On August 14, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported its financial results for the quarter ended June 30, 2026, and provided a corporate update highlighting clinical progress for Plinabulin and the Company’s leadership transition.

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"The second quarter was marked by additional clinical and scientific support for continuing Plinabulin development," said Min Qiu, Chief Executive Officer of BeyondSpring. "Updated Phase 2 data presented at ASCO (Free ASCO Whitepaper) 2026 continued to demonstrate an encouraging 58% two-year OS rate in metastatic NSCLC patients whose disease progressed after first-line immune checkpoint inhibitor (ICI) therapy. This encouraging prospective OS data strengthens our conviction in the DUBLIN-4 study, a confirmatory Phase 3 study with OS as the primary endpoint in non-squamous NSCLC post-ICI with no driver mutation, a severe unmet medical need with docetaxel as the standard of care. With our leadership transition now effective, our priorities are clear: advancing the regulatory, operational and financing preparations necessary to initiate DUBLIN-4."

Mr. Qiu continued, "The DUBLIN-4 study represents our lead clinical development priority for a potential path toward future regulatory submissions. We believe the published DUBLIN-3 results in The Lancet Respiratory Medicine, recent ASCO (Free ASCO Whitepaper) 2026 clinical data, and the AACR (Free AACR Whitepaper) 2026 ADC combination findings collectively reinforce Plinabulin’s differentiated potential as a potent dendritic cell maturation agent to improve survival benefits while mitigating treatment-limiting high-grade neutropenia in NSCLC and beyond."

Recent Clinical and Corporate Highlights of Plinabulin

ASCO 2026 (Phase 2 data): Plinabulin combination demonstrated durable response and survival benefit in post-ICI metastatic NSCLC

Presented updated efficacy and safety results from the investigator-initiated Phase 2 303 Study evaluating Plinabulin/docetaxel and pembrolizumab in 47 patients with metastatic NSCLC and acquired resistance following first-line immune checkpoint inhibitor therapy.
As of the February 28, 2026 data cutoff, median progression-free survival was 7.0 months, median duration of response was 9.3 months, disease control rate was 79.5%, and confirmed objective response rate was 18.2%.
The 12-month and 24-month overall survival rates were 78.1% and 58.0%, respectively, with median overall survival not reached after a median follow-up of 28.8 months.
The combination demonstrated a generally manageable safety profile and evidence of immune activation, including increased frequencies of activated CD4+ and CD8+ T cells as well as higher white blood cell, neutrophil, and platelet counts.
AACR 2026 (preclinical data): Improved complete response rate, overall survival and tolerability of certain antibody-drug-conjugates (ADCs)

Presented preclinical data showing that Plinabulin in combination with the approved topoisomerase I inhibitor (TOP1)-based ADCs enhanced complete tumor regression rates and/or survival of TROP-2-directed datopotamab deruxtecan or HER2-directed trastuzumab deruxtecan, with or without PD-1/PD-L1 inhibition.
Plinabulin improved tolerability in the preclinical combination models and increased the CD8+ T-cell-to-Treg ratio, supporting an immune-mediated mechanism for the enhanced anticancer activity.
The findings support Plinabulin’s potential to address limited durability and treatment-limiting hematologic toxicity associated with ADC-based therapy and broaden the scientific rationale for future ADC combination studies.
DUBLIN-4 Confirmatory Phase 3 Program

DUBLIN-4 is the Company’s planned, randomized, double-blind, 442-patient confirmatory Phase 3 study of Plinabulin plus docetaxel in non-squamous, EGFR wild-type NSCLC patients who have progressed on PD-1/PD-L1 inhibitor-containing therapies.
The program is designed to prospectively confirm the survival and tolerability benefits observed in the DUBLIN-3 Phase 3 study, which was published in The Lancet Respiratory Medicine in 2024.
BeyondSpring Leadership Transition and Corporate Execution

Effective July 1, 2026, Min Qiu was appointed Chief Executive Officer with a mandate focused on advancing DUBLIN-4, extending Plinabulin’s scientific optionality, and building BeyondSpring’s global partner and investor base. Dr. Jiangwen (Jen) Majeti was appointed Vice Chairman, strengthening Board-level governance continuity and strategic depth. Na Li was appointed Chief Financial Officer to support financial discipline, public-company reporting, financing activities, and capital markets engagement.
Dr. Lan Huang remains Co-Founder and Chairman of BeyondSpring, providing strategic vision and Board leadership, while devoting her executive focus to SEED Therapeutics, where she serves as Co-Founder, Chairman, and Chief Executive Officer.
Second Quarter Financial Results

