Abstract

Capricor Therapeutics will report first-quarter 2026 financial results on May 12, 2026, Post Market, and management will host a conference call to provide a corporate update for the period.

Market Forecast

Market expectations for the current quarter center on total revenue of 0.00 million US dollars (down 100.00% year over year), EBIT of -27.15 million US dollars (down 82.09% year over year), and adjusted EPS of -0.52 (down 64.74% year over year), based on the latest forecast inputs. Gross profit margin and net margin guidance have not been provided, and the near-term earnings profile remains dependent on operating expenditure and any non-recurring items rather than product revenue. The main business activity is expected to be driven by non-product sources, with grants and other income continuing to represent the limited recognized revenue while commercial sales are not anticipated for the quarter. Grants contributed 0.17 million US dollars and other income 0.05 million in the prior quarter, for a combined 0.22 million, and total revenue declined 100.00% year over year as the company laps last year’s one-time licensing revenue.

Last Quarter Review

Capricor Therapeutics reported revenue of 0.00 million US dollars (down 100.00% year over year), gross profit margin not available, GAAP net profit attributable to the parent company of -30.17 million US dollars, net profit margin not available, and adjusted EPS of -0.62 (down 287.50% year over year). Quarter on quarter, net profit decreased by 22.79%, reflecting the absence of license-related revenue and the heavier operating cost base captured in the period. Recognized revenues were confined to grants at 0.17 million US dollars and other income at 0.05 million, while total revenue fell 100.00% year over year, underscoring the transition away from milestone-driven revenue recognition.

Current Quarter Outlook

Main business trajectory in Q1 2026

The company’s operating profile for the first quarter is set to be characterized by minimal recognized revenue, consistent with the projection of 0.00 million US dollars and the non-commercial status of its lead program for the period. With EBIT forecast at -27.15 million US dollars and adjusted EPS forecast at -0.52, the quarter is likely to be judged on cost discipline, the cadence of R&D commitments, and preparation work for regulatory milestones rather than top-line growth. Management’s commentary on spending priorities, whether around clinical, regulatory, chemistry manufacturing and controls, and commercial readiness activities, will be closely assessed for its potential to alter the run-rate of expenses through the remainder of the year. In the absence of product revenue, any non-dilutive inflows or collaboration receipts would be a notable swing factor for reported results. The near-term focus, therefore, is less on gross margin or net margin, which are not guided at this stage, and more on whether the loss trajectory tightens in line with the EPS and EBIT forecasts.

Most promising business and its forward path

The near-term value driver is the company’s lead program Deramiocel, where recent developments have re-established momentum across the regulatory pathway. The US Food and Drug Administration has lifted its previously issued Complete Response Letter and resumed review of the biologics license application for Deramiocel, with the submission classified as a Class 2 resubmission and a Prescription Drug User Fee Act target action date of August 22, 2026. The pivotal HOPE-3 Phase 3 trial achieved its primary endpoint (PUL v2.0) alongside key secondary measures, which analysts interpret as de-risking the regulatory path and strengthening the probability of approval. While the program remains pre-revenue for the first quarter, management’s update may outline commercialization preparation, including steps toward potential eligibility for a Priority Review Voucher upon approval, manufacturing scale-up readiness, and core launch activities that define the shape of revenue capture beyond 2026. Because revenue this quarter is projected at 0.00 million US dollars, the principal contribution of the Deramiocel program in Q1 2026 will be intangible—advancing regulatory clarity and operational readiness—which can materially influence the market’s valuation even without recognized sales.

Stock price drivers in this quarter

Share price sensitivity in the current period is expected to be highest around three themes: the degree of variance versus EPS and EBIT forecasts, concrete updates on regulatory timelines and interactions, and the clarity of cash runway and commercialization preparations communicated on May 12, 2026. The market is primed for negative EPS and EBIT consistent with the forecasts; deviations, whether through tighter operating expense control or recognition of any one-time items, could lead to reassessment of near-term valuation anchors. Visibility into the resumed biologics license application review, including any procedural milestones or feedback from regulators that management can disclose, may further shape sentiment; investors will calibrate expectations for launch preparations against the PDUFA date of August 22, 2026. Liquidity remains a key underpinning: the company disclosed cash, cash equivalents, and marketable securities of 318.10 million US dollars at year-end 2025, which management believes can fund operating and capital needs into 2027; reaffirmation or refinement of this runway on the Q1 call will be an important signal for execution capacity through regulatory and commercial transition. The market will also be attentive to operational details—manufacturing readiness, supply chain validation, and payer engagement sequencing—since these elements influence both time-to-revenue and the slope of early commercialization. In the absence of product revenue this quarter, strong narrative control and credible progress markers will be the primary determinants of the stock’s short-term trading range.

Analyst Opinions

Bullish opinions dominate the coverage collected in the year-to-date window, with a ratio of bullish to bearish views at 100% to 0%. H.C. Wainwright reiterated a Buy rating, highlighting HOPE-3 success, a de-risked regulatory path for Deramiocel, and upside potential linked to Priority Review Voucher eligibility; their framing emphasizes that the pivotal dataset supports the resumed biologics license application review and aligns with an approval track. Alliance Global Partners maintained a Buy rating with a 51.00 US dollars price target, reflecting confidence in the program’s regulatory trajectory and in the company’s ability to manage the bridge period without commercial revenue. Roth MKM kept a Buy rating and set a 43.00 US dollars price target, pointing to resumed review dynamics and the prospect of meaningful value unlock upon the FDA decision. B. Riley adjusted its price target to 63.00 US dollars while maintaining a Buy rating, citing strengthened conviction after the pivotal trial met its primary and key secondary endpoints and after the FDA’s decision to resume BLA review was disclosed; they note that operational readiness and cash runway support execution, even as the near-term quarter remains loss-making.

Across these reports, the shared perspective is that first-quarter numbers will chiefly serve as a checkpoint on expense trajectory and regulatory progress rather than an inflection in top-line contribution. Analysts argue that the core part of the investment case this quarter is the visibility into the path to approval and associated launch preparations, which can reduce perceived timeline risk and support valuation even before commercial revenue begins. The consensus view therefore frames Q1 2026 as a transitional reporting period where negative EPS and EBIT in line with forecasts are less important than the qualitative updates management provides on manufacturing, payer engagement, and readiness to convert regulatory milestones into commercial outcomes. That stance also implies that the absence of gross margin and net margin guidance for the current quarter is not an impediment to the broader thesis; rather, clarity on operational steps and the reaffirmed PDUFA date are treated as the main catalysts. In short, the majority of institutionally published opinions are bullish, anchored by the regained regulatory footing of Deramiocel, the supportive pivotal data, and the cash resources to sustain the company through the pre-revenue quarters ahead of the FDA’s target action date.