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VERU

Healthcare

4w

Innovative Tissue-Selective Weight Loss Drug Demonstrates Promising Phase 2b Results

Veru's drug candidate Inovasaram has shown in Phase 2b that it can selectively target fat tissue while preserving lean mass in older patients, a significant advancement over existing GLP-1 therapies.
The Phase 2b trial demonstrated a 42% greater fat loss with the 6 mg dose of Inovasaram combined with semaglutide, with statistical significance (p=0.017).
Inovasaram preserved 100% of lean mass during the trial, reducing the risk of muscle loss associated with weight management in older adults.
Physical function, measured by stair climb test, was preserved in patients treated with Inovasaram, with a 59.8% reduction in physical decline compared to placebo.
Positive safety profile was confirmed in the maintenance extension study, with no significant adverse events related to muscle or bone health.
The company plans to develop a novel modified release oral formulation of Inovasaram, protected by patents through 2037, to improve chronic weight management.

VERU

Healthcare

4w

Financial Performance Summary

Cash, cash equivalents, and restricted cash totaled $15 million as of June 30, 2025, down from $24.9 million as of September 30, 2024.
Current cash is sufficient to fund operations into the next calendar year, beyond the expected FDA end of Phase 2 meeting for Inovasaram.
For Q3 2025, research and development costs decreased to $3 million from $4.8 million in the prior quarter due to the wind down of the Phase 2b quality clinical study for Inovasaram.
For the nine months ended June 30, 2025, R&D costs increased to $12.7 million from $9.5 million due to Phase 2b clinical study expenses, partially offset by decreased spending on terminated programs.
Net loss from continuing operations for the nine months was $17 million or $1.16 per diluted share, improved from $26.7 million or $2.04 per diluted share in the prior period.
Net loss from continuing operations was $7.3 million or $0.50 per diluted share, improved from a net loss of $10.3 million or $0.71 per diluted share in the prior year quarter.
Net loss from discontinued operations related to the FC2 business was $7.2 million or $0.49 per diluted share, including a $4.3 million loss on sale.
Net working capital was $9.5 million as of June 30, 2025, compared to $23.4 million as of September 30, 2024.
Selling, general and administrative expenses decreased to $5 million from $5.8 million primarily due to lower share-based compensation.
Selling, general and administrative expenses for the nine months decreased to $15.4 million from $18.4 million due to lower share-based compensation.
The company is not profitable and has negative cash flow from operations, requiring additional capital to support drug development.
The company recognized a gain on sale of fee assets of $485,000 compared to $110,000 in the prior quarter.
The company recorded gains on sale of NTAPI assets of $2.2 million and a gain on extinguishment of debt of $8.6 million related to the sale of the FC2 Female Condom business.

Inovio Pharmaceuticals, Inc.

INO

Healthcare

4w

Regulatory Progress and BLA Submission Strategy for INO-3107

Inovio remains on track to submit its BLA for INO-3107 in the second half of 2025, with a goal of file acceptance by year-end.
The company has completed the design verification testing of the CELLECTRA 5PSP device, a key regulatory milestone.
Inovio has requested a rolling submission of its BLA under breakthrough therapy designation, aiming for a 6-month review period and a potential PDUFA date around mid-2026.
The company successfully completed an FDA inspection of its clinical trial operations, an important step in regulatory compliance.
Differences in trial design and technology, such as DNA medicine versus viral vectors, distinguish INO-3107 from competitors' programs.

Mersana Therapeutics, Inc.

MRSN

Healthcare

4w

Emi-Le Clinical Data Highlights and Tumor Response Rates

Mersana reported a 31% objective response rate (ORR) in evaluable patients with B7-H4 high tumor expression at ASCO 2025, with doses ranging from 38 to 67 mg/m².
In adenoid cystic carcinoma type 1 (ACC1), 4 confirmed responses and 1 unconfirmed response were observed among 9 evaluable patients, with a confirmed ORR of 56% after data cutoff.
The company emphasized Emi-Le's potential to address unmet needs in triple-negative breast cancer (TNBC) patients previously treated with topoisomerase 1 inhibitors, highlighting poor outcomes with current standard of care.
Data from the TNBC expansion cohort showed a 29% ORR in B7-H4 high patients, with median PFS of 16 weeks, suggesting promising efficacy beyond standard chemotherapy.
Mersana is progressing with dose expansion in TNBC, enrolling over 45 patients across two dosing regimens, with initial data expected in the second half of 2025.
The company believes the post-topo-1 TNBC opportunity is sizable, with Trodelvy expected to generate about $1 billion in 2025, and Emi-Le could serve as a subsequent line of therapy, especially as treatment landscapes evolve.

Karyopharm Therapeutics Inc.

