On August 11, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the second quarter 2025 and provided an update on the company’s recent developments (Press release, FibroGen, AUG 11, 2025, View Source [SID1234655066]).

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"In the second quarter, we continued to make steadfast progress in advancing our clinical pipeline. Trial initiation activities for the Phase 2 monotherapy trial of FG-3246 are progressing, and we expect to start the trial in the third quarter of 2025," said Thane Wettig, Chief Executive Officer, FibroGen. "We are also excited about reaching agreement with the FDA to advance roxadustat towards a pivotal Phase 3 trial in LR-MDS in patients with high transfusion burden, an area with high unmet need. We are working diligently towards finalizing the Phase 3 trial protocol and plan to submit to the FDA in the fourth quarter of 2025. Concurrently, we will be exploring options for either internal development or partnership opportunities. With the expected close of the FibroGen China sale in the near term, extending our cash runway into 2028, we are strongly positioned to bring significant value for both patients and shareholders."

Recent Developments and Key Highlights of Second Quarter 2025:

Sale of FibroGen China to AstraZeneca now expected to be for a total consideration of approximately $210 million, representing an enterprise value of $85 million plus estimated net cash held in China at closing of approximately $125 million. The transaction is expected to close in the third quarter of 2025.
Upon closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure.
FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas.
Appointed Michael Kauffman, M.D., Ph.D. to the Board of Directors.
Had a positive Type-C meeting with the FDA in July 2025, where the Company reached agreement with the FDA on important design elements for a pivotal Phase 3 trial for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden.
Upcoming Milestones:

FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)

Trial initiation activities for the Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC remain ongoing, with an expected trial start in the third quarter of 2025 upon the close of the sale of FibroGen China. The trial will also assess the diagnostic performance of FG-3180 to determine the potential correlation between CD46 expression and response to FG-3246.
Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC expected in the fourth quarter of 2025. The results will include data on FG-3180.
Roxadustat

FibroGen intends to file the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden in the fourth quarter of 2025.
Financial:

Total revenue from continuing operations for the second quarter of 2025 was $1.3 million, as compared to $1.0 million for the second quarter of 2024.
Net loss from continuing operations for the second quarter of 2025 was $13.7 million, or $3.38 net loss per basic and diluted share, compared to a net loss of $47.1 million, or $11.79 net loss per basic and diluted share, one year ago.
On June 30, 2025, FibroGen reported $23.5 million in cash, cash equivalents and accounts receivable in the U.S. and $142.1 million in total consolidated cash, cash equivalents and accounts receivable.
Upon closing of the announced sale of FibroGen China, the Company expects its cash, cash equivalents and accounts receivable to be sufficient to fund our operating plans into 2028.
Conference Call and Webcast Presentation
The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.

About FG-3246
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.

FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The initiation of the Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer is anticipated in the third quarter of 2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

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.

On August 11, 2025 Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the quarter ended June 30, 2025, and provided a business update (Press release, Azitra, AUG 11, 2025, View Source [SID1234655065]).

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Q2 2025 and Recent Business Highlights

Announced initial safety results and 50% enrollment of the Phase 1b clinical trial of the ATR-12 program in Netherton syndrome, demonstrating a promising safety profile
Announced acceptance of poster detailing the Phase 1/2 clinical trial of the ATR-04 program in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Entered into a purchase agreement for up to $20 million to establish an equitly line of credit in partnership with institutional investor Alumni Capital LP, to fund clinical pipeline
"The first half of 2025 was a vital period for Azitra as we hit a key milestone in our first-in-class, precision, live biotherapeutic candidates designed for major undertreated dermatological diseases," said Francisco Salva, CEO of Azitra. "For ATR-12, our lead program targeting the rare, chronic and devastating Netherton syndrome, we announced promising safety data in the first five patients dosed with ATR12-351, and we believe this novel approach has potential to be life-changing for these patients. Netherton syndrome has a high unmet need with no approved treatment options."

Mr. Salva continued: "We also announced the design of our Phase 1/2 trial with our ATR-04 program at ASCO (Free ASCO Whitepaper), which is investigating a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFRi-associated rash. EGFRi-associated rash is a dermatologic toxicity that often accompanies EGFRi treatments for cancer, impacting approximately 150,000 patients in the United States annually. We expect to dose the first patient in our Phase 1/2 trial in the third quarter of this year."

