EyePoint Pharmaceuticals Inc

Previous wording

the potential for DURAVYU™, as an investigational sustained delivery intravitreal treatment deploying a bioerodible Durasert E™ insert of vorolanib, a selective and patented tyrosine kinase inhibitor (TKI) targeting wet age-related macular degeneration (wet AMD), non-proliferative diabetic retinopathy (NPDR), and diabetic macular edema (DME);

Current wording

the potential for DURAVYU™, as an investigational sustained delivery intravitreal treatment deploying a bioerodible Durasert E™ insert of vorolanib, a selective and patented tyrosine kinase inhibitor (TKI) targeting wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME);

Previous wording

our expectations regarding the timing and outcome of our ongoing and planned clinical trials for DURAVYU™ for the treatment of wet AMD, NPDR, and DME;

Current wording

our expectations regarding the timing and outcome of our ongoing and planned clinical trials for DURAVYU™ for the treatment of wet AMD and DME;

Previous wording

our belief that our cash, cash equivalents, and investments in marketable securities of $299.3 million at March 31, 2024, will provide a cash runway into 2026 through topline data for the DURAVYU™ Phase 3 pivotal trials in wet AMD;

Current wording

our belief that our cash, cash equivalents, and investments in marketable securities of $280.2 million at June 30, 2024, will provide a cash runway through anticipated Phase 3 wet AMD topline data for DURAVYU™ in 2026;

Previous wording

the sufficiency of our existing cash resources into 2026 through topline data for the DURAVYU™Phase 3 pivotal trials in wet AMD;

Current wording

the sufficiency of our existing cash resources;

Previous wording

EYEPOINT®, DEXYCU®, YUTIQ®, DURASERT®, DELIVERING INNOVATION TO THE EYE® and WITH AN EYE ON PATIENTS® are our trademarks. Retisert® and Vitrasert® are Bausch & Lomb’s trademarks. YUTIQ® is licensed to Alimera Sciences and Ocumension Therapeutics in their respective territories. ILUVIEN® is Alimera Sciences Inc.’s trademark. The reports we file or furnish with the SEC, including this Quarterly Report on Form 10-Q, also contain trademarks, trade names and service marks of other companies, which are the property of their respective owners.

Current wording

EYEPOINT®, DEXYCU®, YUTIQ®, DURASERT®, DURAVYU®, DELIVERING INNOVATION TO THE EYE®, and WITH AN EYE ON PATIENTS® are our trademarks. Retisert® and Vitrasert® are Bausch & Lomb’s trademarks. YUTIQ® is licensed to Alimera Sciences and Ocumension Therapeutics in their respective territories. ILUVIEN® is Alimera Sciences Inc.’s trademark. The reports we file or furnish with the SEC, including this Quarterly Report on Form 10-Q, also contain trademarks, trade names, and service marks of other companies, which are the property of their respective owners.

Previous wording

We are a company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™, is an investigational sustained delivery treatment for anti-vascular endothelial growth factor (anti-VEGF) -mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E™. DURAVYU™ is presently in Phase 2 clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, non-proliferative diabetic retinopathy (NPDR), and diabetic macular edema (DME). We expect to initiate pivotal Phase 3 clinical trials in wet AMD in the second half of 2024.

Current wording

We are a company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™, is an investigational sustained delivery treatment for anti-vascular endothelial growth factor (anti-VEGF) -mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU™ is presently in Phase 2 clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and diabetic macular edema (DME). We expect to randomize patients for inclusion in pivotal Phase 3 clinical trials in wet AMD in 2024.

Previous wording

In February 2024, we announced results from new subgroup analyses from the Phase 2 DAVIO 2 clinical trial of DURAVYU™. The presented analyses of the data reveal: in the sub-group of patients who were supplement-free up to 6 months, the DURAVYU™ groups demonstrated numerical superiority in change in BCVA along with strong anatomic control compared to the aflibercept control group. This result confirms that the positive topline data from the Phase 2 DAVIO 2 trial were driven by DURAVYU™ and not by study eyes requiring supplemental injection; visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden; and DURAVYU™outcomes are consistent and durable in a range of wet AMD patient types.

Current wording

Positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU™ for the treatment of wet AMD

Previous wording

In May 2024, we announced topline results of our Phase 2 PAVIA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR). The data demonstrated that DURAVYU™ has a biologic effect in patients with NPDR with a favorable safety and tolerability profile, however the trial did not meet the pre-specified primary endpoint. We plan to provide an update on the path forward for DURAVYU™ as a potential treatment in NPDR following a review of the full 12-month data.

Current wording

In May 2024, we announced topline results of our Phase 2 PAVIA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR). The data demonstrated that DURAVYU™ has a biologic effect in patients with NPDR with a favorable safety and tolerability profile, however the trial did not meet the pre-specified primary endpoint. We expect 12-month data from this trial in 3Q 2024.

Previous wording

Product sales, net represents the gross sales of YUTIQ® and DEXYCU® less provisions for product sales allowances. Product sales, net decreased by $6.7 million, or 91%, to $0.7 million for the three months ended March 31, 2024 compared to $7.4 million for the three months ended March 31, 2023. This decrease was driven by the agreement that granted license and rights to YUTIQ® to Alimera in May 2023. For the three months ended March 31, 2024, product sales, net were primarily from the sales of product supply under the existing commercial supply agreement (CSA) with Alimera.

Current wording

Product sales, net represents the gross sales of YUTIQ® and DEXYCU® less provisions for product sales allowances. Product sales, net decreased by $4.2 million, or 80%, to $1.1 million for the three months ended June 30, 2024 compared to the same period the prior year. This decrease was driven by the agreement that granted license and rights to YUTIQ® to Alimera in May 2023. For the three months ended June 30, 2024, product sales, net included $0.6 million of product supply under the existing commercial supply agreement (CSA) with Alimera of $0.6 million, as well as $0.5 million of product supply to Ocumension.

Previous wording

Royalty income increased by $0.2 million, or 82%, to $0.5 million for the three months ended March 31, 2024 compared to $0.3 million for the three months ended March 31, 2023. The increase was attributable to Ocumension Therapeutics royalties from YUTIQ® product sales in China.

Current wording

Royalty income increased by $0.4 million, or 167%, to $0.6 million for the three months ended June 30, 2024 compared to the same period the prior year. The increase was attributable to increased Ocumension Therapeutics royalties from YUTIQ® product sales in China.

Previous wording

Sales and marketing expenses decreased by $5.7 million, or 100%, for the three months ended March 31, 2024 from $5.7 million for the same period in the prior year. This decrease was driven by discontinued YUTIQ® promotion due to the agreement that granted YUITQ® license and rights to Alimera in Q2 2023 and the Company's exit from the commercial business.

Current wording

Sales and marketing expenses decreased by $5.2 million, or 99%, to $0.1 million for the three months ended June 30, 2024 compared to the same period the prior year. This decrease was driven by discontinued YUTIQ® promotion due to the agreement that granted YUTIQ® license and rights to Alimera in Q2 2023 and the Company's exit from the commercial business. Expenses for the three months ended June 30, 2024 included support for ongoing government reporting requirements.

Previous wording

General and administrative expenses increased by $4.9 million, or 53%, to $14.1 million for the three months ended March 31, 2024 from $9.2 million for the same period in the prior year. This increase was primarily attributable to $3.5 million in stock-based compensation and $1.3 million in personnel costs.

Current wording

General and administrative expenses increased by $3.7 million, or 41%, to $12.8 million for the three months ended June 30, 2024 compared to the same period the prior year. This increase was primarily attributable to $4.0 million in stock-based compensation and $1.0 million in personnel costs, partially offset by lower legal and other administrative expenses.

Previous wording

Interest income from investments in marketable securities and institutional money market funds increased by $2.8 million, or 236%, to $4.0 million for the three months ended March 31, 2024 compared to $1.2 million in the prior year quarter. This increase was due primarily to an increase in cash and marketable securities and higher interest rates in the current calendar quarter.

Current wording

Interest income from investments in marketable securities and institutional money market funds increased by $2.1 million, or 129%, to $3.7 million for the three months ended June 30, 2024 compared to the same period the prior year. This increase was due primarily to an increase in cash and marketable securities and higher interest rates in the current calendar quarter.

Previous wording

There was no interest expense in the three months ended March 31, 2024 due to the repayment of the loan under the loan and security agreement with Silicon Valley Bank (SVB Loan Agreement) on May 17, 2023. Interest expense for the three months ended March 31, 2023 was $0.8 million.

Current wording

There was no interest expense in the three months ended June 30, 2024 due to the repayment of the loan under the loan and security agreement with Silicon Valley Bank (SVB Loan Agreement) on May 17, 2023. Interest expense for the three months ended June 30, 2023 was $0.4 million.

Previous wording

Research and development expenses increased by $16.5 million, or 121%, to $30.1 million for the three months ended March 31, 2024 from $13.6 million for the same period in the prior year. This increase was attributable primarily to (i) $5.6 million associated with non-cash equity award modifications expense, (ii) $4.2 million in increased clinical trial costs related to DURAVYU™ in Phase 2 clinical trials for wet AMD (DAVIO2), NPDR (PAVIA), and DME (VERONA), (iii) $2.4 million in higher clinical trial material expense (iv) $2.0 million higher personnel expense to support clinical trial activity and product development, including non-cash stock compensation, (v) $1.5 million in severance related expense, and (vi) $1.0 million in higher other R&D expenses.

