AI Earnings Predictions for Vir Biotechnology Inc. (VIR)

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EX-99.1

2 a20260506-q1ex991earningsr.htm

EX-99.1

Document

Exhibit 99.1

Vir Biotechnology Provides Corporate Update and Reports First Quarter 2026 Financial Results

– Global strategic collaboration with Astellas to advance PSMA-targeted, PRO-XTEN® dual-masked T-cell engager (TCE) VIR-5500 closed and first patient dosed in Phase 1 dose-expansion cohorts in patients with late-line metastatic prostate cancer

– Company will present complete Week 96 Phase 2 SOLSTICE data on its combination regimen for chronic hepatitis delta (CHD) at the European Association for the Study of the Liver (EASL) Congress

– Strong financial position with $809.3 million in cash and investments as of March 31, 2026, excluding $315 million combined Astellas upfront payment1 and equity investment to be received in the second quarter of 2026

– Conference call scheduled for May 6, 2026, at 4:30 p.m. ET / 1:30 p.m. PT

SAN FRANCISCO, May 6, 2026 – Vir Biotechnology, Inc. (Nasdaq: VIR), today provided a corporate update and reported financial results for the first quarter ended March 31, 2026. “Vir Bio delivered incredible momentum during the first quarter with positive, new VIR-5500 Phase 1 data and execution of a global agreement with Astellas in prostate cancer. The closing of our collaboration with Astellas in April has ignited the next stage of development work, bolstering our ability to move faster and think bigger together,” said Marianne De Backer, Chief Executive Officer of Vir Biotechnology. “We also announced promising updated Phase 2 data on our combination regimen in CHD and will be presenting complete Week 96 data at the EASL Congress later this month. CHD is the most severe form of hepatitis. We believe our well-tolerated combination regimen is uniquely positioned to change the standard of care, bringing together robust efficacy with the potential for self-administration at home with once monthly subcutaneous dosing.”

Pipeline Programs

Chronic Hepatitis Delta (CHD)

•The Company will present additional data from the Phase 2 SOLSTICE trial evaluating the combination of tobevibart and elebsiran for CHD at the EASL Congress taking place May 27-30, 2026.

•Earlier this year, the Company reported Phase 2 SOLSTICE data showing that the monthly combination of tobevibart and elebsiran was highly efficacious and well-tolerated. Undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) was achieved and maintained by 77% (24/31) of participants receiving the combination regimen at Week 72. This rate increased to 88% (21/24) in the subset of participants evaluated through Week 96.

•Topline data from the Phase 3 ECLIPSE 1 trial are expected in the fourth quarter of 2026.

•Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.

Solid Tumors

VIR-5500

•The Company closed its global strategic collaboration with Astellas to advance PSMA-targeted, PRO-XTEN® dual-masked TCE VIR-5500 for the treatment of prostate cancer.

•The first patient was dosed in the Phase 1 dose-expansion cohorts evaluating the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in prostate cancer. The first expansion cohort will evaluate VIR-5500 monotherapy in Q3W 800/2000/3500 µg/kg step-up dosing in late-line metastatic castration-resistant prostate cancer (mCRPC). The Company anticipates initiating pivotal Phase 3 trials in 2027.

1

•Positive updated Phase 1 data for VIR-5500 monotherapy showed dose-dependent anti-tumor activity and a well-tolerated safety profile in patients with mCRPC. The data were presented in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium.

VIR-5818

•Phase 1 dose-escalation of VIR-5818, a HER2-targeted PRO-XTEN® dual-masked TCE, in combination with pembrolizumab continues, with response data expected in the second half of 2026.

VIR-5525

•The Phase 1 study of VIR-5525, an EGFR-targeted PRO-XTEN® dual-masked TCE, continues enrollment as expected.

Preclinical Pipeline Candidates

•The Company is currently progressing a number of PRO-XTEN® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder.

Corporate Update

•The Company completed a follow-on public offering of common stock with gross proceeds of $172.5 million, before deducting underwriting discounts and commissions and offering expenses.

First Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: As of March 31, 2026, the Company had $809.3 million in cash, cash equivalents and investments, representing an increase of approximately $27.7 million during the first quarter of 2026. During the first quarter of 2026, the Company completed a public offering of its common stock with gross proceeds of $172.5 million, before deducting underwriting discounts and commissions and offering expenses.

Research and Developmen

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 19, 2026

Vir Biotechnology, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware001-3908381-2730369 (State or Other Jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)

1800 Owens Street, Suite 900

San Francisco, California 94158 (Address of Principal Executive Offices)(Zip Code)

Registrant’s Telephone Number, Including Area Code: (415) 906-4324 (Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered Common stock, $0.0001 par valueVIRNasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company o If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 1.01 Entry into a Material Definitive Agreement. On February 19, 2026, Vir Biotechnology, Inc. (Vir Bio) and Astellas US LLC (together with its subsidiaries and affiliates (including its indirect parent, Astellas Pharma Inc.), Astellas) entered into a Collaboration and License Agreement (the Agreement). Upon closing of the transaction contemplated by the Agreement (the Closing and the Transaction, respectively), Vir Bio and Astellas will enter into a global strategic collaboration to co-develop and co-commercialize VIR-5500, Vir Bio’s PRO-XTEN® dual-masked T-cell engager (TCE) targeting PSMA (prostate-specific membrane antigen), for the treatment of prostate cancer that is currently in Phase 1 development, through a sharing of expenses and revenues. Vir Bio has agreed to grant to Astellas, subject to certain intellectual property rights of Sanofi S.A. (Sanofi), an exclusive license to develop, manufacture, commercialize and otherwise exploit VIR-5500 and certain related derivative compounds throughout the world for therapeutic, prophylactic, palliative and diagnostic uses. Under the terms of the Agreement, Vir Bio will receive $335 million in upfront and near-term milestone payments, including $240 million in cash and a $75 million equity investment pursuant to a separate Stock Purchase Agreement (the SPA, described further below), and an additional $20 million near-term milestone payment upon completion of manufacturing process technology transfer, anticipated in the second quarter or third quarter of 2027. Vir Bio will also be eligible to receive up to $1.37 billion in future development, regulatory and sales milestones, along with tiered, double-digit royalties on ex-U.S. net sales. Global clinical development costs will be shared 40% by Vir Bio and 60% by Astellas, while costs of U.S.-specific studies will be shared equally, and Astellas will be solely responsible for costs of ex-U.S.-specific studies. In the U.S., Vir Bio will have the option to co-promote VIR-5500 and will share profits and losses from future sales of VIR-5500 equally with Astellas, should VIR-5500 receive regulatory approval. Outside of the U.S., Astellas will obtain exclusive rights to commercialize VIR-5500 and be responsible for all commercialization costs. In addition, Vir Bio has the option to opt out of development cost sharing responsibilities and U.S. profit sharing, in which case Vir Bio would be eligible to receive up to $1.37 billion (or $1.60 billion if Vir Bio has met a pre-defined limited funding threshold at the time of the opt-out) in additional future development, regulatory and sales milestones, along with tiered, double-digit royalties on global net sales. The Closing is subjec