Market Newsdesk

• Deramiocel Biologics License Application (BLA) under active FDA review
• HOPE-3 Phase 3 results published in The Lancet; primary endpoint of upper limb function achieved at p=0.029
• Cash, cash equivalents and marketable securities of approximately $238 million as of June 30, 2026
• Conference call and webcast today at 4:30 p.m. ET

SAN DIEGO, Aug. 13, 2026 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced its financial results for the second quarter ended June 30, 2026, and provided a corporate update.

“Our priority is, and always has been, to get Deramiocel to the patients and families living with Duchenne who need it most,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “The Advisory Committee outcome was not the one we hoped for. The indication we requested in 2024 was the treatment of cardiomyopathy in DMD, and that is the question the Committee was asked to vote on, not the HOPE-3 primary endpoint. HOPE-3 was designed and powered to demonstrate efficacy in upper limb function; cardiac function was a key secondary endpoint, measured across all patients enrolled rather than only those with established cardiomyopathy. The full dataset has since been published in The Lancet following extensive and independent peer review, and we continue to believe there is a path to approval for Deramiocel.”

Dr. Marbán continued, “The most powerful part of the Advisory Committee was the open public hearing, where patients, families and clinicians described what this therapy has meant, or could mean, to them. That testimony is on the public record, and it is a reminder of how urgent the unmet need in Duchenne remains. We are continuing to work with the Agency on a path forward.”

Second Quarter 2026 and Recent Highlights

• Deramiocel BLA Under FDA Review: Capricor is continuing to work with the FDA on the review of its BLA. The Company plans to provide a regulatory update on its conference call today and will provide further updates as they become available.
• FDA Advisory Committee Outcome: On July 29, 2026, the Cellular, Tissue and Gene Therapies Advisory Committee voted 3 in favor and 9 against on whether available evidence provides substantial evidence of effectiveness of Deramiocel for the treatment of cardiomyopathy in patients with DMD. The Committee was not asked to vote on the HOPE-3 primary endpoint or on overall benefit-risk, and in a separate discussion of upper limb function its feedback was directionally supportive of the HOPE-3 clinical evidence. The recommendation is advisory and non-binding.
• HOPE-3 Results Published in
  
  The Lancet
  
  : The full HOPE-3 Phase 3 dataset was published in The Lancet in July following extensive and independent peer review. Deramiocel demonstrated a statistically significant slowing of upper limb disease progression as measured by PUL 2.0 (p=0.029), with supportive results across additional functional and cardiac measures, which are characterized as nominally significant under the applicable hierarchical testing procedures. In connection with the peer review, Capricor identified an issue with the statistical model in the clinical study report and reverted to the statistical analysis plan in place prior to unblinding. The only endpoint affected was left ventricular ejection fraction, which yields (p=0.09) and a 1.8 percentage point treatment difference, compared to (p=0.04) and a 2.4 percentage point difference reported as topline data. The pre-specified cardiomyopathy subgroup was unchanged at (p=0.02), nothing else changed in the data or its analysis, and the HOPE-3 primary endpoint was unaffected.
• FDA Bioresearch Monitoring Inspection: As part of the review process, the FDA conducted a BIMO inspection in July 2026 and issued a Form 483 citing one observation. The Company has submitted its responses and is currently awaiting feedback.
• Commercial and Manufacturing Readiness: The Company’s GMP manufacturing facility in San Diego is operational and positioned to support an initial commercial launch, if Deramiocel is approved. The second-floor expansion is targeted for full validation and FDA inspection in 2027, as planned. Michael Maurer joined as Chief Commercial Officer, bringing direct DMD and rare disease experience, and has been judiciously building out the launch organization. Capricor is advancing commercial readiness at a slower pace pending regulatory clarity.
• NS Pharma Dispute: The state court was scheduled to hear Capricor’s motion for preliminary injunction on August 10, 2026, ahead of the PDUFA action date. Capricor withdrew the motion, without prejudice, having determined that resolving this contractual dispute in arbitration following the FDA’s decision would give the parties a more complete regulatory record to work from. The Company estimates arbitration to begin this fall. Capricor’s position on the underlying dispute has not changed: it continues to believe the pricing structure in the U.S. Distribution Agreement is fundamentally flawed in a way that would impede patient access, and continues to seek rescission.
• Long-Term Safety and Efficacy Experience: Capricor has administered approximately 1,300 intravenous infusions of Deramiocel to over 200 patients with DMD across three separate clinical trials. More than 80 patients are enrolled in the Company’s collective open-label extension studies, with some receiving continuous infusions for more than five years, and the long-term safety profile is consistent and well characterized.
• Pipeline and Lifecycle Management: Capricor has initiated regulatory engagement in Europe and Japan for Deramiocel. Expansion into younger DMD patients and Becker muscular dystrophy remains a priority, with trial initiations stage-gated to the U.S. regulatory pathway for Deramiocel. Programs not directly related to Deramiocel, including the Company’s exosome-based platform, are on hold pending further regulatory clarity.

