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What changed in Lite Strategy, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Lite Strategy, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+270 added−298 removedSource: 10-K (2025-06-30) vs 10-K (2024-06-30)

Top changes in Lite Strategy, Inc.'s 2025 10-K

270 paragraphs added · 298 removed · 172 edited across 4 sections

Item 1. Business

Business — how the company describes what it does

79 edited+29 added−50 removed139 unchanged
Biggest changeThe process required by the FDA before drugs may be marketed in the U.S. generally involves the following: • nonclinical laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDA’s Good Laboratory Practices (GLP) regulations to assess pharmacological activity and toxicity potential; • submission and approval of an investigational new drug (IND) application, including results of nonclinical tests, manufacturing information, and protocols for clinical tests, which must become effective before clinical trials may begin in the U.S.; • obtaining approval of institutional review boards (IRBs) to administer the products to human subjects in clinical trials; • adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use; • development of manufacturing processes which conform to the FDA’s current Good Manufacturing Practices (cGMP), as confirmed by FDA inspection or remote regulatory assessments; • submission of results for nonclinical, toxicology, and clinical studies, and chemistry, manufacture and control information on the product to the FDA in a non-disclosure agreement (NDA); and • FDA review and approval of an NDA, prior to any commercial sale or shipment of a product.
Biggest changeThis last year, the FDA announced a plan to phase out animal testing for certain kinds of drugs, potentially replacing animal testing with new approach methodologies; • submission and approval of an investigational new drug (IND) application, including results of nonclinical tests, manufacturing information and protocols for clinical tests, which must become effective before clinical trials may begin in the U.S.; • obtaining approval of institutional review boards (IRBs) to administer the products to human subjects in clinical trials; • adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use; • development of manufacturing processes which conform to the FDA’s current Good Manufacturing Practices (cGMP), as confirmed by FDA inspection or remote regulatory assessments; • submission of results for nonclinical, toxicology and clinical studies and chemistry, manufacture and control information on the product to the FDA in a non-disclosure agreement (NDA); and • FDA review and approval of an NDA, prior to any commercial sale or shipment of a product. 11 Table of Contents The testing and approval process requires substantial time, effort and financial resources and we cannot be certain that we will be able to ultimately submit marketing applications for any of our product candidates, that our development efforts will prove to be successful, that our studies will have positive outcomes, or that any approval will be granted on a timely basis, if at all.
Moreover, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
Moreover, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government healthcare program reimbursement methodologies for drug products.
Pharmaceutical Coverage, Pricing and Reimbursement & Healthcare Reform In addition, future sales of our products, if approved for marketing, will depend, in part, on the availability and extent of coverage and reimbursement by third-party payors, such as government health programs, including Medicare and Medicaid, commercial insurance, and managed healthcare organizations.
Pharmaceutical Coverage, Pricing and Reimbursement & Healthcare Reform In addition, future sales of our products, if approved for marketing, will depend, in part, on the availability and extent of coverage and reimbursement by third-party payors, such as government healthcare programs, including Medicare and Medicaid, commercial insurance and managed healthcare organizations.
The research suggests that voruciclib is potentially an attractive therapeutic agent for treating cancers in combination with venetoclax or other BCL-2 inhibitors, to address potential resistance associated with MCL1, and is supportive of our ongoing clinical evaluation of voruciclib in AML.
The research suggests that voruciclib is potentially an attractive therapeutic agent for treating cancers in combination with venetoclax or other BCL-2 inhibitors, to address potential resistance associated with MCL1 and is supportive of our clinical evaluation of voruciclib in AML.
After making the joint decision to terminate development outside of Japan, we and KKC began closing all ongoing zandelisib clinical studies outside of Japan, including the Phase 3 COASTAL trial, the Phase 2 TIDAL trial, and the Phase 2 CORAL trial. Subsequently, in May 2023, KKC decided to discontinue development of zandelisib in Japan.
After making the joint decision to terminate development outside of Japan, we and KKC began closing all zandelisib clinical studies outside of Japan, including the Phase 3 COASTAL trial, the Phase 2 TIDAL trial and the Phase 2 CORAL trial. Subsequently, in May 2023, KKC decided to discontinue development of zandelisib in Japan.
The research presented suggests that voruciclib could be an attractive therapeutic agent for both hematological cancers, as well as solid tumors, dependent on the activity of MYC. Clinical Programs In a recent Phase 1 clinical trial, we evaluated the dose and schedule of voruciclib in combination with venetoclax, a BCL-2 inhibitor, in patients with R/R AML.
The research presented suggests that voruciclib could be an attractive therapeutic agent for both hematological cancers, as well as solid tumors, dependent on the activity of MYC. Terminated Clinical Programs In a Phase 1 clinical trial, we evaluated the dose and schedule of voruciclib in combination with venetoclax, a BCL-2 inhibitor, in patients with R/R AML.
With the exit of the UK from the EU, the UK did not implement the CTR and the UK provisions implementing the previous law as set out in the previous Clinical Trial Directive (which fundamentally covered the same area as the CTR but was far less detailed and predated the CTIS) will continue to apply until amended by the UK.
With the exit of the UK from the EU in January 2021, the UK did not implement the CTR and the UK provisions implementing the previous law as set out in the previous Clinical Trial Directive (which fundamentally covered the same area as the CTR but was far less detailed and predated the CTIS) will continue to apply until amended by the UK.
Thereafter a new international recognition framework will be in place, which will have regard to decisions already made by the EMA. This means applications with a positive opinion from the Committee for Medicaid Products for Human Use (CHMP) received after December 31, 2023 will be eligible.
Thereafter a new international recognition framework will be in place, which will have regard to decisions already made by the EMA. This means applications with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) received after December 31, 2023 will be eligible.
For instance, it will not delay the submission or approval of a full NDA; though, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and efficacy.
For instance, it will not delay the submission or approval of a full NDA; though, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the pre-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and efficacy.
This may shorten the period of patent protection afforded to therapeutic uses of zandelisib, voruciclib or ME-344 as patent applications in the biopharmaceutical sector often take considerable time to issue. However, in some countries the patent term may be extended.
This may shorten the period of patent protection afforded to therapeutic uses of zandelisib or voruciclib as patent applications in the biopharmaceutical sector often take considerable time to issue. However, in some countries the patent term may be extended.
Almost all patients (39/41) were treated with venetoclax in an earlier line of therapy. 7 Table of Contents Additionally, 30 (73%) patients were noted as being in an adverse 2017 ELN Risk Category due to adverse cytogenetics and molecular mutations. Of the 32 patients administered voruciclib at doses ≥ 100 mg in combination with venetoclax 10 (31%) achieved disease control.
Almost all patients (39/41) were treated with venetoclax in an earlier line of therapy. Additionally, 30 (73%) patients were noted as being in an adverse 2017 ELN Risk Category due to adverse cytogenetics and molecular mutations. Of the 32 patients administered voruciclib at doses ≥ 100 mg in combination with venetoclax 10 (31%) achieved disease control.
The data monitoring committee may advise the sponsor to halt the clinical trial, modify the clinical trial, or continue the clinical trial depending on safety results and the trial’s likelihood of success. We cannot be certain that we will successfully complete clinical testing of our products within any specific time period, if at all.
The data monitoring committee may advise the sponsor to halt the clinical trial, modify the clinical trial, or continue the clinical trial depending on safety results and the trial’s likelihood of success. 12 Table of Contents We cannot be certain that we will successfully complete clinical testing of our products within any specific time period, if at all.
Available Information Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed with or furnished to the SEC pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge through our website at www.meipharma.com as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC.
Available Information Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed with or furnished to the SEC pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge through our website at https://litestrategy.com as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC.
Subsequently, and consistent with the reported pre-clinical studies, data from an ongoing Phase 1 study evaluating voruciclib as a single agent and in combination with venetoclax in patients with relapsed or refractory (R/R) AML have also demonstrated the anticipated decreases in Mcl-1 protein.
Subsequently and consistent with the reported pre-clinical studies, data from a prior Phase 1 study evaluating voruciclib as a single agent and in combination with venetoclax in patients with relapsed or refractory (R/R) AML have also demonstrated the anticipated decreases in Mcl-1 protein.
Among other things, the IRA 18 Table of Contents has multiple provisions that may impact the prices of drug products, such as negotiated ceiling prices and penalties for price increases that exceed the rate of inflation, that are both sold into the Medicare program and throughout the United States.
Among other things, the IRA has multiple provisions that may impact the prices of drug products, such as negotiated ceiling prices and penalties for price increases that exceed the rate of inflation, that are both sold into the Medicare program and throughout the United States.
Initial results from correlative studies assessing myeloid leukemia cell differentiation protein (Mcl-1) and RNA Pol II phosphorylation on Ser2 (RNA Pol II p-S2) demonstrated reduction in expression consistent with the anticipated on-target pharmacodynamic effect of voruciclib on Mcl-1 and RNA Pol II p-S2.
Initial results from correlative studies assessing myeloid leukemia cell differentiation protein (Mcl-1) and RNA Pol II phosphorylation on 7 Table of Contents Ser2 (RNA Pol II p-S2) demonstrated reduction in expression consistent with the anticipated on-target pharmacodynamic effect of voruciclib on Mcl-1 and RNA Pol II p-S2.
Following the November meeting, the companies jointly concluded that a clinical trial consistent with the recent FDA guidance, including modification of the ongoing COASTAL trial, would likely not be feasible to complete within a time period that would support further investment or with sufficient certainty of the regulatory requirements for approval to justify continued global development efforts.
Following the November meeting, the companies jointly concluded that a clinical trial consistent with the recent FDA guidance, including 8 Table of Contents modification of the COASTAL trial, would likely not be feasible to complete within a time period that would support further investment or with sufficient certainty of the regulatory requirements for approval to justify continued global development efforts.
Additionally, as in the U.S., post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution, would apply to any product that is approved in the EU, and failure to comply with such obligations could have a material adverse effect on our ability to successfully commercialize any product.
Additionally, as in the U.S., post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution, would 17 Table of Contents apply to any product that is approved in the EU and failure to comply with such obligations could have a material adverse effect on our ability to successfully commercialize any product.
Even if we are successful in developing products that receive regulatory approval, such products may not compete successfully with products produced by our competitors or with products that may subsequently receive regulatory approval. Our competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions.
Even if we are successful in developing products that receive regulatory 9 Table of Contents approval, such products may not compete successfully with products produced by our competitors or with products that may subsequently receive regulatory approval. Our competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions.
The reauthorization of BPCA adds an additional six months of marketing exclusivity and patent protection to unexpired exclusivities and unexpired patents listed with the FDA for NDA applicants that conduct acceptable pediatric studies of new and currently marketed drug products for which pediatric information would be beneficial, as identified by the FDA in a Pediatric Written Request.
The Best Pharmaceuticals for Children Act (BPCA) adds an additional six months of marketing exclusivity and patent protection to unexpired exclusivities and unexpired patents listed with the FDA for NDA applicants that conduct acceptable pediatric studies of new and currently marketed drug products for which pediatric information would be beneficial, as identified by the FDA in a Pediatric Written Request.
The U.S. Patent and Trademark Office (USPTO) has allowed or issued 19 U.S. patents covering the composition of matter, pharmaceutical compositions, and methods of use to treat cancer which are projected to expire between 2026 and 2037, not including any patent term extension.
Patent and Trademark Office (USPTO) has allowed or issued 21 U.S. patents covering the composition of matter, pharmaceutical compositions and methods of use to treat cancer which are projected to expire between 2026 and 2039, not including any patent term extension.
ANDA 16 Table of Contents applicants generally must only scientifically demonstrate that their product is bioequivalent to, or performs in the same manner as, the innovator drug and can often be substituted by pharmacists under prescriptions written for the reference listed drug.
ANDA applicants generally must only scientifically demonstrate that their product is bioequivalent to, or performs in the same manner as, the innovator drug and can often be substituted by pharmacists under prescriptions written for the reference listed drug.
Additionally, in Japan, the KKC 10 Table of Contents Commercialization Agreement included potential regulatory and commercialization milestone payments plus royalties on net sales of zandelisib in Japan, which are tiered beginning in the teens.
Additionally, in Japan, the KKC Commercialization Agreement included potential regulatory and commercialization milestone payments plus royalties on net sales of zandelisib in Japan, which are tiered beginning in the teens.
Further, the SEC maintains an internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC and can be found on our EDGAR page at http://www.sec.gov.
Further, the SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC and can be found on our EDGAR page at http://www.sec.gov. 18 Table of Contents
The discontinuation of zandelisib in Japan was a business decision by KKC based on the most recent regulatory guidance from the Pharmaceuticals and Medical Devices Agency in Japan and was not related to the zandelisib clinical data generated to date.
The discontinuation of zandelisib in Japan was a business decision by KKC based on the most recent regulatory guidance from the Pharmaceuticals and Medical Devices Agency in Japan and was not related to the zandelisib clinical data that had been generated.
Our Board has appointed Justin J. File, our current Chief Financial Officer, to assume the position of Acting Chief Executive Officer and has appointed Frederick W. Driscoll as Chairperson of the Board.
File, our current Chief Financial Officer, to assume the position of Acting Chief Executive Officer and appointed Frederick W. Driscoll as Chairperson of the Board.
