What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-11 compared with 2026-05-11 · 110 added, 65 removed, 182 unchanged (49% of the section changed)

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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-pharmacy partner were initiated in October 2025, and product became broadly available in retail pharmacies beginning in November 2025.

Professional product sample distribution by the sales force to optometrists and ophthalmologists and commercial product shipments to customers via our ePharmacy 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.

Financial Overview

As of March 31, 2026 , we had $258.4 million of cash, cash equivalents, restricted cash, and marketable secu rities.

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 March 31, 2026 , we had an accumulated deficit of $268.6 million .

As of June 30, 2026 , we had $220.0 million of cash, cash equivalents, restricted cash, and marketable secu rities.

We have incurred net losses in each year since inception, and as of June 30, 2026 , we had an accumulated deficit of $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.

As a result of these and other factors, 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.

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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 March 31, 2026, the Company had no remaining capacity remaining under the Sales Agreement.

As of December 31, 2025, we 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 June 30, 2026, the Company had no remaining capacity remaining under the Sales Agreement.

License and Distribution Agreements

CORXEL 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 “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”).

Everest 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 “Everest 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 CORXEL License during the year ended December 31, 2022.

In June 2026, Everest Medicines (“Everest”) entered into an Asset Purchase Agreement with CORXEL Pharmaceuticals 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.

The Company is eligible to receive additional sublicense payments associated with regulatory and sales milestones under the Asset Purchase Agreement, including a $1.3 million upfront payment, for which the Company recognized license revenue during the three months ended June 30, 2026 upon execution of the Asset Purchase Agreement.

We received nonrefundable, non-creditable upfront payments totaling $15.0 million as initial consideration under the Everest 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, 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 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 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 Everest License during the year ended December 31, 2022.

During the year ended December 31, 2025, the first regulatory milestone under the Everest License was achieved upon submission of the NDA for VIZZ to the NMPA.

A second regulatory milestone under the Everest 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 CORXEL License during the three months ended March 31, 2026 or 2025.

No contractual milestones were met under the Everest License during the three and six months ended June 30, 2026 or 2025.

Lotus Pharmaceutical Co., LTD.

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On May 7, 2025, we entered into a license and commercialization agreement providing an exclusive license (the “Lotus License”) to certain of our intellectual property to commercialize VIZZ for the treatment of presbyopia in humans in the Republic of Korea, the Kingdom of Thailand, Republic of the Philippines, the Socialist Republic of Vietnam, Malaysia, Negara Brunei Darussalam, the Republic of Indonesia, and the Republic of Singapore (collectively, “Southeast Asia”).

Under the terms of the Lotus License, we received a $5.0 million nonrefundable, non-creditable upfront payment, and are

eligible to receive up to $120.0 million of regulatory and commercial milestone payments, as well as tiered, escalating royalties in the range of 10% to 20% on future net sales in Southeast Asia.

Under the terms of the Lotus License, we received a $5.0 million nonrefundable, non-creditable upfront payment, and are eligible to receive up to $120.0 million of regulatory and commercial milestone payments, as well as tiered, escalating royalties in the range of 10% to 20% on future net sales in Southeast Asia.

Laboratoires Théa License and Commercialization Agreement

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 are eligible to receive up to $67.5 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.

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 an 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.

Lunatus Global Medical Supplies Distribution Agreement

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Under the terms of the Lunatus License, we received a nonrefundable, non-creditable upfront payment, and are eligible to receive regulatory and commercial milestone payments and a per unit fee for each unit sold to Lunatus for distribution in the Middle East, pending regulatory approval.

Arrotex Pharmaceuticals Pty Ltd License and Commercialization Agreement

On June 24, 2026, the Company entered into a license and commercialization agreement providing an exclusive license (the “Arrotex License”) to register and commercialize VIZZ for the treatment of presbyopia in Australia and New Zealand.

Under the terms of the Arrotex License, we received a $1.0 million nonrefundable, non-creditable upfront payment, and are eligible to receive a mid double-digit profit share of gross margin on future net sales in Australia and New Zealand.

Key Trends and Factors Affecting Comparability Between Periods

• License revenue increased during the three months ended March 31, 2026 relative to the three months ended March 31, 2025 as a result of the upfront payment received under the Lunatus License.

• Total revenue increased during the three and six months ended June 30, 2026 relative to the three and six months ended June 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 under the Lotus 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-territory sales force that is currently expanding to 117 territories, 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 such expenses to continue to increase for the foreseeable future due to the recent launch of our direct-to-consumer (“DTC”) marketing campaign and the expansion of our sales force.

• Our research and development costs decreased during the three months ended March 31, 2026, relative to the comparative period in 2025 primarily due to FDA approval of VIZZ.

