LENZ 10-K & 10-Q changes, risk factors and insider trading

•We are a pre-commercialcommercial biopharmaceuticalpharmaceutical company with limited operating history. We have incurred significant losses and negative cash flows from operations since our formation, and we anticipate that we will continue to incur losses asin our early stages of commercialization. Until recently, we seekdid approval and begin commercialization. Wenot have noany products approved for commercial sale,sale and we have not generated significant revenue from product sales, which may make it difficult for you to evaluate our current business and predict our future success and viability.

•Our business depends entirely on the development and commercialization of LNZ100,VIZZ® and we do not have additional product candidates in our current development pipeline. If we are unable to successfully complete our clinical development program for LNZ100 and obtain the marketing approvals necessary to commercialize LNZ100, or experience significant delays in doing so, or if after obtaining marketing approvals, we fail to commercialize LNZ100,VIZZ, our business will be materially harmed. We currently generate no revenue from sales of any products and may never generate revenue or be profitable.

•Even if LNZ100 or any other product candidate receives marketing approval, theyVIZZ may fail to achieve market acceptance by eye care professionals (“ECPs”) and patients,patients and the market opportunity for these products, if approved,VIZZ may be smaller than we estimate.

•We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop,VIZZ, our commercial opportunities will be negatively impacted. OurVIZZ product candidates may, if approved,may also face competition from existing branded, generic and off-label products.

•We contract with third parties for the manufacture of our product candidates for our ongoing clinical trials,product, and expect to continue to do so forin additionalconnection clinicalwith trialsour andcommercialization ultimately for commercialization.strategy. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or drugs or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

•The manufacture of drugs is complex and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers encounter such difficulties, our ability to provide adequate supply of LNZ100VIZZ for patients, if approved,patients could be delayed or prevented.

Risks Related to Our Limited Operating History, DevelopmentHistory and Commercialization of Our Product Candidates

We are a pre-commercialcommercial biopharmaceuticalpharmaceutical company with limited operating history. We have incurred significant losses and negative cash flows from operations since our formation, and we anticipate that we will continue to incur losses asin our early stages of commercialization. Until recently, we seekdid approval and begin commercialization. Wenot have noany products approved for commercial sale,sale and we have not generated significant revenue from product sales, which may make it difficult for you to evaluate our current business and predict our future success and viability.

We are a pre-commercialcommercial biopharmaceuticalpharmaceutical company with limited operating history. In July 2025, the FDA approved VIZZ (aceclidine ophthalmic solution) 1.44%, formerly known as LNZ100, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults, and we launched VIZZ commercially in the U.S. in August 2025. Our operations prior to such date have beenwere limited to organizing the company, raising capital, developing our product candidates and beginning to preparepreparing for commercialization, including building our commercial strategy, supply chain and distribution network. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history. In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. If LNZ100 is approved by the FDA, weWe will need to continue to further expand our commercialization infrastructure to successfully launchcommercialize such product.VIZZ. We have not yet demonstrated our ability to successfully obtain marketing approvals, complete arrangements for third parties to manufacture the commercial-scale product on our behalf, or conduct sales and marketing activities necessary for successfulsuccessful, large-scale, profitable product commercialization, and we may not be successful in suchdoing a transition.so.

WeUntil dorecently, we did not have any products approved for sale, we have not generated anysignificant revenue from the sale of products, we have incurred significant net losses since the company’s formation and we have funded our operations primarily from the sale and issuance of redeemable convertible preferred stock, common stock, and the Merger. Our net losses were $49.8$82.1 million and $70.0$49.8 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $145.0$227.1 million. Additionally, the net losses we incur may fluctuate significantly from year to year such that a period-to-period comparison of our results of operations may not be a good indicator of our future performance. The size of our future net losses and our ability to potentially achieve profitability will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.

We expect to continue incurring significant expenses and increasing operating losses as we seek approval and begincontinue commercialization. We anticipate that our expenses will increase substantially if and as we:

•seek foreign marketing approvals for our product candidates;

•maintain, protect, and expand our intellectual property portfolio; and

Our business depends entirely on the development and commercialization of LNZ100,VIZZ and we do not have additional product candidates in our current development pipeline. If we are unable to successfully complete our clinical development program for LNZ100 and obtain the marketing approvals necessary to commercialize LNZ100, or experience significant delays in doing so, or if after obtaining marketing approvals, we fail to commercialize LNZ100,VIZZ, our business will be materially harmed. We currently generate no revenue from sales of any products and may never generate revenue or be profitable.

We have devoted a significant portion of our financial resources and business efforts to the development of LNZ100 (now VIZZ) and LNZ101, both of which include aceclidine as an active ingredient, for the treatment of presbyopia. Based on the results of our Phase 3 CLARITY trials, we selected LNZ100 as our lead product candidate, for which we submitted an NDA to FDA in August 2024. In OctoberJuly 2024,2025, the FDA assignedapproved a Prescription Drug User Fee ActVIZZ ("PDUFA"aceclidine ophthalmic solution) target1.44%, actionthe datefirst and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults, and we launched such product commercially in the U.S. in August 8, 2025. WeProfessional canproduct providesample nodistribution assuranceby thatthe FDAsales willforce approveto optometrists and ophthalmologists and commercial product shipments to customers via our NDAe-pharmacy bypartner thiswere PDUFAinitiated targetin actionOctober date2025, orand atproduct all.became broadly available in retail pharmacies beginning in November 2025. We do not currently have other product candidates in our development pipeline, and our success depends entirely on LNZ100.VIZZ. WeUntil the approval of VIZZ, we did not have noany products approved for commercial sale and dowe have not anticipategenerated generating any revenue unless LNZ100 receives the regulatory approval necessary for commercialization. Our ability to generatesignificant revenue from product sales will depend on us obtaining marketing approval for and commercializing LNZ100, and we cannot accurately predict when or if LNZ100 will be determined by the FDAsale toof be effective in humans for the proposed indication or whether it will receive marketing approval.products. Our ability to generate revenue and achieve profitability also depends significantly on our ability, or any future collaborator’s ability, to achieve a number of objectives, including:

