NanoString Launches nCounter TCR Diversity Panel and Analysis Package at the 2021 Annual Meeting of the Society for Immunotherapy of Cancer

On November 11, 2021 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, reported the launch of the nCounter TCR Diversity Panel and companion cloud-based TCR analysis report created for use with the ROSALIND platform (Press release, NanoString Technologies, NOV 11, 2021, View Source [SID1234595300]). This new gene expression panel allows researchers to measure the usage of T cell receptor (TCR) variable regions and shifts in TCR diversity with a simple assay that can deliver results in less than 24 hours.

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A diverse population of TCRs is a hallmark of a healthy immune system. The mix and abundance of TCR variable regions changes upon challenge with a pathogen, cancer, or any disease that triggers an adaptive immune response. TCRs are studied to understand disease onset, progression, response or non-response to treatment, and disease recovery. By directly quantifying the expression of each TCR variable region, the nCounter TCR Diversity Panel can rapidly screen samples without the time and cost of laborious sequencing methods.

"The nCounter TCR Diversity Panel provides an intuitive, powerful new tool for use with clinical samples," said Dr. Léon van Kempen, an early access user and scientific lead at the Laboratory for Molecular Pathology at University Medical Center Groningen, Netherlands. "The panel allows for a TCR diversity score to be easily calculated based on expression and objectively quantifies a T cell response allowing for broad utility of the panel throughout all types of research."

The new panel utilizes the unique oligonucleotide barcoding chemistry of the nCounter Analysis System to detect mRNA transcripts directly. It contains probes for 129 human genes covering all TCR alpha, beta, gamma, delta variable regions as well as constant regions. The panel also allows for customization with the ability for researchers to add in and measure unique TCRs of interest. This novel solution is coupled with an automated data analysis report purchased separately and accessible within the ROSALIND platform, allowing researchers to analyze results and generate TCR diversity scores within minutes.

"We remain committed to developing innovative tools to advance our understanding of the human immune response. Leveraging the simplicity of the nCounter workflow makes it possible to gain broader insights with higher throughput," said Joseph Beechem, Ph.D., chief scientific officer, NanoString. "In the future, we expect to enable our GeoMx Digital Spatial Profiler to study TCRs spatially within tissues, providing an entirely new dimension of knowledge."

Learn more about the nCounter TCR Diversity Panel and the latest scientific advances in the field of immuno-oncology using the nCounter and GeoMx Digital Spatial Profiler platforms at the virtual symposium and booth #8 at the 36th annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference.

Virtual Symposium: "Quantifying T-cell receptor diversity via expression analysis" is on Friday, Nov. 12, from 1:00 – 1:30 pm EST. The symposium is an opportunity to talk with Dr. Léon van Kempen, a clinical scientist in molecular pathology, about getting started with the spatial biology revolution and the GeoMx Whole Transcriptome Atlas. In addition, this workshop will focus on the nCounter TCR Diversity Gene Expression Panel and a case study on the use of the panel for clinical research.

Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2022

On November 11, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported financial results for its first fiscal quarter ended September 30, 2021 (Press release, Beyond Air, NOV 11, 2021, View Source [SID1234595437]).

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Steve Lisi, Chairman and Chief Executive Officer of Beyond Air commented, "This has been an exciting quarter for Beyond Air, as the team continues to deliver both operationally and strategically. On the strategic front, the launch of Beyond Cancer under the new leadership of CEO Selena Chaisson, M.D. is a special achievement. The separation of the UNO franchise to an independently managed affiliate was made possible through the support of investors in a $23.9 million ongoing private financing. We believe that the spin-off will accelerate UNO’s path to the clinic and create long-term value for shareholders. Beyond Cancer will leverage our NO expertise, IP portfolio, preclinical oncology team, regulatory progress, and initially use existing Company infrastructure. The separation enables Beyond Air to focus on its core business of advancing its LungFit platform for the treatment of respiratory diseases."

