Mineralys Therapeutics (MLYS) boosts cash, buys out lorundrostat royalties ahead of FDA date
Rhea-AI Filing Summary
Mineralys Therapeutics, Inc. reported second-quarter 2026 results and corporate updates centered on its lead candidate lorundrostat. The FDA is reviewing the New Drug Application for lorundrostat for hypertension with a PDUFA target date of December 22, 2026, and commercial launch preparations are described as on track.
The company strengthened lorundrostat economics by eliminating its royalty obligations to Tanabe through a $200.0 million upfront cash payment and up to $100.0 million in new commercial milestones, leaving total remaining potential Tanabe milestones of up to $255.0 million plus up to $10.0 million for a second indication. Mineralys also completed a follow-on offering of 5,660,378 shares for approximately $150.0 million in gross proceeds and entered a senior secured term loan facility of up to $500.0 million, drawing an initial $100.0 million tranche.
Cash, cash equivalents and investments were $661.4 million as of June 30, 2026, and the company expects this to fund operations, including a potential lorundrostat launch, into 2028. Second-quarter 2026 net loss widened to $241.1 million, driven mainly by the Tanabe upfront payment, with higher R&D and G&A expenses as Mineralys scales toward commercialization. The Board appointed James J. “Terry” Ferguson III, M.D., as Chief Medical Officer, while former CMO David Rodman, M.D., transitions to a full-time Strategic Advisor role.
Positive
- FDA review of lorundrostat with December 22, 2026 PDUFA date provides a clear regulatory milestone and timing anchor for potential approval and commercial launch in uncontrolled or resistant hypertension.
- Cash, cash equivalents and investments of $661.4 million as of June 30, 2026 are expected to fund planned operations, including a potential lorundrostat launch, into 2028.
- Elimination of Tanabe royalty obligations via a $200.0 million upfront payment and revised milestones strengthens Mineralys’ long-term economic rights to lorundrostat.
- $150.0 million gross proceeds from a follow-on public offering and a senior secured term loan facility of up to $500.0 million enhance financial flexibility ahead of commercialization.
Negative
- Net loss increased to $241.1 million for the quarter ended June 30, 2026, compared to $43.3 million a year earlier, largely due to the $200.0 million Tanabe payment and higher operating costs.
- Research and development expenses rose to $221.4 million in the quarter from $38.3 million, and general and administrative expenses nearly tripled to $24.7 million, reflecting significantly higher cash burn.
- Total liabilities climbed to $116.9 million at June 30, 2026 from $15.1 million at December 31, 2025, including a new senior secured term loan, while stockholders’ equity declined to $550.9 million.
Insights
Analyzing...
8-K Event Classification
3 items: 2.02, 5.02, 9.01
3 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers
Governance
Key personnel changes including departures, elections, or appointments of directors and executive officers.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Lorundrostat PDUFA target date: December 22, 2026
Cash, cash equivalents and investments: $661.4 million
Follow-on offering gross proceeds: $150.0 million
+5 more
8 metrics
Lorundrostat PDUFA target date
December 22, 2026
FDA review of New Drug Application for lorundrostat in hypertension
Cash, cash equivalents and investments
$661.4 million
Balance as of June 30, 2026; expected to fund operations into 2028
Follow-on offering gross proceeds
$150.0 million
Public offering of 5,660,378 shares of common stock in Q2 2026
Senior secured term loan facility
Up to $500.0 million
Facility from funds managed by Pharmakon Advisors, including $100.0 million drawn in June 2026
Upfront payment to Tanabe
$200.0 million
Cash payment to eliminate lorundrostat royalty obligations under amended license
R&D expenses Q2 2026
$221.4 million
Quarter ended June 30, 2026; increased from $38.3 million in Q2 2025
Net loss Q2 2026
$241.1 million
Quarter ended June 30, 2026; compared to $43.3 million in Q2 2025
Total liabilities June 30, 2026
$116.9 million
Includes senior secured term loan; up from $15.1 million at December 31, 2025
Key Terms
PDUFA target date, New Drug Application (NDA), senior secured term loan facility, royalty obligations, +2 more
6 terms
PDUFA target date regulatory
"with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026"
A PDUFA target date is the deadline set by the U.S. Food and Drug Administration (FDA) for deciding whether to approve or reject a new medical product. It acts like a firm due date for a decision, which can influence investor expectations and market movements, as approval can lead to product launch and revenue opportunities. This date helps investors anticipate potential news and plan their strategies accordingly.