Second Quarter 2026 Financial Results

• Cash position: Cash, cash equivalents and marketable securities totaled approximately $237.9 million as of June 30, 2026, compared to approximately $318.1 million as of December 31, 2025.
• Revenues: There was no revenue recognized for the first half of 2026 or 2025.
• Costs and Expenses: Total operating expenses for the second quarter of 2026 were approximately $42.9 million, compared to approximately $27.7 million for the second quarter of 2025. Total operating expenses for the first half of 2026 were approximately $79.7 million, compared to approximately $52.7 million for the first half of 2025.
• Net loss: The Company reported a net loss of approximately $40.7 million, or $0.70 per share, for the second quarter of 2026, compared to a net loss of approximately $25.9 million, or $0.57 per share, for the second quarter of 2025. The net loss for the first half of 2026 was approximately $74.7 million, or $1.29 per share, compared to a net loss of approximately $50.3 million, or $1.10 per share, for the first half of 2025.
• Financial Outlook: The Company believes that, based on its current operating plan and financial resources, its available cash, cash equivalents and marketable securities are sufficient to fund its operating capital requirements for at least the next twelve months. The Company expects to provide additional guidance on its longer-term financial outlook following greater regulatory clarity, which will inform future strategic and capital allocation decisions. This outlook excludes any potential revenue from product sales, the potential monetization of a Priority Review Voucher, if received, or other non-operating sources of capital.

Upcoming Investor Events

• 2026 Wells Fargo Healthcare Conference, September 8-10, 2026, Boston, MA
• Cantor Global Healthcare Conference 2026, September 9-11, 2026, New York, NY
• H.C. Wainwright 28^th Annual Global Investment Conference, September 14-16, 2026, New York, NY

Conference Call and Webcast

To participate in the conference call, please dial 1-800-717-1738 (Domestic) or 1-646-307-1865 (International) and reference the conference ID: 91880. Participants may dial in using the numbers above and ask to be joined to the call or click the Call Me™ link for instant telephone access to the event. To participate via a webcast, please click here. A replay of the webcast will be available shortly after the conclusion of the live event and will be accessible in the Investors section of the Company’s website.

About Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a severe, X-linked genetic disorder characterized by progressive muscle degeneration affecting the skeletal, respiratory, and cardiac muscles. It is caused by the absence of functional dystrophin, a key structural protein in muscle cells. DMD affects approximately 15,000 individuals in the United States and primarily impacts boys. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the leading cause of death in DMD. There is no cure, and treatment options remain limited.

About Deramiocel

Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing rather than pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials.

Deramiocel has received Orphan Drug Designation for the treatment of DMD from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher upon approval.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing cell and exosome-based therapeutics for the treatment of rare diseases. Our lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy (DMD), evaluated in clinical studies for its potential to preserve skeletal and cardiac muscle function. Capricor is also advancing its proprietary StealthX™ exosome platform for the targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics across a range of diseases. At Capricor, we are committed to delivering new therapies for patients with rare diseases. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and X.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including future interactions with regulatory authorities and the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval, revenue and reimbursement estimates, projected terms of definitive agreements, our financial position, our possible uses of existing cash and investment resources; results of securities litigation; and statements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS Pharma, Inc., including the nature of the dispute, our expectations regarding any legal proceedings, and our ability to commercialize Deramiocel independent of our existing distribution agreement and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 17, 2026 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on May 13, 2026. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:

Caitlin Kasunich / Raquel Cona
KCSA Strategic Communications
[email protected] / [email protected]
212.896.1241 / 516.779.2630

