ZYUS Life Sciences Corporation Announces Issuance of Bonus Warrants Pursuant to Loan Agreements




ZYUS Life Sciences Corporation Announces Issuance of Bonus Warrants Pursuant to Loan Agreements

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

SASKATOON, Saskatchewan–(BUSINESS WIRE)–ZYUS Life Sciences Corporation (the “Company”) (TSX-V: ZYUS), a Canadian-based life sciences company focused on the development and commercialization of novel cannabinoid-based pharmaceutical drug candidates for pain management, announces that it has received conditional acceptance from the TSX Venture Exchange (the “Exchange”) to issue certain common share purchase warrants to independent directors of the Company (“Lenders”) in connection with the issuance and amendment of certain unsecured loans announced in its previous press releases of March 10, 2025 and March 17, 2025.

As previously announced on March 10, 2025, unsecured loans between the Company and one of its independent directors entered on October 1, November 5 and December 20, 2024 (the “Prior Unsecured Loans”) had their maturity dates of April 1, May 5, and June 20, 2025, respectively, extended to March 28, 2027. Additionally, the director also advanced an additional unsecured loan (“Loan 1”) to the Company in the amount of CAD$1,500,000. In exchange for amending the maturity dates of the Prior Unsecured Loans and advancing Loan 1, the director received an aggregate of 4,875,000 common share purchase warrants having an expiry date of April 11, 2027, subject to the acceleration conditions described in the Company’s March 10, 2025 press release. Each warrant entitles the director to acquire one common share of the Company at an exercise price of $0.80 per common share until the expiry date. The warrants and any shares issuable on exercise thereof are subject to a statutory hold period expiring on August 12, 2025 in accordance with applicable Canadian securities law.

As announced on March 17, 2025, a promissory note agreement having a maturity date of August 27, 2025 (the “Promissory Note”) previously entered between the Company’s wholly-owned subsidiary, ZYUS Life Sciences Inc., and a second independent director of the Company was amended and replaced by a loan agreement (“Loan 2”) between the Company and the director. Pursuant to Loan 2, this director advanced to the Company additional cash consideration of $0.25 million and $0.025 million of accrued but unpaid interest under the Promissory Note was capitalized and added to the principal amount of Loan 2 for a total of $0.375 million, increasing the principal amount owing to the director from $0.1 million to $0.375 million and extending the maturity date from August 27, 2025 to March 28, 2027. In exchange for extending the maturity date and advancing additional cash consideration, the director received an aggregate of 281,250 common share purchase warrants having an expiry date of April 11, 2027, subject to the acceleration conditions described in the Company’s March 17, 2025 press release. Each warrant entitles the director to acquire one common share of the Company at an exercise price of $0.80 per common share until the expiry date. The warrants and any shares issuable on exercise thereof are subject to a statutory hold period expiring on August 12, 2025 in accordance with applicable Canadian securities law.

The issuance of warrants constitutes a “related party transaction” as defined under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”) as lenders are each directors of the Company. The Company has relied on the exemption from the valuation requirement pursuant to section 5.5(b) (Issuer Not Listed on Specified Markets) of MI 61-101 and from the minority shareholder approval requirement prescribed by section 5.7(1)(a) (Fair Market Value Not More Than 25 Percent of Market Capitalization) of MI 61-101 respecting issuance of the warrants.

About ZYUS Life Sciences Corporation

ZYUS (TSXV: ZYUS) is a life sciences company focused on the development and commercialization of novel cannabinoid-based pharmaceutical drug candidates for pain management. Through rigorous scientific exploration and clinical research, ZYUS aims to secure intellectual property protection, safeguarding its innovative therapies and bolstering shareholder value. ZYUS’ unwavering commitment extends to obtaining regulatory approval of non-opioid-based pharmaceutical solutions, in pursuit of transformational impact on patients’ lives. For additional information, visit www.zyus.com or follow us on X (formerly known as Twitter) @ZYUSCorp.

