PREP

The TARPEYO delayed-release capsules are indicated for reducing proteinuria to treat primary immunoglobulin A nephropathy in adult patients. Credit: Alexander Grey on Unsplash. Calliditas Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for complete approval of TARPEYO (budesonide). The TARPEYO delayed-release capsule is a corticosteroid indicated for reducing proteinuria to treat primary immunoglobulin A nephropathy (IgAN) in adult patients at risk of quick disease progression, generally having a urine protein-to-creatinine ratio greater than or equal to 1.5g/g. Recommended Reports Reports LOA and PTSR Model - (Aspirin + Dimethyl Fumarate) in Relapsing Remitting Multiple Sclerosis (RRMS) GlobalData Reports Prolyl Endopeptidase (Post Proline Cleaving Enzyme or PREP or EC 3.4.21.26) Drugs in Development ... GlobalData View all Companies Intelligence Calliditas Therapeutics AB SNDA Nefecon AB View all The therapy received accelerated approval based on showing a reduction in proteinuria. The submission of sNDA to the regulator was based on the findings obtained from the Phase III NefIgArd clinical trial. The multicentre, randomised, double-blind trial was designed to evaluate the safety and efficacy of TARPEYO 16 mg compared with placebo against a background of optimised RASi (renin–angiotensin system inhibitor) therapy in primary IgA adult patients. TARPEYO showed a highly statistically significant benefit in estimated glomerular filtration rate (eGFR) over a two-year period of treatment. The treatment period comprises nine months on TARPEYO or placebo, then 15 months of follow-up. Calliditas Therapeutics CEO Renée Aguiar-Lucander stated: “The eGFR treatment benefit observed across the entire study population, irrespective of UPCR levels, provides further evidence that targeting IgAN at its source can offer patients a treatment that holds the promise of being disease-modifying. “We are pleased to be able to provide the FDA with the full results of our Phase III study, and we look forward to interactions with the FDA regarding full approval of TARPEYO.” The company is also collaborating with its European commercial partner STADA Arzneimettel to seek complete approval for Nefecon, branded as Kinpeygo, from the European Commission.

Unique FAP targeting warhead combined with Actinium-225 or Lutetium-177 demonstrated complete tumor regression and long-term survival in preclinical models Initiation of a Phase 1 therapeutic clinical trial planned for 1H2022 INDIANAPOLIS, Sept. 28, 2021 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, today released additional preclinical data from its fibroblast activation protein-alpha (FAP-alpha) inhibitor program called PNT2004. The new data demonstrates best-in-class characteristics including rapid and persistent tumor targeting with very low retention in normal tissues. Over the duration of the preclinical study, complete tumor regression and prolonged survival were observed. Based on this exciting preclinical data, the Company exercised its option on the technology and amended the exclusive global licensing agreement with Bach Biosciences providing the Company with the opportunity to further expand uses with the highly FAP specific D-Ala-boroPro inhibitor as a targeting warhead. FAP-alpha is a serine protease highly expressed in over 90% of epithelial tumors on cancer associated fibroblasts (CAFs) which drive tumor progression and resistance to chemo and immunotherapy. FAP is expressed during development but is absent in adult tissues, making it a compelling target. The clinical candidate in the PNT2004 program, PNT6555, is a D-ala-boroPro based FAP targeting radioligand. D-ala-boroPro is a potent and selective FAP inhibitor that has superior tumor retention and normal tissue clearance. In animal studies PNT6555 has successfully delivered large doses of radiation to tumors while limiting dose to non-target tissues. PNT6555 showed >26,000-fold selectivity for FAP over the closely related enzyme DPP4, which is broadly expressed in normal tissues, including kidneys. The Company believes the high level of selectivity will result in very precise delivery of radiation to tumors during treatment. “We believe Pan-cancer radiopharmaceuticals like our PNT2004 program are going to play a key role in the future of precision oncology,” said Dr. Joe McCann, Chief Executive Officer of POINT Biopharma. “For over a century radiation has been used to treat cancer. A precision radiopharmaceutical that can deliver radiation directly to most solid tumors, while sparing healthy tissue, would be a game changer with both mono and combination therapy opportunities. We are therefore very enthusiastic about the new data and expanded licensing agreement with Bach Biosciences. Looking ahead, we are well underway with the IND enabling studies and clinical design and expect to submit an IND in 1H2022.” “An ideal radiopharmaceutical “sticks” to tumors but is flushed out of healthy tissue quickly,” said Dr. Neil Fleshner, Chief Medical Officer of POINT Biopharma, “as the longer the radioisotope stays in the tumor, the more DNA damage it can inflict. The tricky part is getting the radioisotope to remain in only the tumor tissue – and that is where PNT2004 really shines. PNT2004’s preclinical data demonstrates the desirable quality of sticking in tumor tissue while being flushed from healthy tissue. This is a tremendously exciting program, and we look forward to continue working with leading physicians and scientists to