Mirvetuximab soravtansine

– Announced updated positive interim data from the Phase 1B dose-expansion clinical trial of SL-172154 in combination with Azacitidine (AZA) in frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) patients at the European Society of Hematology (EHA) 2024 Annual Meeting – – Enrollment ongoing in the randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients – – Announced Orphan Drug Designation (ODD) granted by the U.S. Food and Drug Administration (FDA) for SL-172154 for the treatment of AML– AUSTIN, TX and DURHAM, NC, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the quarter ended June 30, 2024 and provided recent business highlights. “Our data presentation at EHA last quarter included complete remission rates for both HR-MDS and TP53m AML patients treated with SL-172154 in combination with AZA that exceeded the expected complete remission rates for AZA alone. It is encouraging to see in our EHA presentation that our complete remission rate improved as the number of patients in each cohort increased, since our initial data presented at ASH in December of 2023. The next milestone for this program is to see how these response rates translate to an overall survival benefit, and those data will mature over the second half of this year,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “In parallel, we are pleased that enrollment has begun so swiftly in our randomized, controlled expansion cohort in frontline HR-MDS patients. We look forward to sharing clinical updates from these trials in the months ahead.” Second Quarter 2024 Business Highlights and Other Recent Developments SL-172154 (SIRPα-Fc-CD40L) Phase 1B Trial of SL-172154 in Frontline HR-MDS and TP53m AML HR-MDS Announced updated interim data from the Phase 1B dose expansion clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients. These data were featured in a poster presentation during the EHA 2024 Congress. Observed 67% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53 mutations, and an initial complete remission (CR)/marrow complete remission rate of 58%. As of the data cut-off date on April 23, 2024, median overall survival had not yet been reached.SL-172154 demonstrated a manageable interim safety profile in combination with AZA, with infusion related reactions (IRRs) as the most common drug related adverse event. Initiated enrollment of the Part D cohort, a randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients. Approximately 60 patients will be randomized in a 1:1:1 ratio to receive SL-172154 at 3mg/kg in combination with AZA, SL-172154 at 1mg/kg in combination with AZA, or AZA as monotherapy. TP53m AML Observed 43% ORR in frontline TP53m AML patients and 33% CR/complete remission rate with incomplete hematologic recovery. As of the data cut-off date of June 4, 2024, the median overall survival had not yet been reached. SL-172154 demonstrated a manageable interim safety profile in combination with AZA.In June 2024, the U.S. FDA granted ODD to SL-172154 for the treatment of AML. Phase 1B Trial of SL-172154 in Platinum-Resistant Ovarian Cancer (PROC) Reported data from the Phase 1B clinical trial of SL-172154 in PROC patients, demonstrating an acceptable safety profile in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (Elahere). IRRs were the most common treatment emergent AE as of the data cutoff. As of April 23, 2024, four of 21 (19%) treated patients in the Phase 1B study of SL-172154 in combination with PLD achieved partial responses. Two additional patients with stable disease showed maximum tumor reductions of 17% and 27%.Completed enrollment for the cohort combining SL-172154 with Elahere. As of the April 23, 2024 data cutoff, ORR benefit beyond Elahere alone was not observed.Shattuck continues to follow patients for progression free survival and overall survival and, should such results mature favorably in either PROC cohort, will evaluate further development in PROC at that time. Corporate Updates On July 1, 2024, Shattuck announced its addition to the Russell 2000® and Russell 3000® Indexes at the conclusion of the 2024 Russell U.S. Indexes annual reconstitution. Upcoming Events Shattuck plans to attend the following investor conferences. Details will be included on the Events & Presentations section of the Company’s website. BTIG Biotechnology Conference (Virtual) August 5-6, 2024Wells Fargo Healthcare Conference (Boston, MA) September 4-6, 2024H.C. Wainwright 26th Annual Global Investment Conference (New York, NY) September 9-11, 2024 Second Quarter 2024 Financial Results Cash and Cash Equivalents and Investments: As of June 30, 2024, cash and cash equivalents and investments were $105.3 million, as compared to $117.2 million as of June 30, 2023.Research and Development (R&D) Expenses: R&D expenses were $19.2 million for the quarter ended June 30, 2024, as compared to $18.2 million for the quarter ended June 30, 2023.General and Administrative (G&A) Expenses: G&A expenses were $5.3 million for the quarter ended June 30, 2024, as compared to $4.7 million for the quarter ended June 30, 2023.Net Loss: Net loss was $21.5 million for the quarter ended June 30, 2024, or $0.42 per basic and diluted share, as compared to a net loss of $21.3 million for the quarter ended June 30, 2023, or $0.50 per basic and diluted share. Financial Guidance Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations into 2026, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken. About SL-172154 SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC® fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with AML, HR-MDS, and PROC. About Shattuck Labs, Inc. Shattuck Labs, Inc. (Nasdaq: STTK) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, (ARC®), platform are designed to simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic. The company’s lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in multiple Phase 1 trials. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com. Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations regarding: plans for our preclinical studies, clinical trials and research and development programs; plans for expansion of clinical trials; the anticipated timing of the results from our clinical trials; the anticipated timing and pace of enrollment in our clinical trials; the clinical benefit, safety and tolerability of SL-172154; and expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While we believe these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in our filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of our preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of our clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in our Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent disclosure documents filed with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD. Investor & Media Contact: Conor RichardsonVice President of Investor RelationsShattuck Labs, Inc.InvestorRelations@shattucklabs.com SHATTUCK LABS, INC.CONDENSED BALANCE SHEETS(In thousands) June 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents$60,693 $125,626 Investments 44,651 4,999 Prepaid expenses and other current assets 9,081 12,595 Total current assets 114,425 143,220 Property and equipment, net 11,895 13,804 Other assets 2,294 2,540 Total assets$128,614 $159,564 Liabilities and Stockholders’ Equity Current Liabilities: Accounts payable$2,822 1,587 Deferred revenue 2,997 343 Total current liabilities 15,026 11,453 Non-current operating lease liabilities 2,972 3,406 Total liabilities$17,998 $14,859 Stockholders’ equity: Common stock 5 5 Additional paid in capital 456,982 451,006 Accumulated other comprehensive (loss) income (5) 4 Accumulated deficit (346,366) (306,310)Total stockholders' equity 110,616 144,705 Total liabilities and stockholders' equity$128,614 $159,564 SHATTUCK LABS, INC.CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(In thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023Collaboration revenue$1,609 $200 $2,724 $257 Operating expenses: Research and development 19,239 18,205 35,503 34,872 General and administrative 5,332 4,742 10,227 9,793 Expense from operations 24,571 22,947 45,730 44,665 Loss from operations (22,962) (22,747) (43,006) (44,408)Other income 1,410 1,401 2,950 2,338 Net loss$(21,552) $(21,346) $(40,056) $(42,070)Unrealized gain (loss) on investments 9 265 (9) 803 Comprehensive loss$(21,543) $(21,081) $(40,065) $(41,267) Net loss per share – basic and diluted$(0.42) $(0.50) $(0.79) $(0.99)Weighted-average shares outstanding – basic and diluted 50,791,241 42,467,664 50,678,818 42,453,513

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