Erythema Induratum

COPENHAGEN, Denmark, April 2, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today that JYNNEOS®, the only FDA-approved mpox vaccine, is now commercially available in the U.S., marking a significant expansion for access to JYNNEOS® by establishing additional pathways for vaccine procurement, distribution, and reimbursement by both public and private payers. Since 2022, in response to the global mpox outbreak, JYNNEOS has been made available through public health channels for individuals at risk of mpox infection. This was made possible through Bavarian Nordic’s long-standing partnership with the U.S. government to supply the vaccine for the national stockpile and enabled by interim guidance from the Centers for Disease Control and Prevention (CDC), recommending pre- and post-exposure use of the vaccine for individuals at risk during the outbreak. These recommendations were updated in October 2023 by unanimous vote by the CDC's Advisory Committee on Immunization Practices (ACIP), and JYNNEOS is now recommended for routine use in individuals 18 years and older with certain risk factors1. While mpox no longer constitutes a public health emergency, infections are still occurring throughout the U.S., with around 200 cases every month on average and transmission of the virus having been reported across most of the states in 2024 to-date2. Since the beginning of the outbreak in 2022, more than 32,000 cases have been reported in the U.S., representing a third of all cases reported globally3. According to estimates from the CDC, two (2) million U.S. individuals are eligible for vaccination against mpox4. Recent data shows 60% of this population remains completely unvaccinated, and 15% have received only one dose of the vaccine5. Real-world data show that protection against mpox disease is superior in vaccinees who received the full schedule of two vaccinations as recommended by the CDC, compared to those who are unvaccinated or have only received one dose of the vaccine6. Through its existing nationwide vaccine distribution structure, Bavarian Nordic is now making the mpox vaccine commercially available across the nation. As of April 1, health care providers can order JYNNEOS through their preferred wholesaler and distribution partners to make it available for at-risk individuals at local pharmacies and physician offices in addition to public health clinics. Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, commented: “From the beginning of the mpox outbreak, almost two years ago, the prompt availability of an approved vaccine combined with a strong public health response have helped to significantly reduce the impact of this debilitating disease, but unfortunately, mpox has not gone away completely. Building on the trust and reliability as a supplier of vaccines to the U.S. government for more than a decade, we are proud to extend our commitment to improving the nation’s public health by making our mpox vaccine widely available to at-risk individuals through the regular channels. We look forward to working with healthcare providers across the nation to increase awareness and availability of the mpox vaccine.” Brian Hujdich, Executive Director, National Coalition for LGBTQ Health, commented: “The expanded availability of JYNNEOS is a vital step toward ensuring equitable access to healthcare for the LGBTQ+ community and marks a significant stride in preventing the spread of mpox. We must continue to advocate for equitable policies that protect and support the health and well-being of all individuals and encourage those at risk to consult with their healthcare providers regarding vaccination.” About mpox Visit the CDC website for comprehensive information about mpox: About Bavarian Nordic Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in travel vaccines and a preferred partner with governments on vaccines for public preparedness. For more information visit . About JYNNEOS® JYNNEOS® (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) is approved for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox and mpox infection. The vaccine was developed in collaboration with the U.S. government originally to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in 2019 and in 2021, ACIP voted to recommended JYNNEOS for pre-exposure vaccination of people at occupational risk for orthopoxvirus exposures. In 2022, the CDC issued interim guidance, enabling pre- and post-exposure use of JYNNEOS during the mpox outbreak and an Emergency Use Authorization (EUA) was issued allowing the use of JYNNEOS in people under 18 years. In October 2023, the CDC updated its guidance for use of JYNNEOS, and now recommends routine use of the vaccine for at risk individuals 18 years and older. Important safety information Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS. Anyone who has experienced a severe allergic reaction following a previous dose of JYNNEOS or following exposure to any component of JYNNEOS may be at increased risk for severe allergic reactions. Syncope (fainting) has been reported following vaccination with JYNNEOS. Procedures should be in place to avoid injury from fainting. Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS. Vaccination with JYNNEOS may not protect all recipients. In smallpox vaccine-naïve healthy adults, the most common (>10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%). In healthy adults previously vaccinated with a smallpox vaccine, the most common (>10%) solicited injection site reactions were redness (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and itching (32.0%); the most common solicited systemic adverse reactions were fatigue (33.5%), headache (27.6%), and muscle pain (21.5%). The frequencies of solicited local and systemic adverse reactions among adults with HIV infection and adults with atopic dermatitis were generally similar to those observed in healthy adults. Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 serious adverse events (SAEs), all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness. Cardiac adverse events of special interest (AESIs) considered causally related to study vaccination were reported in 0.08% of subjects who received JYNNEOS and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. None of the cardiac AESIs considered causally related to study vaccination were considered serious. To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting or calling 1-800-822-7967. Please see full Prescribing Information Contacts – investors Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43 Graham Morrell, Paddock Circle Advisors (US), graham@paddockcircle.com, Tel: +1 781 686 9600 Contact – media Michelle Trasatti, michelle.trasatti@syneoshealth.com, Tel: +1 443-528-7427 Media are also encouraged to visit for additional background information and media kit, including photos and b-roll. References 1 Persons at risk include gay, bisexual, and other men who have sex with men, transgender or nonbinary people who in the past 6 months have had one of the following: A new diagnosis of ≥ 1 sexually transmitted disease; More than one sex partner; Sex at a commercial sex venue; Sex in association with a large public event in a geographic area where mpox transmission is occurring, sexual partners of persons with the aforementioned risks, and persons who anticipate experiencing any of the aforementioned. 2 CDC, weekly data. Accessed April 1, 2024. . 3 CDC. Ongoing 2022 Global Outbreak Cases and Data. Accessed April 1, 2024. . 4 CDC. JYNNEOS Vaccine Coverage by Jurisdiction as of September 26, 2023. 5 6 CDC. 2022/2023 Mpox outbreak: situational awareness and updates (October 25, 2023, ACIP meeting presentation). Accessed April 1, 2024. Attachment 2024-04-02-en

Phase IIa clinical trial evaluated Aurase Wound Gel in patients with venous leg ulcers Former Smith+Nephew CMO, Andy Weymann joins as Chairman to support progression of further Phase II clinical trials CAMBRIDGE, England--(BUSINESS WIRE)-- SOLASCURE Ltd (SolasCure), a biotechnology company developing a hydrogel containing tarumase (provisional INN), a recombinant enzyme derived from maggots, and which aims to accelerate wound debridement and contribute to wound bed preparation & healing, today announced the results of its proof-of-concept, first-in-human, Phase IIa safety study. The CLEANVLU trial evaluated the Company’s first investigational product, Aurase Wound Gel, for use in chronic venous leg ulcer patients over 12 applications of the product (dosed every 3 days). SolasCure’s CLEANVLU Phase IIa clinical trial observed a strong safety pro Aurase Wound Gel, with no evidence of systemic availability, no antibody generation to the enzyme and no effects on systemic coagulation pathways. In addition, no local tolerability issues (erythema, oedema, induration, or bleeding) and no pain from application of the gel was observed. The trial also indicated a dose-dependent effect on wound debridement with higher concentrations of enzyme resulting in more complete debridement, a faster rate of debridement, and an improved wound healing trajectory. The study was performed at centres in the US, UK, and Hungary. SolasCure’s Aurase Wound Gel, a hydrogel containing an enzyme cloned from medical maggots, aims to facilitate debridement, reduce bacterial biofilm, and promote wound bed preparation and healing. Aurase Wound Gel is due to enter further Phase II trials to further evaluate its efficacy across a larger and more diverse patient group than the Phase IIa study, with the positive safety data obtained from the Phase IIa trial allowing for higher concentrations of the gel to now be explored. Chronic wounds are a huge unmet medical need with treatment costs accounting for approximately 1-3% of total healthcare expenditure in developed countries. With over 40 million chronic wounds requiring debridement each year globally, the need for better debridement, wound bed preparation and healing is a growing and urgent problem, currently without safe, pain-free, and effective solutions. Strengthening SolasCure’s leadership team as it moves towards further Phase II clinical trials, medical expert Andy Weymann has been appointed as Chairman of the Board. Andy Weymann M.D., newly appointed Chairman of the Board, SolasCure, said: “I am delighted to join the SolasCure team, especially at such an exciting phase of growth. The positive safety and proof-of-concept data from the Phase IIa trial represents a huge milestone for the Company, accelerating its mission to provide a disruptive wound care product that could significantly improve outcomes for patients with chronic wounds globally. I look forward to working alongside the team as we now focus on developing the efficacy of Aurase Wound Gel in subsequent Phase II trials.” Andy Weymann is an orthopaedic surgeon with 25 years’ experience in the medical device and regenerative medicine industries. Andy has held several global executive and Board roles throughout his career, including Chief Medical Officer and Senior Vice President of Scientific, Clinical and Medical Affairs at Smith+Nephew. Andy completed his Masters