New Drug Application (NDA) regulatory
"the FDA continues its review of the NDA for lorundrostat for the treatment of hypertension"
A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.
senior secured term loan facility financial
"Entered into a senior secured term loan facility for up to $500.0 million from funds managed"
A senior secured term loan facility is a type of borrowed money that a company takes out, which is backed by its valuable assets like property or equipment. Because it is secured by these assets and ranks higher in repayment priority, it is considered safer for lenders and typically offers lower interest rates. For investors, it provides a relatively stable and priority claim on the company's assets if it encounters financial difficulties.
royalty obligations financial
"Amended the Tanabe license agreement to eliminate the Company’s royalty obligations"
Contractual payments a company must make to a rights holder—often an inventor, patent owner, mineral leaseholder, or licensor—based on revenue, units sold, production, or a fixed schedule. Think of it like a toll or rent on each sale or production run that continues for a set time or until certain milestones are met. Investors watch royalty obligations because they reduce cash flow and profit margins, can be variable or long‑lasting, and affect valuation and financing flexibility.
open-label extension trial medical
"Transform-HTN open-label extension trial, which supported the NDA submission, continues"
An open-label extension trial is a follow-up study where participants who finished an earlier clinical trial keep taking the experimental treatment and both they and the researchers know what drug is being given. It lets companies collect longer-term safety and effectiveness information that shorter, blinded trials may not capture. For investors, results from these extensions are like getting additional product testing and user feedback over time, which can reduce uncertainty about future approval, market acceptance, and potential liabilities.
aldosterone synthase inhibitor medical
"lorundrostat is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor"
Aldosterone synthase inhibitors are drugs that reduce production of the hormone aldosterone, which helps control salt, water balance, and blood pressure. Think of them as turning down a faucet that feeds excess blood pressure and fluid buildup; by lowering aldosterone they can ease strain on the heart and kidneys. Investors track these drugs because trial results, regulatory approval, and safety can materially affect a developer’s revenue outlook and stock value.
Earnings Snapshot
Net loss (Q2 2026): $241.1 million
Quarter and six months ended June 30, 2026
Net loss (Q2 2026)
$241.1 million
compared to $43.3 million for the quarter ended June 30, 2025
R&D expenses (Q2 2026)
$221.4 million
compared to $38.3 million for the quarter ended June 30, 2025
G&A expenses (Q2 2026)
$24.7 million
compared to $8.5 million for the quarter ended June 30, 2025
Cash, cash equivalents and investments
$661.4 million
compared to $656.6 million as of December 31, 2025
Net loss per share, basic and diluted (Q2 2026)
$2.85
compared to $0.66 for the quarter ended June 30, 2025
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What is the FDA PDUFA date for Mineralys Therapeutics (MLYS) lorundrostat NDA?
The FDA is reviewing Mineralys’ NDA for lorundrostat with a PDUFA target date of December 22, 2026. This date represents the agency’s goal for completing its review and is the timing focus for the company’s planned commercial launch activities.
How much cash does Mineralys Therapeutics (MLYS) have and how long will it last?
Mineralys reported $661.4 million in cash, cash equivalents and investments as of June 30, 2026. The company believes this balance will be sufficient to fund planned operations, including the anticipated commercial launch of lorundrostat, into 2028.
Why did Mineralys Therapeutics (MLYS) net loss rise sharply in Q2 2026?
Net loss for the quarter ended June 30, 2026 was $241.1 million, up from $43.3 million a year earlier. The increase was primarily driven by a $200.0 million upfront payment to Tanabe, higher R&D and G&A expenses, and costs related to commercialization preparations.
What strategic financing actions did Mineralys Therapeutics (MLYS) take in Q2 2026?
Mineralys completed a follow-on offering of 5,660,378 shares, generating approximately $150.0 million in gross proceeds, and entered a senior secured term loan facility of up to $500.0 million, drawing an initial $100.0 million tranche during the quarter.
How did Mineralys Therapeutics (MLYS) change its royalty obligations to Tanabe?
Mineralys amended its Tanabe license to eliminate royalty obligations in exchange for a $200.0 million upfront cash payment and up to $100.0 million in new commercial milestones, leaving up to $255.0 million in total remaining milestones plus up to $10.0 million for a second indication.
Who is the new Chief Medical Officer at Mineralys Therapeutics (MLYS)?
James J. “Terry” Ferguson III, M.D., has been appointed Chief Medical Officer, effective August 10, 2026. He succeeds David Rodman, M.D., who remains with Mineralys on a full-time basis as a Strategic Advisor supporting lorundrostat’s ongoing development.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 5, 2026
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
(Address of principal executive offices) (Zip Code) | ||||||||
( | ||||||||
(Registrant’s telephone number, including area code) | ||||||||
N/A | ||||||||
(Former name or former address, if changed since last report) | ||||||||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 11, 2026, Mineralys Therapeutics, Inc. (the Company) issued a press release announcing its financial results for the quarter ended June 30, 2026 and provided a corporate update. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On August 5, 2026, the Company’s Board of Directors (the Board) appointed James J. Ferguson III, M.D., as the Company’s new Chief Medical Officer, effective August 10, 2026, replacing David Rodman, M.D., who remains with the Company on a full-time basis as a Strategic Advisor. In connection with this transition, the Board also completed a detailed review of Dr. Rodman’s new functions and responsibilities and, based upon such review, determined that he no longer satisfies the definition of “officer” set forth in Rule 16a-1(f) promulgated under the Exchange Act or the definition of “executive officer” set forth in Rule 3b-7 under the Exchange Act. On August 5, 2026, Dr. Rodman entered into an amendment to his Amended and Restated Employment Letter Agreement (the Amendment) to reflect his transition into a Strategic Advisor role, effective August 10, 2026. The foregoing description of the Amendment is not complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which is attached hereto as Exhibit 10.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
10.1 | Amendment to Amended and Restated Employment Letter Agreement, dated August 5, 2026, by and between David Rodman, M.D., and the Company | |||||||
99.1 | Press Release Issued on August 11, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: August 11, 2026 | MINERALYS THERAPEUTICS, INC. | |||||||
| By: | /s/ Jeffrey A. Munsie | |||||||
| Name: | Jeffrey A. Munsie | |||||||
| Title: | Chief Legal Officer | |||||||
Exhibit 99.1
 | ||
Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
– PDUFA target date of December 22, 2026 for lorundrostat; commercial preparations on-track for launch upon approval –
– Appoints accomplished cardiovascular medicine executive Dr. Terry Ferguson as Chief Medical Officer to lead the Company’s medical and late-stage clinical activities –
– Strengthened balance sheet and enhanced the long-term economics of lorundrostat through strategic financing initiatives and the repurchase of the Tanabe royalty obligation –
– Conference call today at 4:30 p.m. ET –
RADNOR, Pa. — August 11, 2026 — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and aldosterone-related adverse outcomes in comorbid conditions such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update.
“Mineralys is advancing toward an exciting next chapter as we prepare for the commercial launch of lorundrostat, pending FDA approval. The efficacy and safety profile of lorundrostat supports its potential as a compelling treatment option for patients with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys. “We are also excited to welcome Terry Ferguson as our new Chief Medical Officer. His extensive experience in cardiovascular medicine strongly positions him to lead our medical organization. David Rodman, who guided the development of lorundrostat from proof of concept through the pivotal program, as well as our recent new drug application filing with the FDA, will continue to contribute to Mineralys in his full-time role as a Strategic Advisor.”
“I am very pleased to join the team at Mineralys in advance of the December PDUFA target date,” said Dr. Terry Ferguson, Chief Medical Officer of Mineralys. “Uncontrolled or resistant hypertension is a major driver of cardiovascular morbidity and mortality and a continuing issue for millions of Americans. I look forward to helping bring new treatment options, like lorundrostat, to patients with hypertension and other conditions where modulating dysregulated aldosterone may provide significant benefit.”
Recent Highlights and Upcoming Milestones
•Lorundrostat New Drug Application (NDA) — The U.S. Food and Drug Administration (FDA) continues its review of the NDA for lorundrostat for the treatment of hypertension in
combination with other antihypertensive drugs, with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.
•Appointment of New Chief Medical Officer (CMO) — Appointed James J. “Terry” Ferguson III, M.D., as CMO, effective August 10, 2026, succeeding David Rodman, M.D., who will stay on with the Company as a full-time Strategic Advisor. Terry brings more than 35 years of experience in cardiovascular medicine and drug development, including serving as Cardiovascular Therapeutic Area Head at Amgen, nearly a decade in cardiovascular leadership roles at AstraZeneca and The Medicines Company, as well as more than two decades on the faculty of the Texas Heart Institute. Most recently, he served as Chief Medical Officer at Cadrenal Therapeutics. In his new role, Terry will lead Mineralys’ medical and late-stage clinical activities.
•Transform-HTN Open-Label Extension Trial — The Company’s ongoing Transform-HTN open-label extension trial, which supported the NDA submission, continues to enable participants to receive lorundrostat and generate additional long-term safety and efficacy data.
•Commercial Launch Readiness — The Company continues to advance commercial launch preparations ahead of lorundrostat’s PDUFA target date of December 22, 2026 and remains on track. An experienced commercial leadership team is now in place, initial sales territories and priority geographies have been identified, and engagement continues with leading hypertension experts and payers covering a substantial majority of U.S. lives. The Company expects to have the sales organization established in advance of the anticipated PDUFA target date.
•Strengthened Balance Sheet and Lorundrostat Economics — During the second quarter of 2026, Mineralys strengthened its financial position and enhanced the long-term economics of lorundrostat through the following transactions:
◦Completed a follow-on public offering of 5,660,378 shares of common stock, generating gross proceeds of approximately $150.0 million.
◦Entered into a senior secured term loan facility for up to $500.0 million from funds managed by Pharmakon Advisors, LP, including an initial $100.0 million tranche drawn in June 2026.
◦Amended the Tanabe license agreement to eliminate the Company’s royalty obligations, strengthening the Company’s economic rights to lorundrostat. The Company made an upfront cash payment to Tanabe of $200.0 million and agreed to pay additional commercial milestone payments of up to $100.0 million in the aggregate (the New Milestones). As a result, the Company has remaining obligations to pay Tanabe commercial milestone payments, including the New Milestones, of up to $255.0 million in the aggregate upon first commercial sale and upon meeting certain annual sales targets, as well as up to $10.0 million related to commercialization for a potential second indication. Tanabe has also agreed to subsequently assign to Mineralys all of Tanabe’s rights in the licensed intellectual property.
Second Quarter 2026 Financial Highlights
Cash, cash equivalents and investments were $661.4 million as of June 30, 2026, compared to $656.6 million as of December 31, 2025. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund planned operations, including the commercial launch of lorundrostat, into 2028.
Research and development (R&D) expenses for the quarter ended June 30, 2026 were $221.4 million, compared to $38.3 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily due to the $200.0 million upfront payment to Tanabe in June 2026 in connection with the license agreement amendment. The increase was also due to $0.6 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased clinical supply, manufacturing, regulatory and other costs. These increases were partially offset by $17.8 million of lower preclinical and clinical costs, primarily due to the conclusion of the lorundrostat pivotal program in the second quarter of 2025.
General and administrative (G&A) expenses were $24.7 million for the quarter ended June 30, 2026, compared to $8.5 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to $8.0 million in higher professional fees, $8.0 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.2 million of increased other administrative expenses.
Total other income, net was $5.0 million for the quarter ended June 30, 2026, compared to $3.5 million for the quarter ended June 30, 2025. The increase was primarily due to $2.3 million of increased interest earned on investments as a result of higher average cash balances, partially offset by $0.8 million of interest and amortization expense related to the senior secured term loan entered into in June 2026.
Net loss was $241.1 million for the quarter ended June 30, 2026, compared to $43.3 million for the quarter ended June 30, 2025. The increase was primarily attributable to the factors impacting the Company’s expenses described above.
Conference Call
The Company’s management team will host a conference call at 4:30 p.m. ET today, August 11, 2026. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States, referencing conference ID 13760792. A live webcast of the conference call may be found here. A replay of the call will be available on the “News & Events” page in the Investors section of the Mineralys website here.
About Lorundrostat
Lorundrostat is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as CKD, OSA and other diseases driven by dysregulated aldosterone. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, has an observed half-
life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in participants with hypertension.
Mineralys has completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic blood pressure by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.
About Mineralys
Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, X and Bluesky.
Forward Looking Statements
Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on Mineralys’ current beliefs and expectations and include, but are not limited to, statements regarding: the anticipated timing of the FDA’s review of Mineralys’ accepted NDA and any subsequent regulatory approval of lorundrostat; the potential therapeutic benefits of lorundrostat; Mineralys’ expectations regarding activities to prepare for the commercial launch of lorundrostat; the capital available under Mineralys’ secured debt facility, including the potential to draw down additional tranches thereunder; Mineralys’ expectations with respect to finalizing an agreement with Tanabe to terminate the license agreement and to have Tanabe’s rights in the licensed intellectual property transferred to Mineralys; and the sufficiency of Mineralys’ cash, cash equivalents and investments to fund its operations. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Mineralys’ business, including, without limitation: any delays in the FDA’s review of Mineralys’ accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel; the results of Mineralys’ clinical trials, including the Launch-HTN and Advance-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of Mineralys’ NDA submission; the risk that future funding under the secured debt facility may not be available on the timeframe Mineralys expects, or at all, including as a result of its failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the debt facility; Mineralys may not be able to reach agreement on the proposed termination of its license agreement with Tanabe on its expected timeframe, or at all; Mineralys’ future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; Mineralys’ dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development,
regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; Mineralys’ ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; Mineralys’ reliance on its exclusive license with Tanabe to provide Mineralys with intellectual property rights to develop and commercialize lorundrostat; and other risks described in Mineralys’ filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in its annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Mineralys undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Investor Relations
investorrelations@mineralystx.com
Media Relations
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com
Mineralys Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended | Six Months Ended | ||||||||||||||||||||||
| June 30, | June 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | $ | 221,377 | $ | 38,278 | $ | 245,742 | $ | 76,157 | |||||||||||||||
| General and administrative | 24,663 | 8,468 | 45,638 | 15,036 | |||||||||||||||||||
| Total operating expenses | 246,040 | 46,746 | 291,380 | 91,193 | |||||||||||||||||||
| Loss from operations | (246,040) | (46,746) | (291,380) | (91,193) | |||||||||||||||||||
| Interest income, net | 4,956 | 3,474 | 10,952 | 5,713 | |||||||||||||||||||
| Other income (expense) | 13 | (2) | 18 | (5) | |||||||||||||||||||
| Total other income, net | 4,969 | 3,472 | 10,970 | 5,708 | |||||||||||||||||||
| Net loss | $ | (241,071) | $ | (43,274) | $ | (280,410) | $ | (85,485) | |||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (2.85) | $ | (0.66) | $ | (3.35) | $ | (1.44) | |||||||||||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 84,727,282 | 65,451,297 | 83,786,245 | 59,341,368 | |||||||||||||||||||
Mineralys Therapeutics, Inc.
Selected Financial Information
Condensed Balance Sheet Data
(in thousands)
(unaudited)
| June 30, | December 31, | ||||||||||
| 2026 | 2025 | ||||||||||
| Cash, cash equivalents and investments | $ | 661,412 | $ | 656,635 | |||||||
| Total assets | $ | 667,853 | $ | 661,806 | |||||||
Senior secured term loan, net | $ | 97,617 | $ | — | |||||||
| Total liabilities | $ | 116,936 | $ | 15,113 | |||||||
| Total stockholders’ equity | $ | 550,917 | $ | 646,693 | |||||||