develop a Phase 1 protocol.” “We are proud to expand our agreement with POINT and believe they are well-equipped to leverage our FAP-alpha inhibitor-targeting technology to develop the next generation of safer and more efficacious radiopharmaceuticals,” said Dr. William Bachovchin, Chief Executive Officer of Bach Biosciences and Professor of Molecular & Chemical Biology at Tufts University. “I believe that this technology holds great potential for the precision treatment of a variety of solid tumor cancers, as it is differentiated from others with respect to having superior FAP-selectivity and in vivo PK/PD properties, and POINT is the right partner to make it happen. I look forward to a continuing collaboration with POINT to develop PNT2004 and as well as other radioligand treatments to achieve our mutual goal of bringing effective therapies to patients.” Data Summary: 68Ga-PNT6555 demonstrated fast tumor targeting and good tumor retention with low accumulation in other organs. 177Lu-PNT6555 demonstrated prolonged tumor retention and rapid clearance in normal tissues. 177Lu-PNT6555 showed compelling dose responsive anti-tumor efficacy, with 100% (6/6) of mice dosed at 60MBq and 50% (3/6) of mice dosed at 30MBq achieving tumor free survival at 80 days post-injection. Similarly, 225Ac-PNT6555 also showed anti-tumor efficacy, with 67% (4/6) mice dosed at 50kBq achieving tumor free survival at 70 days post-injection. About POINT Biopharma POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT Biopharma Global Inc. is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, expertise in radioisotopes such as Actinium-225 (Ac-225) and Lutetium-177 (Lu-177), and industry-leading manufacturing capabilities and supply chain to revolutionize theragnostic drug development and radioligand commercialization. Learn more about POINT Biopharma Global Inc. at . Information about POINT Biopharma Global Inc.’s Phase 3 SPLASH trial for metastatic castrate resistant prostate cancer (mCRPC) patients can be found at . About Bach Biosciences LLC Bach Biosciences LLC is a mission-driven drug discovery/development company associated with Dr. William Bachovchin's laboratory at Tufts University School of Medicine. Bach Biosciences is making breakthrough discoveries and fostering their advance into therapeutics for patients, on its own or by working in partnership with other life science companies. Bach Biosciences' leadership and development team is highly skilled in the design, synthesis and preclinical characterization of new drug candidates, as well in translational medicine and pharmaceutical development, having had a number of programs move into clinical development and into the marketplace. The company and its founders have established strategic partnerships with contract research organizations, investors, and pharmaceutical partners to support technology development. Dr. Bachovchin is the inventor on 65 issued US patents, including reach-through patents covering the field of DPP-IV inhibitors for treating diabetes, a $10B market, as well as FAP and other post-proline cleaving enzymes of interest to the pharma industry. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the benefits of the recently completed business combination, as well as statements about the potential attributes and benefits of New POINT’s product candidates and the format and timing of New POINT’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the outcome of any legal proceedings that may be instituted against New POINT following the closing of the business combination, the risk that the business combination disrupts current plans and operations, the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of New POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on New POINT’s business, the ability to maintain the listing of New POINT’s common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that New POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in RACA’s definitive proxy statement filed with the SEC on June 9, 2021. Most of these factors are outside of New POINT’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Company Contact: Ari Shomair media@pointbiopharma.com (647) 812-2417 Investor Relations Contact: Alex Lobo Stern Investor Relations investors@pointbiopharma.com

PRINCETON, N.J. & LONDON--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY - News) and AstraZeneca (NYSE: AZN - News) today announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee determined (by a vote of 10 to 2) that the data supporting the new drug application for ONGLYZA™ (saxagliptin) for the treatment of adults with type 2 diabetes were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program. The Committee unanimously recommended that the Sponsors perform a post-marketing trial to confirm the cardiovascular pro ONGLYZA. Bristol-Myers Squibb and AstraZeneca are working on a series of Phase IIIb and IV studies, including a large, controlled, randomized, post-marketing trial, to further characterize the long-term clinical effectiveness as well as the cardiovascular pro ONGLYZA. The companies will now work with the FDA to finalize the post-marketing trial design. “Bristol-Myers Squibb and AstraZeneca are encouraged by the Committee’s recommendation. We will work closely with the FDA to support the review of ONGLYZA,” said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. ONGLYZA is an investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The ONGLYZA application to the FDA includes use as a monotherapy, as an adjunct to diet and exercise, use in combination with three types of commonly used oral anti-diabetic (OAD) medications - metformin, thiazolidinediones and sulfonylureas (SUs) when the single agent alone does not provide adequate glycemic control, as an adjunct to diet and exercise – and use in initial combination therapy with metformin, as an adjunct to diet and exercise. The FDA Endocrinologic and Metabolic Drugs Advisory Committee based its recommendation on review of data from the comprehensive ONGLYZA clinical development program, which included more than 5,000 individuals, more than 4,000 of whom were given ONGLYZA. Data presented included safety and efficacy results from six pivotal Phase III trials, in addition to comprehensive post hoc pooled analyses evaluating cardiovascular risk in the Phase IIb and Phase III studies, which included individuals followed for up to 2.5 years and more than 3,700 person-years of exposure to ONGLYZA. The post hoc pooled analyses did not show evidence of a cardiovascular safety signal in individuals taking ONGLYZA. The FDA is not bound by the Advisory Committee’s recommendations, but takes its advice into consideration when reviewing new drug applications. Bristol-Myers Squibb and AstraZeneca will review the information leading to the Committee’s decision and continue to work closely with the FDA to support the review of ONGLYZA. The new drug application for ONGLYZA was submitted to the FDA on June 30, 2008, and has an action date of April 30, 2009. ONGLYZA, an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes, was specifically designed to be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual routes of clearance. ONGLYZA is being studied in ongoing and further planned clinical trials. About DPP-4 Inhibitors DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels (glucose) by increasing the body’s utilization of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver’s production of glucose. About Type 2 Diabetes Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. Diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage. There are two primary underlying causes associated with type 2 diabetes: the body does not produce enough insulin (insulin deficiency), or the cells ignore the insulin (insulin resistance). Symptoms of type 2 diabetes develop gradually, and their onset is not as sudden as in type 1 diabetes. Symptoms may include fatigue, frequent urination, increased thirst and hunger, weight loss, blurred vision, and slow healing of wounds or sores. Some people, however, have no symptoms. Type 2 diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity and certain ethnicities. People with type 2 diabetes often are characterized with: insulin resistance, abdominal obesity, a sedentary lifestyle, having low HDL-C (“good”) cholesterol levels and high triglyceride levels and hypertension. Type 2 diabetes accounts for approximately 90 to 95 percent of all diabetes. This equates to roughly 221 million people with type 2 diabetes globally, and 21.2 million people in the U.S. alone. The American Diabetes Association recommends a hemoglobin A1C measurement of less than 7 percent for most people with type 2 diabetes. Hemoglobin A1C is a measurement of a person’s average blood glucose level over a two-to-three month period and is considered an important marker of long-term glucose control. Other important markers for type 2 diabetes include fasting plasma glucose, a measure of a person’s blood glucose after at least eight hours of fasting and postprandial glucose, a measure of a person’s blood glucose after a meal. Bristol-Myers Squibb and AstraZeneca Partnership Bristol-Myers Squibb and AstraZeneca entered into collaboration in January 2007 to enable the companies to research, develop and commercialize two investigational drugs for type 2 diabetes – saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information visit About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: Bristol-Myers Squibb Forward-Looking Statement This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the product described in this release will receive regulatory approval. There can be no assurance that if approved, the product will be commercially successful. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2008, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. AstraZeneca Forward-Looking Statement The statement contained herein include forward-looking statements. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of the preparation of this press release and the Company undertakes no obligation to update these forward-looking statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things, those risk factors identified in the Company's Annual Report/Form 20-F for 2008. Nothing contained herein should be construed as a profit forecast. ONGLYZA™ is a trademark of the Bristol-Myers Squibb Company. Contact: Media: Bristol-Myers Squibb Ken Dominski, 609-252-5251 ken.dominski@bms.com or AstraZeneca Neil McCrae, +44 207 304 5045 neil.mccrae@astrazeneca.com or Investors US: Bristol-Myers Squibb John Elicker, 609-252-4611 john.elicker@bms.com or AstraZeneca Edward Seage, 302-886-4065 edward.seage@astrazeneca.com or Jorgen Winroth, 212-579-0506 jorgen.winroth@astrazeneca.com or Investors EU: AstraZeneca Jonathan Hunt, +44 207 304 5087 jonathan.hunt@astrazeneca.com or Karl Hard, +44 207 304 5322 karl.j.hard@astrazeneca.com or James Mead, +44 207 304 5062 james.mead@astrazeneca.com