Tucatinib

Announced positive proof of concept data from Phase 1 clinical trial of ELVN-001 in CML, achieving an initial cumulative MMR rate of 44% (7/16) by 12 weeks in response-evaluable patients Strong balance sheet with $321 million in cash, cash equivalents and marketable securities,which is expected to provide cash runway into late 2026 BOULDER, Colo., May 14, 2024 (GLOBE NEWSWIRE) -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today reported financial results for the first quarter ended March 31, 2024, and provided a business update, including highlights of pipeline progress. “The first quarter of 2024 was a pivotal quarter for Enliven. We released positive proof of concept data from our Phase 1 clinical trial of ELVN-001, which was a significant milestone for the Company,” said Sam Kintz, MBA, Enliven’s Co-founder and Chief Executive Officer. “We are thrilled by the initial ELVN-001 data, particularly the tolerability pro evidence of activity in heavily pre-treated patients, including in patients with asciminib-resistant chronic myeloid leukemia. We also continued to advance our trials of ELVN-002, including the activation of the first site to evaluate ELVN-002 in combination with trastuzumab in patients with HER2+ cancers, which we believe is an area of significant unmet need for patients. Additionally, we extended our cash runway into late 2026 thanks to the support of new and existing investors.” Corporate Updates Entered into a securities purchase agreement for a private investment in public equity (PIPE) financing resulting in gross proceeds of $90 million. The financing, from both new and existing investors, is expected to extend the Company’s cash runway into late 2026 and through multiple key milestones for ELVN-001 and ELVN-002. Appointed to the Board of Directors, Lori Kunkel, MD, an accomplished industry executive and board member with a track record of success in corporate strategy, clinical development and commercialization. Pipeline Updates ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR-ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML). Announced positive proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with CML who are relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs). As of the cutoff date of March 18, 2024, 44% (7/16) of response-evaluable patients achieved a cumulative major molecular response (MMR) rate by week 12, and patients with prior exposure to asciminib and/or who were TKI-resistant also demonstrated responses, with a 44% and 40% cumulative MMR rate, respectively. Among response-evaluable patients, all had improved or stable BCR::ABL1 transcript levels by 12 weeks. ELVN-001 was well tolerated with no Grade 3 or higher non-hematologic treatment-related adverse events and no dose reductions reported. These data compare favorably to precedent Phase 1 cumulative MMR rates for approved BCR::ABL1 TKIs, particularly given the more heavily pre-treated patient population. Further details can be found here. Phase 1b data is expected in 2025 and is expected to include between approximately 60-100 patients across various lines of therapy with significant follow-up. ELVN-002 is a potent, highly selective, central nervous system penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations. Following U.S. Food and Drug Administration approval of its Investigational New Drug application, the Company activated the first site to evaluate ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC). First patient dosing for the combination trial is expected in Q2 2024. The combination trial in patients with HER2+ cancers is supported by the initial data from the ongoing monotherapy trial, which includes: Investigator reported responses (including unconfirmed) in both HER2+ and HER2 mutant tumors, including in patients who have progressed on Enhertu and patients with brain metastases, at doses that have been well tolerated. Importantly, at the clinically predicted optimal monotherapy dose, ELVN-002 had >10x target coverage based on pharmacokinetics in cancer patients and preclinical HER2+ efficacy compared to tucatinib. Phase 1 monotherapy data, Phase 1a/b Herceptin combination data in HER2+ CRC, and initial Phase 1a combination data in HER2+ MBC are expected in 2025. First Quarter 2024 Financial Results Cash Position: As of March 31, 2024, the Company had cash, cash equivalents and marketable securities totaling $320.5 million, which is expected to provide cash runway into late 2026. Research and development (R&D) expenses: R&D expenses were $20.0 million for the first quarter of 2024, compared to $11.9 million for the first quarter of 2023. General and administrative (G&A) expenses: G&A expenses for the first quarter of 2024 were $6.0 million, compared to $4.5 million for the first quarter of 2023. Net Loss: Enliven reported a net loss of $22.7 million for the first quarter of 2024, compared to a net loss of $14.7 million for the first quarter of 2023. About Enliven Therapeutics Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Enliven’s discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans and expectations regarding Enliven’s programs, including ELVN-001 and ELVN-002; Enliven’s pipeline of product candidates; expected milestones for ELVN-001 and ELVN-002, including the expected timing of dosing of ELVN-002 for the combination trial and of data from the clinical trials of ELVN-001 and ELVN-002; statements relating to Enliven’s expected cash runway; and the anticipated use of proceeds from the PIPE financing; and statements by Enliven’s Co-founder and Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the limited operating history of Enliven; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; Enliven’s limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; Enliven’s limited experience as a company in designing and conducting clinical trials; the potential for interim, topline and preliminary data from Enliven’s preclinical studies and clinical trials to materially change from the final data; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; developments relating to Enliven’s competitors and its industry, including competing product candidates and therapies; the decision to develop or seek strategic collaborations to develop Enliven’s current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven’s patent protection; reliance on third parties, including contract manufacturing organizations, contract research organizations and strategic partners; general market or macroeconomic conditions; Enliven’s ability to obtain additional capital to fund Enliven’s general corporate activities and to fund Enliven’s research and development; and other risks and uncertainties, including those more fully described in Enliven’s filings with the Securities and Exchange Commission (SEC), which may be found in the section titled “Risk Factors” in Enliven’s Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven’s future reports to be filed with the SEC. Except as required by applicable law, Enliven 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. Head-to-Head Comparisons The Company has not performed any head-to-head trials for ELVN-001. As a result, the data referenced in this press release is derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, conclusions from cross-trial comparisons cannot be made. Contact: Investors ir@enliventherapeutics.com Media media@enliventherapeutics.com Enliven Therapeutics, Inc. Selected Condensed Consolidated Financial Information (in thousands, except per share data) (unaudited) Statements of Operations Three Months Ended March 31, 2024 2023 Operating expenses: Research and development $ 19,970 $ 11,880 General and administrative 6,017 4,538 Total operating expenses 25,987 16,418 Loss from operations (25,987 ) (16,418 ) Other income (expense), net 3,249 1,694 Net loss $ (22,738 ) $ (14,724 ) Net loss per share, basic and diluted $ (0.54 ) $ (0.80 ) Weighted-average shares outstanding, basic and diluted 42,046 18,515 Balance Sheets March 31, December 31, 2024 2023 Assets Current assets: Cash, cash equivalents and marketable securities $ 320,504 $ 253,148 Restricted cash 54 54 Prepaid expenses and other current assets 6,641 2,949 Contingent value right asset 10,000 10,000 Total current assets 337,199 266,151 Property and equipment, net 683 742 Operating lease right-of-use assets 241 320 Deferred offering costs 563 563 Other long-term assets 4,091 4,091 Total assets $ 342,777 $ 271,867 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 2,727 $ 532 Accrued expenses and other current liabilities 12,304 15,362 Contingent value right liability 10,000 10,000 Total current liabilities 25,031 25,894 Long-term liabilities 34 67 Total liabilities 25,065 25,961 Stockholders' equity 317,712 245,906 Total liabilities and stockholders' equity $ 342,777 $ 271,867

