Lyell Immunopharma Reports Second Quarter Financial Results and Business Highlights

On August 4, 2022 Lyell Immunopharma, Inc. (Lyell) (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company dedicated to developing curative cell therapies for patients with solid tumors, reported financial results for the second quarter of 2022 (Press release, Lyell Immunopharma, AUG 4, 2022, View Source [SID1234617541]).

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"As a clinical stage company, we continue to make progress advancing our pipeline and growing our capabilities," said Liz Homans, CEO of Lyell Immunopharma. "Our strong financial position enables us to see our current pipeline through important milestones in evaluating T-cell exhaustion and lack of durable stemness as key barriers to successful cell therapy in patients with solid tumor cancers while also advancing next generation technologies such as T-cell rejuvenation. We have recently presented new preclinical data that further elucidate the potential of our reprogramming technologies to endow T cells with the ability to resist exhaustion and maintain properties of durable stemness, and we remain on track to announce initial clinical data in 2023 from our lead program, LYL797."

Recent Business Highlights

Presented preclinical data for LYL797, Lyell’s CAR T-cell therapy targeting ROR1+ solid tumors that incorporates Gen-R and Epi-R, at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) demonstrating that Gen-R and Epi‑R reprogramming technologies can enhance and prolong anti-tumor functions of ROR1-targeting CAR T-cell therapy in solid tumor model systems.
Presented preclinical data for LYL132, a TCR therapy targeting NY-ESO-1+ solid tumors that incorporates Epi-R and is being developed in collaboration with GSK, at ASGCT (Free ASGCT Whitepaper) demonstrating that Epi-R reprogramming technology creates populations of stemlike NY-ESO-1-targeting TCR T cells that lead to products with increased proliferative capacity and prolonged functional activity in the presence of persistent antigen exposure.
Presented preclinical data at the International Society for Stem Cell Research 2022 Annual Meeting (ISSCR) demonstrating the application of Lyell’s rejuvenation technology yielded improvements in antitumor properties of engineered adoptive T-cell products as compared to non-rejuvenated T-cell controls.
Second Quarter 2022 Financial Results

Revenue

Revenue was $35.7 million and $2.6 million for the three months ended June 30, 2022 and 2021, respectively, primarily related to the recognized portion of the upfront license fee of Lyell’s Collaboration and License Agreement entered into in 2019 and amended in June 2020 and December 2021 (GSK Agreement) with GlaxoSmithKline Intellectual Property (No. 5) Limited and Glaxo Group Limited (together, GSK). The increase of $33.1 million was primarily related to recognizing $35.3 million in revenue due to a mutual agreement with GSK to conclude research activities on an undisclosed target for hematological cancers.
GAAP and Non-GAAP Operating Expenses

Lyell reported a net loss of $36.3 million for the second quarter ended June 30, 2022, compared to a net loss of $62.6 million for the same period in 2021. Non-GAAP net loss, which excludes non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities, was $10.3 million for the second quarter ended June 30, 2022 compared to $38.1 million for the same period in 2021.
Research and development (R&D) expenses were $43.7 million for the second quarter ended June 30, 2022, compared to $46.4 million for the same period in 2021. The decrease in R&D expense was primarily driven by a reduction in the success payment liability balance, which offset increases in facilities and technology costs to support the expansion of our R&D and manufacturing capabilities. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the second quarter ended June 30, 2022, were $35.9 million, compared to $32.1 million for the same period in 2021.
General and administrative (G&A) expenses were $30.5 million for the second quarter ended June 30, 2022, compared to $19.1 million for the same period in 2021. The increase in G&A expense was primarily due to an $8.1 million increase in stock-based compensation expense, primarily related to award modifications and new awards granted. Non‑GAAP G&A expenses, which exclude non-cash stock-based compensation, for the second quarter ended June 30, 2022 were $12.2 million, compared to $9.0 million for the same period in 2021. The increase in non-GAAP G&A expenses was driven by litigation-related expenses and public company operating costs.
A discussion of these non-GAAP financial measures, including reconciliations of the most comparable GAAP measures to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of June 30, 2022 were $787.0 million, compared to $898.3 million as of December 31, 2021. Lyell believes that its cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into 2025.

