GI Innovation Signs MoU With Cellkey for Biomarker Joint Research to Develop Next-generation Innovative Immuno-oncology

On February 24, 2022 GI Innovation, an innovative new drug development company, reported on February 23 that it has signed a biomarker joint research MoU with CellKey, a Glycoprotein biomarker development company, to develop next-generation innovative immuno-oncology (Press release, GI Innovation, FEB 24, 2022, View Source [SID1234609016]).

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The MoU ceremony was held in GI Innovation’s head office and Myoung-Ho Jang Chairman, Na-Ri Yun VP, Ji-Soo Kim director of GI Innovation and Nam-Yong Lee CEO, Kwang-Hoe Kim Head of Bio-R&D center, Sang-Yong Lee COO of CellKey have attended.

Under the MoU, GI Innovation will progress joint biomarker research to develop next-generation protein and antibody drugs using GI Innovation’s bispecific fusion protein development platform GI-SMART and CellKey’s AI-powered biomarker discovery platform SpAC9 Pipeline. In addition, both companies will progress jointly published thesis, academic publication, research business, etc.

A biomarker is biological index that can sense symptoms in the body using protein, DNA, RNA, metabolite, etc. The more the multiple panels are constructed the more possibilities are to raise accuracy and diagnose early cancer.

In particular, AI and cloud-powered SpAC9 Pipeline of CellKey enables the discovery of the most optimal multi-biomarker panels, consisting of glycoproteins and proteins, up to 100 times faster than with conventional analysis methods.

With this strategic partnership, both companies expect that GI Innovation will predict drug responses on GI Innovation’s immuno-oncology and reinforce the reliability and efficacy of treatment through the biomarker discovery that can monitor treatment effects. CellKey also expects to improve upon the effects of personalized treatments and cancer diagnostic biomarker business.

Myoung-Ho Jang, Chairman of GI Innovation said, "By collaborating with Cellkey that has SpAC9 Pipeline, an innovative proteomics biomarker development platform, the opportunities for successful new drug development are increased. We will do our best to choose prime target patients in the clinical trial stage through the early discovery of biomarker."

Nam-Yong Lee, CEO of CellKey said, "I believe we can innovatively improve the effectiveness of cancer treatments through this joint research with GI Innovation who develops immuno-oncology drugs with world-class R&D capabilities. This collaboration can create various business opportunities in the market of antibody drugs and precision medicine."

GT Biopharma to Present Pre-Clinical Data at Upcoming Medical Conferences

On February 24, 2022 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported that GT Biopharma will be participating in the following upcoming medical conferences (Press release, GT Biopharma, FEB 24, 2022, View Source [SID1234609014]):

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Abstract and poster presentation details are as follows:

ESMO Targeted Anticancer Therapies Congress (TAT) (March 7-8, 2022)

Title:

Driving NK cell immunotherapy against NSCLC, in the context of hypoxia, using Tri-specific Killer Engager (TriKE)

Abstract Number:

250

Session:

Immunotherapy

Presentation Type:

Poster

Session Date and Time:

March 7, 9:20AM (CET) (On-demand e-poster display)

Location:

Virtual

Poster Board Number:

17P

48th Annual European Society for Blood and Marrow Transplantation (EBMT) (March 19-23, 2022)

Title:

A Tri-specific Killer Engager (TriKE) against B7-H3 enhances NK cell mediated killing of multiple myeloma

Abstract Number:

AS-EBMT-2022-00508

Session:

New Drugs- and Cell-Based Immune Therapies

Presentation Type:

Poster

Session Date and Time:

March 19, 2022, 9:50 AM (CET)

Location:

Prague Congress Center, Czech Republic

Poster Board Number:

P153

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (April 8-13, 2022)

Title:

GTB-5550 (cam16-IL15-camB7H3) Tri-specific Killer Engager (TriKE) drives natural killer cell activation and antibody dependent cellular cytotoxicity against head and neck squamous cell carcinomas

Abstract Number:

Abstract control number 3334, permanent abstract number 3435

Session:

Clinical Research Excluding Trials, Combination Immunotherapies / Therapeutic Antibodies

Presentation Type:

Poster

Session Date and Time:

April 12, 2022 1:30 PM – 5:00 PM

Location:

Ernest N. Memorial Convention Center, Exhibit Halls D-H, Poster Section 32, New Orleans

Poster Board Number:

16

HitGen has successfully completed a three-year collaboration with MTPC to discover novel hit compounds for multiple drug targets

On February 24, 2022 HitGen Inc. ("HitGen"), a Shanghai Stock Exchange STAR-listed company, reported that the company has successfully completed a three-year drug discovery research collaboration with Mitsubishi Tanabe Pharma Corporation ("MTPC"), a Japanese pharmaceutical company with the mission of "Creating hope for all facing illness" (Press release, HitGen, FEB 24, 2022, https://www.prnewswire.com/news-releases/hitgen-has-successfully-completed-a-three-year-collaboration-with-mtpc-to-discover-novel-hit-compounds-for-multiple-drug-targets-301489388.html [SID1234609013]). During the three-year collaboration, multiple undisclosed targets (including undruggable targets) were screened against HitGen’s proprietary DNA encoded chemical libraries (DELs). The majority of the targets have resulted in confirmed novel potent hits, which have high potential for downstream development. Now the two parties are exploring the opportunity for further collaboration.

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"Several drug discovery target molecules were screened against HitGen’s DELs. MTPC considers that seed compounds for several target molecules have potential to advance MTPC’s drug discovery in the future. MTPC will create hit compounds and lead compounds through compound development. MTPC is advancing drug discovery research with the goal of creating breakthrough drugs," said Dr. Yoshiharu Hayashi, Executive Officer Head of Sohyaku. Innovative Research Division of MTPC.

"I am delighted to see the successful completion of our three-year collaboration with MTPC. It has been a tremendous pleasure for us to contribute to research effort of many pharmaceutical and biotech companies like MTPC to find novel small-molecule hits where traditional screening has not been successful. Encouraged by the success, HitGen and MTPC teams are now looking forward to tackling more challenges with other targets for unmet medical needs," said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen Inc.

In December 2018, HitGen and MTPC entered into a drug discovery research collaboration to identify novel small molecule hits for multiple targets of interest. MTPC paid HitGen assignment fee to have ownership of the hits for their further development and commercialization.

NantHealth Reports 2021 Fourth-Quarter, Full-Year Financial Results

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.

AbCellera Reports Full Year 2021 Business Results

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.