Cautionary Note Regarding Forward-Looking Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the Company’s business, the Company’s ability to advance clinical research activities, obtain regulatory approval of cannabinoid-based pharmaceutical drug candidates and introduce products that act as alternatives to current pain management therapies such as opioids and acceleration of the exercise period of the warrants. Any such forward-looking statements may be identified by words such as “expects”, “anticipates”, “intends”, “contemplates”, “believes”, “projects”, “plans”, “will” and similar expressions. Readers are cautioned not to place undue reliance on forward-looking statements. Statements about, among other things, the Company’s business, the Company’s ability to advance clinical research activities, obtain regulatory approval of cannabinoid-based pharmaceutical drug candidates, and introduce products that act as alternatives to current pain management therapies such as opioids, and acceleration of the exercise period of the warrants are all forward-looking information. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management’s reasonable assumptions, there can be no assurance that the Company will be able to achieve these results. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances or actual results unless required by applicable law.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.

Contacts

ZYUS Media Inquiries

media@zyus.com
1-833-651-7723

ZYUS Investor Relations

investors@zyus.com

Sphere Bio Expands APAC Distribution Network to Strengthen Presence in Region




Sphere Bio Expands APAC Distribution Network to Strengthen Presence in Region

Operational scale-up accelerates global growth strategy to increase regional access and technical support

CAMBRIDGE, England–(BUSINESS WIRE)–Sphere Bio, a leading provider of picodroplet-based microfluidics for functional single-cell analysis and isolation, today announced a significant expansion of its APAC distributor network. This development marks a key milestone in the Company’s global commercial strategy to meet growing demand for its next-generation single-cell analysis platforms.

The expansion enhances Sphere Bio’s footprint across key Asian and Pacific markets, improving regional access to its innovative technologies, local support, and technical expertise. The Company has formed partnerships with five new distributors: 1st PhileKorea (South Korea), AS ONE Corporation (Japan), Decode Science (Australia and New Zealand), Everlife Research Instruments (Singapore), and Premas Life Sciences (India and Bangladesh). These new partnerships join an already robust network, including Bang Trading (Thailand), Cold Spring Biotech (Taiwan), and Gene Company (China and Hong Kong).

This strategic scale-up enhances Sphere Bio’s ability to provide localized product support and increase adoption of its growing technology portfolio, including the recently launched Cyto-Mine^® Chroma platform and new assay offerings. The investment in new partnerships reflects the Company’s long-term commitment to serving the region and supporting local customers with in-depth expertise.

Dale Levitzke, CEO, Sphere Bio, commented: “2025 is a pivotal year as we scale to meet growing global demand and enter high-growth markets. We have partnered with best-in-class distributors to extend our reach and bring our transformative solutions to more customers worldwide. This expansion supports our mission to accelerate scientific discovery through innovation in single-cell analysis.”

Jay Manikandan, VP Commercial (APAC), Sphere Bio, added: “Our expanded distributor network and enhanced presence reflects our commitment to providing localized customer and technical support across the APAC region. These developments represent an important step in bringing our solutions closer to researchers and advancing global adoption.”

To learn more about Sphere Bio’s integrated life sciences tools and solutions, please visit spherebio.com/our-products

Contacts

For further information please contact:
Dr Claire Cox

Sphere Bio Ltd.

Tel: +44 (0)7365 209 441

Email: claire.cox@spherebio.com

Zyme Communications
Lily Jeffery

Tel: +44 (0)7891 477 378

Email: lily.jeffery@zymecommunications.com

Ferring achieved record sales driven by Reproductive Medicine combined with the emergence of Adstiladrin




Ferring achieved record sales driven by Reproductive Medicine combined with the emergence of Adstiladrin

• Continued strong performance in Reproductive Medicine which exceeded sales of €1 billion for the first time

• Adstiladrin^® (nadofaragene firadenovec-vncg), our novel gene-based therapy for bladder cancer, emerged as a second growth driver following the first full year of U.S. sales

• Commitment to sustainability highlighted by supply of 1.5 million doses of Carbetocin Ferring (carbetocin, room temperature-stable formulation) to reduce maternal deaths in low- and lower-middle-income countries

SAINT-PREX, Switzerland–(BUSINESS WIRE)–Ferring achieved total revenues of €2.3 billion in 2024, an increase of 7% over the previous year at actual exchange rates (AER) and 8% at constant exchange rates (CER). This above market growth reflected the continued strong performance in Reproductive Medicine, which exceeded €1 billion in global sales for the first time. In addition, 2024 was the first full year of U.S. sales of Adstiladrin, our novel gene-based therapy for bladder cancer.

