On December 13, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the closing of the previously announced private placement with certain accredited investors (the "Private Placement") (Press release, Delcath Systems, DEC 13, 2022, View Source [SID1234625194]).

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Delcath issued and sold 1,448,889 shares of its common stock (the "Common Stock") at a price per share of $2.90, or, in lieu of shares of Common Stock, 692,042 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") at a price per Pre-Funded Warrant of $2.89. The Pre-Funded Warrants will have an exercise price of $0.01 per share of Common Stock, be immediately exercisable and remain exercisable until exercised in full.

Delcath received gross proceeds from the Private Placement of approximately $6.2 million before deducting offering expenses payable by Delcath. Delcath intends to use the net proceeds from the Private Placement for working capital purposes and other general corporate purposes.

The securities sold in the Private Placement, including the shares of common stock underlying the Pre-Funded Warrants, have not been registered under the Securities Act of 1933, as amended, or state securities laws as of the time of issuance and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Delcath has agreed to file one or more registration statements with the SEC registering the resale of the Common Stock and the shares issuable upon exercise of the Pre-Funded Warrants purchased in the Private Placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these 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.

On December 13, 2022 Takeda reported that it will acquire NDI-034858 from Nimbus Therapeutics (Press release, Takeda, DEC 13, 2022, View Source [SID1234625193]). NDI-034858 is an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis . When the transaction is complete, NDI-034858 will be known as TAK-279.

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"Adding this TYK2 inhibitor to our late-stage pipeline gives Takeda an exciting program that has the potential to significantly expand our portfolio and patient impact, while enhancing our growth strategy beyond ENTYVIO" said Christophe Weber, president and chief executive officer of Takeda. "We are confident we can execute a broad development program and deliver a best-in-class therapy for these patients, given Takeda’s strong background in immune-mediated diseases, including inflammatory bowel disease (IBD)."

Nimbus recently disclosed positive topline results from a Phase 2b study evaluating NDI-034858 in patients with moderate-to-severe plaque psoriasis. Takeda intends to present results from this Phase 2b study early in 2023. NDI-034858 is anticipated to enter Phase 3 in psoriasis in 2023. It is in an ongoing Phase 2b study in active psoriatic arthritis, and Takeda plans to investigate it for the treatment of IBD and other autoimmune diseases.

"This program further expands Takeda’s GI clinical programs and therapeutic focus. After having seen the NDI-034858 Phase 2b data, particularly the PASI scores, we are excited by the differentiation of this molecule within the TYK2 class, and we believe in its broad potential for people with autoimmune diseases," said Andy Plump, M.D., Ph.D., president of Research & Development at Takeda. "By virtue of its unique allosteric mechanism of action, NDI-034858 is both a potent and highly selective TYK2 inhibitor with exceptional clinical activity, a strong tolerability profile and wide therapeutic margins. NDI-034858 is a potentially best-in-class TYK2 inhibitor across a wide range of immune mediated conditions."

"Since the acquisition of Shire in 2019, we have made excellent progress in reducing our debt ratio towards ‘low-twos’ net debt to adjusted EBITDA and we are on course to achieve this target one year ahead of plan. This acquisition is an opportunity to invest in the company’s mid-to-long term growth. Even after closing the deal, we expect to end this fiscal year with a debt ratio in the ‘low-to-mid-twos,’ and with a weighted average interest fixed rate of approximately 2%," said Costa Saroukos, chief financial officer of Takeda. "Takeda’s solid financial profile and robust cash flow outlook positions the company well to invest in growth drivers and focus on shareholder returns, while maintaining solid investment grade credit ratings."

Under the terms of the agreement, Takeda will pay Nimbus $4B upfront, and two milestone payments of $1B each upon achieving annual net sales of $4B and $5B. The upfront payment will be primarily funded by cash on hand. The transaction is expected to be finalized before the end of FY2022. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.

