On February 24, 2022 NantHealth, Inc. (NASDAQ-GS: NH), a provider of enterprise solutions that help transform complex data into actionable insights, reported financial results for its fourth quarter and full year ended December 31, 2021 (Press release, NantHealth, FEB 24, 2022, View Source [SID1234609012]).

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"The past year was marked by a number of operational highlights, including the continuing launch of new products and services, ongoing efforts to build and expand our business capabilities and successfully completing a major refinancing," said Ron Louks, Chief Operating Officer, NantHealth. "As expected, our 2021 fourth quarter revenues increased from the third quarter, returning to the average quarterly run rate for the year. We are encouraged to have ended 2021 on an upswing, with solid customer interest across our entire portfolio of products and services, and a strengthened cash position.

"We believe we have built a strong foundation that positioned NantHealth for meaningful top line growth in the coming year. This belief is in part based on the progress of our recently launched Eviti Connect program for autoimmune diseases and the exciting business opportunities for our OpenNMS platform. In addition, we continue to see growing interest in our NaviNet suite of authorization solutions from payers and network service providers, which we attribute to the robust product offering and ongoing investments in developing new features and enhanced functionality."

Software and Services Q4 Highlights:

Clinical Decision Support (Eviti):
Signed and went live with Eviti Connect for Autoimmune Diseases program with Maryland Physicians Care (MPC), to provide digital drug authorizations for members living with chronic autoimmune conditions
Continued expansion of Eviti Connect for Oncology services provided through a key Eviti channel partner with the addition of the country’s largest customer-owned health insurer
Expanded utilization management certification to include the states of Kentucky, Florida and Massachusetts, enabling the company to provide Eviti Connect customers with fully delegated end-to-end services
Signed a new partner agreement that enables NantHealth to offer care management services for complex, high risk and chronic diseases, as previously stated
Payer Engagement (NaviNet):
Signed a multi-year agreement with a new third party administrator that will use NaviNet Open to enhance the services it provides to self-insured health plan customers, as previously reported
Recorded 17% year-over-year revenue growth for NaviNet AllPayer Advantage, a direct-to-provider solution
Launched the new NantHealth Partner Portal that offers payer customers self-service, on-demand access to interactive reporting on workflows, trends, analytics and insights
Enhanced NaviNet Open Authorizations to guide users through submission of clinical criteria information and supporting documentation with smart workflow technology and dynamic instructional messaging
Entered into an alliance agreement with Change Healthcare to integrate InterQual Connect automation solution with NaviNet Open, allowing NaviNet payer customers to leverage InterQual medical review criteria in their NaviNet-based electronic prior authorization workflow
Signed agreement with PriorAuthNow that enables it to leverage NaviNet Open Authorizations APIs to automate and streamline prior authorization requests for PriorAuthNow clients
Network Monitoring and Management (The OpenNMS Group, Inc.)
Partnered with a Fortune 500 managed service provider to offer OpenNMS Meridian monitoring to over 150 customers
Released OpenNMS Horizon 29 featuring improved streaming analytics for flow data at scale, and enhancements in distributed monitoring and security: OpenNMS now runs without elevated privileges reducing security risk
Launched OpenNMS Minion virtual appliance and cloud-enabled service to help organizations quickly, reliably, and securely deploy OpenNMS Minion collectors to remote or adjacent private networks
Rapidly delivered updates to address the global Log4j vulnerability, collaborating closely with the OpenNMS open-source community
Business and Financial Highlights:

For the 2021 fourth quarter:

Total net revenue was $16.0 million compared with $18.6 million in the 2020 fourth quarter.
Gross profit was $9.1 million, or 57% of total net revenue, compared with $11.4 million, or 61% of total net revenue, for the prior year period.
Selling, general and administrative (SG&A) expenses increased to $14.8 million compared with $11.7 million in the 2020 fourth quarter.
Research and development (R&D) expenses increased to $5.2 million from $4.8 million mainly from the Company’s ongoing investments in expanding its product offerings.
Net loss from continuing operations, net of tax, of $16.7 million, or $0.14 per share, significantly decreased from $20.1 million, or $0.18 per share, for the 2020 fourth quarter.
On a non-GAAP basis, net loss from continuing operations was $11.8 million, or $0.10 per share, compared with $6.2 million, or $0.06 per share, for the fourth quarter of last year.
For the 2021 full year:

Total net revenue was $62.6 million, compared with $73.2 million.
Gross profit was $34.8 million, or 56% of total net revenue, from $43.9 million, or 60% of total net revenue, for the prior year.
SG&A expense was $52.1 million compared with $48.5 million.
R&D expense increased to $19.7 million from $17.3 million.
Net loss from continuing operations, net of tax, was $58.3 million, or $0.51 per share, compared with $88.3 million, or $0.80 per share, for the 2020 full year.
On a non-GAAP basis, net loss from continuing operations was $41.9 million, or $0.37 per share, up from $27.0 million, or $0.24 per share, for 2020.
At December 31, 2021, cash and cash equivalents totaled $29.1 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 fourth quarter and full year ended December 31, 2021. The conference call will be available to interested parties by dialing 877-407-0312 from the U.S. or Canada, or 201-389-0899. 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 February 24, 2022 AbCellera (Nasdaq: ABCL), a technology company with a centralized operating system for next-generation antibody discovery, reported financial results for full year 2021 (Press release, AbCellera, FEB 24, 2022, View Source [SID1234609011]). All financial information in this press release is reported in U.S. dollars.