CytomX Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

On August 4, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported second quarter 2022 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 4, 2022, View Source [SID1234617557]).

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"Our commitment to destroying cancer differently is stronger than ever at CytomX and we firmly believe that our multi-modality Probody therapeutic platform has the potential to deliver differentiated medicines for the treatment of people with cancer. Our company restructuring announced in July puts CytomX in the strongest possible position to maintain our technological leadership and advance our exciting, emerging pre-clinical and early clinical pipeline, capitalizing on our continued learnings from the clinic," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. "We also continue to work intensively with our partners to advance multiple novel product candidates towards clinical proof of concept," continued Dr. McCarthy.

Second Quarter Business Highlights and Recent Developments

Strategic realignment – CytomX announced restructuring plans to focus on its early-stage pipeline development, including partnered programs, and to realign capital resources, extending cash runway into 2025.
T-cell-engaging bispecific (TCB) EGFRxCD3 program – CX-904 is a conditionally activated TCB designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment, and is partnered with Amgen. The first patient was dosed in a Phase 1 study of CX-904 in patients with advanced solid tumors.
Ipilimumab Probody program – BMS-986249 and BMS-986288 are Probody versions of the CTLA4-targeting antibodies, ipilimumab and non-fucosylated ipilimumab, respectively, and are being developed by Bristol Myers Squibb. BMS-986249 is being evaluated in a randomized Phase 2 study in combination with nivolumab versus ipilimumab plus nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. Bristol Myers Squibb plans to present updated Phase 1 results for BMS-986249 at the ESMO (Free ESMO Whitepaper) Congress 2022 with the poster presentation titled "Anti–Cytotoxic T Lymphocyte Antigen-4 (CTLA 4) Probody BMS-986249 ± Nivolumab (NIVO) in Patients With Advanced Cancers: Updated Phase 1 Results." BMS-986288 is being evaluated as monotherapy and in combination with nivolumab in a Phase 1 study in advanced solid tumors.
CD71-directed antibody-drug conjugate (ADC) program – CX-2029 is a conditionally activated ADC directed toward CD71, the transferrin receptor, that is being co-developed by CytomX and AbbVie. Patient enrollment into the Phase 2 expansion study is now complete in all three solid cancer indications, including the esophageal/gastro-esophageal junction (E/GEJ) cancer cohort. The diffuse large B-cell lymphoma cohort was deprioritized due to strategic and competitive reasons and did not enroll any patients. A data update for the fully enrolled squamous non-small cell lung cancer cohort is expected in the fourth quarter of 2022. Data from the E/GEJ cancer cohort continues to mature.
CD166-directed ADC program – Praluzatamab ravtansine is a conditionally activated ADC directed toward CD166 and is wholly-owned by CytomX. In a three-arm Phase 2 study, praluzatamab ravtansine demonstrated single-agent activity in heavily-pretreated patients with advanced hormone receptor-positive, HER2-non-amplified breast cancer at the starting dose of 7 mg/kg every three weeks, but median progression-free survival data did not support further evaluation at this dose. While the emerging safety profile of the 6 mg/kg dose is encouraging, CytomX is not advancing this program alone and will seek a collaboration partnership.
Interferon (IFN) alpha-2b program – CX-801 is a wholly-owned IFN alpha-2b Probody. In preclinical studies, CX-801 demonstrated a wide therapeutic index with an enhanced tolerability profile versus unmasked IFN, without compromising its potent antitumor effects. CytomX continued to advance this program with the goal of submitting an investigational new drug application (IND) in the second half of 2023. Preclinical data for the program were presented at AACR (Free AACR Whitepaper) 2022.
EpCAM-directed ADC program – CX-2051 is a wholly-owned conditionally activated ADC directed toward the epithelial cell adhesion molecule (EpCAM), with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has prioritized the development of CX-2051 and an IND submission is planned in the second half of 2023.
Early-stage programs – CytomX continued to work internally and with existing partners Astellas, AbbVie, Amgen, and Bristol Myers Squibb on the broad application of its multi-modality Probody platform to additional product candidates.
Publication – CytomX continued to publish key results supporting its platform and pipeline, taking the total preclinical and clinical manuscripts published since 2021 to eight. Nonclinical efficacy and safety of CX-2029 was published in the peer-reviewed journal Molecular Cancer Therapeutics. Preclinically, the anti-CD71 conditionally activated ADC exhibited a highly efficacious and acceptable safety profile that demonstrates the utility of the Probody platform to target CD71, an otherwise undruggable target. View Source
Priorities for 2022/2023

