Vyant Bio Reports First Quarter 2021 Results and Provides Strategic Business Update

On May 17, 2021 Vyant Bio, Inc. (the "Company") (Nasdaq: VYNT), is an innovative biotechnology company reported that focused on partnering with pharmaceutical and other biotechnology companies to identify novel and repurposed therapeutics through the integration of human-derived biology with data science technologies and IND-enabling expertise (Press release, Cancer Genetics, MAY 17, 2021, View Source [SID1234580114]).

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RECENT STRATEGIC AND OPERATIONAL HIGHLIGHTS IN Q-1 2021

■Rebranded the Company from Cancer Genetics to Vyant Bio (Nasdaq: VYNT)
■Completed merger with StemoniX, Inc.
■Completed two equity financing rounds to raise $27.5 million in cash, entered into Q2 with $33.1 million of cash on the balance sheet
■Investing in research and development to optimize drug discovery capabilities
■Launched commercial stage, novel disease models in Rett Syndrome and CDKL5
■Initially focusing on novel and repurposed drugs to treat Rett Syndrome and CDKL5

Jay Roberts, Chief Executive Officer of Vyant Bio stated, "in Q1 2021, we reached an important milestone with the closing of the merger with StemoniX, uniquely positioning the combined company to focus our business on discovering applications for novel and repurposed therapeutics. We believe that drug discovery needs to progressively evolve as we know the traditional methods and models for predicting safe and effective drugs have under-performed, as evidenced by the billions of dollars and years of time it takes to bring novel drugs to market. With this as a backdrop, we are focusing our business on converging an impactful approach to drug discovery with data science and biology-driven technologies at the core with engineering disciplines and regulatory expertise."

"Vyant Bio has commercialized the development, engineering and manufacturing of disease models, built on its induced pluripotent stem cell ("iPSC") technology, and has developed neural and cardiac screening platforms, which are used to screen novel and repurposed compound targets", stated Ping Yeh, Vyant Bio’s Chief Innovation Officer. "The most mature disease models are being used to find therapeutic candidates in the central nervous system with its microBrain, driven by a focus on Rett Syndrome and CDKL5 neurological disorders. With the addition of the vivoPharm cancer cell-line assets and scientific expertise in oncology, the Company believes it can also advance models targeting Glioblastoma and Parkinson’s disease. The team has also made progress with our microHeart platform, so we believe there will be continued interest from partners with an interest in Cardiac Fibrosis and Rett Syndrome", Mr. Yeh continued.

"Our human-derived models, combined with the latest data science and software techniques, can identify and rank order repurposed and novel compounds by target. In our current drug discovery efforts, we aim to leverage our iPSC technology to identify drug candidates for licensure or clinical development. We are in active discussions with prospective pharma partners to offer exclusive licenses to certain disease models, and expect to enter into similar license agreements for access to both novel and repurposed therapies. The Company is striving to receive a mix of upfront payments, licensing fees, milestone-based fees and ongoing royalty payments", Mr. Yeh concluded.

The Company filed its quarterly report for Q1 2021 on Form 10-Q today with the Securities and Exchange Commission. The Company formerly known as Cancer Genetics, Inc., StemoniX and CGI Acquisition, Inc. ("Merger Sub") entered into a merger agreement on August 21, 2020, which was amended on February 8, 2021 and February 26, 2021(as amended, the "Merger Agreement"). Pursuant to the terms of the Merger Agreement, Merger Sub was merged ("the Merger") with and into StemoniX on March 30, 2021, with StemoniX surviving the Merger as a wholly owned subsidiary of the Company. The Merger was accounted for as a reverse acquisition with StemoniX being the accounting acquirer of CGI using the acquisition method of accounting.

FIRST QUARTER 2021 FINANCIAL RESULTS

As StemoniX was deemed to have acquired CGI for accounting purposes and the Merger closed on March 30, 2021, the Company’s first quarter financial results are primarily the StemoniX operations.