KPTI

Healthcare

1mo

Strategic Focus on Phase III Readouts and Clinical Progress

The company is actively progressing towards multiple pivotal Phase III trials, including in myelofibrosis and endometrial cancer, with top-line data expected in 2026.
There is a strong emphasis on the potential of selinexor in combination with ruxolitinib to redefine the standard of care for myelofibrosis, with an estimated peak revenue potential of up to $1 billion annually in the U.S.
Management highlighted the significance of recent enrollment milestones, such as closing new patient screening for the SENTRY trial in myelofibrosis, which is a key step in their clinical development strategy.
The company is leveraging its clinical data to support regulatory and commercial ambitions, emphasizing the potential for selinexor to address unmet needs in diseases with limited treatment options.

Allogene Therapeutics, Inc.

ALLO

Healthcare

4w

Streamlined ALPHA3 Study Enhances Patient Safety and Enrollment

Allogene has restructured the ALPHA3 trial into a 2-arm randomized study to improve safety and scalability, removing the FCA arm.
The protocol change was made in collaboration with the Data Safety Monitoring Board and FDA guidance, emphasizing agility and patient safety.
Over 50 sites are now active across the U.S. and Canada, with international expansion underway, supporting enrollment growth.
The company remains on track for a futility analysis in the first half of 2026, which will provide early efficacy signals.
Investors should note that the simplification of the study design is expected to boost investigator participation and patient enrollment.

Arcturus Therapeutics Holdings Inc.

ARCT

Healthcare

1mo

Progress and Expectations for ARCT-032 Cystic Fibrosis Program

The company is enrolling adult CF patients in a Phase II trial with inhaled ARCT-032, targeting non-responders to CFTR modulators.
Enrollment of the second cohort at 10-milligram dose is expected to complete in early September 2025, with interim data anticipated in September.
The trial focuses on a challenging patient population with severe unmet medical needs, emphasizing safety and lung function improvements.
Regulatory discussions with the FDA are planned for the first half of 2026 to align on pivotal trial design, including adolescent and pediatric enrollment.
The company highlights the potential for inhaled mRNA therapy to be a significant breakthrough for CF non-responders, differentiating from systemic small molecule modulators.
Dosing at 280 mg over 28 days is a novel approach, supported by proprietary delivery technology and drug purification methods.

Anavex Life Sciences Corp.

AVXL

Healthcare

4w

Long-Term Patient Engagement and Continuity in Clinical Trials

The company highlighted that patients in Australia have been on blarcamesine for up to 9 years, indicating strong long-term engagement.
Management emphasized the importance of continuous treatment to maintain cognitive and functional benefits.
Disruptions like COVID-19 impacted some trial measurements, but overall, patient retention remains high.
The company advises early and continuous treatment initiation for optimal outcomes, based on trial data.

Liquidia Corporation

LQDA

Healthcare

4w

Successful Launch and Early Adoption of YUTREPIA in 11 Weeks

Liquidia's new inhaled prostacyclin, YUTREPIA, achieved over 900 prescriptions and 550 patient starts within just 11 weeks of launch, indicating an unprecedented market response.
The launch was executed with high precision and purpose, leading to rapid adoption across both specialty centers and community practices.
The product's ease of use, tolerability, and dose escalation capabilities have been highly praised by physicians and patients, surpassing initial expectations.
Market access strategies, including co-pay assistance and free vouchers, contributed to a 75% script-to-start conversion rate in the first six weeks.
The early momentum was achieved despite typical market entry barriers, suggesting strong unmet needs and product differentiation.

Kymera Therapeutics, Inc.

KYMR

Healthcare

1mo

Advancement of KT-621 STAT6 Program and Clinical Data

Kymera completed the first KT-621 trial in healthy volunteers, reporting positive results that exceeded expectations and demonstrated >95% STAT6 degradation at low doses.
The Phase I healthy volunteer study showed complete degradation of STAT6 in blood and skin at doses of 50 mg and above, with a safety profile comparable to placebo.
Data indicated functional inhibition of the IL-4/13 pathway, with reductions of up to 37% for TARC and 63% for Eotaxin-3, comparable or superior to dupilumab.
The company plans to initiate Phase IIb studies in atopic dermatitis (AD) and asthma later this year and in early 2026, respectively.
A 4-month GLP toxicology study showed no adverse events, supporting the safety profile for further clinical development.

Kymera Therapeutics, Inc.

KYMR

Healthcare

1mo

Financial Performance Summary

Adjusted operating expenses were slightly down from the prior quarter.
Cash balance was $963 million at the end of June, increasing to approximately $1 billion by end of July after follow-on offering proceeds and Gilead upfront payment.
Cash runway extended into the second half of 2028.
G&A expenses were $17.6 million, with $7.4 million non-cash stock-based compensation; adjusted cash G&A increased 6% sequentially.
Kymera reported Q2 2025 revenue of $11.5 million, all from the Sanofi collaboration.
R&D expenses were $78.4 million, including $8 million of non-cash stock-based compensation, reflecting a 3% decrease in adjusted cash R&D spend from Q1 2025.