More than 50 abstracts, including 11 oral presentations, span Pfizer’s robust portfolio of approved and pipeline therapies across its key tumor areas and core scientific modalities New five-year progression-free survival data for LORBRENA® (lorlatinib) in first-line ALK-positive advanced lung cancer Results from ECHELON-3, third Phase 3 study to demonstrate overall survival benefit for ADCETRIS® (brentuximab vedotin) in a type of lymphoma NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago. More than 50 abstracts, including 11 oral presentations, will be presented from Pfizer’s broadened portfolio of approved and pipeline therapies across the company’s key tumor areas and core scientific modalities, including small molecules, antibody-drug conjugates (ADCs) and bispecific antibodies. “We are excited to participate in our first ASCO Annual Meeting following the creation of Pfizer’s new Oncology organization, where we will highlight our efforts to accelerate breakthrough medicines that help people with cancer live better and longer lives,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer. “We are looking forward to key data presentations across our newly expanded portfolio, including additional evidence reinforcing the benefit of several approved medicines and promising new data from our deep and diverse pipeline.” Key research includes an oral presentation of new five-year progression-free survival (PFS) results from the Phase 3 CROWN study of LORBRENA® (lorlatinib) in previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), which will also be featured in ASCO’s embargoed pre-meeting press briefing on Wednesday, May 29. Additionally, results from the Phase 3 ECHELON-3 study of ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and rituximab in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) will be presented for the first time in an oral late-breaking session. Pfizer will also present Phase 1 data for several priority pipeline therapies, including oral presentations with updated results for sigvotatug vedotin (B6A; integrin beta-6 [IB6]-directed ADC) in NSCLC and data for PF-07248144, a potential first-in-class KAT6 inhibitor, in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). “At ASCO, Pfizer will share important data highlighting the long-term impact of our medicines for patients, including five-year follow-up from the LORBRENA CROWN study, as well as the third Phase 3 study to demonstrate overall survival benefit for ADCETRIS in a type of lymphoma – in this case, relapsed/refractory diffuse large B-cell lymphoma,” said Karin Tollefson, Chief Oncology Medical Officer, Pfizer. “We are also looking forward to sharing updated results from our pipeline, where we now have over 50 programs in development and are rapidly advancing 20 ongoing pivotal trials across our key tumor types.” Key ASCO Presentations Pfizer will present data across its four tumor areas of focus at ASCO: breast cancer, genitourinary cancer, hematology-oncology and thoracic cancers, which includes lung cancer. Breast Cancer In breast cancer, Pfizer will present data for two next-generation pipeline medicines for HR+/HER2- mBC: updated Phase 1/2a safety data for atirmociclib, a potential best-in-class, highly selective cyclin-dependent kinase 4 (CDK4) inhibitor currently in Phase 3 development, and an oral presentation featuring Phase 1 data for PF-07248144, a potential first-in-class KAT6 inhibitor. Additionally, data for TUKYSA® (tucatinib) demonstrate its activity in previously treated HER2-mutated mBC, and new real-world evidence continues to support the value of IBRANCE® (palbociclib) in HR+/HER2- mBC, including from HENRI-3, a SEER-Medicare analysis evaluating overall survival (OS) with IBRANCE plus an aromatase inhibitor (AI) versus AI alone. Genitourinary Cancer Highlights from Pfizer’s genitourinary cancer portfolio will include updated data that continue to reinforce the potential of several recent priority launches, including PADCEV® (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) in locally advanced/metastatic urothelial cancer,* XTANDI® (enzalutamide) in non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high-risk for metastasis,** and TALZENNA® (talazoparib) in combination with XTANDI in metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) mutations. Additionally, updated Phase 1 data will be presented for the investigational enhancer of zeste homolog 2 (EZH2) inhibitor mevrometostat in combination with XTANDI in mCRPC; Pfizer anticipates initiating Phase 3 studies for this combination later this year. Hematology-Oncology In addition to the ECHELON-3 OS results for ADCETRIS in relapsed/refractory DLBCL, Pfizer will present seven-year OS results for ADCETRIS in advanced classical Hodgkin lymphoma,*** as well as new clinical and pharmacokinetic data with alternative dosing regimens for ELREXFIO™ (elranatamab-bcmm) in relapsed/refractory multiple myeloma from the MagnetisMM-9 trial. Thoracic Cancer In its thoracic portfolio, in addition to the LORBRENA CROWN results, Pfizer will present updated Phase 1 data for sigvotatug vedotin in advanced NSCLC, a promising investigational ADC that recently initiated a Phase 3 study. Additional Tumor Types An oral presentation on extended duration of response from the Phase 3 MOUNTAINEER trial adds to the positive pro TUKYSA in colorectal cancer. In addition, data will be presented from the innovaTV 301 trial of TIVDAK® (tisotumab vedotin-tftv), for which a supplemental Biologics License Application for the treatment of previously treated recurrent or metastatic cervical cancer was granted priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act date of May 9, 2024.**** Additional information on key Pfizer-sponsored abstracts, including date and time of presentation, follow in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here. Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit to access the summaries starting Friday, May 24. BREAST CANCER Oral Presentation (Abstract 3006) Saturday, June 1, 3:00-6:00 PM CDT A phase 1 dose expansion study of a first-in-class KAT6 inhibitor — (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer Mukohara et al Poster Presentation (Abstract 3108) Saturday, June 1, 9:00 AM-12:00 PM CDT First-in-human phase 1/2a study of the first-in-class, next-generation CDK4-selective inhibitor PF-07220060 + endocrine therapy (ET): Updated safety data in patients with HR+/HER2− mBC Giordano et al Poster Presentation (Abstract 1111) Sunday, June 2, 9:00 AM-12:00 PM CDT Overall survival with palbociclib (PAL) plus an aromatase inhibitor (AI) versus AI alone in older patients (pts) with de novo, HR+/HER2− metastatic breast cancer: A SEER-Medicare analysis Brufsky et al Poster Presentation (Abstract 1105) Sunday, June 2, 9:00 AM-12:00 PM CDT Tucatinib and trastuzumab for previously treated HER2-mutated metastatic breast cancer (SGNTUC-019): A phase 2 basket study Okines et al GENITOURINARY CANCER Oral Presentation (Abstract 4502) Monday, June 3, 8:00-11:00 AM CDT Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC) Gupta et al Oral Presentation (Abstract 4503) Monday, June 3, 8:00-11:00 AM CDT Impact of exposure on outcomes with enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer Petrylak et al Oral Presentation (Abstract 5005) Saturday, June 1, 3:00-6:00 PM CDT EMBARK post-hoc analysis of impact of treatment suspension (TxS) on health-related quality of life (HRQoL) Freedland et al Poster Presentation (Abstract 5021) Sunday, June 2, 9:00 AM-12:00 PM CDT Discovery of a novel non-negative matrix factorization (NMF)-based homologous recombination deficiency (HRD) score and subsequent exploration in TALAPRO-2 (TP-2), a phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) Fizazi et al Poster Presentation (Abstract 5061) Sunday, June 2, 9:00 AM-12:00 PM CDT Phase 1 trial of mevrometostat (PF-06821497), a potent and selective inhibitor of enhancer of zeste homolog 2 (EZH2), in castration-resistant prostate cancer (CRPC) Schweizer et al Poster Presentation (Abstract 5063) Sunday, June 2, 9:00 AM-12:00 PM CDT Matching-adjusted indirect comparisons (MAICs) of talazoparib plus enzalutamide (TALA+ENZA) versus olaparib plus abiraterone and prednisone/prednisolone (OLAP+AAP) for first-line (1L) therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair mutations (HRRm)/BRCAm Castro et al Poster Presentation (Abstract 4562) Sunday, June 2, 9:00 AM-12:00 PM CDT Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of cisplatin (cis)-eligible population from EV-302/KEYNOTE-A39 Bedke et al Poster Presentation (Abstract 4563) Sunday, June 2, 9:00 AM-12:00 PM CDT Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of the cisplatin (cis)-ineligible population from EV-302/KEYNOTE-A39 Van Der Heijden et al HEMATOLOGY-ONCOLOGY