Capricor Company Contact:

AJ Bergmann, Chief Financial Officer
[email protected]
858.727.1755

• Announced sale of manufacturing operations (July 2026) for $122.5 million and transition to fully outsourced model with leaner, approximately 140-person workforce focused on novel therapeutics pipeline
• Data presentations at ESMO planned for MGC026 (B7-H3 ADC) and lorigerlimab (PD-1 × CTLA-4)
• MGC028 (ADAM9 ADC) dose escalation study ongoing; disclosure of preliminary clinical results planned for late 2026
• MGC030 IND application submission cleared ahead of schedule, with first patient expected to be dosed in third quarter
• Pro forma cash, cash equivalents and marketable securities of $327 million; cash runway guidance through 2028

ROCKVILLE, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) — MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today reported financial results for the quarter ended June 30, 2026, and highlighted its recent corporate and pipeline progress.

“Our team delivered strong second-quarter execution: advancing our strategic priorities, strengthening our financial position, and sharpening our focus to accelerate the development of life-changing medicines for patients,” said Eric Risser, President and Chief Executive Officer of MacroGenics. “With a significantly stronger financial foundation, we are well-positioned to advance our pipeline and deliver a catalyst-rich period ahead.”

Advancement of Innovative Pipeline

MacroGenics is developing a portfolio of investigational agents, including both topoisomerase I inhibitor-based antibody-drug conjugates (ADCs) and T-cell engagers (TCEs).

• MGC026 is a novel ADC targeting B7-H3, a protein expressed across the tumor microenvironment, including tumor-associated stroma and vasculature. The dose-escalation portion of the ongoing Phase 1 study has been completed after evaluating doses ranging from 1 mg/kg to 9 mg/kg every three weeks (Q3W). A dose of 7.5 mg/kg Q3W is being further evaluated in four tumor-specific cohorts, including squamous cell carcinoma of the head and neck (SCCHN), endometrial cancer, melanoma and soft tissue sarcoma. MGC026 recently achieved an important milestone, with the SCCHN cohort meeting the pre-specified response threshold to advance into Stage 2. Interim results from the Phase 1 study have been accepted for poster presentation at the European Society for Medical Oncology (ESMO) 2026 Congress in October.
• MGC028 is a first-in-class ADC targeting ADAM9, a protein that is overexpressed in multiple solid tumors. The dose escalation study of MGC028 is ongoing and the Company anticipates providing an update with preliminary clinical results in late 2026.
• MGC030 is a first-in-class ADC targeting an undisclosed antigen expressed across several solid tumors. The Company’s Investigational New Drug (IND) application was submitted ahead of schedule and cleared by the U.S. Food and Drug Administration (FDA) in the second quarter of 2026. The Company plans to commence a Phase 1 dose escalation study in the third quarter of 2026.
• Lorigerlimab is a PD-1 × CTLA-4 bispecific DART® molecule being evaluated in patients with advanced gynecologic cancers. MacroGenics continues the Phase 2 LINNET study of lorigerlimab, with the interim data accepted for poster presentation at the ESMO 2026 Congress. The Company is enrolling 20 additional patients with clear cell gynecologic cancer (CCGC) at a dose of 3 mg/kg Q3W and anticipates reporting updated study results in the first half of 2027.

Future Pipeline

MacroGenics is advancing multiple preclinical programs that incorporate proprietary platforms for next-generation TCEs and ADCs. Following completion of preclinical proof-of-concept studies and preliminary toxicology in non-human primates, the Company recently nominated MGD032, a novel next-generation TCE against an undisclosed target. This molecule is now advancing in IND-enabling studies.

Partnership Updates

MacroGenics maintains partnerships with Incyte Corporation, Sanofi and Gilead Sciences, Inc. spanning multiple commercial, clinical and preclinical programs. Through these collaborations, the Company remains eligible to receive up to approximately $2.4 billion in aggregate future milestone payments, in addition to potential royalties on net product sales.

On August 11, the Company announced that Gilead had exercised its option to license a preclinical bispecific program under the companies’ 2022 collaboration agreement. This option exercise triggers a $10.0 million payment to MacroGenics. The Company remains eligible to earn additional milestones and royalties based on net product sales.

