Ascendo Biotechnology Completes Oversubscribed Series A Financing to Advance Innate Immune Checkpoint Pipeline

On May 8, 2026 Ascendo Biotechnology reported that it has successfully completed an oversubscribed financing round, supported by a strong group of institutional investors, including Taiwania Capital Management Corporation (TaiAx Life Science Fund, L.P.), Yuanta Venture Capital Co., Ltd., Maxpro Investment Co., Ltd., Chenghan Investment Co., Ltd, Darly2 Venture, lnc., TECO Capital Investment Co., Ltd, Industrial Technology Investment Corporation (ITIC), Beiley Biofund Inc., Chang Hwa Bank Venture Capital Co., Ltd., and First Venture Capital Co., Ltd.

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This strong investor support reflects growing confidence in our differentiated approach to targeting innate immune checkpoints, a novel strategy aimed at addressing significant unmet needs in oncology and autoimmune diseases, where current therapies remain limited in efficacy.

Ascendo Biotechnology was founded by Dr. Yen-Ta Lu, a physician from Mackay Memorial Hospital. Our core technologies originate from Taiwan-based clinical and translational research, forming the foundation of our proprietary innate immune checkpoint platform.

Proceeds from this financing will be used to advance our lead program, ASD141, through key clinical milestones in its Phase I trial and to prepare for Phase II development. In parallel, we will also advance IND-enabling studies for ASD001.

ASD141 has demonstrated encouraging early clinical signals, including immune cell activation observed at low- and mid-dose levels, with multiple patients achieving stable disease. As dose escalation continues, we aim to further validate its therapeutic potential and explore its ability to expand response rates beyond current immunotherapy limitations.

We look forward to continuing our clinical progress and advancing global collaborations and licensing discussions to accelerate the development of our pipeline.

We sincerely thank our investors and partners for their support as we move into the next phase of growth.

(Press release, Ascendo Biotechnology, MAY 8, 2026, View Source [SID1234665310])

Gilead Sciences Announces First Quarter Financial Results

On May 7, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the first quarter 2026.

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"Gilead teams have delivered another strong quarter with 8% year-over-year growth in our base business and 10% growth in HIV, supported by the successful launch of Yeztugo. We have raised our full year revenue guidance as a reflection of our performance," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "Building on the strongest pipeline in Gilead’s history, we are adding potentially best-in-disease assets and platforms in oncology and inflammation from our acquisitions of Arcellx, Ouro Medicines and Tubulis. With up to four potential launches and five Phase 3 updates anticipated in 2026, Gilead is well-positioned for sustained growth in the near and long term."

First Quarter 2026 Financial Results

Total first quarter 2026 revenues increased 4% to $7.0 billion compared to the same period in 2025, primarily driven by higher sales of HIV products, Trodelvy (sacituzumab govitecan-hziy), and Livdelzi (seladelpar), partially offset by lower sales of Veklury (remdesivir), as well as chronic hepatitis C virus ("HCV") and Cell Therapy products.
Diluted earnings per share ("EPS") was $1.61 in the first quarter 2026 compared to $1.04 in the same period in 2025. The increase was primarily driven by net unrealized gains from equity securities compared to net unrealized losses in 2025 and higher product sales, as well as lower acquired in-process research and development ("IPR&D") expenses. The increase was partially offset by higher income tax and selling, general and administrative ("SG&A") expenses.
Non-GAAP diluted EPS was $2.03 in the first quarter 2026 compared to $1.81 in the same period in 2025. The increase was primarily driven by higher product sales and lower acquired IPR&D expenses, partially offset by higher income tax and SG&A expenses.
As of March 31, 2026, Gilead had $8.6 billion of cash, cash equivalents and marketable debt securities compared to $10.6 billion as of December 31, 2025. The decrease was primarily driven by $2.8 billion of debt repayments, $1.0 billion of dividend payments and $419 million of common stock repurchases, partially offset by $2.5 billion of operating cash flow.
First Quarter 2026 Product Sales

Total first quarter 2026 product sales increased 5% to $6.9 billion compared to the same period in 2025. Total first quarter 2026 product sales excluding Veklury increased 8% to $6.8 billion compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of HCV and Cell Therapy products.

HIV product sales increased 10% to $5.0 billion in the first quarter 2026 compared to the same period in 2025, primarily driven by higher demand and average realized price, partially offset by unfavorable inventory dynamics.