in Human Medicine at the University of Zurich, Switzerland, an MBA at the Simon Business School, University of Rochester, NY, and his Board Program at Harvard, Boston, MA. Rob Kirsner, M.D., PhD, Head of Medical Advisory Board at SolasCure, Chairman and Harvey Blank Professor of Dermatology at the University of Miami, added: “SolasCure’s Aurase Wound Gel is an innovative technology, harnessing an enzyme cloned from medical maggots to accelerate wound cleaning, and therefore healing. We have a shared vision to deliver a meaningful solution for patients with chronic wounds, and the positive data observed in the CLEANVLU Phase IIa trial brings us another step closer.” Further validating SolasCure’s innovative approach to wound care, the Company was recently selected for the EIC Accelerator Horizon grant which recognises the potential impact the innovative technology could have on the lives of patients suffering from chronic wounds without adequate solutions. For more information about SolasCure, please visit: . View source version on businesswire.com: Contacts Esmé Walters Zyme Communications Email: esme.walters@zymecommunications.com Source: SolasCure View this news release online at:

Study met primary end point and demonstrated successful subcutaneous administration of a 10 mL biologic co-formulated with ENHANZE® in 30 seconds using Halozyme's proprietary high-volume auto-injector SAN DIEGO, Oct. 16, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") will present the positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE® drug delivery technology, in approximately 30 seconds, at the 13th Annual PODD: Partnership Opportunities in Drug Delivery Conference. In the study, the biologic was delivered with Halozyme's proprietary high-volume auto-injector (HVAI) in healthy volunteers. The injection was delivered successfully to all 23 participants and was well tolerated. "To our knowledge, this is the first clinical study of its kind," said Mike LaBarre, chief technical officer of Halozyme. "Traditional subcutaneous auto-injector delivery methods are typically limited to volumes less than 2 mL or require long delivery times at slow rates for higher volumes. By enabling rapid subcutaneous injection of high volumes of biologic products, our ENHANZE drug delivery technology in combination with our proprietary HVAI has the potential to improve the patient experience for multiple therapies." In the study, a representative biologic, immunoglobulin 10%, was delivered to 23 healthy volunteers. The primary endpoint of the study was achieved with all subjects receiving the completed dose with HVAI, demonstrating that 10 mL of a representative biologic product can be rapidly delivered using Halozyme's ENHANZE® and HVAI technologies. The data will be presented in an oral presentation titled "Demonstrating High-Volume Auto-Injector Delivery of 10 mL in ~30 sec: Halozyme Clinical Study HALO-104-105" on Tuesday, October 17 at 10:35am ET. Data Highlights 96% of participants stated that they would be willing to receive the injection again. 90% of participants indicated feeling either no pain or mild pain immediately after injection. Erythema, swelling, and induration were generally minimal to mild and resolved by 90 minutes or less. Biologics delivered subcutaneously through auto-injectors are typically restricted to doses of 1-2 mL. This limitation is caused by hyaluronan, a molecule that inhibits fluid dispersion in the subcutaneous space. Halozyme's ENHANZE® drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally degrades hyaluronan in the subcutaneous space. This temporarily increases the permeability of the tissue under the skin, allowing space for the biologic to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream. "These results support our continued dedication to providing innovative drug delivery options to patients," said Helen Torley, chief executive officer of Halozyme. "Our ENHANZE drug delivery and HVAI technologies have the potential to rapidly deliver large volume therapeutics subcutaneously with the potential for meaningful clinical benefits." Halozyme's HVAI is available to partners for clinical use. About Halozyme Therapeutics, Inc. Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical, Pfizer and Idorsia Pharmaceuticals. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's development and clinical trial results of a high volume auto-injector and statements concerning the Company's ENHANZE® drug delivery technology (including statements regarding use in combination with the Company's high volume auto-injector) including the possible benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and certain other benefits of ENHANZE® including improving the treatment experience for patients. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts, including the use of the Company's high-volume auto-injector and ENHANZE® drug delivery technologies to facilitate rapid delivery of large volume therapeutics subcutaneously. These forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including risks that clinical trial results may not be replicated, unexpected results or delays in the development and growth of the Company's high volume auto-injector business, or in the development, regulatory review or commercialization of the Company's potential high volume auto-injector partnered products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Dawn Schottlandt Argot Partners 212-600-1902 [email protected] Shannia Coley CG Life 443-471-6830 [email protected] SOURCE Halozyme Therapeutics, Inc.