On August 7, 2025 Eli Lilly and Company (NYSE: LLY) reported its financial results for the second quarter of 2025 (Press release, Eli Lilly, AUG 7, 2025, View Source [SID1234654974]).

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"Lilly delivered another quarter of strong performance, achieving 38% year-over-year revenue growth driven by robust sales of Zepbound and Mounjaro and sustained momentum across our key medicines," said David A. Ricks, Lilly chair and CEO. "Our pipeline continued to advance, highlighted by positive study results in oncology and cardiometabolic health—including Mounjaro’s demonstrated cardio-protective effects in patients with type 2 diabetes and heart disease and strong data for our oral incretin, orforglipron, in obesity. We also expanded manufacturing capacity to meet increasing demand and invested in key R&D initiatives to support our long-term growth."

Financial Results

$ in millions, except

per share data

Second-Quarter

2025

2024

% Change

Revenue

$ 15,557.7

$ 11,302.8

38 %

Net income – Reported

5,660.5

2,967.0

91 %

Earnings per share – Reported

6.29

3.28

92 %

Net income – Non-GAAP

5,679.3

3,541.2

60 %

Earnings per share – Non-GAAP

6.31

3.92

61 %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Second-Quarter Reported Results
In Q2 2025, worldwide revenue was $15.56 billion, an increase of 38% compared with Q2 2024, driven by a 42% increase in volume, partially offset by a 6% decrease due to lower realized prices. Key Products1 revenue grew to $10.40 billion in Q2 2025, led by Zepbound and Mounjaro.

Revenue in the U.S. increased 38% to $10.81 billion, driven by a 46% increase in volume, partially offset by an 8% decrease due to lower realized prices. The increase in U.S. volume and decline in realized prices was driven by Zepbound and Mounjaro.

Revenue outside the U.S. increased 37% to $4.74 billion, driven by a 35% increase in volume and to a lesser extent a 3% favorable impact on foreign exchange rates, partially offset by a 1% decrease due to lower realized prices. The volume increase outside the U.S. was driven primarily by Mounjaro.

Gross margin increased 44% to $13.11 billion in Q2 2025. Gross margin as a percent of revenue was 84.3%, an increase of 3.5 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

In Q2 2025, research and development expenses increased 23% to $3.34 billion, or 21.4% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 30% to $2.75 billion in Q2 2025, primarily driven by promotional efforts supporting ongoing and future launches.

There were no asset impairment, restructuring and other special charges in Q2 2025. In Q2 2024, there was a charge of $435.0 million, which related to litigation.

The effective tax rate was 16.5% in Q2 2025 compared with 15.6% in Q2 2024. The lower tax rate in Q2 2024 reflects the favorable tax impact of asset impairment, restructuring and other special charges in Q2 2024.

In Q2 2025, net income and earnings per share (EPS) were $5.66 billion and $6.29, respectively, compared with net income of $2.97 billion and EPS of $3.28 in Q2 2024. EPS in Q2 2025 and Q2 2024 both included acquired IPR&D charges of $0.14.

1 The Company defines Key Products as Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio, and Zepbound.

Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2025 gross margin increased 43% to $13.23 billion. Gross margin as a percent of revenue was 85.0%, an increase of 3.0 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

On a non-GAAP basis, Q2 2025 net income and EPS were $5.68 billion and $6.31, respectively, compared with net income of $3.54 billion and EPS of $3.92 in Q2 2024. Non-GAAP EPS in Q2 2025 and Q2 2024 both included acquired IPR&D charges of $0.14.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Second-Quarter

2025

2024

% Change

Earnings per share (reported)

$ 6.29

$ 3.28

92 %

Amortization of intangible assets

.11

.12

Asset impairment, restructuring and other
special charges

—

.38

Net losses (gains) on investments in equity
securities

(.09)

.14

Earnings per share (non-GAAP)

$ 6.31

$ 3.92

61 %

Acquired IPR&D

.14

.14

— %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

Second-Quarter

Year-to-Date

Selected Products

2025

2024

% Change

2025

2024

% Change

Mounjaro

$ 5,198.9

$ 3,090.8

68 %

$ 9,040.7

$ 4,897.4

85 %

Zepbound

3,381.4

1,243.2

172 %

5,693.3

1,760.6

NM

Verzenio

1,489.3

1,331.9

12 %

2,648.2

2,382.2

11 %

Total Revenue

15,557.7

11,302.8

38 %

28,286.2

20,070.8

41 %

NM – not meaningful

Mounjaro
For Q2 2025, worldwide Mounjaro revenue increased 68% to $5.20 billion. U.S. revenue was $3.30 billion, an increase of 37%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $1.90 billion compared with $677.2 million in Q2 2024, primarily driven by volume growth, including entry into new markets.

Zepbound
For Q2 2025, U.S. Zepbound revenue increased 172% to $3.38 billion, compared with $1.24 billion in Q2 2024, primarily driven by increased demand, partially offset by lower realized prices.

Verzenio
For Q2 2025, worldwide Verzenio revenue increased 12% to $1.49 billion. U.S. revenue was $929.0 million, an increase of 8%, driven by increased volume. Revenue outside the U.S. was $560.3 million, an increase of 19%, primarily driven by volume growth.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

Donanemab receives positive opinion from the Committee for Medicinal Products
for Human Use (CHMP) in early symptomatic Alzheimer’s disease (announcement)

FDA approves updated label for Lilly’s Kisunla (donanemab-azbt) with new dosing
in early symptomatic Alzheimer’s disease (announcement).

FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support
diagnosis of Alzheimer’s disease in patients (announcement).

Lilly’s Kisunla (donanemab) receives marketing authorization in Australia for the
treatment of early symptomatic Alzheimer’s disease (announcement).

Clinical

Lilly’s oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs
in first of two pivotal Phase 3 trials in adults with obesity (announcement)

Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated
cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in
patients with type 2 diabetes and heart disease (announcement)

Lilly’s Kisunla (donanemab-azbt) showed growing benefit over three years in early
symptomatic Alzheimer’s disease (announcement)

Lilly’s Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible)
BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus
Imbruvica (ibrutinib) in CLL/SLL (announcement)

Lilly’s once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety
profile consistent with daily insulin in multiple Phase 3 trials (announcement).

Lilly’s oral GLP-1, orforglipron, showed compelling efficacy and a safety profile
consistent with injectable GLP-1 medicines, in complete Phase 3 results published
in The New England Journal of Medicine (announcement).

Lilly presents first clinical data for its investigational, next-generation FRα targeting
ADC in platinum-resistant ovarian cancer at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting
(announcement).

Zepbound (tirzepatide) showed superior weight loss over Wegovy (semaglutide) in
complete SURMOUNT-5 results published in The New England Journal of Medicine
(announcement).

Other

Lilly to acquire Verve Therapeutics to advance one-time treatments for people with
high cardiovascular risk (announcement). Lilly and Verve announce expiration of
Verve tender offer (announcement).

Lilly to offer all approved doses of Zepbound (tirzepatide) single-dose vials through
LillyDirect Self Pay Pharmacy Solutions (announcement).

Lilly to expand its pain pipeline with acquisition of SiteOne Therapeutics
(announcement).

Lilly plans to expand Purdue University collaboration with up to a $250 million
investment to accelerate pharmaceutical innovation (announcement).

Lilly announces transitions in executive leadership (announcement).

For information on important public announcements, visit the news section of Lilly’s website.

2025 Financial Guidance
Full year guidance increased to the range of $60.0 billion to $62.0 billion, primarily driven by strong underlying business performance across the portfolio and foreign exchange rates.

The performance margin2 is now expected to be in the range of 42.0% and 43.5% on a reported basis and 43.0% and 44.5% on a non-GAAP basis. Both ratios reflecting the increase in revenue guidance.

Other income (expense) on a reported basis is now expected to be expense in the range of $750 million to $650 million due to a decrease in net losses on investments in equity securities and is still expected to be expense in the range of $700 million to $600 million on a non-GAAP basis.

