Company is advancing its proprietary LYNX™ drug delivery platform to develop oral therapies that last for up to a month, including a monthly oral contraceptive

Company seeks pipeline expansion via industry partnerships

Nortiva Bio, Inc. ("Nortiva") today announced its launch as a clinical-stage biopharmaceutical company dedicated to developing long-acting oral medicines using its proprietary LYNX™ drug delivery platform. Nortiva's LYNX platform can transform daily pills into long-acting oral therapies with single doses that last up to a month in multiple therapeutic areas. This advancement can optimize efficacy and safety, improve medication adherence, and positively impact patients' quality of life.

The LYNX platform is built on foundational science from the labs of Robert Langer and Gio Traverso at MIT and fortified by years of research, development, and clinical validation — including proof of concept in multiple therapeutic areas and a successful Phase 3 study. Nortiva is a wholly owned subsidiary of Innoviva, Inc. (NASDAQ:INVA), which acquired the LYNX platform from Lyndra Therapeutics, Inc. in 2025.

"Long-acting oral medicines have the potential to meaningfully reshape how patients manage their health and lead to better outcomes," said Austin Hackett, MD, President of Nortiva Bio. "The LYNX platform is built on innovative science and supported by robust clinical evidence. Our work now is to build on that foundation to revolutionize drug delivery by advancing our development programs and forming industry partnerships to bring multiple long-acting oral therapies to patients."

"The LYNX platform attracted us with its potential to address significant unmet medical needs," said Pavel Raifeld, Chief Executive Officer of Innoviva. "We are excited about Nortiva's ability to develop truly differentiated long-acting therapies that improve patients' lives and create value for partners."

Advisory Board

Nortiva has formed an advisory board of industry leaders with expertise in drug delivery, medicines development, and pharmaceutical business strategy:

Robert Langer, ScD, Board Chair, MIT Institute Professor and Co-Founder of more than 40 biotechnology companies including Moderna and Lyndra Therapeutics.
Giovanni Traverso, MD, PhD, Associate Professor of Mechanical Engineering at MIT, gastroenterologist at Brigham and Women's Hospital, and Associate Member of the Broad Institute. Co-Founder of multiple biotechnology companies including Lyndra Therapeutics.
Janet Woodcock, MD, former Acting FDA Commissioner and Director of the FDA's Center for Drug Evaluation and Research (CDER).
Jay Galeota, President and CEO of Kallyope and former Chief Strategy and Business Development Officer at Merck.
Scott Braunstein, MD, Operating Partner at Aisling Capital, former CEO of Marinus Pharmaceuticals, and former Lead Portfolio Manager for JP Morgan's Global Healthcare Fund.
Sophie Kornowski, PharmD, MBA, former CEO of Boston Pharmaceuticals and former Global Head of Roche Partnering.

The LYNX™ Platform: A New Approach to Oral Drug Delivery

The LYNX drug delivery platform consists of a standard-size capsule containing an innovative structure that unfolds when it reaches the stomach, where it remains for the duration of the programmed drug delivery window. LYNX delivers a stable dose of drug during that window, minimizing the peaks and troughs of drug concentration often seen with daily oral medicines. This steady drug delivery has the potential to reduce side effects caused by high drug peaks and improve efficacy by preventing drug levels from dropping too low between doses.

LYNX is modular and can accommodate a wide range of small-molecule APIs with different potency, solubility and molecular weight profiles. The platform is protected by more than 50 granted patented innovations in design, engineering and materials science and builds on more than a decade of scientific, preclinical and clinical research, including:

More than 270 individuals dosed in clinical studies across multiple therapeutic areas and drug classes
Nearly 600 total administrations in humans and more than 1,300 total administrations in animal trials
Clinical proof of concept in multiple therapeutic areas
A successful Phase 3 study

Development Pipeline and Partnership Potential

Nortiva's strategy includes two complementary activities: advancing a proprietary lead development program and building a partnering pipeline that enables biotech and pharmaceutical companies to develop long-acting oral versions of branded and generic therapies.

Lead development program: Nortiva's lead asset is a once-monthly oral contraceptive, being developed with the support of a $5 million grant from the Gates Foundation. The work builds on preclinical research demonstrating proof of concept with LYNX steadily delivering contraceptive hormones to support once-monthly dosing. If successful, this could address a major unmet need in the U.S. and globally, as an estimated 50% of women miss doses at least once per month, reducing contraceptive efficacy and complicating the logistics and education required for family planning in low-resource communities.ⁱ

"Our oral contraceptive program is both a mission-driven commitment to improving access to family planning worldwide and a powerful proof point for the LYNX platform," said Dr. Hackett. "We are proud to advance this work with support from the Gates Foundation."

Partnering business: Nortiva is engaging with biotech and pharmaceutical partners interested in developing long-acting oral versions of approved or development-stage small molecule therapies. For partners, LYNX offers the ability to convert a daily medicine into a once-monthly dose with potential improvements in safety, efficacy, and adherence, delivering meaningful impact to patients.

"Long-acting oral dosing could significantly differentiate many marketed and pipeline drugs across multiple therapeutic areas," said Dr. Hackett. "With possibility of improving both clinical factors and patient satisfaction, the LYNX platform provides an opportunity to stand out in competitive indications."

For more information about the LYNX platform and to connect with the Nortiva Bio team, email info@nortivabio.com.

About Nortiva Bio, Inc.

Nortiva Bio, Inc. is a clinical-stage biopharmaceutical company developing long-acting oral therapies. This is possible thanks to Nortiva's LYNX drug delivery platform, which enables drugs to be released at a controlled rate over one week or longer from a single dose. The company is partnering to advance long-acting oral versions of approved and development-stage small molecule therapies. Nortiva Bio is a wholly owned subsidiary of Innoviva, Inc. (NASDAQ:INVA) and is headquartered in Lexington, Massachusetts. For more information, visit www.nortivabio.com.

About Innoviva, Inc.

Innoviva, Inc. (NASDAQ:INVA) is a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ("IST"), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ("GSK"). For more information, visit www.inva.com.

LYNX™ is a trademark of Nortiva Bio, Inc.

Forward-Looking Statements

This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words "anticipate", "expect", "goal", "intend", "objective", "opportunity", "plan", "potential", "target" and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; the strategies, plans and objectives of Innoviva (including Innoviva's growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the development of the LYNX™ platform; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company's growth strategy. Other risks affecting Innoviva are described under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" contained in Innoviva's Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission ("SEC") and available on the SEC's website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

ⁱ Molloy, G. J., Graham, H., & McGuinness, H. (2012). Adherence to the oral contraceptive pill: A cross-sectional survey of modifiable behavioural determinants. BMC Public Health, 12, 838. https://doi.org/10.1186/1471-2458-12-838

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Nortiva Bio Launches to Develop Long-Acting Oral Medicines