Evercore Group LLC is acting as exclusive financial advisor to Takeda and Cleary Gottlieb Steen & Hamilton LLP is acting as its legal advisor.

Takeda management will be hosting a virtual meeting for investors and analysts to discuss this announcement from 5:30 – 6:15 p.m. EST on Tuesday, December 13 / 7:30 – 8:15 a.m JST on Wednesday, December 14. Please click here to participate.

About NDI-034858

NDI-034858 is an allosteric TYK2 inhibitor developed by Nimbus Therapeutics that is being evaluated for the treatment of multiple autoimmune diseases. In preclinical studies, NDI-034858 has demonstrated exceptional functional selectivity and wide therapeutic margins. In Phase 1 studies, NDI-034858 showed a good tolerability profile, a dose-dependent trend in exploratory clinical activity and a pharmacokinetic profile allowing for once-daily solid oral dosing. Positive topline results were reported from a Phase 2b clinical trial evaluating NDI-034858 in patients with moderate-to-severe plaque psoriasis. NDI-034858 is in an ongoing Phase 2b trial in active psoriatic arthritis (NCT05153148).

On December 13, 2022 QIAGEN reported the U.S. Food and Drug Administration (FDA) approval of its therascreen KRAS RGQ PCR kit (therascreen KRAS kit) as a companion diagnostic test to Mirati Therapeutic’s drug KRAZATI (adagrasib) for non-small cell lung cancer (NSCLC) (Press release, Qiagen, DEC 13, 2022, View Source [SID1234625192]).

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QIAGEN and Mirati Therapeutics, Inc. (NASDAQ:MRTX), a targeted oncology company, announced their cooperation in May 2021. The tissue based KRAS companion diagnostic assay, which QIAGEN developed specifically to identify patients with NSCLC that have a KRAS G12C mutation, is instrumental in determining who may benefit from treatment with KRAZATI. The drug is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA approved test, who have received at least one prior systemic therapy.

"therascreen KRAS is a fast and cost-effective test ensuring physicians receive patient reports in the most efficient and straight forward way to make treatment decisions," said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. "This last approval is confirming and strengthening QIAGEN leadership in RAS companion diagnostics."

"It is critical to expand access to genomic testing for both health care providers and people living with cancer equipping them with meaningful information to inform treatment plans," said Kenna Anderes, Vice President Translational Medicine & Companion Diagnostics at Mirati Therapeutics. "The partnership with QIAGEN has led to meaningful advancements in the development of KRAS-specific biomarker testing."

This 4th approval of QIAGEN’s therascreen KRAS RGQ PCR kit adds to the existing 3 therapies already indicated in the label for use in NSCLC and colorectal cancer (CRC). It builds on the company’s experience in KRAS companion diagnostic test development and commercialization, which reaches back more than a decade.

Adagrasib is being evaluated in several clinical trials in combination with other anti-cancer therapies with strong scientific rationale in patients with advanced solid tumors. Lung cancer is one of the world’s most widespread cancers. In 2020, 2.21 million new cases and 1.8 million deaths were recorded worldwide.i The therascreen-based companion diagnostic detects KRAS G12C, a genetic mutation that is one of the most common KRAS alterations linked to cancer. This mutation is estimated to be present in around 13% of NSCLC casesii – and thus the most prevalent driver mutation.

QIAGEN is a pioneer in precision medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN is striving to fill the clinical gap for patient access and provide technology platform options to address varying clinical testing requirements for KRAS. These include next-generation sequencing (NGS) for comprehensive genomic profiling and digital PCR via QIAcuity for minimal residual disease monitoring.

With the new approval of therascreen KRAS for NSCLC, QIAGEN has eleven PCR based companion diagnostic indications that are FDA approved – the broadest portfolio of IVD approved PCR based companion diagnostics on the market. It includes also therascreen KRAS for CRC, therascreen EGFR for non-small cell lung cancer (NSCLC), therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients.

QIAGEN’s Day-One readiness program

Cancer drugs submitted to the FDA for approval are ideally already paired with companion diagnostics during their clinical trials. A companion diagnostic test that is approved and available as soon as the therapeutic drug is released to the market allows patients to benefit immediately from the targeted therapy. This timing is crucial, as some cancer patients may not have time to wait for labs to validate a new test.

To close this gap, QIAGEN has developed a dedicated Day-One readiness program to ensure that the companion diagnostic is available on the day the drug is approved. The program enables diagnostic labs to implement the activities necessary to prepare new companion diagnostic testing services for commercial launch before FDA approval is granted.

On December 13, 2022 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative AI-driven pharmaco-pheno-multiomic integration, reported its financial results for its second quarter of fiscal 2023, ended October 31, 2022 (Press release, Champions Oncology, DEC 13, 2022, View Source [SID1234625191]).

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Second Quarter and Recent Highlights:

•Record quarterly revenue of $14.3 million, an increase of 21% year over year
•Adjusted EBITDA of $686,000
•Discovery targets progressing along the development timeline; expectation to advance to preclinical phase testing in calendar 2023

Ronnie Morris, CEO of Champions, commented, "We continued to deliver good financial results while simultaneously investing in the future growth of the business. Morris added, "while long term prospects remain strong, we experienced a slowdown in the pace of our bookings growth during the quarter. We attribute the slow down to the global economic environment as our customers reanalyzed their spending budgets. We’re monitoring the situation closely and we’re optimistic this is a short-term adjustment as we’ve seen a re-acceleration in the beginning of our third quarter."

David Miller, CFO of Champions, added, "We reached another revenue milestone for Champions exceeding $14 million for the first time. The increase to $14.3 million represents 21% year over year growth which was in-line with the projected growth rate for the year. However, due to the economic climate, we saw an increase in cancellations during the quarter which will impact the revenue in the second half of the year. Accordingly, we’re revising our full year growth target to be in the 10% – 15% range."

Exhibit 99.1
Second Fiscal Quarter Financial Results

Total revenue for the second quarter of fiscal 2023, was a record $14.3 million, an increase of 21.2%, compared to $11.8 million for the same period last year. The increase in revenue was due to continued demand for our services, leading to larger pharmacology studies in both our in-vivo and ex-vivo platforms. Total costs and operating expenses for the second quarter of fiscal 2023 were $14.3 million compared to $11.5 million for the second quarter of fiscal 2022, an increase of $2.8 million or 23.9%.

For the second quarter of fiscal 2023, Champions reported income from operations of $7,000, including $119,000 in stock-based compensation and $560,000 in depreciation and amortization expenses, compared to income from operations of $263,000, inclusive of $134,000 in stock-based compensation and $346,000 in depreciation and amortization expenses, in the second quarter of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA for the quarter of $686,000 compared to $743,000 in the prior year period.
Cost of oncology solutions was $7.4 million for the three-months ended October 31, 2022, an increase of $1.8 million, or 32.7% compared to $5.6 million for the three-months ended October 31, 2021. The increase in cost of sales was primarily from compensation, mice and lab supply expenses for pharmacology studies, and an increase in compensation expense for our SaaS platform. For the three- months ended October 31, 2022, total gross margin was 48% compared to 52% for the three-months ended October 31, 2021. Pharmacology services margin was 51% vs 53% in the year ago period. The lower margin resulted from an increase in study related expenses against lower than expected revenue conversion.

Research and development expense for the three-months ended October 31, 2022 was $2.6 million, an increase of $305,000 or 13.3%, compared to $2.3 million for the three-months ended October 31, 2021. The increase was primarily from compensation and lab supply expenses related to the investment in our therapeutic discovery platform. Sales and marketing expense for the three-months ended October 31, 2022 was $1.7 million, a slight increase of $60,000, or 3.7%, compared to $1.6 million for the three-months ended October 31, 2021. General and administrative expense for the three-months ended October 31, 2022 was $2.5 million, an increase of $552,000, or 27.9%, compared to $2.0 million for the three-months ended October 31, 2021. The increase was primarily due to depreciation and amortization expenses and IT related costs to support the growth of the business.