• 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 a sales force, and will continue to strategically support our sales and commercial infrastructure with capabilities designed to support the commercialization of VIZZ.

We expect to continue to incur such expenses to continue to support our commercial strategy, including our direct-to-consumer (“DTC”) marketing campaign.

• Our research and development costs decreased to zero during the three and six months ended June 30, 2026, primarily due to FDA approval of 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 near zero over the remainder of 2026, relative to 2025, given the FDA approval of VIZZ.

We expect our research and development costs will be de minimis over the remainder of 2026.

Recent Developments

Submission of Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency

On April 20, 2026, we announced the submission of a Marketing Authorization Application (“MAA”) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) for the review and approval of VIZZ.

The submission of the MAA in the United Kingdom represented the sixth ex-U.S.

regulatory submission for VIZZ.

Submission of Marketing Authorization Application to European Medicines Agency

On March 10, 2026, we announced the submission of an MAA to the European Medicines Agency (“EMA”) for the review and approval of VIZZ.

If approved, the EMA's positive opinion would serve as a foundational step toward making VIZZ available to the millions of Europeans living with age-related blurry near vision.

The submission of the MAA in Europe represented the fifth ex-U.S.

regulatory submission for VIZZ.

Launch of New Telehealth Prescribing Option to Accelerate Patient Access to VIZZ

On July 6, 2026, we announced that VIZZ is now available through a convenient telehealth platform, providing the convenience of an integrated online evaluation by independent licensed eye care providers (“ECPs”), ePharmacy prescription fulfillment and home delivery.

Accessible through VIZZ.com, the integrated telehealth platform connects

patients with an independent network of licensed eye care professionals who will evaluate patient telehealth eligibility based upon their medical history.

Prescriptions will be automatically routed and fulfilled by LENZ’s ePharmacy partner providing a seamless and convenient consumer journey from product interest to home delivery.

Launch of the telehealth channel will be promoted alongside the Company’s ‘Tired of Reading Glasses’ campaign featuring brand spokesperson Sarah Jessica Parker through both a national television advertising campaign and digital DTC strategy.

Arrotex Pharmaceuticals Pty Ltd License and Commercialization Agreement

On June 24, 2026, we and Arrotex Pharmaceuticals Pty Ltd announced an exclusive license and commercialization agreement for Arrotex to register and commercialize VIZZ for the treatment of presbyopia in Australia and New Zealand.

Under the terms of the agreement, LENZ received an upfront payment and is eligible to receive a mid double-digit profit share of gross margin on future net sales in Australia and New Zealand.

Acquisition of Rights to Develop and Commercialize VIZZ in Greater China by Everest Medicines

On June 7, 2026, we announced that Everest entered into an Asset Purchase Agreement with CORXEL to acquire the rights to develop, manufacture, and commercialize VIZZ in Greater China.

We are eligible to receive additional sublicense payments in connection with the execution of the agreement between CORXEL and Everest.

Basis of Presentation

The following discussion highlights our results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described and provides information that management believes is relevant for an assessment and understanding of the unaudited condensed consolidated balance sheets and statements of operations and comprehensive loss presented herein.

The following discussion and analysis are based on our unaudited condensed consolidated financial statements and related notes thereto, which we have prepared in accordance

The following discussion and analysis are based on our unaudited condensed consolidated financial statements and related notes thereto, which we have prepared in accordance with U.S.

You should read the discussion and analysis together with such unaudited condensed consolidated financial statements and the related notes thereto.

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Prior to FDA approval of VIZZ, manufacturing and other inventory costs were recorded to research and development expenses, resulting in zero cost inventory.

Cost of sales of VIZZ will increase on a per unit basis after zero cost inventory is depleted, which we expect to occur during 2026.

Once zero cost inventory is depleted, cost of sales of VIZZ will increase on a per unit basis.

Substantially all of our zero cost inventory has been sold as of June 30, 2026.

Selling, General and Administrative

Selling, general and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, business development, sales and marketing, human resources and other corporate functions.

Other selling, general and administrative expenses include marketing, and advertising costs to support our sales force, professional fees for legal, tax and business consulting services, public company related expenses such as audit fees and insurance costs, intellectual property and patent costs, facility costs and travel costs.

audit fees and insurance costs, intellectual property and patent costs, facility costs and travel costs.

Subsequent to the FDA approval of VIZZ, selling, general and administrative expenses also include salaries and related benefits and stock-based compensation costs related to our quality assurance, regulatory, supply chain and operations, and medical affairs functions.

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Results of Operations

Comparison of the Three Months Ended March 31, 2026 and 2025

Comparison of the Three Months Ended June 30, 2026 and 2025

The following table presents the results of operations for the periods indicated (amounts in thousands, except percentages):

Three Months Ended March 31,

Three Months Ended June 30,

2026 2025 $ Change % Change

Product sales, net $ 1,736 $ — $ 1,736 N/A

License revenue 250 — 250 N/A

License revenue 3,750 5,000 (1,250) (25) %

Cost of sales 280 — 280 N/A

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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 March 31, 2026 was $1.7 million and was primarily driven by approximately 25,000 paid and filled monthly prescriptions in the period.

