Surface Oncology to Participate in the 2023 Guggenheim Oncology Days Conference

On February 2, 2023 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Rob Ross, M.D., chief executive officer, will participate in a fireside chat at the 2023 Guggenheim Oncology Days conference in New York City on Thursday, February 9, 2023, at 1:35 p.m. ET (Press release, Surface Oncology, FEB 2, 2023, View Source [SID1234626731]).

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A live audio webcast of the session may be accessed by visiting the Events page on the Investors & Media section of the Surface Oncology website. In addition, a replay of the webcast will be available on the company’s website following the presentation.

Verastem Oncology Outlines Key 2023 Strategic Priorities and Upcoming Catalysts for Advancing Avutometinib as a Backbone of Therapy for RAS Pathway-Driven Cancers

On February 2, 2023 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported key strategic priorities and upcoming catalysts to support its lead compound RAF/MEK clamp avutometinib in RAS pathway-driven cancers (Press release, Verastem, FEB 2, 2023, View Source [SID1234626730]).

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"Building on the Breakthrough Therapy designation for the combination of avutometinib with defactinib in recurrent LGSOC and the positive results from the interim analysis of Part A of the RAMP 201 trial, we are working rapidly to bring forward the first U.S. Food and Drug Administration (FDA)-approved therapy for these patients who deserve better options," said Brian Stuglik, CEO of Verastem Oncology. "Further, we plan to efficiently advance our development program and provide early data read-outs with avutometinib combinations across other RAS pathway-driven cancers with high unmet need, including combinations in KRAS G12C mutant NSCLC and frontline metastatic pancreatic cancer. With the recently announced financing, we have strengthened our balance sheet and cash runway to deliver on these key initiatives."

2022 and Recent Accomplishments

Completed target enrollment in the RAMP 201 trial evaluating avutometinib + defactinib in recurrent LGSOC and reported positive interim data from Part A that included blinded independently confirmed response rates in both KRAS Mutant and KRAS wild-type tumors with a favorable safety and tolerability profile.
The combination of avutometinib and defactinib was selected as the go-forward treatment regimen for the recurrent LGSOC program.
In the KRAS G12C Mutant NSCLC program, the RAMP 203 trial, evaluating the combination of avutometinib with Amgen’s LUMAKRASTM (sotorasib), advanced to final dose level of 4 mg avutometinib with 960 mg of LUMAKRASTM and enrollment was initiated in the RAMP 204 trial of avutometinib with Mirati’s KRAZATI (adagrasib).
Initiated the RAMP 205 trial evaluating avutometinib and defactinib with standard of care chemotherapy in frontline metastatic pancreatic cancer.
Secured up to $150 Million in non-dilutive financing from Oxford Finance LLC and entered into a definitive agreement to sell up to approximately 2.1 million shares of its Series B Convertible Preferred Stock to affiliates of BVF Partners L.P. in a private placement to raise aggregate gross proceeds of up to approximately $60 million in two tranches. On January 27, 2023 Verastem Oncology closed on the initial tranche of 1.2 million shares of its Series B Convertible Preferred Stock (the "Preferred Stock") with gross proceeds of $30 million.
2023 Strategic Priorities

Initiate confirmatory study of avutometinib + defactinib in recurrent LGSOC upon agreement with the FDA on study design in support of filing for accelerated approval.
Advance KRAS G12C mutant NSCLC program with initial read-outs of the RAMP 203 and RAMP 204 trials evaluating avutometinib in combination with LUMAKRASTM (sotorasib) or KRAZATITM (adagrasib).
Determine recommended Phase 2 dose and complete enrollment of the initial Phase 2 expansion cohort of the RAMP 205 trial evaluating avutometinib and defactinib plus standard of care chemotherapy in frontline metastatic pancreatic cancer.
Progress signal-finding, investigator-initiated trial program of combinations with avutometinib in additional RAS pathway-driven cancers with high unmet need.
Anticipated 2023 Milestones and Catalysts

Q1-2023

Determine recommended Phase 2 dose for RAMP 203 trial (KRAS G12C NSCLC avutometinib + LUMAKRASTM (sotorasib)) combination trial.
Launch education campaign in LGSOC to differentiate LGSOC from high-grade ovarian cancer, highlight signs and symptoms and younger age at diagnosis.
Q2-2023

Present updated results of Part A of RAMP 201 trial (LGSOC avutometinib + defactinib) at a scientific medical conference.
Finalize confirmatory trial study design for recurrent LGSOC program.
Present updated results of investigator-sponsored trial of avutometinib and everolimus in KRAS-mutant NSCLC.
2H-2023

