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On May 10, 2022 Kyowa Kirin Co., Ltd. reported that Consolidated Financial Summary (IFRS) Fiscal 2022 First Quarter(Press release, Kyowa Hakko Kirin, MAY 10, 2022, View Source [SID1234614019])

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1. Consolidated Financial Results for the Three Months Ended March 31, 2022
(1) Consolidated operating results
(2) Consolidated financial position

2. Dividends

3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2022 (from January 1, 2022 to December 31, 2022)

* Quarterly financial results reports are exempt from quarterly review conducted by certified public accountants or an audit corporation.
* Notice regarding the appropriate use of the earnings forecasts and other special comments

The forward-looking statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons

1. Operating Results and Financial Statements
(1) Summary of Consolidated Financial Position  Assets as of March 31, 2022, were ¥907.8 billion, a decrease of ¥14.1 billion compared to the end of the previous fiscal year.  Non-current assets increased by ¥5.8 billion compared to the end of the previous fiscal year, to ¥409.4 billion, due mainly to an increase in deferred tax assets.  Current assets were ¥498.4 billion, a decrease of ¥19.9 billion compared to the end of the previous fiscal year, mainly reflecting a decrease in trade and other receivables as well as a decrease in cash and cash equivalents due to the payment of dividends and income taxes.

 Liabilities as of March 31, 2022, were ¥163.4 billion, a decrease of ¥21.3 billion compared to the end of the previous fiscal year, due mainly to decreases in income taxes payable and trade and other payables.  Equity as of March 31, 2022, was ¥744.5 billion, an increase of ¥7.3 billion compared to the end of the previous fiscal year, due mainly to an increase due to the recording of profit attributable to owners of parent as well as an increase in exchange differences on translation of foreign operations resulting from the impact of exchange rates, despite a decrease due to the payment of dividends, etc.

As a result, the ratio of equity attributable to owners of parent to total assets as of the end of the first quarter was 82.0%, an increase of 2.0 percentage points compared to the end of the previous fiscal year.

(2) Summary of Consolidated Business Performance
1) Overview of results The Group now applies the International Financial Reporting Standards ("IFRS") in line with its policy of expanding business globally, and adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amountFor the three months ended March 31, 2022 (January 1, 2022 to March 31, 2022), revenue was ¥87.8 billion (up 8.2% compared to the same period of the previous fiscal year), and core operating profit was ¥17.3 billion (up 11.8%). Profit attributable to owners of parent was ¥16.0 billion (up 24.1%).

 The increase in revenue was the result of growth of global strategic products in North America and EMEA and a rise in revenue from technology out-licensing, despite lower revenue in Japan. The positive effect on revenue from foreign exchange was ¥3.6 billion.
 Core operating profit rose, despite increases in selling, general and administrative expenses and research and development expenses, due to higher gross profit resulting from an increase in overseas revenue and a rise in revenue from technology out-licensing. The positive effect on core operating profit from foreign exchange was ¥1.2 billion.  Profit attributable to owners of parent increased as a result of an increase in finance income and a decrease in income tax expense in addition to an increase in core operating profit.

On May 10, 2022 Theratechnologies Inc. ("Theratechnologies" or "the Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that initiated enrollment of patients in the basket portion of the first-in-human study of TH1902, Theratechnologies’ investigational lead peptide drug conjugate (PDC) for the treatment of sortilin-expressing cancers (Press release, Theratechnologies, MAY 10, 2022, View Source [SID1234614053]).

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Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies, noted, "We are pleased to move forward to the next stage of development of TH1902, the basket portion of the first-in-human study. We firmly believe that the unique mechanism of entry of TH1902 in cancer cells is a key advantage to improve the therapeutic window of docetaxel. TH1902’s targeted delivery and rapid internationalization in cancer cells via the Sortilin receptor enables the potential to accumulate 7.5 to 10 times more docetaxel in cancer cells — as compared to the administration of docetaxel alone. Based on the pre-clinical results obtained so far, we are optimistic in the development of a first-in-class and promising treatment for patients with Sortilin positive solid tumors. Additionally, we continue to advance the development of our SORT1+ TechnologyTM platform by conjugating our proprietary peptide with other effective anti-cancer agents."

Based on the data of the dose escalation part of the study, the dose of TH1902 for the expansion study was established at 300 mg/m2 or 1.5 times the therapeutic dose of docetaxel alone. No dose limiting toxicities were observed following the completion of the first cycle in the last 6 patients treated at 300 mg/m2. The basket portion of the first-in-human study is an expansion study designed to assess TH1902 as monotherapy treatment of advanced refractory or resistant solid tumor types expressing high levels of Sortilin, including Hormone Receptor-positive (HR+) Breast Cancer, Triple Negative Breast Cancer, Ovarian Cancer, Endometrial Cancer, and Melanoma with approximately 10 patients per tumor type. One arm will include a mix of tumor types including Thyroid, Small Cell Lung, Prostate and potential other high Sortilin expressing cancers with approximately 15 patients in total. In addition to evaluating the anti-tumor activity of TH1902, the study will continue to evaluate the safety and pharmacokinetics of TH1902. Exploratory pharmacodynamic and biomarker analyses will also be conducted.

About TH1902
TH1902 is Theratechnologies’ proprietary peptide drug conjugate (PDC) linked to docetaxel, a well-established and well-characterized cytotoxic agent. TH1902 is being developed as a single agent for the treatment of all advanced solid tumors expressing sortilin that are refractory to standard therapy. TH1902 is the Company’s lead PDC drug candidate stemming from Theratechnologies’ SORT1+ Technology in oncology.

About SORT1+ TechnologyTM
Theratechnologies has developed a peptide which specifically targets sortilin (SORT1) receptors. SORT1 is expressed in ovarian, triple negative breast, skin, lung, colorectal and pancreatic cancers, among others. SORT1 plays a significant role in protein internalization, sorting and trafficking, making it an attractive target for drug development.

Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to Theratechnologies’ investigational novel peptides to specifically target sortilin receptors with the aim of improving the efficacy and safety of those agents.

What is a basket trial?
A type of clinical trial that tests how well a new drug or other substance works in patients who have different types of cancer that all have the same mutation or biomarker. In basket trials, patients all receive the same treatment that targets the specific mutation or biomarker found in their cancer. Basket trials may allow new drugs to be tested and approved more quickly than traditional clinical trials. Basket trials may also be useful for studying rare cancers and cancers with rare genetic changes.

On May 10, 2022 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Gossamer Bio, MAY 10, 2022, View Source [SID1234614070]).

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"We are looking forward to the fourth quarter release of topline data from the ongoing Phase 2 TORREY Study, which has now completed enrollment," said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer Bio.

"Additionally, through a recent internal reprioritization and the implementation of certain cost containment measures, we are pleased to see Gossamer’s expected capital runway further extended into the first half of 2024. As part of this reprioritization, we now anticipate moving GB7208 into the clinic in the first half of 2023, pending the TORREY Study results."

Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment has completed in the ongoing TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance from baseline at week 24.
Topline data from the TORREY Study are expected in the fourth quarter of 2022.
GB5121: Oral, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL) and other Rare CNS Malignancies

We expect to initiate the Phase 1b/2 STAR CNS Study in relapsed / refractory PCNSL and other rare CNS malignancies in the second quarter of 2022.
GB7208: Oral, CNS-Penetrant BTK Inhibitor for Neuroinflammatory Diseases

Pending the outcomes of ongoing preclinical studies and the seralutinib Phase 2 TORREY Study topline results, we expect to initiate a Phase 1 clinical trial in healthy volunteers in the first half of 2023.
Financial Results for Quarter Ended March 31, 2022

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2022, were $271.6 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into 2024.
Research and Development (R&D) Expenses: For the quarter ended March 31, 2022, R&D expenses were $42.3 million, compared to R&D expenses of $41.8 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the quarter ended March 31, 2022, G&A expenses were $12.0 million, compared to $11.3 million for the same period in 2021.
Net Loss: Net loss for the quarter ended March 31, 2022, was $57.8 million, or $0.76 per share, compared to a net loss of $57.6 million, or $0.78 per share, for the same period in 2021.

On May 10, 2022 Cardinal Health (NYSE: CAH) reported that its Board of Directors approved a quarterly dividend of $0.4957 per share out of the Company’s capital surplus (Press release, Cardinal Health, MAY 10, 2022, View Source [SID1234614085]). The dividend will be payable on July 15, 2022 to shareholders of record at the close of business on July 1, 2022.

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