4D Molecular Therapeutics

4D Molecular Therapeutics, Inc. engages in the design, development, and commercialization of transformative gene therapeutic products for serious unmet medical conditions. It offers products for ophthalmology, cardiology, and pulmonology. The company was founded by David H. Kirn, Melissa Kotterman, Theresa Janke, and David Schaffer on September 12, 2013 and is headquartered in Emeryville, CA.

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4DMT operates as a clinical-stage genetic medicines company focused on inventing and developing genetic medicines to treat large market diseases in ophthalmology, pulmonology and cardiology. It develops genetic medicines using its proprietary invention platform, Therapeutic Vector Evolution. It combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences. Its product design, development and manufacturing engine create a valuable and diverse product pipeline. The company is currently advancing five clinical-stage and two preclinical product candidates, each tailored to address rare and large market diseases. 4DMT was founded by David H. Kirn, Melissa Kotterman, Theresa Janke, and David Schaffer on September 12, 2013 and is headquartered in Emeryville, CA.

4D Molecular Therapeutics, Inc. (FDMT) came out with a quarterly loss of $0.77 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.87 per share a year ago.

4D Molecular Therapeutics, Inc. (FDMT) Reports Q2 Loss, Misses Revenue Estimates

EMERYVILLE, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company) a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, today reported second quarter 2023 financial results and provided operational highlights.

4D Molecular Therapeutics Reports Second Quarter 2023 Financial Results and Operational Highlights

EMERYVILLE, Calif., July 29, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced additional positive interim clinical data from the Phase 1 Dose Exploration stage (N=15) of the 4D-150 Phase 1/2 PRISM clinical trial for patients with wet age-related macular degeneration (wet AMD). The data were presented at the 2023 American Society of Retinal Specialists (ASRS) Annual Meeting in Seattle, Washington on Saturday, July 29 by Christine N. Kay, M.D., a vitreoretinal surgeon and the Director of Electrophysiology, Retinal Genetics, and Clinical Trials at Vitreoretinal Associates in Gainesville, Florida. 4D-150 is a potentially transformative genetic medicine that utilizes 4DMT's evolved and customized retinotropic R100 vector, while targeting four VEGF family members. 4D-150 is being developed as a single dose, routine outpatient intravitreal therapy with the goal of reducing treatment burden and maintaining efficacy in patients with wet AMD and diabetic macular edema (DME).

4DMT Presents Additional Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ASRS 2023

EMERYVILLE, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced that it has completed enrollment of the Phase 2 Dose Expansion stage of the PRISM clinical trial for patients with wet age-related macular degeneration (wet AMD) over approximately two quarters, and that no significant 4D-150 safety events or inflammation have been reported to date.

4DMT Completes Enrollment of Phase 2 PRISM Clinical Trial for Intravitreal 4D-150 in Patients with Wet AMD and Reports Interim Safety and Tolerability Data

TOKYO and EMERYVILLE, Calif. , July 10, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) (President and CEO: Naoki Okamura, "Astellas") and 4D Molecular Therapeutics, Inc. (NASDAQ: FDMT) (CEO: David Kirn, MD, "4DMT") today announced a license agreement under which Astellas gains rights to utilize the intravitreal retinotropic R100* vector invented by 4DMT for one genetic target implicated in rare monogenic ophthalmic disease(s), with options to add up to two additional targets implicated in rare monogenic ophthalmic diseases after paying additional option exercise fees.

Astellas and 4D Molecular Therapeutics (4DMT) Enter into License Agreement to Use 4DMT's Proprietary Intravitreal R100 Vector for Rare Ophthalmic Targets

4D Molecular Therapeutics demonstrates a robust economic position and promising line-up of gene therapies, with a commitment to innovation and strategic financial management. The company's financials show a steady growth trajectory, with successful fundraising efforts, strategic cost management, and investment in research and development. 4DMT's gene therapy products offer potential solutions for a variety of severe ailments, but also face potential challenges and competition in the rapidly evolving field of gene therapy.

4D Molecular Therapeutics: Pioneering Gene Therapies And An Impressive Fiscal Performance

Shares of "directed evolution" genetic medicine concern 4D Molecular Therapeutics, Inc. have more or less hovered near $20 since positive 4D-150 data in November 2022. The company's approach to AAV delivery could change the industry, but results have been spotty, featuring a Fabry disease program on clinical hold and two others abandoned by Roche. A full investment analysis follows in the paragraphs below.