Initiate confirmatory study of avutometinib and defactinib in recurrent LGSOC.
Report initial read-out of safety and preliminary efficacy of the RAMP 203 trial (KRAS G12C NSCLC avutometinib + LUMAKRASTM (sotorasib)) combination trial.
Provide initial safety read-out and recommended dose of RAMP 204 (KRAS G12C NSCLC avutometinib + KRAZATITM (adagrasib)) combination trial.
Determine recommended Phase 2 dose and complete enrollment of the initial Phase 2 expansion cohort of RAMP 205 (frontline metastatic pancreatic cancer avutometinib and defactinib plus standard of care).
Financial Update

As of December 31, 2022, Verastem Oncology had preliminary unaudited cash and short-term investments of $87.9 million.

On January 24, 2023, Verastem Oncology announced that it had entered into a definitive agreement to sell up to approximately 2.1 million shares of Preferred Stock to affiliates of BVF Partners L.P. in a private placement to raise aggregate gross proceeds of up to approximately $60 million in two tranches, before deducting fees to the placement agent and other estimated offering expenses payable by Verastem Oncology. Verastem Oncology closed on the initial tranche of 1.2 million shares of Preferred Stock for a purchase price of $30 million on January 27, 2023.

Upon closing of the initial tranche of the private placement, Verastem Oncology achieved the Term B Milestone under the Oxford Loan and Security Agreement which will allow Verastem Oncology to draw an additional $15M in term loans ("Term B Loan").

About Avutometinib (VS-6766)

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. Avutometinib is currently in late-stage development.

In contrast to other MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS-driven tumors as part of its (Raf And Mek Program). RAMP 201 is a registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC. Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively. As part of the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, Verastem Oncology is conducting RAMP 205, a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.

BIO-TECHNE RELEASES SECOND QUARTER FISCAL 2023 RESULTS

On February 2, 2023 Bio-Techne Corporation (NASDAQ: TECH) today reported its financial results for the second quarter ended December 31, 2022 (Press release, Bio-Techne, FEB 2, 2023, View Source [SID1234626729]).

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Second Quarter FY2023 Highlights

Second quarter organic revenue increased by 4% (1% reported) to $271.6 million and 5% (3% reported) in the first half of fiscal 2023 to $541.2 million.
GAAP earnings per share1) (EPS) was $0.31 versus $0.49 one year ago. Delivered adjusted EPS1) of $0.47, consistent with the prior year, with foreign currency exchange negatively impacting EPS by $0.02 per share when compared to the prior year.
Growth in the ExoDx Prostate test continued with its fourth consecutive record quarter, as tests performed grew over 70% and revenue more than doubled year-over-year.
Successful execution and expansion of our cell and gene therapy platform with a record quarter in GMP protein sales and the launch of RNAscope Plus.
Enhancement of our ProteinSimple branded product offering with the launch of the MauriceFlex instrument and the opening of a state-of-the-art immunoassay product innovation and manufacturing facility.
1)On November 29, 2022, the company executed a four-for-one split of Bio-Techne’s common stock in the form of a stock dividend to all shareholders of record on November 14, 2022. All references made to share or per share amounts in this press release have been retroactively adjusted to reflect the effects of the stock split.

The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic growth, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"As we lap high revenue growth rates from last year, we continued to grow in Q2 despite a slow-down in Biotech funding and the Covid illness that is sweeping China," said Chuck Kummeth, President and CEO of Bio-Techne. "Within the quarter, we delivered much improved results in Europe. Also, our run-rate consumable business in the US and our Cell Therapy portfolio grew double-digits, indicating continued underlying strength in our end markets."

Kummeth continued, "Meanwhile, our ExoDx Prostate test continued its rapid adoption, with revenues more than doubling in the quarter compared to the prior year. Our portfolio of innovative tools, bioactive reagents, and technologies are aimed at some of the highest growth life science tools and diagnostic markets. This diverse portfolio combined with the investments we have made in our people, our facilities, and our new product pipeline, position the Company to execute on our strategic growth plan and deliver our long-term targets."

Second Quarter Fiscal 2023

Revenue

Net sales for the second quarter increased 1% to $271.6 million. Organic growth was 4% compared to the prior year with acquisitions contributing 1% and foreign currency exchange having an unfavorable impact of 4%.

GAAP Earnings Results

GAAP EPS was $0.31 per diluted share, versus $0.49 in the same quarter last year. Prior year GAAP EPS was favorably impacted by a non-recurring gain of approximately $28.4 million on our ChemoCentryx investment. GAAP operating income for the second quarter of fiscal 2023 increased 9% to $67.9 million, compared to $62.3 million in the second quarter of fiscal 2022. GAAP operating margin was 25.0%, compared to 23.2% in the second quarter of fiscal 2022. GAAP operating margin compared to prior year was positively impacted by a non-recurring impairment in the prior year related to our Eminence investment.