•completion of clinical studies inmaintaining compliance with regulatory requirements, including the FDA’s current Good ClinicalManufacturing PracticesPractice (“GCPscGMP”) with positive resultsrequirements;

•managing the prevalence and severity of adverse events experienced with any of our product candidates;

•obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United StatesU.S. and internationally;

•obtaining favorable terms in any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our existing or acquired product candidatesVIZZ;

We may never be successful in achieving our objectives and, even if we are successful, we may never generate revenue that is significant or large enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we fail to become and remain profitable, the value of our company could decrease. This could impair our ability to maintain or expand our research and development efforts, raise necessary additional capital, grow our business, and continue our operations.

We are a pre-commercialcommercial biopharmaceuticalpharmaceutical company focused on the development and commercialization of innovativeVIZZ® therapies(aceclidine toophthalmic improvesolution) vision.1.44%, Ourthe initialfirst focusand isonly FDA-approved aceclidine-based eye drop for the treatment of presbyopia, thea inevitablecondition lossimpacting ofan nearestimated vision1.8 that impacts the daily lives of nearly allbillion people overglobally 45.and In128 million people in the United States,States (“U.S.”). We are commercializing VIZZ in the estimated addressable population who suffer from this condition, known as presbyopes, is 128 million, almost four times the number of individuals suffering from dry eye diseaseU.S. and threecontinue timesto theestablish numberlicensing ofpartnerships individualsinternationally sufferingto fromprovide childhoodaccess myopia,to macularVIZZ degeneration, diabetic retinopathy and glaucoma combined.globally. We believe that a once-daily pharmacological eye drop that can effectively and safely improve near vision throughout the full workday, without the need for reading glasses, could beis a highly attractive commercial product with an estimated U.S. market opportunity in excess of $3 billion. It is our goal to develop andsuccessfully commercialize such a product,VIZZ, and we have assembled an executive team with extensive clinical and commercial experience to execute this goal and become the category leader.

As of December 31, 2024,2025, we had $209.1$292.3 million of cash, cash equivalents, restricted cash, and marketable securities. We believe that our existing cash, cash equivalents and marketable securities as of December 31, 20242025 will allow us to continue to build infrastructure and commercialize LNZ100, subject to FDA approval,VIZZ, and will be sufficient to fund the Company to positive operating cash flow subsequent to such commercial launch. We do not expect to generate any revenue from product sales unless and until we successfully obtain regulatory approval for LNZ100.flow. We have incurred net losses in each year since inception, and as of December 31, 2024,2025, we had an accumulated deficit of $145.0$227.1 million. These losses have resulted principally from costs incurred in connection with research and development activities and selling, general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses as we seek FDA approval and begin commercialization. These costs include expenses associated with the regulatory approval process and, subject to such approval, preparation for the potential commercial launch of LNZ100, subject to FDA approval. Additionally, we anticipate incurring expenses related to product sales, marketing, manufacturing, and distribution,distribution of VIZZ as we are in the early stages of commercialization, and additional costs associated with being a public company, including audit, legal, regulatory and tax-related services associated with maintaining compliance with an exchange listing and SEC requirements. As a result of these and other factors, while we believe that our existing cash, cash equivalents and marketable securities as of December 31, 20242025 will fund the Company to positive operating cash flow subsequent to commercial launch, if LNZ100 is approved,flow, it is possible that we may require additional financing to fund our operations and planned growth.

ThroughSince theour completioninception, ofwe the Merger, LENZ OpCohave financed itsour operations primarily through public offerings of our common stock, proceeds from the Merger, and private placements of itsour common stock and convertible preferred stock. Concurrent with the closing of the Merger on March 21, 2024, we completed a private placement (the “March 2024 PIPE Financing”) of 3,559,565 shares of common stock for an aggregate gross purchase price of $53.5 million. Additionally, on July 17, 2024, we completed a private placement (the “July 2024 PIPE Financing”) with Ridgeback Capital Investments, L.P. of 1,578,947 shares of common stock for an aggregate gross purchase price of $30.0 million. As of December 31, 2025, we have sold an aggregate of 3,618,634 shares of common stock under the sales agreement with TD Securities (USA) LLC (the “Sales Agreement”), resulting in net proceeds to the Company of $147.7 million. As of December 31, 2025, the Company had no remaining capacity under the Sales Agreement.

In April 2022, we entered into a License and Collaboration Agreement with CORXEL Pharmaceuticals (formerly known as Ji Xing Pharmaceuticals Hong Kong Limited) (“CORXEL”) granting CORXEL an exclusive license (the “CORXEL License” formerly referred to as the “Ji Xing License”) to certain of our intellectual property rights to develop, use, import, and sell products containing LNZ100 (commercially known as VIZZ in the U.S.) (“Products”) for use in the treatment of presbyopia in humans in mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (collectively, “Greater China”). We also granted CORXEL (i) the right to negotiate in good faith and enter into agreements to purchase Products from us for clinical and commercial uses at cost plus a negotiated percentage and (ii) the right of first negotiation to obtain a regional license from us on other products we might develop outside of the field of presbyopia for commercialization in Greater China.