It was 6 Table of Contents also demonstrated that voruciclib downregulates MCL1, which is relevant for the synergy between voruciclib and venetoclax, and further that voruciclib downregulates MYC, which also contributes to the synergies with venetoclax.
It was also demonstrated that voruciclib downregulates MCL1, which is relevant for the synergy between voruciclib and venetoclax and further that voruciclib downregulates MYC, which also contributes to the synergies with venetoclax.
If the FDA imposes a clinical hold at any time before or 13 Table of Contents during clinical trials, the IND sponsor must resolve the FDA’s concerns before clinical trials can begin or continue.
If the FDA imposes a clinical hold at any time before or during clinical trials, the IND sponsor must resolve the FDA’s concerns before clinical trials can begin or continue.
Inspections may be in-person or conducted remotely. If applicable regulatory criteria are not satisfied, the FDA may issue a complete response letter (CRL) to the sponsor requiring additional nonclinical or clinical studies or data or additional CMC information.
If applicable regulatory criteria are not satisfied, the FDA may issue a complete response letter (CRL) to the sponsor requiring additional nonclinical or clinical studies or data or additional CMC information.
Over expression of MCL1 is frequently observed in many tumor types and is closely associated with tumorigenesis, poor prognosis and drug resistance. In AML, MCL1 is upregulated in about half of patients with relapsed and refractory (R/R) disease and is associated with poor prognosis in these patients. Also important, high levels of MCL1 expression are associated with resistance to venetoclax.
Over expression of MCL1 is frequently observed in many tumor types and is closely associated with tumorigenesis, poor prognosis and drug resistance. In AML, MCL1 is upregulated in about half of patients with relapsed and refractory (R/R) disease and is associated with poor prognosis in these patients.
The reauthorization of PREA requires that most applications for drugs include a pediatric assessment (unless waived or deferred) to ensure the drugs’ safety and effectiveness in children.
The Pediatric Research Equity Act (PREA) also requires that most applications for drugs include a pediatric assessment (unless waived or deferred) to ensure the drugs’ safety and effectiveness in children.
Accordingly, there is a marked degree of change and uncertainty both in the regulation of clinical trials and in respect of marketing authorizations which we face for our products in the EU. Manufacturing We do not have the facilities or capabilities to commercially manufacture any of our drug candidates.
This UK legislation comes into effect on April 28, 2026. Accordingly, there is a marked degree of change and uncertainty both in the regulation of clinical trials and in respect of marketing authorizations which we face for our products in the EU. Manufacturing We do not have the facilities or capabilities to commercially manufacture any of our drug candidates.
In pre-clinical studies, voruciclib shows dose-dependent suppression of MCL1; in December 2017, a study of voruciclib published in the journal Nature Scientific Reports reported that the combination of voruciclib plus the BCL-2 inhibitor venetoclax was capable of inhibiting two master regulators of cell survival, MCL-1 and BCL-2, and achieved synergistic antitumor effect in an aggressive subset of DLBCL cells.
Also important, high levels of MCL1 expression are associated with resistance to venetoclax. 6 Table of Contents In pre-clinical studies, voruciclib shows dose-dependent suppression of MCL1; in December 2017, a study of voruciclib published in the journal Nature Scientific Reports reported that the combination of voruciclib plus the BCL-2 inhibitor venetoclax was capable of inhibiting two master regulators of cell survival, MCL-1 and BCL-2 and achieved synergistic antitumor effect in an aggressive subset of DLBCL cells.
Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.
Even if a product receives marketing approval, the approval is limited to specific clinical indications. Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.
Voruciclib recently completed a Phase 1 trial evaluating dose and schedule in patients with acute myeloid leukemia (AML) in combination with the B-cell lymphoma 2 (BCL-2) inhibitor venetoclax (marketed as Venclexta®).
Voruciclib: Potent Orally Administered CDK9 Inhibitor in Phase 1 Studies Voruciclib, a selective orally administered CDK9 inhibitor completed a Phase 1 trial in September 2024 evaluating dose and schedule in patients with acute myeloid leukemia (AML) in combination with the B-cell lymphoma 2 (BCL-2) inhibitor venetoclax (marketed as Venclexta®).
The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly address the agreement between the sponsor and the FDA in the Pediatric Written Request, the additional protection is granted. The Pediatric Research Equity Act (PREA) also was reauthorized and amended by the FDAAA.
The data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly address the agreement between the sponsor and the FDA in the Pediatric Written Request, the additional protection is granted.
The total dividend of $11.7 million was paid on December 6, 2023, and was recorded as a reduction of additional paid-in capital in the consolidated statements of stockholders' equity, as we have an accumulated deficit, rather than retained earnings. Other Events Subject to approval by our stockholders, we, Infinity Pharmaceuticals, Inc.
The total dividend of $11.7 million was paid on December 6, 2023, and was recorded as a reduction of additional paid-in capital in the consolidated statements of stockholders' equity, as we have an accumulated deficit, rather than retained earnings.
We commenced a reduction-in-force beginning August 1, 2024, which will continue in stages as our operational and strategic direction evolves. We have discontinued the clinical development of voruciclib, while certain nonclinical activities related to our drug candidate assets will continue to be conducted by us.
We commenced a reduction-in-force beginning August 1, 2024, that continued in stages as our operational and strategic direction evolved. In connection with this evaluation, we discontinued the clinical development of voruciclib, while certain nonclinical activities related to our drug candidate assets continued to be conducted by us.
Cooperation Agreement On October 31, 2023, we announced our entry into a Cooperation Agreement (Cooperation Agreement) with Anson Funds Management LP and Cable Car Capital LLC (Anson and Cable Car, respectively), which, among other non-financial related items, provided for a capital return to stockholders in the form of a dividend in the amount of $1.75 per share of common stock, as further discussed below.
Cooperation Agreement and Cash Dividend On October 31, 2023, we announced our entry into a cooperation agreement with Anson Funds Management LP and Cable Car Capital LLC (Cooperation Agreement), which, among other non-financial related items, provided for a capital return to stockholders in the form of a dividend in the amount of $1.75 per share of common stock, that was declared on November 6, 2023, to stockholders of record at the close of business on November 17, 2023 (Capital Return).
The Food and Drug Administration Safety and Innovation Act signed into law on July 9, 2012, permanently renewed and strengthened BPCA and PREA. 17 Table of Contents Under the FDA Reauthorization Act of 2017, sponsors submitting original applications on or after August 18, 2020, for product candidates intended for the treatment of adult cancer which are directed at molecular targets that the FDA determines to be substantially relevant to the growth or progression of pediatric cancer must submit, prior to marketing application submission, an initial Pediatric Study Plan for FDA agreement, and with the application, reports from molecularly targeted pediatric cancer clinical investigations designed to yield clinically meaningful pediatric study data, using appropriate pediatric formulations, to inform potential pediatric labeling.
Further, sponsors submitting original applications on or after August 18, 2020, for product candidates intended for the treatment of adult cancer which are directed at molecular targets that the FDA determines to be substantially relevant to the growth or progression of pediatric cancer must submit, prior to marketing application submission, an initial Pediatric Study Plan for FDA agreement and with the application, reports from molecularly targeted pediatric cancer clinical investigations designed to yield clinically meaningful pediatric study data, using appropriate pediatric formulations, to inform potential pediatric labeling.
In March 2022, we and KKC reported the outcome of an end of Phase 2 meeting with the FDA wherein the agency discouraged a filing based on data from a single-arm Phase 2 TIDAL trial.
Currently, there are no clinical trial efforts for zandelisib and we are assessing the pre-clinical development program. In March 2022, we and KKC reported the outcome of an end of Phase 2 meeting with the FDA wherein the agency discouraged a filing based on data from a single-arm Phase 2 TIDAL trial.
The FDA may refer certain applications to an advisory committee, which is a panel of experts that make a recommendation as to whether the application should be approved and under what conditions.
The FDA may refer certain applications to an advisory committee, which is a panel of experts that make a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Finally, if a product is intended to treat a serious condition and, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of the condition, the product may be eligible for priority review meaning that the FDA’s goal for the review of an NDA is shortened to six months (after a two month period during which the FDA decides whether the application is ready for filing) rather than the standard review of ten months from application acceptance.
Products designated as breakthrough therapies are eligible for intensive FDA guidance, a commitment from the FDA to involve senior managers and experienced review staff in a proactive collaborative and cross-disciplinary review, rolling submission of the application and the facilitation of cross-disciplinary review. 14 Table of Contents Finally, if a product is intended to treat a serious condition and, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of the condition, the product may be eligible for priority review meaning that the FDA’s goal for the review of an NDA is shortened to six months (after a two month period during which the FDA decides whether the application is ready for filing) rather than the standard review of ten months from application acceptance.
The data are generated by our pre-clinical studies and clinical trial programs. 12 Table of Contents The key aspects of our research and development program have been to provide more complete characterization of the following: • the relevant molecular targets of action of our drug candidates; • the relative therapeutic benefits and indications for use of our drug candidates as a monotherapy or as part of combinational therapy with other agents; and • the most appropriate therapeutic indications and dosage forms for voruciclib, ME-344 and zandelisib.
The key aspects of our R&D program have been to provide more complete characterization of the following: • the relevant molecular targets of action of our drug candidates; • the relative therapeutic benefits and indications for use of our drug candidates as a monotherapy or as part of combinational therapy with other agents; and • the most appropriate therapeutic indications and dosage forms for voruciclib or zandelisib, based upon pre-clinical findings.
Success in nonclinical or early-stage clinical trials does not ensure success in later stage clinical trials. Data obtained from nonclinical and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit, or prevent marketing approval. Even if a product receives marketing approval, the approval is limited to specific clinical indications.
Success in nonclinical or early-stage clinical trials does not ensure success in later stage clinical trials. Data obtained from nonclinical and clinical activities are not always conclusive and may be 13 Table of Contents susceptible to varying interpretations that could delay, limit, or prevent marketing approval.
The USPTO has issued seven patents covering zandelisib as composition of matter, pharmaceutical compositions, and methods of use to treat cancer. The issued U.S. patents with composition of matter claims covering zandelisib are projected to expire between 2031 and 2032, not including any patent term extension. There are approximately 50 foreign patents granted or allowed.
The USPTO has issued nine patents covering zandelisib as composition of matter, pharmaceutical compositions, methods of use to treat cancer and combinations with additional therapies. The issued U.S. patents with composition of matter claims covering zandelisib are projected to expire between 2030 and 2032, not including any patent term adjustment and patent term extension.
Intellectual Property We own, by assignment or exclusive license, worldwide rights to each of our current drug candidates. Our intellectual property portfolio includes approximately 38 issued U.S. patents, 201 issued foreign patents, 10 pending U.S. patent applications, and 83 pending foreign applications. We have acquired exclusive worldwide rights to develop, manufacture and commercialize voruciclib from Presage Biosciences, Inc. (Presage).
Intellectual Property We own, by assignment or exclusive license, worldwide rights to each of our current drug candidates. We have acquired exclusive worldwide rights to develop, manufacture and commercialize voruciclib from Presage Biosciences, Inc. (Presage). The U.S.
At this meeting, the FDA stated that data generated from single arm studies such as the Phase 2 TIDAL trial are insufficient to adequately assess the risk/benefit of PI3Kδ inhibitors evaluating indolent non-Hodgkin lymphoma.
At this meeting, the FDA stated that data generated from single arm studies such as the Phase 2 TIDAL trial are insufficient to adequately assess the risk/benefit of PI3Kδ inhibitors evaluating indolent non-Hodgkin lymphoma. Additionally, the FDA emphasized that we continue efforts with the randomized Phase 3 COASTAL trial evaluating patients with relapsed or refractory follicular or marginal zone lymphomas.
None of our employees are represented by a labor union or covered by collective bargaining agreements. We have never experienced a work stoppage and believe our relationship with our employees is good. Management considers our relations with employees to generally be positive.
We have never experienced a work stoppage and believe our relationship with our employees is good. Management considers our relations with employees to generally be positive.
Following product approval, drug products are also subject to annual program fees. The FDA adjusts the PDUFA user fees on an annual basis. A written request can be submitted for a waiver for the application fee for the first human drug application that is filed by a small business, but there are no small business waivers for program fees.
Subject to meeting certain requirements, a written request can be submitted for a waiver for the application fee for the first human drug application that is filed by a small business, but there are no small business waivers for program fees.
We cannot be certain that we will be able to take advantage of either the patent term extension or marketing exclusivity provisions of these laws or that, if received, they will adequately protect any approved products from competition. The Best Pharmaceuticals for Children Act (BPCA) was reauthorized and amended by the FDA Amendments Act of 2007 (FDAAA).
We cannot be certain that we will be able 15 Table of Contents to take advantage of either the patent term extension or marketing exclusivity provisions of these laws or that, if received, they will adequately protect any approved products from competition.
There is no assurance that any of our pending patent applications will issue, or that any of our patents will be enforceable or will cover a drug or other commercially significant product or method.
We seek patent protection for our key inventions, including drug candidates we identify, routes for chemical synthesis and pharmaceutical formulations. There is no assurance that any of our pending patent applications will issue, or that any of our patents will be enforceable or will cover a drug or other commercially significant product or method.
Under the Regulation, clinical trial sponsors were able to use the Clinical Trials Information System (CTIS) since January 31, 2022, but are not obliged to use it immediately, in line with a three-year transition period. National regulators in the EU Member States and European Economic Area (EEA) countries could use the CTIS since January 31, 2022.
Under the CTER, clinical trial sponsors were able to use the Clinical Trials Information System (CTIS) since January 31, 2022, but were not obliged to use it immediately, in line with a three-year transition period, which expired January 31, 2025.
We believe that we have been successful in attracting skilled and experienced personnel, but there can be no assurance that we will be able to attract and retain the individuals needed. 19 Table of Contents Our people are a critical component in our continued success.
We believe that we have been successful in attracting skilled and experienced personnel, but there can be no assurance that we will be able to attract and retain the individuals needed. We strive to create a workplace of choice to attract, retain and develop top talent to achieve our strategic goals.
FDA approval of the manufacturing procedures and the site will be required prior to commercial distribution. Human Capital Management As of June 30, 2024, we had 28 employees, 3 of whom hold a Ph.D. or M.D. degree, all of which reside in the United States.
FDA approval of the manufacturing procedures and the site will be required prior to commercial distribution. Human Capital Management As of June 30, 2025, we had four employees whom all reside in the United States and were engaged in business development, finance, information systems or administrative support.
In the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but they also have their own methods and approval process apart from Medicare coverage and reimbursement determinations.
In the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but they also have their own methods and approval process apart from Medicare coverage and reimbursement determinations. 16 Table of Contents In addition, the containment of healthcare costs has become a priority for federal and state governments and the prices of drugs have been a focus in this effort.
There are 5 pending U.S. patent applications, 1 pending Patient Cooperation Treaty (PCT) and 10 pending foreign patent applications directed to ME-344 and related compounds or methods of use thereof. We have acquired, by assignment, worldwide rights to zandelisib and other related compounds from Pathway Therapeutics, Inc.
There are approximately 90 allowed or issued foreign patents, 8 pending U.S. provisional patent applications and approximately 50 pending foreign patent applications for voruciclib, related compounds and related methods of use. We have acquired, by assignment, worldwide rights to zandelisib and other related compounds from Pathway Therapeutics, Inc.
We cannot be sure that any license required under any such patents or proprietary rights would be made available on terms acceptable to us, if at all. If we do not obtain such licenses, we may encounter delays in product market introductions, or may find that the development, manufacture or sale of products requiring such licenses may be precluded.
If we do not obtain such licenses, we may encounter delays in product market introductions, or may find that the development, manufacture or sale of products requiring such licenses may be precluded.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. 14 Table of Contents Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured and may inspect the sponsor, clinical study vendors, and clinical sites at which the product candidate was studied and will not approve the product unless cGMP and GCP compliance are satisfactory.
Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured and may inspect the sponsor, clinical study vendors and clinical sites at which the product candidate was studied and will not approve the product unless cGMP and GCP compliance are satisfactory. Inspections may be in-person or conducted remotely.
Research and Development The objective of our research and development program is the generation of data sufficient to achieve regulatory approval of our drug candidates in one or more dosage forms in major markets such as the U.S., to meet medical needs and develop a clinical and commercial profile with attractive attributes, and/or to allow us to enter into a development and/or commercial relationship with another party.
Research and Development The objective of our research and development (R&D) program is the generation of data sufficient to meet medical needs and develop a clinical and commercial profile with attractive attributes and/or to allow us to enter into a development and/or commercial relationship with another party. The data are generated by our pre-clinical studies and clinical trial programs.
Voruciclib is also being evaluated in pre-clinical studies to explore potential activity in various solid tumor cancers including in combination with therapies that target the RAS signaling pathway, such as KRAS inhibitors.
Previously, voruciclib was also being evaluated in pre-clinical studies to explore potential activity in various solid tumor cancers including in combination with therapies that target the RAS signaling pathway, such as KRAS inhibitors. All clinical trial efforts for voruciclib were ceased as of July 22, 2024, and we are currently assessing the pre-clinical development program in potentially non-oncology disease indications.
In November 2022, we and KKC met with the FDA in a follow-up meeting to the March 2022 end of Phase 2 meeting. At this meeting, the FDA provided further guidance regarding the design and statistical analysis for the Phase 3 COASTAL trial.
At this meeting, the FDA provided further guidance regarding the design and statistical analysis for the Phase 3 COASTAL trial.
We cannot be certain that we, or our present or future suppliers or third-party manufacturers, will be able to comply with all FDA regulatory requirements, and potential consequences of noncompliance could have a material adverse impact on our business prospects. 15 Table of Contents The FDA’s policies may change, and additional governmental regulations may be enacted that could delay, limit, or prevent regulatory approval of our products, that require that we implement additional compliance steps, or affect our ability to manufacture, market, or distribute our products after approval.
Maintaining compliance is costly and time-consuming. We cannot be certain that we, or our present or future suppliers or third-party manufacturers, will be able to comply with all FDA regulatory requirements and potential consequences of noncompliance could have a material adverse impact on our business prospects.
As part of the review of strategic alternatives, we may consider options such as out-licensing opportunities for existing programs and merger and acquisition opportunities. Consistent with our intention to preserve cash, David M. Urso, our President and Chief Executive Officer, and Richard Ghalie, M.D., our Chief Medical Officer, have stepped down effective August 1, 2024. Mr.
As part of the review of strategic alternatives, we considered options such as out-licensing opportunities for or the sale of our existing programs and merger and acquisition opportunities, as well as other potential opportunities. Consistent with our intention to preserve cash, David M.
At that time, the FDA emphasized that we continue efforts with the ongoing randomized Phase 3 COASTAL trial evaluating patients with relapsed or refractory follicular or marginal zone lymphomas. Subsequently, at an April 2022 meeting of the FDA Oncology Drugs Advisory Committee, the committee voted that future approvals of PI3Kδ inhibitors for hematologic malignancies should be supported by randomized data.
Subsequently, at an April 2022 meeting of the FDA Oncology Drugs Advisory Committee, the committee voted that future approvals of PI3Kδ inhibitors for hematologic malignancies should be supported by randomized data. In November 2022, we and KKC met with the FDA in a follow-up meeting to the March 2022 end of Phase 2 meeting.
In addition, the containment of healthcare costs has become a priority for federal and state governments, and the prices of drugs have been a focus in this effort. The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement, and requirements for substitution of generic products.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results.
We have already initiated research and development activity of the new formulation, with the goal of increasing biological activity, improving patient convenience of administration and increasing commercial opportunity. Zandelisib: PI3Kδ Inhibitor Overview Zandelisib is an oral, once-daily, selective PI3Kδ inhibitor that we were jointly developing with KKC under a global license, development and commercialization agreement entered into in April 2020.
Zandelisib: PI3Kδ Inhibitor Overview Zandelisib is an oral, once-daily, selective PI3Kδ inhibitor that we were jointly developing with Kyowa Kirin Co., Ltd (KKC) under a global license, development and commercialization agreement entered into in April 2020 that was later terminated in 2023 (as further discussed below).
The FDA also issued guidance regarding the conduct of decentralized clinical trials, use of electronic records, systems and signatures in clinical trials, and the conduct of risk-based clinical trial monitoring. Following issuance of a final guidance, the FDA will further be requiring diversity action plans for certain clinical studies.
FDA has issued a number of guidances regarding the conduct of clinical studies including with respect to good clinical practices and the conduct of different clinical studies.Following issuance of a final guidance, the FDA will further be requiring diversity action plans for certain clinical studies.
We strive to create a workplace of choice to attract, retain and develop top talent to achieve our strategic goals. We strive to maximize the potential of our human capital resources by creating a respectful, rewarding, and inclusive work environment that enables our employees to further our mission.
We strive to maximize the potential of our human capital resources by creating a respectful, rewarding and inclusive work environment that enables our employees to further our mission. We adhere to a philosophy that includes, among other things, commitments to create ongoing job opportunities, pay fair wages and protect worker health and safety.
Urso also left the Board at that date. We have entered into consulting agreements with both Mr. Urso and Dr. Ghalie under which they will remain available to assist us in our strategic efforts. Charles V. Baltic III, the Chairperson of the Board, also stepped down from the Board contemporaneously with the announcement on July 22, 2024.
In addition, we entered into a consulting agreement with Mr. Urso, which was terminated in February 2025. Charles V. Baltic III, the Chairperson of the Board, also stepped down from the Board contemporaneously with the announcement on July 22, 2024. Our Board appointed Justin J.
Use of these compounds and any other drug candidates may give rise to claims that they infringe the patents or proprietary rights of other parties, existing now and in the future. An adverse claim could subject us to significant liabilities to such other parties and/or require disputed rights to be licensed from such other parties.
The pharmaceutical industry is highly competitive and patents may have been applied for by and issued to, other parties relating to products competitive with voruciclib or zandelisib. Use of these compounds and any other drug candidates may give rise to claims that they infringe the patents or proprietary rights of other parties, existing now and in the future.
We rely on a combination of patent, trade secret, copyright, and trademark laws, as well as confidentiality, licensing and other agreements, to establish and protect our proprietary rights. We seek patent protection for our key inventions, including drug candidates we identify, routes for chemical synthesis and pharmaceutical formulations.
Our success depends in large part on our ability to protect our proprietary technologies, compounds and information and to operate without infringing the proprietary rights of third parties. We rely on a combination of patent, trade secret, copyright and trademark laws, as well as confidentiality, licensing and other agreements, to establish and protect our proprietary rights.
Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. Orphan drug designation does, however, entitle a party to financial incentives such as opportunities for grant funding towards clinical study costs, tax advantages, and certain user-fee waivers.
Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
We also cannot be sure that our proprietary information or intellectual property will be protected by these agreements or that others will not independently develop substantially equivalent proprietary information or intellectual property. The pharmaceutical industry is highly competitive, and patents may have been applied for by, and issued to, other parties relating to products competitive with zandelisib, voruciclib or ME-344.
We also cannot be sure that our proprietary information or intellectual property will be 10 Table of Contents protected by these agreements or that others will not independently develop substantially equivalent proprietary information or intellectual property.
There are 2 pending U.S. patent applications, 1 pending PTC application and approximately 11 pending foreign patent applications directed to zandelisib and related compounds or methods of use thereof. Our success depends in large part on our ability to protect our proprietary technologies, compounds and information, and to operate without infringing the proprietary rights of third parties.
There are approximately 48 foreign patents granted. There is 1 pending U.S. patent application and are approximately 13 pending foreign patent applications directed to zandelisib and related compounds or methods of use thereof.
At a special meeting of our stockholders held on July 23, 2023, the transaction did not obtain the necessary approval from our stockholders and, accordingly, on July 23, 2023, we sent Infinity a notice terminating the Merger Agreement. 5 Table of Contents In December 2022, we announced plans to realign our clinical development efforts after jointly deciding with our development partner, Kyowa Kirin Co., Ltd.
(Infinity) and Meadow Merger Sub, Inc., our wholly owned subsidiary (Merger Sub). At such special meeting, the Merger Agreement did not obtain the necessary approval from our stockholders and, accordingly, on July 23, 2023, we sent Infinity a notice terminating the Merger Agreement.
Our approach to oncology drug development has been to evaluate our drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and address clear medical needs to provide improved patient benefit. Our drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 (CDK9) inhibitor, and ME-344, an intravenous small molecule mitochondrial inhibitor targeting the oxidative phosphorylation pathway.
We built our pipeline by acquiring promising cancer agents and creating value in programs through clinical development, strategic partnerships and out-licensing or commercialization, as appropriate. Our approach to oncology drug development has been to evaluate our drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and address clear medical needs to provide improved patient benefit.
We adhere to a philosophy that includes, among other things, commitments to create ongoing job opportunities, pay fair wages, and protect worker health and safety. We invest in our workforce by offering competitive salaries and benefits. We endeavor to foster a strong sense of ownership by offering stock options under our equity incentive plan.
We invest in our workforce by offering competitive salaries and benefits. We endeavor to foster a strong sense of ownership by offering stock options under our equity incentive plan. We also offer locally relevant benefits for all eligible employees. None of our employees are represented by a labor union or covered by collective bargaining agreements.
Of the 28 employees, 12 were engaged in research and development activities and 16 were engaged in business development, finance, information systems, facilities, human resources or administrative support. Other personnel resources are used from time to time as consultants or third-party service organizations on an as-needed basis.
Other personnel resources are used from time to time as consultants or third-party service organizations on an as-needed basis for scientific and human resources activities. Our Acting Chief Executive Officer and Chief Financial Officer has prior experience with pharmaceutical, biotechnology and medical product companies.
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Item 1. Business Overview MEI Pharma, Inc. (Nasdaq: MEIP) is a pharmaceutical company that has been developing novel and differentiated cancer therapies. We built our pipeline by acquiring promising cancer agents and creating value in programs through clinical development, strategic partnerships, and out-licensing or commercialization, as appropriate.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe trading price of our common stock could be highly volatile in response to various factors, many of which are beyond our control, including, but not limited to, the following: • failure to successfully develop our drug candidates; • design, results and timing of clinical trials and pre-clinical studies; • announcements of technological innovations by us or our competitors; • new products introduced or announced by us or our competitors; • changes in financial estimates by securities analysts; • actual or anticipated variations in operating results; • expiration or termination of licenses, research contracts or other collaboration agreements; • conditions or trends in the regulatory climate and the biotechnology, pharmaceutical and genomics industries; • instability in the stock market as a result of current or future domestic and global events; • changes in the market valuations of similar companies; • the liquidity of any market for our securities; and • threatened or actual delisting of our common stock from a national stock exchange. 28 Table of Contents Equity markets in general, and the market for biotechnology and life sciences companies in particular, have experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of companies traded in those markets.
Biggest changeThe trading price of our common stock could be highly volatile in response to various factors, many of which are beyond our control, including, but not limited to, the following: • failure to successfully develop our drug candidates; • the trading price of, and other developments or events relating to the value of Litecoin; • design, results and timing of pre-clinical studies; • announcements of technological innovations by us or our competitors; • new products introduced or announced by us or our competitors; • changes in financial estimates by securities analysts; • actual or anticipated variations in operating results; • expiration or termination of licenses, research contracts or other collaboration agreements; • conditions or trends in the regulatory climate and the biotechnology, pharmaceutical and genomics industries; • instability in the stock market as a result of current or future domestic and global events; • changes in the market valuations of similar companies; • the liquidity of any market for our securities; and • threatened or actual delisting of our common stock from a national stock exchange.
These provisions include: • a staggered board providing for three classes of directors, which limits the ability of a stockholder or group to gain control of our board; • no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; 29 Table of Contents • the right of our board to elect a director to fill a vacancy created by the expansion of our board or the resignation, death or removal of a director in certain circumstances, which prevents stockholders from being able to fill vacancies on our board; and • advance notice procedures that stockholders must comply with in order to nominate candidates to our board or to propose matters to be acted upon at a meeting of stockholders, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us.
These provisions include: • a staggered board providing for three classes of directors, which limits the ability of a stockholder or group to gain control of our board; • no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; • the right of our board to elect a director to fill a vacancy created by the expansion of our board or the resignation, death or removal of a director in certain circumstances, which prevents stockholders from being able to fill vacancies on our board; and • advance notice procedures that stockholders must comply with in order to nominate candidates to our board or to propose matters to be acted upon at a meeting of stockholders, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us.
If a natural disaster, or public health emergency such as COVID-19, power outage or other event occurred that prevented us from conducting our clinical trials, including by damaging our critical infrastructure, such as third-party facilities, or that otherwise disrupted operations and travel, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.
If a natural disaster, or public health emergency, power outage or other event occurred that prevented us from conducting our clinical trials, including by damaging our critical infrastructure, such as third-party facilities, or that otherwise disrupted operations and travel, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.
Should we resume development of our drug candidate or any future drug candidates, the success of such drug candidates will depend on many factors, including but not limited to: ● successful enrollment in, and completion of, clinical trials, as well as completion of preclinical studies; ● favorable efficacy and acceptable safety data from our clinical trials and other studies; ● receipt of additional regulatory approvals; ● managing our reliance on sole-source third parties such as our third-party vendors, suppliers, and manufacturers; ● the performance by CROs or other third parties and consultants we may retain of their duties to us in a manner that complies with our protocols and applicable laws and that protects the integrity of the resulting data; ● obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity; ● ensuring we do not infringe, misappropriate or otherwise violate the valid patent, trade secret or other intellectual property rights of third parties; ● successfully launching, either alone or with a commercial partner, any drug candidate for which regulatory approval is received; ● obtaining and maintaining favorable reimbursement from third-party payers and governments for drugs and drug candidates; ● competition with other drugs; ● post-marketing commitments, if any, to regulatory agencies following regulatory approval of any drug candidate; ● continued acceptable safety profile following regulatory approval; and ● manufacturing or obtaining sufficient supplies of our drugs and any drug candidate that may be necessary for use in clinical trials for evaluation of any drug candidate and commercialization of any approved drug.
Should we resume development of our drug candidate or any future drug candidates, the success of such drug candidates will depend on many factors, including but not limited to: ● successful enrollment in and completion of, clinical trials, as well as completion of pre-clinical studies; 22 Table of Contents ● favorable efficacy and acceptable safety data from our clinical trials and other studies; ● receipt of additional regulatory approvals; ● managing our reliance on sole-source third parties such as our third-party vendors, suppliers and manufacturers; ● the performance by CROs or other third parties and consultants we may retain of their duties to us in a manner that complies with our protocols and applicable laws and that protects the integrity of the resulting data; ● obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity; ● ensuring we do not infringe, misappropriate or otherwise violate the valid patent, trade secret or other intellectual property rights of third parties; ● successfully launching, either alone or with a commercial partner, any drug candidate for which regulatory approval is received; ● obtaining and maintaining favorable reimbursement from third-party payers and governments for drugs and drug candidates; ● competition with other drugs; ● post-marketing commitments, if any, to regulatory agencies following regulatory approval of any drug candidate; ● continued acceptable safety profile following regulatory approval; and ● manufacturing or obtaining sufficient supplies of our drugs and any drug candidate that may be necessary for use in clinical trials for evaluation of any drug candidate and commercialization of any approved drug.
Our internal computer systems and those of our CROs and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures.
Our internal computer systems and those of other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.
Sales of our stock by our executive officers and directors, or the perception that such sales may occur, could cause the market price of our common stock to decline or could make it more difficult for us to raise funds through the sale of equity in the future, either as part, or outside, of trading plans under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended (the Exchange Act).
Sales of our stock by our executive officer and directors, or the perception that such sales may occur, could cause the market price of our common stock to decline or could make it more difficult for us to raise funds through the sale of equity in the future, either as part, or outside, of trading plans under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended (the Exchange Act).
We cannot be certain that additional funding will be available on acceptable terms, or at all, and our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, including high rates of inflation and interest rates, the continuing disruptions to 23 Table of Contents and volatility in the credit and financial markets in the United States and worldwide, including resulting from the ongoing conflicts between Russia and the Ukraine, conflicts in the Middle East, and increasing tensions between China and Taiwan.
We cannot be certain that additional funding will be available on acceptable terms, or at all and our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, including high rates of inflation and interest rates, the continuing disruptions to and volatility in the credit and financial markets in the United States and worldwide, including resulting from the ongoing conflicts between Russia and the Ukraine, conflicts in the Middle East and increasing tensions between China and Taiwan.
If we fail to comply with the continued listing standards and the Nasdaq Capital Market delists our securities from trading on its exchange, we and our stockholders could face significant negative consequences including: reducing the liquidity and market price of our common stock; reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; decreasing the amount of news and analyst coverage of us; and limiting our ability to issue additional securities or obtain additional financing in the future.
If we fail to comply with the continued listing standards and the Nasdaq Capital Market delists our securities from trading on its exchange, we and our stockholders could face significant negative consequences including: reducing the liquidity and market price of our common stock; reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; decreasing the amount of news and analyst coverage of us; and limiting 26 Table of Contents our ability to issue additional securities or obtain additional financing in the future.
If we fail to comply with the continued listing standards of the Nasdaq Capital Market, we may be delisted and the price of our common stock, our ability to access the capital markets and our financial condition could be negatively impacted. Our common stock is currently listed on Nasdaq under the symbol MEIP.
If we fail to comply with the continued listing standards of the Nasdaq Capital Market, we may be delisted and the price of our common stock, our ability to access the capital markets and our financial condition could be negatively impacted. Our common stock is currently listed on Nasdaq under the symbol LITS.
Misconduct by employees, independent contractors, consultants, commercial partners, manufacturers, investigators, or CROs could include intentional, reckless, negligent, or unintentional failures to comply with FDA regulations, comply with applicable fraud and abuse laws, provide accurate information to the FDA, properly calculate pricing information required by federal programs, comply with federal procurement rules or contract terms, report financial information or data accurately or disclose unauthorized activities to us.
Misconduct by employees, independent contractors, consultants or commercial partners could include intentional, reckless, negligent, or unintentional failures to comply with FDA regulations, comply with applicable fraud and abuse laws, provide accurate information to the FDA, properly calculate pricing information required by federal programs, comply with federal procurement rules or contract terms, report financial information or data accurately or disclose unauthorized activities to us.
The loss of services of our Acting Chief Executive Officer, Chief Financial Officer or other key employees could adversely impact our operations and ability to generate or raise additional capital. 25 Table of Contents Negative U.S. and global economic conditions may pose challenges to our business strategy, which relies on funding from the financial markets or collaborators.
The loss of services of our Acting Chief Executive Officer and Chief Financial Officer or other key employees could adversely impact our operations and ability to generate or raise additional capital. Negative U.S. and global economic conditions may pose challenges to our business strategy, which relies on funding from the financial markets or collaborators.
For example, the loss of clinical trial data from completed, ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
For example, the loss of clinical trial data from completed clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
The U.S. capital markets are currently experiencing extreme volatility and disruption following the global outbreak of COVID-19, high inflation and the government response thereto, potential economic downturn, publicized failures in the regional banking 27 Table of Contents sector, the war in Ukraine, the upcoming U.S. presidential election, and other global events.
The U.S. capital markets are currently experiencing extreme volatility and disruption following the global outbreak of COVID-19, high inflation and the government response thereto, potential economic downturn, publicized failures in the regional banking sector, the war in Ukraine, the upcoming U.S. presidential election and other global events.
We may experience reluctance or refusal by current or 26 Table of Contents prospective European clinical trial sites and CROs to use our products, and we may find it necessary or desirable to make further changes to our processing of personal data of EEA or U.K. data subjects.
We may experience reluctance or refusal by current or prospective European clinical trial sites and CROs to use our products and we may find it necessary or desirable to make further changes to our processing of personal data of EEA or U.K. data subjects.
Our financial results may fluctuate significantly from year to year, depending on whether we resume development of our drug candidates or any future drug candidates, the timing of any clinical trials, the receipt of payments under any future agreements we may 22 Table of Contents enter into, and our expenditures on other research and development (R&D) activities as well as any payments owed under the License Agreement with Presage and any future similar agreements.
Our financial results may fluctuate significantly from year to year, depending on the timing of whether we resume development of our drug candidates or any future drug candidates, the timing of any clinical trials, the receipt of payments under any future agreements we may enter into and our expenditures on other R&D activities as well as any payments owed under the License Agreement with Presage and any future similar agreements.
If we decide to resume development of our drug candidate or any future drug candidate, we will need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our drug development programs.
Whenever we decide to resume development of our drug candidate or any future drug candidate, we may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our drug development programs.
We face competition for such personnel, and we believe that risks and uncertainties related to our business, including the timing and risk associated with research and development, our available and anticipated cash resources, and the volatility of our stock price, may impact our ability to hire and retain key and other personnel.
We face competition for such personnel and we believe that risks and uncertainties related to our business, including the timing and risk associated with R&D, our available and anticipated cash resources and the volatility of our stock price, may impact our ability to hire and retain key and other personnel.
MEI Pharma observes the developments and will agree to the appropriate data transfer mechanism. In addition to standard contractual clauses, we may rely on individual contents of the patients where appropriate and necessary to safeguard the data flow from the EU to the U.S.
Lite Strategy observes the developments and will agree to the appropriate data transfer mechanism. In addition to standard contractual clauses, we may rely on individual contents of the patients where appropriate and necessary to safeguard the data flow from the EU to the U.S.
Our executive officers and directors may sell shares of their stock, and these sales could adversely affect our stock price.
Our executive officer and directors may sell shares of their stock and these sales could adversely affect our stock price.
Our efforts will be seriously jeopardized if we are unable to retain and attract key employees. Our success depends on the continued contributions of our principal management, development and scientific personnel.
Our efforts will be seriously jeopardized if we are unable to retain and attract key employees. Our success depends on the continued contributions of our principal management, development and availability of consultants or third-party scientific personnel.
Therefore, our stockholders will not be able to receive a return on their investment unless a strategic transaction that requires a dividend is successful or the value of our common stock appreciates and they sell their shares. We will have broad discretion over the use of the net proceeds from any exercise of outstanding warrants and options.
Therefore, our stockholders will not be able to receive a return on their investment unless the value of our common stock appreciates and they sell their shares. We will have broad discretion over the use of the net proceeds from any exercise of outstanding warrants and options.
Other than the Capital Return, w e have never paid or declared any cash dividends on our common stock, and we intend to retain any future earnings to finance the development and expansion of our business. We do not anticipate paying any cash dividends on our common stock in the foreseeable future other than in connection with a strategic transaction.
Other than the Capital Return, w e have never paid or declared any cash dividends on our common stock and we intend to retain any future earnings to finance the development and expansion of our business. We do not anticipate paying any cash dividends on our 27 Table of Contents common stock in the foreseeable future.
Our future funding requirements will depend on many factors, including, but not limited to: • the discontinuation of the clinical programs in our pipeline; • the exploration of strategic alternatives to maximize shareholder value; • should we resume development activities in the future, the rate of progress and costs related to development of and any trials for drug candidates; • should we resume development activities in the future, the rate of progress and costs for any drug candidates that we may in-license or acquire in the future; • the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with any drug candidate, including any such costs we may be required to expend if our licensors are unwilling or unable to do so; • the effect of competing technological and market developments; and • the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we may establish.
Our future funding requirements will depend on many factors, including, but not limited to: • the implementation and execution of our Litecoin Treasury Strategy; • whenever we resume development activities in the future, the rate of progress and costs related to development of any drug candidates; • whenever we resume development activities in the future, the rate of progress and costs for any drug candidates that we may in-license or acquire in the future; • the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with any drug candidate, including any such costs we may be required to expend if our licensors are unwilling or unable to do so; • the effect of competing technological and market developments; and • the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we may establish.
The trading price of the shares of our common stock has been and may continue to be highly volatile and could decline in value and we may incur significant costs from class action litigation.
In addition, delisting from Nasdaq may negatively impact our reputation and, consequently, our business. The trading price of the shares of our common stock has been and may continue to be highly volatile and could decline in value and we may incur significant costs from class action litigation.
As of June 30, 2024, we had outstanding warrants exercisable to purchase 102,513 shares of common stock at an exercise price of $6.80 per share, which expire in October 2027. We also have outstanding options to purchase 1,357,213 shares of common stock .
As of June 30, 2025, we had outstanding warrants exercisable to purchase 102,513 shares of common stock at an exercise price of $6.80 per share, which expire in October 2027.
These events have limited and could continue to limit our capital investment considerations, limit our abilit y to fund further clinical development, limit our ability to identify and implement any potential strategic alternatives and have a material negative impact on our operating results.
These events have limited and could continue to limit our capital investment considerations, limit our abilit y to fund further clinical development, limit our ability to implement our Litecoin Treasury Strategy and have a material negative impact on our operating results.
Similarly, our third-party providers possess certain of our sensitive protected health data. The secure maintenance of this information is critical to our operations and business strategy. Despite our reasonable security measures, our information technology and infrastructure may be vulnerable to cyber-attacks or breached due to employee error, malfeasance or other disruptions.
The secure maintenance of this information is critical to our operations and business strategy. Despite our reasonable security measures, our information technology and infrastructure may be vulnerable to cyber-attacks or breached due to employee error, malfeasance or other disruptions.
Thus, any access, disclosure or other loss of information, including our data being breached at our partners or third-party providers, along with violations of privacy laws that exist and are increasing around the world, could result in legal claims or proceedings and liability under laws that protect the privacy of personal information, disrupt our operations and damage our reputation, which could adversely affect our business.
Thus, any access, disclosure or other loss of information, including our data being breached at our partners or third-party providers, along with violations of privacy laws that exist and are increasing around the world, could result in legal claims or proceedings and liability under laws that protect the privacy of personal information, disrupt our operations and damage our reputation, which could adversely affect our business. 25 Table of Contents If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
To maintain the listing of our common stock on the Nasdaq Capital Market, we are required to meet certain listing requirements, including, among others, maintaining a minimum closing bid price of $1.00 per share. As we continue to explore strategic alternatives, we intend to actively monitor the bid price of our common stock and its compliance with the listing requirement.
To maintain the listing of our common stock on the Nasdaq Capital Market, we are required to meet certain listing requirements, including, among others, maintaining a minimum closing bid price of $1.00 per share.
Until recently, we had focused our efforts primarily on developing voruciclib, a selective orally administered CDK9 inhibitor, and ME-344, an intravenous small molecule mitochondrial inhibitor targeting the oxidative phosphorylation pathway, with the goal of achieving regulatory approval. In connection with our decision to undertake a comprehensive exploration of strategic alternatives, we have discontinued our clinical programs involving voruciclib and ME-344.
Until recently, we had focused our efforts primarily on developing voruciclib, a selective orally administered CDK9 inhibitor and ME-344 (prior to its sale in October 2024), an intravenous small molecule mitochondrial inhibitor targeting the oxidative phosphorylation pathway, with the goal of achieving regulatory approval.
Since inception, we have incurred significant operating losses. During the fiscal year ended June 30, 2024, we had net income of $17.8 million, while during the fiscal year ended June 30, 2023, we incurred a net loss of $31.8 million. As of June 30, 2024, we have an accumulated deficit of $388.2 million.
During the fiscal year ended June 30, 2025, we incurred a net loss of $15.9 million, while during the fiscal year ended June 30, 2024, we had net income of $17.8 million. As of June 30, 2025, we have an accumulated deficit of $404.2 million.
The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our Board, on our board committees or as executive officers. We cannot estimate accurately the amount or timing of additional costs we may incur to respond to these laws, rules and regulations.
The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our Board, on our board committees or as executive officers.
From time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste. Even if we contract with third parties for the disposal of these materials and waste, we cannot completely eliminate the risk of contamination or injury resulting from these materials.
Even if we contract with third parties for the disposal of these materials and waste, we cannot completely eliminate the risk of contamination or injury resulting from these materials.
Stockholders will experience significant dilution if we sell these future shares at prices significantly below the price at which such previous stockholders invested. Other than as described below or in connection with a strategic transaction we do not intend to pay, and we have not paid, any cash dividends on our shares of common stock.
Other than as described below or in connection with a strategic transaction we do not intend to pay and we have not paid, any cash dividends on our shares of common stock. Our stockholders will not be able to receive a return on their shares unless the value of our common stock appreciates and they sell their shares.
We may seek additional capital through one or more additional equity transactions in the future; however, such transactions will be subject to market conditions and there can be no assurance any such transactions will be completed. If we sell shares in the future, the prices at which we sell these future shares will vary, and these variations may be significant.
We may seek additional capital through one or more additional equity transactions in the future, such as the one completed subsequent to June 30, 2025 and more fully described in Note 15. Subsequent Events ; however, such transactions will be subject to market conditions and there can be no assurance any such transactions will be completed.
Notwithstanding the foregoing, the forum selection provision of our sixth amended and restated bylaws will not apply to suits brought to enforce any liability or duty created by the federal securities laws or any other claim for which the federal district courts of the U.S. of America shall be the sole and exclusive forum.
Notwithstanding the foregoing, the forum selection provision of our sixth amended and restated bylaws will not apply to suits brought to enforce any liability or duty created by the federal securities laws or any other claim for which the federal district courts of the U.S. of America shall be the sole and exclusive forum. 28 Table of Contents This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims.
Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition.
Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition. Risks Related to Investing in Litecoin The price of Litecoin has been and will likely continue to be, highly volatile.
Security breaches and privacy issues could compromise our information and expose us to liability, which would cause our business and reputation to suffer. In the ordinary course of our business, we collect and store sensitive data, including intellectual property, our proprietary business information and that of our suppliers, as well as personally identifiable information of clinical trial participants and employees.
In the ordinary course of our business, we collect and store sensitive data, including intellectual property, our proprietary business information and that of our suppliers, as well as personally identifiable information of clinical trial participants and employees. Similarly, our third-party providers possess certain of our sensitive protected health data.
Should we resume development activities in the future, we expect that research and development costs would increase significantly and we would continue to incur significant expenses and operating and net losses, as we develop and seek regulatory approval for such drug candidates.
In connection with the termination of all clinical programs noted above, our R&D expenses have decreased. Should we resume development activities in the future, we expect that R&D costs would increase and we would continue to incur expenses and operating and net losses, as we develop and seek development and/or commercial relationships with other partners for such drug candidates.
Should we resume the development activities in the future, we expect we would to continue to incur significant losses for the foreseeable future as we: • continue the development of any drug candidate; • seek regulatory approvals for any drug candidate that successfully completes clinical trials; • establish a sales, marketing and distribution infrastructure in the United States and scale up external manufacturing capabilities to commercialize any drugs for which we may obtain regulatory approval; • maintain, expand and protect our global intellectual property portfolio; • hire additional clinical, quality control and scientific personnel; and • add operational, financial and management information systems and personnel, including personnel to support our drug development and potential future commercialization efforts.
Should we resume R&D activities in the future, we expect we would to continue to incur losses for the foreseeable future as we: • continue the development of any drug candidate; 21 Table of Contents • maintain, expand and protect our global intellectual property portfolio; • hire additional clinical, quality control and scientific personnel or utilize consultants or third-party organizations; and • add operational, financial and management information systems and personnel, including personnel to support our drug development efforts.
The patent applications may not proceed to grant or may be amended to reduce the scope of protection of any patent granted. The applications and patents may also be opposed or challenged by third parties.
The applications and patents may also be opposed or challenged by third parties.
Furthermore, we cannot be sure that should patents issue, they will be of commercial value to us, or that private parties, including competitors, will not successfully challenge our patents or circumvent our patent position in the U.S. or abroad.
Furthermore, we cannot be sure that should patents issue, they will be of commercial value to us, or that private parties, including competitors, will not successfully challenge our patents or circumvent our patent position in the U.S. or abroad. 23 Table of Contents General Business Risks Our employees, independent contractors, consultants or commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
In connection with the termination of all ongoing clinical programs, our research and development expenses have decreased. We expect to continue to incur costs and expenditures in connection with the process of evaluating our strategic alternatives. Should we resume development activities in the future, we expect that research and development costs would increase significantly.
In connection with the termination of all clinical programs, our R&D expenses have decreased, but will resume should we re-commence pre-clinical development of either or both voruciclib and zandelisib. Whenever we resume development activities in the future, we expect that R&D costs would increase.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business. We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes.
We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. From time to time and in the future, our operations may involve the use of hazardous and flammable materials, including chemicals and biological materials and may also produce hazardous waste.
After taking into account the discontinuation of our clinical development programs, reduction-in-force and comprehensive exploration of strategic alternatives, we expect that our current unrestricted cash and cash equivalents and short-term investments will be sufficient to fund our currently anticipated operating plan for at least the next 12 months.
Whenever we resume development of our drug candidates or any future drug candidate, we may need to raise additional capital to continue such development. We expect our current unrestricted cash and cash equivalents will be sufficient to fund our currently anticipated operating plan for at least the next 12 months.
Removed
Risks Related to Our Review of Strategic Alternatives We may not be successful in identifying and implementing any potential strategic alternatives in a timely manner, or at all, and any strategic transactions that we may consummate in the future could have negative consequences.
Added
Litecoin is a highly volatile asset that has traded between $50.43 and $146.61 per Litecoin on Coinbase in the 12 months ended July 3, 2025. More recently, during the second calendar quarter of 2025, Litecoin has traded between $63.75 and $106.15 per Litecoin through June 30, 2025. In addition, Litecoin does not pay interest.
Removed
In July 2024, we announced that we are undertaking a comprehensive exploration of strategic alternatives focused on maximizing stockholder value. We expect to devote substantial time and resources to exploring strategic alternatives that our Board believes will maximize stockholder value.
Added
The ability to generate a return on investment from the purchase of Litecoin will depend on whether there is appreciation in the value of Litecoin following our purchases. Future fluctuations in Litecoin’s trading prices may result in our converting Litecoin into cash with a value substantially below the cost of such purchases.
Removed
Despite management devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that we will be able to successfully consummate any particular strategic transaction on attractive terms, on a timely basis, or at all.
Added
Our Litecoin holdings are less liquid than our existing cash and cash equivalents and may not be able to serve as a source of liquidity for us to the same extent as cash and cash equivalents.
Removed
For example, certain types of strategic transactions may require third-party consents, such as stockholder approval, which could be difficult or costly to obtain. We have not set a timetable for completion of this strategic review process, and our Board has not approved a definitive course of action.
Added
Historically, the crypto markets have been characterized by significant volatility in price, limited liquidity and trading volumes compared to sovereign currencies markets, relative anonymity, a developing regulatory landscape, potential susceptibility to market abuse and manipulation, compliance and internal control failures at exchanges and various other risks inherent in its entirely electronic, virtual form and decentralized network.
Removed
Additionally, there can be no assurance that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value or that we will make any cash distributions to our stockholders.
Added
During times of market instability, we may not be able to sell our Litecoin at favorable prices or at all.
Removed
The process of continuing to evaluate our strategic alternatives may be costly, time-consuming and complex, and we may incur significant legal, accounting and advisory fees and other expenses, some of which may be incurred regardless of whether we successfully enter into a transaction. We may also incur additional unanticipated expenses in connection with this process.
Added
Further, any Litecoin we hold with our custodians and transact with our trade execution partners does not enjoy the same protections as are available to cash or securities deposited with or transacted by institutions subject to regulation by the Federal Deposit Insurance Corporation or the Securities Investor Protection Corporation.
Removed
Any such expenses will decrease the remaining cash available for use in our business. Our ability to pursue or consummate strategic transactions also depends upon our ability to retain certain of our employees, the loss of whose services may adversely impact the ability to 20 Table of Contents identify, negotiate and consummate such transaction.
Added
Additionally, we may be unable to enter into term loans or other capital raising transactions collateralized by our unencumbered Litecoin or otherwise generate funds using our Litecoin holdings, including in particular during times of market instability or when the price of Litecoin has declined significantly.
Removed
If we are unable to successfully retain certain of our key remaining personnel, we are at risk of a disruption to our exploration and consummation of one or more strategic transactions. In addition, potential counterparties in a strategic transaction involving us may place minimal or no value on our assets and our public listing.
Added
If we are unable to sell our Litecoin, enter into additional capital raising transactions using Litecoin as collateral, or otherwise generate funds using our Litecoin holdings, or if we are forced to sell our Litecoin at a significant loss, in order to meet our working capital requirements, our business and financial condition could be negatively impacted.
Removed
Further, should we resume the development of future drug candidates, such as one or more of the programs in our pipeline for which we halted further development, the development and any potential commercialization of our future drug candidates will require substantial additional cash to fund the costs associated with conducting the necessary preclinical and clinical testing and obtaining regulatory approval.
Added
The launch of central bank digital currencies (CBDCs) may adversely impact our business. The introduction of a government-issued digital currency could eliminate or reduce the need or demand for private-sector issued crypto currencies, or significantly limit their utility.
Removed
Consequently, any potential counterparty in a strategic transaction involving us may choose not to spend additional resources to resume or continue development of our future drug candidates and may attribute little or no value, in such a transaction, to our future drug candidates.
Added
National governments around the world could introduce CBDCs, which could in turn limit the size of the market opportunity for cryptocurrencies, including Litecoin. We may be subject to regulatory developments related to crypto assets and crypto asset markets, which could adversely affect our business, financial condition and results of operations.
Removed
In addition, any strategic transactions that we may pursue could have a variety of negative consequences, and we may enter into a transaction that yields unexpected results that adversely affect our business and decreases the remaining cash available for use in our business.
Added
As Litecoin and other digital assets are relatively novel and the application of state and federal securities laws and other laws and regulations to digital assets is unclear in certain respects, it is possible that regulators in the United States or foreign countries may interpret or apply existing laws and regulations in a manner that adversely affects the price of Litecoin.
Removed
Any potential transaction would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, the interest of third parties in a potential transaction with us, obtaining stockholder approval and the availability of financing to third parties in a potential transaction with us on reasonable terms.
Added
The U.S. federal government, states, regulatory agencies and foreign countries may also enact new laws and regulations, or pursue regulatory, legislative, enforcement or judicial actions, that could materially impact the price of Litecoin or the ability of individuals or institutions such as us to own or transfer Litecoin.
Removed
There can be no assurance that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated, lead to increased stockholder value, or achieve the anticipated results.
Added
If Litecoin is determined to constitute a security for purposes of the federal securities laws, the additional regulatory restrictions imposed by such a determination could adversely affect the market price of Litecoin and in turn adversely affect the market price of our common stock.
Removed
If we are not successful in setting forth a new strategic path for us, or if our plans are not executed in a timely fashion, this may cause reputational harm with our stockholders and the value of our securities may be adversely impacted.
Added
Moreover, the risks of us engaging in a Litecoin treasury strategy could create complications due to the lack of 19 Table of Contents experience that third parties have with companies engaging in such a strategy, such as increased costs of director and officer liability insurance or the potential inability to obtain such coverage on acceptable terms in the future.
Removed
In addition, speculation regarding any developments related to the review of strategic alternatives and perceived uncertainties related to the future of us could cause our stock price to fluctuate significantly.
Added
Regulatory change reclassifying Litecoin as a security could lead to our falling within the definition of “investment company” under the Investment Company Act of 1940, as amended, or the 1940 Act and could adversely affect the market price of Litecoin and the market price of our common stock.
Removed
Even if we successfully consummate any strategic transaction, or series of transactions, from our strategic assessment, we may fail to realize all or any of the anticipated benefits of any such transaction, such benefits may take longer to realize than expected, we may encounter integration difficulties or we may be exposed to other operational and financial risks.
Added
Under Sections 3(a)(1)(A) and (C) of the 1940 Act, a company generally will be deemed to be an “investment company” for purposes of the 1940 Act if (1) it is, or holds itself out as being, engaged primarily, or proposes to engage primarily, in the business of investing, reinvesting or trading in securities or (2) it is engaged, or proposes to engage, in the business of investing, reinvesting, owning, holding or trading in securities and it owns or proposes to acquire investment securities having a value exceeding 40% of the value of its total assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis.
Removed
Our ability to realize the anticipated benefits of any potential strategic transaction will depend on a number of factors, including our ability to integrate with any future business partner, our ability to obtain value for portions of our business, if divested, and our ability to generate future stockholder value.
Added
While the SEC has not stated a view as to whether Litecoin is or is not a “security” for purposes of the federal securities laws, a determination by the SEC or a court of competent jurisdiction that Litecoin is a security could lead to our meeting the definition of “investment company” under the 1940 Act, if the portion of our assets that consists of investments in Litecoin exceeds the 40% limit prescribed in the 1940 Act, which would subject us to significant additional regulatory requirements that could have a material adverse effect on our business and operations and may also require us to change the manner in which we conduct our business.
Removed
The process may be disruptive to our business, and the expected benefits may not be achieved within the anticipated time frame, or at all. The failure to overcome the challenges involved and to realize the anticipated benefits of any potential transaction could adversely affect our business and financial condition.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

5 edited+2 added−0 removed14 unchanged
Biggest changeWe routinely assess material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information systems or any information residing within these systems. 30 Table of Contents We conduct periodic risk assessments to identify cybersecurity threats, as well as assessments in the event of a material change in our business practices that may affect information systems that are vulnerable to such cybersecurity threats.
Biggest changeWe routinely assess material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information systems or any information residing within these systems.
Our Acting Chief Executive Officer, CFO and Vice President of Information Technology, are responsible for assessing and managing our material risks from cybersecurity threats and have decades of experience in overseeing operations, including information technology functions, in the public company environment.
Our Acting Chief Executive Officer, CFO and Senior Director, Information Security and Infrastructure, are responsible for assessing and managing our material risks from cybersecurity threats and have decades of experience in overseeing operations, including information technology functions, in the public company environment.
Our management team, including our Acting Chief Executive Officer, Chief Financial Officer and Vice President of Information Technology, provide periodic briefings to the Audit Committee regarding our cybersecurity risks and activities, including any recent cybersecurity incidents and related responses, if applicable. The Audit Committee receives annual reports from management on our cybersecurity risks.
Our management team, including our Acting Chief Executive Officer and Chief Financial Officer and Senior Director, Information Security and Infrastructure, provide periodic briefings to the Audit Committee regarding our cybersecurity risks and activities, including any recent cybersecurity incidents and related responses, if applicable. 29 Table of Contents The Audit Committee receives annual reports from management on our cybersecurity risks.
Primary responsibility for assessing, monitoring and managing our cybersecurity risks rests with the Vice President of Information Technology who reports to our Acting Chief Executive Officer, Chief Financial Officer to manage the risk assessment and mitigation process.
Primary responsibility for assessing, monitoring and managing our cybersecurity risks rests with the Senior Director, Information Security and Infrastructure who reports to our Acting Chief Executive Officer and Chief Financial Officer to manage the risk assessment and mitigation process.
The cybersecurity risk management program also includes tools and activities to prevent, detect, and analyze current and emerging cybersecurity threats, and plans and strategies to address threats and incidents. Item 2. Properties We occupy approximately 45,100 square feet of office space in San Diego, California under a lease that expires September 30, 2024.
The cybersecurity risk management program also includes tools and activities to prevent, detect and analyze current and emerging cybersecurity threats and plans and strategies to address threats and incidents. Item 2. Properties None Item 3.
Added
We conduct periodic risk assessments to identify cybersecurity threats, as well as assessments in the event of a material change in our business practices that may affect information systems that are vulnerable to such cybersecurity threats.
Added
Legal Proceedings We are not currently party to a material legal proceeding that we believe will have a material adverse effect on our business or financial conditions. Item 4. Mine Safety Disclosures Not applicable. PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

43 edited+20 added−23 removed31 unchanged
Biggest changeOur future capital requirements will depend on many factors, including: • the Board's decision regarding strategic alternatives; • the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our product candidates; • the costs, timing and outcome of regulatory review of our product candidates; • the costs of establishing or contracting for sales, marketing and distribution capabilities if we obtain regulatory approvals to market our product candidates; • the costs of securing and producing drug substance and drug product material for use in preclinical studies, clinical trials and for use as commercial supply; • the costs of securing manufacturing arrangements for development activities and commercial production; • the scope, prioritization and number of our research and development programs; • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under future collaboration agreements, if any; and • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims.
Biggest changeFor additional details regarding these agreements, see the section titled Note 8—Other License Agreements and Note 6—Commitments and Contingencies to our consolidated financial statements and related notes included elsewhere in this Annual Report; • Obligations under contracts which are cancelable without significant penalty; • Purchase orders issued in the ordinary course of business as they represent authorizations to purchase the items rather than binding agreements; and Our future capital requirements will depend on many factors, including: • the scope and nature of our Litecoin Treasury Strategy; • the scope, progress, results and costs of drug discovery, pre-clinical development, laboratory testing and clinical trials for our product candidates; • the costs, timing and outcome of regulatory review of our product candidates; • the costs of establishing or contracting for sales, marketing and distribution capabilities if we obtain regulatory approvals to market our product candidates; • the costs of securing and producing drug substance and drug product material for use in pre-clinical studies, clinical trials and for use as commercial supply; • the costs of securing manufacturing arrangements for development activities and commercial production; • the scope, prioritization and number of our research and development programs; • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under future collaboration agreements, if any; and 36 Table of Contents • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims.
Research and Development Costs Research and development costs are expensed as incurred and include costs paid to third-party contractors to perform research, conduct clinical trials and develop and manufacture drug materials. Clinical trial costs, including costs associated with third-party contractors, are a significant component of research and development expenses and we expense research and development costs based on work performed.
Research and Development Costs Research and development costs are expensed as incurred and include costs paid to third-party contractors to perform research, conduct clinical trials and develop and manufacture drug materials. Clinical trial costs, including costs associated with third-party contractors, are a significant component of R&D expenses and we expense R&D costs based on work performed.
To date, we have obtained cash and funded our operations primarily through equity financings and license agreements and to resume the development of our drug candidates we would require one or more capital transactions, whether through the sale of equity securities, debt financing, license agreements or entry into strategic partnerships at some point in the future.
To date, we have obtained cash and funded our operations primarily through equity financings and license agreements and to resume the development of our drug candidates we would require one or more capital transactions, whether through the sale of equity 35 Table of Contents securities, debt financing, license agreements or entry into strategic partnerships at some point in the future.
The weighted-average exercise price presented is the weighted-average exercise price of vested and unvested options. 32 Table of Contents Item 6. [Reserved] Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis should be read in conjunction with Item 8. Consolidated Financial Statements and Supplementary Data included below in this Annual Report.
The weighted-average exercise price presented is the weighted-average exercise price of vested and unvested options. Item 6. [Reserved] Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis should be read in conjunction with Item 8. Consolidated Financial Statements and Supplementary Data included below in this Annual Report.
Except as provided below, there have been no material changes from the critical accounting estimates identified below nor our significant accounting policies set forth in Note 2.
Except as provided below, there have been no material changes from the critical accounting estimates identified below nor our significant accounting policies set forth in Note 2. Summary of Significant Accounting Policies .
During the fiscal year ended June 30, 2024, we recorded long-lived asset impairment charges of $10.9 million. During the fiscal year ended June 30, 2023, we had no similar charge.
During the fiscal year ended June 30, 2024, we recorded long-lived asset impairment charges of $10.9 million. During the fiscal year ended June 30, 2025, we had no similar charge.
The total dividend of $11.7 million was paid on December 6, 2023, and was recorded as a reduction of additional paid-in capital in the consolidated statements of stockholders' equity, as we have an accumulated deficit, rather than retained earnings.
The total dividend of $11.7 million was paid on 32 Table of Contents December 6, 2023 and was recorded as a reduction of additional paid-in capital in the consolidated statements of stockholders' equity, as we have an accumulated deficit, rather than retained earnings.
(2) Consists of 86,263 shares of common stock issuable upon exercise of options granted under the MEI Pharma, Inc. 2021 Inducement Plan (Inducement Plan), under which 217,000 shares of common stock are authorized for issuance. The Inducement Plan provides for the grant of options and/or other stock-based or stock-denominated awards to attract and retain selected individuals to serve as employees.
(2) Consists of 53,302 shares of common stock issuable upon exercise of options granted under the MEI Pharma, Inc. 2021 Inducement Plan (Inducement Plan), under which 217,000 shares of common stock are authorized for issuance. The Inducement Plan provides for the grant of options and/or other stock-based or stock-denominated awards to attract and retain selected individuals to serve as employees.
All forward-looking statements included in this Annual Report are based on the information available to us as of the time we file this Annual Report, and except as required by law, we undertake no obligation to update publicly or revise any forward-looking statements. Overview MEI Pharma, Inc.
All forward-looking statements included in this Annual Report are based on the information available to us as of the time we file this Annual Report and except as required by law, we undertake no obligation to update publicly or revise any forward-looking statements.
A contract’s transaction price is allocated among each distinct performance obligation based on relative standalone selling price and recognized as revenue when, or as, the applicable performance obligation is satisfied.‌ The terms of our arrangements include upfront and license fees, research and development services, milestone and other contingent payments for the achievement of defined objectives and certain preclinical, clinical, regulatory and sales-based events, as well as royalties on sales of commercialized products.
A contract’s transaction price is allocated among each distinct performance obligation based on relative standalone selling price and recognized as revenue when, or as, the applicable performance obligation is satisfied.‌ The terms of our arrangements include upfront and license fees, R&D services, milestone and other contingent payments for the achievement of defined objectives and certain pre-clinical, clinical, regulatory and sales-based events, as well as royalties on sales of commercialized products.
Summary of Significant Accounting Policies . 34 Table of Contents Impairment of Long-Lived Assets (Property and Equipment, and Intangible Assets) In accordance with the authoritative guidance for impairment or disposal of long-lived assets Accounting Standards Codification (ASC) Topic 360, Property, Plant and Equipment (ASC 360), we assess potential impairments to our long-lived assets, including property, equipment and right-of-use assets, when there is evidence that events or changes in circumstances indicate that the carrying value may not be recoverable.
Impairment of Long-Lived Assets (Property and Equipment and Intangible Assets) In accordance with the authoritative guidance for impairment or disposal of long-lived assets Accounting Standards Codification (ASC) Topic 360, Property, Plant and Equipment (ASC 360), we assess potential impairments to our long-lived assets, including property, equipment and right-of-use assets, when there is evidence that events or changes in circumstances indicate that the carrying value may not be recoverable.
Our Board has appointed Justin J. File, our current Chief Financial Officer, to assume the position of Acting Chief Executive Officer and has appointed Frederick W. Driscoll as Chairperson of the Board.
File, our current Chief Financial Officer, to assume the position of Acting Chief Executive Officer and appointed Frederick W. Driscoll as Chairperson of the Board.
We continue to re-evaluate the transaction price in each reporting period as contingencies are resolved and other changes in circumstances occur.‌ Revenue recognition is subject to uncertainty due to the variable consideration estimates required to be made. These estimates include the level of effort required to satisfy our obligations under our research and development services arrangements.
We continue to re-evaluate the transaction price in each reporting period as contingencies are resolved and other changes in circumstances occur.‌ 33 Table of Contents Revenue recognition is subject to uncertainty due to the variable consideration estimates required to be made. These estimates include the level of effort required to satisfy our obligations under our R&D services arrangements.
Prior to June 30, 2024, the Termination Amounts had been paid and we had no further financial obligations under the Agreement. 37 Table of Contents As of June 30, 2024, we have the following potential purchase obligations for which the timing and/or likelihood of occurrence is unknown; however, if such claims arise in the future, they could have a material effect on our financial position, results of operations, and cash flows. • Under our remaining license agreements, we have payment obligations, which are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones and are required to make royalty payments in connection with the sales of products developed under those agreements.
As of June 30, 2025, we have the following potential purchase obligations for which the timing and/or likelihood of occurrence is unknown; however, if such claims arise in the future, they could have a material effect on our financial position, results of operations and cash flows. • Under our remaining license agreements, we have payment obligations, which are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones and are required to make royalty payments in connection with the sales of products developed under those agreements.
We commenced a reduction-in-force beginning August 1, 2024, which will continue in stages as our operational and strategic direction evolves. We have discontinued the clinical development of voruciclib, while certain nonclinical activities related to MEI’s drug candidate assets will continue to be conducted by us.
We commenced a reduction-in-force beginning August 1, 2024, which continued in stages as our operational and strategic direction evolved. In connection with this evaluation, we discontinued the clinical development of voruciclib, while certain nonclinical activities related to our drug candidate assets will continue to be conducted by us.
Costs incurred related to the purchase or 35 Table of Contents licensing of in-process research and development for early-stage products or products that are not commercially viable and ready for use, or have no alternative future use, are charged to expense in the period incurred.
Costs incurred related to the purchase or licensing of in-process R&D for early-stage products or products that are not commercially viable and ready for use, or have no alternative future use, are charged to expense in the period incurred.
General and Administrative : General and administrative expenses decreased $9.8 million to $23.3 million for the fiscal year ended June 30, 2024, compared to $33.1 million for the fiscal year ended June 30, 2023.
General and Administrative : General and administrative expenses decreased $9.8 million to $13.5 million for the fiscal year ended June 30, 2025, compared to $23.3 million for the fiscal year ended June 30, 2024.
Net cash provided by investing activities for the fiscal year ended June 30, 2024, was $49.1 million compared to $53.7 million for the fiscal year ended June 30, 2023.
Net cash provided by investing activities for the fiscal year ended June 30, 2025, was $35.2 million compared to $49.1 million for the fiscal year ended June 30, 2024.
Sources and Uses of Our Cash Net cash used in operating activities for the fiscal year ended June 30, 2024, of $50.5 million consisted of our net income of $17.8 million and $84.3 million cash used by operating activities partially offset by $16.0 million for noncash items.
Net cash used in operating activities during the fiscal year ended June 30, 2024, of $50.5 million consisted of our net income of $17.8 million and $84.3 million associated with changes in our assets and liabilities used in our operations partially offset by $16.0 million of noncash items.
Leases , and a $0.5 million loss recognized related to the furniture and fixtures we agreed to sell to our landlord, as more fully described in Note 3 - Balance Sheet Details , recorded in accordance with Accounting Standards Codification 360 - Property. Plant and Equipment . During the fiscal year ended June 30, 2023, there were no similar transactions.
Leases ) and our furniture and fixtures we agreed to sell to our landlord (which is more fully described in Note 3 - Balance Sheet Details , recorded in accordance with Accounting Standards Codification 360 - Property, Plant and Equipment ), respectively. During the fiscal year ended June 30, 2025, there were no similar transactions.
Cooperation Agreement On October 31, 2023, we announced our entry into a Cooperation Agreement (Cooperation Agreement) with Anson Funds Management LP and Cable Car Capital LLC (Anson and Cable Car, respectively), which, among other non-financial related items provided for a capital return to stockholders in the form of a dividend in the amount of $1.75 per share of common stock, as further discussed below.
Cooperation Agreement and Cash Dividend On October 31, 2023, we announced our entry into a cooperation agreement with Anson Funds Management LP and Cable Car Capital LLC (Cooperation Agreement), which, among other non-financial related items, provided for a capital return to stockholders in the form of a dividend in the amount of $1.75 per share of common stock that was declared on November 6, 2023 to stockholders of record at the close of business on November 17, 2023 (Cooperation Agreement).
Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is listed on the Nasdaq Capital Market under the symbol MEIP. Holders As of September 13, 2024, there were 6,662,857 shares of our common stock outstanding and 321 holders of record of our common stock.
Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is listed on the Nasdaq Capital Market under the symbol LITS. Holders As of September 23, 2025, there were 35,655,155 shares of our common stock outstanding and 315 holders of record of our common stock.
In connection with the exploration of strategic alternatives, we commenced a reduction-in-force on August 1, 2024 and discontinued the clinical development of voruciclib. As a result of this announcement, we expect our research and development expenses to decrease significantly as we discontinued our clinical research and development activities.
In connection with the exploration of strategic alternatives, we commenced a reduction-in-force on August 1, 2024 and discontinued the clinical development of voruciclib. As a result of this announcement, our R&D expenses decreased significantly as we discontinued our clinical R&D activities. We are currently assessing the recommencement of pre-clinical development of our two drug candidates.
Clinical Development Programs Our drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 (CDK9) inhibitor and ME-344, an intravenous small molecule mitochondrial inhibitor targeting the oxidative phosphorylation pathway. For a more complete discussion of our business, see the section of this Annual Report Item 1. Business above.
Clinical Development Programs Our drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 (CDK9) inhibitor and zandelisib, an oral, once-daily, selective PI3Kδ inhibitor. 31 Table of Contents For a more complete discussion of our business, see the section of this Annual Report Item 1. Business above.
The increase from prior year was primarily due to the payment of $11.7 million in dividends agreed to under the Cooperation Agreement and the payment of approximately $0.2 million for issuance costs of our ATM. Cash used in financing activities during fiscal year 2023, was associated with the payment of tax withholdings related to vesting of restricted stock units.
The decrease from prior year was primarily due to the payment of $11.7 million in dividends agreed to under the Cooperation Agreement and the payment of approximately $0.2 million for issuance costs of our ATM Program during fiscal 2024, with no financing activities occurring during fiscal year 2025.
Capital Resource Requirements On June 18, 2024, we entered into a lease termination agreement (Agreement) with our landlord, for our offices at 11455 El Camino Real, Suite 200 and Suite 250, San Diego, California. Under the Agreement, the lease will be terminated as of September 30, 2024, rather than its scheduled expiration date of November 30, 2029.
Capital Resource Requirements On June 18, 2024, we entered into a lease termination agreement (Agreement) with our landlord, for our offices at 11455 El Camino Real, Suite 200 and Suite 250, San Diego, California.
Consolidated Financial Statements and Supplementary Data of this Annual Report. Liquidity and Capital Resources We have accumulated losses of $388.2 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of June 30, 2024, we had $38.3 million in cash, cash equivalents and short-term investments.
Liquidity and Capital Resources We have accumulated losses of $404.2 million since inception and expect to incur operating losses and generate negative cash flows from operations for the foreseeable future. As of June 30, 2025, we had $18.0 million in cash and cash equivalents.
We paid the landlord a termination fee totaling approximately $11.1 million in addition to prepaying the remaining rent under the Agreement in the amount of approximately $0.2 million (collectively, the Termination Amounts).
Under the Agreement, the lease terminated as of September 30, 2024, rather than its scheduled expiration date of November 30, 2029 and we paid the landlord a termination fee totaling approximately $11.1 million in addition to prepaying the remaining rent under the Agreement in the amount of approximately $0.2 million (collectively, the Termination Amounts).
Plan Category Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) Weighted-average exercise price of outstanding options, warrants and rights (b) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c) Equity compensation plans approved by security holders (1) 1,270,950 $ 32.50 465,633 Equity compensation plans not approved by security holders (2) 86,263 18.25 130,737 Total 1,357,213 $ 31.60 596,370 (1) Consists of 1,270,950 shares of common stock issuable upon exercise of options granted under the MEI Pharma, Inc.
Plan Category Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) Weighted-average exercise price of outstanding options, warrants and rights (b) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c) Equity compensation plans approved by security holders (1) 815,846 $ 34.66 920,737 Equity compensation plans not approved by security holders (2) 53,302 6.01 163,698 Total 869,148 $ 32.90 1,084,435 (1) Consists of 815,846 shares of common stock issuable upon exercise of options granted under the MEI Pharma, Inc.
(Nasdaq: MEIP) is a pharmaceutical company that has been developing novel and differentiated cancer therapies. We built our pipeline by acquiring promising cancer agents and creating value in programs through clinical development, strategic partnerships, and out-licensing or commercialization, as appropriate.
Overview On September 10, 2025, MEI Pharma, Inc. changed its name to Lite Strategy, Inc. and its ticker symbol to LITS. We are a pharmaceutical company that has been developing novel and differentiated cancer therapies. We built our pipeline by acquiring promising cancer agents and creating value in programs through clinical development, strategic partnerships and out-licensing or commercialization, as appropriate.
Our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in changes in our estimates.
Our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in changes in our estimates. As of June 30, 2025, we had no active clinical trial programs.
Net cash used in financing activities for the fiscal year ended June 30, 2024, was $11.9 million compared to $40,000 of cash used in financing activities for the fiscal year ended June 30, 2023.
During the fiscal year ended June 30, 2024, cash used in financing activities totaled $11.9 million.
Securities authorized for issuance under equity compensation plans The table below shows, as of June 30, 2024, information for equity compensation plans previously approved by stockholders and for compensation plans not previously approved by stockholders.
Any future determination related to our dividend policy will be made at the discretion of our board of directors. 30 Table of Contents Securities authorized for issuance under equity compensation plans The table below shows, as of June 30, 2025, information for equity compensation plans previously approved by stockholders and for compensation plans not previously approved by stockholders.
The decrease in net cash provided by investing activities was due to fewer purchases of short-term investments offset by a lower amount of maturities in short-term investments being utilized to fund ongoing operations during the fiscal year ended June 30, 2024.
The decrease in net cash provided by investing activities was due to a greater investment balance and maturities in fiscal year ended June 30, 2024 as compared to June 30, 2025 with the matured investments utilized to fund ongoing operations during each of the fiscal years. During fiscal year ended June 30, 2025, we had no financing activities.
As part of the review of strategic alternatives, we may consider options such as out-licensing opportunities for existing programs and merger and acquisition opportunities. Consistent with our intention to preserve cash, David M. Urso, our President and Chief Executive Officer, and Richard Ghalie, MD, our Chief Medical Officer, have stepped down effective August 1, 2024. Mr.
As part of the review of strategic alternatives, we considered options such as out-licensing opportunities for or the sale of our existing programs and merger and acquisition opportunities, as well as other potential opportunities. Consistent with our intention to preserve cash, David M.
We do not anticipate paying additional cash dividends in the foreseeable future other than in connection with a strategic transaction which requires it, and currently intend to retain all available funds and future earnings, if any, to support operations. Any future determination related to our dividend policy will be made at the discretion of our board of directors.
We do not anticipate paying additional cash dividends in the foreseeable future and currently intend to retain all available funds and future earnings, if any, to support operations.
Results of Operations Comparison of Fiscal Years Ended June 30, 2024 and 2023 The following table summarizes certain components of our results of operations (in thousands): For the Fiscal Year Ended June 30, 2024 2023 $ Change % Change Revenues $ 65,297 $ 48,816 $ 16,481 33.8 % Research and development 16,561 52,450 (35,889 ) (68.4 )% General and administrative 23,295 33,130 (9,835 ) (29.7 )% Impairment of long-lived assets 10,899 — 10,899 100.0 % Other income, net 3,236 4,926 (1,690 ) (34.3 )% Revenue: We recognized revenue of $65.3 million for the fiscal year ended June 30, 2024, compared to $48.8 million for the fiscal year ended June 30, 2023.
Results of Operations Comparison of Fiscal Years Ended June 30, 2025 and 2024 The following table summarizes certain components of our results of operations (in thousands): For the Fiscal Year Ended June 30, 2025 2024 $ Change % Change Revenues $ — $ 65,297 $ (65,297 ) (100.0 )% Research and development 3,923 16,561 (12,638 ) (76.3 )% General and administrative 13,532 23,295 (9,763 ) (41.9 )% Impairment of long-lived assets — 10,899 (10,899 ) (100.0 )% Other income, net 1,510 3,236 (1,726 ) (53.3 )% Revenue: During the fiscal year ended June 30, 2025, we recognized no revenue due to all deferred revenue associated with the KKC Commercialization Agreement having been recognized in fiscal year 2024, upon entry into the Termination Agreement.
Research and Development : The following table illustrates the components of our research and development expenses for the years presented (in thousands): For the Fiscal Year Ended June 30, 2024 2023 zandelisib $ 435 $ 25,900 voruciclib 3,413 2,335 ME-344 4,724 1,137 Other 7,989 23,078 Total research and development expenses $ 16,561 $ 52,450 Costs related to zandelisib decreased $25.5 million primarily as a result of the discontinuation of the program during fiscal year 2023 with lower costs in fiscal year 2024 associated with wind-down activities.
During the fiscal year ended June 30, 2024, we recognized revenue of $65.3 million from the KKC Commercialization Agreement. 34 Table of Contents Research and Development : The following table illustrates the components of our research and development expenses for the years presented (in thousands): For the Fiscal Year Ended June 30, 2025 2024 zandelisib $ (18 ) $ 435 voruciclib 801 3,413 ME-344 253 4,724 Other 2,887 7,989 Total research and development expenses $ 3,923 $ 16,561 Research and development costs decreased by $12.6 million to $3.9 million for the fiscal year ended June 30, 2025, compared to $16.6 million for the fiscal year ended June 30, 2024.
Urso also left the Board at that date. We have entered into consulting agreements with both Mr. Urso and Dr. Ghalie under which they will remain available to assist us in our strategic efforts. Charles V. Baltic III, the Chairperson of the Board, also stepped down from the Board contemporaneously with the announcement on July 22, 2024.
In addition, we entered into a consulting agreement with Mr. Urso, which was terminated in February 2025. Charles V. Baltic III, the Chairperson of the Board, also stepped down from the Board contemporaneously with the announcement on July 22, 2024. Our Board appointed Justin J.
Net cash used in in operating activities during the fiscal year ended June 30, 2023, of $52.5 million consisted of our net loss of $31.8 million and $24.9 million cash used in operating activities partially offset by $4.3 million of noncash items.
Sources and Uses of Our Cash Net cash used in operating activities for the fiscal year ended June 30, 2025, of $20.8 million consisted of our net loss of $15.9 million and $4.9 million associated with changes in our operating assets and liabilities used in our operations.
Other Income, Net: Other income, net, decreased by $1.7 million to $3.2 million for the fiscal year ended June 30, 2024, as compared to $4.9 million for the fiscal year ended June 30, 2023.
Other Income, Net: Other income, net, decreased by $1.7 million to $1.5 million for the fiscal year ended June 30, 2025, as compared to $3.2 million for the fiscal year ended June 30, 2024. The decrease in other income, net, was due to lower average investment balances partially offset by a gain recognized on the sale of our ME-344 asset.
Impairment of Long-lived Assets : The impairment of our long-lived assets of $10.9 million consists of a $10.4 million loss recognized for our right-of-use (ROU) asset, as more fully described in Note 9.
These decreases were partially offset by increases in termination benefits of $3.6 million. Impairment of Long-lived Assets : During fiscal year 2024, we recognized impairment losses of $10.4 million and $0.5 million, on our long-lived assets related to our right-of-use (ROU) asset (which is more fully described in Note 9.
We recorded a noncash gain of $1.6 million during the fiscal year ended June 30, 2023, due to a change in the fair value of our warrant liability. The warrants expired in May 2023. New Accounting Pronouncements See Note 2. Summary of Significant Accounting Policies , to the Consolidated Financial Statements included in Item 8.
New Accounting Pronouncements See Note 2. Summary of Significant Accounting Policies , to the Consolidated Financial Statements included in Item 8. Consolidated Financial Statements and Supplementary Data of this Annual Report.
Removed
Additionally, the Cooperation Agreement contemplated a potential second return of capital not to exceed $9.33 million (Potential Second Return of Capital) if authorized by Board should our ongoing ME-344 Phase 1b trial fail to meet certain defined endpoints or our Board determines not to proceed with a second cohort.
Added
Urso, our President and Chief Executive Officer and Richard Ghalie, MD, our Chief Medical Officer, stepped down effective August 1, 2024. Mr. Urso also left the Board at that date. We entered into a consulting agreement with Dr. Ghalie under which he remains available to assist us in strategic efforts or ongoing operations.
Removed
In April 2024, the Board unanimously determined not to proceed with the Potential Second Return of Capital under the Cooperation Agreement in order to conserve resources and align strategic investment, and thereby extend our operational runway. As part of the Cooperation Agreement, Anson and Cable Car withdrew their consent solicitation and agreed to abide by customary standstill provisions.
Added
The evaluation of strategic alternatives concluded with the August 2025 implementation of our Litecoin Treasury Strategy and a commitment to long-term innovation in capital structure and financial technology, along with the initiation of an expanding strategy that could include the commencement of Litecoin mining activities, as well as our continued assessment of pre-clinical activities with our drug candidate pipeline, as to which we anticipate conducting further investigational research and development in the next several months.
Removed
Additionally, we reimbursed Anson's and Cable Car’s fees and expenses related to their engagement 33 Table of Contents with us as of the date of the Cooperation Agreement in an amount of $1.1 million, which is recorded within general and administrative expenses in the consolidated statements of operations for the fiscal year ended June 30, 2024.
Added
Private Investment in Private Equity (PIPE) and Related Agreements As more fully discussed in Note 15.
Removed
Cash Dividend On November 6, 2023, pursuant to the Cooperation Agreement, the Board declared a special cash dividend of $1.75 per share of common stock to stockholders of record at the close of business on November 17, 2023.
Added
Subsequent Events , in July 2025, we closed on a $100.0 million PIPE and issued an aggregate of (i) 23,216,898 shares (the Shares) of our common stock, at an offering price of $3.42 per share and (ii) pre-funded warrants (the Pre-Funded Warrants (together with the common stock, the Securities)), to purchase up to an aggregate of 6,022,869 shares of our common stock (the Pre-Funded Warrant Shares) at an offering price of $3.4199 per Pre-Funded Warrant (collectively, the Offering).
Removed
Equity Transactions Shelf Registration Statement We have a shelf registration statement (February 2024 Shelf Registration Statement) that permits us to sell, from time to time, up to $100.0 million of common stock, preferred stock, warrants rights and units subject to the "Baby Shelf Limitation" described below.
Added
On July 24, 2025, Pre-Funded Warrants for the purchase of 2,084,509 shares of common stock were exercised for a de minimis amount of cash proceeds. As of September 23, 2025, we issued 2,807,967 shares of common stock upon cashless exercises of 2,808,070 Pre-Funded Warrants. Also, in July 2025 and as more fully discussed in Note 15.
Removed
The February 2024 Shelf Registration Statement was filed February 20, 2024 and declared effective February 28, 2024. At-The-Market Equity Offering On February 20, 2024, we entered into a capital on demand sales agreement with JonesTrading Institutional Services LLC, pursuant to which we can offer and sell shares having an aggregate offering price of up to $25.0 million (ATM Program).
Added
Subsequent Events , we entered into various agreements with certain advisors to the PIPE, asset managers and custodians who will deploy our Litecoin Investment Strategy, including but not limited to: (i) a placement agency agreement, (ii) an asset management agreement, (iii) an advisory agreement, (iv) a strategic advisor agreement and (v) a new at-the-market sales agreement.
Removed
In no event will we sell securities registered on this registration statement in a public primary offering with a value exceeding more than one-third of our public float in any 12-month period so long as our public float remains below $75 million (Baby Shelf Limitation).
Added
In connection with these various agreements associated with the PIPE, we issued warrants for the purchase of up to 3,070,177 shares of our common stock with a weighted-average exercise price of approximately $4.10 per share.
Removed
As of January 2, 2024, the date used under applicable rules of the Securities and Exchange Commission to determine our public float at the commencement of the offering, one-third of our public float was equal to approximately $9.9 million. As of June 30, 2024, no shares have been issued and sold under our ATM Program.
Added
On September 24, 2025, as payment of the annual Asset-based Fee under the Asset Management Agreement, we issued to GSR, 546,348 Pre-Funded Warrants with an exercise price of $0.0001 per share. Subject to the limitations on exercise set forth in the warrant agreement, the Pre-Funded Warrants may be exercised at any time until they are exercised in full.
Removed
Rights Agreement On October 1, 2023, our Board approved and adopted a rights agreement (Rights Agreement) by and between us and Computershare, Inc., as Rights Agent (as defined in the Rights Agreement).
Added
Litecoin Treasury Strategy On August 5, 2025, we announced the commencement of our primary reserve asset and implementation strategy built on a digital asset infrastructure and long-term capital innovation (a Litecoin Treasury Strategy) through our acquisition of Litecoin (LTC) tokens, reflecting the full deployment of the net proceeds of the PIPE.
Removed
Pursuant to the Rights Agreement, the Board declared a dividend of one preferred share purchase right (each, a Right) for each outstanding share of our common stock, par value $0.00000002 (each, a Common Share and collectively, the Common Shares). The Rights are distributable to stockholders of record as of the close of business on October 12, 2023.
Added
Litecoin is an open source, global payment network that is fully decentralized without any central authorities. Mathematics secures the network and empowers individuals to control their own finances. Litecoin features faster transaction confirmation times and improved storage efficiency than the leading math-based currency.
Removed
One Right also will be issued together with each Common Share issued by us after October 12, 2023, but before the Distribution Date (as defined in the Rights Agreement) (or the earlier of the redemption or expiration of the Rights) and, in certain circumstances, after the Distribution Date.
Added
We believe this strategy will allow us to diversify reserves, enhance capital efficiency and align with emerging financial technologies.
Removed
Warrants In May 2023, outstanding warrants to purchase 802,949 shares of our common stock expired. The warrants were fully vested and exercisable at a price of $50.80 per share.
Added
Effective July 22, 2025, in conjunction with the closing of the Offering, the parties to the Cooperation Agreement mutually agreed to terminate such Cooperation Agreement. Merger Termination At a special meeting of our stockholders held on July 23, 2023, stockholders voted on the agreement and plan of merger (Merger Agreement) entered into in February 2023, by us, Infinity Pharmaceuticals, Inc.
Removed
Pursuant to the terms of the warrants, we could have been required to settle the warrants in cash in the event of an acquisition of the company and, as a result, the warrants were required, prior to their expiration, to be measured at fair value and reported as a liability in the consolidated balance sheets.
Added
(Infinity) and Meadow Merger Sub, Inc., our wholly owned subsidiary (Merger Sub). At such special meeting, the Merger Agreement did not obtain the necessary approval from our stockholders and, accordingly, on July 23, 2023, we sent Infinity a notice terminating the Merger Agreement.
Removed
As of June 30, 2022, the warrants were valued at $1.6 million. Prior to their expiration, the warrants had been revalued to $0, as of December 31, 2022. All corresponding changes in fair value were recorded as a component of other income (expense) in our consolidated statements of operations. The warrants expired in May 2023.
Added
This decrease was as a result of our announcement in July 2024 to explore strategic alternatives, at which time all clinical studies were ceased and we initiated reductions in our workforce, along with the ME-344 Sale (as defined in Note 13. Disposition of a Non-Financial Asset ).
Removed
As of June 30, 2024, we have outstanding warrants to purchase 102,513 shares of our common stock, all issued to Torreya Partners LLC in fiscal year 2023. The warrants are fully vested, exercisable at a price of $6.80 per share and expire in October 2027. No warrants were exercised during the years June 30, 2024 and 2023.
Added
This decrease was primarily a result of reduced legal and professional fees of $3.7 million due to various stockholder related items from the prior fiscal year with no current period recurrence.
Removed
In determining the amount to expense, management relies on estimates of total costs based on contract components completed, the enrollment of subjects, the completion of trials, and other events.
Added
Additionally, corporate overhead, employee related expense and noncash share-based compensation decreased by $3.4 million, $4.4 million and $1.9 million, respectively, primarily due to the termination of our lease and our announcement in July 2024 to explore strategic alternatives, at which time all administrative support activities related to clinical studies were ceased.
Removed
The increase in revenue was due to the recognition of all remaining deferred revenue associated with the KKC Commercialization Agreement that was terminated in July 2023, offset by a decrease in revenue recognized related to cost sharing from the terminated KKC Commercialization Agreement.
Added
We believe our current cash balance is sufficient to fund operations for at least the next 12 months. In July 2025, we entered into securities purchase agreements pursuant to which we sold common stock and Pre-Funded Warrants in a PIPE for aggregate net proceeds of $92.1 million, as more fully discussed in Note 15. Subsequent Events .
Removed
Costs related to voruciclib increased $1.1 million due to higher clinical costs partially offset by lower manufacturing costs. Costs related to ME-344 increased $3.6 million due to higher clinical costs related to the Phase 1b study and manufacturing costs of ME-344 to support clinical and nonclinical studies.
Added
In August 2025, we initiated a primary reserve asset and implementation strategy built on a digital asset infrastructure and long-term capital innovation (a Litecoin Treasury Strategy) through our acquisition of Litecoin (LTC) tokens, reflecting the deployment of the net proceeds of the PIPE. As more fully discussed in Note 15.
Removed
Other research and development costs decreased $15.1 million primarily due to a decrease of $14.1 million in personnel costs, including a $2.6 million decrease in one-time employee termination benefits, resulting from our reductions in workforce during fiscal year 2023 and a $0.4 million decrease in noncash stock-based compensation.

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