Mr. Salva concluded: "The remainder of 2025 is anticipated to be a milestone-rich period for Azitra during which we look forward to showcasing the potential of ATR-12 and ATR-04, as well as our unique, proprietary platform for delivering engineered proteins using topical live biotherapeutic products."

Pipeline and Anticipated Milestones

Q3 2025: First patient to be dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04
Q1 2026: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients
Financial Results for the Quarter Ended June 30, 2025

Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2025, were $1.4 million compared to $1.1 million for the comparable period in 2024.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2025, were $1.5 million compared to $1.5 million for the comparable period in 2024.
Net Loss was $2.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the comparable period in 2024.
Cash and cash equivalents: As of June 30, 2025, Azitra had cash and cash equivalents of $1.0 million.

On August 11, 2025 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the second quarter 2025 and business updates (Press release, Atara Biotherapeutics, AUG 11, 2025, View Source [SID1234655064]).

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Tabelecleucel (tab-cel or Ebvallo) for Post-Transplant Lymphoproliferative Disease (PTLD)

The U.S. Food and Drug Administration (FDA) has accepted the filing of Atara’s Biologics License Application (BLA) for tabelecleucel (tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. There are no FDA approved therapies in this treatment setting.

The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.

In July, the Company completed transferring substantially all operational activities and associated costs related to tab-cel to Pierre Fabre Laboratories. The sponsorship of the BLA continues to be maintained by the Company.

Corporate Updates

Strategic Options Evaluation: In April 2025, the Company temporarily paused its review of strategic alternatives pending resubmission of the tab-cel BLA. The Company has resumed its evaluation of strategic options following the resubmission of the tab-cel BLA. These options may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, licensing, sale of assets, or other strategic transactions. It is possible that Atara may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, will not be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated.

Financial Update:

Second Quarter 2025 Financial Results:

Cash, cash equivalents and short-term investments as of June 30, 2025, totaled $22.3 million, as compared to $13.8 million as of March 31, 2025
Net cash used in operating activities was $7.4 million for the second quarter 2025, as compared to $10.6 million in the same period in 2024
Total revenues were $17.6 million for the second quarter 2025, as compared to $28.6 million for the same period in 2024. Total revenues decreased by $11.0 million year-over-year, primarily due to the accelerated recognition of deferred revenue in the first quarter 2025 following the transition of manufacturing responsibilities to Pierre Fabre Laboratories. As a result, less deferred revenue remained available for recognition in the comparative period.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $3.0 million for the second quarter 2025, as compared to $7.7 million for the same period in 2024
Research and development expenses were $7.3 million for the second quarter 2025, as compared to $33.3 million for the same period in 2024
Research and development expenses include $0.7 million of non-cash stock-based compensation expenses for the second quarter 2025, as compared to $3.3 million for the same period in 2024
General and administrative expenses were $6.5 million for the second quarter 2025, as compared to $8.9 million for the same period in 2024
General and administrative expenses include $2.1 million of non-cash stock-based compensation expenses for the second quarter 2025, as compared to $3.0 million for the same period in 2024
Atara reported net income of $2.4 million, or $0.20 basic earnings per share and $0.19 diluted earnings per share for the second quarter 2025. The net income position is due to the acceleration of revenue recognized following the transition of tab-cel development and safety responsibilities to Pierre Fabre Laboratories in July 2025
2025 Outlook and Cash Runway:

Under its commercialization agreement with Pierre Fabre Medicament, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA. In addition, Atara will be eligible to receive double-digit tiered royalties as a percentage of net sales and milestones related to commercial sales of EBVALLO.
We anticipate the full-year 2025 operating expenses will decrease by at least 60% compared to 2024, driven by the transition of substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories as well as the implementation of operational efficiencies in the first half of the year.
Atara projects that cash, cash equivalents and short-term investments as of June 30, 2025, combined with the proceeds of the milestone payment upon tab-cel BLA approval under its commercialization agreement with Pierre Fabre Medicament, will provide significant cash runway and flexibility for the company to execute on its strategic priorities.

On August 11, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the second quarter ended June 30, 2025, and highlighted recent Company progress (Press release, ArriVent Biopharma, AUG 11, 2025, View Source [SID1234655063]).