Operating expenses were carefully managed while prioritising investment in growth opportunities, such as Adstiladrin. This resulted in an overall cost reduction of -3% (at AER and CER). Consequently, operating profit reached €192 million, an increase of 38% over the previous year (at AER, +43% at CER).

Jean-Frédéric Paulsen, Chairman of the Board of Directors, said: “For Ferring, this was a year of both continuity and change as we drew on the company’s strengths while evolving our approach to the business. In our core area of Reproductive Medicine, the demand for our products was greater than ever, reflecting worldwide concern about falling birthrates. At the same time, Adstiladrin, a highly innovative gene therapy, emerged as another main driver of growth for the company. Our focus has been to maximise our impact, as we pursue our ambition to unlock opportunities to deliver life-changing solutions to patients at every stage of life.”

Ferring maintained its commitment to protecting the environment, creating value for society, and upholding high standards of responsible and ethical business governance. As part of our commitment to social responsibility, we continued making progress with our Project Family: Safe Birth initiative, aimed at reducing maternal deaths in some of the world’s most underserved communities. In 2024, we supplied 1.5 million doses of our life-saving medicine, heat-stable Carbetocin Ferring, at an affordable access price to low- and lower-middle-income countries, an increase of around 50% over the previous year. With respect to the environment, we reduced Scope 1 and 2 greenhouse gas (GHG) emissions by 9.5%, ahead of our goal of 3%.

These and other achievements are detailed in our 2024 Annual Report and Sustainability Report.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries.

Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X.

Contacts

For more information, please contact

Carine Julen

Senior Manager, Corporate Communications & Public Affairs

+41 76 301 0178 (mobile)

carine.julen@ferring.com

PureTech Appoints Peel Hunt as Joint UK Corporate Broker




PureTech Appoints Peel Hunt as Joint UK Corporate Broker

BOSTON–(BUSINESS WIRE)–PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), is pleased to announce that it has appointed Peel Hunt as Joint UK Corporate Broker alongside UBS.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech’s R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration-enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.

For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.

Contacts

PureTech
Public Relations

publicrelations@puretechhealth.com
Investor Relations

IR@puretechhealth.com

Fasikl Announces Breakthrough Pivotal Data Demonstrating Superiority of Felix NeuroAI Wristband over Sham Device for Essential Tremor




Fasikl Announces Breakthrough Pivotal Data Demonstrating Superiority of Felix NeuroAI Wristband over Sham Device for Essential Tremor

—Wristband is a first-of-its-kind investigational wearable designed to provide dynamic, all-day, personalized relief for people with essential tremor (ET); powered by advanced AI to continuously adapt stimulation based on real-time feedback—

—TRANQUIL study results presented in late-breaker at the 2025 American Academy of Neurology (AAN) annual meeting demonstrate clinically meaningful improvements in ET symptoms and ability to perform daily activities—

SAN DIEGO–(BUSINESS WIRE)–Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that its pivotal TRANQUIL study met its primary endpoint of superiority for the company’s Felix™ NeuroAI™ wristband over a sham device. The Felix wristband significantly reduced tremors and showed statistically and clinically significant improvement in the users’ ability to perform daily activities compared to those using the sham device.

“This wearable technology delivered significant improvement in tremor, with both clinicians and patients more likely to report benefit by the end of the study,” said Rajesh Pahwa, M.D., Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System, and the principal investigator for TRANQUIL. “The TRANQUIL study represents what could be a shift in how we approach essential tremor treatment, a condition for which new options are sorely needed. Although oral medications are often used to treat essential tremor, they can be frequently unsatisfactory, and while deep brain stimulation and focused ultrasound are effective, they require surgical intervention.”

At the end of the 90-day period the Felix group showed clear superiority over the sham group.

• The Felix group experienced a statistically and clinically significant improvement in ET treatment, with a mean reduction of 6.9 points in modified Activities of Daily Living (mADL) scores compared to 2.7 points in the sham group (P < 0.0001).
• Nearly two-thirds of participants using Felix achieved at least a 20% reduction in mADL scores versus just one-quarter in the sham group.
• Efficacy benefits were consistent across age, gender, tremor severity, and ET medication use.