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"In 2021 we made significant advancements in executing our long-term strategy by growing our portfolio, deepening our platform to unlock new modalities, and expanding our deal structures to add new ways to capture value," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We move into 2022 with momentum and a strong cash position to continue to grow our business and to make investments that will increase the speed, efficiency, and scalability of our platform."

2021 Business Highlights

Earned $375 million in total revenue, including $335 million in milestones and royalties, of which $138 million is in accounts receivable.
Ended the year with over $720 million in cash, equivalents, and marketable securities.
Generated $153 million in net earnings, up from $119 million in 2020.
Started discovery on 26 programs, bringing the cumulative number of program starts to 78.
Achieved a cumulative total of 156 programs under contract with 36 partners.
Reached a cumulative total of five molecules in the clinic across oncology, infectious disease, animal health, and immunology, dermatology and gastrointestinal disease.
Acquired TetraGenetics to expand capabilities for high-value transmembrane protein targets.
Expanded the leadership team with the appointment of Neil Berkley as Chief Business Officer, Neil Aubuchon as Chief Commercial Officer, and appointed Andrew Lo, Ph.D., to the Board of Directors.

AbCellera added 53 discovery programs in 2021 to reach a cumulative total of 156 discovery programs as of December 31, 2021 (up 51% from 103 on December 31, 2020), that are either completed, in progress, or under contract with 36 different partners (up from 27 on December 31, 2020). AbCellera started discovery on 26 programs in 2021 to reach a cumulative total of 78 program starts (up from 52 on December 31, 2020). AbCellera’s partners advanced four additional molecules into the clinic in 2021, bringing the cumulative total to five.

Revenue – Total revenue was $375.2 million, compared to $233.2 million in 2020, of which $327.3 million is attributable to royalties. The partnership business generated research fees of $19.1 million, compared to $19.8 million in 2020. Licensing revenue was $20.8 million.
Research & Development (R&D) Expenses – R&D expenses were $62.1 million, compared to $29.4 million in 2020, reflecting continuing investments in the capacity and capabilities of AbCellera’s discovery and development platform.
Sales & Marketing (S&M) Expenses – S&M expenses were $6.9 million, compared to $3.8 million in 2020.
General & Administrative (G&A) Expenses – G&A expenses were $41.8 million, compared to $11.9 million in 2020, with the increase driven primarily by investments to support the growth of the company, non-cash stock-based compensation in line with publicly listed companies, and protecting intellectual property.
Net Earnings – Net earnings were $153.5 million, or $0.56 per share on a basic and $0.48 per share on a diluted basis, compared to net earnings of $118.9 million, or $0.53 per share on a basic and $0.45 per share on a diluted basis in 2020.
Liquidity – $723.0 million of cash, cash equivalents, and marketable securities.
Q4 Highlights and Financial Results

Started nine programs.
U.S. shipments of bamlanivimab resumed.
Added one program under contract with a new, undisclosed partner.
Revenue for the fourth quarter of 2021 was $139.3 million, representing 37% of the total for 2021. $134.5 million was generated in the quarter from royalties on net sales of bamlanivimab and $4.7 million from research fees, representing 41% and 25% of the respective totals for 2021.

Operating expenses totaled $57.8 million in the fourth quarter or 34% of the total for 2021 and include $21.9 million in royalty fees (48% of the total for the year).

Net earnings for the fourth quarter were $59.9 million, 39% of the total for 2021, or $0.21 per share on a basic and $0.19 per share on a diluted basis.

Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Standard Time (5:00 p.m. Eastern Standard Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On February 24, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported the closing of its previously announced registered direct offering with an institutional investor of 1,496,400 shares of common stock (or common stock equivalents) at a price of $2.80 per share for gross proceeds of approximately $4.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company (Press release, Applied DNA Sciences, FEB 24, 2022, View Source [SID1234609010]). In a concurrent private placement, Applied DNA also issued to the institutional investor in the offering unregistered warrants to purchase up to an aggregate of 1,496,400 shares of common stock.

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Immediately following the closing of the registered direct offering and the concurrent private placement, the number of outstanding shares of common stock in the Company will be 8,234,320.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital and to advance the adoption of its LinearDNA manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The shares of common stock (or common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 21, 2020 and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On February 24, 2022 Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, reported a partnership with Dovetail Genomics demonstrating the value and performance of Dovetail’s proximity ligation-based next-generation sequencing (NGS) library prep solutions on Element’s AVITI System (Press release, Element Biosciences, FEB 24, 2022, View Source [SID1234609009]).

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The ability to unlock access to genomic structure enables cutting-edge science in the fields of epigenetics, developmental biology, cancer research, conservation and evolutionary biology. Advances in chromatin conformation capture technologies sit at the forefront of this effort. Dovetail Genomics’ best-in-class products and services capture 3D genome architecture alongside primary sequence information using NGS approaches.

"We are pleased to form a partnership with Dovetail Genomics to deliver seamless compatibility between the AVITI System and Dovetail’s library preparation kits. Their proximity ligation technology couples well with Element’s improvements in sequencing accuracy, lower optical duplication rate and consistency of data, across a range of applications," said Shawn Levy, Senior Vice President of Applications and Scientific Affairs at Element Biosciences.

"We are thrilled to partner with Element Biosciences to add Dovetail Genomics’ cutting-edge proximity ligation technology to this new and exciting NGS platform," said Dovetail CEO Todd Dickinson. "The long-range, unbiased nature of the Dovetail data opens up many new applications not typically accessible with a short-read platform, offering a richer view of the genome from every sequencing run."

To learn more about the AVITI System, including detailed specifications, application data, and performance testimonials, register now for Element’s virtual event on March 14th, 9 a.m. PT / 5 p.m. CET, at View Source

On February 24, 2022 Novocure (NASDAQ: NVCR) reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, NovoCure, FEB 24, 2022, View Source [SID1234609008]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields ("TTFields").

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"We founded Novocure to exploit the novel observation that electric fields can be harnessed to disrupt cancer cell division," said William Doyle, Novocure’s Executive Chairman. "More than two decades later, we continue to build our knowledge and capabilities to optimize the Tumor Treating Fields therapy platform and to bring Tumor Treating Fields therapy to cancer patients. Last year, we generated over half a billion dollars in net revenues and invested two hundred million dollars in R&D. With multiple pivotal clinical studies set to read out in the coming 24 months, we are nearing a key inflection point for cancer patients and our business."

Financial updates for the full year and fourth quarter ended December 31, 2021:

Total net revenues for the year were $535.0 million, an increase of 8% year-over-year.
Total net revenues for the quarter were $133.2 million. The company did not recognize material revenue from its Medicare backlog in the quarter. This compares to $11 million received from the successful appeal of previously denied Medicare claims in the fourth quarter of 2020.
The United States, EMEA and Japan contributed $92.0 million, $26.5 million, and $8.8 million in quarterly net revenues, respectively. Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.8 million.
Gross margin for the quarter was 78%.
Research, development and clinical studies expenses for the quarter were $56.9 million.
Sales and marketing expenses for the quarter were $39.0 million.
General and administrative expenses for the quarter were $31.0 million.
Net loss for the quarter was $26.5 million with loss per share of $0.25.
Adjusted EBITDA* for the quarter was $1.7 million.
Cash, cash equivalents and short-term investments were $937.7 million as of December 31, 2021.
Operational updates for the fourth quarter ended December 31, 2021:

As of December 31, 2021, there were 3,587 active patients on therapy, an increase of 5% year-over-year. Active patients from North America, EMEA and Japan contributed 2,272, 1,008 and 307 active patients, respectively.
1,430 prescriptions were received in the quarter, an increase of 1% year-over-year. Prescriptions from North America, EMEA and Japan contributed 966, 349 and 115 prescriptions, respectively.
Quarterly achievements:

In November, we announced the last patient had been enrolled in our phase 3 pivotal LUNAR study for the treatment of non-small cell lung cancer ("NSCLC"). Patients will be followed for 12 months, with top-line data expected by year-end 2022.
In November, Dr. David Tran, Chief of the Division of Neuro-Oncology at the McKnight Brain Institute at the University of Florida, released updated data from the phase 2 pilot 2-THE-TOP study testing the safety and efficacy of TTFields together with pembrolizmuab and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma ("GBM"). In patients with greater than 9 months of follow-up, median progression-free survival was at least 11.2 months compared to 6.7 months from Novocure’s pivotal EF-14 study, in which patients received TTFields and temozolomide, and 4.0 months from the control arm of EF-14, where patients received temozolomide alone.
In December, we announced the acquisition and construction of an office building in downtown Portsmouth, New Hampshire. The property will provide space for our growing employee base and house a world-class training and development center.
2022 Outlook:

The company expects to achieve active patient growth between 2% to 5% in 2022, in-line with the growth rate experienced in the fourth quarter of 2021. Longer term, the company continues to expect further adoption in its core GBM business.
Anticipated clinical milestones:

Data from phase 2 pilot EF-31 study in gastric cancer (2022)
Data from phase 2 pilot EF-33 study with high-intensity arrays in recurrent GBM (2022)
Last patient enrollment in phase 3 pivotal METIS study in brain metastases (2022)
Data from phase 3 pivotal LUNAR study in NSCLC (2022)
Last patient enrollment in phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2023)
Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer (2023)
Data from phase 3 pivotal METIS study in brain metastases (2023)
Data from phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2021 financial results at 8 a.m. EST today, Thursday, February 24, 2022. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 8879093.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.