LENZ Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 3, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 3, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001815776-26-000052
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-03.
0001815776-26-000059
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 120 previous paragraphs and 124 current paragraphs.
79 unchanged; 35 reworded; 8 added; 4 removed; 2 previous and 2 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
•Sales of VIZZ commenced in the fourth quarter of 2025, thus, there were no product sales in the comparable periods in 2025. Total revenue for the three and nine months ended September 30, 2025 was solely derived from upfront and milestone payments under license agreements. We may generate future revenue from additional license and collaboration agreements to commercialize VIZZ outside the U.S.
Current report
Strategic Reorganization
Current report
On October 28, 2026, the board of directors approved a strategic reorganization to prioritize consumer marketing, allocate capital to maximize sales growth, and reduce operating expenses, which included decreasing our headcount by approximately 75% to approximately 40 full-time employees. Total net restructuring charges associated with the strategic reorganization are expected to be approximately $5 million, consisting primarily of severance and related termination benefits. Cash payments related to these expenses will be paid out and the strategic reorganization is expected to be substantially completed during the fourth quarter of 2026. The charges we expect to incur in connection with this strategic reorganization are subject to a number of assumptions, risks and uncertainties, and actual results may materially differ. We may also incur other material charges not currently contemplated due to events that may occur as a result of, or associated with, these actions.
Current report
Leadership Transition
Current report
Effective December 1, 2026, Evert Schimmelpennink will transition from his role as our President and Chief Executive Officer and member of our board of directors, and Daniel Chevallard, our Chief Financial Officer, will serve as our interim President and Chief Executive Officer, replacing Mr. Schimmelpennink in such roles. Mr. Chevallard will continue to serve in his role as our Chief Financial Officer in addition to his role as interim President and Chief Executive Officer. Following the transition, Mr. Schimmelpennink will serve as a strategic advisor to the Chief Executive Officer from December 1, 2026, to December 31, 2026.
Current report
In October 2026, the Emirates Drug Establishment granted Product Marketing Authorization Approval in the UAE for VIZZ. VIZZ is registered in the UAE as a Prescription Only Medicine, with LENZ as the Marketing Authorization Holder. This represents the first ex-U.S. regulatory approval of VIZZ and first approval under the Lunatus License.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
•costs associated with the strategic reorganization announced in October 2026;
Removed paragraphs (4)
Previous report
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 Everest License during the three and six months ended June 30, 2026 or 2025.
Previous report
•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.
Previous report
Acquisition of Rights to Develop and Commercialize VIZZ in Greater China by Everest Medicines
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Reworded paragraphs (35)
Previous wording
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 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.
Current wording
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 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 eye care professionals (“ECPs”), ePharmacy prescription fulfillment and home delivery.
Previous wording
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, it is possible that we may require additional financing to fund our operations and planned growth.
Current wording
As of September 30, 2026, we had$197.3 million of cash, cash equivalents, and marketable secu rities. We have incurred net losses in each year since inception, and as of September 30, 2026, we had an accumulated deficit of$331.5 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, it is possible that we may require additional financing to fund our operations and planned commercial growth.
Previous wording
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 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.
Current wording
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 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 September 30, 2026, the Company had no remaining capacity under the Sales Agreement.
Previous wording
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.
Current wording
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 nine months ended September 30, 2026 upon execution of the Asset Purchase Agreement.
Previous wording
On January 2, 2026, we entered into a distribution agreement appointing an exclusive distributor for VIZZ in the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Qatar, Bahrain, Oman, Jordan, Lebanon, and Iraq (collectively, the “Middle East”) (the “Lunatus License”). 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.
Current wording
On January 2, 2026, we entered into a distribution agreement appointing an exclusive distributor for VIZZ in the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Qatar, Bahrain, Oman, Jordan, Lebanon, and Iraq (collectively, the “Middle East”) (the “Lunatus License”). 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. In October 2026, the Emirates Drug Establishment granted Product Marketing Authorization Approval in the United Arab Emirates (“UAE”) for VIZZ. This represents the first regulatory approval under the Lunatus License.
Previous wording
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.
Current wording
Arrotex Pharmaceuticals Pty Ltd License and Commercialization Agreement
Previous wording
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.
Current wording
On June 24, 2026, we 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 percentage profit share of gross margin on future net sales in Australia and New Zealand.
Previous wording
•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.
Current wording
•Our selling, general and administrative expenses have increased in 2026, relative to 2025, as we have built a cross-functional commercial team consisting of sales, marketing and commercial operations personnel, and the requisite infrastructure to support the commercialization of VIZZ. We expect to continue to incur expenses necessary to support our commercial strategy, including our direct-to-consumer (“DTC”) marketing campaign. We expect our selling, general and administrative expenses to decrease following the strategic reorganization announced in October 2026, which is expected to be substantially completed during the fourth quarter of 2026.
Previous wording
•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 de minimis over the remainder of 2026.
Current wording
•Our research and development costs decreased to zero during the three and nine months ended September 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 de minimis over the remainder of 2026.
Previous wording
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.
Current wording
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 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 our ePharmacy partner providing a seamless and convenient consumer journey from product interest to home delivery. Launch of the telehealth channel will be promoted alongside our
Previous wording
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. 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.
Current wording
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. We have no remaining zero cost inventory as of September 30, 2026.
Previous wording
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 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.
Current wording
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 September 30, 2026 was $2.6 million and was primarily driven by approximately 38,000 packs sold and delivered to customers in the period. We had no product sales during the three months ended September 30, 2025.
Previous wording
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.
Current wording
License revenue for the three months ended September 30, 2026 was comprised of the upfront payment under the Arrotex License. License revenue recognized in the three months ended September 30, 2025 was due to the upfront payment under the Théa License and the achievement of two regulatory milestones under the Everest License.
Previous wording
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.
Current wording
Cost of sales for the three months ended September 30, 2026 was primarily driven by cost of sales recognized in connection with sales of VIZZ. There was no cost of sales during the three months ended September 30, 2025.
Previous wording
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.
Current wording
Selling, general and administrative expenses increased $8.3 million, or 30%, to $35.8 million for the three months ended September 30, 2026 compared to $27.6 million for the three months ended September 30, 2025. The change was primarily driven by increases of $7.3 million in commercial marketing, advertising and sales infrastructure expenses as we launched our DTC marketing campaign in January 2026, $1.9 million in employee salaries and related expenses primarily due to non-cash share-based compensation, partially offset by a $0.7 million decrease in legal costs. Selling, general and administrative expenses included $4.1 million and $3.2 million of non-cash share-based compensation for the three months ended September 30, 2026 and 2025, respectively.
Previous wording
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. 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.
Current wording
Research and development expenses decreased by $3.8 million, or 100%, for the three months ended September 30, 2026, compared to $3.8 million for the three months ended September 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.
Previous wording
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.
Current wording
Other income, net for the three months ended September 30, 2026, was $1.9 million, compared to $2.2 million for the three months ended September 30, 2025. Interest income earned on our cash, cash equivalents, and marketable securities decreased period over period primarily due to a decrease in cash on hand during the period in 2026 compared to 2025.
Previous wording
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.
Current wording
Following the FDA approval of VIZZ in July 2025, sales of commercial product began in October 2025. Product sales, net for the nine months ended September 30, 2026 was $6.0 million and was primarily driven by approximately 90,000 packs sold and delivered to customers in the period. We had no product sales during the nine months ended September 30, 2025.
Previous wording
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.
Current wording
License revenue for the nine months ended September 30, 2026 was comprised of revenue recognized from the upfront payments under the Lunatus and Arrotex Licenses, 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 nine months ended September 30, 2025 was due to the upfront payments under the Lotus and Théa Licenses, and the achievement of two regulatory milestones under the Everest License.
Previous wording
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.
Current wording
Selling, general and administrative expenses increased $68.7 million, or 133%, to $120.2 million for the nine months ended September 30, 2026 compared to $51.5 million for the nine months ended September 30, 2025. Increases in the comparative period included $37.6 million in commercial marketing, advertising and sales infrastructure as we launched our DTC campaign in January 2026, $25.6 million in employee salaries and related expenses due to a rise in headcount, including the hiring of our sales force, $2.5 million in chemistry and control and regulatory related expenses which were classified as selling, general and administrative expenses subsequent to FDA approval, $2.0 million in other corporate overhead, and $1.9 million in travel expenses primarily related to our sales force. Selling, general and administrative expenses included $12.8 million and $7.2 million of non-cash share-based compensation for the nine months ended September 30, 2026 and 2025, respectively.
Previous wording
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. 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.
Current wording
Research and development expenses decreased by $18.7 million, or 100%, for the nine months ended September 30, 2026, compared to $18.7 million for the nine months ended September 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.
Previous wording
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.
Current wording
Other income, net for the nine months ended September 30, 2026 and 2025, was $6.9 million. 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, offset by an increase in cash on hand during the period in 2026 compared to 2025.
Previous wording
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.
Current wording
As of September 30, 2026, we had $197.3 million of cash, cash equivalents and marketable securities. We have incurred net losses in each year since inception and as of September 30, 2026, we had an accumulated deficit of $331.5 million. Our net losses were $31.0 million and $16.7 million for the three months ended September 30, 2026 and 2025, respectively, and $104.4 million and $46.2 million for the nine months ended September 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 continue commercialization of VIZZ, including costs related to product sales, marketing, manufacturing, and distribution.
Previous wording
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. Under the Sales Agreement, we set the parameters for the sale of shares, including the number or dollar amount of shares to be issued, the time period during which sales are requested to be made, limitations on the number or dollar amount of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, TD Cowen may sell the shares by methods deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. We have no obligation to sell any shares under the Sales Agreement and may at any time suspend solicitation and offers under the Sales Agreement. The shares were issued pursuant to our shelf registration statement on Form S-3, including the prospectus supplement contained therein, which was declared effective by the SEC on April 14, 2025. During theyear ended December 31, 2025, the Company sold an aggregate of 3,618,634 shares of common stock at a weighted-average price of$41.45 under the Sales Agreement, resulting in net proceeds of $147.7 million, utilizing the full capacity of the Sales Agreement.
Current wording
On April 4, 2025, we entered into 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. Under the Sales Agreement, we set the parameters for the sale of shares, including the number or dollar amount of shares to be issued, the time period during which sales are requested to be made, limitations on the number or dollar amount of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, TD Cowen may sell the shares by methods deemed to be an “at the market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. We have no obligation to sell any shares under the Sales Agreement and may at any time suspend solicitation and offers under the Sales Agreement. The shares were issued pursuant to our shelf registration statement on Form S-3, including the prospectus supplement contained therein, which was declared effective by the SEC on April 14, 2025. During theyear ended December 31, 2025, we sold an aggregate of 3,618,634 shares of common stock at a weighted-average price of$41.45 under the Sales Agreement, resulting in net proceeds of $147.7 million, utilizing the full capacity of the Sales Agreement.
Previous wording
•costs associated with maintaining and expanding a sales, marketing, and distribution infrastructure to commercialize VIZZ;
Current wording
•costs associated with maintaining the requisite infrastructure to commercialize VIZZ;
Previous wording
•our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company;
Current wording
•our efforts to maintain or enhance operational systems and hire or retain personnel to satisfy our obligations as a public company;
Previous wording
We intend to evaluate financing opportunities from time to time, and our ability to obtain financing will depend, among other things, on our development efforts, business plans, operating performance and the condition of the capital markets at the time we seek financing. We cannot be assured that additional financing will be available to us on favorable terms when required, or at all. If we raise additional funds through the issuance of equity or equity-linked securities, those securities may have rights, preferences or privileges senior to the rights of our common stock, and our stockholders may experience dilution. If we raise additional funds through the incurrence of indebtedness, then we may be subject to increased fixed payment obligations and could be subject to restrictive covenants, such as limitations on our ability to incur additional debt, and other operating restrictions that could adversely impact our ability to conduct our business.
Current wording
We believe that our existing cash, cash equivalents, and marketable securities through the date of filing of this report will be sufficient to support our operations for at least the next 12 months. We intend to evaluate financing opportunities from time to time, and our ability to obtain financing will depend, among other things, on our development efforts, business plans, operating performance and the condition of the capital markets at the time we seek financing. We cannot be assured that additional financing will be available to us on favorable terms when required, or at all. If we raise additional funds through the issuance of equity or equity-linked securities, those securities may have rights, preferences or privileges senior to the rights of our common stock, and our stockholders may experience dilution. If we raise additional funds through the incurrence of indebtedness, then we may be subject to increased fixed payment obligations and could be subject to restrictive covenants, such as limitations on our ability to incur additional debt, and other operating restrictions that could adversely impact our ability to conduct our business.
Previous wording
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.
Current wording
For the nine months ended September 30, 2026, cash used in operating activities was $94.6 million and resulted from a net loss of $104.4 million and a $3.8 million decrease in operating assets and liabilities, offset by $13.6 million in non-cash adjustments primarily driven by share-based compensation expense.
Previous wording
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.
Current wording
For the nine months ended September 30, 2025, cash used in operating activities was $36.1 million and resulted from a net loss of $46.2 million, offset by $6.3 million in non-cash adjustments primarily driven by share-based compensation expense and a $3.8 million increase in operating assets and liabilities.
Previous wording
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.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2026 was $99.6 million, primarily due to $132.1 million in proceeds from maturities of marketable securities, and partially offset by $32.5 million of purchases of marketable securities.
Previous wording
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.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2025 was $14.1 million, primarily due to $162.6 million in proceeds from maturities of marketable securities, and partially offset by $147.7 million of purchases of marketable securities and $0.8 million in purchases of property and equipment.
Previous wording
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.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2026 was driven by proceeds from the issuance of common stock under the employee stock purchase plan.
Previous wording
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.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2025 was primarily driven by $26.1 million in net proceeds from common stock sold under the Sales Agreement and $0.8 million in proceeds from exercises of stock options.
Previous wording
We also have contracts with various suppliers and manufacturing companies to supply the active pharmaceutical ingredient used in VIZZ, and manufacture the drug product for commercial sale and used in the regulatory process. The scope of the services under these contracts can be modified and the contracts cancelled by us upon written notice. In the event of a cancellation, the company would be liable for the cost and expenses incurred to date as well as any close out costs of the service arrangement.
Current wording
We also have contracts with various suppliers and manufacturing companies to supply the active pharmaceutical ingredient used in VIZZ, and manufacture the drug product for commercial sale and used in the regulatory process. The scope of the services under these contracts can be modified and the contracts cancelled by us upon written notice. In the event of a cancellation, we would be liable for the cost and expenses incurred to date as well as any close out costs of the service arrangement.
Previous wording
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. We may continue to be a smaller reporting company in any given year if either (i) the market value of our stock held by non-affiliates is less than $250 million as of June 30 in the most recently completed fiscal year or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million as of June 30 in the most recently completed fiscal year. 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
Current wording
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, 2025 and our annual revenue was less than $100 million during the fiscal year ended December 31, 2025. We may continue to be a smaller reporting company in any given year if either (i) the market value of our stock held by non-affiliates is less than $250 million as of June 30 in the most recently completed second quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million as of June 30 in the most recently completed fiscal year. 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.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
‘Tired of Reading Glasses’ campaign featuring brand spokesperson Sarah Jessica Parker through both a national television advertising campaign and digital DTC strategy.
Current report — wording carried from elsewhere
Approval of VIZZ in the United Arab Emirates
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.