Corporate Update

Corporate Restructuring and Divestiture of Manufacturing Operations. In July, MacroGenics announced the completion of the sale of its GMP drug substance manufacturing operations to Bora Pharmaceuticals Co., Ltd. and Bora Biologics USA, LLC (collectively, Bora) for a previously disclosed base purchase price of $122.5 million. At closing, the Company received $119.6 million in cash consideration, reflecting adjustments for net working capital and indebtedness, before transaction fees and expenses. Approximately 140 previous MacroGenics employees were hired by Bora and, together with a concurrent restructuring, MacroGenics’ workforce is anticipated to be reduced to approximately 140 employees by year-end. As part of the transaction, MacroGenics entered into a supply agreement with Bora to support process development and drug substance production for the Company’s internal pipeline. MacroGenics’ transition to a fully-outsourced manufacturing model and a leaner organization is expected to enable greater focus on the advancement of its novel therapeutics pipeline, while providing increased flexibility and cost effectiveness.

Second Quarter 2026
Financial Results

• Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026, were $173.3 million, compared with $189.9 million as of December 31, 2025. The balance as of June 30, 2026, included $60.0 million received from Sagard Healthcare Partners related to the monetization of ZYNYZ® royalties. During the quarter, the Company also earned a $24.5 million regulatory milestone from Sanofi related to a U.S. approval of TZIELD®, with payment expected in the third quarter of 2026. Subsequent to June 30, 2026, MacroGenics received cash consideration of $119.6 million from Bora in connection with the completed sale of the Company’s GMP manufacturing operations. In addition, in August, the Company achieved a $10.0 million milestone pursuant to Gilead’s exercise of its option to obtain an exclusive license for a preclinical bispecific program under the companies’ 2022 collaboration agreement. The Company’s pro forma cash, cash equivalents and marketable securities as of June 30, 2026, including net proceeds from Bora, Sanofi and Gilead, totaled $327 million.
• Revenue: Total revenue was $32.8 million for the quarter ended June 30, 2026, compared with $6.9 million for the quarter ended June 30, 2025. The increase was primarily due to achievement of the $24.5 million regulatory milestone from Sanofi related to U.S. approval of TZIELD.
• R&D Expenses: Research and development expenses were $38.8 million for the quarter ended June 30, 2026, compared with $40.8 million for the quarter ended June 30, 2025. The decrease was primarily due to decreased costs related to lorigerlimab and discontinued programs, partially offset by increased trial costs related to MGC026 and MGC028.
• G&A Expenses: General and administrative expenses were $7.9 million for the quarter ended June 30, 2026, compared with $9.3 million for the quarter ended June 30, 2025. The decrease was primarily due to lower personnel-related costs, including stock-based compensation expense.
• Net Income (Loss): Net income was $19.5 million for the quarter ended June 30, 2026, compared with net loss of $36.3 million for the quarter ended June 30, 2025. Net income for the quarter ended June 30, 2026, reflects income from discontinued operations of $89.2 million related to the sale of the Company’s GMP manufacturing operations to Bora, and a $52.8 million non-cash loss on the extinguishment of the ZYNYZ royalty monetization liability.
• Shares Outstanding: Shares of common stock outstanding as of June 30, 2026, were 63,645,711.
• Cash Runway Guidance: MacroGenics anticipates that its pro forma cash, cash equivalents and marketable securities of $327 million as of June 30, 2026, plus other projected future payments from partners, will support the Company’s cash runway through 2028.

About MacroGenics, Inc.

MacroGenics (the Company) is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo, and DART are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of clinical updates and safety and efficacy data for the Company’s ongoing clinical trials, anticipated cash runway and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy, including our ability to execute on our key strategic priorities for 2026, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks related to the reproducibility of any results initially seen in any product candidate; risks that TZIELD, lorigerlimab, ZYNYZ, or any other product candidate’s revenue, expenses and costs may not be as expected; risks relating to TZIELD, lorigerlimab, ZYNYZ, or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, including timing and results of efficacy and safety data with respect to product candidates in ongoing clinical trials; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations regarding the expansion of ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company’s product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; risks related to the transition of the CDMO operations to the purchaser following the sale of our CDMO operations (the “Transaction”); risks related to the Company’s post-closing manufacturing arrangements with the purchaser in the Transaction, including under the manufacturing and supply agreement and the transition services agreement; the possibility that the anticipated benefits of the Transaction may not be realized; and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

CONTACTS

Jim Karrels, Senior Vice President, CFO
1-301-251-5172
[email protected] 

Argot Partners
1-212-600-1902
[email protected]

• Completed enrollment for 4D-150 4FRONT-2 wet AMD Phase 3; topline data expected in H2 2027 
• 4D-150 4FRONT-1 Phase 3 topline data expected in Q2 2027
• Presented positive 2-year data from 4D-150 PRISM Phase 2b at ASRS, highlighting long-term continuous treatment effect and ongoing favorable safety profile
• Plan to initiate a 4D-150 DME Phase 3 in Q3 2026
• Company to host an Investor Day on October 21, 2026, in New York City
• Entered into a strategic credit facility agreement with Hercules Capital, Inc.
  for up to $200 million, initial draw of $20 million
• $431 million
  in cash, cash equivalents and marketable securities expected to fund current operating plan into second half of 2028
  

EMERYVILLE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today reported Q2 2026 financial results, provided operational highlights and outlined expected upcoming milestones.    

“The second quarter of 2026 reflected continued strong execution across 4DMT, including completion of enrollment for 4FRONT-2, presenting positive long-term PRISM data and strengthening our financial flexibility through securing a strategic credit facility with Hercules,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “With topline data from both 4FRONT-1 and 4FRONT-2 in wet AMD expected in 2027, our DME Phase 3 expected to initiate in the third quarter and our Investor Day planned in October, we are well positioned to advance 4D-150 as a potential paradigm-changing backbone therapy for patients with wet AMD and DME.”

Recent Highlights and Expected Milestones

• Corporate Highlights:
  • Secured credit facility for up to $200 million from Hercules Capital to provide the Company with strategic and operational flexibility
    • Under the terms of the agreement, the Company drew an initial $20 million at closing
  • Company to host an Investor Day in New York City on October 21, 2026
    • Investor Day will provide an overview of the commercial potential of 4D-150 and include participation from senior leadership and leading retinal disease key opinion leaders. Additional details will be provided in advance of the event
• 4D-150 for Wet Age-related Macular Degeneration (AMD):  
  • 4FRONT Global Phase 3 Program:
    • 4FRONT-1, North American Clinical Trial: 
      • Enrollment completed in February 2026 and randomization completed (N=523) in March 2026; topline data expected in Q2 2027 

• • • 4FRONT-2, Global Clinical Trial:
      • Enrollment completed in June 2026 with N>500 expected to be randomized; topline data expected in H2 2027

• • PRISM Phase 1/2 Clinical Trial:
    • Phase 2b 2-year data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, presented at American Society of Retina Specialists (ASRS) Annual Meeting on July 18, 2026:
      • Consistent maintenance of best corrected visual acuity (BCVA)
      • Consistent control of central subfield thickness (CST) as measured by optical coherence tomography
      • Consistent, durable and clinically meaningful reduction in treatment burden:
        • Overall cohort:
          • 78% overall treatment burden reduction (2.7 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)
        • Recently diagnosed subgroup:
          • 87% overall treatment burden reduction (1.6 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)
      • 4D-150 continues to be well tolerated with no new cases of inflammation with 2 to more than 4 years of follow-up on all patients as of the data cutoff and no 4D-150-related hypotony, endophthalmitis, vasculitis, occlusive/non-occlusive retinal vasculitis or choroidal effusions observed to date

• 4D-150 for Diabetic Macular Edema (DME):  
  • Global Phase 3 trial design and initiation expected in Q3 2026
  • SPECTRA clinical trial 2-year data expected in Q4 2026
•  4D-175 for Geographic Atrophy:  
  • Company maintains an active IND and is evaluating opportunities to advance the program into the clinic
• 4D-710 for Cystic Fibrosis:  
  • AEROW Phase 1/2 clinical trial and program update expected in Q4 2026

Q2 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $430.6 million as of June 30, 2026, as compared to $514.0 million as of December 31, 2025. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities, and expected payments under our collaboration agreement with Otsuka, will be sufficient to fund our operating expenses and capital expenditure requirements at least into the second half of 2028.   

Collaboration and License Revenue: Collaboration and license revenue was $3.8 million for the second quarter of 2026, as compared to an insignificant amount for the second quarter of 2025. The increase in revenue was primarily due to the clinical trial cost sharing and reimbursement amounts from Otsuka. 

R&D Expenses: Research and development expenses were $68.3 million for the second quarter of 2026, as compared to $48.0 million for the second quarter of 2025. This increase was primarily driven by execution of 4D-150 Phase 3 clinical trials in wet AMD.

G&A Expenses: General and administrative expenses were $12.5 million for the second quarter of 2026, as compared to $11.5 million for the second quarter of 2025.

Net Loss: Net loss was $72.9 million for the second quarter of 2026, as compared to net loss of $54.7 million for the second quarter of 2025.

About 4DMT  

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, Backbone 4 Retina™, and the 4DMT logo are trademarks of 4DMT.   

All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied.  

Learn more at www.4DMT.com and follow us on LinkedIn. 

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for, the clinical development of our product candidates, the potential benefits of the strategic partnership with Otsuka, the amount of any potential cost sharing or milestone payments pursuant to the Company’s agreement with Otsuka, the Company’s expectations regarding financing alternatives and potential partnerships, the Company’s use of proceeds, and statements regarding our financial performance, results of operations and anticipated cash runway. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled “Risk Factors” in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q to be filed on or about the date hereof, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
  

Contacts:

Media:

Jenn Gordon 
dna Communications 
[email protected]

Investors:

Julian Pei
Head of Investor Relations and Strategic Finance
[email protected]

Revenue reached $5.1 million; Gross margin improved to 90% from 80% in the prior year 

Broad Vision AI platform traction drove strong growth in ROC SDK, ROC ABIS, and ROC Enroll

ROC Evidence achieves milestone upon 2Q26 commercialization, generated first revenue ahead of plan

DENVER, Aug. 13, 2026 (GLOBE NEWSWIRE) — Rank One Computing Corporation d/b/a ROC, (Nasdaq: ROC) (“ROC” or the “Company”), a U.S. leader in Vision AI, building unified biometric, video analytics, and decision intelligence solutions, today announces financial results for the second quarter ended June 30, 2026.

“In 2Q, ROC’s revenue nearly doubled sequentially to $5.1 million, gross margin expanded to 90%, and government R&D revenue increased 41% year over year,” said B. Scott Swann, ROC’s Chief Executive Officer. “These results demonstrate measurable progress in our contract revenue due to improving government program activity and broader commercialization across our Vision AI platform. ROC SDK, ROC ABIS, and ROC Enroll each delivered significant revenue growth, while ROC Evidence generated its first commercial revenue ahead of plan.”

“Importantly, in the first quarter, we indicated our outlook on government procurement activity was beginning to improve. Consistent with the outlook, ROC’s government contracting activity and revenue demonstrated this improvement. This increase in contract revenue gives us greater confidence in an anticipated revenue ramp during the second half of 2026. Our long-term strategy remains unchanged, with a focus on converting this activity into larger, longer-duration programs while expanding commercial adoption across our product portfolio,” concluded Mr. Swann.

Second Quarter 2026 and Recent Business Updates

• Awarded a $4.9 million follow-on R&D contract with a U.S. Department of War (DoW) agency to advance Vision AI capabilities in support of augmented warfighter operations
• ROC Evidence generated its first commercial revenue through an early-adopter deployment with the U.S. Drug Enforcement Administration (DEA), previously announced in first quarter 2026, achieving this commercial milestone ahead of plan
• Converted ROC ABIS’s first two pilot customers, announced in the first quarter of 2026, into long-term commercial deployments, demonstrating successful progression from evaluation to adoption
• Continued to expand the ROC Watch customer base and maintained the relationship with the government agency associated with the deployment in the prior-year period
• ROC SDK growth supported by new and expanded customer deployments
• ROC Enroll program expansion with MTN in South Africa across regional footprint

Second Quarter 2026 Corporate Highlights and Subsequent Events

• Entered into a definitive agreement to acquire Zuccaro Technical Consulting LLC (ZTC), adding digital forensics capabilities designed to accelerate the commercial expansion of ROC Evidence. Closing is expected to occur during the third quarter of 2026, subject to customary closing conditions
• Received Developmental Testing and Evaluation Designation (DT&E) for ROC Watch under the U.S. Department of Homeland Security SAFETY Act, providing certain federal liability protections for ROC and customer organizations that deploy the platform
• Achieved leading global rankings in National Institute of Standards and Technology (NIST) benchmarks for fastest search speed and identification accuracy in the NIST ELFT latent fingerprint evaluation and across multiple NIST FRIF fingerprint search benchmarks, further validation of ROC’s American-made technology for large-scale ABIS applications
• Appointed Dr. Kathleen Kiernan, former federal law-enforcement and national-security executive, to the Company’s Board of Directors
• Formed an official Homeland Security and Intelligence division led by first Senior Advisor Steven L. McQueen, former FBI Threat Screening Center Director
• Named “Facial Recognition System of the Year” in the 2026 AI Breakthrough Awards

Second Quarter 2026 Financial Results (as compared to Second Quarter 2025)

Revenue of $5.1 million increased approximately $0.1 million, or 2% for the three months ended June 30, 2026, compared to $5.0 million for the three months ended June 30, 2025. The increase reflected higher R&D contract revenue due to an increased pace in government funding activity in the second quarter of 2026, which more than offset lower product revenue related to the completion of a mission-focused ROC Watch deployment.

On a sequential basis, second-quarter revenue increased approximately 100% from $2.5 million, in the first quarter of 2026. The sequential increase in revenue was largely driven by an expanded government program, totaling $4.9 million, which was previously delayed due to the slowdown in government funding activity through early 2026.

Product revenue was $2.1 million for the three months ended June 30, 2026, a decrease of $0.7 million, or 26%, from $2.8 million for the three months ended June 30, 2025. The decline was the result of a mission-focused ROC Watch deployment, which commenced in the first quarter of 2025, successfully expanded, and was subsequently completed in the fourth quarter of 2025.

As reflected in ROC Watch’s second quarter revenue, certain mission deployments are phased and finite in nature. The Company continued to expand its ROC Watch customer base during the quarter and is encouraged by the ongoing relationship with the government customer associated with the completed program for potential future opportunities.

During the second quarter of 2026, ROC’s Vision AI products generated strong growth partially offsetting the year-over-year decrease in ROC Watch revenue:

• ROC SDK revenue was $1.6 million, a YoY increase of 84%, from $0.9 million, reflecting new customers and expansion opportunities
• ROC ABIS revenue was $164,000, a YoY increase of 723%, from approximately $20,000, reflecting initial commercialization and early-adopter activity
• ROC Enroll revenue was approximately $83,000, a YoY increase of 125%, from approximately $37,000, representing commercial expansion across MTN’s national telecom network in South Africa
• ROC Evidence secured a monetization opportunity ahead of plan, generating approximately $18,000 of initial commercial revenue

Government R&D contract revenue was approximately $3.0 million for the three months ended June 30, 2026, an increase of approximately $0.9 million, or 41%, from $2.1 million for the three months ended June 30, 2025. The increase primarily reflected revenue recognized from a significant government contract expansion awarded during the quarter and improving government contracting activity following the slower award environment experienced in late 2025 and early 2026.

The pace of new contract awards and customer order placement during the quarter indicates steady progress in government contracting activity following the slower award environment experienced in late 2025 and early 2026.

Gross profit was $4.6 million for the three months ended June 30, 2026, an increase of $0.6 million, or 14%, compared with $4.0 million for the three months ended June 30, 2025. Additionally, gross margin expanded to 90% for the three months ended June 30, 2026, from 80% for the three months ended June 30, 2025. The improvement primarily reflected a higher contribution of software license revenue and lower cost of sales. Gross margin may fluctuate between reporting periods depending on product mix and the level of government R&D contract activity.

Operating expenses totaled $5.3 million for the three months ended June 30, 2026, compared to $3.2 million for the three months ended June 30, 2025. The increase reflects planned growth investments following the Company’s initial public offering in February 2026. In addition, research and development expenses of $2.0 million reflect continued investment in engineering personnel and the development and enhancement of ROC’s Vision AI products. The Company also made significant strategic capital investments to expand high-performance data center infrastructure, including private cloud and SaaS delivery environments, securing the underlying compute scale required to power high-throughput enterprise analytics.

Net loss was $0.8 million for the three months ended June 30, 2026, compared with net income of $0.6 million for the three months ended June 30, 2025. Basic and diluted net loss per share was ($0.04) for the three months ended June 30, 2026, compared with basic and diluted net income per share of $0.04 for the three months ended June 30, 2025.

As of June 30, 2026, ROC had $11.9 million in cash, $14.8 million in working capital, and no debt outstanding following the full repayment of its revolving credit facility.

Business Outlook

Based on current contract schedules, ROC expects government revenue to increase in the third quarter of 2026, with continued program activity and related revenue in the fourth quarter.

The Company remains focused on near-term priorities to build a larger base of product and support revenue through converting government contract activity into larger and longer-duration programs, advancing ROC ABIS early adopters and pilot programs to expanded deployments, building upon the initial monetization of ROC Evidence and ROC Access, expanding ROC Watch deployments across new and active customers, finalizing the acquisition of ZTC, and continuing active discussions with anchor ROC ABIS and ROC Evidence customers.

Further, ROC believes its long-term revenue profile will be supported by expanding its anchor government customer relationships into multi-year programs that drive high-margin, recurring revenue related to ROC product and support services.

Conference Call Information

ROC will host a conference call today, August 13, 2026, at 4:30 PM ET to discuss the results for the second quarter of 2026 and conduct a question-and-answer session. The dial-in number for the conference call is (877) 270-2148 (toll-free) or (412) 317-6060 (international). Please dial into the number 10 minutes prior to the scheduled start time.

In addition, a live webcast of the conference call will be available on ROC’s Investor Relations website at https://investors.roc.ai/.  A replay of the webcast will be available on ROC’s Investor Relations website for one year following the call.

About ROC

ROC is a leading U.S. developer and manufacturer of Vision AI, delivering sovereign biometrics, video analytics, and mission intelligence through a unified platform. This enables agency and integrator partners to unlock faster, more accurate, and cost-efficient capabilities. At its core, ROC transforms raw pixels into real-time operational awareness for defense, public safety, and digital commerce. The Company is headquartered in Denver, Colo., with additional hubs in Grand Rapids, Mich., and Morgantown, W.V. For more information, please visit the Company’s website: www.roc.ai.

Forward-Looking Statements
This Earnings Release and materials included contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended and the Private Securities Litigation Reform Act of 1995, as amended. These statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect current views about future events and financial performance based on certain assumptions. They include opinions, forecasts, intentions, plans, goals, projections, guidance, expectations, beliefs or other statements that are not statements of historical fact. Forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “would,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “targets,” “projects,” “forecasts,” “guidance,” “outlook,” “approximates,” “predicts,” “potential,” “continue,” “likely,” “ongoing,” “confident,” and similar statements, or the negative or other variation of such expressions, and similar expressions may identify a statement as a forward-looking statement. Any statements that are not historical facts or that refer to projections of our future financial performance, our anticipated growth and trends in our businesses, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results and the development of our products, are forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. Forward-looking statements are based on the Company’s current expectations and assumptions regarding its business, the economy, and other future conditions, and involve known and unknown risks, uncertainties, and other factors — many of which are outside the Company’s control — that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Such factors include, but are not limited to: the Company’s ability to execute on its goals and strategies; its future business development, financial condition, results of operations, and cash flows; competitive dynamics and changes in the markets in which the Company operates; macroeconomic and geopolitical conditions, including inflation, interest rates, tariffs, trade policy, and currency fluctuations; the Company’s ability to attract, retain, and develop talent; cybersecurity incidents and information technology disruptions; the Company’s ability to protect its intellectual property; the impact of artificial intelligence and other emerging technologies on the Company’s business; supply chain disruptions; changes in laws, regulations, and government policies, including tax, trade, data privacy, environmental, and AI-related regulation; legal proceedings and regulatory inquiries; climate-related risks and the Company’s sustainability initiatives; and the other risks and uncertainties described under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC, which are accessible on the SEC’s website at www.sec.gov. The public can also read and copy any materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. You can obtain additional information about the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. You should not place undue reliance on any forward-looking statement. All forward-looking statements contained in this earnings release speak only as of the date of this earnings release. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise that may arise after the date of this Earnings Release.