The 2025 estimated effective tax rate increased from approximately 17% on a reported basis to 19% which reflects an anticipated third quarter charge as a result of recently enacted U.S. tax legislation. The non-GAAP estimated tax rate is still expected to be approximately 17%.

Based on these changes, EPS guidance increased to the range of $20.85 to $22.10 on a reported basis and $21.75 to $23.00 on a non-GAAP basis. The company’s updated 2025 financial guidance reflects adjustments shown in the reconciliation table below.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2025 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 8:30 a.m. Eastern time today and will be available for replay via the website.

On August 7, 2025 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the second quarter ended June 30, 2025 (Press release, Monte Rosa Therapeutics, AUG 7, 2025, View Source [SID1234654990]).

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"With the advancement of our third program into clinical development, we continue to efficiently execute across our portfolio of only-in-class and first-in-class molecular glue degraders," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "We have now dosed the initial single ascending dose (SAD) cohort in our Phase 1 study of MRT-8102, the only clinical-stage MGD that selectively degrades NEK7. Based on the potency, selectivity, and durable pharmacodynamics seen in our preclinical studies, we believe MRT-8102 offers a highly differentiated approach to potentially address a wide range of inflammatory and cardio-immunology indications driven by the NLRP3 inflammasome, IL-1β and IL-6. The execution of this program builds on the experience and success of our Phase 1 study for MRT-6160, our MGD directed against VAV1. We continue, in collaboration with Novartis, to progress MRT-6160 towards a broad development program of multiple well-powered Phase 2 studies in immune-mediated diseases, building on our highly encouraging Phase 1 clinical data disclosed earlier this year. In oncology, we continue to evaluate MRT-2359 in castration-resistant prostate cancer and are on track to report additional clinical data later this year. We also eagerly anticipate a development candidate (DC) nomination this year and IND submission next year for one or both of our cell cycle programs directed at CCNE1 and CDK2, two well-validated tumor drivers poorly addressed by conventional approaches."

Dr. Warmuth continued, "In parallel with the progress made with our clinical programs, we were proud to see fundamental results from our QuEEN discovery engine featured in Science, highlighting Monte Rosa’s leadership applying proprietary AI/ML techniques to the discovery of molecular glue degraders, dramatically expanding the addressable protein target space as well as the chemical space for MGDs to address these targets. These advances underscore the broad potential applications of the platform and our ability to create long-term value through focused pipeline execution and strategic collaborations."

RECENT HIGHLIGHTS

MRT-6160, VAV1-directed MGD for immune-mediated conditions

•
Advancement of MRT-6160 toward multiple Phase 2 studies in immune-mediated diseases is ongoing, in collaboration with Novartis. Results from the Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy volunteers (clinicaltrials.gov identifier NCT06597799) support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases.
•
Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs including MRT-6160. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

MRT-8102, NEK7-directed MGD for inflammatory diseases driven by IL-1β and the NLRP3 inflammasome

•
In July 2025, Monte Rosa dosed the first subjects in a Phase 1 study of MRT-8102, a first-in-class, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, IL-1β, and IL-6. The ongoing study includes SAD/MAD cohorts in healthy volunteers and an additional cohort designed to evaluate potential early proof of concept in subjects with increased cardiovascular disease (CVD) risk and elevated C-reactive protein (CRP). Initial data are expected in H1 2026.

MRT-2359, GSPT1-directed MGD for MYC-driven solid tumors

•
Monte Rosa continues to enroll and evaluate MRT-2359 in patients with castration-resistant prostate cancer (CRPC), with the potential to expand enrollment to 20-30 patients if a positive efficacy signal continues to be observed. The Company expects to present additional results in H2 2025. Monte Rosa is also assessing activity in patients with hormone receptor (HR)+ breast cancer and expects to present results for this cohort in H2 2025.

Cyclin E1 and CDK2-directed MGD programs for treatment of solid tumors

•
In April 2025, Monte Rosa presented preclinical data on the potential of its highly selective CDK2-directed molecular glue degrader, MRT-51443, to treat HR-positive/HER2-negative breast cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025.

QuEEN (Quantitative and Engineered Elimination of Neosubstrates) discovery engine

•
In July 2025, Monte Rosa’s publication in Science showcased the Company’s QuEEN AI/ML-powered degrader discovery engine. The findings significantly expand the targetable protein space for MGD drug discovery, unlocking new opportunities to address previously undruggable therapeutic targets.

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

•
Continue advancement of MRT-6160 toward Phase 2 initiation, in collaboration with Novartis.
•
Share MRT-8102 Phase 1 results in H1 2026.
•
Submit an IND application for the second-generation NEK7-directed MGD with enhanced CNS penetration in 2026.

•
Share additional MRT-2359 Phase 1/2 study data in heavily pretreated CRPC patients and in patients with HR+ breast cancer in H2 2025.
•
Nominate a development candidate for a CDK2 and/or cyclin E1-directed MGD in H2 2025 and submit an IND application in 2026

SECOND QUARTER 2025 FINANCIAL RESULTS

Collaboration revenue: Collaboration revenue for the second quarter of 2025 was $23.2 million, compared to $4.7 million for the quarter ended June 30, 2024. Collaboration revenue represents amounts earned from our collaboration and license agreements with Roche and Novartis, primarily revenue recognized from the Novartis $150 million upfront payment in the fourth quarter of 2024 based on progress made on our performance obligations defined in the Novartis License Agreement.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2025 were $30.7 million, compared to $28.1 million for the second quarter of 2024. These increases were driven by the successful achievement of key milestones in our R&D organization, including the continuation of the MRT-2359 clinical study, continued program activities for MRT-6160 in preparation for Phase 2 studies, the advancement of MRT-8102 to enter the clinic, the progression of our preclinical pipeline, including research performed in connection with our collaboration with Roche, and the continued development of the Company’s QuEEN discovery engine. Non-cash stock-based compensation constituted $2.9 million of R&D expenses for Q2 2025, compared to $2.6 million in the same period in 2024.

General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2025 were $8.1 million compared to $9.3 million for the second quarter of 2024. G&A expenses included non-cash stock-based compensation of $2.0 million for the second quarter of 2025, compared to $1.9 million in the same period in 2024.

Net Loss: Net loss for the second quarter of 2025 was $12.3 million, compared to a net loss of $30.3 million for the second quarter of 2024.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2025, were $295.5 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $331.0 million as of March 31, 2025. The decrease of $35.5 million was primarily due to the operational use of cash.

Based on current cash, cash equivalents, restricted cash, marketable securities, and certain anticipated Roche collaboration revenue, the Company expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures into 2028.

About MRT-6160
MRT-6160 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader of VAV1, which in preclinical studies has shown deep degradation of its target with no detectable effects on other proteins. VAV1 is a key signaling protein downstream of both the T- and B-cell receptors. VAV1 expression is restricted to immune cells, including T and B cells. MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions. In a Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy subjects (clinicaltrials.gov identifier NCT06597799), MRT-6160 demonstrated sustained, dose-dependent VAV1 degradation in peripheral blood T and B cells after single and multiple dose administration. MRT-6160 also substantially inhibited secretion of inflammatory cytokines from whole blood derived T and B cells following ex vivo stimulation. Under the terms of an agreement announced in October 2024, Novartis has exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 MGDs. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

About MRT-8102
MRT-8102 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that targets NEK7 for the treatment of inflammatory diseases linked to NLRP3, IL-1β, and IL-6 dysregulation. NEK7 has been shown to be required for NLRP3 inflammasome assembly, activation and IL-1β release both in vitro and in vivo. Aberrant NLRP3 inflammasome activation and the subsequent release of active IL-1β and interleukin-18 (IL-18) has been implicated in multiple inflammatory disorders, including cardiovascular disease, gout, osteoarthritis, neurologic disorders including Parkinson’s disease and Alzheimer’s disease, and metabolic disorders. In a non-human primate model, MRT-8102 was shown to potently, selectively, and durably degrade NEK7, and resulted in near-complete reductions of IL-1β and caspase-1 following ex vivo stimulation of whole blood. MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology studies.

About MRT-2359
MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) of GSPT1. MYC transcription factors (c-MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Preclinical studies have shown this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 is designed to exploit this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors. MRT-2359 is being investigated in an ongoing Phase 1/2 study (clinicaltrials.gov identifier NCT05546268) in solid tumors, including castration-resistant prostate cancer (CRPC). In heavily pretreated CRPC patients, a patient group characterized by widespread expression of c-MYC, MRT-2359 demonstrated encouraging early signals of clinical response.

On August 7, 2025 Minghui Pharmaceutical ("Minghui"), a late-stage clinical biopharmaceutical company, reported the closing of a USD 131 million Pre-IPO financing led by new investors OrbiMed and co-led by Qiming Venture Partners (Press release, Minghui Pharmaceutical, AUG 7, 2025, View Source [SID1234655009]). Further support came from existing investor TF Capital, and seven new investors, including including BioTrack Capital, 5Y Capital, New Day Fund, and Wider Link Enterprise Investment limited. Representatives from OrbiMed and Qiming Venture Partners will join the company’s Board of Directors.

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Proceeds will be used to advance the company’s clinical programs, with a particular focus on its PD-1/VEGF bispecific antibody and combination strategies with antibody-drug conjugates (ADCs). The funds will also support the planned commercial launch of its topical JAK inhibitor in China.

"This financing marks an important milestone as we continue to advance a globally competitive pipeline and enter our next stage of growth," said Dr. Guoqing Cao, Chief Executive Officer of Minghui. "We’re grateful for the confidence and support of our investors and remain committed to delivering innovative medicines that improve outcomes for patients worldwide."

"We have been impressed by Minghui’s scientific rigor, execution capabilities, and differentiated pipeline," said Dr. David Wang, Partner and Senior Managing Director at OrbiMed Asia. "We’re excited to support the company as it transitions towards commercialization and expands its global footprint."

"Minghui has built a compelling portfolio of novel drug candidates targeting critical unmet medical needs," said Dr. Kan Chen, Partner and Co-lead of Healthcare at Qiming Venture Partners. "We are pleased to support its continued growth and help bring transformative therapies to patients around the world."

On August 7, 2025 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, reported its financial results for the second quarter of 2025 and provided a corporate update (Press release, Aclaris Therapeutics, AUG 7, 2025, View Source [SID1234654959]).

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"Aclaris is in a period of strong execution throughout the business as we advance our innovative therapies toward our goal of improving therapeutic options for patients with certain I&I diseases," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "For example, the results from the single arm Phase 2a clinical trial of our ITK/JAK3 inhibitor ATI-2138 represent a significant achievement for our ITK franchise by both confirming the strong tolerability profile and mechanism of ATI-2138 in AD ahead of our planned alopecia areata clinical trial and validating ITK as an important therapeutic target. Importantly, with an expected cash runway that funds our operations into the second half of 2028, we have sufficient capital to execute our strategic plan. We are also exploring additional non-dilutive opportunities to extend our cash runway even further."

Second Quarter 2025 Highlights and Recent Updates

Pipeline:

Achieved Primary and Key Secondary Endpoints in Phase 2a Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3: Positive results from this open-label, single arm trial further confirmed the favorable tolerability profile of ATI-2138, demonstrated clinically meaningful improvements from baseline in assessments of disease severity in patients with moderate-to-severe AD receiving low doses of ATI-2138, and validated ITK as a therapeutic target. Overall, these results provide evidence that the contribution of ITK may enable ATI-2138, even at low doses, to achieve efficacy results comparable to approved JAK inhibitors in moderate-to-severe AD, but with improved tolerability and without the significant safety risks typically associated with JAK inhibition. (press release here)
Initiated Dosing in Phase 2 Trial of Potential Best-in-Class Investigational Anti-TSLP Monoclonal Antibody Bosakitug: Patient dosing is ongoing in the randomized, double-blind, placebo-controlled global Phase 2 trial designed to evaluate bosakitug in approximately ninety (90) patients with moderate-to-severe AD. The Company expects to provide top line results in the second half of 2026. (press release here)
Initiated Dosing in Phase 1a/1b Program for Potential Best-in-Class Investigational Bispecific Anti-TSLP/IL-4R Antibody ATI-052: Dosing is ongoing in the randomized, blinded, placebo-controlled Phase 1a portion, designed to evaluate single and multiple ascending doses of ATI-052 in healthy adults. The Phase 1b proof-of-concept portion in up to two indications is expected to follow the Phase 1a portion. Aclaris expects to complete the Phase 1a portion by year-end 2025 and provide top line results in early 2026, followed by top line results from the Phase 1b portion in the second half of 2026. (press release here)

Corporate:

Strong Cash Runway Funds the Company’s Planned Operations into the Second Half of 2028: The Company is assessing potential non-dilutive opportunities to extend the cash runway further.
Provided Update on Senior Leadership: Roland Kolbeck, Ph.D. has been appointed as Chief Scientific Officer, replacing Joe Monahan, Ph.D. who will remain with the Company as Special Scientific Advisor to the Chief Executive Officer through the first quarter of 2026 as part of his planned retirement. (press release here)
Financial Results

Liquidity and Capital Resources

As of June 30, 2025, Aclaris had cash, cash equivalents and marketable securities of $180.9 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2028, without giving effect to any potential business development transactions or financing activities.

Second Quarter 2025 and Year-to-Date 2025

Net loss was $15.4 million for the second quarter of 2025 compared to $11.0 million for the second quarter of 2024. Net loss was $30.5 million for the six months ended June 30, 2025 compared to $27.9 million for the six months ended June 30, 2024.

Total revenue was $1.8 million for the second quarter of 2025 compared to $2.8 million for the second quarter of 2024. Total revenue was $3.2 million for the six months ended June 30, 2025 compared to $5.2 million for the six months ended June 30, 2024. The decrease for both comparison periods was primarily driven by the sale of a portion of royalty payments under the Company’s agreement with Eli Lilly and Company to OCM IP Healthcare Portfolio IP, an investment vehicle for Ontario Municipal Employees Retirement System (OMERS), in July 2024.

Research and development (R&D) expenses were $11.4 million and $23.0 million for the quarter and six months ended June 30, 2025, respectively, compared to $8.8 million and $18.6 million for the corresponding prior year periods. The increases were primarily driven by product candidate manufacturing costs, preclinical development activities, and clinical development expenses associated with the Phase 2 trial in AD for bosakitug and the Phase 1a/1b program for ATI-052. For the six-month comparison period, clinical development expenses associated with the Phase 2a trial in AD for ATI-2138 also contributed to the increase. The increases were partially offset by a reduction in development expenses for zunsemetinib for both comparison periods.

General and administrative (G&A) expenses were $5.4 million for the quarter ended June 30, 2025 compared to $4.8 million for the corresponding prior year period. The increase was primarily driven by higher personnel expenses as a result of higher headcount. G&A expenses were $11.5 million for the six months ended June 30, 2025 compared to $11.6 million for the six months ended June 30, 2024. The decrease was primarily driven by lower personnel expenses as a result of lower termination benefits.

Revaluation of contingent consideration resulted in a $1.5 million charge for the quarter ended June 30, 2025 compared to a $0.2 million charge for the prior year period. The increase was primarily due to changes to the probability of success for certain product candidates and lower discount rates resulting from changes in credit spreads being applied to potential payments during the quarter ended June 30, 2025. For the six months ended June 30, 2025, revaluation of contingent consideration resulted in a charge of $1.8 million compared to $3.0 million for the prior year period. The decrease was primarily due to changes in estimated sales levels and changes to the probability of success for certain product candidates during the six months ended June 30, 2024.

On August 7, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadustat for the treatment of anemia in patients with LR-MDS and high RBC transfusion burden, based on a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial (Press release, FibroGen, AUG 7, 2025, View Source [SID1234654975]).

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"We are very pleased with the feedback we received from the FDA regarding roxadustat in patients with LR-MDS and anemia with high transfusion burden. This indication, despite recent approvals, still represents a patient population with significant unmet need," said Thane Wettig, Chief Executive Officer of FibroGen. "We believe roxadustat’s differentiated mechanism of action, favorable tolerability profile, and oral route of administration can potentially be an important addition to the treatment options for patients with high transfusion burden. We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. We plan to submit the Phase 3 trial protocol to the FDA in the fourth quarter of this year."

"Anemia is a major cause of morbidity and complications in patients with LR-MDS, especially those with high transfusion burden, and is often associated with poor quality of life and shortened survival. While we have recent approvals of injectable drugs for this indication, there is a significant unmet need for novel, effective oral agents for this patient population," added Amer Zeidan, M.B.B.S, M.H.S., Professor of Medicine at Yale School of Medicine and Chief of the Division of Hematologic Malignancies at Yale Cancer Center, and the global principal investigator of the planned Phase 3 study. "Roxadustat has already shown promising efficacy in this group of patients in the post-hoc analysis of the MATTERHORN study, and I am glad we have agreed on a pathway with the regulators to explore the full potential of roxadustat in the upcoming Phase 3 trial. I am excited by the prospect of roxadustat potentially becoming a novel, safe, convenient, and effective therapy for LR-MDS patients with high transfusion burden."

FibroGen requested the Type C meeting based on the findings of a post-hoc analysis of data from the Phase 3 MATTERHORN trial of roxadustat in anemia-associated with LR-MDS. In patients with high RBC transfusion burden at baseline (≥4 units over 8 weeks1), a pronounced treatment effect was observed: 36% (8/22) of patients achieved transfusion independence (TI) for ≥ 56 days on roxadustat vs 7% (1/15) of patients on placebo within 28 weeks (nominal p-value of 0.041).

The planned Phase 3 trial will assess the safety and efficacy of roxadustat in a randomized, double-blind, placebo-controlled design in approximately 200 patients with LR-MDS. Alignment was reached with the FDA on the patient population (patients requiring ≥ 4 pRBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESA) therapy), dose regimen, as well as management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria. As the primary endpoint for the study, the Company is considering either 8-week or 16-week RBC TI.

FibroGen plans to submit the full Phase 3 protocol to the FDA in the fourth quarter of 2025.

About Myelodysplastic Syndromes Anemia
Myelodysplastic syndromes (MDS) are a group of disorders characterized by dysfunctional progenitor blood cells and stem cells, resulting in chronic anemia in most patients. Annual incidence rates of MDS are estimated to be 4.9/100,000 adults in the U.S, thereof 77% are considered lower-risk MDS. Approximately 80% of patients with MDS have anemia at the time of diagnosis, and around 60% of patients with MDS will experience severe anemia (hemoglobin <8 g/dL) at some point during the course of their disease. Anemia in patients with MDS is associated with increased risk of cardiovascular complications and the need for blood transfusion. Approximately 50% of patients with MDS require regular red blood cell transfusions. Transfusion dependent MDS patients suffer higher rates of cardiac events, infections, and iron overload with the related complications. In addition, anemia frequently leads to significant fatigue, cognitive dysfunction, and decreased quality of life. Today, patients are routinely treated with erythropoiesis-stimulating agents (ESAs), luspatercept, imetelstat, or lenalidomide in lower-risk MDS with isolated del(5q), and hypomethylating agents (HMAs) in higher-risk disease. Only 35-40% of patients respond to current treatments and the durability of response is short. Moreover, these treatments are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion. There remains a high unmet need for the treatment of anemia associated with MDS, and new strategies that provide durable response and the convenience of oral administration are highly desired in managing patients with MDS.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.