We had no product sales during the three months ended March 31, 2025.

Product sales, net for the three months ended June 30, 2026 was $1.7 million and was primarily driven by approximately 27,000 packs sold and delivered to the customer in the period.

We had no product sales during the three months ended June 30, 2025.

License Revenue

License revenue for the three months ended March 31, 2026 was comprised of revenue recognized from the upfront payment under the Lunatus License.

There was no license revenue in the three months ended March 31, 2025.

License revenue for the three months ended June 30, 2026 was comprised of sublicense revenue recognized from our share of the upfront payment under the sublicense to Everest, and the milestone payment associated with the submission of the NDS to Health Canada under the Théa License.

License revenue recognized in the three months ended June 30, 2025 was due to the upfront payment under the Lotus License.

Cost of Sales

Cost of sales for the three months ended March 31, 2026 was primarily driven by two nonrecurring charges to inventory stemming from an out-of-specification temperature excursion of inventory while in transit from our manufacturer and a write-off of packaging supplies associated with a manufacturing process transition.

There was no cost of sales during the three months ended March 31, 2025.

Cost of sales for the three months ended June 30, 2026 was primarily driven by cost of sales recognized in connection 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 that occurred during the three months ended March 31, 2026.

There was no cost of sales during the three months ended June 30, 2025.

Selling, General and Administrative

Selling, general and administrative expenses increased $33.8 million, or 305%, to $45.0 million for the three months ended March 31, 2026 compared to $11.1 million for the three months ended March 31, 2025.

The change was primarily driven by increases of $17.2 million in commercial marketing, advertising and sales infrastructure expenses as we launched our DTC marketing campaign in January 2026, $12.8 million in employee salaries and related expenses due to an increase in headcount, including the hiring of our sales force, $1.8 million in chemistry and control and regulatory related expenses which were classified as selling, general and administrative expenses subsequent to FDA approval, $1.1 million in travel related costs primarily related to our sales force, and a $0.8 million nonrecurring write-off of sample packaging and materials due to a manufacturing transition.

Selling, general and administrative expenses increased $26.6 million, or 208%, to $39.4 million for the three months ended June 30, 2026 compared to $12.8 million for the three months ended June 30, 2025.

The change was primarily driven by increases of $13.3 million in commercial marketing, advertising and sales infrastructure expenses as we launched our DTC

marketing campaign in January 2026, $11.0 million in employee salaries and related expenses due to an increase in headcount, including the hiring of our sales force, $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.

Sales, general and administrative expenses included $4.4 million and $2.1 million of non-cash share-based compensation for the three months ended June 30, 2026 and 2025, respectively.

Research and Development

Research and development expenses decreased by $5.8 million, or 100%, for the three months ended March 31, 2026 compared to $5.8 million for the three months ended March 31, 2025.

Research and development expenses decreased by $9.1 million, or 100%, for the three months ended June 30, 2026 compared to $9.1 million for the three months ended June 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.

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Other Income, net

Other income, net for the three months ended March 31, 2026, was $2.6 million, compared to $2.3 million for the three months ended March 31, 2025.

Interest income earned on our cash, cash equivalents, and marketable securities increased period over period due to a higher balance of marketable securities.

Other income, net for the three months ended June 30, 2026, was $2.3 million, compared to $2.4 million for the three months ended June 30, 2025.

Interest income earned on our cash, cash equivalents, and marketable securities was flat period over period due to a lower effective yield on our marketable securities resulting from a decline in interest rates.

Comparison of the Six Months Ended June 30, 2026 and 2025

The following table presents the results of operations for the periods indicated (amounts in thousands, except percentages):

Six Months Ended June 30,

2026 2025 $ Change % Change

Product sales, net $ 3,387 $ — $ 3,387 N/A

License revenue 4,000 5,000 (1,000) (20) %

Cost of sales 1,356 — — 1,356 — N/A

Selling, general and administrative expenses 84,338 23,909 60,429 253 %

Research and development expenses — 14,879 (14,879) (100) %

Other income, net 4,904 4,757 147 3 %

Product Sales, net

Following the FDA approval of VIZZ in July 2025, sales of commercial product began in October 2025.

Product sales, net for the six months ended June 30, 2026 was $3.4 million and was primarily driven by approximately 52,000 packs sold and delivered to the customer in the period.

We had no product sales during the six months ended June 30, 2025.