Complete company restructuring by end of 2022
Provide a data update for the Phase 2 study of CX-2029 in patients with squamous non-small cell lung cancer in the fourth quarter of 2022
Provide updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer in the fourth quarter of 2022
Continue enrolling patients with advanced solid tumors in the Phase 1 study of CX-904
Submit INDs for CX-801 and CX-2051 in the second half of 2023
Second Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $228 million as of June 30, 2022, compared to $305 million as of December 31, 2021.

Total revenue was $18 million for the three months ended June 30, 2022 compared to $16 million for the corresponding period in 2021. The increase in total revenue was largely related to the CD71 collaboration with AbbVie.

Research and development expenses increased by $5 million during the three months ended June 30, 2022 to $31 million compared to $26 million for the second quarter of 2021. The increase was primarily due to higher personnel-related expenses and laboratory contract services in support of our pre-clinical and clinical pipeline.

General and administrative expenses increased by $2.4 million during the second quarter of 2022 to $11.7 million. The increase was mainly in personnel and professional expenses.

Conference Call & Webcast Information
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (800) 715-9871 (domestic) or (646) 307-1963 (international) and reference the conference ID 4032732. A live webcast of the call can be accessed on the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website.

HOOKIPA Pharma to Report Second Quarter 2022 Financial Results on August 11, 2022

On August 4, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported that it will release its second quarter 2022 financial results and Company update before the market open on Thursday, August 11, 2022 (Press release, Hookipa Biotech, AUG 4, 2022, View Source [SID1234617573]).

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The Company will not be conducting a conference call in conjunction with this earnings release.

BIO-TECHNE RELEASES FOURTH QUARTER FISCAL 2022 RESULTS

On August 4, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the fourth quarter ended June 30, 2022 (Press release, Bio-Techne, AUG 4, 2022, View Source [SID1234617589]).

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Fourth Quarter FY2022 Highlights

Fourth quarter organic revenue increased by 14% (11% reported) to $288.2 million. Full year organic growth of 17% (19% reported) to $1.1 billion.
GAAP EPS was $1.51 versus $0.37 one year ago. Delivered adjusted earnings per share (EPS) of $2.05, an increase of 9% from the prior year. Full year GAAP EPS was $6.63 vs $3.47 a year ago. Achieved record full year adjusted EPS of $7.89, an increase of 17% from the prior year.
Sustained operational excellence across the organization, including Protein Sciences which achieved 16% organic growth (13% reported) in the fourth fiscal quarter and 19% organic growth (18% reported) for the full year.
Fourth quarter adjusted operating income was $106.6 million ($80.6 million reported), an increase of 6% (17% reported) from the prior year, despite foreign currency exchange negatively impacting operating income by 6%. Adjusted operating income for full year 2022 was $421.3 million ($296.6 million reported), an increase of 16% (25% reported) from the prior year.
Expanded Bio-Techne’s proteomic analytical tools portfolio through the acquisition of leading cell sorting company Namocell, which closed on July 1, 2022.
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.

"We had a tremendous finish to a spectacular fiscal 2022, as the Bio-Techne team delivered 14% organic growth for the fourth quarter and 17% organic growth for the year. This growth enabled us to cross the $1 billion in fiscal year revenue for the first time in our corporate history," said Chuck Kummeth, President and CEO of Bio-Techne. "I am particularly pleased with this performance given the prolonged headwinds we faced in China, as lockdowns in this geography lasted longer than we initially expected. We experienced robust demand across our portfolio of proteomic reagents and analytical tools, especially from our biopharma end markets, as well as accelerating momentum in our ExosomeDx business and a return to double-digit growth in our Spatial Biology business."

