ImaginAb, Inc.

back ImaginAb and Vice Chairman, Ian Wilson are featured in the article, “ImaginAb: Building a Legacy of Excellence in Radiopharmaceutical Development” The article provides insight on leadership strategies, navigating challenges, overcoming barriers from the perspective of one burgeoning radiopharmaceutical company. ImaginAb: Building a Legacy of Excellence in Radiopharmaceutical Development

Core royalty platform on track; receiving GSK royalties of $61.9 million Achieved net product revenues of $19.1 million, representing 66% year-over-year growth driven by launch of XACDURO® and growth of key core product GIAPREZA® Strong pipeline progress: positive Phase 3 zoliflodacin clinical trial results in uncomplicated gonorrhea highlighted at ESCMID Global 2024; on track to submit NDA in early 2025 Derek Small appointed to the Company’s Board of Directors BURLINGAME, Calif.--(BUSINESS WIRE)-- Innoviva Inc., (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding 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, today reported financial results for the first quarter ended March 31, 2024, and highlighted select corporate achievements. “Our first quarter financial results continue to demonstrate the successful transformation for Innoviva. We had a strong performance driven by resilient cash flows from our core GSK royalties portfolio and robust revenue growth across our commercial products marketed by IST, a leader in critical care medicine and infectious disease,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “We also remain laser focused on utilizing our strong financials to drive shareholder value by continuing to exercise cost discipline, investing prudently in our strategic healthcare assets, and completing our share buyback plan.” Matt Ronsheim, Ph.D., President of IST, noted: “Our IST platform is a powerful engine for growth anchored by a robust portfolio of differentiated life saving therapies. We are pleased with our first quarter performance, led by the strong launch of our novel therapeutic XACDURO®. Our core products GIAPREZA® and XERAVA® continue to grow, propelled by increasing awareness of our strong data underscoring the value of our products. We are also excited about our lead pipeline product, zoliflodacin, a potential first in class well tolerated oral drug for uncomplicated gonorrhea, whose Phase 3 data was highlighted in an oral presentation by our non-profit partner GARDP at ESCMID Global 2024, the largest global infectious disease congress. We remain on track to submit our New Drug Application for zoliflodacin in early 2025.” Financial Highlights Royalty revenue: First quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was $61.9 million, compared to $60.3 million for the first quarter of 2023. Net Product Sales: First quarter 2024 net product sales and license revenue were $19.1 million, which included $12.1 million from GIAPREZA®, $4.8 million from XERAVA®, and $2.2 million from XACDURO®, a 66% increase compared to $11.5 million for the first quarter of 2023. Equity and long-term investments: First quarter 2024 net change in fair values of equity and long-term investments of $22.0 million was primarily attributable to Armata Pharmaceuticals (“Armata”) share price appreciation. Net income: First quarter 2024 net income was $36.5 million, or $0.58 basic per share, compared to a net income of $34.9 million, or $0.51 basic per share, for the first quarter of 2023. Share repurchases: During the first quarter 2024, Innoviva repurchased 0.6 million shares of its outstanding common stock for $9.7 million. Subsequent to March 31, 2024, and through April 25, 2024, we completed the program by repurchasing 0.4 million shares for a total amount of approximately $5.3 million. Cash and cash equivalents: Totaled $178.4 million. Royalty and net product sales receivables totaled $76.0 million as of March 31, 2024. Key Business and R&D Highlights XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: targeted antibacterial for patients with HABP/VABP caused by Acinetobacter Following the launch in September 2023, commercial efforts continue to deliver strong performance with growing number of health systems integrating XACDURO® into their protocols. Zoliflodacin: a potential first-in-class, single dose, oral antibiotic in development for the treatment of patients with uncomplicated gonorrhea Positive Phase 3 zoliflodacin clinical trial results highlighted in an oral presentation given by the Company’s non-profit partner, The Global Antibiotic Research & Development Partnership (GARDP), at the European Society of Clinical Microbiology and Infectious Disease Global Congress (ESCMID Global 2024). The data showed that in the micro-intent-to-treat population (n=744), zoliflodacin achieved a microbiological cure rate of 90.9%, a 5.3% difference compared to ceftriaxone and azithromycin, the current global standard of care, which achieved a 96.2% cure rate (95% CI: 1.4%, 8.7%). Microbiological cure rates at extragenital sites were comparable between treatment arms (secondary endpoints). Zoliflodacin was generally well tolerated and emergent adverse events were comparable between treatment arms (46.2% vs 46.4%). No deaths or other serious adverse events were reported. The Company expects a New Drug Application to be submitted to the U.S. FDA in early 2025. Strategic Healthcare Assets Our portfolio of strategic assets under the Company’s various subsidiaries was valued at $628.4 million as of March 31, 2024, compared to $561.0 million as of December 31, 2023. In