License Revenue

License revenue for the six months ended June 30, 2026 was comprised of revenue recognized from the upfront payment under the Lunatus License, sublicense revenue recognized from the upfront payment under the Asset Purchase Agreement to Everest and the achievement of a regulatory milestone under the Théa License.

License revenue recognized in the six months ended June 30, 2025 was due to the upfront payment under the Lotus License.

Selling, General and Administrative

Selling, general and administrative expenses increased $60.4 million, or 253%, to $84.3 million for the six months ended June 30, 2026 compared to $23.9 million for the six months ended June 30, 2025.

Increases in the comparative period included $30.5 million in commercial marketing, advertising and sales infrastructure as we launched our DTC campaign in January 2026, $23.8 million in employee salaries and related expenses due to a rise in headcount, including the hiring of our sales force, $2.2 million in chemistry and control and regulatory related expenses which were classified as selling, general and administrative expenses subsequent to FDA approval, $1.8 million in travel expenses primarily related to our sales force and $1.8 million in other corporate overhead.

Sales, general and administrative expenses included $8.7 million and $4.0 million of non-cash share-based compensation for the six months ended June 30, 2026 and 2025, respectively.

Research and Development

Research and development expenses decreased $14.9 million, or 100%, for the six months ended June 30, 2026 compared to $14.9 million for the six months ended June 30, 2025.

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

Other income, net for the six months ended June 30, 2026, was $4.9 million, compared to $4.8 million for the six months ended June 30, 2025.

Interest income earned on our cash, cash equivalents, and marketable securities increased by $0.3 million as a result of an overall increase in cash on-hand in 2026 over the comparative period, partially offset by a lower effective yield on our marketable securities resulting from a decline in interest rates.

Liquidity and Capital Resources

Sources of Liquidity

As of March 31, 2026, we had $258.4 million of cash, cash equivalents and marketable securities.

We have incurred net losses in each year since inception and as of March 31, 2026, we had an accumulated deficit of $268.6 million.

Our net losses were $41.5 million and $14.6 million for the three months ended March 31, 2026 and 2025, respectively.

As of June 30, 2026, we had $220.0 million of cash, cash equivalents and marketable securities.

We have incurred net losses in each year since inception and as of June 30, 2026, we had an accumulated deficit of $300.5 million.

Our net losses were $31.9 million and $14.9 million for the three months ended June 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 March 31, 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.

From inception through June 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.

On April 4, 2025, we entered into a Sales Agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”) under which we may offer and sell up to $150.0 million of shares of our common stock from time to time through an “at the market” offering program under which TD Cowen will act as sales agent.

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Funding Requirements

We believe that our cash, cash equivalents, and marketable securities as of March 31, 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.

We believe that our cash, cash equivalents, and marketable securities as of June 30, 2026 will allow us to continue to commercialize VIZZ.

This belief is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than expected.

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The following table summarizes our cash flows for the periods presented (amounts in thousands):

Three Months Ended March 31,

Six Months Ended June 30,

Net cash (used in) provided by:

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Cash flows will also continue to be affected by other operating and general administrative activities.

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

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

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

For the six months ended June 30, 2025, cash used in operating activities was $27.6 million and resulted from a net loss of $29.5 million, in addition to a $1.2 million increase in operating assets, offset by $3.5 million in non-cash adjustments primarily driven by share-based compensation expense.

Net Cash Provided by Investing Activities

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

Cash provided by investing activities for the three months ended March 31, 2025 was $18.9 million, primarily due to $52.1 million in proceeds from maturities of marketable securities, and partially offset by $33.1 million of purchases of marketable securities.

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

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

Net Cash Provided by Financing Activities

Cash provided by financing activities for the three months ended March 31, 2026 and March 31, 2025 was driven by proceeds from exercises of stock options.

Cash provided by financing activities for the six months ended June 30, 2026 was driven by proceeds from the issuance of common stock under the employee stock purchase plan.

Cash provided by financing activities for the six months ended June 30, 2025 was primarily driven by $26.1 million in net proceeds from common stock sold under the Sales Agreement.

Material Cash Requirements from Contractual Obligations

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Product Sales, net

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-pharmacy partner.

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 ePharmacy 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.

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We estimate the fair value of equity awards using the Black-Scholes option pricing model and recognize forfeitures as they occur.

Estimating the fair value of equity awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of variables, including the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant.

Estimating the fair value of equity awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is

affected by assumptions regarding a number of variables, including the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant.

Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized.

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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.

Prior to the Merger, Graphite elected to use, and we intend to continue to use, this extended transition period for complying with certain 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.

We are also a “smaller reporting company” because the market value of our stock held by non-affiliates was less than $700 million as of June 30, 2026 and the Company's annual revenue was less than $100 million during the fiscal year ended December 31, 2025.

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If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.

Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual

Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Recent Accounting Pronouncements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis