Half-Year Results 2022

On July 21, 2022 Roche reported half-yearly results 2022 (Presentation, Hoffmann-La Roche, JUL 21, 2022, blob:View Source [SID1234618487]).

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Cytokinetics to Announce Second Quarter Results on August 4, 2022

On July 21, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report second quarter results on August 4, 2022 at 4:00 PM Eastern Time (Press release, Cytokinetics, JUL 21, 2022, View Source [SID1234616881]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics Q2 2022 Earnings Conference Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call. An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.

BridgeBio Pharma Announces Founding Affiliation with Bakar Labs, Incubator at UC Berkeley’s Bakar BioEnginuity Hub

On July 21, 2022 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported its founding affiliation with Bakar Labs, the incubator at UC Berkeley’s Bakar BioEnginuity Hub (Press release, BridgeBio, JUL 21, 2022, View Source [SID1234616871]). Bakar Labs was established by the University of California (UC), Berkeley and QB3, UC’s research institute for innovation and entrepreneurship in the life sciences and is open to academic researchers from around the world. The Labs will host up to 50 innovative life science start-up companies seeking to advance promising research.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Partnering with UC Berkeley and QB3 to launch Bakar Labs is a natural extension of our mission to discover, create, test, and deliver transformative medicines to as many patients as possible. Through this collaboration, we aim to strengthen the Bay Area biotech ecosystem and potentially unlock new therapies for patients with unmet needs," said BridgeBio founder and CEO Neil Kumar, Ph.D.

The multi-disciplinary startup companies at Bakar Labs are supported by world-class facilities, resources, and expertise from industry and academia. BridgeBio intends to review discoveries, provide support to entrepreneurs, and consider possible partnership opportunities with startups focused on potential therapies for patients with genetically-driven diseases and cancers.

"We admire BridgeBio’s innovation in pioneering a decentralized model with shared resources, addressing vital unmet needs for therapies for genetic diseases," said Regis Kelly, Ph.D., OBE, director of Bakar Labs. "We look forward to learning from and interacting with BridgeBio as we develop Bakar Labs as a shared resource for entrepreneurs developing a wide range of new biotechnologies."

A core part of BridgeBio’s efforts to help patients is the identification of new discoveries in academia. With an extensive pipeline and research and development capabilities, BridgeBio seeks to provide the insights and support needed to rapidly progress promising academic research from labs to clinical development. This new partnership will allow the Company to play a role in finding and accelerating research for patients as quickly and safely as possible.

Plus Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights

On July 21, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported financial results for the second quarter ended June 30, 2022, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, JUL 21, 2022, View Source [SID1234616870]).

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"During the second quarter, we maintained the momentum to successfully complete our key corporate goals for 2022," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Clinical data from our glioblastoma and leptomeningeal metastasis trials, though early in development, continue to show promise and we remain on track to complete key CMC and regulatory objectives."

RECENT HIGHLIGHTS

Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets

In July 2022, the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions. Additionally, the intermediate drug product is in stability testing and compliant with the U.S. Food and Drug Administration (FDA) guidance for manufacture of nanoliposomal drug products for use in late-stage clinical trials and commercialization. The Company expects to have GMP drug availability in the second half of 2022 for ongoing and planned clinical trials in adults with recurrent glioblastoma, leptomeningeal metastasis and future disease targets.
In July 2022, at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting, the Company presented positive interim data on the lead investigational drug, 186RNL, from the Phase 1/2a ReSPECT-GBM dose escalation clinical trial in patients with recurrent glioblastoma (GBM). During the presentation, the Company noted that the trial has evaluated 23 adult patients with recurrent GBM across 7 cohorts of increasing dose. To date, there have been no dose limiting toxicities and promising efficacy signals have been observed in patients receiving average absorbed doses of radiation > 100 Gy.
The Company’s principal investigator will provide a full data update on the Phase 1/2a ReSPECT-GBM dose escalation clinical trial at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Meeting in Paris France, September 9-13, 2022.
In the second quarter of 2022, the Company completed enrollment of Cohort 1 of the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with leptomeningeal metastases (LM). 186RNL was successfully delivered without dose limiting toxicities in this initial cohort and the independent ReSPECT-LM trial Data Safety & Monitoring board has approved the plan to move ahead with the Cohort 2.
The Company submitted two briefing packages to the FDA to seek their opinion on the recurrent GBM clinical program and CMC development plans.
The Company entered into a multi-year agreement with Biocept, Inc. to employ its cerebrospinal fluid assay in the ReSPECT-LM Phase 1/2a dose-escalation clinical trial. Biocept’s assay provides a highly sensitive method to assess and quantify tumor cell burden in LM of the central nervous system. Assay results will be used to evaluate biologic response to treatment and treatment efficacy for patients enrolling in the ReSPECT-LM trial.
The Company obtained FDA approval for the ReSPECT-GBM multiple dose extension trial.
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere ( 188 RNL-BAM), a novel radiotherapy in development for solid organ cancers