Cash and cash equivalents totaled approximately $33.1 million as of March 31, 2021.

Total revenues increased 32%, or $54 thousand, to $222 thousand for the three months ended March 31, 2021, as compared with $168 thousand for the three months ended March 31, 2020.

Cost of goods sold – service aggregated $89 thousand and $132 thousand, respectively, for the three months ended March 31, 2021 and 2020, resulting in a cost of goods sold of 77% and 97%, respectively, of service revenues.

Cost of goods sold – product aggregated $396 thousand and $166 thousand for the three months ended March 31, 2021 and 2020, respectively, resulting in a cost of goods sold gross margin deficit of $290 thousand and $134 thousand. Our product manufacturing capabilities currently have excess capacity to support future growth.

Research and development expenses decreased by 19%, or $189 thousand to $820 thousand for the three months ended March 31, 2021 from $1.0 million for the three months ended March 31, 2020.

Selling, general and administrative expenses increased by 46%, or $383 thousand, to $1.2 million for the three months ended March 31, 2021, as compared with $833 thousand for the three months ended March 31, 2020.

Merger related costs for the three-month period ended March 31, 2021 were $2.1 million.

Total other expense for the three months ended March 31, 2021 was $2.9 million, which consisted of a number of non-recurring non-cash items related to the conversion of the StemoniX’s capital structure to StemoniX common stock and exchange for Company common stock.

Calithera Biosciences and Antengene Enter Worldwide License Agreement for Development & Commercialization of CB-708

On May 17, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, and Antengene Corporation, Ltd. (SEHK: 6996.HK), a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases, reported an exclusive, worldwide license agreement for the development and commercialization of CB-708, Calithera’s small molecule inhibitor of CD73 (Press release, Calithera Biosciences, MAY 17, 2021, View Source [SID1234580113]).

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"This agreement validates the capabilities of our drug discovery engine and represents a significant milestone for our CD73 program," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "Antengene brings significant enthusiasm and proven global capabilities to the development and future commercialization of CB-708, a potential best-in-class oral small molecule CD73 inhibitor. This licensing agreement enables the continued advancement of this promising program, while allowing Calithera to focus our resources on our more advanced clinical programs evaluating telaglenastat in non-small cell lung cancer and CB-280 in cystic fibrosis."

CB-708 is a highly potent, selective, orally-bioavailable small molecule inhibitor of CD73. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting demonstrated that CB-708 has immune-mediated, single agent activity in syngeneic mouse tumor models. In preclinical studies, CB-708 was well-tolerated and showed enhanced anti-tumor activity when combined with either an anti-PD-L1 immunotherapy or with chemotherapeutic agents, such as oxaliplatin or doxorubicin. CB-708 has completed GLP toxicology studies and is poised to advance into clinical development.

"We are excited to continue the advancement of CB-708 through our deep experience in global clinical development and extensive track record in commercialization in major markets around the world," said Dr. Jay Mei, Founder and Chief Executive Officer of Antengene. "CB-708 is a highly differentiated oral small molecule CD73 inhibitor with best-in-class potential. Antengene will continue to complete the GMP manufacturing of CB-708 and advance it into clinical trials for the treatment of multiple cancers including solid tumors and hematologic malignancies. This agreement brings a great addition to our synergistic portfolio of 12 assets with combinatory potential, is a testament to our abilities in accelerating global development, and represents another step in realizing our mission of treating patients beyond borders."

Under the terms of the license agreement, Calithera will receive an upfront payment and potential development, regulatory and sales milestones of up to $255.0 million. Additionally, Calithera is eligible to receive tiered royalties on sales of the licensed product up to low double-digits. Antengene Investment Ltd, a wholly owned subsidiary of Antengene Corporation, will receive exclusive, worldwide rights to develop and commercialize CB-708.

Bellicum Reports First Quarter 2021 Financial Results and Provides Operational Update

On May 17, 2021 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the first quarter 2021 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAY 17, 2021, View Source [SID1234580112]).

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"In the first quarter, Bellicum maintained focus on the clinical studies of our next generation CAR-T cell therapies," said Rick Fair, President and Chief Executive Officer. "Our trials of BPX-601 in prostate cancer and BPX-603 in HER2+ solid tumors are well underway, and we look forward to providing future updates on our clinical progress for both programs."

Program Highlights and Current Updates

BPX-601 GoCAR-T

Patient enrollment is ongoing in the Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer.
Bellicum plans to present a Phase 1 data update on BPX-601 and rimiducid in patients with metastatic castration-resistant prostate cancer in the first quarter of 2022.
BPX-603 GoCAR-T

Bellicum is conducting its Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. The company expects to present initial Phase 1 data from this trial in the fourth quarter of 2021.
CaspaCIDe

As announced in February, the first reported use of the CaspaCIDe safety switch to mitigate CAR-T cell toxicity was published as an ahead-of-print publication in the digital edition of Blood, a journal published by The American Society of Hematology (ASH) (Free ASH Whitepaper). The report described a case from an investigator-sponsored trial at the University of North Carolina Lineberger Comprehensive Cancer Center of autologous CAR-T cells expressing CD19 and CaspaCIDe. In this patient, grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS) refractory to standard therapies was treated with rimiducid to activate CaspaCIDe. Within 12 hours of rimiducid administration, ICANS grade improved from 3 to 1 and was fully resolved after four days.
First Quarter 2021 Financial Results

R&D Expenses: Research and development expenses were $6.5 million for the first quarter of 2021 compared to $10.4 million during the first quarter of 2020. The reduction in expenses in the first quarter 2021 resulted primarily from reduced rivo-cel activities and the corporate restructuring implemented during the fourth quarter of 2020, partially offset by an increase in expenses related to the GoCAR programs.

G&A Expenses: General and administrative expenses were $2.0 million in the first quarter of 2021 compared to $4.2 million in the period a year ago. The reduction in expenses during the first quarter 2021 relative to the comparable period in 2020 was primarily due to the effects of the corporate restructuring that reduced employee-related charges.

Loss from Operations: Bellicum reported a loss from operations of $8.9 million for the first quarter of 2021 compared to a loss from operations of $14.6 million for the comparable period in 2020.

Net Income/Loss: Bellicum reported a net loss of $11.3 million for the first quarter of 2021 compared to net income of $17.6 million for the comparable period in 2020. The results included a non-cash loss of $2.3 million related to the change in fair value of the warrant and private placement option liability for the first quarter of 2021.

Shares Outstanding: As of May 10, 2021, Bellicum had 8,397,803 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock is convertible into 10 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $29.6 million as of March 31, 2021, compared to $37.0 million as of December 31, 2020. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2022.

Athenex, Texas Children’s Cancer Center, and the Center for Cell and Gene Therapy at Baylor College of Medicine Present New Clinical Data on GD2 CAR-NKT Cells in Neuroblastoma at ASGCT Annual Meeting

On May 17, 2021 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, led by its Orascovery platform, reported that investigators from Texas Children’s Cancer Center and the Center for Cell and Gene Therapy at Baylor College of Medicine presented new clinical data from the ongoing GINAKIT2 phase 1 study of Athenex’s cell therapy candidate KUR-501 targeting GD2 in neuroblastoma at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting on Friday, May 14, at 11 am ET (Press release, Athenex, MAY 17, 2021, View Source [SID1234580111]).

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Observed responses to date in 11 evaluable, heavily pretreated patients with neuroblastoma, include one complete response (CR) and one partial response (PR). Four additional patients have exhibited stable disease (SD). The durations of response for the CR and PR were approximately 5 and 3 months, respectively. No patients experienced grade 2 or higher toxicities related to the GD2-CAR NKTs. Post-treatment tumor biopsies showed GD2-CAR NKTs homing to metastatic lesions at all dose levels. The CAR-NKT AUC normalized to disease burden (AUC/Curie score using MIBG scan quantified tumor burden) appears to be associated with response to therapy.

