About 4D-175 for Geographic Atrophy Katherine Smith Inizio Evoke Comms Katherine.Smith@inizioevoke.com "GA is a leading cause of irreversible vision loss for over 5 million people globally and while current bolus complement inhibitor treatments reduce the rate of growth in GA lesions, they require burdensome monthly or bimonthly intravitreal injections and do not demonstrate functional vision benefit," said David Kirn, M.D., Cofounder and Chief Executive Officer of 4DMT. "4D-175 has the potential for durabl ...

Core Insights - 4D Molecular Therapeutics (4DMT) is set to present initial interim 24-week landmark analysis data from the Population Extension cohort of the PRISM Phase 2 Clinical Trial for 4D-150, targeting wet age-related macular degeneration (AMD) [1][6] - The presentation will occur at the ASRS Annual Scientific Meeting in Stockholm, Sweden, from July 17-20, 2024, with a webcast scheduled for July 17 at 6:30 a.m. ET [1][6] - The clinical trial involves 45 patients, with specific data on 30 patients treated at a dosage of 3E10 vg/eye expected to be shared [6] Company Overview - 4DMT is a clinical-stage genetic medicines company focused on developing therapies for large market diseases, particularly in ophthalmology and pulmonology [3] - The company utilizes its proprietary Therapeutic Vector Evolution platform, which combines directed evolution technology with synthetic AAV capsid-derived sequences to create customized vectors for its product candidates [3] - Currently, 4DMT is advancing five clinical-stage and two preclinical product candidates, addressing diseases in ophthalmology, pulmonology, and cardiology, along with gene editing programs in CNS [3]

Injection-free subgroup results demonstrated that a single intravitreal dose of 4D-150 without any supplemental anti-VEGF injections resulted in stable mean visual acuity that was equal to or higher than in the standard bimonthly aflibercept control group at all six timepoints through Week 24 Single intravitreal 3E10 vg/eye dose resulted in sustained reduction and stabilization of mean central subfield thickness (CST) compared to aflibercept at all timepoints EMERYVILLE, Calif., June 08, 2024 (GLOBE NEWSWIR ...

Clinically meaningful improvements in ppFEV1 at 12 months observed in 2 of 3 participants with mild to moderate baseline lung function impairment (ppFEV1 50-80%) and >6 months follow up Aerosolized 4D-710 was well tolerated at doses up to 1E15 vg (n=6) Dose-dependent and widespread 4D-710-mediated CFTR transgene RNA and protein expression observed in all lung biopsies from all participants evaluated to date Pre-existing AAV immunity cross-reactive with A101 did not affect transgene expression, biological ac ...

Clinically meaningful improvements in ppFEV1 at 12 months observed in 2 of 3 participants with mild to moderate baseline lung function impairment (ppFEV1 50-80%) and >6 months follow up Aerosolized 4D-710 was well tolerated at doses up to 1E15 vg (n=6) Dose-dependent and widespread 4D-710-mediated CFTR transgene RNA and protein expression observed in all lung biopsies from all participants evaluated to date Pre-existing AAV immunity cross-reactive with A101 did not affect transgene expression, biological ac ...

Core Viewpoint - 4D Molecular Therapeutics is set to present interim clinical data from the Phase 1/2 AEROW clinical trial for aerosolized 4D-710, aimed at treating cystic fibrosis lung disease, at the 47th European Cystic Fibrosis Conference on June 6, 2024 [1][2] Group 1: Company Overview - 4D Molecular Therapeutics is a clinical-stage genetic medicines company focused on developing therapies for large market diseases, particularly in ophthalmology and pulmonology [6] - The company utilizes a proprietary platform called Therapeutic Vector Evolution to create customized AAV vectors for its product candidates [6] - Currently, 4DMT is advancing five clinical-stage and two preclinical product candidates targeting rare and large market diseases [6] Group 2: Product Information - 4D-710 is designed for aerosol delivery to achieve targeted CFTR expression in lung airway epithelial cells and aims to treat approximately 15% of cystic fibrosis patients whose conditions are not amenable to existing CFTR modulator therapies [4] - The product has received Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. FDA [5] Group 3: Cystic Fibrosis Context - Cystic fibrosis is a progressive inherited disease affecting nearly 40,000 people in the U.S. and over 105,000 globally, with lung disease being the primary cause of morbidity and mortality [3] - The disease leads to impaired lung function and requires lifelong treatment, often resulting in repeated hospitalizations and increased need for antibiotics [3]