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"Firmonertinib continues to advance with strong momentum toward registration, demonstrating promise across all key EGFR-mutant NSCLC populations including underrepresented and difficult to treat patient types," said Bing Yao, CEO of ArriVent. "The positive interim PACC Phase 1b data build on our clinical progress in Exon 20 insertion mutations and further validate the therapeutic potential of firmonertinib across EGFR mutations. We look forward to presenting final PACC Phase 1b data at the World Conference on Lung Cancer in September, and we anticipate enrolling the first patient in our global pivotal Phase 3 PACC study in the second half of 2025. Following completion of enrollment in our registrational Exon 20 insertion trial in Q1 2025, topline pivotal data is projected to be in early 2026."

Dr. Yao continued, "We believe our antibody-drug conjugate (ADC) pipeline is also making meaningful progress, led by ARR-217, a CDH17-targeted ADC with best-in-class potential for the treatment of gastrointestinal cancers. The first patient has been dosed, marking the first clinical entry from our ADC portfolio. Following our strengthened balance sheet and extended cash runway, we are well positioned to deliver on a series of important catalysts over the next twelve months."

Second Quarter 2025 and Recent Highlights

Firmonertinib

● Positive interim update in EGFR PACC mutant NSCLC. In June 2025, ArriVent presented updated interim Phase 1b data for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations (FURTHER; NCT05364043). Firmonertinib demonstrated clinically meaningful progression free survival, CNS complete responses, and a manageable safety profile consistent with previous trials in what we believe to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC.

● PACC clinical development plans. In June 2025, ArriVent announced the design of ALPACCA (FURMO-006), a randomized global Phase 3 study designed to evaluate first-line firmonertinib monotherapy for the treatment of PACC mutant NSCLC with potential for both accelerated and full approval.
Pipeline

● Clinical advancement of ADC lead ARR-217 (MRG007). Dosed the first patient in the Phase 1 study for ARR-217, a CDH17 targeted ADC, in gastrointestinal tumors by our partner, Lepu Biopharma Co., Ltd. ("Lepu BioPharma").
Upcoming Milestones

● Final EGFR PACC Phase 1b data. Final EGFR PACC cohort data to be presented at the WCLC in September 2025.
● First-line EGFR PACC registrational study. Enrollment of first patient in the randomized, global pivotal ALPACCA Phase 3 study for first-line firmonertinib monotherapy in EGFR PACC mutant NSCLC expected in 2H 2025.
● Firmonertinib Pivotal EGFR Exon 20 insertions data. Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR Exon 20 insertions mutant NSCLC is projected to be in early 2026.
2025 Financial Results

● As of June 30, 2025, the Company had cash and investments of $254.5 million. The cash balance as of June 30, 2025 does not include the net proceeds of $81.1 million raised in the recently completed public offering in July 2025. With the recent net proceeds in addition to our cash and investments, we expect to fund operations to mid-2027.
● Net cash used in operations was $94.1 million and $37.7 million for the six months ended June 30, 2025 and 2024, respectively. The increase in net cash used in operations in the first six months of 2025 was primarily driven by the one-time upfront payment of $40 million made to Lepu Biopharma.
● Research and development expenses were $89.0 million and $38.8 million for the six months ended June 30, 2025 and 2024, respectively. The increase in expense was primarily due to a one-time upfront payment made to Lepu Biopharma for our collaboration that began in January 2025, along with increased headcount and clinical expense related to firmonertinib.
● General and administrative expenses were $11.4 million and $7.6 million for the six months ended June 30, 2025 and 2024, respectively.
● Net loss was $95.8 million and $39.3 million for the six months ended June 30, 2025 and 2024, respectively.

On August 11, 2025 Agenus Inc. ("Agenus" or the "Company") (Nasdaq: AGEN), an immuno-oncology company focused on innovation, reported financial results for the second quarter of 2025 and highlighted major clinical, regulatory, and operational milestones supporting the advancement of its botensilimab (BOT) and balstilimab (BAL) immunotherapy combination (Press release, Agenus, AUG 11, 2025, View Source [SID1234655062]). Botensilimab is a next-generation, multifunctional, Fc enhanced, CTLA-4 antibody and BAL is a proprietary PD-1 antibody; together they are designed to trigger robust and durable immune attacks against "cold," treatment-resistant tumors, offering new hope where standard therapies have failed.

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"Our team is committed to advancing BOT/BAL to deliver meaningful benefits to patients with treatment-resistant cancers, and we are working with regulatory agencies to expedite access through a streamlined Phase 3 trial," said Garo Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "With significant clinical progress, strategic partnerships, and prudent financial management, we are well-positioned to execute our vision of transforming cancer care."

