SEZ6

Aadi Enters into Exclusive License for Three-Asset ADC Portfolio Developed through a Collaboration between WuXi Biologics and HANGZHOU DAC Aadi Enters Agreement to Sell FYARRO® and Associated Infrastructure to KAKEN Pharmaceutical for $100M; Announces PIPE Financing of $100M Cumulative Capital Expected to Fund Operations into Late 2028, Including Anticipated Clinical Data for the ADC Portfolio Co-Founder and Former CEO of ProfoundBio, Baiteng Zhao, Appointed to Aadi Board of Directors Aadi to Hold Webcast and Conference Call on December 20 at 8:00 AM EST LOS ANGELES, Dec. 19, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI) today announced it has entered into an exclusive license agreement for development and global commercialization of a three-asset portfolio of preclinical, next-wave antibody-drug conjugates (ADCs), in collaboration with WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and HANGZHOU DAC BIOTECHNOLOGY CO., LTD. (HANGZHOU DAC), a global leader in ADC innovation. Per the terms of the license agreement, Aadi is granted exclusive rights to certain patents and know-how pertaining to three preclinical ADC programs leveraging HANGZHOU DAC's CPT113 linker payload technology targeting each of Protein Tyrosine Kinase 7 (PTK7), Mucin-16 (MUC16) and Seizure Related 6 Homolog (SEZ6). Aadi will pay aggregate upfront payments of $44 million for in-licensing such ADC programs. Additionally, Aadi is obligated to pay cumulative development milestone payments of up to $265 million, cumulative commercial milestone payments of up to $540 million and single-digit royalties of sales. To support this transaction, Aadi entered into a subscription agreement with certain qualified institutional buyers and accredited investors for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds of approximately $100 million, before deducting placement agent fees and other offering expenses. The Company is selling an aggregate of 21,592,000 shares of its common stock ("Common Stock") at a price of $2.40 per share, representing a premium of approximately 3.4% to the closing price on December 19, 2024 on Nasdaq, and pre-funded warrants ("Pre-Funded Warrants") to purchase up to an aggregate of 20,076,500 shares of Common Stock at a purchase price of $2.3999 per Pre-Funded Warrant share. The syndicate was led by Ally Bridge Group, with participation from new investors OrbiMed, Invus, Kalehua Capital and other accredited investors, Tae Han co-founder of ProfoundBio, as well as existing investors, including Avoro Capital, KVP Capital and Acuta Capital Partners. The PIPE financing is expected to close in the first half of 2025, subject to stockholder vote and satisfaction of customary closing conditions. "I'm thrilled to announce our partnership with WuXi Biologics and HANGZHOU DAC to bring forward this thoughtfully selected ADC portfolio. We were deliberate in identifying broadly expressed tumor targets where first-generation ADCs have already shown proof of concept. With our next wave ADC portfolio, we aim to build upon these earlier therapies to deliver improved outcomes for people living with cancer," said David Lennon, PhD, President and CEO of Aadi Bioscience. "The financing underscores the confidence our investors have in both the potential of this portfolio and the strength of Aadi's management team." About the ADC Portfolio Each of the three ADC assets utilizes HANGZHOU DAC's CPT113 ADC platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The CPT113 platform's linker stability and novel payload has the potential to be highly competitive among the next generation ADC platforms. To effectively leverage the CPT113 platform, Aadi selected tumor targets that are upregulated in high-potential cancer indications and where clinical efficacy has been demonstrated by first-generation ADCs. PTK7-CPT113 potentially represents a differentiated opportunity to be among the first next-wave ADCs in clinical development for high PTK7 expressing cancers, including non-small cell lung cancer (NSCLC), ovarian cancer and several other major indications. mMUC16-CPT113 is the first ADC that targets membrane-bound portion of MUC16, a glycoprotein often overexpressed in cancers of female origin. biSEZ6-CPT113 is designed to address the neuronal target, SEZ6, which is often overexpressed in cancers of neuroendocrine origin. biSEZ6-CPT113 utilizes a dual epitope binding, or biparatopic, approach which can potentially improve internalization and effectiveness of the ADC. These assets were discovered through the collaborative efforts of WuXi Biologics and HANGZHOU DAC, utilizing the innovative antibody discovery platform provided by WuXi Biologics and advanced linker-payload technology provided by HANGZHOU DAC. "Leveraging our advanced antibody discovery service, we're glad to enable Aadi to accelerate the discovery of precision therapies targeting some of the most challenging cancers," said Dr. Chris Chen, CEO of WuXi Biologics. "This collaboration underscores our wide recognition as an industry leader in discovery service solutions, and further validates our ability to provide integrated discovery technology platforms for global partners to develop next-generation modalities. We look forward to partnering with Aadi and HANGZHOU DAC to expeditiously move these assets forward into clinical development and benefit patients worldwide." "HANGZHOU DAC's CPT-ADC platform is designed to enable next wave ADC capabilities that surpass first-generation technologies, including two programs already in clinical development in China," said Dr. Robert Y. Zhao, President and CEO of HANGZHOU DAC Biotechnology. "As a global leader in ADC innovation, we are excited to partner with Aadi and WuXi Biologics to deliver this promising portfolio to patients." Aadi to Sell FYARRO for $100 Million, Cumulative Capital Expected to Fund Operations into Late 2028 In a separate agreement, KAKEN Pharmaceutical Co., Ltd., an R&D driven pharmaceutical company in Japan, has entered into a stock purchase agreement under which KAKEN will acquire Aadi Subsidiary, Inc. and all of its assets, including FYARRO® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) and associated infrastructure, including the majority of Aadi employees who support the FYARRO® business. FYARRO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), with cumulative revenue of $25.2 million reported over the prior four quarters ended September 30, 2024. Per the terms of the agreement, Kaken will pay Aadi $100 million in cash at closing, subject to certain adjustments. The transaction is expected to close in the first half of 2025, subject to Aadi stockholder approval and certain closing conditions. Upon the closing of this transaction, KAKEN will also acquire the rights to the Aadi name and trademark. "We are enormously proud of the impact FYARRO has had for people with PEComa, and Kaken's capabilities, coupled with the proven track record of the Aadi team, ensures physicians and patients will continue to have access to this critical treatment," said Lennon. The net proceeds from the PIPE financing and the sale of FYARRO, together with the Company's existing cash, cash equivalents and marketable securities are expected to fund operations into late-2028, including anticipated clinical data readouts for the ADC portfolio. Baiteng Zhao Appointed to the Board of Directors, Brings Significant ADC Expertise Baiteng Zhao, PhD, joins Aadi's board of directors. Zhao co-founded ProfoundBio, a clinical stage next-gen ADC developer, in 2018 and served as the Chairman and CEO of the company until it was acquired by Genmab for $1.8 billion in May 2024. Prior to ProfoundBio, Dr. Zhao worked at Seagen (now part of Pfizer) for more than eight years and was responsible for the modeling and simulation strategies for the development pipeline and supported preclinical and clinical development of ADC drug candidates. "We are delighted to welcome Baiteng to our Board. His deep expertise and successful track record in ADC development will be instrumental as we tenaciously move this exciting portfolio forward," said Caley Castelein, MD, Chair of the Board of Directors of Aadi Bioscience. "I am thrilled to join the Board at this pivotal moment for Aadi," said Baiteng Zhao, PhD, Board of Directors of Aadi Bioscience and co-founder of ProfoundBio. "PTK7, MUC16 and SEZ6 represent highly promising targets that are commonly overexpressed in cancers with significant unmet therapeutic needs. Coupled with an advanced linker-payload platform that has the potential to enable next-gen ADCs, I believe Aadi is uniquely positioned to make a meaningful impact on patient outcomes. I look forward to collaborating with the leadership team and fellow Board directors to advance these innovative programs and drive transformative progress for patients." Advisors Leerink Partners is serving as financial advisor to Aadi on the sale of FYARRO and the licensing of the ADC portfolio. Jefferies LLC is acting as exclusive placement agent for the PIPE financing. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Aadi. McDermott Will & Emery LLP is serving as legal counsel to Kaken. Cooley LLP is serving as legal counsel to Jefferies LLC. Nomura Securities Co., Ltd. is serving as financial advisor to KAKEN. Conference Call Information The Aadi management team is hosting a conference call and webcast tomorrow, Friday, December 20th at 8:00 AM EST (5:00 AM PST) to discuss these updates. Participants may access a live webcast of the call and the associated slide presentation on these data through the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. Additional Information for Stockholders This communication relates to the proposed sale of FYARRO and the proposed PIPE financing and may be deemed to be solicitation material in respect of such transactions. In connection with these proposed transactions, Aadi will file a Proxy Statement with the SEC. This communication is not a substitute for the Proxy Statement or any other documents that Aadi may file with the SEC or send to Aadi stockholders in connection with the proposed transactions. Before making any voting decision, investors and securityholders are urged to read the Proxy Statement and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transactions as they become available because they will contain important information about the proposed transactions and related matters. Stockholders may obtain a copy of the Proxy Statement and other documents the Company files with the SEC (when they are available) through the website maintained by the SEC at www.sec.gov, as well as on the Investor and News section of Aadi's website at www.aadibio.com. Certain stockholders of Aadi holding approximately 36% of Aadi's outstanding shares, as of the date hereof, including members of its board of directors and related entities, have entered into voting and support agreements in favor of KAKEN Pharmaceutical and Aadi, pursuant to which such stockholders have agreed to vote in favor of the stock purchase transaction with KAKEN Pharmaceutical and the other transactions described above. Participants in the Solicitation Aadi and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Aadi in connection with the proposed transactions. Information about Aadi's directors and executive officers is set forth in Aadi's definitive proxy statement filed with the SEC on April 26, 2024, and in subsequent filings made by Aadi with the SEC. Other information regarding the interests of such individuals, as well as information regarding Aadi's directors and executive officers and other persons who may be deemed participants in the proposed transactions, will be set forth in the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of these documents as described in the preceding paragraph. No Offer or Solicitation This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor a solicitation of any vote or approval with respect to the proposed transactions or otherwise, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offer and sale of securities of Aadi described above are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the subscription agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file, following the closing of the PIPE financing, a registration statement with the SEC registering the resale of the shares of Common Stock and the shares of Common Stock underlying the Pre-Funded Warrants sold in the PIPE financing. About Aadi Bioscience Aadi is a precision oncology company with a vision to make bold choices in applying technology to efficiently deliver improved precision oncology therapies for people living with difficult-to-treat cancers. More information on the Company is available on the Aadi website at www.aadibio.com and connect with us on LinkedIn. Forward-Looking Statements This press release contains certain forward-looking statements regarding the business of Aadi Bioscience that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: the timing and completion of the proposed sale of FYARRO to Kaken Pharmaceuticals and the anticipated timing of the closing of the transaction; expectations regarding the timing, closing and completion of the PIPE financing; Aadi's expected cash position at the closing and cash runway of the company following the sale of FYARRO and PIPE financing; the future operations of Aadi; the development and potential benefits of any of Aadi's product candidates, including the preclinical ADC assets proposed to be licensed from WuXi; anticipated preclinical and clinical development activities and related timelines, including the expected timing for announcement of data and other preclinical and clinical results and potential submission of IND filings for one or more product candidates; and other statements that are not historical fact. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with (i) the risk that the conditions to the closing of the proposed sale of FYARRO or the PIPE financing are not satisfied, including the failure to timely obtain stockholder approval for the transactions, if at all; (ii) uncertainties as to the timing of the consummation of the proposed transactions and the ability of each of Kaken and Aadi to consummate the proposed sale of FYARRO; (iii) risks related to Aadi's ability to manage its operating expenses and its expenses associated with the proposed transactions pending the closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed transactions; (v) unexpected costs, charges or expenses resulting from the transactions; (vii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed sale of FYARRO or the proposed PIPE financing; (vii) the uncertainties associated with Aadi's product candidates, as well as risks associated with the preclinical and clinical development and regulatory approval of product candidates, including potential delays in the completion of preclinical studies and clinical trials; (viii) risks related to the inability of Aadi to obtain sufficient additional capital to continue to advance these product candidates; (ix) uncertainties in obtaining successful preclinical and clinical results for product candidates and unexpected costs that may result therefrom; (x) risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (xi) risks associated with the possible failure to realize certain anticipated benefits of the proposed sale of FYARRO or the proposed PIPE financing, including with respect to future financial and operating results. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including under the caption "Item 1A. Risk Factors," and in Aadi's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: IR@aadibio.com View original content to download multimedia:https://www.prnewswire.com/news-releases/aadi-bioscience-transforms-with-in-licensing-of-novel-adc-portfolio-100-million-sale-of-fyarro-and-100-million-pipe-financing-302336743.html SOURCE Aadi Bioscience

Reports Second-Quarter Diluted EPS of $0.77 on a GAAP Basis, a Decrease of 32.5 Percent; Adjusted Diluted EPS of $2.65, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $0.52 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $14.462 Billion, an Increase of 4.3 Percent on a Reported Basis and 5.6 Percent on an Operational Basis Second-Quarter Global Net Revenues from the Immunology Portfolio Were $6.971 Billion, an Increase of 2.3 Percent on a Reported Basis, or 3.5 Percent on an Operational Basis; Global Humira Net Revenues Were $2.814 Billion; Global Skyrizi Net Revenues Were $2.727 Billion; Global Rinvoq Net Revenues Were $1.430 Billion Second-Quarter Global Net Revenues from the Oncology Portfolio Were $1.634 Billion, an Increase of 10.5 Percent on a Reported Basis, or 12.2 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $833 Million; Global Venclexta Net Revenues Were $637 Million Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.162 Billion, an Increase of 14.7 Percent on a Reported Basis, or 15.2 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $814 Million; Global Vraylar Net Revenues Were $774 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $381 Million Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.390 Billion, an Increase of 0.5 Percent on a Reported Basis, or 2.8 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $729 Million; Global Juvederm Net Revenues Were $343 Million Raises 2024 Adjusted Diluted EPS Guidance Range from $10.61 - $10.81 to $10.71 - $10.91, which Includes an Unfavorable Impact of $0.60 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2024 NORTH CHICAGO, Ill., July 25, 2024 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2024. "Our business continues to perform exceptionally well, with second quarter results meaningfully ahead of our expectations," said Robert A. Michael, chief executive officer, AbbVie. "Based upon the significant momentum of our ex-Humira growth platform, our continued investments in the business and our pipeline progress, we are very well positioned to deliver our top-tier long-term outlook." Second -Quarter Results Worldwide net revenues were $14.462 billion, an increase of 4.3 percent on a reported basis, or 5.6 percent on an operational basis. Global net revenues from the immunology portfolio were $6.971 billion, an increase of 2.3 percent on a reported basis, or 3.5 percent on an operational basis. Global Humira net revenues of $2.814 billion decreased 29.8 percent on a reported basis, or 28.9 percent on an operational basis. U.S. Humira net revenues were $2.360 billion, a decrease of 31.6 percent. Internationally, Humira net revenues were $454 million, a decrease of 18.9 percent on a reported basis, or 12.5 percent on an operational basis. Global Skyrizi net revenues were $2.727 billion, an increase of 44.8 percent on a reported basis, or 45.6 percent on an operational basis. Global Rinvoq net revenues were $1.430 billion, an increase of 55.8 percent on a reported basis, or 59.2 percent on an operational basis. Global net revenues from the oncology portfolio were $1.634 billion, an increase of 10.5 percent on a reported basis, or 12.2 percent on an operational basis. Global Imbruvica net revenues were $833 million, a decrease of 8.2 percent, with U.S. net revenues of $595 million and international profit sharing of $238 million. Global Venclexta net revenues were $637 million, an increase of 11.5 percent on a reported basis, or 15.8 percent on an operational basis. Global Elahere net revenues were $128 million. Global net revenues from the neuroscience portfolio were $2.162 billion, an increase of 14.7 percent on a reported basis, or 15.2 percent on an operational basis. Global Botox Therapeutic net revenues were $814 million, an increase of 8.7 percent on a reported basis, or 9.6 percent on an operational basis. Global Vraylar net revenues were $774 million, an increase of 17.6 percent. Global Ubrelvy net revenues were $231 million, an increase of 17.5 percent. Global Qulipta net revenues were $150 million, an increase of 56.3 percent. Global net revenues from the aesthetics portfolio were $1.390 billion, an increase of 0.5 percent on a reported basis, or 2.8 percent on an operational basis. Global Botox Cosmetic net revenues were $729 million, an increase of 6.4 percent on a reported basis, or 8.6 percent on an operational basis. Global Juvederm net revenues were $343 million, a decrease of 6.8 percent on a reported basis, or 3.1 percent on an operational basis. On a GAAP basis, the gross margin ratio in the second quarter was 70.9 percent. The adjusted gross margin ratio was 85.2 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 23.3 percent of net revenues. The adjusted SG&A expense was 22.9 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 13.5 percent of net revenues. The adjusted R&D expense was 13.3 percent of net revenues. Acquired IPR&D and milestones expense was 6.5 percent of net revenues. On a GAAP basis, the operating margin in the second quarter was 27.6 percent. The adjusted operating margin was 42.6 percent. Net interest expense was $506 million. On a GAAP basis, the tax rate in the quarter was 36.0 percent. The adjusted tax rate was 18.8 percent. Diluted EPS in the second quarter was $0.77 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.65. These results include an unfavorable impact of $0.52 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events As previously announced, Robert A. Michael assumed the role of chief executive officer (CEO) and has joined AbbVie's Board of Directors, effective July 1, 2024. Mr. Michael succeeds Richard A. Gonzalez, who served as CEO since the company's inception in 2013. Mr. Gonzalez has become executive chairman of the board of directors. AbbVie announced the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab) for adults with moderately to severely active ulcerative colitis (UC). AbbVie also announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Skyrizi for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. The FDA approval and positive CHMP opinion are based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of Skyrizi in adults with moderately to severely active UC. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. AbbVie announced that it submitted applications for a new indication to the FDA and EMA for Rinvoq (upadacitinib) for the treatment of adult patients with giant cell arteritis (GCA). The regulatory submissions are supported by results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of Rinvoq in patients with GCA. At the 2024 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented 15 abstracts, including three oral presentations, reinforcing AbbVie's commitment to advancing the standards of care in inflammatory bowel diseases (IBD). Highlights included data from the SEQUENCE head-to-head trial comparing Skyrizi versus Stelara (ustekinumab) in Crohn's disease (CD), as well as presentations that included efficacy and safety data evaluating clinical, endoscopic, and histologic outcomes from both the INSPIRE Phase 3 induction study and the COMMAND Phase 3 maintenance study of Skyrizi as a therapy for adults with moderately to severely active UC. AbbVie announced that it completed its acquisition of Landos Biopharma. The transaction adds the first-in-class investigational asset, ABBV-113 (NX-13), to AbbVie's pipeline, which has the potential to offer a novel approach to the treatment of UC and CD. AbbVie and FutureGen Biopharmaceutical announced a license agreement to develop FG-M701, a next generation anti-TL1A antibody for the treatment of IBD, currently in preclinical development. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation anti-TL1A antibodies, with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD. AbbVie announced the acquisition of Celsius Therapeutics, a privately held biotechnology company pioneering new therapies for patients with inflammatory disease. Celsius' lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody for the treatment of IBD that has completed a Phase 1 clinical study. AbbVie announced the FDA approved Epkinly (epcoritamab) to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of prior therapy. AbbVie also announced that the EMA's CHMP adopted a positive opinion for Tepkinly (epcoritamab) for the treatment of adults with r/r FL. The FDA approval and positive CHMP opinion are based on results from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Epkinly/Tepkinly in adult patients with r/r FL. Epkinly/Tepkinly is being co-developed by AbbVie and Genmab. AbbVie announced positive topline results from the Phase 2 PICCOLO trial evaluating Elahere (mirvetuximab soravtansine) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The trial met its primary endpoint with an objective response rate (ORR) of 51.9% and demonstrated a median duration of response (DOR), a key secondary endpoint, of 8.25 months. The safety profile of Elahere was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting. AbbVie announced the start of the Phase 3 CERVINO clinical trial which will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r multiple myeloma (MM) who have received at least two lines of prior therapy. The start of the CERVINO trial marks an important step forward in AbbVie's continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients. At the American Society of Clinical Oncology (ASCO) Annual Meeting, AbbVie showcased its solid tumor pipeline with new data from its innovative antibody-drug conjugate (ADC) platform. Highlights included new safety and efficacy data from a Phase 1 study of ABBV-400, a next-generation, potential best-in-class c-Met directed ADC, in patients with metastatic colorectal cancer (CRC); data from a first-in-human study of ABBV-706, a potential best-in-class SEZ6 directed ADC, in small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine neoplasms (NENs); data from the primary analysis of the Phase 2 LUMINOSITY trial evaluating Telisotuzumab vedotin (Teliso-V), a potential first-in-class c-Met directed ADC, in advanced non-small cell lung cancer (NSCLC); and data from the Phase 3 MIRASOL trial of Elahere in patients with platinum-resistant ovarian cancer (PROC) and high FRα expression. AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). In its letter, the FDA cited observations that were identified during inspection of a third-party manufacturer listed in the NDA. The CRL did not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device, and does not request that AbbVie conduct additional efficacy or safety trials related to the drug or device-related testing. AbbVie continues to work with the FDA to bring ABBV-951 to patients in the U.S. as quickly as possible. AbbVie and Gilgamesh Pharmaceuticals announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. These next-generation therapies known as neuroplastogens target mechanisms that have shown potential to provide significant clinical benefits and are designed to minimize the challenging effects seen with first-generation compounds. This collaboration will leverage AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform to discover novel neuroplastogens. Full-Year 2024 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2024 from $10.61 - $10.81 to $10.71 - $10.91, which includes an unfavorable impact of $0.60 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2024. The company's 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2024, as both cannot be reliably forecasted. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2024 and 2023 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the proposed acquisition of Cerevel Therapeutics, including the possibility that the acquisition may not be consummated on the anticipated timeframe or at all, risks related to the ability to realize the anticipated benefits of the proposed acquisition on the anticipated timeframe or at all, risks that the costs to consummate the proposed acquisition or to obtain the anticipated benefits of the proposed acquisition could be greater than expected, the risk that an event occurs that could give rise to the right of AbbVie, on the one hand, or Cerevel Therapeutics, on the other hand, to terminate the acquisition agreement for such transaction, the risk that the business will not be integrated successfully, disruption from the proposed acquisition making it more difficult to maintain business and operational relationships, the diversion of management's attention from ongoing business operations and opportunities, negative effects of the consummation of the proposed acquisition on business or employee relationships or the market price of the Company's common stock and/or operating results, significant transaction costs, the assumption of unknown liabilities, the risk of litigation and/or regulatory actions related to the proposed acquisition of Cerevel Therapeutics's business, risks related to the financing of the proposed acquisition, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's and Cerevel Therapeutics's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information; Item 1A, "Risk Factors," of Cerevel Therapeutics's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that Cerevel Therapeutics subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie

AbbVie's ADC push follows the failure of Rova-T, an ADC picked up in a $5.8 billion buyout of Stemcentrx eight years ago. A new trend has emerged at this year’s American Society of Clinical Oncology conference: the possibility of replacing decades-old chemotherapy with novel approaches. “We want to be part of that wave,” AbbVie Pedro Valencia, Ph.D., AbbVie’s vice president of solid tumor pipeline strategy and execution, told Fierce Biotech onsite in Chicago. “This is the ASCO where we show the most antibody-drug conjugate (ADC) data in history for AbbVie.” “You look back five years ago, ADCs were primarily in the hematology space. Now you're seeing ADCs playing a significant role in solid tumors,” Daejin Abidoye, M.D., head of solid tumors, oncology development, said in a joint interview with Valencia. “If there is, for me, one takeaway, it’s that we expect that over time there will be therapies available for patients that do not include chemotherapy.” The Illinois-based company shared primary results from a phase 2 study, dubbed Luminosity, evaluating next-gen ADC telisotuzumab vedotin (Teliso-V) in non-small cell lung cancer (NSCLC). The c-Met directed asset is made up of the monoclonal antibody (mAb) telisotuzumab and the microtubule polymerization inhibitor monomethyl auristatin E. Among 161 patients with previously treated c-Met–overexpressing non-squamous EGFR wildtype advanced NSCLC, the overall response rate (ORR) was 28.6%. “We're pretty encouraged by what we've seen thus far in terms of there was not only a response rate, but the durability of those responses, as well as the overall safety profile,” Abidoye said. The 28.6% compares to chemotherapy docetaxel, which historically has an ORR of about 15% to 20%, or a slightly higher 20-22% when adding mAb ramucirumab, according to Valencia. Patients with high c-Met expression had a higher ORR of 34.6% in the phase 2 ADC trial, compared to a 22.9% ORR for patients with intermediate c-met expression. The data is down from what AbbVie previously shared of the study. A 2022 update, which helped secure a breakthrough designation for Teliso-V, linked the ADC to response rates of 53.8% and 25% in c-Met high and c-Met intermediate patients, respectively.    The new data reveals two treatment-related patient deaths, one from interstitial lung disease (ILD) and one from respiratory failure. “ILD has obviously been a concern for a lot of these ADCs, particularly the ones that are being evaluated in non-small cell lung cancer,” Abidoye said. “We do have a ILD adjudication team that's really looking at these cases to better understand which cases are actually treatment related.” The current general consensus is that the nature of the damage to the lungs coming into the trial might put a person at greater risk of the adverse event. “For the most part, we see that the safety profile is manageable,” Abidoye added. Abbvie will look to an ongoing phase 3 trial to better understand the ADC’s safety profile, he explained. The confirmatory study compares Teliso-V to docetaxel in 700 patients with c-Met overexpressing, previously treated NSCLC. A primary readout is slated for mid-2025. Last November, the pharma said it planned on seeking accelerated FDA approval for the ADC. That’s still the plan, according to Abidoye, who said the company couldn’t provide further comment at this time. In addition to Teliso-V, AbbVie shared early data from a monotherapy dose escalation portion of a phase 1 trial assessing ABBV-706, a SEZ6 directed ADC, among patients with advanced solid tumors. The pharma also presented early data from a phase 1 dose-escalation and colorectal cancer dose-expansion cohort of ABBV-400, an investigational c-Met directed ADC. The ADC push follows the failure of AbbVie’s Rova-T, an ADC the pharma picked up in a $5.8 billion buyout of Stemcentrx eight years ago. The pharma let go of its hopes for the asset after several lung cancer trials failed to deliver significant efficacy results.    AbbVie learned quite a bit from Rova-T, Valencia said, emphasizing that the Stemcentrx platform had a different payload and set of antibodies. “Since then, we've spent a lot of time trying to find a combination of target linkers, of payloads, that maximizes the therapeutic interface, as opposed to just being very narrow. You have to hit in the right dose before it gets too toxic,” Valencia said. AbbVie’s next generation of ADCs are carefully engineered to be purified, have very stable linkers, and optimize drug antibody ratios to maximize efficiency, the solid tumor executive said.