On August 16, 2021 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, reported financial results for the second quarter ended June 30, 2021 and corporate highlights (Press release, Terns Pharmaceuticals, AUG 16, 2021, View Source [SID1234586635]).

"We are pleased to report significant progress across our clinical programs this quarter marked by several important achievements, including initiations of our Phase 1b AVIATION Trial of TERN-201 and the multiple ascending dose (MAD) cohort of our TERN-501 Phase 1 trial, as well as positive top-line data from our Phase 2a LIFT Study of TERN-101," said Senthil Sundaram, Chief Executive Officer at Terns. "These milestones highlight our commitment to rapidly advance our broad NASH pipeline. We look forward to proof of concept data for TERN-501 later this year and for TERN-201 in 2022."

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Recent Developments and Anticipated Upcoming Milestones

TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

Initiated 14-day multiple ascending dose (MAD) portion of Phase 1 trial in June 2021
Top-line, proof of concept data readout expected in 4Q 2021, including:
Pharmacodynamic markers of THR-β engagement in the liver linked to NASH efficacy, including sex hormone binding globulin (SHBG) and low-density lipoprotein (LDL) cholesterol
Indicators of pharmacokinetic stability
Safety and tolerability

Received Fast Track Designation (FTD) from the U.S. FDA in June 2021

Provides eligibility for more frequent FDA interactions, accelerated approval and priority review
TERN-501 is Terns’ third development-stage compound with FTD for the treatment of NASH
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

Initiated 12-week Phase 1b AVIATION Trial in NASH in June 2021
Top-line results from Part 1 of AVIATION Trial expected in 1H 2022, including:
Key efficacy readout in corrected T1 (cT1), an imaging marker of liver inflammation and fibrosis linked to clinical outcomes
Safety, tolerability and plasma VAP-1 activity
TERN-101: Liver-distributed farnesoid X receptor (FXR) agonist

Reported positive top-line data from 12-week Phase 2a LIFT clinical trial in NASH in June 2021, demonstrating three firsts:
First FXR agonist trial to demonstrate no discontinuations due to adverse events, including pruritus
First 12-week placebo-controlled trial of an FXR agonist in NASH to show significant improvements in cT1, an imaging marker of liver inflammation and fibrosis linked to clinical outcomes
First FXR agonist planned to be studied in combination with a THR-β agonist (TERN-501)
Phase 1 data accepted for publication in Clinical Pharmacology in Drug Development
GLP1-R: Oral, small-molecule glucagon-like peptide-1 (GLP1) receptor agonist

Nomination of final candidate expected in 2H 2021
Second Quarter Financial Results

Cash Position: As of June 30, 2021, cash, cash equivalents and marketable securities were $185.1 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2024
Research and Development (R&D) Expenses: R&D expenses were $6.0 million for the quarter ended June 30, 2021, as compared with $7.6 million for the quarter ended June 30, 2020
General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the quarter ended June 30, 2021, as compared with $2.5 million for the quarter ended June 30, 2020
Net Loss: Net loss was $10.7 million for the quarter ended June 30, 2021, as compared with $9.7 million for the quarter ended June 30, 2020

On August 16, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the second quarter ended June 30, 2021 (Press release, Mustang Bio, AUG 16, 2021, View Source [SID1234586634]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "In the first half of 2021, Mustang continued to progress the development of our CAR T therapies across multiple cancers, as well as our lentiviral gene therapies for the treatment of X-linked severe combined immunodeficiency ("XSCID"), also known as bubble boy disease. We are encouraged by the updated interim MB-106 CD20-targeted, autologous CAR T data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress ("EHA2021") in June. The data presented showed a favorable safety profile and compelling clinical activity, with a 93% overall response rate and 67% complete response rate in patients with high-risk B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL") who were treated with our modified cell manufacturing process. Additionally, the U.S. Food and Drug Administration ("FDA") accepted Mustang’s Investigational New Drug ("IND") application to initiate a multicenter Phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for relapsed or refractory B-NHL and CLL. We look forward to enrolling the first patient in the trial later this quarter and to further advancing MB-106 for patients with B-NHL and CLL."

