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SELLAS Life Sciences Announces Independent Data Monitoring Committee Periodic Review and Positive Recommendation to Continue Pivotal Phase 3 REGAL Trial of GPS in AML Without Modification

On August 7, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the Independent Data Monitoring Committee (IDMC) has completed a pre-specified analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), and has issued a positive recommendation to continue the trial without modification (Press release, Sellas Life Sciences, AUG 7, 2025, View Source [SID1234654999]).

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The IDMC concluded that the risk-benefit profile of GPS supports continued evaluation under the current study protocol. No safety concerns were identified, and available efficacy data were consistent with expectations for continued trial conduct.

The study completed enrollment in April 2024, with a total of 126 patients randomized. Study sites in the U.S. and Europe accounted for approximately 75% of patients enrolled, with the U.S.-based sites representing the highest enrolling country.

The Phase 3 REGAL trial is a survival-driven study, and the next and final analysis will be triggered once 80 events (deaths) have occurred, further determining the potential of GPS in addressing the needs of AML patients. As of the time of this IDMC review, that threshold has not yet been reached.

About Phase 3 REGAL Trial

REGAL (NCT04229979) is a Phase 3 randomized registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses.

Replimune Reports Fiscal First Quarter 2026 Financial Results and Provides Corporate Update

On August 7, 2025 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal first quarter ended June 30, 2025 and provided a business update (Press release, Replimune, AUG 7, 2025, View Source [SID1234654998]).

The Company announced on July 22, 2025 that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for the RP1 BLA in advanced melanoma.

"Based on the compelling clinical data and safety profile generated to date with RP1 in the IGNYTE study, the melanoma community, including clinical experts and patients, strongly believe RP1 should be made available to patients that have few remaining treatment options as soon as possible. We are committed to finding an expeditious path forward with the FDA," said Sushil Patel, Ph.D., CEO of Replimune.

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

The global Phase 3 trial, IGNYTE-3 assessing RP1 in combination with nivolumab is ongoing. The trial is expected to enroll approximately 400 patients across 100 sites globally and is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival and key secondary endpoints are progression free survival and overall response rate. Following the CRL, the Company anticipates discussing the design of this trial with the FDA.

RP1 (vusolimogene oderparepvec)

RP1 + nivolumab in non-melanoma skin cancers
The Company continues to evaluate the potential of RP1 in merkel cell carcinoma, basal cell carcinoma and angiosarcoma, and locally advanced cutaneous squamous cell carcinoma, including anti-PD1-failed patients, in the ongoing IGNYTE trial cohort.
RP1 in skin cancer organ transplant patients
The Company continues to evaluate RP1 as monotherapy in cutaneous squamous cell carcinoma patients with organ transplants in its Phase 2 ARTACUS trial. Data to-date has shown RP1 to be well tolerated with no cases of RP1-related allograft rejection observed. The overall response rate was 34.6% with a duration of response of 24 months in 61% of patients in the intent-to-treat population. ARTACUS continues to enroll patients.
RP2

RP2 in uveal melanoma
The registration-directed Phase 2/3 REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling. The clinical trial is expected to enroll approximately 280 patients with metastatic uveal melanoma who are immune checkpoint inhibitor-naïve and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate.
RP2 in hepatocellular carcinoma (HCC)
The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD1/PD-L1 progressed HCC is currently enrolling with data anticipated in the first half of 2026. This trial will evaluate RP2 combined with the second-line therapy of atezolizumab and bevacizumab and is expected to enroll 30 patients. The trial is being conducted under a collaboration and supply agreement with Roche.
RP2 in biliary tract cancer (BTC)
As previously reported, the Company expects to dose its first patient in the second half of 2025 in a cohort evaluating RP2 in patients with biliary tract cancer. This trial will evaluate RP2 combined with durvalumab and is expected to enroll 30 patients.
Financial Highlights

Cash Position: As of June 30, 2025, cash, cash equivalents and short-term investments were $403.3 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.
Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of June 30, 2025 will enable the Company to fund operations into the fourth quarter of 2026 which includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.

R&D Expenses: Research and development expenses were $57.8 million for the fiscal first quarter and $43.0 million for the fiscal first quarter ended June 30, 2024. This increase was primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch of RP1, as well as medical affairs and consulting costs. Research and development expenses included $4.7 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2025.
S,G&A Expenses: Selling, general and administrative expenses were $32.6 million for the fiscal first quarter ended June 30, 2025, as compared to $14.4 million for the fiscal first quarter ended June 30, 2024. Selling, general and administrative expenses included $4.1 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2025.
Net Loss: Net loss was $86.7 million for the fiscal first quarter ended June 30, 2025 and $53.8 million for the fiscal first quarter ended June 30, 2024.
About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

Relay Therapeutics Reports Second Quarter 2025 Financial Results and Corporate Updates

On August 7, 2025 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing life-changing therapies for patients living with cancer and genetic disease, reported second quarter 2025 financial results and corporate updates (Press release, Relay Therapeutics, AUG 7, 2025, View Source [SID1234654997]).

