DMAC

Clinical Development Progress

• Early-Onset Fetal Growth Restriction (FGR): Enrollment is complete for the first 6-participant cohort (5 microgram per kg dose) of the open-label Phase II trial. This expands DM-19 development into a second women's health indication with no approved therapies. Enrollment for the second cohort (10 microgram per kg) will begin shortly, with the third cohort dose (1-15 microgram per kg range) to be selected based on initial results. A Key Opinion Leader (KOL) event will be held in September 2026 to share top-line results from the first cohort and discuss the scientific rationale for DM-19 in FGR.
• Preeclampsia Development: The extension cohort of the Part 1a late-onset preeclampsia Phase 1 dose-escalation study is complete. Combined data from dose-escalation and extension cohorts confirms a clinically meaningful dose response: mid-dose ranges produce the optimal combination of maternal blood pressure reduction and reduced uteroplacental vascular resistance (indicating improved placental blood flow), with receptor desensitization observed at higher doses. Topline full data will be presented at an upcoming medical conference and published in a peer-reviewed journal by the end of 2026. Health Canada has authorized the open-label Phase II dose-ranging early-onset preeclampsia trial (targeting 30 patients across 3 dose levels), with first patient dosing planned for Q4 2026. The trial is being expanded to the UK, pending regulatory authorization and site readiness. A protocol amendment adjusting dosing to prioritize mid-range levels was submitted in July 2026, with first patient dosing expected after regulatory acceptance in the coming weeks.
• U.S. Preeclampsia Regulatory Path: The company is conducting a pharmacokinetic and enzymatic activity study of DM-19 in rats to address FDA requests to support a U.S. IND application. The study will be completed in September 2026, with a final report available in October 2026, after which the company plans to submit the IND to the FDA.
• Acute Ischemic Stroke (Remedy 2 Phase 2-3 Trial): The trial has surpassed 85% enrollment of the 200 patients required for the pre-specified interim efficacy analysis. Enrollment slowed slightly in July 2026, with 70 active sites across North America, Europe, and the UK. The interim analysis (conducted by the independent DSMB, with the company remaining blinded to data) is expected to read out in Q1 2027. Enrollment will continue during the follow-up and analysis period, and the trial's final sample size will be determined after the interim analysis to range between 300 and 728 patients, or the trial could be stopped for futility.

Drug Mechanism Overview

DM-19 is a recombinant form of the naturally occurring human KLK1 protease, which acts through BK2 receptors on endothelial blood vessels to improve vascular function and increase perfusion, addressing the common endothelial dysfunction underlying FGR, preeclampsia, and acute ischemic stroke.

Financial Position

As of Q2 2026, the company holds $43.5 million in cash, equivalents, and short-term investments, which management confirms is sufficient to fund all planned operations and clinical trials through 2027, covering all key upcoming milestones.

• Management expects R&D expenses to moderately increase in future periods, driven by the ongoing Remedy 2 trial and expansion of the DM-19 clinical development program in women's health indications.
• G&A expenses are expected to remain relatively consistent compared to recent prior periods.
• Current cash position is confirmed to fund all planned operations and clinical studies through 2027, covering key upcoming milestones including the Remedy 2 interim analysis, preeclampsia and FGR data readouts, and Phase 2 trial advancement in Canada and the UK.
• The Remedy 2 interim analysis readout is guided for Q1 2027, shifted slightly from the prior expectation of Q4 2026 due to slower July 2026 enrollment.
• First patient dosing for the Canadian early-onset preeclampsia Phase II trial is guided for Q4 2026, with UK trial initiation expected in late 2026 to early 2027.
• U.S. IND submission for the early-onset preeclampsia program is planned after completion of the rat pharmacology study in October 2026, assuming the study meets FDA requirements.

Diametica Therapeutics is a clinical-stage biotech with only one pipeline product (DM-19, also referenced as DM-199) in development across multiple indications, so discrete revenue-generating product segments are not reported. For the second quarter ending June 30, 2026:

• R&D expenses: $8.2 million (vs. $5.8 million in Q2 2025)
• YTD (six months ending June 30, 2026) R&D expenses: $16.1 million (vs. $11.5 million YTD 2025)
• G&A expenses: $2.3 million (vs. $2.2 million in Q2 2025)
• YTD G&A expenses: $4.8 million (vs. $4.7 million YTD 2025)
• Net cash used in operating activities YTD 2026: $17.2 million (vs. $14.7 million YTD 2025)
• Cash, cash equivalents, and short-term investments as of June 30, 2026: $43.5 million (down from $59.9 million as of December 31, 2025)
• Current liabilities as of June 30, 2026: $6.6 million
• Working capital as of June 30, 2026: $37.7 million

• Forward-looking statements regarding trial timelines, regulatory approval, and clinical efficacy are subject to inherent risks and uncertainties that could cause actual results to differ materially from projections, as detailed in the company's SEC filings.
• The Remedy 2 interim analysis could recommend halting the trial for futility if no meaningful efficacy signal is identified by the independent DSMB.
• Enrollment for the Remedy 2 trial has shown inconsistent pace, with a slowdown in July 2026 that pushed the interim analysis timeline back by one quarter.
• U.S. clinical initiation of the preeclampsia program is contingent on FDA acceptance of the supplemental reproductive toxicology data, which is still being generated and has not yet been reviewed by the agency.
• All clinical programs are in early stages, and positive signals from early cohorts do not guarantee positive results in larger late-stage trials or regulatory approval.

Q: Why is the company focusing on mid-dose ranges for late-onset preeclampsia but still exploring higher doses in early-onset indications, and what inclusion criteria are used for the FGR trial? / A: Management explained DM-19 has an optimal mid-dose sweet spot due to receptor desensitization at higher doses that reduces vascular dilation, which has been observed across prior studies in other indications and is covered by an issued patent. The FGR trial enrolls only severe patients with estimated fetal weight at or below the 3rd percentile between 27 and 32 weeks gestation, who are expected to deliver within 1-6 days under standard of care. Top-line first cohort data will be shared at the September 2026 KOL event.

Q: What is the importance of chronic dosing in the FGR trial, what extension of gestation is considered clinically meaningful, what is the current thinking on IV vs subcutaneous dosing for early-onset preeclampsia, and when will the U.S. IND be submitted? / A: The FGR trial uses subcutaneous dosing every three days until delivery, and an extra 5-6 days of gestation would be considered a clinically meaningful outcome for this high-severity patient population. For early-onset preeclampsia, the program will prioritize subcutaneous dosing every three days until delivery, with a separate continuous IV infusion cohort in late-onset patients to test adjustable dosing for targeted blood pressure control. The required rat reproductive toxicology study for the U.S. IND will be completed in September 2026, with IND submission planned after that, as this is the last outstanding requirement from the FDA.

Q: Will the full Part 1a late-onset preeclampsia data be published, and how much enrollment will Remedy 2 have completed by the time of the interim analysis? / A: All endpoints from the Part 1a study, including placental transfer and uterine artery dilation, are being prepared for publication in a peer-reviewed journal. After the 200th patient is dosed for the interim analysis, 90 days of follow-up are required plus 4-6 weeks of analysis; enrollment will continue during this period, and the company expects to be close to the 300-patient base case final sample size by the time of the interim readout.

Q: What has driven the delayed Remedy 2 interim timeline, and what implications does enrollment experience have for future real-world use? / A: Enrollment has been inconsistent month-to-month, with a slowdown in July 2026 pushing the interim analysis to Q1 2027. Management noted DM-19 has a strong safety profile that would allow use in community hospitals, which supports strong future commercial prospects if the trial is successful.