the first quarter 2024, Innoviva invested an additional $35.0 million in one of our assets, Armata, to help advance its lead therapeutic phage candidates. In addition, Innoviva invested an additional $5.8 million, with accrued interest, in Gate Neurosciences to support its strategy of developing next generation targeted CNS therapies, and an additional $2.7 million into ImaginAb Inc. to support its radiopharmaceutical platform. Corporate Updates In April 2024, Derek Small, an accomplished biopharmaceutical entrepreneur and executive, joined the Company’s Board of Directors. Management will participate in the upcoming Bank of America Securities Health Care Conference, taking place on May 15, 2024, in Las Vegas. A live webcast of the Company’s corporate presentation is scheduled for 9:20 a.m. PT and can be accessed here. An archived replay will be available following the event. About Innoviva Innoviva is a diversified holding 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”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. 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; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®, GIAPREZA®, XERAVA® and XACDURO® in the jurisdictions in which these products have been approved; 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 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 impact of the novel coronavirus (“COVID-19”); 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, 2023 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at . 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. INNOVIVA, INC. Condensed Consolidated Statements of Income and Comprehensive Income (in thousands, except per share data) (Unaudited) Three Months Ended March 31, 2024 2023 Revenue: Royalty revenue, net (1) $ 58,415 $ 56,858 Net product sales 19,084 11,514 License Revenue - 8,000 Total revenue 77,499 76,372 Expenses: Cost of products sold (inclusive of amortization of inventory fair value adjustments) 10,971 8,749 Cost of license revenue - 1,600 Selling, general and administrative 30,405 19,735 Research and development 3,878 12,588 Amortization of acquired intangible assets 6,440 3,805 Changes in fair values of equity method investments, net (35,342 ) (15,817 ) Changes in fair values of equity and long-term investments, net 13,335 2,164 Interest and dividend income (4,399 ) (3,365 ) Interest expense 5,851 4,427 Other expense, net 1,236 1,346 Total expenses 32,375 35,232 Income before income taxes 45,124 41,140 Income tax expense 8,592 6,275 Net income and comprehensive income $ 36,532 $ 34,865 Net income per share Basic $ 0.58 $ 0.51 Diluted $ 0.46 $ 0.42 Shares used to compute net income per share Basic 63,185 67,786 Diluted 84,531 89,788 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended March 31, 2024 2023 (unaudited) Royalties $ 61,871 $ 60,314 Amortization of capitalized fees (3,456 ) (3,456 ) Royalty revenue, net $ 58,415 $ 56,858 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) March 31, December 31, 2024 2023 Assets Cash and cash equivalents $ 178,357 $ 193,513 Royalty and product sale receivables 76,010 84,075 Inventory, net 37,437 40,737 Prepaid expense and other current assets 19,538 25,894 Property and equipment, net 324 483 Equity and long-term investments 628,437 560,978 Capitalized fees 80,328 83,784 Right-of-use assets 2,269 2,536 Goodwill 17,905 17,905 Intangible assets 223,895 230,335 Other assets 3,112 3,267 Total assets $ 1,267,612 $ 1,243,507 Liabilities and stockholders’ equity Other current liabilities $ 28,059 $ 33,435 Accrued interest payable 833 3,422 Deferred revenues 987 1,277 Convertible senior notes, due 2025, net 191,476 191,295 Convertible senior notes, due 2028, net 255,283 254,939 Other long term liabilities 71,686 71,870 Deferred tax liabilities 3,807 563 Income tax payable - long term 11,800 11,751 Innoviva stockholders’ equity 703,681 674,955 Total liabilities and stockholders’ equity $ 1,267,612 $ 1,243,507 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Three Months Ended March 31, 2024 2023 Net cash provided by operating activities $ 37,047 $ 25,684 Net cash used in investing activities (43,038 ) (35,722 ) Net cash used in financing activities (9,165 ) (136,962 ) Net change $ (15,156 ) $ (147,000 ) Cash and cash equivalents at beginning of period 193,513 291,049 Cash and cash equivalents at end of period $ 178,357 $ 144,049

January 17, 2024 Molecular imaging in clinical trials to reduce costs of failure For many years pharmaceutical companies have been struggling with high failure rates. Around 90% of clinical drug development fails, costing the industry billions. While the process of bringing a new drug to market is divided into fixed, required steps, the study design may differ. This is where there are opportunities to increase the chances of success and reduce costs. About this article This article discusses two trends in drug development. One of them is the use of molecular imaging to gather extra data from the same clinical trial phases that drug developers are used to. The other is implementing Phase 0 with molecular imaging as a first-in-human trial to save time and costs and to increase chances in subsequent trials. This article is written together with TRACER CRO, a contract research organization specializing in imaging, and experienced in the Phase 0 clinical trial. Incorporating visualizing CD8 T-cells and Phase 0 clinical trial in your drug development process CD8 ImmunoPET™ imaging allows the study of the immune response through downstream signaling. ImaginAb’s