Kummeth added, "We recently strengthened our proteomic analytical tools portfolio with the acquisition of Namocell, a leading provider of cell sorting and dispensing instruments and consumables, adding to our portfolio of solutions for Cell and Gene Therapy workflows. In the quarter, we continued to scale our GMP protein manufacturing facility, commercializing two additional GMP proteins at scale to address current and forecasted demand. Overall, our portfolio of Cell and Gene Therapy workflow solutions had a stellar year, including greater than 50% organic growth. Separately, our ExoDx Prostate test continued its momentum from the prior quarter, as test volume set another record, increasing almost 70% in the quarter."

Kummeth continued, "Fiscal 2022 was an incredible year for Bio-Techne. We strengthened our team across the organization, announced another acquisition and continued to advance our leading portfolio of diagnostic solutions, proteomic reagents and analytical tools to advance science and enable discoveries. We are positioned to successfully navigate the current environment and continue our momentum into fiscal 2023 and beyond."

Fourth Quarter Fiscal 2022

Revenue

Net sales for the fourth quarter increased 11% to $288.2 million. Organic growth was 14% compared to the prior year with foreign currency exchange having an unfavorable impact of 3%.

GAAP Earnings Results

GAAP EPS was $1.51 per diluted share, versus $0.37 in the same quarter last year. GAAP EPS was negatively impacted in the prior year by a non-operating mark-to-market loss on our ChemoCentryx investment. GAAP operating income for the fourth quarter of fiscal 2022 increased 17% to $80.6 million, compared to $68.6 million in the fourth quarter of fiscal 2021. GAAP operating margin was 28.0%, compared to 26.5% in the fourth quarter of fiscal 2021. GAAP operating margin compared to prior year was positively impacted by volume leverage, which was partially offset by unfavorable foreign currency exchange impacts.

Non-GAAP Earnings Results

Adjusted EPS increased to $2.05 per diluted share, versus $1.88 in the same quarter last year, an increase of 9%. Adjusted EPS increased primarily due to revenue growth. Adjusted operating income for the fourth quarter of fiscal 2022 increased 6% compared to the fourth quarter of fiscal 2021. Adjusted operating margin was 37.4%, compared to 38.8% in the fourth quarter of fiscal 2021. Adjusted operating margin decreased compared to the prior year due to the impact of unfavorable foreign currency exchange.

Full Year Fiscal 2022

Revenue

Net sales for the full year fiscal 2022 increased 19% to $1,105.6 million. Organic growth was 17%, with acquisitions having a favorable impact of 3% and foreign currency translation having an unfavorable impact of 1%. Organic revenue growth was broad based and driven by accelerated momentum of the Company’s long-term growth strategy.

GAAP Earnings Results

GAAP EPS was $6.63 per diluted share compared to $3.47 per diluted share last fiscal year. GAAP EPS was favorably impacted by a non-operating mark-to-market gain of $16 million on our ChemoCentryx investment, compared to a loss on investment of $68 million in the prior fiscal year. GAAP operating income for full year fiscal 2022 increased 25.0% to $296.6 million, compared with $237.3 million in the full year fiscal 2021. GAAP operating margin was 26.8%, compared to 25.5% in the full year fiscal 2021. GAAP operating income and operating margin compared to prior year was positively impacted by both volume leverage and product mix.

Non-GAAP Earnings Results

Adjusted EPS was $7.89 per diluted shares, versus $6.76 in full fiscal year 2021. Adjusted operating margin for full fiscal year 2022 decreased to 38.3%, compared with 39.1% in full year fiscal 2021. Adjusted operating margin compared to the prior year was unfavorably impacted by foreign currency exchange, the full year impact of prior year’s Asuragen acquisition, and strategic investments.