Dr. Litchman continued, "Last week, we announced an exclusive license agreement for a novel in situ CAR T technology that may be able to transform the administration of CAR T therapies, facilitating how the treatments are delivered to patients, with the potential to be used broadly as an off-the-shelf therapy. With this collaboration with the Mayo Clinic, we gain access to an innovative platform technology that we hope will become the discovery engine for a whole new generation of CAR T products at Mustang. We also announced that the first patient was dosed at City of Hope in a clinical trial to establish the safety and feasibility of administering MB-101 (autologous IL13Rα2-targeted CAR T cells) to patients with leptomeningeal brain tumors. On the regulatory front, we are delighted that the European Medicines Agency ("EMA") recently granted Priority Medicines ("PRIME") designation to MB-107, our lentiviral gene therapy for the treatment of XSCID in newly diagnosed infants. We anticipate enrolling the first patient in the pivotal Mustang-IND MB-107 trial for newborns with XSCID shortly and also expect to file an IND for a pivotal MB-207 trial in previously transplanted XSCID patients later this quarter. We look forward to continuing to provide updates on our CAR T and gene therapy clinical programs in the second half of the year."

Recent Corporate Highlights:

In May 2021, Mustang announced that the FDA approved its IND application to initiate a multicenter Phase 1/2 clinical trial investigating the safety and efficacy of MB-106, a CD20-targeted CAR T for relapsed or refractory B-NHL and CLL.
Also in May 2021, Mustang announced that the first patient was dosed at City of Hope in a clinical trial to establish the safety and feasibility of administering MB-101 (autologous IL13Rα2-directed CAR T cells) to patients with leptomeningeal brain tumors (e.g., glioblastoma, ependymoma or medulloblastoma).
In June 2021, Mustang announced MB-106 CD20-targeted CAR T data were presented at EHA (Free EHA Whitepaper)2021. Dr. Mazyar Shadman of Fred Hutchinson Cancer Research Center presented updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL, which showed a favorable safety profile and compelling clinical activity with a 93% overall response rate and 67% complete response rate in patients treated with the modified cell manufacturing process.
Also in June 2021, Mustang hosted a key opinion leader webinar featuring a presentation from Dr. Shadman, who discussed interim results from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 CD20-targeted CAR T for B-NHL and CLL. A replay of the webinar can be found here.
Additionally in June 2021, Mustang announced that it has been awarded a $300,000 Massachusetts Life Sciences Center tax incentive based on a hiring commitment of 20 net new full-time equivalent employees for calendar year 2021 and retaining that headcount level through 2025.
Earlier this month, Mustang announced that the EMA granted PRIME designation to MB-107, its lentiviral gene therapy for the treatment of XSCID in newly diagnosed infants.
Last week, Mustang announced an exclusive license agreement with Mayo Clinic for a novel technology that may be able to transform the administration of CAR T therapies and has the potential to be used as an off-the-shelf therapy.
Financial Results:

As of June 30, 2021, Mustang’s cash and cash equivalents and restricted cash totaled $130.9 million, compared to $130.4 million at March 31, 2021 and $98.8 million as of December 31, 2020, an increase of $0.5 million for the quarter and an increase of $32.1 million year-to-date.
Research and development expenses including license acquisitions were $11.9 million for the second quarter of 2021, compared to $11.1 million for the second quarter of 2020. Non-cash, stock-based expenses included in research and development were $0.3 million for the second quarter of 2021, compared to $0.4 million for the second quarter of 2020.
General and administrative expenses were $2.5 million for the second quarter of 2021, compared to $3.0 million for the second quarter of 2020. Non-cash, stock-based expenses included in general and administrative expenses were $0.6 million for the second quarter of 2021, compared to $1.5 million for the second quarter of 2020.
Net loss attributable to common stockholders was $14.4 million, or $0.16 per share, for the second quarter of 2021, compared to a net loss attributable to common stockholders of $14.6 million, or $0.32 per share, for the second quarter of 2020.

On August 16, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported financial results for the quarter ended June 30, 2021 (Press release, Kinnate Biopharma, AUG 16, 2021, View Source [SID1234586633]). The company also announced that the first patient has commenced treatment in its Phase 1 KN-8701 clinical trial evaluating its lead RAF product candidate, KIN-2787, a pan-RAF inhibitor being developed for the treatment of patients with lung cancer, melanoma and other solid tumors.

