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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.

Inovio Pharmaceuticals, Inc.

INO

Healthcare

4w

Financial Performance Summary

Cash, cash equivalents, and short-term investments totaled $47.5 million at the end of Q2 2025, down from $94.1 million at the end of 2024.
Cash runway is projected into Q2 2026, including the recent capital raise and estimated $22 million net cash burn for Q3 2025.
Net loss for Q2 2025 dropped 27% to $23.5 million from $32.2 million in Q2 2024.
Net loss per share decreased 49% to $0.61 in Q2 2025 from $1.19 in Q2 2024.
Operating expenses decreased by 31% year-over-year to $23.1 million in Q2 2025 from $33.3 million in Q2 2024.
Raised approximately $22.5 million net proceeds from a public offering in July 2025.

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.

VXRT

Healthcare

4w

Impact of Second Stop Work Order on COVID-19 Trial Progress

Vaxart received a second stop work order from ATI, funded by BARDA, surprising the company with no prior notice.
The order was issued when approximately 5,000 participants had already been enrolled in the Phase IIb COVID-19 trial.
Despite the order, enrollment was allowed to continue for those already enrolled, maintaining trial momentum.
Management remains optimistic about the potential of the oral COVID-19 vaccine despite the disruption.
The company is awaiting further details from BARDA and ATI to determine next steps for the trial.
The trial's design includes a head-to-head efficacy comparison with an mRNA vaccine, aiming for data in 2026.

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.

Bionano Genomics, Inc.

BNGO

Healthcare

3w

Potential Strategic Partnerships and Acquisition Discussions Ongoing

Management acknowledged ongoing discussions with potential strategic partners and the interest from the market.
Bionano highlighted its advanced position in the space, with a strong financial profile and strategic focus.
The company emphasized its commitment to its digital pathology transformation strategy.
While not explicitly seeking acquisitions, Bionano remains open to strategic collaborations that align with its goals.
The company’s visibility and market presence make it a target for strategic interest, but no specific deals were disclosed.

Bionano Genomics, Inc.

BNGO

Healthcare

3w

Financial Performance Summary

Cash and equivalents totaled $27.4 million at quarter-end, with $11 million subject to restrictions.
Consumables and software revenue grew 16% year-over-year in Q2 and represented 73% of total product revenue, up from 55% last year.
Flowcell sales increased 17% year-over-year to 7,233 units, indicating strong utilization growth.
Installed base of optical genome mapping systems was 378, a 4% increase from 363 systems a year ago, with a net decrease of 1 system in the quarter.
Non-GAAP gross margin improved significantly to 52% from 35% a year ago, driven by cost reductions and manufacturing improvements.
Non-GAAP operating expenses decreased 53% year-over-year to $8.8 million, reflecting substantial cost-cutting and headcount reduction.
Total revenue for Q2 2025 was $6.7 million, down 13% year-over-year, or 5% when excluding $700,000 from discontinued services.

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.

CDXS

Healthcare

4w

Financial Performance Summary

Operating loss for Q2 2025 was $13.3 million, nearly half of the $23.8 million loss in Q2 2024.
Product gross margin improved significantly to 72% in Q2 2025 from 45% in Q2 2024 due to sales shifts to more profitable products.
Q2 2025 revenue was $15.3 million, up from $8 million in Q2 2024, driven by Pharma Biocatalysis customer manufacturing schedules and clinical trial progression.
Research and development expenses increased to $13.8 million from $11.4 million, mainly due to higher headcount and reclassification of employees.
Revenue variability expected to continue short term due to lumpiness in Pharma Biocatalysis orders but will be mitigated as ECO revenues grow.
Selling, general and administrative expenses decreased to $12.39 million from $15.7 million, driven by lower stock-based compensation, legal expenses, and outside services.
Strong cash position with $66.3 million in cash, cash equivalents, and investments, expected to fund operations through Q1 2027.

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.