Biktarvy(bictegravir 50mg/emtricitabine ("FTC") 200mg/tenofovir alafenamide ("TAF") 25mg) sales increased 7% to $3.4 billion in the first quarter 2026 compared to the same period in 2025, primarily driven by higher demand and average realized price, partially offset by unfavorable inventory dynamics.
Descovy(FTC 200mg/TAF 25mg) sales increased 38% to $807 million in the first quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand.
The Liver Disease portfolio sales increased 1% to $767 million in the first quarter 2026 compared to the same period in 2025, primarily reflecting higher demand for Livdelzi, partially offset by unfavorable inventory dynamics and lower sales for HCV products.

Veklury sales decreased 52% to $144 million in the first quarter 2026 compared to the same period in 2025, primarily driven by lower rates of COVID-19-related hospitalizations.

Cell Therapy product sales decreased 12% to $407 million in the first quarter 2026 compared to the same period in 2025, reflecting ongoing competitive headwinds.

Yescarta (axicabtagene ciloleucel) sales decreased 14% to $332 million in the first quarter 2026 compared to the same period in 2025, primarily driven by in- and out-of-class competition.
Tecartus (brexucabtagene autoleucel) sales decreased 4% to $75 million in the first quarter 2026 compared to the same period in 2025, primarily driven by in-class competition.
Trodelvy (sacituzumab govitecan-hziy) sales increased 37% to $402 million in the first quarter 2026 compared to the same period in 2025, primarily driven by higher demand, favorable inventory dynamics and higher average realized price.

First Quarter 2026 Product Gross Margin, Operating Expenses and Effective Tax Rate

Product gross margin was 79.2% in the first quarter 2026 compared to 76.7% in the same period in 2025. Non-GAAP product gross margin was 87.5% in the first quarter 2026 compared to 85.5% in the same period in 2025. These increases are primarily due to the expiration of a royalty-related obligation and product mix.
Research and development ("R&D") expenses remained relatively flat at $1.4 billion in the first quarter 2026 compared to the same period in 2025, primarily due to lower oncology clinical study activity and lower restructuring costs being fully offset by higher investment in virology clinical manufacturing. Non-GAAP R&D expenses were $1.4 billion in the first quarter 2026 compared to $1.3 billion in the same period in 2025, primarily driven by higher investment in virology clinical manufacturing, partially offset by lower oncology clinical study activity.
Acquired IPR&D expenses were $107 million in the first quarter 2026, primarily related to an $80 million upfront payment related to our collaboration with Suzhou Genhouse Bio Co., Ltd. ("Genhouse").
SG&A expenses were $1.5 billion in the first quarter 2026 compared to $1.3 billion in the same period in 2025, primarily driven by higher HIV promotional expenses and donations of equity securities made to the Gilead Foundation. Non-GAAP SG&A expenses were $1.4 billion in the first quarter 2026 compared to $1.2 billion in the same period in 2025, primarily due to higher HIV promotional expenses.
The effective tax rate ("ETR") was 21.7% in the first quarter 2026 compared to 20.2% in the same period in 2025. The non-GAAP ETR was 18.3% in the first quarter 2026 compared to 16.3% in the same period in 2025. These increases are primarily driven by a prior year state tax benefit that did not recur.
Guidance and Outlook

For the full year 2026, Gilead now expects:

(in millions, except per share amounts)

May 7, 2026 Guidance

Comparison to February 10, 2026 Guidance

Low End

High End

Product sales

$

30,000

$

30,400

Previously $29,600 to $30,000

Product sales excluding Veklury

$

29,400

$

29,800

Previously $29,000 to $29,400

Veklury

$

600

$

600

Unchanged

Diluted (loss) earnings per share

$

(3.25

)

$

(2.85

)

Previously $6.75 to $7.15

Non-GAAP diluted (loss) earnings per share

$

(1.05

)

$

(0.65

)

Previously $8.45 to $8.85

As compared to our February guidance, our updated full year 2026 GAAP and non-GAAP diluted earnings per share guidance was reduced by approximately $9.50 due to the anticipated acquired IPR&D charges of $11.5 billion as well as financing costs related to the Arcellx, Inc. ("Arcellx"), Ouro Medicines, LLC ("Ouro"), and Tubulis GmbH ("Tubulis") transactions discussed further below.