Continuing operations:

Research and development (R&D) expenses were $1.0 million for the quarter ended June 30, 2026, compared to $1.0 million for the quarter ended June 30, 2025. R&D expenses remained relatively flat, as a $0.3 million increase in drug manufacturing activities to prepare for potential future study initiation was substantially offset by lower patent-related professional services and personnel expenses.
General and administrative (G&A) expenses were $0.8 million for the quarter ended June 30, 2026, compared to $0.9 million for the quarter ended June 30, 2025. The $0.1 million decrease was primarily due to lower legal and consulting expenses related to accounting advisory and business development.
Net loss was $1.8 million for the quarter ended June 30, 2026, compared to $1.9 million for the quarter ended June 30, 2025.
Cash, cash equivalents, and short-term investments were $6.5 million as of June 30, 2026, compared to $12.6 million as of December 31, 2025.
Year-to-Date Financial Results

Continuing operations:

Research and development (R&D) expenses were $2.0 million for the six months ended June 30, 2026, compared to $1.9 million for the six months ended June 30, 2025. The $0.1 million increase was primarily due to higher drug manufacturing expenses, partially offset by lower patent-related professional services, regulatory filing advisory and personnel expenses.
General and administrative (G&A) expenses were $1.9 million for the six months ended June 30, 2026, compared to $2.7 million for the six months ended June 30, 2025. The $0.8 million decrease was primarily due to lower incentive compensation and share-based compensation and lower professional services expenses related to legal advisory matters.
Net loss was $4.1 million for the six months ended June 30, 2026, compared to $4.5 million for the six months ended June 30, 2025.

(Press release, BeyondSpring Pharmaceuticals, AUG 14, 2026, View Source [SID1234670120])

On August 14, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported advances across its Actimab-A program, including recently acquired patents adding to a broad suite of IP, and expansion of the Company’s manufacturing capacity, as the program approaches clinical milestones from the fourth quarter of 2026 and into 2027. The Company also provided an update on the status of its NYSE American listing.

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Actiniums holds a broad IP portfolio covering the manufacture of Actimab-A, as well as its use alone and in combination with other therapies in the treatment of myeloid hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in addition to solid tumor cancers via targeting of tumor-resident myeloid-derived suppressor cells (MDSCs). Actimab-A patent portfolio activity in the last twelve months:

Actimab-A targeting of myeloid-derived suppressor cells (MDSCs) for the treatment of solid tumors: Two United States patents issued — US 12,491,274 for the treatment of sarcoma, expiring 15 October 2043, and US 12,539,340 for the treatment of solid tumors generally, alone or with checkpoint therapy, expiring 31 October 2043. Together they extend the anti-CD33 franchise beyond hematologic malignancy into solid tumors by targeting the immunosuppressive myeloid cells of the tumor microenvironment rather than the tumor cells themselves. Applications remain pending in the United States, Canada and Europe.

Actimab-A treatment of low peripheral blast AML: US 12,410,249 issued, with a term to 12 October 2039, and Canadian application 3,022,802 entered pre-grant status, with a term to 25 May 2037. Additional patents in this family have already issued in the United States and Japan; applications remain pending in the United States and Europe.

Actimab-A venetoclax (BCL-2 inhibitor) combination therapy for the treatment of AML: Canadian application 3,059,752 entered pre-grant status, with a term to 26 April 2038, covering the use of Actimab-A together with venetoclax in AML. Three patents have already issued in the United States and one in Mexico; applications remain pending in the United States, Europe, Japan and China.

Actimab-A CLAG-M combination therapy for the treatment of AML: Canadian application 3,087,346 was allowed, with a term to 8 January 2039. A counterpart patent has already issued in Japan; applications remain pending in the United States, Europe and Japan.

Actinium has amended its Investigational New Drug (IND) application to add an additional manufacturer. The additional manufacturer will supply studies conducted under the Company’s Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), together with additional Company-sponsored studies, which carry clinical milestones expected from the second half of 2026 and throughout 2027. Establishing an additional manufacturing source is intended to expand capacity and supply flexibility as Actimab-A advances into a broader set of studies across hematologic malignancies and solid tumors.

NYSE American Listing Update

Actinium also announced today that NYSE Regulation has accepted the Company’s plan submitted June 18, 2026, to regain compliance with the NYSE American continued listing standards and granted the Company a plan period through November 27, 2027 (the "Plan Period") – the maximum period available under Section 1009 of the NYSE American Company Guide (the "Company Guide").

The Company’s common stock continues to be listed and traded on NYSE American under the symbol ATNM during the Plan Period, subject to the Company’s compliance with the terms of the compliance plan and the other continued listing standards of the NYSE American Company Guide. NYSE Regulation staff will periodically review the Company’s compliance with the initiatives outlined in the compliance plan.

As previously disclosed, the Company is not currently in compliance with Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide, and its listing is being continued pursuant to an extension through November 27, 2027.

(Press release, Actinium Pharmaceuticals, AUG 14, 2026, View Source [SID1234670119])

On August 13, 2026 Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, reported financial results for the quarter ended June 30, 2026.

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Second Quarter 2026 Highlights

Net product revenue of $12.0 million, an increase of 32.9% compared to $9.0 million in the prior-year period.
Gross margin of 80%, compared to 71% in the prior-year period, an improvement of approximately 920 basis points, reflecting the lower Ameluz cost structure established following the closing of the strategic transaction with Biofrontera AG in October 2025 (the "Strategic Transaction").
Net loss of $0.6 million, or $(0.05) per share, compared to a net loss of $5.3 million, or $(0.57) per share, in the prior-year period.
Adjusted EBITDA of $(0.2) million, compared to $(5.1) million in the prior-year period, an improvement of approximately $5.0 million.
First Half 2026 Highlights

Net product revenue of $22.1 million, an increase of 25.4%, from $17.6 million in the prior-year period.
Gross margin of 80%, compared to 67% in the prior-year period.
Net loss of $5.4 million, or $(0.44) per share, compared to a net loss of $9.5 million, or $(1.05) per share, in the prior-year period.
Adjusted EBITDA of $(3.7) million, compared to $(9.5) million in the prior-year period.
Cash used in operating activities of $1.7 million, compared to $7.2 million in the prior-year period, a reduction of approximately 76%.
Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: "This was the strongest operating Q2 and H1 in the Company’s history as a standalone business, and it reflects work that has been underway for more than a year – a restructured cost base, a more disciplined commercial organization, and steady growth in Ameluz demand. We are seeing the pace of reorders accelerate, which reflects strength of underlying demand. We also continue to be encouraged by the new indications advancing in our development pipeline, including superficial basal cell carcinoma (sBCC), for which we have a PDUFA date in late September of this year and expect to launch in Q1 of 2027. If approved for sBCC, Ameluz will be the first PDT in the United States approved for the treatment of cancerous tumors. Our clinical pipeline also includes recent positive Phase III results in AK on the extremities/neck/trunk and encouraging Phase 2B data in acne that we believe can expand the reach of our PDT platform in the years ahead."

"We see positive effects from the Strategic Transaction and our overall cost management, the impacts of which are now visible in the Q2 results," said Fred Leffler, Chief Financial Officer. "Gross margin improved roughly 920 basis points year over year, operating expenses declined 11%, and we brought Adjusted EBITDA to within $0.2 million of breakeven. Operating cash used in the first half of 2026 was $1.7 million, down from $7.2 million a year ago. That figure includes a $3.7 million paydown of related party payables connected to the Strategic Transaction. Excluding that item, changes in working capital would have been a net source of cash in the first half. We continue to make progress towards cash flow breakeven in 2026."

Second Quarter 2026 Financial Results

Net product revenue for the second quarter of 2026 was $12.0 million, an increase of $3.0 million, or 32.9%, from $9.0 million in the second quarter of 2025. While the revenue increase was partly due a price increase, unit volume grew, which was partly driven by the impact of order timing from certain customers in anticipation of potential supply restrictions resulting from an exclusion order by the International Trade Commission (ITC) related to our RhodoLED XL lamp that took effect on July 7, 2026, impacting the timing of orders rather than total demand. We are pursuing a remediation plan to allow us to begin selling a modified version of our XL lamp. Because the substantial majority of our installed lamp base is unaffected by the ITC order, any shift in orders to the second quarter from the second half of the year is not expected to impact our full-year 2026 revenue goals.

Cost of revenues was $2.4 million, compared to $2.6 million in the prior-year period, producing gross profit of $9.6 million and a gross margin of 80%, compared to gross profit of $6.4 million and a gross margin of 71% in the second quarter of 2025. The improvement was driven principally by the transition from the prior transfer pricing arrangement to a cost structure comprising Ameluz direct cost plus a 12% earnout on net revenue.

Selling, general and administrative expenses were $9.7 million, compared to $10.6 million in the prior-year quarter, a decrease of $0.9 million, driven primarily by a $2.1 million reduction in litigation-related legal fees, partially offset by planned investment in the commercial organization and costs associated with the manufacturing and regulatory functions established following the Strategic Transaction.

Research and development expenses were $0.4 million, compared to $0.9 million in the prior-year quarter, reflecting the substantial completion of clinical trials.

Net loss for the second quarter was $0.6 million, or $(0.05) per share, compared to a net loss of $5.3 million, or $(0.57) per share, for the prior-year quarter. Adjusted EBITDA, a non-GAAP measure reconciled below, was $(0.2) million, compared to $(5.1) million in the prior-year period.

First Half 2026 Financial Results

Net product revenue for the six months ended June 30, 2026 was $22.1 million, an increase of $4.5 million, or 25.4%, from $17.6 million in the first six months of 2025. The increase reflects Ameluz unit volume growth and the full-period effect of the list price increase implemented in the fourth quarter of 2025.

Cost of revenues was $4.5 million, compared to $5.9 million in the prior-year period, producing gross profit of $17.6 million and gross margin of 80%, compared to gross profit of $11.7 million and gross margin of 67% in the prior-year period. The improvement was driven principally by the same transition in Ameluz cost structure described above.

Selling, general and administrative expenses were $20.7 million, compared to $19.3 million in the prior-year period, an increase of $1.4 million, driven primarily by planned investment and lower turnover in the commercial organization and costs associated with the manufacturing and regulatory functions established following the Strategic Transaction, partially offset by lower litigation-related legal fees.

Research and development expenses were $1.3 million, compared to $2.1 million, reflecting the substantial completion of clinical trials.

Net loss was $5.4 million, or $(0.44) per share, compared to a net loss of $9.5 million, or $(1.05) per share, in the prior-year period. Adjusted EBITDA was $(3.7) million, compared to $(9.5) million in the prior-year period.

Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the second quarters and first haves of 2026 and 2025.

Balance Sheet and Cash Flow

Cash and cash equivalents were $4.7 million as of June 30, 2026, compared to $6.4 million as of December 31, 2025. Cash used in operating activities for the six months ended June 30, 2026 was $1.7 million, compared to $7.2 million in the prior-year period.

Total liabilities were $18.1 million as of June 30, 2026, essentially unchanged from $18.1 million at December 31, 2025. The Company’s outstanding indebtedness as of June 30, 2026 consisted of $4.6 million of convertible notes, net, maturing in November 2027. The Company has no bank or other term debt. Total stockholders’ equity was $6.0 million as of June 30, 2026, compared to $10.5 million at December 31, 2025.

(Press release, Biofrontera, AUG 13, 2026, View Source [SID1234671262])

On August 13, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"Our patient focus has driven achievement of important milestones and strong demand for our TransCon products as Ascendis continues to transform into a leading biopharma company," said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. "This focus on addressing unmet medical needs continues to drive a growing pipeline of innovative TransCon programs, further positioning Ascendis for durable, long-term growth in rare endocrine diseases and new therapeutic areas."

(Press release, Ascendis Pharma, AUG 13, 2026, https://investors.ascendispharma.com/news-releases/news-release-details/ascendis-pharma-reports-second-quarter-2026-financial-results?utm_source=chatgpt.com [SID1234670719])

On August 13, 2026 Evotec reported Half-Year Interim Report 2026.

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(Presentation, Evotec, AUG 13, 2026, View Source [SID1234670282])