Non-GAAP Earnings Results

Adjusted EPS was $0.47 per diluted share in both the second quarter of fiscal 2023 and in the comparative period. Adjusted EPS remained flat year-over-year with unfavorable foreign currency exchange being offset by reduced net interest expense. Adjusted operating income for the second quarter of fiscal 2023 decreased 6% compared to the second quarter of fiscal 2022. Adjusted operating margin was 35.5%, compared to 38.3% in the second quarter of fiscal 2022. Adjusted operating margin decreased compared to the prior year due to unfavorable foreign currency exchange, higher inflation, and strategic growth investments including the Namocell acquisition.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s second quarter fiscal 2023 net sales were $203.9 million, a decrease of 1% from $205.0 million for the second quarter of fiscal 2022. Organic growth for the segment was 2%, with foreign currency exchange having an unfavorable impact of 4% and acquisitions contributing 1%. Protein Sciences segment’s operating margin was 43.8% in the second quarter of fiscal 2023 compared to 45.5% in the second quarter of fiscal 2022. The segment’s operating margin compared to the prior year was negatively impacted by unfavorable foreign currency exchange, higher inflation, and the Namocell acquisition.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s second quarter fiscal 2023 net sales were $68.0 million, an increase of 5% from $64.5 million for the second quarter of fiscal 2022. Organic growth for the segment was 7%, with foreign exchange having an unfavorable impact of 2%. The Diagnostics and Genomics segment’s operating margin was 12.2% in the second quarter of fiscal 2023 compared to 16.9% in the second quarter of fiscal 2022. The segment’s operating margin was negatively impacted by foreign exchange, higher inflation, and the timing of strategic growth investments.

Conference Call

Bio-Techne will host an earnings conference call today, February 2, 2023 at 8:00 a.m. CST. To listen, please dial 1-877-407-9208 or 1-201-493-6784 for international callers, and reference conference ID 13735661. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512- 2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13735661. The replay will be available from 11:00 a.m. CST on Thursday, February 2, 2023, until 11:00 p.m. CST on Thursday, March 2, 2023.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted net earnings
Adjusted tax rate
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
Earnings before interest, taxes, depreciation, and amortization (EBITDA)
Adjusted EBITDA
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months, the impact of foreign currency, as well as the impact of partially-owned consolidated subsidiaries. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period. Revenues from partially-owned subsidiaries consolidated in our financial statements are also excluded from our organic revenue calculation, as those revenues are not fully attributable to the Company. There was no revenue from partially-owned consolidated subsidiaries for the quarter ended December 31, 2022 due to the sale of Changzhou Eminence Biotechnology Co., Ltd. (Eminence) in the first quarter of fiscal 2023. Revenue from partially-owned consolidated subsidiaries was $2.0 million for the six months ended December 31, 2022.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, adjusted EBITDA, and adjusted net earnings, in total and on a per share basis, exclude stock-based compensation, the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring items including non-recurring costs, goodwill and long-lived asset impairments, and gains. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjection assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring items including gains or losses on legal settlements, goodwill and long-lived asset impairment charges, and one-time assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity. The Company also excludes revenue and expense attributable to partially-owned consolidated subsidiaries in the calculation of our non-GAAP financial measures as the revenues and expenses are not fully attributable to the Company.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense.

Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded.

Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.

Purple Biotech Expands Pipeline of First-in-Class Therapeutics with Acquisition of Immunorizon and Its Portfolio of Tri-Specific Antibodies for the Treatment of Cancer

On February 2, 2023 Purple Biotech Ltd. (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported that it has entered into an agreement for the acquisition of Immunorizon Ltd., a private company developing potential multi-specific T and NK cell engager oncology therapies that selectively activate the immune response within the tumor microenvironment (Press release, Purple Biotech, FEB 2, 2023, View Source;id=253551&p=2256767&I=1206939-c7Z3G6f3m8 [SID1234626728]). The acquisition will provide Purple Biotech with an expanded portfolio of investigational tri-specific antibody compounds that target multiple antigens and offer the potential to further expand to additional targets.

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Immunorizon’s lead asset is a conditionally-activated tri-specific antibody that engages both T cells and NK cells to mount a strong, localized immune response within the tumor microenvironment. The third arm of the lead compound specifically targets the Tumor Associated Antigen (TAA) 5T4, that is expressed in a variety of solid tumors and is correlated with advanced disease, increased invasiveness and poor clinical outcomes. 5T4 is a well-known target that has been validated by multiple pre-clinical and clinical programs. The drug candidates Purple Biotech is acquiring are differentiated from other multi-specific cell therapies targeting 5T4+ tumors by its cleavable capping technology, which confines the compound’s therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window in patients. The acquisition will also provide Purple Biotech with additional preclinical assets targeting other TAAs through this technology platform.

