SEC 8-K filings with transcript text
Aug 11, 2026
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Exhibit 99.1
Veradermics Reports Second Quarter 2026 Financial Results and Highlights Recent Corporate and Clinical Progress
Positive topline results from open-label Phase 2 Study ‘207’ evaluating VDPHL01 in female pattern hair loss demonstrated rapid onset and consistent hair growth
Completion of patient enrollment for Phase 2/3 Study ‘306’, a 556 participant, registration-directed trial evaluating VDPHL01 in female pattern hair loss, marking a milestone in the development of the potential first oral prescription treatment for women; topline readout anticipated in 1H27
VDPHL01 has the potential to be the first extended-release oral minoxidil therapy for women and men with pattern hair loss, a condition affecting an estimated 30 million women and 50 million men in the United States
Company remains on track to deliver multiple data milestones in 2H26 for its male pattern hair loss trials, including 12-month data from Phase 2/3 Study ‘302’ and topline data from confirmatory Phase 3 Study ‘304’
Cash, cash equivalents and marketable securities of $819.9 million as of June 30, 2026, expected to fund operations into 2030 through multiple Phase 3 readouts and potential commercial launch of VDPHL01
NEW HAVEN, Conn.--(BUSINESS WIRE)—August 11, 2026 Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent corporate and clinical progress.
“In the second quarter of 2026, we made significant advancements in the development of VDPHL01 for female pattern hair loss, supporting key milestones for the program. The positive Phase 2 results from Study ‘207’ marked the first successful clinical demonstration of an oral treatment for female pattern hair loss in the United States and increased our conviction in VDPHL01 as a potential treatment for women as we advance toward registration-directed topline data from the now fully enrolled Phase 2/3 Study ‘306’ in the first half of 2027," said Reid Waldman, M.D., Chief Executive Officer of Veradermics. "With enrollment in Study ‘306’ now complete, we look forward to a catalyst-rich remainder of 2026 as we progress toward topline data from the confirmatory Phase 3 Study ‘304’ in men and 12-month data from Study ‘302’, both anticipated in the second half of 2026. Veradermics remains well capitalized to execute
Exhibit 99.1
against these milestones while continuing preparations for a potential commercial launch, with the goal of establishing VDPHL01, if approved, as a foundational treatment for women and men living with pattern hair loss."
Recent Business Highlights and 2026 Anticipated Milestones
VDPHL01 Registrational Program for Men and Women with Pattern Hair Loss (“PHL”)
•Positive Topline Results from Phase 2 Study ‘207’ in Female Pattern Hair Loss: In July 2026, Veradermics announced positive topline results from its open-label Phase 2 clinical trial (Study ‘207’) evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation, in women with mild-to-moderate pattern hair loss. Among participants who received VDPHL01 4.5 mg once (QD) or twice (BID) daily for six months, VDPHL01 demonstrated rapid onset of activity, consistent response across participants, and increases in hair count while being generally well tolerated. Participants achieved a mean increase in non-vellus target area hair count (TAHC) of 22.7 hairs/cm² (QD) and 23.3 hairs/cm² (BID) at Month 6, and 88.9% (QD) and 90.0% (BID) of participants achieved ‘improved’ or ‘much improved’ hair coverage on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 6. No treatment-related serious adverse events (SAEs) and no adverse events of special interest (AESIs) of cardiac origin were observed. These results were observed on the same endpoints being evaluated in the registration-directed Phase 2/3 Study ‘306’.
•Patient Enrollment Complete in Study ‘306’ in Females with PHL; Topline Data Anticipated in 1H27: Veradermics has completed enrollment of Study ‘306’, a Phase 2/3 multi-center, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of VDPHL01 at two dose regimens (4.5 mg once-daily and twice-daily) over 52 weeks in 556 female participants with mild-to-moderate pattern hair loss. The co-primary endpoints are change in non-vellus hair count and patient-reported hair coverage benefit at 24 weeks. Study ‘306’ is the first registration-directed trial evaluating an oral therapy specifically for women with pattern hair loss in the United States. The Company expects to report topline data in the first half of 2027.
•Phase 3 Study ‘304’; Topline Data Anticipated in 2H26: Topline data from Study ‘304’, a confirmatory Phase 3 trial evaluating the safety and efficacy of VDPHL01 in the treatment of male
May 12, 2026
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Exhibit 99.1
Veradermics Reports First Quarter 2026 Financial Results and
Highlights Recent Corporate and Clinical Progress
Positive topline results from Phase 2/3 Study ‘302’ position VDPHL01 to potentially become the first FDA-approved oral treatment for pattern hair loss in nearly 30 years
Upsized IPO and follow-on financing generated approximately $766.8 million in aggregate gross proceeds; pro forma cash expected to fund operations into 2030 through multiple Phase 3 readouts and potential launch
NEW HAVEN, Conn. – May 12, 2026 – Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today reported financial results for the first quarter ended March 31, 2026, and highlighted recent corporate and clinical progress.