"It is an exciting time for Relay as we have initiated our Phase 3 ReDiscover-2 Trial, studying RLY-2608 + fulvestrant versus capivasertib + fulvestrant in HR+/HER2- breast cancer patients," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "The interim data from our Phase 1 trial have remained consistent with previously announced data, showing what we believe are the potential benefits of RLY-2608 compared to historical standard of care data for both safety and efficacy. It is our company’s top priority to enroll patients and execute this trial, and hopefully deliver a novel medicine in the post-CDK4/6 breast cancer setting where there is a large unmet medical need."

RLY-2608 Highlights

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Presented updated interim clinical data from the open-label Phase 1b study for RLY-2608 + fulvestrant at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, showing data consistent with previous disclosures:
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10.3-month median progression-free survival (PFS) and 39% objective response rate (ORR) across all patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer
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For 2L patients
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11.0-month median PFS in second line
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median PFS was 18.4 months for patients with kinase mutations and 8.5 months for patients with non-kinase mutations
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42% confirmed ORR across 2L patients with measurable disease
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Safety profile remained strong with mostly low-grade treatment-related adverse events
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12.5-month median follow-up
•
Breast Cancer Clinical Trial Execution
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Initiated Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
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Continued advancement of the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib or ribociclib
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Vascular Malformations Clinical Trial
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Continued execution of ongoing Phase 1 vascular malformations clinical trial

Second Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2025, cash, cash equivalents and investments totaled $656.8 million, as compared to $710.4 million as of March 31, 2025. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

Revenue: Revenue was $0.7 million for the second quarter of 2025, as compared to $0 for the second quarter of 2024.

R&D Expenses: Research and development expenses were $63.9 million for the second quarter of 2025, as compared to $92.0 million for the second quarter of 2024. The decrease of $28.1 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the license agreement with Elevar Therapeutics, Inc. in December 2024.

G&A Expenses: General and administrative expenses were $13.6 million for the second quarter of 2025, as compared to $20.1 million for the second quarter of 2024. The decrease of $6.5 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.

Net Loss: Net loss was $70.4 million for the second quarter of 2025, or a net loss per share of $0.41, as compared to a net loss of $92.2 million for the second quarter of 2024, or a net loss per share of $0.69.

RAPT Therapeutics Reports Second Quarter 2025 Financial Results

On August 7, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company"), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported financial results for the second quarter and six months ended June 30, 2025 (Press release, RAPT Therapeutics, AUG 7, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-second-quarter-2025-financial-results [SID1234654996]).

"The first half of 2025 has been productive, with several key achievements setting the stage for important catalysts anticipated in the second half of the year," said Brian Wong, President and CEO of RAPT. "We strengthened our team with the addition of Jessica Savage, an experienced drug developer in the food allergy space, and our board of directors with the appointments of industry veterans Drs. Scott Braunstein and Ashley Dombkowski. We have been focused on execution and as we enter the second half of the year we remain on track to initiate our Phase 2b trial of RPT904 in food allergy later this year. We also remain on track with our partner, Jemincare, to report topline results from Jemincare’s Phase 2 trials of RPT904 in CSU and asthma in the second half of this year. Lastly, we continue to advance our next-generation CCR4 pipeline and we see the diversity of our pipeline as a differentiating strength."

Financial Results for the Second Quarter and Six Months Ended June 30, 2025

Please note: All share amounts and per share amounts in this press release have been adjusted to reflect the 1-for-8 reverse split of the Company’s common stock, effected on June 16, 2025.

Second Quarter Ended June 30, 2025

Net loss for the second quarter of 2025 was $17.6 million, compared to $27.7 million for the second quarter of 2024.

Research and development expenses for the second quarter of 2025 were $12.3 million, compared to $22.6 million for the second quarter of 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in costs related to development of RPT904 and early-stage programs.

General and administrative expenses for the second quarter of 2025 were $7.2 million, compared to $6.7 million for the same period in 2024. The increase in general and administrative expenses was primarily due to increases in consulting costs and facilities costs.

Six Months Ended June 30, 2025

Net loss for the six months ended June 30, 2025 was $34.8 million, compared to $58.2 million for the second quarter of 2024.

Research and development expenses for the six months ended June 30, 2025 were $24.4 million, compared to $47.4 million for the same period in 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in costs related to development of RPT904 and early-stage programs.

General and administrative expenses for each of the six months ended June 30, 2025 and 2024 were $14.4 million. General and administrative expenses were flat primarily due to decreased costs for personnel offset by increases in facilities costs.