Secondary outcomes further highlighted the impact of Felix. Both clinicians and patients reported greater symptom improvement with Felix, and quality of life scores improved more substantially in the treatment group. Importantly, no serious device-related adverse events were reported, confirming the device’s strong safety profile.

The Felix NeuroAI Wristband is a first-of-its-kind investigational wearable designed to deliver all-day, personalized relief for people with ET. Powered by advanced AI, Felix continuously adapts stimulation based on real-time feedback, providing dynamic, individualized therapy. Unlike surgical or pharmacologic interventions, Felix is non-invasive and wearable, connecting seamlessly to Fasikl’s cloud-based AI platform for ongoing optimization and learning.

“The TRANQUIL study marks a breakthrough as the first multicenter, double-blind, sham-controlled, non-surgical randomized controlled trial in essential tremor to meet its primary endpoint in over two decades,” said Zhi Yang, Ph.D., CEO of Fasikl. “Felix is a transformative advancement in AI-powered therapeutics, offering a safe, non-invasive, and personalized treatment option for ET patients and their physicians. With the efficacy and safety of Felix now validated and presented, we believe this represents a pivotal moment in the treatment of essential tremor and the broader landscape of movement disorders.”

About Essential Tremor (ET)

Essential tremor (ET) is the most common type of tremor disorder, affecting approximately 7 million people in the United States.¹ It causes involuntary, rhythmic shaking, most often in the hands, which can make everyday activities like drinking from a glass or tying shoelaces difficult.² Over time, ET can worsen and significantly impact a person’s quality of life.²

The TRANQUIL Study

The TRANQUIL study, a randomized, double-blind, sham-controlled clinical trial, enrolled 125 adults across 12 clinical sites in the U.S. and China. Participants were randomized 2:1 to receive either the Felix™ NeuroAI™ Wristband or a sham device and wore it during waking hours for 90 days. The study’s primary endpoint was change in the modified Activities of Daily Living (mADL) score from the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS), a commonly used tremor assessment that combines 10 activities of daily living (ADLs) and 2 clinical assessments of tremor.³ The mADL has a maximum score of 52.

About Fasikl

Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. A 2019 spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves, enabling intelligent, adaptive therapy. The company is on a mission to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments through cutting-edge neuromodulation innovations. Fasikl’s portfolio, currently under FDA review, includes the Felix™ NeuroAI™ Wristband and the MindForce™ Nerve-Computer Interface. To learn more, visit fasikl.com.

References:

1. Louis ED, Ottman R. How many people in the USA have essential tremor? Deriving a population estimate based on epidemiological data. Tremor Other Hyperkinet Mov (N Y). 2014;4:259. https://doi.org/10.7916/D8TT4P4B
2. Mayo Foundation for Medical Education and Research. (2025, March 15). Essential tremor. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/essential-tremor/symptoms-causes/syc-20350534
3. Elble R, Comella C, Fahn S, Hallett M, Jankovic J, Juncos JL, Lewitt P, Lyons K, Ondo W, Pahwa R, Sethi K, Stover N, Tarsy D, Testa C, Tintner R, Watts R, Zesiewicz T. Reliability of a new scale for essential tremor. Mov Disord. 2012 Oct;27(12):1567-9.

Contacts

Media Contact:
Jenna Kane

Health+Commerce

480-388-9587

jennakane@healthandcommerce.com

New Coalition Calls for Urgent Action to Address Rising Stroke Crisis




New Coalition Calls for Urgent Action to Address Rising Stroke Crisis

GENEVA–(BUSINESS WIRE)–#StrokeActionNow–Launching today, the world’s first multisector advocacy movement dedicated to stroke – the Global Stroke Action Coalition – has issued an urgent call to action to address growing inequities in stroke. Already a leading cause of death and disability, without intervention, the global burden of stroke is projected to rise by a further 50% over the next 25 years, claiming 100 million lives and costing US$1.6 trillion each year.