We received nonrefundable, non-creditable upfront payments totaling $15.0 million as initial consideration under the CORXEL License during the year ended December 31, 2022. In addition, we received $5.0 million upon submission of the New Drug Application (“NDA”) for VIZZ to the National Medical Products Administration (“NMPA”) in Greater China for the treatment of presbyopia and another $5.0 million upon FDA approval of VIZZ during the year ended December 31, 2025. We are also eligible to receive (i) up to $95.0an additional $85.0 million in regulatory and sales milestone payments, (ii) tiered, escalating royalties in the range of 5% to 15% on net sales of Products in Greater China by CORXEL, its affiliates and sublicensees, and (iii) tiered, deescalating royalties in the range of 15% to 5% of sublicensing income received by CORXEL prior to the regulatory approval of the first Product in Greater China.

The $15.0 million upfront payments allocated to that single performance obligation was recognized on execution of the CORXEL License during the year ended December 31, 2022. During the year ended December 31, 2025, the first regulatory milestone under the CORXEL License was achieved upon submission of the NDA for VIZZ to the NMPA. A second regulatory milestone under the CORXEL License was achieved upon FDA approval of VIZZ. We recognized revenue and received payment totaling $10.0 million for the achievement of both regulatory milestones during the year ended December 31, 2025. No other contractual milestones were met under the CORXEL License during the years ended December 31, 20242025 or 2023.2024.

On October 27, 2024, CORXEL and the Company announced positive topline data from the Phase 3 JX07001 clinical trial of LNZ100VIZZ in patients with presbyopia in China. In this China Phase 3 safety and efficacy trial, LNZ100VIZZ achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (“BCDVA”) at near, without losing one-line or more in distance visual acuity.

•We expect thatOur selling, general and administrative expenses will continue to increaseincreased in 2025, relative to 2024, as we have built a cross-functional commercial team consisting of marketing andmarketing, commercial operations and an 88-territory sales force, and will continue to strategically buildsupport our sales and commercial infrastructure with capabilities designed to scale when necessary to support athe potential commercial launchcommercialization of LNZ100,VIZZ. subject to FDA approval. These expenses increased during the year ended December 31, 2024, as compared to the year ended December 31, 2023, and weWe expect such expenses to continue to increase for the foreseeable future.future due to the recent launch of our direct-to-consumer (“DTC”) marketing campaign and the expansion of our sales force.

Research and development expenses, which consistconsisted primarily of costs associated with our product research and development efforts, arewere expensed as incurred. Research and development expenses consistconsisted primarily of: (i) employee related costs, including salaries, benefits and share-based compensation expense for employees engaged in research and development activities; (ii) third-party contract costs relating to research, formulation, manufacturing, nonclinical studies and clinical trial activities; (iii) external costs of outside consultants who assist with technology development, regulatory affairs, clinical development and quality assurance prior to FDA approval; and (iv) allocated facility-related costs.

Costs for certain activities, such as manufacturing, nonclinical studies and clinical trials arewere generally recognized based on the evaluation of the progress of completion of specific tasks using information and data provided by our vendors and collaborators. Research and development activities are central to our business.

Other IncomeIncome, (Expense), Netnet

Other income (expense),income, net consists of the change in fair value of preferred stock warrants liability, interest income earned on cash, cash equivalents, and short-term investments, and changes in the fair value of long-term investments due to observable price changes in orderly transactions for an identical or similar investment.investment, and the change in fair value of preferred stock warrants liability. Upon completion of the Merger, the preferred stock warrants became exercisable into shares of common stock and will no longer continue to be remeasured at each reporting date.

Until recently, we did not have any products approved for sale, we have not generated significant revenue from the sale of products, we have incurred significant net losses since the company’s formation and we have funded our operations primarily from the sale and issuance of redeemable convertible preferred stock, common stock, and the Merger. Our net losses were $41.5$31.9 million and $14.6$14.9 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, and $73.4 million and $29.5 million for the six months ended June 30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $268.6$300.5 million. Additionally, the net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indicator of our future performance. The size of our future net losses and our ability to potentially achieve profitability will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.

•createmaintain additionalor increase our infrastructure to support our operations as a public company and our product development and commercialization efforts;

Our business depends entirely on the development and commercialization of VIZZ and we do not have additional product candidates in our current development pipeline. If we are unable to successfully commercialize VIZZ, our business will be materially harmed.

We have devoted a significant portion of our financial resources and business efforts to the development of LNZ100 (now VIZZ) and LNZ101, both of which include aceclidine as an active ingredient, for the treatment of presbyopia. Based on the results of our Phase 3 CLARITY trials, we selected LNZ100 as our lead product candidate, for which we submitted an NDA to FDA in August 2024. In July 2025, the FDA approved VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults, and we launched such product commercially in the U.S. in August 2025. Professional product sample distribution by the sales force to optometrists and ophthalmologists and commercial product shipments to customers via our e-pharmacyePharmacy partner were initiated in October 2025, and product became broadly available in retail pharmacies beginning in November 2025. Beginning in July 2026, VIZZ became available via a telehealth platform, providing the convenience of an integrated online evaluation by independent licensed ECPs, ePharmacy prescription fulfillment and home delivery. We do not currently have other product candidates in our development pipeline, and our success depends entirely on VIZZ. Until the approval of VIZZ, we did not have any products approved for sale and we have not generated significant revenue from the sale of products. Our ability to generate revenue and achieve profitability depends significantly on our ability, or any future collaborator’s ability, to achieve a number of objectives, including:

VIZZ may fail to gain sufficient market acceptance by ECPs, patients, and others in the medical community. Presbyopia is typically self-diagnosed and self-managed with over-the-counter reading glasses, or managed, after evaluation by an ECP, with prescription reading or bifocal glasses or multifocal contact lenses. Prescriptions for VIZZ requiresmay abe, prescriptionamongst byother anmethods, ECP,obtained which requires a visit tofrom an ECP, which can be perceived to be more burdensome to an individual who has never previously visited an ECP and limit the number of prescriptions that are written. Further, while in July 2026 VIZZ became available via a telehealth platform, such method still requires an integrated online evaluation by an independent licensed ECP and ePharmacy prescription fulfillment, which may also be perceived as overly burdensome to a patient. VIZZ may not demonstrate sufficient additional clinical benefits to ECPs or patients to justify a higher price compared to using glasses, which are potentially just a one-time purchase, and/or to offset the impact of side effects that patients may experience when using VIZZ. Some ECPs may also be deterred by the potential loss of revenue from the sale of contact lenses and glasses or feel uncomfortable prescribing a new product.