As of June 30, 2025, the Company had cash and cash equivalents and marketable securities of $168.9 million.

Puma Biotechnology Reports Second Quarter Financial Results

On August 7, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2025 (Press release, Puma Biotechnology, AUG 7, 2025, View Source [SID1234654995]). Unless otherwise stated, all comparisons are for the second quarter 2025 compared to the second quarter 2024.

Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the second quarter of 2025 was $49.2 million, compared to product revenue, net of $44.4 million in the second quarter of 2024. Product revenue, net in the first six months of 2025 was $92.3 million, compared to $84.6 million in the first six months of 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $5.9 million, or $0.12 per basic and diluted share, for the second quarter of 2025, compared to a net loss of $4.5 million, or $0.09 per share, for the second quarter of 2024. Net income for the first six months of 2025 was $8.8 million, or $0.18 per basic and diluted share, compared to a net loss of $9.3 million, or $0.19 per share, for the first six months of 2024.

Non-GAAP adjusted net income was $7.5 million, or $0.15 per basic and diluted share, for the second quarter of 2025, compared to a non-GAAP adjusted net loss of $2.5 million, or $0.05 per share, for the second quarter of 2024. Non-GAAP adjusted net income for the first six months of 2025 was $12.4 million, or $0.25 per basic and diluted share, compared to a non-GAAP adjusted net loss of $4.9 million, or $0.10 per share, for the first six months of 2024. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the second quarter of 2025 was $14.1 million, compared to $1.0 million in the second quarter of 2024. Net cash provided by operating activities for the first six months of 2025 was $17.7 million, compared to net cash provided by operating activities of $12.3 million in the first six months of 2024. At June 30, 2025, Puma had cash, cash equivalents and marketable securities of $96.0 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.

"We are pleased to report both the growth in revenues in the second quarter as well as the positive net income for the quarter," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We are pleased to see the year over year growth being driven by NERLYNX demand and we are also pleased with the progress in the clinical development of alisertib in both chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer as well."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2025) and (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (Q4 2025)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the second quarter ended June 30, 2025, total revenue was $52.4 million, of which $49.2 million was net product revenue and $3.2 million was royalty revenue. This compares to total revenue for the second quarter of 2024 of $47.1 million, of which $44.4 million was net product revenue and $2.7 million was royalty revenue. For the first six months of 2025, total revenue was $98.4 million, of which $92.3 million was net product revenue and $6.1 million was royalty revenue. This compares to total revenue for the first six months of 2024 of $90.8 million, of which $84.6 million was net product revenue and $6.2 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $45.8 million for the second quarter of 2025, compared to $49.3 million for the second quarter of 2024. Operating costs and expenses in the first six months of 2025 were $87.8 million, compared to $95.3 million in the first six months of 2024.

Cost of Sales

Cost of sales was $12.3 million for the second quarter of 2025, compared to $10.7 million for the second quarter of 2024. Cost of sales was $22.9 million for the first six months of 2025, compared to $21.4 million for the first six months of 2024. The increase in the first six months of 2025 was due to higher royalty expense and product costs resulting from increased worldwide net sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $18.0 million for the second quarter of 2025, compared to $25.0 million for the second quarter of 2024. SG&A expenses for the first six months of 2025 were $35.6 million, compared to $46.7 million for the first six months of 2024. The $11.1 million year-over-year decrease for the first six months resulted primarily from legal fees associated with the AstraZeneca litigation in the prior year.

Research and Development Expenses

Research and development (R&D) expenses were $15.5 million for the second quarter of 2025, compared to $13.6 million for the second quarter of 2024. R&D expenses for the first six months of 2025 were $29.3 million, compared to $27.2 million for the first six months of 2024. The $2.1 million year-over-year increase for the first six months resulted primarily from increased alisertib study activity.

Total Other Income (Expenses)

Total other income/expenses were $0.4 million for the second quarter of 2025, compared to total other expenses of $2.0 million for the second quarter of 2024. Total other income/expenses were $1.2 million for the first six months of 2025, compared to total other expenses of $4.2 million for the first six months of 2024. The $3.0 million year-over-year decrease in other expenses for the first six months of 2025 was primarily due to a lower debt balance as we continue to pay down our principal.

Third Quarter and Full Year 2025 Financial Outlook

Third Quarter 2025

Full Year 2025 (current)

Full Year 2025 (previous)

Net Product Revenue

$46-$48 million

$192–$198 million

Royalty Revenue

$2-$3 million

$20–$24 million

License Revenue

$0 million

Total Revenue $48-$51 million $212–$222 million $212–$222 million
Net Income/(Loss)*

$2-$4 million

$23–$28 million

Gross to Net Adjustment

22.5%–23.5%

21.5%–22.0%

20.5%–21.5%

*The outlook above does not include any adjustments for tax valuation allowance.

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2025 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, August 7, 2025. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.