"The results of the ongoing phase I study further validate the clinical activity of CAR-NKT cells," said Dr. Kurt Gunter, Chief Medical Officer of Athenex Cell Therapy. "The data thus far demonstrate clinical responses and tumor homing with an attractive safety profile. We are grateful to the patients and families for their participation in these studies and to the scientists and physicians at Texas Children’s Cancer Center and Baylor College of Medicine for their scientific leadership."

Dr. Andras Heczey, from Baylor College of Medicine, presented updated data from the GINAKIT2 study of autologous CAR-NKT cells. The title of the presentation is "Natural Killer T Cells Expressing a GD2-CAR and IL-15 Are Safe and Can Induce Complete Remission in Children with Relapsed Neuroblastoma – A First-in-Human, Phase 1 Trial". Dr. Heczey is the principal investigator for this study. The abstract and his work were selected for presentation at this year’s Clinical Trials Spotlight Symposium.

"We are encouraged by the reassuring safety profile, expansion/persistence/tumor trafficking parameters and by the evidence of clinical activity with autologous, engineered CAR-NKT cell therapy at relatively low doses," said Dr. Heczey, Associate Professor of Pediatrics – Oncology at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center. "We look forward to advancing the program into additional dose levels and treating additional patients."

About KUR-501

KUR-501 is an autologous product in which NKT cells are engineered with a CAR targeting GD2, which is expressed on almost all neuroblastoma tumors, as well as other malignancies. KUR-501 is being tested in the phase 1 GINAKIT2 clinical study (NCT03294954) in patients with R/R high risk neuroblastoma. The single-arm study will evaluate six dose levels of KUR-501 with patients receiving pre-dose lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine.

Neuroblastoma is a pediatric cancer and patients with R/R high risk neuroblastoma have a poor prognosis and a significant unmet medical need. The KUR-501 development program is also designed to provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target.

The GINAKIT2 study is supported by Athenex, Inc., which acquired Kuur Therapeutics in May 2021, and Alex’s Lemonade Stand Foundation, is conducted by Athenex’s collaborator, BCM, and is currently recruiting patients.

Astellas to Present Data from Expanding Oncology Portfolio During the 2021 ASCO Annual Meeting

On May 17, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that it will share new data across its oncology portfolio during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, Astellas, MAY 17, 2021, View Source [SID1234580110]). Covering three approved treatments and one investigational therapy, the 12 Astellas-sponsored abstracts underscore the company’s commitment to advancing treatment options for difficult-to-treat cancers, including bladder, prostate and gastric/gastroesophageal junction (GEJ) cancers, as well as acute myeloid leukemia (AML).

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"While oncology has seen incredible advancements over the last decade, there are still many patients whose disease has few or no effective treatments. Astellas is determined to change that reality," said Andrew Krivoshik, M.D., Ph.D., Astellas Senior Vice President and Oncology Therapeutic Area Head. "Our data suggest that progress is possible, and we are committed to working with physicians, patients and others in the cancer community to change the course of hard-to-treat forms of cancer."

"The latest investigational research supported by Astellas reflects our commitment to understanding unmet needs in cancer care and our mission to turn innovative science into treatments that are truly valued by patients and healthcare professionals," said Erhan Berrak, M.D., Astellas Vice President of Medical Affairs, Oncology. "For example, research to be presented at ASCO (Free ASCO Whitepaper) includes a closer look at real-world treatment patterns in several clinical states of advanced prostate cancer, including the use of advanced treatments across racial groups – a topic closely aligned with the ASCO (Free ASCO Whitepaper) 2021 theme of equity."

Astellas will share data across its portfolio and investigational therapies, with highlights including:

Quality of life results from the Phase 3 EV-301 trial of enfortumab vedotin (EV) and an updated analysis of efficacy and safety data from EV-201 cohort 2 of EV; updated durability and long-term outcomes from the EV-103 clinical trial of EV and pembrolizumab – all in advanced types of urothelial cancer
Research on racial disparities in advanced prostate cancer treatment, as well as real-world treatment patterns for patients with advanced prostate cancer
Follow-up data from the Phase 3 ADMIRAL trial evaluating gilteritinib in patients with relapsed or refractory (resistant to treatment) AML with a FLT3 mutation
Data from the Phase 2 study of zolbetuximab plus mFOLFOX6 in claudin 18.2-positive (CLDN18.2+) locally advanced or metastatic gastric or GEJ adenocarcinoma
Astellas Presentations at ASCO (Free ASCO Whitepaper)21

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

Enfortumab vedotin in cisplatin-ineligible
patients with locally advanced or
metastatic urothelial cancer who
received prior PD-1/PD-L1 inhibitors: An
updated analysis of EV-201 Cohort 2

B. McGregor

Type: Poster

Abstract Number: 4524

Study EV-103: Update on durability
results and long-term outcome of
enfortumab vedotin + pembrolizumab in
first line locally advanced or metastatic
urothelial carcinoma (la/mUC)

T. Friedlander

Type: Poster

Abstract Number: 4528

Quality of life, functioning, and
symptoms in patients with previously
treated locally advanced or metastatic
urothelial carcinoma from EV-301: A
randomized phase 3 trial of enfortumab
vedotin vs chemotherapy

R. Mamtani

Type: Poster

Abstract Number: 4539

KEYNOTE-B15/EV-304: Randomized
phase 3 study of perioperative
enfortumab vedotin plus pembrolizumab
versus chemotherapy in cisplatin-
eligible patients with muscle-invasive
bladder cancer (MIBC)

C. Hoimes

Type: Poster

Abstract Number: TPS4587

Opioid use in locally advanced or
metastatic urothelial carcinoma patients
and matched non-cancer controls

S. Grewal

Type: Publication Only

Abstract Number: e16517

Enzalutamide

Presentation Title

Lead Author

Presentation Details

The efficacy of enzalutamide (ENZA)
plus androgen deprivation therapy
(ADT) on bone oligometastatic
hormone-sensitive prostate cancer: A
post hoc analysis of ARCHES

A. Armstrong

Type: Poster

Abstract Number: 5071

Real world first-line (1L) treatment
patterns in patients (pts) with metastatic
castration-sensitive prostate cancer
(mCSPC) in a U.S. health insurance
database

U. Swami

Type: Poster

Abstract Number: 5072

Real-world utilization of advanced
therapies and racial disparity among
patients with metastatic castration-
sensitive prostate cancer (mCSPC): A
Medicare database analysis

S. Freedland

Type: Poster
Abstract Number: 5073

Real-world treatment patterns among
patients diagnosed with metastatic
castration-sensitive prostate cancer
(mCSPC) in community oncology
settings

D. George

Type: Poster
Abstract Number: 5074

Gilteritinib

Presentation Title

Lead Author

Presentation Details

Follow-up of patients with FLT3-mutated
R/R AML in the phase 3 ADMIRAL trial

A. Perl

Type: Poster

Abstract Number: 7013

Zolbetuximab

View News Release Full Screen
Presentation Title

Lead Author

Presentation Details

Phase 2 study of zolbetuximab plus
mFOLFOX6 in claudin 18.2-positive
locally advanced or metastatic gastric or
gastroesophageal junction adenocarcinoma (G/GEJ): ILUSTRO
cohort 2

K. Lee

Type: Publication Only

Abstract Number: e16078

The ASCO (Free ASCO Whitepaper) 2021 Annual Meeting abstracts are available at the ASCO (Free ASCO Whitepaper) Meeting Library.

Enfortumab Vedotin Collaborations
Astellas and Seagen Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin. In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

Astellas and Seagen entered a clinical collaboration agreement with Merck to evaluate the combination of enfortumab vedotin and Merck’s KEYTRUDA (pembrolizumab), in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Enzalutamide and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.