"We are delighted to add Immunorizon’s portfolio of tri-specific antibodies to our drug development pipeline," said Gil Efron, CEO of Purple Biotech. "The acquisition of these assets highly fits our strategy of expanding our pipeline, and we believe that the acquired technology platform has the potential to expand to multiple additional development programs. This new technology is differentiated not only by the combination of the NK and T cell engagement, but also by the conditional activation at the tumor microenvironment, which we believe provides an opportunity for better therapeutic outcomes for cancer patients. Bi-specifics as a class have undergone multiple iterations of technological improvements that have culminated in a basket of approved and/or clinically de-risked assets with several recent industry partnerships that have formed around such platforms. Novel multi-specifics have seen increasing industry attention and we are excited with our first step into this field. We believe that we will be able to leverage the knowledge and expertise we have gained over the years through both preclinical and clinical development. We expect to advance the first of the newly acquired assets to an IND submission in approximately two years in parallel to our ongoing promising clinical programs from which we expect to report clinical data during this year."

Purple Biotech is acquiring 100% of the shares of Immunorizon Ltd., a privately held, VC-backed biopharmaceutical company, in exchange for an aggregate upfront payment of $3.5 million in cash and an aggregate $3.5 million in American Depository Shares (ADSs), at a price per ADS equal to the NASDAQ volume-weighted average price of the Company’s ADSs for the 60-day period preceding the execution date of the agreement. Additional long-term development, regulatory and sales milestones are set at an aggregate amount of $94 million, with royalties of low single digit out of net sales. The accumulated transaction payments, excluding the upfront payment, will not exceed $100 million.

The ADSs will be issued to certain of the Immunorizon selling shareholders and will be subject to a three – month lock-up period, and the Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission to register the ADSs for resale following the lock-up period. The selling shareholders of Immunorizon that shall receive ADSs as partial consideration in the transaction will be entitled to an ADS price adjustment during the 12-month period following the closing of the transaction, for the remaining ADSs held by them at such time (if any), in the event of an issuance by us of additional ADSs or other securities in certain types of financing transactions, at a price per ADS lower than the price per ADS under the agreement; provided that such price adjustment shall only be provided once.

The closing of the transaction is subject to satisfaction of customary closing conditions, expected within 10 business days.

This communication does not constitute an offer to sell or the solicitation of an offer to buy the ADSs or any securities, nor shall there be any sale of the ADSs or any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The ADSs of Purple Biotech will be issued to the certain selling shareholders of Immunorizon on a private placement basis pursuant to applicable exemptions from the prospectus requirements under applicable Israeli securities laws and from the registration requirements of the United States Securities Act of 1933, as amended (the "U.S. Securities Act"). The securities offered have not been registered under the U.S. Securities Act or any U.S. state or Israeli securities laws, and may not be offered or sold in the United States or in Israel, or to, or for the account or benefit of, United States persons or persons in Israel absent registration or any applicable exemption from the registration and/or prospectus requirements of the U.S. Securities Act and applicable U.S. state and/or Israeli securities law.

West to Host Fourth-Quarter and Full-Year 2022 Conference Call and Announces Participation in Upcoming Investor Conferences

On February 2, 2023 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release fourth-quarter and full-year 2022 financial results before the market opens on Thursday, February 16, 2023, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, FEB 2, 2023, View Source;utm_medium=Email&utm_campaign=Investors_Email&campaignid=null&utm_content=2_February_2023&utm_term=0_4b4b77d239-c7eeb04aed-584006100&creative=null&device=null&matchtype=null#2023-feb-02-west-to-host-fourth-quarter-and-full-year-2022-conference-call-and-announces-participation-in-upcoming-investor-conferences [SID1234626727]).

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The live audio-only webcast will be made available via the Company’s Investor Relations website here or by clicking here.

To participate in the conference call by asking questions to Management, please register in advance by clicking here. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that will be used to access the call.

Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website. A replay of the conference call and webcast will be available on the Company’s website for 30 days.

West will also participate in the Barclays Global Healthcare Conference in Miami, Florida, on March 14, 2023 and the KeyBanc Life Sciences & MedTech Investor Forum taking place virtually on March 22, 2023.

A live audio webcast will be available in the "Investors" section of the Company’s website at www.westpharma.com. Replay of the webcasts will be available for approximately 90 days after the events.