“The announcement of positive Phase 2/3 topline results from Study ‘302’ in April 2026 was an inflection point for Veradermics and supports our belief that VDPHL01 can become a foundational treatment for pattern hair loss,” said Reid Waldman, M.D., Chief Executive Officer of Veradermics. “We are working with urgency to deliver multiple data milestones in the second half of 2026. Following our successful IPO and subsequent financing activities, we are well capitalized to execute on these milestones and advance our mission to provide the first-ever FDA-approved non-hormonal oral treatment for pattern hair loss to both men and women.”
Recent Business Highlights and 2026 Anticipated Milestones
VDPHL01 Registrational Program for Men and Women with Pattern Hair Loss (“PHL”)
•Positive Topline Results from Part A in Study ‘302’ Support Potential Best-in-Indication Profile. In April 2026, Veradermics reported positive topline data from Part A of Study ‘302’, a four-arm, multicenter, randomized, double-blinded, placebo-controlled, Phase 2/3 clinical trial evaluating VDPHL01 8.5 mg in males with mild-to-moderate PHL. VDPHL01 achieved early, consistent, and robust hair growth, and demonstrated a favorable safety and tolerability profile and adverse event rates comparable to placebo. These results support the potential for VDPHL01 to become the first FDA-approved oral treatment for pattern hair loss in nearly 30 years. Twelve-month data from Study ‘302’ is anticipated in the second half of 2026.
•Enrollment Completed in Study ‘304’. In February 2026, Veradermics announced completion of enrollment in Study ‘304’, a confirmatory Phase 3 trial evaluating the safety and efficacy of VDPHL01 in the treatment of male PHL. Across Study ‘302’ and
Exhibit 99.1
Study ‘304’, more than 1,000 male participants received VDPHL01 or placebo, representing one of the largest registrational programs conducted to date in PHL. Topline data from Study ‘304’ are expected in the second half of 2026.
•Enrollment Ongoing in Study ‘306’ in Females with PHL. Veradermics is actively enrolling patients into Study ‘306’, a Phase 2/3 clinical trial evaluating VDPHL01 in female PHL. The trial is expected to enroll more than 500 patients in the United States and represents the first non-hormonal oral therapy studied in a registrational-directed trial specifically for women with PHL.
•Additional Clinical and Patient Experience Data Presented at American Academy of Dermatology Annual Meeting (AAD 2026). In March 2026, Veradermics presented three abstracts at AAD 2026 including analyses of investigator-assessed efficacy and patient experience insights highlighting the limitations of currently available treatment options.
Corporate
•Strengthened Balance Sheet Through Successful Capital Markets Execution. Veradermics raised approximately $766.8 million in aggregate gross proceeds in 2026 through its upsized initial public offering and subsequent follow-on offering and concurrent private placement. These proceeds, together with existing cash, cash equivalents and marketable securities, are expected to support Veradermics' operating plans into 2030, including multiple anticipated Phase 3 readouts and the potential commercial launch of VDPHL01, if approved.
First Quarter 2026 Financial Results
•Cash Position: Cash, cash equivalents, and marketable securities totaled $390.8 million as of March 31, 2026, reflecting net proceeds from the company’s upsized initial public offering completed in February 2026. Subsequent to March 31, 2026, we completed our follow-on offering, in which the company raised gross proceeds of approximately $472.0 million, before deducting underwriting discounts and commissions and other offering expenses.
•R&D Expenses: Research and development (R&D) expenses were $20.9 million for the quarter ended March 31, 2026 as compared with $11.4 million for the quarter ended March 31, 2025. The increase in R&D expenses of $9.5 million was primarily due to increases in clinical development and other development expenses of VDPHL01 and an increa
Apr 27, 2026
mane-20260427
0001827635False00018276352026-04-272026-04-27
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 27, 2026
(Exact name of registrant as specified in its charter)
Delaware001-4309784-3304423
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
470 James Street
New Haven, CT 06513
(Address of principal executive offices)(Zip Code)
(Registrant’s telephone number, including area code): (228) 372-3376
Not Applicable
(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 (see General Instruction A.2. below):
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, par value $0.00001 per shareMANENew York Stock Exchange
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.
Veradermics, Incorporated (the “Company”) reports that it had a preliminary unaudited amount of cash, cash equivalents and marketable securities of approximately $390.8 million as of March 31, 2026. This amount is preliminary and unaudited and is subject to completion of the Company’s financial closing procedures. As a result, this amount may differ materially from the amount that will be reflected in the Company’s unaudited condensed consolidated financial statements for the three months ended March 31, 2026. This preliminary unaudited financial data has been prepared by, and is the responsibility of, the Company’s management. Deloitte & Touche LLP, the Company’s auditor, has not audited, reviewed, examined, compiled, nor applied agreed-upon procedures with respect to the preliminary financial data. Accordingly, Deloitte & Touche LLP does not express an opinion or any other form of assurance with respect thereto.
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.
By:/s/ Reid Waldman, M.D.
Name: Reid Waldman, M.D.
Chief Executive Officer
Date: April 27, 2026
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