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 fourth quarter fiscal 2022 net sales were $217.0 million, an increase of 13% from $192.3 million for the fourth quarter of fiscal 2021. Organic growth for the segment was 16%, with foreign currency exchange having an unfavorable impact of 3%. Protein Sciences segment’s operating margin was 44.9% in the fourth quarter of fiscal 2022 compared to 47.0% in the fourth quarter of fiscal 2021. The segment’s operating margin compared to the prior year was negatively impacted by foreign currency exchange.

Protein Sciences segment’s full year fiscal 2022 net sales were $832.3 million, an increase of 18% from $704.6 million for fiscal 2021. Organic growth for the segment was 19% for the fiscal year, with currency translation having an unfavorable 1% impact on revenue. Protein Sciences segment’s operating margin was 45.4% in fiscal 2022 compared to 46.9% in fiscal 2021. Segment operating margin compared to the prior year was unfavorably impacted by foreign currency exchange and strategic investments.

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 fourth quarter fiscal 2022 net sales were $71.7 million, an increase of 7% from $67.1 million for the fourth quarter of fiscal 2021. Organic growth for the segment was 8%, with foreign currency exchange having an unfavorable 1% impact. The Diagnostics and Genomics segment’s operating margin was 15.7% in the fourth quarter of fiscal 2022 compared to 16.7% in the fourth quarter of fiscal 2021. The segment’s operating margin was negatively impacted by foreign currency exchange and strategic investments.

The Diagnostics segment’s full year fiscal 2022 net sales were $274.8 million, an increase of 21% from $227.7 million for fiscal 2021. Organic growth for the segment was 10% with acquisitions contributing a favorable impact of 11% and currency translation having an immaterial impact on revenue growth. The Diagnostics segment’s operating margin was 17.8% in fiscal 2022 compared to 16.9% in fiscal 2021. Fiscal 2022 operating margin was favorably impacted by volume leverage and product mix.

Conference Call

Bio-Techne will host an earnings conference call today, August 4, 2022 at 8:00 a.m. CDT. To listen, please dial 1-800-926-5187 or 1-312-281-2972 for international callers, and reference conference ID 22019664. 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 22019664. The replay will be available from 11:00 a.m. CDT on Thursday, August 4, 2022 until 11:00 p.m. CDT on Sunday, September 4, 2022.

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 earnings
Adjusted tax rate
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
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. Revenue from partially-owned subsidiaries was $3.0 million and $4.6 million for the quarter and year ended June 30, 2022, respectively.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, 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.

AnHeart Therapeutics to Present Poster and Host Investigator Meeting at WCLC 2022

On August 4, 2022 AnHeart Therapeutics reported it will host an investigator meeting in addition to a e-poster presentation at the World Conference on Lung Cancer (WCLC) in Vienna, Austria at 11:00 am ET on Sunday, Aug. 7, 2022 (Press release, AnHeart Therapeutics, AUG 4, 2022, View Source [SID1234617605]).

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Ignatius Ou, M.D., Ph.D., Professor of Medical Oncology, University of California Irvine School of Medicine, along with members of AnHeart’s clinical development team and study investigators, will discuss the most recent clinical data of taletrectinib and the current status of the TRUST-II clinical trial for its ROS-1 inhibitor taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC).

Taletrectinib received FDA granted Breakthrough Therapy Designation (BTD) for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib.

Details of the e-poster presentation at WCLC 2022:

Abstract Title: TRUST-II: A Global Phase II Study for Taletrectinib in ROS1-fusion Positive Lung Cancer and Other Solid Tumors
Session: EP08.02 – Metastatic Non-small Cell Lung Cancer – Molecular Targeted Treatments
Final Program #: EP08.02-118
Author: Misako Nagasaka, M.D. Ph.D., University of California Irvine, School of Medicine

E-posters will be displayed on both days of the conference from August 7-8, 2022, 09:45 – 18:00. For more information, visit: View Source

The e-poster, as with other selected presentations regarding developments in AnHeart’s business given by management at certain investor and medical conferences, can be found on the company’s website, www.anhearttherapeutics.com, under Publications.