At this afternoon’s launch, health and economic policy specialists, clinical experts and people with lived experience of stroke, will highlight key data and recommendations for action to address human and financial impact of stroke. Drawing on both data and the lived experiences of people affected by stroke, the Coalition will share their inaugural policy document Stroke Action Now which sets out evidence-based examples of interventions that can significantly advance progress on a disease that is largely:

• Preventable: 80% of the current stroke burden is linked to 10 modifiable risk factors. Identifying and managing hypertension alone could cut the rate of stroke in half.
• Treatable: Advances in clot removal and clot-busting technologies (thrombectomy and thrombolysis) can dramatically improve patient health outcomes, minimizing disability and reducing the economic impact of stroke.
• Recoverable: Access to rehabilitation helps people regain independence and reduces the risk —and cost— of long-term disability.

Despite the clear opportunities, prevention, treatment and rehabilitation services are only available to a fraction of stroke patients. For example, only 3% of medically eligible patients currently receive thrombectomy, with 20-40% of healthcare settings worldwide yet to implement basic stroke rehabilitation services.

“The global burden of stroke has doubled in the past 30 years,” explains Coalition co- Chair, Professor Bo Norrving. “During that same period huge advances have been made across the care pathway that offer us an incredible opportunity to reduce inequitable health outcomes and make significant progress towards global health and development targets. Committing to the development of National Stroke Plans should be a key priority for governments as part of their forward strategy for prevention and control of NCDs. We can’t afford to wait another 30 years to turn this around. Millions of lives depend on governments taking action now.”

Coalition leaders are calling on governments attending the 4th High-Level UN Meeting on NCDs in September this year, to commit to five actions:

1. Making stroke a priority in NCD prevention and control strategies so that it becomes an explicit and integral part of national and internal health agendas.

2. Developing National Stroke Action Plans that address the entire care pathway and include measurable targets that respond to in-country needs.

3. Committing to funding evidence-based interventions and exploring innovative financing models, such as taxing harmful substances, to build domestic resources.

4. Implementing robust stroke monitoring systems that measure changes in the stroke burden and the provision and outcomes of stroke care.

5. Including stroke survivors and caregivers in policy development and prioritize meaningful representation at all levels of decision-making.

The Coalition’s call comes at a defining moment. The upcoming UN High-Level Meeting is a rare opportunity for world leaders to shape the next 25 years of action on NCDs. Stroke must not be overlooked. The Coalition urges governments to seize this moment and ensure that stroke is recognized, prioritized, and acted upon.

Notes

Members of the Coalition include the World Stroke Organization, American Stroke Association, Asia Pacific Stroke Organization, Bayer, Boehringer Ingelheim, European Stroke Organisation, Heart & Stroke Foundation South Africa, Ipsen, March of Dimes Canada, Medtronic, Philips, Stroke Association UK and Society of Vascular and Interventional Neurology.

Contacts

strokecoalition@infinitycommunications.ch

KalVista Pharmaceuticals Enters Into Licensing Agreement With Kaken Pharmaceutical to Commercialize Sebetralstat for HAE in Japan




KalVista Pharmaceuticals Enters Into Licensing Agreement With Kaken Pharmaceutical to Commercialize Sebetralstat for HAE in Japan

-Up to $24 million in upfront and milestone payments, plus royalties-

-Sebetralstat has potential to become first, oral on-demand treatment of HAE in Japan, underscoring commercial opportunity-

-Kaken brings regional expertise and proven track record in commercializing innovative therapies-

CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that its wholly-owned subsidiary, KalVista Pharmaceuticals, Ltd., has licensed commercialization rights in Japan to Kaken Pharmaceutical, Co., Ltd. (JPX: 4521.T) for sebetralstat, an investigational, oral on-demand treatment for hereditary angioedema (HAE). KalVista will receive an upfront payment of $11 million, with an additional payment of up to $11 million upon achievement of a regulatory milestone anticipated in early 2026. Beyond these payments, the Company is also eligible for commercial milestone payments, plus royalties based on the Japan National Health Insurance (NHI) price, with the royalty rate as a percentage of sales approximately in the mid-twenties.

“We are pleased to partner with Kaken, whose expertise and demonstrated success in the region make them well-suited to work alongside our exceptional team to bring sebetralstat to the HAE community in Japan,” said Ben Palleiko, CEO of KalVista. “This collaboration is an important part of our strategy to expand the global reach of sebetralstat as we prepare for several commercial launches starting this year. Our focus remains on delivering a safe and effective oral on-demand therapy that we believe will make a meaningful difference for people living with HAE worldwide.”