4D Molecular Therapeutics: A Complicated Story

EMERYVILLE, Calif., June 07, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced positive interim clinical data from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis lung disease. 4D-710 is comprised of our targeted and evolved vector, A101, and a codon-optimized CFTR∆R transgene and is designed for aerosol delivery to achieve CFTR expression within lung airway epithelial cells. In this clinical update, participants ineligible for (n=2) or intolerant of (n=1) existing CFTR modulators were dosed with 4D-710 in cohort 1 (dose 1E15 vg) and showed meaningful improvement in cystic fibrosis-related quality of life measured by CFQ-R-R and improved or stabilized ppFEV1. Interim data from the study will be presented in an oral presentation titled, “AAV mediated gene therapy for cystic fibrosis: Interim results from a Phase 1/2 clinical trial,” at the European Cystic Fibrosis Society (ECFS) 46th Annual Meeting held in Vienna, Austria on Thursday, June 8 at 5:00 p.m. CET (11:00 a.m. ET).

4DMT Presents Positive Interim Data from Aerosolized 4D-710 Phase 1/2 AEROW Clinical Trial in Patients with Cystic Fibrosis at the ECFS 46th Annual Meeting

EMERYVILLE, Calif., June 01, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, announced today it will participate in the following upcoming investor conferences:

4D Molecular Therapeutics to Participate in Upcoming Investor Conferences

EMERYVILLE, Calif., May 24, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced an oral presentation of the interim data from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic fibrosis lung disease at the European Cystic Fibrosis Society 46th Annual Meeting held in Vienna, Austria on June 7-10, 2023. 4D-710 is comprised of our targeted and evolved vector, A101, and a codon-optimized CFTR∆R transgene and is designed for aerosol delivery to achieve CFTR expression within lung airway epithelial cells. 4D-710 is being initially developed in the approximately 15% of patients whose disease is not amenable to existing CFTR modulator medicines targeting the CFTR protein.

4DMT to Present Interim Data from 4D-710 Phase 1/2 AEROW Clinical Trial for Cystic Fibrosis Lung Disease at the European Cystic Fibrosis Society (ECFS) 46th Annual Meeting

Viking Global Investors LP, the firm managed by Andreas Halvorsen (Trades, Portfolio), disclosed in a regulatory filing that it boosted its holding in 4D Molecular Therapeutics ( FDMT , Financial) in May according to GuruFocus Real-Time Picks, a Premium feature based on Schedule 13D, 13G and Form 4 filings.

Andreas Halvorsen's Firm Packs Further Into 4D Molecular Therapeutics

EMERYVILLE, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced a presentation on 4D-710 for the treatment of cystic fibrosis lung disease at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting held in Los Angeles, California on May 16-20, 2023.

4DMT Announces Presentation on Aerosolized 4D-710 for Treatment of Cystic Fibrosis at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting

4D Molecular Therapeutics, Inc. (FDMT) came out with a quarterly loss of $0.88 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.82 per share a year ago.

4D Molecular Therapeutics, Inc. (FDMT) Reports Q1 Loss, Lags Revenue Estimates

EMERYVILLE, Calif., May 10, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company) a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, today reported first quarter 2023 financial results and provided operational highlights.

4D Molecular Therapeutics Reports First Quarter 2023 Financial Results and Operational Highlights

Underwriters' full exercise of option brings gross proceeds to $138.0 million Underwriters' full exercise of option brings gross proceeds to $138.0 million

4D Molecular Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Full Exercise of Underwriters' Option to Purchase Additional Shares

4D Molecular Therapeutics, Inc. (FDMT) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

4D Molecular Therapeutics, Inc. (FDMT) Surges 5.4%: Is This an Indication of Further Gains?

EMERYVILLE, Calif., April 27, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced positive interim clinical data from the Phase 1 Dose Exploration stage (three doses, n=15) of the 4D-150 Phase 1/2 PRISM clinical trial for wet age-related macular degeneration (wet AMD). 4D-150, a novel genetic medicine that utilizes 4DMT's evolved and customized R100 vector for intravitreal delivery to the retina, was well- tolerated at all doses. All doses demonstrated clinical activity, including a reduction in anti-VEGF injection burden, stable or improved retinal edema and thickness, and stable visual acuity. A dose response was demonstrated in favor of the high dose 3E10 vg/eye. Interim data from the study will be presented today in an oral presentation titled, “Interim results for the Phase 1/2 PRISM Trial evaluating 4D-150, a dual-transgene intravitreal genetic medicine in individuals with neovascular (wet) age-related macular degeneration,” at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in New Orleans, LA at 11:30 a.m. ET.

4DMT Presents Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ARVO 2023

EMERYVILLE, Calif., April 24, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, “4DMT”), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large-market diseases, today announced that it acquired the rights and know-how for short-form human complement factor H (sCFH) from Aevitas Therapeutics, Inc. The transgene encoding sCFH, a shortened and optimized form of a natural inhibitor of the inflammatory complement pathway invented at the University of Pennsylvania, will be combined with 4DMT's proprietary retinotropic R100 vector to engineer the product candidate 4D-175 for treatment of GA secondary to AMD.

4DMT Acquires Complement Pathway Inhibitor Payload for 4D-175 Product Candidate for Geographic Atrophy

4D Molecular Therapeutics, Inc. (FDMT) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

4D Molecular Therapeutics, Inc. (FDMT) Soars 11.2%: Is Further Upside Left in the Stock?

EMERYVILLE, Calif., April 13, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced an oral presentation of interim data from the 4D-150 Phase 1/2 PRISM clinical trial for wet age-related macular degeneration (wet AMD) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held April 23-27, 2023 in New Orleans, Louisiana. 4D-150 is designed for single, low-dose intravitreal delivery of a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi and is currently in clinical development for wet AMD and diabetic macular edema (DME).

4DMT to Present Interim Data from 4D-150 Phase 1/2 PRISM Clinical Trial for Wet AMD at ARVO 2023, and Promotes Robert Kim, M.D. to Chief Medical Officer

With its strong focus on product design and development excellence, as evidenced by its sustained success in IND clearance, 4D Molecular Therapeutics is a promising biotech company with significant growth. 4D Molecular Therapeutics' recently released data from its PRISM clinical trial for wet age-related macular degeneration (wet AMD) further validates its R100 intravitreal vector's potential for treating large-market eye diseases.

4D Molecular Therapeutics: Promising Preliminary Safety And Efficacy For 4D-310

4D Molecular Therapeutics, Inc. (FDMT) delivered earnings and revenue surprises of -12% and 74.90%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

4D Molecular Therapeutics, Inc. (FDMT) Reports Q4 Loss, Lags Revenue Estimates

EMERYVILLE, Calif., March 15, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT'), a clinical-stage biotherapeutics company harnessing the power of directed evolution for genetic medicines targeting large market diseases, today announced full year 2022 financial results and provided operational highlights.

4D Molecular Therapeutics Reports Full Year 2022 Financial Results and Operational Highlights

EMERYVILLE, Calif., Feb. 22, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT'), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced updated interim safety and efficacy data from the two 4D-310 INGLAXA Phase 1/2 clinical trials for Fabry disease cardiomyopathy. All three patients with 12 months of follow-up demonstrated improvement on cardiac contractility, exercise capacity and quality of life endpoints. Treatment was generally well tolerated, with transient acute aHUS being the only significant adverse event. Following a detailed investigation into the etiology of aHUS, 4DMT is engaging with the FDA to resume enrollment based on updated exclusion criteria and the highly effective rituximab/sirolimus immunosuppressive regimen. Data will also be presented at the WORLDSymposium™ 2023 in Orlando, Florida on February 25th, 2023.

4D Molecular Therapeutics Presents Interim Data from 4D-310 INGLAXA Phase 1/2 Clinical Trials & Development Plans for Fabry Disease Cardiomyopathy at WORLDSymposium™

EMERYVILLE, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, ‘4DMT'), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced that the Company will host a live webcast on February 22 to present interim clinical data from its 4D-310 INGLAXA Phase 1/2 clinical trials for the treatment of Fabry disease cardiomyopathy and will give an update on clinical development plans.

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