Exhibit 99.1 4DMT Reports First Quarter 2024 Financial Results and Operational Highlights EMERYVILLE, Calif., May. 9, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today reported first quarter 2024 financial results and provided operational highlights. "The first quarter of 2024 kicks off another transformative year for 4DMT ...

PART I. FINANCIAL INFORMATION [Item 1. Condensed Unaudited Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Unaudited%20Financial%20Statements) The unaudited financial statements show a higher net loss from increased spending, alongside a significantly strengthened balance sheet due to a recent public offering [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) The balance sheet shows a substantial increase in total assets and stockholders' equity, driven by proceeds from the February 2024 public offering Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $275,594 | $249,108 | | Marketable securities | $313,259 | $50,078 | | Total current assets | $535,589 | $296,588 | | **Total assets** | **$629,884** | **$339,891** | | **Liabilities & Equity** | | | | Total current liabilities | $16,403 | $18,951 | | Total liabilities | $29,323 | $32,062 | | **Total stockholders' equity** | **$600,561** | **$307,829** | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) The company's net loss increased year-over-year due to higher R&D and G&A expenses, partially offset by greater interest income Condensed Statement of Operations (in thousands) | Account | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Collaboration and license revenue | $28 | $298 | | Research and development | $27,870 | $22,412 | | General and administrative | $10,294 | $7,992 | | Loss from operations | ($38,136) | ($30,106) | | Interest income | $5,745 | $1,443 | | **Net loss** | **($32,401)** | **($28,682)** | | **Net loss per share** | **($0.66)** | **($0.88)** | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Financing activities from a public offering provided a significant cash inflow, offsetting cash used in operating and investing activities Condensed Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($29,088) | ($27,906) | | Net cash provided by (used in) investing activities | ($263,258) | $43,130 | | Net cash provided by financing activities | $318,832 | $10,994 | | **Net increase in cash and cash equivalents** | **$26,486** | **$26,218** | | **Cash and cash equivalents, end of period** | **$275,594** | **$78,569** | [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail a significant public offering, the company's liquidity, key agreements, and an accumulated deficit of $447.7 million - In February and March 2024, the company completed a public offering, selling common stock and pre-funded warrants, resulting in total net proceeds of approximately **$316.1 million** ($281.2 million + $34.9 million)[33](index=33&type=chunk)[34](index=34&type=chunk) - The company has an accumulated deficit of **$447.7 million** as of March 31, 2024, but believes its cash, cash equivalents, and marketable securities are sufficient to fund planned operations for at least one year[35](index=35&type=chunk) - In July 2023, the company entered a license agreement with Astellas Gene Therapies (AGT), receiving a **$20 million** upfront payment and potential future milestones up to **$942.5 million**[82](index=82&type=chunk) - In January 2024, the company entered into a new lease for warehouse space with future minimum lease payments of approximately **$1.5 million** over five years[98](index=98&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its focus on developing genetic medicines, the status of its clinical trials, and the financial impact of increased R&D and G&A spending [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Operating expenses rose 26% year-over-year, driven by increased clinical trial activity and higher payroll costs in both R&D and G&A Comparison of Results of Operations (in thousands) | Line Item | Q1 2024 | Q1 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $28 | $298 | ($270) | (91)% | | Research and development | $27,870 | $22,412 | $5,458 | 24% | | General and administrative | $10,294 | $7,992 | $2,302 | 29% | | Loss from operations | ($38,136) | ($30,106) | ($8,030) | 27% | | Net loss | ($32,401) | ($28,682) | ($3,719) | 13% | - The increase in R&D expenses was primarily driven by a **$3.9 million** increase in clinical trial costs for product candidate 4D-150 and a **$1.3 million** increase in payroll[162](index=162&type=chunk) - The increase in G&A expenses was primarily due to a **$1.7 million** increase in payroll and personnel expenses and a **$0.9 million** increase in facilities and other expenses[162](index=162&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $588.9 million in cash and securities and believes this is sufficient to fund operations for at least the next year - As of March 31, 2024, the company had cash, cash equivalents and marketable securities of **$588.9 million**[172](index=172&type=chunk) - The company believes its existing cash and cash equivalents will fund planned operations for at least one year from the date of the report's issuance[177](index=177&type=chunk) - Net cash provided by financing activities of **$318.8 million** in Q1 2024 was primarily due to **$315.7 million** in net proceeds from the public offering[186](index=186&type=chunk) Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended Mar 31, 2024 | Three Months Ended Mar 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($29,088) | ($27,906) | | Net cash provided by (used in) investing activities | ($263,258) | $43,130 | | Net cash provided by financing activities | $318,832 | $10,994 | [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its $588.9 million in cash and securities, which management deems not material - The company holds **$588.9 million** in cash, cash equivalents, and marketable securities and believes a 10% change in interest rates would not have a material effect on their fair value[198](index=198&type=chunk) - The company does not believe that inflation or interest rate changes have had a significant impact on its results of operations for the periods presented[199](index=199&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of March 31, 2024 - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2024[203](index=203&type=chunk) - There were no material changes to the company's internal control over financial reporting during the first quarter of 2024[204](index=204&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings are outstanding as of the end of the quarter - As of March 31, 2024, there are **no material legal proceedings** outstanding against the company[103](index=103&type=chunk)[206](index=206&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its early stage of development, history of net losses, and reliance on novel gene therapy technology - The company is in the early stages of drug development with a limited operating history, recurring net losses (**$447.7 million** accumulated deficit), and no approved products[209](index=209&type=chunk)[211](index=211&type=chunk) - All product candidates are based on novel AAV genetic medicine technology, which has limited regulatory and clinical experience, making development unpredictable[209](index=209&type=chunk)[229](index=229&type=chunk) - Gene therapies are complex to manufacture, and the company could experience production problems or raw material shortages that delay development[209](index=209&type=chunk)[294](index=294&type=chunk)[304](index=304&type=chunk) - The company's success depends on its ability to protect its intellectual property, which may be challenged, invalidated, or circumvented[214](index=214&type=chunk)[373](index=373&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=102&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - There were **no unregistered sales** of equity securities in the quarter[491](index=491&type=chunk) [Default Upon Senior Securities](index=102&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There were **no defaults** upon senior securities[492](index=492&type=chunk) [Mine Safety Disclosures](index=102&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[493](index=493&type=chunk) [Other Information](index=102&type=section&id=Item%205.%20Other%20Information) Several company officers and directors adopted or terminated Rule 10b5-1 trading plans during the quarter - President and COO Fariborz Kamal adopted a Rule 10b5-1 trading plan on January 4, 2024, for the sale of up to **15,000 shares**[494](index=494&type=chunk) - CMO Robert Kim terminated a prior Rule 10b5-1 plan and adopted a new one on March 19, 2024, for the sale of up to **16,000 shares**[495](index=495&type=chunk)[496](index=496&type=chunk) - CEO David Kirn terminated a prior Rule 10b5-1 plan and adopted a new one on March 21, 2024, for the sale of up to **305,083 shares**[497](index=497&type=chunk)[498](index=498&type=chunk) [Exhibits](index=104&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the quarterly report, including required officer certifications - Exhibits filed include **CEO and CFO certifications** (31.1, 31.2, 32.1) and Inline XBRL documents[502](index=502&type=chunk)

Wall Street expects a year-over-year increase in earnings on higher revenues when 4D Molecular Therapeutics, Inc. (FDMT) reports results for the quarter ended March 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they mi ...

Preclinical data for 4D-175 for geographic atrophy to be presented in an oral presentation4D-150 PRISM randomized Phase 2 Dose Expansion Cohort (N=51) 24-week encore results to be presented in a poster EMERYVILLE, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (NASDAQ:FDMT, 4DMT or the Company))), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced presentations at the 2024 Associa ...