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"2021 continues to be a year of progress for Kinnate. Initiating our first in-human trial for KIN-2787 and dosing our first patient were important steps forward toward expanding options for cancer patients who are not benefiting from currently approved RAF inhibitors," said Nima Farzan, Chief Executive Officer of Kinnate. "As we enter the second half of the year, our expanding team of clinical and business leaders are well positioned to drive further progress in our KIN-2787 program and advance our pipeline of targeted precision oncology therapies, including our lead FGFR inhibitor candidate for which we anticipate filing an IND in the first half of 2022."

The KN-8701 trial is a multi-center, open-label, two-part study of approximately 115 patients to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with Class I, Class II, or Class III BRAF-mutated advanced or metastatic solid tumors.

"Successfully targeting patients with Class II and Class III BRAF mutations remains a substantial unmet need in cancer care. KIN-2787 brings a unique approach to potentially address the shortcomings of existing therapies by inhibiting dimer signaling in specific patient populations with BRAF mutations while also minimizing MAPK paradoxical activation," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology. "We are proud to be the first site to treat a patient with KIN-2787 and look forward to working with Kinnate to continue enrollment in this important Phase 1 trial."

Other Recent Business Highlights and Corporate Update:

In May 2021, we closed a $35 million Series A preferred stock financing of a China joint venture ("China JV"), of which Kinnate is the majority shareholder. Established with OrbiMed Asia Partners, OrbiMed Private Investments and Foresite Capital, the China JV will be headquartered in Shanghai and the financing will enable the potential development and commercialization by the China JV of certain Kinnate targeted oncology product candidates across Greater China (PRC, Hong Kong, Taiwan, and Macau).
We appointed Neha Krishnamohan as our Chief Financial Officer and Executive Vice President, Corporate Development, and we continued to expand our leadership team, including with the appointment of Ken Kobayashi, M.D., our Senior Vice President, Clinical Development.
Helen Sabzevari, Ph.D. was appointed to our Board of Directors, and Stephen Kaldor, Ph.D., one of our founders, was not nominated for re-election to our Board of Directors when his term expired at our 2021 annual meeting of shareholders.
We expanded our organization to 52 full-time employees at June 30, 2021, of which 39 were engaged in research and development activities.
During a virtual poster session at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), we presented results from preclinical studies evaluating the efficacy and tolerability of KIN-2787, in vitro and in vivo in BRAF mutation-driven human cancer models.
Second Quarter 2021 Financial Results

Second quarter net loss for 2021 was $21.4 million, compared to $7.6 million for the same period in 2020.
Second quarter research and development expenses for 2021 were $16.2 million, compared to $5.6 million for the same period in 2020.
Second quarter general and administrative expenses for 2021 were $5.3 million, compared to $2.0 million for the same period in 2020.
As of June 30, 2021, the total of cash and cash equivalents and investments was $365.1 million, exclusive of $35.0 million in the China JV.

On August 16, 2021 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an emerging global drug discovery company, reported that it is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases (Press release, Cancer Genetics, AUG 16, 2021, View Source [SID1234586632]). Today, Vyant Bio reports its Second Quarter 2021 strategic and business updates in a conference call scheduled for 4:30 p.m. ET.

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"We have achieved a tremendous amount of momentum in the first 90 days since launching the Vyant Bio brand and completing the merger we announced at the end of March 2021. Vyant Bio is committed to transforming the way drugs are discovered by quickly adapting to exciting new technologies and combining capabilities in ways that leverage their strengths," stated Jay Roberts, CEO of Vyant Bio. "Our internal teams of scientists, data scientists and engineers, coupled with the capabilities of select strategic partners that are now integrated into our platform, allow us all to work together to design and develop superior therapeutics and position us to build a robust pipeline of novel therapeutics targeting degenerative and developmental neurological disorders and cancers with high unmet needs."