CD8 ImmunoPET™ agent is a developed a radiolabeled minibody that specifically targets the CD8 receptor, enabling the in vivo mapping of CD8+cells throughout the human body to visualize the immune response status. This minibody can be used in a diagnostic and theranostic setting, resulting in a physical profile of a patient's immune status and to measure response to treatment. The same method can be used in drug development to visualize the effect of a new drug by CD8 ImmunoPET™ Imaging. This can also be used in Phase 0 for early PK/PD data of the compound in patients. Imaging of immune response in clinical trials Good to know: Multiple imaging processes can be done simultaneously in a clinical trial. A compound can be labeled with a radionuclide to image the on- and off-target behavior of the compound itself. CD8 ImmunoPET™ imaging provides information on downstream signaling and immune status. Making it especially beneficial for many therapeutic drugs, vaccines and/or cell therapies that can modulate the immune response throughout the body and/or in tumours. Contact ImaginAb to discuss the possibilities of CD8 ImmunoPET™ Imaging. Prevent false negatives by enhanced personalized medicine patient stratification That a drug does not work on one specific patient or single tumor does not mean that the drug is ineffective. Molecular imaging can provide proof of, or change in target expression in individual patients and each specific tumor and lesion. This allows drug developers to understand whether drugs have different efficacies dependent on location or type of tumor lesion or type of cancer being treated, allowing them to make better decisions regarding how the move forward with the clinical development of new drug candidates. This is all data that can be gathered by adding molecular imaging to a clinical trial. Start clinical trials with GLP material To avoid costs in the early phases of drug development, drug developers can start their clinical trials from GLP material. For in-human use of a compound, GMP is always mandatory, but when the GLP material is labeled under GMP conditions, the end product is GMP grade. In a Phase 0 study with imaging, the labeled compound can be used. For the Phase 1 study, an unlabeled compound is commonly needed. Phase 0 is an addition to the regular drug development process but can, depending on the context, replace large animal models in the preclinical trajectory. This allows drug developers to go in-human faster and avoid strict regulation. An extended single-dose toxicity study is often not required since Phase 0 uses a microdose of the compound. Phase 0 as an alternative for large animal models To test a drug in large animal models, regulations can be tough while the value of the acquired data from those experiments can be difficult to extrapolate to humans. Phase 0 allows drug developers to test their drug early in-patient and can allow them to skip extensive testing in large animal models before Phase 0. This means time and costs can be reduced, while the relevance of the data can increase. Both the FDA and EMA support Phase 0 studies, hoping it will bring down the failure rate of new compounds. Reduce costs of failure in drug development Terminating research at an early stage for drugs that will ultimately fail, can reduce clinical costs significantly. By reducing phase lengths, capitalized total cost can be reduced further. For example, if phase lengths could be reduced by 25%, capitalization costs per approved drug could drop by 16%. Probability of Technical and Regulatory Success (PTRS) Innovating clinical trials, and especially Phase 0 can play a crucial role for a pharmaceutical company to improve the Probability of Technical and Regulatory Success (PTRS). It allows the identification of promising compounds and portfolio progressions. Other levers that leverage the PTRS are digital biology, AI-driven predictive approaches, regulatory innovation, and new science. Increase chance of success in clinical trials Data obtained from imaging during Phase 0 can allow drug developers to optimize subsequent clinical trials. Here are some of the important factors of clinical study design that it can impact: drug target, inclusion criteria, endpoint definition, treatment response assessment, safety monitoring, sample size determination, and biomarker validation. Early phase clinical trials: Phase 0 vs Phase 1 In conclusion, we compare the well-known Phase 1 study with the innovative Phase 0 study. Both are early-phase clinical trials and both can be the first-in-human study. The biggest difference is the study objective. Phase 1 is about optimal dose-finding, often in healthy volunteers and without measuring efficacy. Phase 0 on the other hand uses a microdose and therefore does not provide information on the optimal therapeutic dose. Imaging can show if the target of interest is reached, if binding occurs, where off-target accumulation exists, and what the method of excretion is. What is the right clinical trial design for you? Are you a drug developer on the path to your clinical trial? Or are you an investor, or medical professional, or are you in a different role in the field of drug development? We would like to get in contact so we can advise on what clinical trial design suits your compound and objectives. For information about CD8 ImmunoPET™, contact ImaginAb. For more information on clinical trials – like Phase 0, contact TRACER at https://www.tracercro.com/. END article. Info: https://imaginab.com/clinical-...; Download Article Here