For example, Vuity was launched by AbbVie and, in April 2025, a second pharmacologic option for the treatment of presbyopia was launched under the brand Qlosi. Marketed by Orasis, Qlosi was the second pilocarpine-based product for the treatment of presbyopia approved by the FDA. In August 2025, a generic version of Vuity was launched by Amneal Pharmaceuticals. In January 2026, the FDA approved Yuvezzi for the treatment of presbyopia, a carbochol-based eye-drop developed by Tenpoint Therapeutics, andwhich subsequently launched in March 2026. While we believe Qlosi, Yuvezzi and the generic version of Vuity will face similar challenges to those faced by Vuity, if ECPs or patients prefer Qlosi, Yuvezzi or the generic toversion Vuity,of Vuity over VIZZ, our market opportunity may be limited.

OurWhile we launched our telehealth channel in July 2026, our commercial strategy is still primarily focused on targeting and partnering with the estimated 15,000 ECPs that prescribed over 85% of the pharmaceutical presbyopia prescriptions in the U.S. in 2022. If we are unable to obtain access to these ECPs or successfully demonstrate the clinical benefits of our products to adequate numbers of ECPs, our efforts to commercialize such products will be severely inhibited, which would have a material adverse effect on our business.

Additionally, a direct-to-consumer (“DTC”) strategy can potentially be extremely costly. We have deployed a targeted,targeted cost-effective,and digitally focusedcost-effective DTC strategy, but if we are unable to be sufficiently effective with a limited budget and are required to spend more than anticipated, we may need to raise more capital, divert resources from other strategies or just fail to reach the intended market. As a result, a DTC strategy that is not sufficiently cost-effective can have a material adverse effect on our business.

If our product or future product candidates are associated with undesirable side effects or have unexpected characteristics in nonclinical studies or clinical trials when used alone or in combination with other approved products or investigational new drugs, we may decide or be required to perform additional clinical studies or to interrupt, delay or abandon our development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the clinical trial, or result in potential product liability claims. Any of these occurrences may prevent us from achieving or maintaining market acceptance of the affected product candidate and may harm our business, financial condition, and prospects significantly. Moreover, if we elect, or are required, to not initiate, delay, suspend or terminate any future clinical trial of any of our product candidates, the commercial prospects of such product candidates may be harmed and our ability to generate product revenue from any of these product candidates may be delayed or eliminated. Any of these occurrences may harm our ability to develop other product candidates, and may harm our business, financial condition, and prospects significantly.

If significant adverse events or other side effects are observed in any of our future clinical trials, we may have difficulty recruiting patients to the clinical trials, patients may drop out of our clinical trials, or we may be required to abandon the clinical trials or our development efforts of that product candidate altogether. We, the FDA or other comparable regulatory authorities, or an IREIRB may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such clinical trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage clinical trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance due to its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition, and prospects.

Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws within the U.S. We may need to share our trade secrets and proprietary know-how with current or future partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the U.S. and abroad. In addition, some courts inside and outside the U.S. are sometimes less willing or unwilling to protect trade secrets. If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs. Even if we are successful, these types of lawsuits may consume our time and other resources. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

VIZZ and any future product candidates we may seek to develop, and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export are subject to comprehensive regulation by the FDA and other regulatory agencies in the U.S. and by comparable foreign regulatory authorities. Before we can commercialize any of our product candidates, we must obtain marketing approval. In July 2025, the FDA approved VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults, and we launched such product commercially in the U.S. in August 2025. Professional product sample distribution by the sales force to optometrists and ophthalmologists and commercial product shipments to customers via our e-pharmacyePharmacy partner were initiated in October 2025, and product became broadly available in retail pharmacies beginning in November 2025. We will require approval from applicable foreign regulatory authorities before we are able to market VIZZ in such foreign jurisdictions. Any future product candidate that we may seek to develop will require approval by the FDA and other comparable foreign regulatory authorities before we can commercialize such product.

Despite FDA approval of VIZZ, such product will be subject to ongoing regulatory requirements applicable to manufacturing, labeling, packaging, storage, advertising, promoting, sampling, record-keeping and submission of safety or other post-market information, among other things. Any regulatory approvals that we receive for our product candidates will require surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require a REMS, limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or requirements that we conduct potentially costly post-market testing and surveillance studies, including Phase 4 trials and surveillance to monitor the quality, safety and efficacy of the drug. An unsuccessful post-marketing study or failure to complete such a study could result in the FDA imposing additional requirements in order to approve our product candidates, which could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

In June 2024, the U.S. Supreme Court overruled the Chevron doctrine, which gives deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, such as the FDA, where the law is ambiguous. This landmark Supreme Court decision may invite more companies and other stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, including FDA’s statutory interpretations of market exclusivities and the “substantial evidence” requirements for drug approvals, which could undermine the FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions. Further, the current administration, including changes in the leadership at the FDA and other federal agencies, may issue new policies and regulations that can impact the compliance status of our product candidate. We cannot predict the full impact of this decision, future judicial challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action.