Oral Presentation (Abstract LBA7005) Saturday, June 1, 3:00-6:00 PM CDT Brentuximab vedotin in combination with lenalidomide and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma: Results from the phase 3 ECHELON-3 study Kim et al Poster Presentation (Abstract 7053) Monday, June 3, 9:00 AM-12:00 PM CDT Seven-year overall survival analysis from ECHELON-1 study of A+AVD versus ABVD in patients with previously untreated stage III/IV classical Hodgkin lymphoma Ansell et al Poster Presentation (Abstract 7522) Monday, June 3, 9:00 AM-12:00 PM CDT Evaluation of cytokine release syndrome (CRS) in patients with relapsed or refractory multiple myeloma (RRMM) receiving step-up priming doses and longer dosing intervals of elranatamab: MagnetisMM-9 Sborov D THORACIC CANCER Oral Presentation (Abstract LBA8503) Friday, May 31, 2:45-5:45 PM CDT Lorlatinib vs crizotinib in treatment-naïve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study Solomon et al Rapid Oral Presentation (Abstract 8521) Saturday, June 1, 4:30-6:00 PM CDT Efficacy and safety of sigvotatug vedotin, an investigational ADC, in NSCLC: Updated phase 1 results (SGNB6A-001) Peters et al GYNECOLOGICAL CANCER Poster Presentation (Abstract 5531) Monday, June 3, 9:00 AM-12:00 PM CDT Tisotumab vedotin in 2L/3L recurrent or metastatic cervical cancer: subsequent therapy data from ENGOT-cx12/GOG-3057/innovaTV 301 Manso Sánchez et al GASTROINTESTINAL CANCER Oral Presentation (Abstract 3509) Monday, June 3, 1:15-2:45 PM CDT Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER) Strickler et al *Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV® and KEYTRUDA® in patients with previously untreated metastatic urothelial cancer. **XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States. ***Pfizer and Takeda jointly develop ADCETRIS® on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Pfizer has U.S. and Canadian commercialization rights, and Takeda has rights to commercialize ADCETRIS® in the rest of the world. ****TIVDAK® is co-owned by Genmab and Pfizer, under an agreement in which the companies share costs and profits for the product on a 50:50 basis. Prescribing Information for Pfizer Medicines Please see full Prescribing Information, including BOXED WARNING, for ADCETRIS® (brentuximab vedotin). Please see full Prescribing Information, including BOXED WARNING, for ELREXFIOTM (elranatamab-bcmm). Please see full Prescribing Information for IBRANCE® (palbociclib) tablets and IBRANCE® (palbociclib) capsules. Please see full Prescribing Information for LORBRENA® (lorlatinib). Please see full Prescribing Information, including BOXED WARNING, for PADCEV® (enfortumab vedotin). Please see full Prescribing Information for TUKYSA® (tucatinib). Please see full Prescribing Information for TALZENNA® (talazoparib). Please see full Prescribing Information, including BOXED WARNING, for TIVDAK® (tisotumab vedotin-tftv). Please see full Prescribing Information for XTANDI® (enzalutamide). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Disclosure Notice The information contained in this release is as of April 29, 2024. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s oncology portfolio of marketed and investigational therapies; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data; anticipated operating and financial performance; the development or commercial potential of our product pipeline, in-line products, product candidates and additional indications or combinations, including expected clinical trial protocols, the potential and timing for the initiation and progress of clinical trials and data read-outs from trials; the timing and potential for the submission of applications for and receipt of regulatory approvals; the timing and potential for product launches and commercialization; expected breakthrough, best- or first-in-class or blockbuster status or expected market entry of our medicines; potential patients reached; the regulatory landscape; the competitive landscape; and other statements about our business, operations and financial results that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s oncology portfolio; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . View source version on businesswire.com: Contacts Media Contact: +1 (212) 733-1226 PfizerMediaRelations@Pfizer.com Investor Contact: +1 (212) 733-4848 IR@Pfizer.com Source: Pfizer Inc. View this news release online at: