FDMT — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Additionally, in June 2025, we initiated 4FRONT-2, our second Phase 3 trial of 4D-150 in wet AMD. 4FRONT-2 is a global clinical trial and enrolled both treatment-naïve and recently diagnosed, treatment-experienced patients. We completed enrollment for 4FRONT-2 in June 2026 ahead of schedule with >50…

• Research and development expenses increased by $44.6 million, or 50%, from the six months ended June 30, 2025 to the six months ended June 30, 2026. The increase of $44.6 million was primarily due to an increase in clinical trial activity for wet AMD.

• General and administrative expenses increased by $1.0 million, or 9%, from the three months ended June 30, 2025 to the three months ended June 30, 2026. General and administrative expenses decreased by $0.2 million, or 1%, from the six months ended June 30, 2025 to the six months ended June 30, 2026…

• Other income, net, decreased by $0.7 million, or 15%, from the three months ended June 30, 2025 to the three months ended June 30, 2026. Other income, net, decreased by $1.5 million, or 14%, from the six months ended June 30, 2025 to the six months ended June 30, 2026. The decreases were primarily b…

• As of June 30, 2026, we had cash, cash equivalents and marketable securities of $430.6 million. We have funded our operations primarily through the sale and issuance of our equity securities, including Follow-on Offerings and our “at-the-market” offering program, from borrowings under our Loan and S…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• Additionally, 4FRONT-2, our second Phase 3 trial of 4D-150 in wet AMD, was initiated in June 2025. 4FRONT-2 is a global clinical trial and is enrolling both treatment-naïve and recently diagnosed, treatment-experienced patients. We expect to complete enrollment for 4FRONT-2 in the second half of 202…

• choose. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.

• On July 2, 2025, we announced a workforce reduction of approximately 25% of current and planned roles, primarily in the areas supporting early-stage research and development and support functions following a strategic pipeline prioritization to focus on the development of 4D-150 and 4D-710. In conne…

• General and administrative expenses decreased by $1.2 million, or 10%, from the three months ended March 31, 2025 to the three months ended March 31, 2026. The decrease was primarily due to decreased headcount of general and administrative personnel.

• Other income, net, decreased by $0.8 million, or 14%, from the three months ended March 31, 2025 to the three months ended March 31, 2026. The decrease was primarily due to lower market yields on our cash equivalents and marketable securities.

Text added vs the prior filing · source: 10-Q · 2026-08-13

• As of June 30, 2026, we had $20.0 million outstanding under our Loan and Security Agreement, which bears interest at a floating rate. A hypothetical 75 basis point increase in interest rates would increase our annual interest expense by approximately $0.2 million, assuming the outstanding principal …

Text added vs the prior filing · source: 10-Q · 2026-08-13

• As of June 30, 2026, we had $430.6 million in cash and cash equivalents and marketable securities.

• Due to the significant resources required for the development of our product candidates, in particular our product candidates in IND-enabling studies and those in clinical trials, we must decide which product candidates and indications to pursue and advance and the amount of resources to allocate to…

• Our loan and security agreement with Hercules contains operating and financial covenants that may restrict our business and financing activities, is secured by substantially all of our assets, including our intellectual property, and we may be required to repay our outstanding indebtedness earlier t…

• In June 2026, we entered into a loan and security agreement (the "Loan Agreement") with Hercules Capital, Inc. (“Hercules”), which provides for term loans in an aggregate principal amount of up to $200.0 million, of which $20.0 million was funded at closing. The term loans bear interest at floating …

• The Loan Agreement contains customary affirmative and restrictive covenants that, among other things, limit our ability to transfer or dispose of assets, merge with other companies or consummate certain changes of control, make investments, incur additional indebtedness and liens and enter into new …

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.

• our early-stage research projects, continue preclinical and clinical development of our product candidates and, in particular, advance our product candidates through clinical trials. Even if we are successful in developing our product candidates, obtaining regulatory approvals and launching and comm…

• As of March 31, 2026, we had $457.6 million in cash and cash equivalents and marketable securities.

• Due to the significant resources required for the development of our product candidates, in particular our product candidates in IND-enabling studies and those in clinical trials, we must decide which product candidates and indications to pursue and advance and the amount of resources to allocate to…

• resources toward particular product candidates or therapeutic areas may not lead to the development of any viable commercial product and may divert resources away from better opportunities. Similarly, our potential decisions to delay, terminate or collaborate with third parties in respect of certain…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• During the fiscal quarter ended June 30, 2026, none of our directors or officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• During the fiscal quarter ended March 31, 2026, the following officer, as defined in Rule 16a-1(f), adopted a “Rule 10b5-1 trading arrangement,” as defined in Regulation S-K Item 408, as follows:

• On January 9, 2026, David Kirn, M.D., our President and Chief Executive Officer, adopted a Rule 10b5-1 trading arrangement providing for the potential sale from time to time of up to 450,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10…

• None of our other directors or officers (as defined in Section 16 of the Exchange Act adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 t…