There has been increasing legislative and enforcement interest in the U.S. with respect to specialty drug pricing practices. In August 2022, Congress passed the Inflation Reduction Act of 2022 (the “IRA”), which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, CMS selected 10 high-cost Medicare Part D drugs in 2023 and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, upCMS toselected an15 additional 15drugs drugs,in whichJanuary may2026, bemarking coveredthe first time drugs payable under either Medicare Part BB, orrather than only Part D, willwere beincluded selected,in the negotiation program, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. Various industry stakeholders, including pharmaceutical companies and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the IRA are unconstitutional.unconstitutional; to date, manufacturers have not prevailed on the merits in any such challenge, and in May 2026, the U.S. Supreme Court declined to review several of these cases, leaving in place lower court decisions upholding the program, although a small number of challenges remain pending in other federal appellate courts. Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the U.S. The One Big Beautiful Bill Act, which was signed into law in July 2025, includes provisions that will impact the U.S. healthcare system in various ways, including by cuts to Medicaid and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage. In November 2025, CMS announced a voluntary initiative called the GENEROUS Model (GENErating cost Reductions for U.S. Medicaid Model) to introduce the option of most-favored-nation pricing to the Medicaid program, whereby a drug manufacturer may voluntarily offer supplemental rebates to participating state Medicaid programs for a manufacturer’s covered outpatient drugs. Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the U.S., or that increase generic and biosimilar drug entry sooner than expected, can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future. We cannot predict the full impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the U.S. The impact of ongoing and future judicial challenges, as well as future legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the current administration, including the Department of Government Efficiency, on our company and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

Because of the breadth of these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities, including our advisory board arrangements with physicians, some of whom receive stock or stock options as compensation for services provided, our arrangement with a telehealth platform to provide online evaluations by independent licensed ECPs and ePharmacy prescription fulfillment for VIZZ, which is also subject to state laws governing the corporate practice of medicine, fee-splitting, and the licensure of prescribers and pharmacies, and any sales and marketing activities after a product candidate has been approved for marketing in the U.S., could be subject to legal challenge and enforcement actions. If our operations are found to be in violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to significant civil, criminal, and administrative penalties, including, without limitation, damages, fines, disgorgement, imprisonment, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Among other matters, U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, which are collectively referred to as Trade Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of trade laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We also expect our non- U.S.non-U.S. activities to increase over time. We plan to engage third parties for clinical trials or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

In the U.S., in addition to HIPAA, HITECH and state laws addressing health-related information, numerous federal and state laws and regulations govern the collection, use, disclosure, and other processing of information relating to individuals. In California, the California Consumer Privacy Act (“CCPA”) requires covered companies to provide disclosures to consumers about such companies’ data collection, use and sharing practices, provide such consumers ways to opt-out of certain sales or transfers of personal information, and provide consumers with additional causes of action in data breach situations. The CCPA went into effect on January 1, 2020, and was modified significantly by the California Privacy Rights Act (“CPRA”), which was approved by California voters in the November 3, 2020 election and became effective January 1, 2023. The CCPA has prompted numerous proposals for federal and state privacy legislation. Numerous U.S. states have proposed, and in certain cases enacted, laws addressing privacy and cybersecurity matters. Many of these laws are comprehensive privacy statutes imposing obligations similar to the CCPA. Certain U.S. states also have enacted laws and regulations addressing specific subject matter, such as Washington’s My Health, My Data Act, which, among other things, provides for a private right of action.action and Vermont’s Data Privacy and Online Surveillance Act, which takes effect in 2028 and imposes specific restrictions on the collection, use and sale of consumer health data.

In April 2022, we entered into the Everest License (formerly referred to as the “CORXEL License,License”), pursuant to which we granted CORXEL an exclusive license to certain of our intellectual property rights to develop, use, import, and sell products containing VIZZ or LNZ101 (“LNZ Products”) for the treatment of presbyopia in humans in mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (collectively, “Greater China”) and the first right of negotiation for CORXEL to license any other product that we develop or commercialize containing aceclidine or brimonidine for uses outside of the treatment of presbyopia in Greater China. In June 2026, Everest Medicines (“Everest”) entered into an Asset Purchase Agreement with CORXEL to acquire the rights to develop, manufacture, and commercialize VIZZ in Greater China. As part of this agreement, the rights and obligations and certain related ancillary agreements under the Everest License entered into by CORXEL in April 2022 were assigned and transferred to Everest. Under the terms of the CORXELEverest License, we shall refrain from developing or commercializing any competing product, or knowingly enabling a third party to develop or commercialize a product containing aceclidine or brimonidine that would reasonably be expected to result in off-label sales of such products, for the treatment of presbyopia in humans in Greater China. We have entered into similar agreements with Lotus Pharmaceutical Co., Ltd. (“Lotus”) to commercialize VIZZ in the Republic of Korea and certain countries in Southeast Asia (the “Lotus License”), with Laboratoires Théa (“Laboratoires Théa”) to commercialize VIZZ in Canada (the “Théa License”), and with Lunatus Global Medical Supplies (“Lunatus” and together with CORXEL, Lotus and Laboratoires Théa, our “License Partners”) to commercialize VIZZ in the Middle East (the “Lunatus License”), and Arrotex Pharmaceuticals Pty Ltd (“Arrotex”) to commercialize VIZZ in Australia and New Zealand (the “Arrotex License”), and together with Everest, Lotus, Laboratoires Théa and Lunatus, our “License Partners,” and together with the CORXELEverest License, the Lotus License, the Théa License and the ThéaLunatus License, the “License Agreements,” and the territories covered by the License Agreements, the “Licensed Territories”).

The market price of our common stock has been, and may continue to be, subject to significant fluctuations. For example, from April 1, 2024 through MarchJune 31,30, 2026, the closing price for our common stock ranged from a low of $8.29$5.51 to a high of $49.05 per share. Some of the factors that may cause the market price of our common stock to fluctuate include:

As of December 31, 2025, we had federal and state net operating loss (“NOL”) carryforwards of $178.9 million and $12.4 million, respectively. The federal NOL carryforwards of $178.9 million may be carried forward indefinitely. State NOL carryforwards totaling $12.4 million begin to expire in 2040, unless previously utilized. In addition, we had federal and R&D credit carryforwards totaling $8.3 million, which will begin to expire in 2040 unless previously utilized.

Under current law, U.S. federal NOLs generated in taxable periods beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such NOL carryforwards is limited to 80% of taxable income for taxable periods beginning after December 31, 2020. Many state jurisdictions conform to federal law for this purpose or have similar or other provisions that limit the deductibility of state NOL carryforwards in a taxable period. For example, California has temporarily disallowed the use of NOLs to offset California taxable income prior to 2027. In addition, under Sections 382 and 383 of the Code, U.S. federal NOL carryforwards and other tax attributes may become subject to an annual limitation in the event of certain cumulative changes in ownership. An “ownership change” pursuant to Section 382 of the Code generally occurs if one or more stockholders or groups of stockholders who own at least 5% of a company’s stock increase their ownership by more than 50 percentage points (by value) over their lowest ownership percentage within a rolling three-year period. We believe we underwent an ownership change in 2024, which resulted in a limitation that reduced the availability of our NOL and tax credit carryforwards. We adjusted the carryforward attributes accordingly, with an offsetting adjustment to the valuation allowance. Subsequent ownership changes may further limit our ability to utilize NOL and tax credit carryforwards in future years. To the extent we have experienced or will experience an ownership change(s), our ability to utilize our NOL carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited. If we earn taxable income, such limitations could result in increased future income tax liability to us, and our future cash flows could be adversely affected.

We are a commercial pharmaceutical company focused on the commercialization of VIZZ® (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States (“U.SU.S.”). We are commercializing VIZZ in the U.S. and continue to establish licensing partnerships internationally to provide access to VIZZ globally. We believe that a once-daily pharmacological eye drop that can effectively and safely improve near vision throughout the full workday, without the need for reading glasses, is a highly attractive commercial product with an estimated U.S. market opportunity in excess of $3 billion. It is our goal to successfully commercialize VIZZ, and we have assembled an executive team with extensive clinical and commercial experience to execute this goal and become the category leader.

On July 31, 2025, the FDA approved VIZZ, making it the first and only aceclidine-based product approved by the FDA. VIZZ has five years of NCE exclusivity in the U.S., expiring in July 2030. The Company commercially launched VIZZ in the U.S. in August 2025, with direct-to-eye care professional sales and marketing activities initiated immediately upon approval. Professional product sample distribution by the sales force to optometrists and ophthalmologists and commercial product shipments to customers via our e-pharmacyePharmacy partner were initiated in October 2025, and product became broadly available in retail pharmacies beginning in November 2025. Beginning in July 2026, VIZZ became available via a telehealth platform, providing the convenience of an integrated online evaluation by independent licensed ECPs, ePharmacy prescription fulfillment and home delivery.

As of MarchJune 31,30, 2026, we had $258.4$220.0 million of cash, cash equivalents, restricted cash, and marketable securities. We believe that our existing cash, cash equivalents and marketable securities as of March 31, 2026 will allow us to continue to commercialize VIZZ, and we anticipate will be sufficient to fund the Company to positive operating cash flow. We have incurred net losses in each year since inception, and as of MarchJune 31,30, 2026, we had an accumulated deficit of $268.6$300.5 million. These losses have resulted principally from costs incurred in connection with research and development activities and selling, general and administrative costs associated with our operations. We expect to continue to incur significant expenses related to product sales, marketing, manufacturing, and distribution of VIZZ as we are in the early stages of commercialization, and additional costs associated with being a public company, including audit, legal, regulatory and tax-related services associated with maintaining compliance with an exchange listing and SEC requirements. As a result of these and other factors, while we believe that our existing cash, cash equivalents and marketable securities as of March 31, 2026 will fund the Company to positive operating cash flow, it is possible that we may require additional financing to fund our operations and planned growth.

Since our inception, we have financed our operations primarily through public offerings of our common stock, proceeds from the Merger, and private placements of our common stock and convertible preferred stock. Concurrent with the closing of the Merger on March 21, 2024, we completed a private placement (the “March 2024 PIPE Financing”) of 3,559,565 shares of common stock for an aggregate gross purchase price of $53.5 million. Additionally, on July 17, 2024, we completed a private placement (the “July 2024 PIPE Financing”) of 1,578,947 shares of common stock for an aggregate gross purchase price of $30.0 million. As of December 31, 2025, we have sold an aggregate of 3,618,634 shares of common stock under the sales agreement with TD Securities (USA) LLC (the “Sales Agreement”), resulting in net proceeds to the Company of $147.1 million. As of MarchJune 31,30, 2026, the Company had no remaining capacity remaining under the Sales Agreement.

CORXELEverest Medicines License and Collaboration Agreement

In April 2022, we entered into a License and Collaboration Agreement with CORXEL Pharmaceuticals (formerly known as Ji Xing Pharmaceuticals Hong Kong Limited) (“CORXEL”) granting CORXEL an exclusive license (the “CORXELEverest License” formerly referred to as the “CORXEL License” and the “Ji Xing License”) to certain of our intellectual property rights to develop, use, import, and sell products containing LNZ100 (commercially known as VIZZ in the U.S.) (“Products”) for use in the treatment of presbyopia in humans in mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (collectively, “Greater China”). We also granted CORXEL (i) the right to negotiate in good faith and enter into agreements to purchase Products from us for clinical and commercial uses at cost plus a negotiated percentage and (ii) the right of first negotiation to obtain a regional license from us on other products we might develop outside of the field of presbyopia for commercialization in Greater China.

We received nonrefundable, non-creditable upfront payments totaling $15.0 million as initial consideration under the CORXELEverest License during the year ended December 31, 2022. In addition, we received $5.0 million upon submission of the New Drug Application (“NDA”) for VIZZ to the National Medical Products Administration (“NMPA”) in Greater China for the treatment of presbyopia and another $5.0 million upon FDA approval of VIZZ during the year ended December 31, 2025. We are also eligible to receive (i) up to an additional $85.0 million in regulatory and sales milestone payments, (ii) tiered, escalating royalties in the range of 5% to 15% on net sales of Products in Greater China by CORXEL,Everest, its affiliates and sublicensees, and (iii) tiered, deescalating royalties in the range of 15% to 5% of sublicensing income received by CORXEL and Everest prior to the regulatory approval of the first Product in Greater China.

The $15.0 million upfront payments allocated to that single performance obligation was recognized on execution of the CORXELEverest License during the year ended December 31, 2022. During the year ended December 31, 2025, the first regulatory milestone under the CORXELEverest License was achieved upon submission of the NDA for VIZZ to the NMPA. A second regulatory milestone under the CORXELEverest License was achieved upon FDA approval of VIZZ. We recognized revenue and received payment totaling $10.0 million for the achievement of both regulatory milestones during the year ended December 31, 2025. No contractual milestones were met under the CORXELEverest License during the three and six months ended MarchJune 31,30, 2026 or 2025.

On July 7, 2025, we entered into a license and commercialization agreement providing an exclusive license (the “Théa License”) to register and commercialize VIZZ for the treatment of presbyopia in Canada. Under the terms of the Théa License, we received a $2.5 million nonrefundable, non-creditable upfront payment, and an additional $2.5 million milestone payment triggered by the submission of the New Drug Submission (“NDS”) to Health Canada on June 29, 2026. We are eligible to receive up to $67.5an additional $65 million in regulatory and commercial milestone payments, as well as tiered, escalating royalties in the range of 10% to 20% on future net sales in Canada.

•LicenseTotal revenue increased during the three and six months ended MarchJune 31,30, 2026 relative to the three and six months ended MarchJune 31,30, 2025 as a result of sales of VIZZ and license revenue recognized during the three and six months ended June 30, 2026. Total revenue for the three and six months ended June 30, 2025 was solely attributable to the upfront payment received under the LunatusLotus License. We may generate future revenue from additional license and collaboration agreements to commercialize VIZZ outside the U.S.

•Our selling, general and administrative expenses will continue to increase in 2026, relative to 2025, as we have built a cross-functional commercial team consisting of marketing, commercial operations and an 88-territorya sales force that is currently expanding to 117 territories,force, and will continue to strategically support our sales and commercial infrastructure with capabilities designed to scale when necessary to support the commercialization of VIZZ. We expect to continue to incur such expenses to continue to increasesupport forour thecommercial foreseeablestrategy, future due to the recent launch ofincluding our direct-to-consumer (“DTC”) marketing campaign and the expansion of our sales force.campaign.

•Our research and development costs decreased to zero during the three and six months ended MarchJune 31,30, 2026, relative to the comparative period in 2025 primarily due to FDA approval of VIZZ.VIZZ in July 2025. On a prospective basis subsequent to FDA approval on July 31, 2025, certain expenses that were historically classified as research and development expenses were and will be prospectively classified into sales, general and administrative expenses, including certain medical affairs and chemistry, manufacturing and controls expenses that indirectly support VIZZ. We expect our research and development costs will be nearde zerominimis over the remainder of 2026, relative to 2025, given the FDA approval of VIZZ.2026.

Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of VIZZ, including raw materials, third-party manufacturing costs, packaging services, and freight costs. Cost of sales also includes period costs related to certain operations personnel and inventory adjustment charges. The Company began capitalizing inventory costs upon FDA approval of VIZZ in July 2025. Prior to FDA approval of VIZZ, manufacturing and other inventory costs were recorded to research and development expenses, resulting in zero cost inventory. CostOnce zero cost inventory is depleted, cost of sales of VIZZ will increase on a per unit basisbasis. afterSubstantially all of our zero cost inventory ishas depleted,been whichsold weas expectof toJune occur during30, 2026.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Following the FDA approval of VIZZ in July 2025, sales of commercial product began in October 2025. Product sales, net for the three months ended MarchJune 31,30, 2026 was $1.7 million and was primarily driven by approximately 25,00027,000 paidpacks sold and filleddelivered monthlyto prescriptionsthe customer in the period. We had no product sales during the three months ended MarchJune 31,30, 2025.

Cost of sales for the three months ended MarchJune 31,30, 2026 was primarily driven by twocost nonrecurringof chargessales torecognized inventoryin stemmingconnection with sales of VIZZ, partially offset by an insurance recovery received during the three months ended June 30, 2026 from an out-of-specification temperature excursion of inventory while in transit from our manufacturer andthat aoccurred write-offduring ofthe packagingthree suppliesmonths associatedended withMarch a31, manufacturing process transition.2026. There was no cost of sales during the three months ended MarchJune 31,30, 2025.

Selling, general and administrative expenses increased $33.8$26.6 million, or 305%,208%, to $45.0$39.4 million for the three months ended MarchJune 31,30, 2026 compared to $11.1$12.8 million for the three months ended MarchJune 31,30, 2025. The change was primarily driven by increases of $17.2$13.3 million in commercial marketing, advertising and sales infrastructure expenses as we launched our DTC marketing campaign in January 2026, $12.8$11.0 million in employee salaries and related expenses due to an increase in headcount, including the hiring of our sales force, $1.8$1.1 million in other corporate overhead, and $0.9 million in chemistry and control and regulatory related expenses which were classified as selling, general and administrative expenses subsequent to FDA approval,approval. $1.1Sales, general and administrative expenses included $4.4 million inand travel$2.1 relatedmillion costsof primarilynon-cash relatedshare-based tocompensation ourfor salesthe force,three months ended June 30, 2026 and a2025, $0.8 million nonrecurring write-off of sample packaging and materials due to a manufacturing transition.respectively.

Research and development expenses decreased by $5.8$9.1 million, or 100%, for the three months ended MarchJune 31,30, 2026 compared to $5.8$9.1 million for the three months ended MarchJune 31,30, 2025. Subsequent to FDA approval, people-related, chemistry and control, and regulatory costs previously classified as research and development expenses were prospectively classified as selling, general and administrative expenses. Prior to FDA approval of VIZZ on July 31, 2025, costs related to the production of inventory were expensed in the period incurred within research and development expenses, resulting in zero cost inventory. Subsequent to FDA approval of VIZZ, direct and indirect manufacturing costs were capitalized to inventory.

Other income, net for the three months ended MarchJune 31,30, 2026, was $2.6$2.3 million, compared to $2.3$2.4 million for the three months ended MarchJune 31,30, 2025. Interest income earned on our cash, cash equivalents, and marketable securities increasedwas flat period over period due to a higherlower balanceeffective ofyield on our marketable securities.securities resulting from a decline in interest rates.

As of MarchJune 31,30, 2026, we had $258.4$220.0 million of cash, cash equivalents and marketable securities. We have incurred net losses in each year since inception and as of MarchJune 31,30, 2026, we had an accumulated deficit of $268.6$300.5 million. Our net losses were $41.5$31.9 million and $14.6$14.9 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, and $73.4 million and $29.5 million for the six months ended June 30, 2026 and 2025, respectively. These losses have resulted principally from costs incurred in connection with research and development activities and selling, general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses as we begin commercialization of VIZZ, including costs related to product sales, marketing, manufacturing, and distribution.

From inception through MarchJune 31,30, 2026, we received funding of $13.0 million from our initial seed financing, $47.0 million from the sale of Series A Convertible Preferred stock, $10.0 million from the sale of Series A-1 Convertible Preferred Stock, gross proceeds of $83.5 million from the sale of Series B Convertible Preferred stock, approximately $117.8 million in cash and cash equivalents from the Merger, approximately $53.5 million in gross cash proceeds from the March 2024 PIPE Financing, and $30.0 million in gross cash proceeds from the July 2024 PIPE Financing.

We believe that our cash, cash equivalents, and marketable securities as of MarchJune 31,30, 2026 will allow us to continue to build infrastructure and commercialize VIZZ, and such funds are anticipated to fund the Company to positive operating cash flow.VIZZ. This belief is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than expected. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than currently anticipated, and we may need to seek additional funds sooner than planned.

For the threesix months ended MarchJune 31,30, 2026, cash used in operating activities was $33.6$72.3 million and resulted from a net loss of $41.5$73.4 million,million and a $7.9 million decrease in operating assets, offset by $4.4$9.0 million in non-cash adjustments primarily driven by share-based compensation expense and a $3.5 million increase in operating assets.expense.

For the threesix months ended MarchJune 31,30, 2025, cash used in operating activities was $16.0$27.6 million and resulted from a net loss of $14.6$29.5 million, in addition to an approximate $2.0 million cash outflow from the payment of accounts payable and accrued liabilities and a $1.0$1.2 million increase in operating assets, offset by $1.5$3.5 million in non-cash adjustments primarily driven by share-based compensation expense.

Cash provided by investing activities for the threesix months ended MarchJune 31,30, 2026 was $33.2$70.9 million, primarily due to $49.2$94.4 million in proceeds from maturities of marketable securities, and partially offset by $16.1$23.4 million of purchases of marketable securities.

Cash provided by investing activities for the threesix months ended MarchJune 31,30, 2025 was $18.9$18.5 million, primarily due to $52.1$110.2 million in proceeds from maturities of marketable securities, and partially offset by $33.1$91.4 million of purchases of marketable securities.securities and $0.4 million in purchases of property and equipment.

Cash provided by financing activities for the threesix months ended MarchJune 31,30, 2026 and March 31, 2025 was driven by proceeds from exercisesthe issuance of common stock options.under the employee stock purchase plan.

To date, product sales, net has consisted of sales of VIZZ to (i) certain wholesalers (who in turn sell VIZZ to retail pharmacies) and (ii) directly to patients through our e-pharmacyePharmacy partner. Product sales, net is recognized net of reserves for variable components, including but not limited to distribution service fees, prompt pay discounts and product returns. These variable components are reassessed each reporting period, and adjustments are recorded on a cumulative catch-up basis, which affects product sales, net in the period of adjustment. The actual amounts of variable consideration ultimately received may differ from our estimates. To date, actual amounts have not differed materially from our estimates.

Additionally, under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. Prior to the Merger, Graphite elected to use, and we intend to continue to use, this extended transition period for complying with certain or new or revised accounting standards until the earlier of (i) the last day of the fiscal year (a) following the fifth anniversary of the closing of Graphite's initial public offering (i.e., December 31, 2026), (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, (ii) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period, or (iii) if we affirmatively and irrevocably opt out of the extended transition period provided by the JOBS Act.