Current wording

Research and development expenses increased by $30.7 million, or 104%, to $60.0 million for the six months ended June 30, 2024 compared to the same period the prior year. This increase was attributable primarily to (i) $6.3 million higher personnel expense to support clinical trial activity and product development, including $3.7 million of non-cash stock compensation, (ii) $5.7 million associated with non-cash equity award modifications expense, (iii) $5.0 million for a milestone payment due for completion of our Phase 2 wet AMD (DAVIO2) clinical trial (iv) $4.8 million in increased clinical trial costs related to DURAVYU™ in Phase 2 clinical trials for wet AMD (DAVIO2), NPDR (PAVIA), and DME (VERONA), (v) $3.1 million in higher clinical trial material expense, (vi) $2.7 million higher DURAVYU™ non-clinical expenses, (vii) $1.5 million in severance related expense, and (viii) $1.1 million of other R&D expenses.

Previous wording

We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at March 31, 2024 we had a total accumulated deficit of $771.4 million. Our operations have been financed primarily from sales of our equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income, and other fees received from collaboration partners.

Current wording

We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at June 30, 2024 we had a total accumulated deficit of $802.3 million. Our operations have been financed primarily from sales of our equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners.

Previous wording

During the three months ended March 31, 2024, we did not sell any shares of our common stock under our at-the-market offering facility.

Current wording

During the six months ended June 30, 2024, we did not sell any shares of our common stock under our at-the-market offering facility. During July 2024, we sold 1,299,506 shares of our common stock under our at-the-market offering facility at a weighted average price of $9.36 per share for gross proceeds of approximately $12.2 million. Share issue costs, including sales agent commissions, totaled approximately $0.4 million.

Previous wording

At March 31, 2024, we had cash, cash equivalents, and investments in marketable securities of $299.3 million. We expect that our cash and investments in marketable securities will enable us to fund our current operating plan through topline data for the planned Phase 3 wet AMD pivotal trials into 2026. Due to the difficulty and uncertainty associated with the design and implementation of preclinical studies and clinical trials, we will continue to assess our cash and cash equivalents and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for any of our product candidates, we will incur significant sales, marketing and manufacturing expenses. We also expect to continue to incur significant costs to comply with corporate governance, internal controls and similar requirements associated with operating as a public reporting company.

Current wording

At June 30, 2024, we had cash, cash equivalents, and investments in marketable securities of $280.2 million. We expect that our cash and investments in marketable securities will enable us to fund our current operating plan through anticipated Phase 3 wet AMD topline data for DURAVYU™ in 2026. Due to the difficulty and uncertainty associated with the design and implementation of preclinical studies and clinical trials, we will continue to assess our cash and cash equivalents and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations. We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for any of our product candidates, we will incur significant sales, marketing, and manufacturing expenses. We also expect to continue to incur significant costs to comply with corporate governance, internal controls, and similar requirements associated with operating as a public reporting company.

Previous wording

Operating cash outflows for the three months ended March 31, 2024 totaled $31.2 million, primarily due to our net loss of $29.3 million reduced by $12.4 million of non-cash expenses, which included $12.7 million of stock-based compensation and $0.3 million for depreciation of property and equipment, partially offset by $0.6 million of amortization and accretion of marketable securities. This was partially offset by cash outflows related to changes in working capital of $14.3 million, including $8.8 million of deferred revenue related to the agreement to license YUTIQ® product rights to Alimera, and $5.5 million of other working capital changes.

Current wording

Operating cash outflows for the six months ended June 30, 2024 totaled $51.4 million primarily due to our net loss of $60.1 million reduced by $19.8 million of non-cash expenses, which included $21.4 million of stock-based compensation, partially offset by $2.3 million for amortization of discount on available for sale of marketable securities. This was further offset by changes in working capital of $11.0 million, including $14.3 million of deferred revenue related to the agreement to license YUTIQ® product rights to Alimera.

Previous wording

For the three months ended March 31, 2023, $32.6 million of net cash was provided by the sales of marketable securities, and $0.5 million was used for the purchase of property and equipment.

Current wording

For the six months ended June 30, 2024, $137.5 million of net cash was used for the purchase of marketable securities, and $2.1 million was used for the purchase of property and equipment.

Previous wording

For the three months ended March 31, 2024, $22.0 million of net cash was provided by the sales of marketable securities, and $1.2 million was used for the purchase of property and equipment.

Current wording

For the six months ended June 30, 2023, $46.4 million of net cash was provided by the sales of marketable securities, and $0.9 million was used for the purchase of property and equipment.

Previous wording

Net cash used in financing activities for the three months ended March 31, 2023 totaled $5.1 million and consisted of the following:

Current wording

Net cash provided by financing activities for the six months ended June 30, 2024 totaled $0.4 million and consisted of the following:

Previous wording

$0.1 million net proceeds primarily from the exercise of stock options.

Current wording

$5.2 million from the exercise of stock options

Previous wording

$0.1 million used for payment of equity issue costs.

Current wording

$4.7 million used for the settlement of stock units and payment of equity issue costs

Previous wording

Net cash used in financing activities for the three months ended March 31, 2024 totaled $0.1 million and consisted of the following:

Current wording

Net cash used in financing activities for the six months ended June 30, 2023 totaled $41.8 million and consisted of the following: