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Milestone Cuts Spending 30% to Stretch Cash Into Late 2028

Milestone Pharmaceuticals will cut operating expenses about 30% to extend its cash runway into late 2028, past the readout of its Phase 3 ReVeRA-301 trial in AFib with rapid ventricular rate.

Exhibit AMilestone Pharmaceuticals Q3 Earnings Call Highlights
Milestone Pharmaceuticals Q3 Earnings Call Highlights — jarmoluk / pixabay

By Sophie Lindqvist

Milestone Pharmaceuticals will cut operating expenses by approximately 30%, a reduction designed to extend its cash runway into late 2028 — more than a year beyond prior guidance. The announcement accompanied third-quarter results showing roughly 1,800 prescriptions for CARDAMYST, up 50% from the prior quarter, and $1 million in net product revenue against $600,000 in the second quarter. CARDAMYST, a nasal spray marketed for paroxysmal supraventricular tachycardia (sudden episodes of abnormally fast heart rate), is the company's commercial engine.

President and CEO Joseph Oliveto said the cost measures, together with an amended financing agreement, should carry Milestone through the anticipated second-half 2028 readout of its Phase 3 ReVeRA-301 study in atrial fibrillation with rapid ventricular rate, or AFib-RVR. The arithmetic is straightforward: spend less, live longer, arrive at the data. Not the boldest strategy in biotech, but rarely the worst.

What changes at the company?

Milestone plans to bring its contracted field team of approximately 45 representatives in-house and internalize data systems and analytical capabilities. The sales team had already been trimmed from roughly 60 representatives in August, with the company concentrating on electrophysiology and high-prescribing cardiology accounts, Oliveto said. The company also plans to discontinue marketing and support programs it deems less effective and to streamline headquarters operations.

The leadership bench is thinner. Chief Financial Officer Amit Hasija and Chief Medical Officer Dr. David Bharucha have departed; Bharucha will continue as a consultant. Vice President of Finance Anthony Krick has been named principal financial and principal accounting officer — a title that now covers rather more of the finance function than it once did.

Milestone expects to complete the changes by the first quarter of 2027 and to incur approximately $2 million in one-time charges, primarily severance, conversion fees and other workforce-reduction costs. The company also amended its note purchase agreement with RTW Investments LP, extending the payment-in-kind interest period (interest paid in additional notes rather than cash) from March 31, 2027, to March 2029.

How is the prescription trend developing?

Approximately 750 unique health care providers prescribed CARDAMYST in the third quarter, bringing the total since launch through September to about 1,600, the company said. Prescriptions were written for roughly 1,400 patients during the quarter and 2,700 since launch.

Chief Commercial Officer Lorenz Muller said approximately 40% of prescribers had written the drug for more than one patient. Milestone has identified more than 5,000 high-value providers who treat disproportionately large numbers of PSVT patients, and is working to raise both the number of prescribers and the patients treated by each.

Oliveto said prescriptions should continue rising in the fourth quarter, though growth could flatten in the first quarter as patients' out-of-pocket costs and insurance plans reset. The season, not the science, sets the tempo. Milestone provided no numerical sales guidance.

Formulary coverage (the list of drugs an insurer will reimburse) has expanded to approximately two-thirds of commercially insured lives, up from about 50% at the time of the second-quarter call, Muller said. Milestone has not secured broad national formulary placement with CVS Caremark and continues to engage the pharmacy benefit manager.

Medicare is unlikely to drive near-term prescription growth, Muller said. A small number of regional Medicare plans have added CARDAMYST for the start of 2027, but national Part D coverage has been challenging. The company plans to invest in medical necessity exception pathways while remaining selective about Medicare contracting.

What did the numbers say?

Milestone reported a third-quarter net loss of $25.8 million, or $0.18 per share, compared with a loss of $11.9 million, or $0.12 per share, a year earlier. Selling, general and administrative expenses rose to $24.2 million from $7.9 million, primarily on costs associated with the CARDAMYST launch. Research and development expenses, net of tax credits, fell to $3.5 million from $3.9 million.

The company ended September with $145.4 million in cash, cash equivalents and short-term investments, compared with $106 million at the end of 2025. The balance sheet, for now, cooperates.

On the trial front, ReVeRA-301 is enrolling patients in the United States, Canada and Europe. Oliveto said the event-driven study is expected to enroll approximately 500 to 700 patients to reach a target of about 150 treatment events. The primary endpoint is reduction in ventricular rate; the study is powered around a second endpoint measuring symptom improvement, which Oliveto said is also needed for regulatory approval.

Milestone Pharmaceuticals (NASDAQ:MIST) is a biopharmaceutical company focused on cardiovascular treatments, centered on therapies that let patients and caregivers manage acute heart rhythm episodes outside a clinical setting. Its lead product is etripamil, a short-acting calcium channel blocker formulated as a nasal spray for self-administration. The plan now rests on disciplined spending, a modestly accelerating launch and one Phase 3 readout in 2028. In that order, presumably.

Audit trail

  1. Milestone will cut operating expenses by approximately 30% and expects its cash runway to extend into late 2028.
  2. Q3 CARDAMYST prescriptions reached about 1,800, up 50% from the prior quarter; net product revenue was $1 million.
  3. Third-quarter net loss widened to $25.8 million, or $0.18 per share, from $11.9 million a year earlier.
  4. One-time charges of approximately $2 million are expected, with changes complete by Q1 2027.
  5. Phase 3 ReVeRA-301 is expected to enroll 500-700 patients toward roughly 150 treatment events.

via dailypolitical.com (Source)

Filed under

  • milestone-pharmaceuticals
  • cash-runway
  • operating-expense-reduction
  • cardamyst
  • phase-3-trial
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Market editor covering technology and product news in corporate finance and the leaders who run it at CFO Observer.

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