Net cash provided by operating activities was $3.3 million for the three months ended October 31, 2022. The cash generated from operating activities was primarily due to income from operations excluding stock-based compensation, depreciation and amortization expenses as well as an increase in accounts payable due to timing differences in the ordinary course of business. The Company ended in the quarter in a strong cash position with cash on hand of $10.8 million and no debt.

Year-to-Date Financial Results

For the first six months of fiscal 2023, revenue increased 21.6% to $28.0 million compared to $23.0 million for the first six months of fiscal 2022. The increase in revenue was due to the expansion of our platforms and business lines. Total costs and operating expenses for the first six months of fiscal 2023 were $28.3 million compared to $23.0 million for the first six months of fiscal 2022, an increase of $5.4 million or 23.3%.

For the first six months of fiscal 2023, Champions reported a net loss from operations of $277,000, including $325,000 in stock-based compensation and $1.1 million in depreciation and amortization expenses, compared to income from operations of $88,000, inclusive of $414,000 in stock-based compensation and $663,000 in depreciation and amortization expenses, in the first six months of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA of $1.1 million for the first six months of fiscal 2023 compared to adjusted EBITDA of $1.2 million in the first six months of fiscal 2022.

Cost of oncology solutions was $14.5 million for the six-months ended October 31, 2022, an increase of $3.5 million, or 31.7% compared to $11.0 million for the six-months ended October 31, 2021. For the six-months ended October 31, 2022, total gross margin was 48.3% compared to 52.2% for the six-months ended October 31, 2021. For the same respective periods, pharmacology services margin was 51.1% vs 52.8%. The decrease in gross margin was primarily attributable to an increase in study related expenses in advance of the revenue recognition and lower than expected revenue conversion.

Research and development expense for the six-months ended October 31, 2022 was $5.5 million, an increase of $888,000 or 19.3%, compared to $4.6 million for the six-months ended October 31, 2021. The increase was primarily from compensation, sequencing costs, and lab supplies as we increased investment in our therapeutic target discovery platforms. Sales and marketing expense for the six-months ended October 31, 2022 was $3.4 million, a slight increase of $178,000, or 5.5%, compared to $3.2 million for the six-months ended October 31, 2021. General and administrative expense for the six-months ended October 31, 2022 was $4.9 million, an increase of $800,000, or 19.3%, compared to $4.1 million for the six-months ended October 31, 2021. The increase was primarily due to an increase in compensation and IT related expenses to support the overall infrastructure growth of the organization as well as depreciation and amortization expenses.

Net cash provided by operating activities was $3.1 million for the six-months ended October 31, 2022. The cash generated from operating activities was primarily due to an increase in income from operations excluding stock-based compensation and depreciation and amortization expenses as well as an increase in accounts payable due to timing differences in the ordinary course of business. Net cash used in investing activities was $1.4 million and was primarily from investment in additional lab and computer equipment.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 877-545-0523 (Domestic) or 973-528-0016 (International) and enter the access code 541646, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by December 15, 2022 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information
See the attached Reconciliation of GAAP net income (loss) to Non-GAAP net income for an explanation of the amounts excluded to arrive at Non-GAAP net income and related Non-GAAP earnings per share amounts for the three and six months ended October 31, 2022 and 2021. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income and Non-GAAP earnings per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings per share amounts as Non-GAAP net earnings divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings and Non-GAAP diluted earnings per share may differ from similarly named measures used by other companies.

On December 13, 2022 Cellectis presented its clinical trial update presentation (Presentation, Cellectis, DEC 13, 2022, View Source [SID1234625189]).

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