As previously announced, KalVista received Orphan Drug Designation for sebetralstat from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Company has submitted a New Drug Application (NDA) for sebetralstat in Japan. If approved, sebetralstat would be the first oral on-demand treatment for HAE in the country.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The Company’s lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, KalVista has completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency, the Pharmaceuticals and Medical Devices Agency, and multiple other global regulatory authorities. For more information about KalVista, please visit www.kalvista.com.

About Sebetralstat

Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.

About Kaken Pharmaceutical, Co., Ltd.

Kaken Pharmaceutical is a specialty pharmaceutical company in Japan with strong experience in developing and commercializing novel pharmaceuticals in the fields of orthopedics and dermatology. Kaken concentrates its R&D resources in areas such as immune system, nervous system, infectious diseases and rare diseases with unmet medical needs. Kaken, in its philosophy, strives to improve the quality of life of patients through the development and distribution of superior pharmaceuticals. For further information, visit www.kaken.co.jp/english.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will,” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timings or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise.

Contacts

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Molly Cameron

Director, Corporate Communications

(857) 356-0164

molly.cameron@kalvista.com

Monroe Capital Supports Olympus Partners’ Acquisition of PAI Pharma




Monroe Capital Supports Olympus Partners’ Acquisition of PAI Pharma

CHICAGO–(BUSINESS WIRE)–Monroe Capital LLC (“Monroe”) announced it acted as joint lead arranger on the funding of a senior credit facility to support the acquisition of PAI Pharma (“PAI”) by Olympus Partners.

Founded in 1968 and based in Greenville, SC, PAI is a leading US oral generic liquids manufacturer of ready-to-dose cups and oral liquids bottles. PAI offers the broadest portfolio of generic oral liquid medicines in the industry, supporting retail chains, independent pharmacies, hospitals, long-term care facilities and government agencies.

About Monroe Capital

Monroe Capital LLC (“Monroe”) is a premier asset management firm specializing in private credit markets across various strategies, including direct lending, technology finance, venture debt, alternative credit solutions, structured credit, real estate and equity. Since 2004, the firm has been successfully providing capital solutions to clients in the U.S. and Canada. Monroe prides itself on being a value-added and user-friendly partner to business owners, management, and both private equity and independent sponsors. Monroe’s platform offers a wide variety of investment products for both institutional and high net worth investors with a focus on generating high quality “alpha” returns irrespective of business or economic cycles. The firm is headquartered in Chicago and has 11 locations throughout the United States, Asia and Australia.

Monroe has been recognized by both its peers and investors with various awards including Private Debt Investor as the 2024 Lower Mid-Market Lender of the Year, Americas and 2023 Lower Mid-Market Lender of the Decade; Inc.’s 2024 Founder-Friendly Investors List; Global M&A Network as the 2023 Lower Mid-Markets Lender of the Year, U.S.A.; DealCatalyst as the 2022 Best CLO Manager of the Year; Korean Economic Daily as the 2022 Best Performance in Private Debt – Mid Cap; Creditflux as the 2021 Best U.S. Direct Lending Fund; and Pension Bridge as the 2020 Private Credit Strategy of the Year. For more information and important disclaimers, please visit www.monroecap.com.

Contacts

For more information, please contact:

Zia Uddin

Monroe Capital LLC

312-523-2374

zuddin@monroecap.com

Daniel Abramson

BackBay Communications

857-305-8441

daniel.abramson@backbaycommunications.com

Leyden Labs Publishes New Data Confirming Potential of Intranasal Antibody Approach




Leyden Labs Publishes New Data Confirming Potential of Intranasal Antibody Approach

• In vivo influenza protection was achieved at a significantly lower antibody dose with intranasal compared to systemic administration
• In contrast to what is observed with systemic administration, Leyden Labs’ lead influenza antibody CR9114 has a unique mechanism of protection when administered intranasally
• The unmatched breadth of CR9114 is further supported by the discovery of binding to influenza C and D alongside A and B viruses – an essential attribute for durability of protection against new, emerging strains

LEIDEN, Netherlands–(BUSINESS WIRE)–Leyden Laboratories B.V. (the “Company” or “Leyden Labs”) today announced the publication of new findings that showcase the advantages of intranasal administration of monoclonal antibodies over systemic administration for protection against airborne viruses.