Vyant Bio’s drug discovery platform uses both human-induced pluripotent stem cell-derived (hiPSC) and primary human cell organoids as proprietary disease models combined with analysis of human genetics and the use of machine learning algorithms for the identification of new targets, validation of known targets, and high-throughput screening for drug discovery. Vyant Bio’s drug discovery platform is intended to overcome the shortcomings of traditional drug discovery efforts that rely more heavily on insights from animal models to identify targets and to develop therapies intended for human disease. The Company is currently focused on the specific utility for the identification of targets and therapies in CNS and Oncology.

The Company filed its quarterly report for the Second Quarter 2021 on Form 10-Q today with the Securities and Exchange Commission. Please refer to our Form 10-Q for more detailed information with respect to our financial results for the three and six months ended June 30, 2021.

SECOND QUARTER 2021 FINANCIAL RESULTS1

As StemoniX, Inc. was deemed to have acquired Cancer Genetics, Inc. for accounting purposes and the Merger closed on March 30, 2021, the Company’s Second Quarter 2021 financial results include the post-merger results of the combined companies, now known as Vyant Bio. The analysis below excludes the Second Quarter 2020 results as they are based solely on StemoniX’s historical stand-alone operations and therefore do not reflect the post-merger enterprise.

Cash and cash equivalents totaled $26.5 million as of June 30, 2021.

Total revenues were $1.9 million for the three months ended June 30, 2021. Cost of goods sold – service aggregated to $1.0 million for the three months ended June 30, 2021 resulting in a cost of goods sold of 56% of service revenues. Cost of goods sold – product aggregated to $345 thousand for the three months ended June 30, 2021 resulting in a cost of goods sold gross margin deficit of $229 thousand. Our product manufacturing capabilities currently have excess capacity to support future growth. Research and development expenses were $910 thousand for the three months ended June 30, 2021. Selling, general and administrative expenses, which include public company costs and non-cash expenses of $620 thousand, were $3.7 million for the three months ended June 30, 2021.

While the Company executes its drug development strategy for long-term growth, the Company currently generates revenue from its vivoPharm and StemoniX subsidiaries. On a pro forma basis, assuming the Merger occurred on January 1, 2020, revenues for the three and six-month ended June 30, 2021 were $1.9 million and $3.8 million, respectively, as compared with $1.5 million and $3.1 million for the respective prior-year periods. On a pro forma basis, revenues increased by 26% and 21% in the current-year three and six-month periods as compared with the same prior-year periods.

1Pro forma information gives effect to the Merger between Cancer Genetics, Inc. and StemoniX, Inc. as if the Merger had occurred as of January 1, 2020. The pro forma information is presented solely for informational purposes and is not necessarily indicative of the combined results of operations or financial position that might have been achieved for the periods or dates indicated, nor is it necessarily indicative of the future results of the Company.

Vyant Bio’s Conference Call and Webcast and Information

Vyant Bio’s management will host a conference call on Monday, August 16, 2021 at 4:30pm ET to discuss the Second Quarter 2021 results and provide strategic business updates, as well as answer questions. Event information is below:

On August 16, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that Lantern Pharma’s abstract titled ‘LP-184, a novel alkylating agent, is highly effective in pancreatic cancers with DNA damage repair defects‘ has been accepted as a virtual poster at the upcoming AACR (Free AACR Whitepaper) Virtual Special Conference on Pancreatic Cancer being held on September 29-30, 2021 (Press release, Lantern Pharma, AUG 16, 2021, View Source;utm_medium=rss&utm_campaign=abstract-on-effectiveness-of-lp-184-in-pancreatic-cancers [SID1234586631]).

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The abstract submitted by Lantern Pharma and researchers at Fox Chase Cancer Center describes work demonstrating promising efficacy of LP-184 in multiple in vitro and in vivo pancreatic cancer models. The abstract also highlights the increased efficacy and synthetic lethality of LP-184 in pancreatic cancers with DNA damage repair deficiencies.

Virtual posters will be available on-demand to attendees starting on September 29, 2021 and will remain accessible for 90 days after the live program ends. Accepted abstracts will be published as an online-only proceedings supplement to an AACR (Free AACR Whitepaper) journal after the completion of the meeting.

LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including pancreatic cancer. LP-184 has recently been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer.