chemistry stage, the real-world synthesis of novel candidate compounds.
Previous wording
Our second focus is building high fidelity, 3D tissues that recapitulate key aspects of human disease. We use our proprietary technology to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease. We believe these attributes can enable critical complex, multicellular disease models that can be used to develop clinically effective drugs across multiple therapeutic areas.
Current wording
We use our proprietary technologies to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. We believe these attributes can enable critical complex, multicellular disease models that can be used to study and develop clinically effective drugs across multiple therapeutic areas.
Previous wording
As with the clinical development program, we are initially focusing on the intestine and have ongoing 3D tissue development efforts in human tissue models of UC and CD. We use these models to identify new molecular targets responsible for driving the disease and to explore the mechanism of action of known drugs including FXR314 and related molecules. We intend to initiate drug discovery programs around these new validated targets to identify drug candidates for partnering and/or internal clinical development.
Current wording
We have also used these human disease models to identify new molecular targets responsible for driving IBD and to explore the mechanism of action of known drugs including JAK inhibitors and related molecules. A portion of our internal research continues to focus on early stage internal drug discovery programs, validating targets, and testing potentially licensable or transactable external drug compounds to identify drug candidates for partnering and/or internal clinical development. This includes the Preclinical IND Program, which has reached a more mature stage than other efforts in this area.
Previous wording
For the three months ended December 31, 2024 and 2023, total revenue was less than $0.1 million. Royalty revenue is related to sales-based royalties from licensing intellectual property. The increase in the third fiscal quarter royalty revenue year over year relates to overestimating royalty revenue in the second quarter of fiscal 2023, resulting in an adjustment to actual sales. Going forward, we expect quarterly sales of royalty bearing products by the licensee to remain consistent with the sales in the third quarter of fiscal 2025. Product revenue is related to the sale of human cells developed by Mosaic. As Mosaic's commercial operations ended during the third quarter of fiscal 2025, there will be no product revenue going forward.
Current wording
For the three months ended June 30, 2025 and 2024, total revenue was less than $0.1 million. Royalty revenue is related to sales-based royalties from licensing intellectual property. Product revenue was zero and less than $0.1 million for the three months ended June 30, 2025 and 2024, respectively. Product revenue is related to the Company's former Mosaic division which ended operations during the third quarter of fiscal 2025.
Previous wording
For the nine months ended December 31, 2024, total research and development expenses were $4.2 million, a decrease of $0.3 million, or approximately 6% from the prior year period. Our average full-time research and development staff decreased from an average of eighteen full-time employees for the nine months ended December 31, 2023 to an average of fourteen full-time employees for the nine months ended December 31, 2024. Our operations for the nine months ended December 31, 2024 as compared to the nine months ended December 31, 2023 resulted in a $0.1 million decrease in material related costs. Of the $0.1 million decrease in material costs, a $0.8 million increase was due to the write-off and transfer of Mosaic's inventory to R&D, which was offset by a $0.9 decrease in lab supplies costs. Our fiscal 2025 operations also resulted in a $0.2 million decrease in personnel related costs which included stock-based compensation, , and a $0.2 million decrease in facilities costs, offset by a $0.2 million increase in consulting expenses. Going forward, we intend to continue to advance the clinical drug development of FXR314 and our 3D models for target discovery and drug development.
Current wording
For the three months ended June 30, 2025, total research and development expenses were $1.0 million, a decrease of $0.4 million, or approximately 29%, from the prior year period. Our average full-time research and development staff decreased from an average of fifteen full-time employees for the three months ended June 30, 2024 to an average of ten full-time employees for the three months ended June 30, 2025. Our operations for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 resulted in a $0.1 million decrease in personnel related costs and a $0.3 million decrease in materials related costs.
Previous wording
For the three months ended December 31, 2024, total selling, general and administrative expenses were approximately $1.7 million, a decrease of $0.5 million, or approximately 24%, compared to the prior year period. Our average full-time general and administrative staff of four employees remained the same for each of the three months ended December 31, 2024 and 2023. Our operations for the three months ended December 31, 2024 as compared to the three months ended December 31, 2023 resulted in a $0.1 million decrease in personnel related expenses which includes stock-based compensation, and a $0.4 million decrease in legal and other corporate costs, which was mostly related to a decrease in investor relations costs.
Current wording
For the three months ended June 30, 2025 and 2024, total selling, general and administrative expenses were approximately $2.0 million, a decrease of approximately 3%, from the prior year period. Our average full-time selling, general and administrative staff decreased from an average of five full-time employees for the three months ended June 30, 2024 to an average of three full-time employees for the three months ended June 30, 2025. Our operations for the three months ended June 30, 2025 as compared to the three months ended June 20, 2024 resulted in a $0.2 million decrease in personnel related expenses which includes stock-based compensation, which was offset by a $0.2 million increase in consulting costs.
Previous wording
Other income was less than $0.1 million and $0.1 million for the three months ended December 31, 2024 and 2023, respectively, which was related to interest income.
Current wording
Other income was $0.1 million and less than $0.1 million for the three months ended June 30, 2025 and 2024, respectively, which was related to interest income.
Previous wording
The accompanying consolidated financial statements have been prepared on the basis that we are a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. At December 31, 2024, we had cash and cash equivalents of approximately $1.2 million, restricted cash of approximately $0.1 million and an accumulated deficit of approximately $349.0 million. The restricted cash was pledged as collateral for a letter of credit that we are required to maintain as a security deposit under the terms of the lease agreement for our facilities. We had negative cash flow from operations of approximately $7.4 million during the nine months ended December 31, 2024. At March 31, 2024, we had cash and cash equivalents of approximately $2.9 million, restricted cash of approximately $0.1 million and an accumulated deficit of approximately $339.7 million.
Current wording
The accompanying Condensed Consolidated Financial Statements have been prepared on the basis that we are a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. As of June 30, 2025, we had cash and cash equivalents of approximately $9.1 million, restricted cash of approximately $0.1 million and an accumulated deficit of $345.0 million. The restricted cash was pledged as collateral for a letter of credit that the Company is required to maintain as a security deposit under the terms of the lease agreement for its facilities. We had negative cash flow from operations of approximately $3.9 million during the three months ended June 30, 2025. At March 31, 2025, we had cash and cash equivalents of approximately $11.3 million, restricted cash of approximately $0.1 million and an accumulated deficit of approximately $342.2 million.
Previous wording
At December 31, 2024, we had total current assets of approximately $2.1 million and current liabilities of approximately $2.9 million, resulting in negative working capital of $0.8 million. At March 31, 2024, we had total current assets of approximately $3.9 million and current liabilities of approximately $1.9 million, resulting in working capital of $2.0 million.
Current wording
At June 30, 2025, we had total current assets of approximately $9.7 million and current liabilities of approximately $2.1 million, resulting in working capital of $7.6 million. At March 31, 2025, we had total current assets of approximately $12.1 million and current liabilities of approximately $3.7 million, resulting in working capital of $8.4 million.
Previous wording
The following table summarizes the primary sources and uses of cash for the nine months ended December 31, 2024 and 2023 (in thousands):
Current wording
The following table summarizes the primary sources and uses of cash for the three months ended June 30, 2025 and 2024 (in thousands):
Previous wording
Net cash used in operating activities for the nine months ended December 31, 2024, was approximately $7.4 million as compared to $12.0 million used in operating activities for the nine months ended December 31, 2023. This $4.6 million decrease in operating cash usage can be attributed primarily to a strategic effort to decrease selling, general, and administrative expenses in fiscal 2025, as well as the $2.0 million cash payment in fiscal 2024 for acquired in-process research and development assets.
Current wording
Net cash used in operating activities for the three months ended June 30, 2025, was approximately $3.9 million as compared to $3.0 million used in operating activities for the three months ended June 30, 2024. This $0.9 million increase in operating cash usage can be attributed primarily to the timing of R&D projects and related payables.
Previous wording
Net cash provided by investing activities was less than $0.1 million for the nine months ended December 31, 2024, which consisted of the purchases of investments of $2.5 million and the maturities of investments of $2.5 million. Net cash provided by investing activities was $0.8 million for the nine months ended December 31, 2023, which consisted of the purchases of investments of $9.9 million, the maturities of investments of $10.0 million, the liquidation of equity securities of $0.7 million, and fixed asset purchases of less than $0.1 million.
Current wording
There were no investing activities for the three months ended June 30, 2025. Net cash provided by investing activities was less than $0.1 million for the three months ended June 30, 2024, which consisted of interest income.
Previous wording
Net cash provided by financing activities was $5.7 million and $1.2 million for the nine months ended December 31, 2024 and 2023, respectively. Financing activities consisted of the sale of common stock through at-the-market (“ATM”) share offerings and a public offering of common stock and accompanying common warrants and pre-funded warrants. Refer to “Operations funding requirements” below for further information regarding financing activities.
Current wording
Net cash provided by financing activities was $1.7 million and $6.2 million for the three months ended June 30, 2025 and 2024, respectively. Financing activities consisted of the sale of common stock through at-the-market (“ATM”) share offerings for proceeds of approximately $1.8 million as well as the repayment of the insurance premium financing liability of $0.1 million for the three months ended June 30, 2025. Financing activities consisted of the sale of common stock through at-the-market (“ATM”) share offerings and a public offering of common stock and accompanying common warrants and pre-funded warrants for the three months ended June 30, 2024.
Previous wording
Through December 31, 2024, we have financed our operations primarily through the sale of common stock through public and ATM offerings, the private placement of equity securities, from revenue derived from the licensing of intellectual property, products and research-based services, grants, and collaborative research agreements, and from the sale of convertible notes.
Current wording
Through June 30, 2025, we have financed our operations primarily through the sale of common stock through public offerings, including our ATM program, from revenue derived from the licensing of intellectual property, products and research-based services, grants, and collaborative research agreements, the sale of our FXR program, and from the sale of convertible notes.
Previous wording
Our ongoing cash requirements include research and development expenses, compensation for personnel, consulting fees, legal and accounting support, insurance premiums, facilities, maintenance of our intellectual property portfolio, license and collaboration agreements, listing on the Nasdaq Capital Market, and other miscellaneous fees to support our operations. We expect our total operating expense for the fiscal year ending March 31, 2025 to be between $12.0 million and $14.0 million. Based on our current operating plan and available cash resources, we will need substantial additional funding to support future operating activities. We have concluded that the prevailing conditions and ongoing liquidity risks faced by us raise substantial doubt about our ability to continue as a going concern for at least one year following the date these financial statements are issued. The accompanying consolidated financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.
Current wording
Our ongoing cash requirements include research and development expenses, compensation for personnel, consulting fees, legal and accounting support, insurance premiums, facilities, maintenance of our intellectual property portfolio, license and collaboration agreements, listing on the Nasdaq Capital Market, and other miscellaneous fees to support our operations. We expect our total operating expense for the fiscal year ending March 31, 2026 to be between $10 million and $11 million. Based on our current operating plan and available cash resources, we will need substantial additional funding to support future operating activities. We have concluded that the prevailing conditions and ongoing liquidity risks faced by us raise substantial doubt about our ability to continue as a going concern for at least one year following the date these financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.
Previous wording
We previously had an effective shelf registration statement on Form S-3 (File No. 333-252224), declared effective by the SEC on January 29, 2021 (the “2021 Shelf”), which registered $150.0 million of common stock, preferred stock, warrants and units, or any combination of the foregoing, that expired on January 29, 2024. On January 26, 2024, we filed a new shelf registration statement on Form S-3 (File No. 333-276722) to register $150.0 million of common stock, preferred stock, debt securities, warrants and units, or any combination of the foregoing (the “2024 Shelf”). The 2024 Shelf was declared effective by the SEC on February 8, 2024 and replaced the 2021 Shelf at that time.
Current wording
On January 26, 2024, we filed a new shelf registration statement on Form S-3 (File No. 333-276722) to register $150.0 million of common stock, preferred stock, debt securities, warrants and units, or any combination of the foregoing (the “2024 Shelf”). The 2024 Shelf was declared effective by the SEC on February 8, 2024.
Previous wording
On March 16, 2018, we entered into a Sales Agreement (“Sales Agreement”) with H.C. Wainwright & Co., LLC and Jones Trading Institutional Services LLC (each an “Agent” and together, the “Agents”). On January 29, 2021, we filed a prospectus supplement to the 2021 Shelf (the “2021 ATM Prospectus Supplement”), pursuant to which we could offer and sell, from time to time through the Agents, shares of our common stock in ATM sales transactions having an aggregate offering price of up to $50.0 million. Any shares offered and sold were issued pursuant to our 2021 Shelf until it was replaced by the 2024 Shelf.
Current wording
On March 16, 2018, we entered into a Sales Agreement with Jones Trading Institutional Services LLC (the “Agent”).
Previous wording
On January 26, 2024, we filed a prospectus to the 2024 Shelf (the “2024 ATM Prospectus”), pursuant to which we may offer and sell, from time to time, through the Agents, shares of its common stock in ATM sales transactions having an aggregate offering price of up to $2,605,728. Any shares offered and sold in these ATM transactions are issued pursuant to the 2024 Shelf.
Current wording
On January 26, 2024, we filed a prospectus to the 2024 Shelf (the “2024 ATM Prospectus”), pursuant to which we may offer and sell, from time to time, through the Agents, shares of its common stock in ATM sales transactions having an aggregate offering price of up to $2,605,728. We filed amendments to the 2024 ATM Prospectus on February 26, 2025 and again on April 11, 2025, pursuant to which we may offer and sell, from time to time through the Agent, shares of our common stock in ATM sales transactions having an additional aggregate offering price of up to $5,311,508 and $4,766,105, respectively. Any shares offered and sold in these ATM transactions are issued pursuant to the 2024 Shelf.
Previous wording
During the three and nine months ended December 31, 2024, we issued 52,628 and 1,405,228 shares of common stock in ATM offerings, respectively, for net proceeds of approximately less than $0.1 million and $1.7 million, respectively, all of which were sold pursuant to the 2024 Shelf. As of December 31, 2024, we have sold an aggregate of 1,441,630 shares of common stock in ATM offerings under the 2024 ATM Prospectus, with gross proceeds of approximately $1.8 million and net proceeds of approximately $1.8 million. As of December 31, 2024, there was approximately $100.0 million available for future offerings under the 2024 Shelf, and approximately $0.8 million available for future offerings through our ATM program under the 2024 ATM Prospectus.
Current wording
During the three months ended June 30, 2025, we issued 701,729 shares of common stock for net proceeds of approximately $1.8 million, all of which were sold pursuant to the 2024 Shelf. As of June 30, 2025, we have sold an aggregate of 1,198,134 shares of common stock in ATM offerings under the 2024 ATM Prospectus, with gross proceeds of approximately $6.9 million and net proceeds of approximately $6.7 million. As of June 30, 2025, there was approximately $140.1 million available for future offerings under the 2024 Shelf, and approximately $3.1 million available for future offerings through our ATM program under the 2024 ATM Prospectus, as amended on April 11, 2025.
Previous wording
Having insufficient funds may require us to relinquish rights to our technology on less favorable terms than we would otherwise choose. Failure to obtain adequate financing could eventually adversely affect our ability to operate as a going concern. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. We cannot be sure that additional financing will be available if and when needed, or that, if available, we can obtain financing on terms favorable to our stockholders. Any failure to obtain financing when required will have a material adverse effect on our business, operating results, financial condition and ability to continue as a going concern.
Current wording
Having insufficient funds may require us to relinquish rights to our technology on less favorable terms than we would otherwise choose. Failure to obtain adequate financing could adversely affect our operations. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. We cannot be sure that additional financing will be available if and when needed, or that, if available, we can obtain financing on terms favorable to our stockholders. Any failure to obtain financing when required will have a material adverse effect on our business, operating results, and financial condition.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the nine months ended December 31, 2024 and 2023 (in thousands, except %):
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses for the nine months ended December 31, 2024 and 2023 (in thousands, except %):
Previous report — wording carried elsewhere
The following table summarizes our selling, general and administrative expenses for the nine months ended December 31, 2024 and 2023 (in thousands, except %):
Previous report — wording carried elsewhere
Other income was $0.1 million and $0.4 million for the nine months ended December 31, 2024 and 2023, respectively, which was related to interest income.