On May 6, 2021 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the first quarter ended March 31, 2021, and recent corporate highlights (Press release, Checkpoint Therapeutics, MAY 6, 2021, View Source [SID1234579436]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, stated, "During the first quarter of 2021, we continued to advance the development of our two lead drug candidates while also enhancing our cash position. Enrollment in our registration-enabling study for cosibelimab in metastatic cutaneous squamous cell carcinoma ("mCSCC") is nearly complete and the study remains on track to report top-line results by year-end. With a successful study, we anticipate submitting our first application for marketing approval for cosibelimab next year."

Mr. Oliviero continued, "Additionally, our collaboration partner in Asia for olafertinib (CK-101), Neupharma Inc., continues to enroll patients as planned into a Phase 3, registration-enabling study in first-line, EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer ("NSCLC"). We intend to meet with the FDA to discuss the ongoing Phase 3 study design and its potential use to support a New Drug Application submission in the United States."

Recent Corporate Highlights:

In March 2021, Checkpoint announced the formation of a Scientific Advisory Board comprised of industry thought leaders. Members include Wayne A. Marasco, M.D., Ph.D., Roy S. Herbst, M.D., Ph.D., F. Stephen Hodi, Jr., M.D., Bruce E. Johnson, M.D., David Miller, M.D., Ph.D., and Emily Ruiz, M.D., M.P.H.
During the first quarter of 2021, Checkpoint raised $23.9 million of net proceeds from the utilization of the Company’s At-the-Market Issuance Sales Agreement at an average price of $3.50.
Financial Results:

Cash Position: As of March 31, 2021, Checkpoint’s cash and cash equivalents totaled $60.0 million, compared to $40.8 million at December 31, 2020, an increase of $19.2 million.
R&D Expenses: Research and development expenses for the first quarter of 2021 were $4.2 million, compared to $2.6 million for the first quarter of 2020, an increase of $1.6 million. Research and development expenses for the first quarter of 2021 included $0.2 million of non-cash stock expenses, compared to $0.1 million in the first quarter of 2020.
G&A Expenses: General and administrative expenses for the first quarter of 2021 were $2.4 million, compared to $1.7 million for the first quarter of 2020, an increase of $0.7 million. General and administrative expenses for the first quarter of 2021 included $1.2 million of non-cash stock expenses, compared to $0.5 million for the first quarter of 2020.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2021 was $6.5 million, or $0.09 per share, compared to a net loss of $3.3 million, or $0.06 per share, in the first quarter of 2020. Net loss for the first quarter of 2021 included $1.4 million of non-cash stock expenses, compared to $0.6 million for the first quarter of 2020.

On May 6, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Patent and Trademark Office (USPTO) has granted the patent application for Clarity’s SAR-bisPSMA compound and its variants (Press release, Clarity Pharmaceuticals, MAY 6, 2021, View Source [SID1234579259]). The grant of the patent application bolsters Clarity’s strong Intellectual Property (IP) position on the Prostate Specific Membrane Antigen (PSMA) targeting agent for imaging and treatment of prostate cancer.

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SAR-bisPSMA is the result of Clarity’s optimisation of the well characterised PSMA targeting peptide, which has been in many thousands of patients to date, by combining two PSMA targeting peptides with Clarity’s proprietary SAR Technology and the theranostic isotopes of copper, copper-64 for imaging and copper-67 for therapy. The copper pairing enables diagnosis, staging and subsequent treatment of prostate cancers that express PSMA. The optimisation of the targeting peptide has resulted in superior targeting of, and retention in, tumours compared to a singular PSMA targeting peptide in preclinical models (Zia et al., 2019)1. The product was developed through the long-standing collaboration between Clarity and Professor Paul Donnelly at the University of Melbourne.

Clarity’s Executive Chairman, Dr Alan Taylor, commented: "The grant of the SAR-bisPSMA patent application is an example of the effectiveness of Clarity’s broad patent strategy around its SAR Technology, which allows the filing of additional patents with a wide range of new disease targeting agents."

The news from the USPTO come shortly after Clarity has completed the assignment of its key patent portfolio from the University of Melbourne, providing Clarity with the full rights and ownership of the patents.

"The grant of the SAR-bisPSMA patent application also comes soon after Clarity received a response from the U.S. Food and Drug Administration on its an Investigational New Drug (IND) application for a theranostic trial of 64Cu/67Cu SAR-bisPSMA in the U.S. (NCT04868604)2 that the study may proceed. With our diagnostic trial of 64Cu SAR-bisPSMA in previously diagnosed but yet untreated patients prior to surgical removal of the prostate in the start-up phase (NCT04839367)3, we are now ready to embark on two clinical trials of SAR-bisPSMA in the next few months," said Dr Taylor.

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of death worldwide4. The American Cancer Society estimates in 2021 there will be 248,530 new cases of prostate cancer in the U.S. and around 34,130 deaths from the disease5. For metastatic prostate cancer, the 5-year relative survival rate is 30%, indicating a high unmet need for early detection and better treatment options for mCRPC. Annually, there are around ~34,000 men in the U.S. who are diagnosed with mCRCP5, ~90% of whom have tumours which express PSMA6.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The theranostic SAR-bisPSMA product has blockbuster market potential for prostate cancer. The product has ideal characteristics for a radiopharmaceutical and numerous advantages associated with the optimisation of the targeting peptide and using the copper pairing, including increased targeting and retention of the product in tumours, centralised manufacture, reaching more treatment sites and patients around the world, as well as diagnostic, dosimetry and therapeutic benefits. We are excited to progress the development of this proprietary asset into the clinic for the treatment of men with prostate cancer as part of our ultimate goal of improving treatment outcomes for kids and adults with cancer. We are pleased to have received the patent grant to reinforce Clarity’s IP position around our PSMA compounds, giving us confidence in the commercialisation process moving forward."

On May 6, 2021 CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and Nkarta, Inc. (NASDAQ: NKTX), a biopharmaceutical company developing engineered NK cell therapies to treat cancer, reported a strategic partnership to research, develop, and commercialize CRISPR/Cas9 gene-edited cell therapies for cancer (Press release, Nkarta, MAY 6, 2021, View Source [SID1234579318]).

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Under the agreement, the companies will co-develop and co-commercialize two CAR NK cell product candidates, one targeting the CD70 tumor antigen and the other target to be determined. In addition, the companies will bring together their complementary cell therapy engineering and manufacturing capabilities to advance the development of a novel NK+T product candidate harnessing the synergies of the adaptive and innate immune systems. Finally, Nkarta obtains a license to CRISPR gene editing technology to edit five gene targets in an unlimited number of its own NK cell therapy products.

CRISPR Therapeutics and Nkarta will equally share all research and development costs and profits worldwide related to the collaboration products. For each non-collaboration product candidate incorporating a gene editing target licensed from CRISPR Therapeutics, Nkarta will retain worldwide rights and pay CRISPR Therapeutics milestones and royalties on net sales. The agreement includes a three-year exclusivity period between CRISPR Therapeutics and Nkarta covering the research, development, and commercialization of allogeneic, gene-edited, donor-derived NK cells and NK+T cells.

"By bringing together CRISPR Therapeutics’ and Nkarta’s highly complementary expertise and proprietary platforms we plan to accelerate the development of potentially groundbreaking genome engineered NK cell therapies," said Samarth Kulkarni, Ph.D., Chief Executive Officer at CRISPR Therapeutics. "This collaboration broadens the scope of our efforts in oncology cell therapy, and expands our efforts to discover and develop novel cancer therapies for patients."

"Uniting the best-in-class gene editing solution and allogeneic T cell therapy expertise of CRISPR with Nkarta’s best-in-class CAR NK cell therapy platform will be a major advantage to advancing the next wave of transformative cancer cell therapies," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "With this partnership, Nkarta can systematically apply world-class gene editing across our entire pre-clinical pipeline going forward. CRISPR’s deep understanding of CD70 biology and experience in allogeneic T cell clinical development can accelerate the development of early-stage Nkarta programs, to deliver innovative treatments to patients that much faster."

Nkarta Conference Call Details

Nkarta management will host a conference call to discuss the collaboration today at 4:30 p.m. Eastern Time (ET). The event will be simultaneously webcast and available for replay from the Nkarta website at www.nkartatx.com, under the Investors section. Investors may also participate in the conference call by calling 877-876-9174 (domestic) or +1-785-424-1669 (international). The conference ID is NKARTA.

On May 6, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a provider of enterprise solutions that help businesses transform complex data into actionable insights, reported financial results for its first quarter ended March 31, 2021 (Press release, NantHealth, MAY 6, 2021, View Source [SID1234579347]).

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"Last month, we successfully completed a $137.5 million financing transaction and will use a portion of the proceeds to retire our existing convertible notes," said Ron Louks, Chief Operating Officer, NantHealth. "We intend to use the balance of the proceeds to, among other things, support our growth initiatives, which include further developing our existing SaaS offerings, expanding our recently acquired OpenNMS business and investing in our data services and cloud capabilities.

"Turning to our 2021 first-quarter financial results, as expected revenues declined largely due to the accounting for amortization of services related to expired or renewed contracts at the end of the 2020 fourth quarter. While we remain committed to managing our overhead costs, we have continued the ramp up of our investment in research and development to improve and expand the innovative solutions we bring to our customers.

"Looking ahead, we see growing opportunities to expand and diversify our business within and beyond healthcare. Earlier this week, we launched Eviti Connect for autoimmune diseases, extending our proven payer solution beyond oncology, and announced plans to further develop the Eviti platform to allow us to expand into additional disease states, over time. In addition, we are expanding OpenNMS offerings to include a new cloud-based platform to supplement our already robust on-premise platform, which will both broaden the solutions we offer to our healthcare customers and attract new customers across a variety of industries."

Software and Services Highlights:

Clinical Decision Support (Eviti):
In May, launched Eviti Connect for autoimmune diseases, bringing the Company’s payer solution for oncology to a disease type that affects more than 50 million in the U.S. alone. The Company developed a new, flexible platform that will enable it to expand into disease areas beyond oncology and autoimmune
Launched Eviti Connect 8.4, which included:
New functionality enables drug customization per payer or line of business providing more flexibility to meet diverse policies within the payer organization
New payer communication capability that reduces delays in treatment plan reviews
In May, Eviti Connect won the MedTech Breakthrough award for "Best MedTech Overall Software," recognized for the platform’s innovative ability to break through digital health and technology markets
Payer Engagement (NaviNet and Population Health Management):
Continued customer renewals, securing three multi-year agreements in Q1 with over $700K of annual contract value
AllPayer, the Company’s direct-to-provider solution, had its seventh consecutive quarter of growth
Enhanced NaviNet essential workflows to support automation and promote greater usability
Open Authorizations now allows health plans to configure rules defining which services do not require prior authorization. This increases transparency for providers and saves time by eliminating unnecessary requests
New Referral Submission API enables providers to automate management of referral requests through NaviNet, making it easier to guide patients to optimal quality and cost referral sites
Announced Population Health Management, a new product offering that integrates multiple data sources into one platform, providing a more complete view of the patient. This enables payers and providers to engage proactively with patients, increasing the quality of care while reducing costs
Network Monitoring and Management (OpenNMS):
Deployed a solution for a global energy customer that scales the monitoring and analysis of network communications by aggregating the data streams (netflow) to greatly improve scalability and usability of the solution
Initiated a Zero-touch Appliance service pilot with a large national retailer
Business and Financial Highlights

For the 2021 first quarter:

Total net revenue was $16.2 million compared with $18.2 million in Q1 of 2020. Within total revenue, total software-related revenue was $16.2 million compared with $18.1 million in prior-year first quarter.
Gross profit was $9.1 million, or 56% of total net revenue, compared with $11.0 million, or 60% of total net revenue, for the prior-year period.
Selling, general and administrative (SG&A) expenses increased to $12.5 million from $12.4 million in the 2020 first quarter.
Research and development (R&D) expenses increased to $5.0 million from $3.6 million.
Net loss from continuing operations attributable to NantHealth, net of tax, was $15.4 million, or $0.14 per share, compared with $8.9 million, or $0.08 per share, in the 2020 first quarter.
Non-GAAP net loss from continuing operations attributable to NantHealth was $9.6 million, or $0.09 per share, compared with $6.1 million, or $0.06 per share, for the first quarter of 2020.
At March 31, 2021, cash and cash equivalents totaled $10.8 million.
Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the first quarter ended March 31, 2021. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 8364209. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On May 6, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the quarter ended March 31, 2021 (Press release, Guardant Health, MAY 6, 2021, View Source [SID1234579364]).

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Recent Highlights
•Revenue of $78.7 million for the first quarter of 2021, an increase of 17% over the corresponding period of 2020
•Reported 18,390 tests to clinical customers and 3,522 tests to biopharmaceutical customers in the first quarter of 2021, representing an increase of 21% and a decrease of 33%, respectively, over the first quarter of 2020
•Successfully launched Guardant Reveal, the first blood-only test with a 7-day turnaround time, for residual disease and recurring monitoring in patients with early-stage colorectal cancer and received positive early feedback from oncologists
•Received Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360 CDx test to be reimbursed at a rate of $5,000 effective April 1, 2021, for all Medicare patients
•Study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrated that Guardant Reveal identifies patients most likely to recur with high clinical accuracy
•Appointed Dr. Craig Eagle as Chief Medical Officer
"I am proud of our team for their continued hard work this quarter. Despite continuing impacts of COVID, we achieved record revenue and solid growth in our clinical business, and continued to progress our product pipeline," said Helmy Eltoukhy, PhD, co-founder and CEO. "I am so excited about what is ahead for Guardant and believe 2021 will be a pivotal year for us as we expand our product portfolio and invest across our business to build the foundations for complete cancer testing across the continuum of care."
First Quarter 2021 Financial Results
Revenue was $78.7 million for the three months ended March 31, 2021, a 17% increase from $67.5 million for the three months ended March 31, 2020. Precision oncology revenue grew 6% driven predominantly by an increase in clinical testing revenue which grew 31% over the prior year period. There were 18,390 clinical tests and 3,522 biopharmaceutical tests performed during the first quarter of 2021. Development services and other revenue increased 106% primarily related to the timing of project related milestones for companion diagnostic development programs.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $49.9 million for the first quarter of 2021, an increase of $2.9 million from $47.0 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 63%, as compared to 70% for the corresponding prior year period.
Operating expenses were $157.8 million for the first quarter of 2021, as compared to $81.9 million for the corresponding prior year period, an increase of 93%. Non-GAAP operating expenses were $100.7 million for the first quarter of 2021, as compared to $65.9 million for the corresponding prior year period.
Net loss attributable to Guardant Health, Inc. common stockholders was $109.7 million for the first quarter of 2021, as compared to $27.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.09 for the first quarter of 2021, as compared to $0.29 for the corresponding prior year period. Non-GAAP net loss was $49.4 million for the first quarter of 2021, as compared to $15.4 million for the corresponding prior year period. Non-GAAP net loss per share was $0.49 for the first quarter of 2021, as compared to $0.16 for the corresponding prior year period.
Adjusted EBITDA loss was $45.4 million for the first quarter of 2021, as compared to a $15.5 million loss for the corresponding prior year period.
Cash, cash equivalents and marketable securities were $1.9 billion as of March 31, 2021.
2021 Guidance
Guardant Health now expects full year 2021 revenue to be in the range of $360 million to $370 million, representing 26% to 29% growth over full year 2020. Clinical volumes for 2021 are expected to be greater than 90,000 tests, growing at least 42% over 2020.
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Webcast Information
Guardant Health will host a conference call to discuss the first quarter 2021 financial results after market close on Thursday, May 6, 2021 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.
Non-GAAP Measures
Guardant Health has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of precision oncology testing, non-GAAP research and development expense, non-GAAP sales and marketing expense, non-GAAP general and administrative expense, non-GAAP loss from operations, non-GAAP net loss, non-GAAP net loss attributable to Guardant Health, Inc., common stockholders, non-GAAP net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted, and Adjusted EBITDA.

We define our non-GAAP measures as the applicable GAAP measure adjusted for the impacts of stock-based compensation and related employer payroll tax payments; changes in estimated fair value redeemable noncontrolling interest; contingent consideration; acquisition related expenses, amortization of intangible assets, and other non-recurring items.

Adjusted EBITDA is defined as net loss attributable to Guardant Health, Inc. common stockholders adjusted for interest income; interest expense; other income (expense), net, provision for (benefit from) income taxes; depreciation; and amortization expense; stock-based compensation expense and related employer payroll tax payments; adjustments relating to non-controlling interest and contingent consideration and, if applicable in a reporting period, acquisition-related expenses and other non-recurring items.

We believe that the exclusion of certain income and expenses in calculating these non-GAAP financial measures can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. We use these non-GAAP financial measures to evaluate ongoing operations, for internal planning and forecasting purposes, and to manage our business.

These non-GAAP financial measures are not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.