Mr. Lisi continued, "Consistent with our global regulatory update from September, our PMA for LungFit PH continues to be under review at FDA. We successfully completed our Stage 1 Assessment Audit for a CE Mark in Europe and anticipate approval during the first half of calendar year 2022, after which we plan to partner the program internationally. In the United States, we continue to guide a commercial launch in the fourth quarter of this calendar year. Our commercial team has grown considerably and is ready to bring the first-ever integrated generator and delivery system that produces NO to hospitals across the country. The Beyond Air team also continues to execute on the R&D front with the release of interim data from our NTM pilot study using LungFit GO to deliver up to 250 ppm NO in a home setting. Despite the COVID-19 related lockdowns in Australia, as of September 6th we had 8 patients successfully enrolled and titrated up to 250 ppm NO, with no study discontinuations and no treatment-related serious adverse events. The pilot study continues enrolling patients, and we expect to report complete safety and efficacy results in 2022."

Recent Highlights and Upcoming Milestones

LungFit PH
Commercial launch in the United States on track for the fourth quarter of calendar year 2021, pending FDA PMA approval
Successfully completed Stage 1 Assessment Audit in the CE Mark process; expect to receive CE Mark in 1H CY2022 followed by international commercial partnership

LungFit PRO
Acute Viral Pneumonia Data
Ongoing pilot study for acute viral pneumonia in adults, including COVID-19 patients, in Israel using LungFit PRO at 150 ppm NO
Upcoming Study (pending discussion with FDA)
Plan on initiating a pivotal trial for patients hospitalized with viral lung infections in the fourth quarter of calendar year 2022

LungFit GO
Reported positive interim data for at-home pilot study in Australia using LungFit GO for self-administration of up to 250 ppm NO for the treatment of refractory NTM lung disease in adult patients
Interim results showed that 250 ppm NO was well-tolerated with no study discontinuations or treatment-related serious adverse events observed in 8 patients, with methemoglobin and NO2 concentrations remaining within acceptable safety ranges in all subjects
Expect to report full efficacy and safety data for the at-home NTM lung infection pilot study at a medical or scientific conference in calendar year 2022
Published a compassionate use case study called "Non-tuberculous mycobacteria infection treated with intermittently inhaled high-dose nitric oxide" using high concentration NO treatment to treat the Mycobacterium abscessus strain of NTM in The BMJ1

Beyond Cancer’s Solid Tumor Program
Secured commitments of $23.9 million in a concurrent private placement of common shares, not to exceed $30 million, to form Beyond Cancer that will leverage Beyond Air’s NO experience and accelerate and enhance the solid tumor pipeline
After this financing, Beyond Air will retain at least 80% equity ownership in Beyond Cancer
Anticipate beginning enrollment of patients in the first half of calendar year 2022
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1 Goldbart A, Gatt D, Golan Tripto I. BMJ Case Rep 2021;14:e243979. doi:10.1136/bcr-2021-243979

Financial results for the fiscal quarter ended September 30, 2021

Revenue for the fiscal quarter ended September 30, 2021 was $0 as compared to $350,000 for the fiscal quarter ended September 30, 2020, all of which was licensing revenue.

Research and development expenses for the fiscal quarter ended September 30, 2021 were $2.8 million, compared to $3.1 million for the fiscal quarter ended September 30, 2020.

General and administrative expenses for the fiscal quarter ended September 30, 2021 were $3.4 million, compared to $2.2 million for the fiscal quarter ended September 30, 2020.

Other income and expense for the fiscal quarter ended September 30, 2021 was a loss of $2.5 million, compared to a loss of $0.2 million for the fiscal quarter ended September 30, 2020.

For the fiscal quarter ended September 30, 2021, the Company had a net loss of $8.7 million, or ($0.36) per share, compared to a net loss of $5.1 million, or ($0.30) per share for the fiscal quarter ended September 30, 2020.

As of September 30, 2021, the Company had cash, cash equivalents and restricted cash of $48.7 million.

A2 Bio Provides First Preclinical Data Presentation for CEA and MSLN Programs, Including Trial Update at SITC 2021

On November 11, 2021 A2 Biotherapeutics, Inc., "A2 Bio", is a biotechnology company focused on the development of a first-in-class Tmod T cell therapy platform to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to distinguish between tumor and normal cells (Press release, A2 Biotherapeutics, NOV 11, 2021, View Source [SID1234595471]).

