Intermediate Atypical Prostate Carcinoma

POINT Biopharma unveiled the Phase III data that its shareholders have been waiting for, with the SPLASH study of 177Lu-PNT2002 in patients with metastatic castration-resistant prostate cancer (mCRPC) hitting its primary endpoint. However, the PSMA-targeted radioligand therapy did not seem to perform better than Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) – something that investors had been hoping for.Eli Lilly reached a deal back in October to buy POINT for $12.50 per share in cash, or approximately $1.4 billion, representing a premium of 87%. Despite the agreement having the backing of POINT’s board, the majority of shareholders have chosen to hold onto their stock, with only around 22.81% of outstanding shares validly tendered into the offer as of December 15.Investor hopes pinned to dataInstead, POINT’s stock price has steadily risen since Eli Lilly’s offer was announced, reaching just over $14 per share ahead of the SPLASH readout, with investors possibly hoping that positive results could lead to a higher offer or another buyout offer. Following the data release, shares in POINT fell back below Eli Lilly’s offer price, with the latter extending the closing of the tender to December 22.The SPLASH trial enrolled 412 patients with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. Subjects were randomised to receive 177Lu-PNT2002 or either Johnson & Johnson’s Zytiga (abiraterone) or Astellas and Pfizer’s Xtandi (enzalutamide), with the study’s main goal being radiographic progression-free survival (rPFS).Results below expectationsTop-line results showed that 177Lu-PNT2002 significantly reduced the risk of radiographic progression or death by 29% versus ARPI therapy, with rPFS in the two groups of 9.5 months and 6.0 months, respectively. POINT noted that while interim overall survival (OS) results are immature, the hazard ratio was 1.1. Ahead of the readout, Jefferies analysts suggested that the base-case scenario for 177Lu-PNT2002 in the SPLASH study would be rPFS of around 10 months to 11 months.Earlier this year, Novartis reported that median rPFS for Pluvicto in the Phase III PSMAfore trial was 12 months, compared to 5.6 months for those on ARPI therapy. However, the study – which enrolled patients with PSMA-positive mCRPC after treatment with ARPI therapy – has so far failed to show a survival benefit, with Pluvicto associated with a hazard ratio of 0.8 for OS. Novartis has said that this may be "confounded" by the high crossover rate, as 84% of those who discontinued ARPI due to radiographic progression switched to Pluvicto.POINT also highlighted a high crossover rate in SPLASH, with 84.6% of patients who experienced progressive disease in the control arm subsequently switching to treatment with 177Lu-PNT2002. “With only four treatment administrations over a 32-week period, this regimen provides reduced treatment intensity compared to the control arm,” remarked Neil Fleshner, POINT’s chief medical officer. The company, along with partner Lantheus, expect additional, follow-up data in 2024 prior to a potential marketing application to the FDA.Novartis remains leaderCommenting on the SPLASH results, Stifel Nicolaus analysts said POINT’s therapy is no longer considered “as a too serious competitor” to Pluvicto, which they added “very much looks like first and best-in-class now.” Sales of Novartis’ product jumped 220% in the third quarter to $256 million, with Stifel Nicolaus estimating revenue of $4.5 billion in 2028.While 177Lu-PNT2002 is POINT’s most advanced development candidate, Eli Lilly is keen to acquire the company to give it a starting point for entering the radioligand field. Speaking to FirstWord earlier this year, Jacob Van Naarden, president of Eli Lilly's oncology unit Loxo@Lilly, said it was important to acquire a company that has “already built a lot of great capabilities,” in order to “jumpstart” its efforts in the space, adding “it was absolutely not a capability that I thought we could build on our own.”

BEDFORD, Mass. and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI). “There is an urgent unmet need for targeted treatment options for mCRPC patients, particularly for those whose cancer has progressed on androgen receptor pathway inhibitors,” said Dr. Kim Chi, SPLASH Principal Investigator, Medical Oncologist, BC Cancer. “The SPLASH study results demonstrate that 177Lu-PNT2002 is well-tolerated and has the potential to play an important role in addressing those needs for patients with chemotherapy-naïve mCRPC.” The SPLASH trial met its primary endpoint, demonstrating a median radiographic progression-free survival (rPFS) per blinded independent central review of 9.5 months for patients treated with 177Lu-PNT2002, compared to 6.0 months for patients treated with ARPI in the control arm, a statistically significant 29% reduction in the risk of radiographic progression or death (hazard ratio [HR] 0.71; p=0.0088). At the time of the analysis, interim overall survival (OS) results were immature (46% of protocol-specified target OS events reached), the HR was 1.11. The companies expect additional, follow-up data in 2024 prior to the potential submission of a New Drug Application (NDA). 177Lu-PNT2002 demonstrated a favorable safety pro grade ≥3 treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events (CTCAE), serious TEAEs, and TEAEs leading to discontinuation occurring at lower rates in the 177Lu-PNT2002 arm than in the ARPI arm (30.1%, 17.1%, and 1.9% vs. 36.9%, 23.1%, and 6.2%, respectively). 177Lu -PNT2002 Arm ARPI Arm TEAEs of CTCAE Grade ≥3 30.1% 36.9% Serious TEAEs 17.1% 23.1% TEAEs Leading to Discontinuation 1.9% 6.2% The open-label study randomized 412 patients with PSMA-expressing mCRPC who had progressed on ARPI therapy and either refused or were not eligible for chemotherapy, in a 2:1 randomization ratio (177Lu-PNT2002: control group). At the time of the analysis, 84.6% of patients who experienced progressive disease in the control arm subsequently crossed over to receive 177Lu-PNT2002. SPLASH was conducted across the United States, Canada, Europe, and the United Kingdom. Eighty percent of SPLASH patients resided in North America and approximately 10% of all participants were Black or African American. "The success of 177Lu-PNT2002 in this trial demonstrates the value of treating patients with radioligand therapy at this stage of the disease continuum. With only four treatment administrations over a 32-week period, this regimen provides reduced treatment intensity compared to the control arm, while also delaying disease progression with lower toxicity,” said Neil Fleshner, M.D., Co-founder and Chief Medical Officer at POINT Biopharma. “We extend our deepest gratitude to the SPLASH study participants and their families and caregivers, as well as the investigators and their hard-working staff." “We are encouraged by the results of the SPLASH trial, which showed the benefits that 177Lu-PNT2002 offers to patients with mCRPC. We are proud to be at the forefront of advancing the potential of targeted RLT with 177Lu-PNT2002. As the leading radiopharmaceutical-focused company, we are committed to providing clinicians with cutting-edge options to fight disease and improve patient outcomes,” said Jean-Claude Provost, M.D., Chief Medical Officer at Lantheus. “We look forward to sharing additional data in the future, and to collaborating with regulatory authorities and POINT Biopharma to bring this promising therapy to the prostate cancer patient community.” Full SPLASH trial results will be presented at a future medical congress. About the SPLASH Trial The phase 3 SPLASH trial is a multicenter, randomized, open label assessment of 177Lu-PNT2002 in patients with PSMA-expressing mCRPC who have progressed on ARPI therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study randomized 412 patients across North America, Europe, and the United Kingdom. Patients were randomized 2:1 with those in arm A receiving 177Lu-PNT2002 and those in arm B receiving either abiraterone or enzalutamide. Patients in arm B who experience centrally assessed radiographic progression and meet protocol eligibility have the option to crossover and receive 177Lu-PNT2002. Patients will be followed for up to 5 years from their first 177Lu-PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. More information about the trial is accessible at , identifier NCT04647526. About 177Lu-PNT2002 177Lu-PNT2002 is a PSMA-targeted, lutetium 177-based radioligand therapy candidate that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added lutetium-177. Lantheus Holdings, Inc. in-licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2002 from POINT in December of 2022. In April of 2023, the FDA granted Fast Track designation for 177Lu-PNT2002 for the treatment of mCRPC. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs. About Prostate Cancer Prostate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2023, almost 288,300 new cases of prostate cancer will be diagnosed, and about 34,700 men will die of the disease.1 About Lantheus Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit . 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 aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. Learn more about POINT Biopharma Global Inc. at . Safe Harbor for Forward-Looking and Cautionary Statements This press release contains “forward-looking statements” that are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements relating to the potential of PNT2002 and statements regarding Lantheus’ and POINT’S expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements may be identified by their use of terms such as "expected,” “look,” “planned,” “potential,” “will,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the outcome of the SPLASH trial after full data is available; (ii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and regulatory authorities for PNT2002; (iii) the additional costs and risks associated with Lantheus’ ability to successfully launch PNT2002 as a commercial product; (iv) the market and patient receptivity to PNT2002 as a radiopharmaceutical therapy; (v) the existence, availability and pro competing products and therapies; (vi) Lantheus’ ability to obtain and maintain adequate coding, coverage and payment for PNT2002; (vii) the intellectual property protection of PNT2002; (viii) POINT’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2002; and (ix) the risks and uncertainties discussed in Lantheus’ and POINT’s filings with the Securities and Exchange Commission (including those described in the Risk Factors section in their Annual Reports on Form 10-K and their Quarterly Reports on Form 10-Q).The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. Neither Lantheus nor POINT undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Additional Information and Where to Find it In connection with the proposed acquisition of POINT, Eli Lilly and Company (“Lilly”) caused its acquisition subsidiary to commence a tender offer for all of the issued and outstanding shares of common stock of POINT. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any securities, nor is it a substitute for the tender offer materials that Lilly and its acquisition subsidiary filed with the SEC upon commencement of the tender offer. A solicitation and offer to buy outstanding shares of POINT is being made only pursuant to the tender offer materials that Lilly and its acquisition subsidiary have filed with the SEC. Lilly and its acquisition subsidiary have filed with the SEC a tender offer statement on Schedule TO, and POINT has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO. INVESTORS AND STOCKHOLDERS OF POINT ARE URGED TO READ THESE DOCUMENTS CAREFULLY (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND STOCKHOLDERS OF POINT SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE TENDER OFFER. The tender offer materials (including the Offer to Purchase and the related Letter of Transmittal) are available to all stockholders of POINT at no expense to them at Lilly’s website at investor.lilly.com. The information contained in, or that can be accessed through, Lilly’s website is not a part of, or incorporated by reference in, this press release. The tender offer materials (including the Offer to Purchase and the related Letter of Transmittal), as well as the Solicitation/Recommendation Statement, are also available for free on the SEC’s website at In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Lilly and POINT quarterly, and current reports, proxy statements and other information with the SEC. You may read any reports, statements or other information filed by Lilly and POINT with the SEC for free on the SEC’s website at 1. American Cancer Society. Facts & Figures 2023. American Cancer Society. Atlanta, GA. 2023 Contacts: Lantheus Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus.com Melissa Downs Senior Director, External Communications 646-975-2533 media@lantheus.com POINT Biopharma Daniel Pearlstein Director, Strategy investors@pointbiopharma.com

Pivotal Study of NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population LATHAM, N.Y.--(BUSINESS WIRE)-- AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, today announced the completion of enrollment and final treatment in its Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE). The PRESERVE study was initiated by AngioDynamics, Inc. in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). "The PRESERVE study demonstrates AngioDynamics’ commitment to innovating care delivery,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Clinical and Scientific Affairs. “As we mark the completion of enrollment and final treatment in the study, we take another important step towards demonstrating the NanoKnife System’s ability to expand treatment options for patients with intermediate-risk prostate cancer and advance our mission to improve patient quality of life. We appreciate the support provided by our PRESERVE study sites and the partnership with the SUO-CTC team in this important effort.” Final patient enrollment in the study was initially announced during AngioDynamics’ Fiscal 2023 Fourth Quarter and Full-Year Financial Results conference call on July 12, 2023. Co-Principal Investigators leading the study are Jonathan Coleman, MD, Urologic Surgeon, Memorial Sloan Kettering Cancer Center, and Arvin George, MD, Urologic Surgeon, University of Michigan. The PRESERVE study will have its primary endpoint analysis at 12 months following treatment. “As diagnostic tools develop to allow earlier identification and localization of clinically significant forms of prostate cancer, there is a matching need to establish effective forms of treatment that target the disease and preserve patients' quality of life. Evidence is growing to support the use of partial gland ablation for prostate cancer as a reasonable alternative treatment strategy in carefully selected patients. The PRESERVE study, studying the efficacy of irreversible electroporation (IRE) with the NanoKnife System from AngioDynamics in men with intermediate-risk tumors (Gleason Grade 3+4 and 4+3), will help to address further the validity of this therapeutic approach using a treatment, which is well tolerated and easy to apply in prostate tissue,” said Co-Principal Investigator Jonathan Coleman, MD, Urologic Surgeon, Memorial Sloan Kettering Cancer Center. In 2023, the American Cancer Society estimates that there will be about 288,300 new cases of prostate cancer and about 34,700 deaths from the disease in the U.S. It is estimated that 1 out of every 8 men will be diagnosed with prostate cancer during their lifetime, and prostate cancer is more likely to develop in older and non-Hispanic Black men. It is American men's second leading cause of death.1 The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted tissue, delivering precise treatment margins while preserving vital structures by retaining the structural integrity of the targeted tissue. The delivery of non-thermal energy allows for the preservation of the extra-cellular matrix, facilitating post-ablation histological and functional tissue regeneration. To learn more and view risk information, visit NanoKnife.com. The PRESERVE study’s primary objectives are determining the NanoKnife System’s ablation effectiveness by measuring the negative in-field biopsy rate at 12 months and determining the NanoKnife System’s procedural and post-procedural safety pro evaluating adverse event incidence, type and severity through 12 months. The study enrolled and treated 121 patients in 17 facilities across the United States. Learn more about PRESERVE at angiodynamics.com/studies/preserve. About the NanoKnife System The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue. Visit nanoknife.com for full product information. Visit bit.ly/NanoKnifeRiskInfo for risk information. The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition. The NanoKnife System, when used for the treatment of prostate cancer, is an investigational device. It is limited by United States law to investigational use. About AngioDynamics, Inc. AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients. The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit . About the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) Created, owned and operated by its members, the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) is a clinical research investigator network of more than 400 members from more than 200 clinical sites in the U.S. and Canada. This national alliance of leading academic and community based uro-oncologists is committed to furthering urology research. The SUO-CTC is a registered 501c3 not-for-profit corporation and has a cooperative relationship with the Society of Urologic Oncology (SUO). For more information, visit suoctc.org. Safe Harbor This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects”, “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2022. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason. In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition. AngioDynamics, the AngioDynamics logo, and NanoKnife are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are the property of their respective owners. ©2023 AngioDynamics, Inc ________________________ 1 Key Statistics for Prostate Cancer | Cancer.org. . Published 2023. Accessed July 27, 2023. View source version on businesswire.com: Contacts Investor Relations: Stephen Trowbridge 518-795-1408 strowbridge@angiodynamics.com Media: Saleem Cheeks 518-795-1174 scheeks@angiodynamics.com Source: AngioDynamics, Inc. View this news release online at: