On August 9, 2022 Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, reported results from the myCare-203A study, which demonstrate that the Cellworks Biosimulation Platform and Singula Therapy Response Index (TRI) was strongly predictive of Overall Survival (OS) for non-small cell lung cancer (NSCLC) patients and can provide personalized therapy decision guidance (Press release, Cellworks, AUG 9, 2022, View Source [SID1234617960]). In the study, Singula Therapy Response Index (TRI) provided patient-specific scores that demonstrated predictive value of OS beyond NCCN-guideline genomic biomarkers, physician-prescribed treatments and standard clinical factors such as the patient’s age and sex.

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The results from the myCare-203A clinical study were featured in a poster presentation at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and held in Vienna, Austria from August 6-9, 2022.

"The current population-based cancer therapy guidelines do not consider the full biological complexity of an individual patient’s disease and therefore may limit the patient’s duration of therapy response and overall effectiveness of the treatment," said Dr. Mark Klein, Staff Physician, Hematology/Oncology Section, Minneapolis VA; Associate Professor, Division of Hematology, Oncology and Transplantation, University of Minnesota; and Co-Principal Investigator of the myCare-203A clinical study. "In contrast to population-based therapy guidelines, the Cellworks Biosimulation Platform produces personalized therapy predictions for each NSCLC patient based on a patient-specific multi-omic disease model. The myCare-203A study found that the personalized approach of Cellworks Singula TRI produces a more precise therapeutic decision guide for patients with NSCLC."

"There are multiple approved drugs for treating NSCLC, which makes selecting the most efficacious treatment for each patient more complicated," said Dr. Apar Kishor Ganti, Staff Physician, VA Nebraska Western Iowa Health Care System; Professor in the Department of Internal Medicine, Division of Oncology/Hematology, at the University of Nebraska Medical Center; and Co-Principal Investigator of the myCare-203A clinical study. "The myCare-203A study shows us that the Cellworks Biosimulation Platform and Singula TRI can streamline the treatment decision-making process and improve NSCLC patient outcomes through personalized therapy response predictions."

The Cellworks Biosimulation Platform simulates how a patient’s personalized genomic disease model will respond to therapies prior to treatment. The platform is powered by Cellworks groundbreaking Computational Omics Biology Model (CBM), a network of 7,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. As part of the biosimulation process, personalized disease models are created for each patient using their cytogenetic and molecular data as input to the Cellworks CBM. The Cellworks platform analyzes the impact of specific therapies on the patient’s personalized disease model and generates a Singula biosimulation report with Therapy Response Index (TRI) scores from 0 to 100 that predict low to high therapeutic benefit.

myCare-203A Clinical Study

Background
In this study, the Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) was used to prospectively generate Singula Therapy Response Index (TRI) scores for a retrospective cohort of 453 NSCLC patients aged 39-87 (22 female, 431 male) from Veterans Affairs facilities, who were treated with physician-prescribed therapies.

Methods
Cellworks Singula TRI scores were generated for physician-prescribed therapies and 109 alternate therapies for each patient, enabling selection of optimal therapies with estimates of improvements in median OS compared to standard care. Multivariate Cox Proportional Hazards regression models were used to test the hypothesis that Cellworks Singula TRI provides predictive value of OS above and beyond physician-prescribed treatment, NCCN-guideline genomic biomarkers, patient age and patient sex.

Results and Conclusions
Multivariate analyses demonstrated that Cellworks Singula TRI is a significant predictor of OS and provided predictive value of OS above and beyond physician-prescribed treatment, NCCN-guideline genomic biomarkers, patient age and patient sex. These results show that physicians can use Cellworks Singula TRI scores to more precisely guide therapeutic decisions for individual patients with NSCLC.

On August 9, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported its financial and operating results for the second quarter ended June 30, 2022 and provided an update on its full year 2022 financial guidance and recent corporate activities (Press release, Halozyme, AUG 9, 2022, View Source [SID1234617991]).

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"As we report our strong second quarter results and execute our plans to continue to deliver sustained high growth, I have never been more excited about the future and potential of Halozyme. We see strong ENHANZE momentum with our Wave 2 products DARZALEX SC and Phesgo and with recent positive Phase III study results for efgartigimod SC and Tecentriq SC, two of our four Wave 3 launch products with the potential for launch 2023-2025. As planned, we project at least six Phase 2 or Phase 3 study starts in 2022," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The acquisition of Antares Pharma enhances our revenue growth and durability, adding a commercialized, broadly licensable autoinjector platform and two innovative commercial products in the large and growing testosterone replacement therapy market."

Recent Partner Highlights:

In August 2022, Roche announced that the Phase III IMscin001 study evaluating a subcutaneous (SC) formulation of Tecentriq (atezolizumab) with ENHANZE met its co-primary endpoints. The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion, in cancer immunotherapy-naïve patients with advanced or metastatic non-small cell lung cancer for whom prior platinum therapy has failed. The safety profile of the SC formulation was consistent with IV Tecentriq.
In July 2022, Takeda announced positive topline results from pivotal Phase 3 trial evaluating HYQVIA (Immunoglobulin infusion 10% (Human) with rHuPH20), for maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
In June 2022, Bristol Myers Squibb nominated an undisclosed target resulting in a $5 million milestone payment.
In June 2022, ViiV initiated enrollment of a Phase 1 single dose escalation study in subjects with HIV to evaluate pharmacokinetics, safety and tolerability of long-acting cabotegravir administered subcutaneously with ENHANZE.
In June 2022, argenx initiated a Phase 2 study evaluating efgartigimod with ENHANZE in subjects with bullous pemphigoid.
In May 2022, Chugai initiated a Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and safety of targeted antibody administered subcutaneously with ENHANZE.
In April 2022, Roche initiated a Phase 3 study evaluating OCREVUS (ocrelizumab) with ENHANZE in subjects with multiple sclerosis.
Recent Corporate Highlights:

In May 2022, we completed the acquisition of Antares Pharma, Inc. resulting in an expansion of our commercial portfolio of proprietary and partnered products and the potential for future growth through new partnership agreements.
In June 2022, we announced the commercial launch of TLANDO, an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.
In June 2022, we completed the $150 million Accelerated Stock Repurchase that was initiated in December of 2021, resulting in the total repurchase of 3.9 million shares at an average price of $38.51 per share.
Second Quarter Financial Highlights

Revenue for the second quarter was $152.4 million compared to $136.5 million for the second quarter of 2021. The 12% year-over-year increase was driven by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab) and the addition of product sales as a result of the Antares Pharma acquisition, partially offset by a decrease in revenues under collaborative agreements due to a $40 million upfront payment associated with entering into the ViiV collaboration in the prior year period. Revenue for the quarter included $85.3 million in royalties, an increase of 86% compared to $45.8 million in the prior year period.
Cost of sales for the second quarter was $33.9 million, compared to $23.0 million for the second quarter of 2021. The year-over-year increase was driven by an increase in product sales as a result of the Antares Pharma acquisition.
Amortization of intangibles expense in the second quarter was $11.4 million, an increase from no expense in the second quarter of 2021 due to the Antares Pharma acquisition, in which we acquired intangible assets that are amortized over a useful life related to the auto injector technology platform, XYOSTED and TLANDO.
Research and development expenses for the second quarter were $15.5 million, compared to $8.1 million for the second quarter of 2021. The increase is primarily due to planned investments in ENHANZE and one-time compensation costs related to the Antares Pharma acquisition.
Selling, general and administrative expenses for the second quarter were $57.5 million, compared to $12.3 million for the second quarter of 2021. The increase was primarily due to one-time transaction and compensation costs related to the Antares Pharma acquisition and an increase in compensation expense related to the ongoing combined workforce.
Operating Income in the second quarter of 2022 was $34.1 million, compared to an operating income of $93.0 million in the second quarter of 2021.
Net Income: On a GAAP basis in the second quarter of 2022, net income was $22.7 million, compared with net income of $91.5 million in the second quarter of 2021. Non-GAAP net income was $75.7 million in the second quarter of 2022, compared with non-GAAP net income of $97.8 million in the second quarter of 2021.1 The Company notes that 2022 is the first year in which Halozyme will record income tax expense as part of its income statement.
Earnings per Share: On a GAAP basis in the second quarter of 2022, diluted earnings per share was $0.16, compared with $0.62 in the second quarter of 2021. On a non-GAAP basis diluted earnings per share was $0.53, compared with diluted earnings per share of $0.66 in the second quarter of 2021.1
Cash, cash equivalents and marketable securities were $209.4 million on June 30, 2022, compared to $740.9 million on December 31, 2021.
Financial Outlook for 2022

The Company is raising its financial guidance for 2022 which was last provided on May 10, 2022, as a result of the recent close of the Antares Pharma transaction and strong year-to-date results. For the full year 2022, the Company expects:

Total revenue of $655 million to $685 million, an increase from our prior guidance range of $530 million to $560 million, representing growth of 48% to 55% over 2021 total revenue primarily driven by projected revenue contribution from the Antares business of $115 million to $125 million. The Company expects revenue from royalties to increase greater than 65% over revenue from royalties in 2021 to approximately $340 million to $350 million.
Operating income of $240 million to $265 million, a decrease from our prior guidance range of $350 million to $380 million, representing a decline of 4% to 13% over 2021 operating income. Our 2022 guidance includes one-time transaction costs related to the Antares Pharma acquisition, including amortization of intangible assets, as well as an incremental $20 million operating expense investment to maximize ENHANZE and to extend royalty revenue durability.
GAAP net income of $170 million to $195 million, a decrease from our prior guidance range of $270 million to $295 million; and non-GAAP net income of $295 million to $320 million, an increase from our prior guidance range of $290 million to $315 million.1 The Company notes that 2022 will be the first full fiscal year in which Halozyme will record income tax expense as part of its income statement.
GAAP diluted earnings per share of $1.20 to $1.35, a decrease from our prior guidance of $1.90 to $2.05, due to acquisition related costs in 2022.
Non-GAAP diluted earnings per share are expected to be $2.10 to $2.25, an increase from our prior guidance range of $2.05 to $2.20,1 reflective of the projected accretion from the Antares Pharma acquisition.
The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the second quarter ended June 30, 2022 today, Tuesday, August 9, 2022 at 4:30 p.m. ET/1:30 p.m. PT. The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the "Investors" section of www.halozyme.com.

Ligand has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On August 9, 2022 Kureha Corporation reported that it has upgraded its earnings forecast for the first half-year of FY2022 ending March 31, 2023, in light of the recent performance trends. Changes from the previous forecast, which was announced on May 12, 2022, are as follows (Press release, Kureha Corporation, AUG 9, 2022, View Source [SID1234617845]).

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1. FY2022 2Q Earnings Forecast (April 1, 2022 through September 30, 2022)(Reasons for the revision)

For the first six months of FY2022, revenue is expected to exceed the previous forecast due to effects of a weaker Japanese yen and strong pricing actions against energy and raw material cost inflations, in addition to higher Specialty Chemicals volumes resulting from a front-loaded shipment of agrochemicals. Operating profit will also rise due to increased sales of high-margin products and the postponement in spending SG&A expenses to the latter half of the year. Subsequently, profit before taxes and profit attributable to owners of Kureha Corporation are projected to exceed the forecasts.

Kureha will also update and release its FY2022 full-year earnings forecast, reflecting changes in the business conditions, when it reports 2Q results (scheduled for November 9, 2022.)

Note: The statement regarding the above-mentioned forecast is based on current information acquired by Kureha Corporation as of the date of this announcement. Actual results may differ from these forecasts due to various unforeseeable factors.

On August 9, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that it has received a Study May Proceed letter from the United States Food and Drug Administration (FDA) to begin its 15 patient study evaluating REM-001 Photodynamic Therapy (PDT) for the treatment of Cutaneous Metastatic Breast Cancer (CMBC) (Press release, Kintara Therapeutics, AUG 9, 2022, View Source [SID1234617898]). This study is intended to aid in the design of a planned phase 3 registrational study.

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"The FDA’s reactivation of our Investigational New Drug application for REM-001 is an important milestone for Kintara," stated Robert E. Hoffman, President and CEO of Kintara. "This clinical study is part of a broad strategy designed to demonstrate proof of concept for our Photodynamic Therapy platform in CMBC, an area of unmet medical need, as well as across other cutaneous metastatic cancers."

PDT is a treatment that uses light sensitive compounds, or photosensitizers, that, when exposed to specific wavelengths of light, act as a catalyst to produce a form of oxygen that induces local tumor cell death. The planned clinical study is expected to enroll 15 patients with CMBC that is refractory or not eligible for radiotherapy or surgery. The study will evaluate cutaneous tumor response using standardized and calibrated 3D digital photography.

"We’re excited to further explore the potential benefits of this second-generation photosensitizer, particularly given the unmet need of CMBC," added Dr. Mario E. Lacouture, Professor and Director of the Oncodermatology Program in the Dermatology Service Department of Medicine at Memorial Sloan Kettering Cancer Center and Chairman of Kintara’s REM-001 Scientific Advisory Board.