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.

Key Updates Since Our Last Quarterly Release

Virology

Announced U.S. Food and Drug Administration ("FDA") accepted New Drug Application for bictegravir and lenacapavir ("BIC/LEN") for virologically suppressed people with HIV under priority review, with a Prescription Drug User Fee Act ("PDUFA") target action date of August 27, 2026.
Presented late-breaking Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials at the 2026 Conference on Retroviruses and Opportunistic Infections (CROI), evaluating the investigational daily oral single-tablet regimen of BIC/LEN for virologically suppressed people with HIV. BIC/LEN maintained high levels of virologic suppression, demonstrating comparable efficacy to complex regimens and to Biktarvy at Week 48 in people with HIV who switched antiretroviral therapy. These data support global regulatory filings.
Announced a $12 million investment to the Community Health Worker Comprehensive HIV Prevention Initiative program to expand HIV prevention initiatives across 14 U.S. states and the District of Columbia.
Announced a new investment from the U.S. State Department, the U.S. President’s Emergency Plan for AIDS Relief ("PEPFAR") and The Global Fund to deliver lenacapavir for HIV prevention to an additional 1 million people, bringing the total commitment up to 3 million people in countries supported by both PEPFAR and the Global Fund.
Oncology

Completed the acquisition of Arcellx for $115 per share, or an implied equity value of $7.8 billion, and one contingent value right of $5 per share. This acquisition builds on an existing collaboration agreement with Arcellx for the development of anitocabtagene autoleucel ("anito-cel") in relapsed or refractory ("R/R") multiple myeloma ("MM"), and also adds Arcellx’s D-Domain BCMA binder that has the potential to strengthen Gilead’s portfolio in oncology and inflammation.
Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026.
Announced a definitive agreement to acquire Tubulis, a private clinical-stage biotechnology company developing next-generation antibody-drug conjugates ("ADC"), including lead asset TUB-040, a NaPi2b-directed topoisomerase-I inhibitor ADC currently in Phase 1b/2 development for platinum-resistant ovarian cancer and non-small cell lung cancer. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions.
Received FDA full approval for Tecartus in adult patients with R/R mantle cell lymphoma, following an accelerated approval in this setting in July 2020. Tecartus’ label now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor-naïve.
Inflammation

Announced a definitive agreement to acquire Ouro, a private clinical-stage biotechnology company developing T cell engager ("TCE") therapies for autoimmune diseases. This acquisition adds Ouro’s lead asset, OM336 (gamgertamig), a BCMAxCD3 TCE, to Gilead’s portfolio. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions. Gilead has entered into a framework agreement with Galapagos NV ("Galapagos") in relation to this acquisition, which includes equally splitting the $1.675 billion upfront payment and up to $500 million in milestone payments, among other terms.
Corporate

The Board declared a quarterly dividend of $0.82 per share of common stock for the second quarter of 2026. The dividend is payable on June 29, 2026, to stockholders of record at the close of business on June 15, 2026. Future dividends will be subject to Board approval.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.

Conference Call

At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.

(Press release, Gilead Sciences, MAY 7, 2026, View Source [SID1234665389])

Genelux Corporation Reports First Quarter Financial Results and Provides Business Updates

On May 7, 2026 Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported financial results for the first quarter of 2026 and provided general business updates.

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"As we build on our momentum entering 2026, we remain focused on disciplined execution of our registrational program. The randomized Phase 3 OnPrime/GOG-3076 trial remains on track for topline data in the second half of 2026. It is designed to generate robust, controlled clinical evidence intended to support filing for regulatory approval by demonstrating the efficacy of Olvi-Vec-primed immunochemotherapy relative to the active comparator arm," said Thomas Zindrick, President, CEO and Chairman of Genelux. "In addition, we continue to advance our systemic lung cancer programs as we evaluate Olvi-Vec’s potential to resensitize tumors to platinum-based chemotherapy and expand beyond ovarian cancer."

"In parallel, we are making steady progress in advancing our manufacturing and operational capabilities to support the continued development of Olvi-Vec and position the Company for potential commercial readiness. Our focus remains on establishing the necessary supply, quality, and organizational infrastructure as our registration-directed programs advance," concluded Mr. Zindrick.

Clinical Program Highlights

Olvi-Vec in Platinum-Resistant/Refractory Ovarian Cancer:
Genelux continues to advance Olvi-Vec toward potential registration in platinum-resistant/refractory ovarian cancer (PRROC), where patients have limited treatment options and poor outcomes. Ovarian cancer is the 5th leading cause of cancer-related death among women. Approximately 243,572 women in the United States are diagnosed with ovarian cancer, and it is estimated that more than 70% will not respond to or will relapse after frontline platinum-based therapy (NIH Ovarian Cancer Fact Sheet 2022).

Olvi-Vec’s intraperitoneal administration enables high, localized dosing within the peritoneal cavity and is designed to drive anti-tumor activity and resensitize tumors to platinum-based chemotherapy.

OnPrime/GOG-3076 (NCT05281471) is an ongoing multi-center, randomized, open-label Phase 3 registrational trial being conducted at sites across the United States, with topline data anticipated in the second half of 2026.
The trial is evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the active comparator arm of physician’s choice of chemotherapy and bevacizumab in women with PRROC (including fallopian tube and primary peritoneal cancers).
As of its most recent assessment in February 2026, the Independent Data Monitoring Committee recommended continuation of the trial without modification.

Olvi-Vec in Lung Cancer:
Genelux is advancing two ongoing lung cancer trials of systemically delivered Olvi-Vec to evaluate its potential beyond intraperitoneal delivery and into a broader range of solid tumor types. These studies also support the Company’s strategy to resensitize multiple tumor types to platinum-based chemotherapy and to optimize a systemic dosing regimen for the advancement of future registration-path development in lung cancer.

The Phase 1b/2 study (OLVI-VEC-SCLC-202) in SCLC (NCT07136285) is evaluating Olvi-Vec in combination with platinum and etoposide chemotherapy in SCLC patients with platinum-resistant or relapsed disease after failing previous treatment, including frontline platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co., Ltd., in China. Data from dose-escalation cohorts are expected to inform selection of a systemic dose for Phase 2 and subsequent development. The following preliminary findings were reported in January 2026:
Partial responses in 3 of 9 SCLC patients (33%), including two responses in the highest dose cohort with ~55% and ~85% tumor shrinkage from baseline.
The disease control rate was 67% (6/9 patients), with tumor shrinkage ranging from 24–85% from baseline among patients achieving disease control.
Durability signals were observed, including one patient with ongoing progression‑free survival (PFS) of 12.1 months and another patient with PFS of 7.7 months, the latter exceeding their prior line of therapy by 5.8 months (PFS of 7.7 months vs. 1.9 months).
The Phase 2 VIRO-25 study (NCT06463665) is assessing Olvi-Vec in combination with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent NSCLC who failed standard frontline treatment of platinum chemotherapy and an ICI. The trial is being conducted in the United States.
In preliminary findings reported in January 2026, Olvi‑Vec demonstrated a 60% disease control rate (3/5 evaluable patients), with tumor size changes of 8.9%, -18.9%, and -22.7% respectively, as compared to baseline.
Olvi‑Vec was generally well tolerated across the SCLC and NSCLC studies as of their data review cutoff dates of December 23, 2025 and December 31, 2025, respectively.

Additional dose‑finding updates from both the SCLC Phase 1b/2 and NSCLC Phase 2 VIRO‑25 trials are expected throughout 2026. Together, these studies are intended to inform the potential for broader systemic use of Olvi-Vec across additional solid tumor types.

First Quarter 2026 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $26.3 million as of March 31, 2026. The Company expects that combined cash, cash equivalents, marketable securities and restricted cash will fund operations into the first quarter of 2027.

Research and development (R&D) expenses were $5.8 million and $4.7 million for the three months ended March 31, 2026 and 2025, respectively, an increase of $1.1 million. The increase was primarily driven by clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 On Prime/GOG-3076 registration trial and employee compensation and related expenses.

General and administrative (G&A) expenses were $3.4 million and $3.1 million for the three months ended March 31, 2026 and 2025, respectively, an increase of $0.3 million. The increase was primarily driven by higher employee compensation and related expenses.

Net loss was $8.9 million or $0.20 per share for the three months ended March 31, 2026, as compared to $7.5 million or $0.21 per share over the same period in 2025.