The studies reported in this paper demonstrate the uniqueness of intranasal administration of broadly protective antibodies as a novel, non-vaccine approach to protect against respiratory viral infection. These new insights pave the way towards intranasal antibody delivery to provide protection against influenza and other airborne viruses.

Key Findings:

• Intranasal antibody administration is effective at significantly lower dosages compared to systemic administration. Central to the strategy of Leyden Labs is to deliver broadly protective antibodies directly at the gate of viral entry, namely, to the respiratory mucosa. With these in vivo data, it is demonstrated that intranasal administration of CR9114 is efficacious at significant lower dosages than required for systemic administration. CR9114 is the monoclonal antibody component of the Company’s PanFlu candidate. CR9114 was shown to have a more potent (low dose) protective effect when administered intranasally vs intravenously in mice. Typically, there is a trade-off between potency and breadth in antibody activity: broadly-neutralizing antibodies often are less potent in vitro. This publication however shows that intranasal administration resolves this trade-off in vivo: by administering CR9114 intranasally, low-dose protection is effective.

• Intranasal antibody administration enables protection that is not dependent on Fc-mediated effector functions. CR9114 protection against influenza was shown to be Fc-independent with intranasal administration in vivo. Although Fc-mediated effector functions play a large role in the mechanism of action of systemically administered antibodies, they are not required for efficacy following intranasal administration. Intranasal CR9114 can provide protection through its front-end (Fab) alone, both against strains that are neutralized in vitro and strains that are not neutralized in vitro. Importantly, this observation further highlights the opportunity to redefine criteria for preclinical evaluation of the protective potential of an antibody based on the route of administration.

Clarissa Koch, PhD, Chief Research Officer of Leyden Labs commented, “We are excited to share this great work from our team and collaborators as we continue to expand our understanding about the nuances of administration of protective antibodies directly to the respiratory mucosa. We expect to publish additional data later this year regarding intranasal antibody dynamics as well. Under our Mucosal Protection Platform, findings such as these help in important ways to inform the ongoing development of PanFlu, as well as to shape additional pipeline programs by our team.”

Nigel Temperton, Professor of Molecular Virology and Director of Viral Pseudotype Unit at the Medway School of Pharmacy, University of Kent and University of Greenwich UK, who collaborated with Leyden Labs on these studies, said, “These findings have the potential to meaningfully impact the field of viral prophylaxis using antibodies. Although many valuable efforts have been made over time to optimize antibody composition for prophylactic use, contribution of the route of administration may have been underappreciated.”

Not only does this paper report discoveries about the uniqueness of intranasal administration, it also demonstrates that the breadth of activity of CR9114 is even greater than previously recognized. In addition to its known affinity for influenza A and B subtypes, it has now been shown that CR9114 also binds influenza C and D. Although influenza C and D are less at the forefront of current healthcare concerns – they mostly circulate in cattle and other animals – this finding reinforces the unique breadth of activity of CR9114 achieved by targeting a highly conserved domain. Since it is known that breadth is important for the effectiveness and durability of antibody prophylaxis, particularly when seeking to protect against new, emerging strains, this too is a significant discovery.

The article published in Scientific Reports is entitled, “Intranasal administration of a panreactive influenza antibody reveals Fc-independent mode of protection.”

About Leyden Laboratories B.V.

Leyden Labs is working to free people from the threat of respiratory viruses. Leyden Labs is leveraging its Mucosal Protection Platform to develop a portfolio of candidates aimed at providing protection against influenza, coronaviruses, and other respiratory viruses through a new class of broadly protective nasal sprays.

Systemically administered antibodies or vaccines primarily generate systemic protection. Airborne viruses, including influenza and coronaviruses, enter the body through the nose and mouth. Thus, what we need is protection right at the gate, at the respiratory mucosa, to more effectively prevent initial infection and subsequent illness.

Leyden Labs is pursuing this strategy by developing nasal sprays that administer broadly protective antibodies directly to the respiratory mucosa. These antibodies aim to protect against full viral families, so they keep working even when a virus mutates and evolves. In addition, this intranasal strategy is beneficial for people with weakened immune systems because it does not require a fully functional immune response.

To learn more, visit www.leydenlabs.com.

About PanFlu candidate CR9114

CR9114, Leyden Labs’ lead product candidate for the PanFlu program, is a human monoclonal antibody that protects against influenza in preclinical models. Leyden Labs holds an exclusive license from Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize CR9114.

Contacts

Investor Contact
Elizabeth Goodwin

+1 781-460-1784

investors@leydenlabs.com

Media Contact
Megan Prock McGrath

+1 978-800-7468

media@leydenlabs.com

DATROWAY® Approved in the EU for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer




DATROWAY® Approved in the EU for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

• First approval in the EU for Daiichi Sankyo and AstraZeneca’s DATROWAY based on TROPION-Breast01 trial showing 37% reduction in the risk of disease progression or death versus chemotherapy
• Second DXd antibody drug conjugate approved in EU based on Daiichi Sankyo’s DXd technology

TOKYO & MUNICH–(BUSINESS WIRE)–DATROWAY^® (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.

DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The approval by the European Commission follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast01 phase 3 trial.

In TROPION-Breast01, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 months (95% CI: 4.9-6.8) in the chemotherapy arm. The final overall survival (OS) results of the trial did not achieve statistical significance (median OS of 18.6 months in the DATROWAY arm versus 18.3 months in the chemotherapy arm [HR 1.01; 95% CI: 0.83-1.22]) and may have been affected by subsequent ADC treatment.

“With the majority of breast cancer cases historically considered HR positive, HER2 negative, additional treatment options are needed to improve outcomes for patients with metastatic disease that continues to progress following endocrine-based therapy and initial chemotherapy,” said Barbara Pistilli, MD, Head of the Breast Cancer Unit in the Medical Oncology Department of Gustave Roussy Cancer Center, Villejuif, France. “The approval of DATROWAY in the EU will provide these patients with a new treatment option that can help slow the progression of this disease.”

“Treating metastatic HR positive, HER2 negative breast cancer presents challenges, particularly treatment resistance and disease progression that occur following endocrine-based therapy and initial chemotherapy,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “DATROWAY represents the second antibody drug conjugate approved for breast cancer based on Daiichi Sankyo’s DXd technology and the third medicine to be approved in the EU from our oncology pipeline, underscoring our commitment to creating new medicines for patients with cancer.”

“Though the HR positive breast cancer treatment landscape has evolved in the last several years, disease progression on front-line therapies remains a common and complex challenge for patients with metastatic disease,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “With today’s approval of DATROWAY, patients in the EU with HR positive, HER2 negative breast cancer now have a new and needed alternative to conventional chemotherapy.”

Grade 3 or higher adverse events from a pooled safety analysis of two clinical studies, including 443 patients who received DATROWAY (6 mg/kg) for a median duration of 6.2 months (range: 0.7-28.5), were stomatitis (7.9%), fatigue (4.3%), anemia (3.2%), AST increased (2.7%), vomiting (1.6%), ALT increased (1.6%), nausea (1.4%), urinary tract infection (1.4%), COVID-19 (1.1%), decreased appetite (1.1%), neutropenia (1.1%) and pneumonia (1.1%). Grade 5 adverse events occurred in 0.7% of patients due to interstitial lung disease/pneumonitis, dyspnea and sepsis.

About TROPION-Breast01

TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease.

Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.

TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Hormone Receptor Positive, HER2 Negative Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.¹ In Europe, approximately 557,000 cases of breast cancer are diagnosed annually.² While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.³

Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).³ Endocrine therapy is widely given consecutively in the early lines of treatment for metastatic HR positive breast cancer.⁴ However, after initial treatment, further efficacy from endocrine therapy is often limited.⁴

About DATROWAY

DATROWAY (datopotamab deruxtecan) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results of the TROPION-Breast01 trial.

About the DATROWAY Clinical Development Program

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU^® in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

Contacts

Media Contacts:

Global:
Jennifer Brennan

Daiichi Sankyo, Inc.

jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)

EU:
Simone Jendsch-Dowé

Daiichi Sankyo Europe GmbH

simone.jendsch-dowe@daiichisankyo.com
+49 176 11780822

Japan:
Daiichi Sankyo Co., Ltd.

DS-PR_jp@daiichisankyo.com

Investor Relations Contact:
DaiichiSankyoIR_jp@daiichisankyo.com