The Company has completed key technology transfer activities from UT Health Science Center at San Antonio and is on track to complete key CMC feasibility and IND enabling preclinical studies in the fourth quarter of 2022.
SECOND QUARTER 2022 FINANCIAL RESULTS

The Company’s cash balance was $18.1 million at June 30, 2022, compared to $18.4 million at December 31, 2021.
Total operating expenses for the second quarter of 2022 were $5.1 million, compared to total operating expenses of $2.6 million for second quarter of 2021. The increase is due primarily to incremental CMC spend relating to the development of GMP 186RNL drug and key regulatory consulting activities, both of which are on track to be completed in the third quarter of 2022. In addition, to a lesser extent, the Company had a forecasted increase in legal, professional fees and other general corporate expenses.
Net loss for the second quarter of 2022 was $5.3 million, or $(0.24) per share, compared to a net loss of $2.8 million, or $(0.25) per share, for the second quarter of 2021.
UPCOMING EVENTS AND MILESTONES

During the remainder of 2022, the Company expects to accomplish the following key business objectives:

Present updated data from the ReSPECT-GBM and ReSPECT-LM at European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and Society of Neuro-Oncology scientific conferences.
Receive FDA feedback from CMC and clinical Type C meetings for the recurrent GBM program.
Complete GMP manufacturing milestones for 186RNL.
Submit a protocol for the study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC).
Complete key CMC & IND-enabling studies for 188RNL-BAM.
Second Quarter 2022 Results Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call.

Champions Oncology Reports Quarterly Revenue of $12.9 Million

On July 21, 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 the year and fourth fiscal quarter ended April 30, 2022 (Press release, Champions Oncology, JUL 21, 2022, View Source [SID1234616869]).

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Fourth Quarter and Fiscal Year 2022 Financial and Recent Business Highlights:
•Fourth quarter revenue increased 22% to $12.9 million
•Record annual revenue of $49.1 million, an increase of 20% year-over-year
•Achieved high end of revenue guidance of 20%
•Gross margin improved to 52% for fiscal year 2022
•Adjusted EBITDA of $3.1 million for fiscal year 2022

Ronnie Morris, CEO of Champions, commented, "Fiscal year 2022 was an outstanding year for Champions as we successfully expanded our business lines while continuing to develop and implement our longer term strategies. Our ex-vivo business was especially promising as we saw rising demand for those services. Our computational discovery tools continue to evolve and this upcoming year will focus on moving these programs into preclinical development."

David Miller, CFO of Champions added, "We realized another year of financial milestones, reaching a record $49.1 million in revenue and delivering 20% top line growth, in line with the high end of revenue guidance. Our pipeline of opportunities remains robust and with the expansion of our platforms, we are well positioned to deliver strong financial results in fiscal year 2023. We’re projecting another year of top line revenue growth in the 20% range."

Fourth Fiscal Quarter Financial Results

Total revenue for the fourth quarter of fiscal 2022 was $12.9 million, an increase of 22%, compared to $10.6 million for the same period last year. The increase in revenue was due to continued demand and larger study sizes for our pharmacology studies, including in-vivo and ex-vivo services. Total costs and operating expenses for the fourth quarter of fiscal 2022 were $13.2 million compared to $11.0 million for the fourth quarter of fiscal 2021, an increase of $2.2 million or 20%.

For the fourth quarter of fiscal 2022, Champions reported a loss from operations of $311,000, which includes $188,000 in stock-based compensation and $568,000 in depreciation and amortization compared to a loss from operations of $456,000, inclusive of $161,000 in stock-based compensation and $302,000 in depreciation and amortization in the fourth quarter of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions

reported adjusted EBITDA for the quarter of $445,000, compared to $7,000 in the prior year period.

Cost of oncology solutions was $6.2 million for the three months ended April 30, 2022, an increase of $568,000, or 10% compared to $5.7 million for the three months ended April 30, 2021. The increase in cost of sales was primarily due to an increase in compensation expense for our SaaS platform. For the three months ended April 30, 2022, gross margin was 52% compared to 46% for the three months ended April 30, 2021. The improvement in gross margin was the direct result of decreasing the Company’s reliance on outsourcing and leveraging revenue growth over the fixed cost component of cost of sales.
Research and development expense was $2.6 million for the three months ended April 30, 2022, an increase of $520,000, or 25%, compared to $2.1 million in the prior year. The increase was primarily due to compensation and lab expenses as we increased investment in our drug discovery program. Sales and marketing expense for the three months ended April 30, 2022 was $1.6 million, remaining relatively flat with an increase of $143,000, or 10%, compared to $1.5 million for the three months ended April 30, 2021. General and administrative expense was $2.8 million for the three months ended April 30, 2022 compared to $1.8 million for the three months ended April 30, 2021, an increase of $936,000, or 51%. The increase was primarily due to an increase in depreciation and amortization expenses of approximately $300,000, write-off of bad debt of $200,000, and an increase in IT expenses, specific to computing costs, of $300,000 to support the overall growth of the organization.

Net cash generated from operating activities for the quarter was approximately $700,000 resulting from operating income excluding stock-based compensation and other non-cash related expenses, and an increase in deferred revenue stemming from our bookings growth. Net cash used in investing activities was $400,000 primarily from investment in additional lab equipment. The Company ended the quarter with a strong cash position of $9.0 million and no debt.

Year-to-Date Financial Results

Total revenue for fiscal year 2022 was $49.1 million, an increase of 20%, compared to $41.0 million for fiscal year 2021. The increase in revenue was due to the expansion of our platforms, business lines, and demand for our services. Total operating expenses increased 19% to $48.5 million for fiscal year 2022, as compared to $40.7 million for the prior year.

For the twelve months ended April 30, 2022, Champions reported net income from operations of $607,000, inclusive of $912,000 in stock-based compensation expense and $1.6 million in depreciation and amortization expenses compared to income from operations of $366,000, inclusive of $598,000 in stock-based compensation expense, and $1.2 million in depreciation and amortization expenses for the prior year. Excluding stock-based compensation, depreciation and amortization, Champions reported adjusted EBITDA of $3.1 million for fiscal year 2022 compared to adjusted EBITDA of $2.1 million in the prior year.

Cost of oncology solutions was $23.6 million for the twelve months ended April 30, 2022, an increase of $2.2 million or 10%, compared to $21.4 million, for the twelve months ended April 30, 2021. The increase in cost of oncology services was mainly due to an increase in compensation and supply expenses resulting from increased study volume and compensation expenses for our SaaS platform. These increases were offset by a decrease in outsourced lab services. Gross margin was 52% for the twelve months ended April 30, 2022 compared to 48% for the twelve months ended April 30, 2021.The improvement in gross margin was the direct result of decreasing the Company’s reliance on outsourcing and leveraging revenue growth over the fixed cost component of cost of sales.

Research and development expense was $9.4 million for fiscal year 2022, an increase of $2.2 million, or 30%, compared to $7.2 million for the prior year. The increase was mainly due to the investment in therapeutic discovery programs with the increase coming primarily from compensation and lab supply expenses. Sales and marketing expense for fiscal year 2022 was $6.4 million, an increase of $859,000, or 16%, compared to $5.5 million for fiscal year 2021. The increase was primarily due to compensation expense driven by the continued expansion of our business development teams and travel expenses which increased with the easing of Covid restrictions. General and administrative expense was $9.1 million for fiscal year 2022, an increase of $2.6 million, or 40%, compared to $6.5 million for fiscal year 2021. General and administrative expenses were primarily comprised of compensation, insurance, professional fees, IT, and depreciation and amortization expenses. The increase in general and administrative expense was primarily due to increases in non-cash expenses of $900,000, compensation, and IT computing expenses to support the overall growth of the company.

Net cash generated from operations was $6.5 million for fiscal year 2022. Cash generated from operations was primarily due to improving cash based operational results as well as an increase in deferred revenue due to strong bookings. Changes in working capital accounts occurred in the ordinary course of business. Net cash used in investing activities was $2.4 million primarily from investment in additional lab equipment and software development costs. The Company ended the year in strong cash position of $9.0 million and has no debt.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its fourth quarter financial results. To participate in the call, please call 888-506-0062 (domestic) or 973-528-0011 (international) ten minutes ahead of the call and enter the access code 908668. A replay of the call will be available by dialing 877-481-4010 (Domestic) or 919-882-2331 (International) and entering passcode: 46134, or by accessing the investors section of the company’s website within 72 hours.

Full details of the Company’s financial results will be available on, or before, Monday July 25, 2022 in the Company’s Form 10-K at View Source

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP to non-GAAP Net Income (loss) (Unaudited) for an explanation of the amounts excluded to arrive at non-GAAP net income (loss) and related non-GAAP net income per share amounts for the three and twelve months ended April 30, 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 (loss) and non-GAAP income (loss) per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive income (loss) per share amounts as non-GAAP net income (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net income (loss) and non-GAAP diluted income (loss) per share may differ from similarly named measures used by others.