(Press release, Genelux, MAY 7, 2026, View Source [SID1234665368])

Zelluna ASA: First Quarter 2026 results

On May 7, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported its results for the first quarter 2026.

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Webcast scheduled for 7 May 2026 at 08:30 CET. Link to webcast here.

Operational Highlights Q1 2026:

First clinical site activated:
As announced yesterday, Zelluna has activated its first clinical site, The Christie NHS Foundation Trust in the United Kingdom. This marks the transition from clinical preparation to the execution phase of the ZIMA-101 study. Activation of the second clinical site, The Royal Marsden, is expected in the near term.
CTA approval:
On 20 February 2026, Zelluna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) had approved the Company’s Clinical Trial Application (CTA) for ZIMA-101, a first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.
Collaboration with Etcembly Ltd:
On 9 March 2026, the Company announced a collaboration with Etcembly Ltd to leverage AI-enabled TCR engineering to develop KKLC1-targeting TCRs.
Medpace selected as CRO:
On 11 February 2026, Zelluna announced that it had entered into a clinical partnership with Medpace to support the Phase 1 trial of ZI-MA4-1 (ZIMA-101).
Financial Highlights Q1 2026

Total operating expenses: MNOK 20.4
Total loss: MNOK 20.4
Cash and cash equivalents: MNOK 49.3 as of 31 March 2026
Financial runway: into Q1 2027
"Q1 2026 marked a major step forward for Zelluna as we moved from regulatory submission into the clinic, following approval of our CTA for ZI-MA4-1 and activation of our first clinical site, announced earlier today. As we progress through 2026, our priorities are clear: dose the first patients in the ZIMA-101 study and execute with discipline as we begin generating clinical data in patients. In parallel, we will continue to selectively advance our pipeline to build on the long-term potential of the TCR-NK platform," says CEO Namir Hassan.

Outlook

Zelluna enters 2026 with its lead programme, ZI-MA4-1, progressing toward first clinical evaluation in patients following successful GMP manufacturing and CTA approval in the UK. As announced earlier today, the Phase 1 study ZIMA-101 is now underway following activation of the first clinical site. Initial clinical data are expected from mid-2026. The current cash position is expected to support operations into Q1 2027.

The quarterly report and presentation will be made publicly available on the Zelluna website. The Company will host a webcast on 7 May at 08:30 CET, and questions can be submitted throughout the event. The webcast will be archived for replay following the conference call. Link to webcast here.

(Press release, Zelluna Immunotherapy, MAY 7, 2026, View Source [SID1234665367])

BriaCell Adds NYU Langone Health’s Perlmutter Cancer Center as Clinical Site in Pivotal Phase 3 Breast Cancer Study

On May 7, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care reported the addition of NYU Langone Health’s Laura and Isaac Perlmutter Cancer Center, a renowned cancer center in New York City, as a clinical trial site in its ongoing pivotal Phase 3 clinical study (Bria-ABC).

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BriaCell has enjoyed a marked uptick in interest from premier cancer centers and patient enrollment numbers following the prominent independent feature of its Phase 3 clinical trial in Nature Medicine’s publication, "Eleven clinical trials that will shape medicine in 2026", linked here.

BriaCell’s pivotal Phase 3 clinical study in Advanced Breast Cancer (Bria-ABC) is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus an immune check point inhibitor versus treatment of physician’s choice in advanced metastatic breast cancer.

"At NYU Langone Health’s Perlmutter Cancer Center, we are dedicated to offering state-of-the-art treatments to patients with difficult-to-treat cancers," stated Nancy Chan MD, Director, Breast Cancer Clinical Research, NYU Langone Health’s Perlmutter Cancer Center. "We look forward to helping accelerate the development of Bria-IMT, a novel immunotherapy with the potential to improve outcomes for patients with advanced metastatic breast cancer."

"We are thrilled to partner with clinical experts at the renowned NYU Langone Health’s Perlmutter Cancer Center, a patient-focused, NCI-designated Comprehensive Cancer Center, to further expand patient access to our novel immunotherapy treatment," said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We continue to advance the study and look forward to sharing interim data in the coming months."

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer. Importantly, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

For additional information on BriaCell’s pivotal Phase 3 study, please visit ClinicalTrials.gov NCT06072612.

(Press release, BriaCell Therapeutics, MAY 7, 2026, View Source [SID1234665366])