Regulatory Highlights

•
Breakthrough Survival in Refractory MSS CRC – At the 2025 ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress, BOT + BAL reported a 42% two-year survival rate and median overall survival of ~21 months in a trial of 123 patients with refractory no liver met MSS metastatic colorectal cancer (mCRC).
•
Regulatory Alignment on Registrational Phase 3 Trial (BATTMAN) – Following an End-of-Phase 2 meeting on July 1, 2025, the FDA agreed to a streamlined two-arm BATTMAN Phase 3 design, having agreed to BOT/BAL’s contribution of components. This agreement also marks a shift from a three-arm trial previously proposed by regulators and enables trial initiation in Q4 2025.
•
Expanding Evidence Across Tumor Types – New data from a neoadjuvant pan-cancer trial (NEOASIS study) showed robust pathological responses across MSS and MSI-H solid tumors, including triple-negative breast cancer, with no dose-limiting toxicities. Translational data from ASCO (Free ASCO Whitepaper) confirmed BOT/BAL’s ability to activate T cells and address resistance in MSS tumors, supporting its potential across cancers.

Exhibit 99.1

"The BOT/BAL combination is delivering durable responses and survival outcomes in refractory MSS colorectal cancer," said Richard M. Goldberg, M.D., Chief Development Officer of Agenus. "With regulatory clarity and a focused development team, we are poised to execute the BATTMAN trial and explore earlier treatment settings to maximize patient impact."

Strategic Partnerships

•
Zydus Lifesciences Collaboration – The collaboration for U.S. manufacturing and commercialization in India/Sri Lanka is progressing toward a Q3 2025 closing, delivering $91M in upfront capital and equity investment upon closing to support development and regulatory activities.
•
Noetik AI Biomarker Collaboration using AI algorithms – Agenus commenced a partnership with Noetik AI to refine patient selection, enhancing BOT/BAL’s clinical impact and unlocking potential future revenue streams through precision oncology.
•
Broader Portfolio Synergies – Agenus continues to leverage its significant ownership of MiNK Therapeutics and SaponiQx, to advance combination treatments with adoptive cell therapies and adjuvants, broadening its immuno-oncology pipeline.
Key 2H 2025 Catalysts—Building on recent clinical, regulatory, and partnership momentum, Agenus anticipates several significant milestones in the second half of 2025:

•
Registrational Trial Launch – In Q4 2025, initiate the global BATTMAN Phase 3 trial of BOT/BAL in refractory MSS CRC in partnership with the Canadian Clinical Trials Group (CCTG), committed to executing with speed and precision.
•
Significant Clinical Data Generation – Expand evidence for BOT/BAL’s activity in earlier-line and neoadjuvant MSS colorectal cancer and other tumors through strategic collaborations and investigator-sponsored trials.
•
Upcoming Data Presentations – Share new BOT/BAL clinical results in colorectal and other solid tumors at major oncology congresses in Q4 2025, reinforcing its therapeutic potential.
Financial Highlights—Agenus continues to strengthen its financial position through prudent cost management and strategic capital-raising efforts in addition to Zydus collaboration, positioning the company to execute its clinical and regulatory objectives. Key financial metrics for Q2 2025 are summarized below:

•
Revenue and Net Loss – Agenus reported revenue of $25.7 million for Q2 2025 and $49.8 million for Q2 YTD 2025, primarily from non-cash royalty revenue, compared to $51.5 million in Q2 YTD 2024. The net loss Q2 YTD 2025 was $56.4 million, or $2.03 per share, a significant improvement from $118.3 million, or $5.56 per share, for Q2 YTD 2024.
•
Reduced Cash Burn – Cash used in operations decreased to $45.8 million for Q2 YTD 2025 from $76.4 million for Q2 YTD 2024. These reductions are a consequence of prudent cost management and are expected to continue into the second half of 2025. Agenus is also in active negotiations for collaborations that could result in additional significant infusions of cash resources.
•
Liquidity and Future Outlook – With the $91 million Zydus infusion expected upon closing, combined with its current cash balance, Agenus expects to fund the launch of its Phase 3 trial. Further, the company is in negotiations to secure additional funding streams from partnerships currently under negotiation and BOT/BAL’s commercial prospects in geographies beyond North America, Europe and Japan.
Webcast and Conference Call Information

The Company will host a webcast and Stakeholder Briefing on August 27, 2025, to review Q2 financial results, anticipated data milestones, and the global BOT/BAL development program.