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A2 Bio reported the first presentation of its Tmod platform; a powerful, precise targeting system controlled by tumor deletions which transforms CEA and MSLN CAR T cells into tumor-selective agents. Preclinical results demonstrate how Tmod primary T cells selectively kill tumor cells mixed with normal cells in vitro, and display robust activity in vivo. CEA Tmod cells selectively kill tumor cells within the same mouse implanted with established "normal" and tumor xenografts. MSLN Tmod constructs show similar selectivity, illustrating the breadth and modularity of the Tmod platform. Data are being featured on Nov. 13 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting at the Walter E. Washington Convention Center in Washington, D.C.

"These data demonstrate some of the impressive properties of the Tmod system, and its potential to address a key obstacle to more effective cancer treatments: tumor vs. normal tissue selectivity," said Alexander Kamb, Founder and Chief Scientific Officer of A2 Bio.

A2 Bio is also presenting a clinical trials poster on Nov 12, BASECAMP-1 (NCT04981119): An observational study to identify relapsed solid tumor patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH). The study will use the Tempus xT-Onco Next Generation Sequencing diagnostic to identify patients with loss of HLA-A*02 heterozygosity. If eligible, these patients will be leukapheresed to bank T cells for subsequent autologous Tmod CAR T cell therapy at the time of relapse. BASECAMP-1 is currently recruiting patients with colorectal, pancreatic or non-small cell lung cancer at NYU Langone Medical Center, and will soon open at other cell therapy centers of excellence, including Mayo Clinic Rochester, UCLA Medical Center, UCSD Medical Center, and MD Anderson Cancer Center.

Diane Simeone, MD, Perlmutter Professor of Surgery at NYU who is a Principal Investigator stated, "BASECAMP-1 is an exciting study that is a potential game changer for relapsed patients after surgical resection with little viable treatment options. I am completely committed to helping to identify and enroll patients in this unique logic-gated CAR T immunotherapy."

A2 Bio’s posters presented at SITC (Free SITC Whitepaper) can be viewed on the company’s website at www.a2bio.com/science/abstracts-and-publications.

Karyopharm to Participate at Jefferies London Healthcare Conference

On November 11, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that Richard Paulson, President and Chief Executive Officer of Karyopharm, will participate in a fireside chat at the Jefferies London Healthcare Conference (Press release, Karyopharm, NOV 11, 2021, View Source [SID1234595251]). The fireside chat will be made available for on-demand listening beginning Thursday, November 18, 2021 at 3:00 a.m. Eastern Time.

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A webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the fireside chat will be archived on the Company’s website for 30 days following the fireside chat.

Knight Therapeutics Reports Third Quarter 2021

On November 11, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading Pan-American (ex-US) specialty pharmaceutical company, reported financial results for its third quarter ended September 30, 2021 (Press release, Knight Therapeutics, NOV 11, 2021, View Source [SID1234595285]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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Q3 2021 Highlights

Financials

Revenues were $73,340, an increase of $28,101 or 62% over the same period in prior year.
Gross margin of $37,766 or 51% compared to $19,533 or 43% in the same period in prior year.
Adjusted EBITDA1 was $17,334, an increase of $13,118 or 311% over the same period in prior year.
Net loss on financial assets measured at fair value through profit or loss of $21,301 for the three-month period ended September 30, 2021.
Net gain on financial assets measured at fair value through profit or loss of $16,644 for the nine-month period ended September 30, 2021.
Net loss was $8,586, compared to $17,492 net income in the same period in prior year.
Cash inflow from operations was $10,321, compared to a cash outflow from operations of $8,412 in prior year.
Corporate Developments

Re-launched a normal course issuer bid ("NCIB") in July 2021 and purchased 2,963,022 common shares for an aggregate cash consideration of $15,361.
Hired Monica Percario as Global VP Scientific Affairs, Daniela Marino as Global VP Legal and Compliance and Susan Emblem as Global VP Human Resources.
Products

Entered into exclusive supply and distribution agreement with Incyte Biosciences International Sàrl ("Incyte") for tafasitamab and pemigatinib in Latin America
Strategic Investments

Received distributions of $2,042 from strategic fund investments and realized a gain of $1,634.
Key Subsequent Events

Received $9,243 (US$7,460) as part of the final distribution from the liquidation of New Emerging Medical Opportunities Fund II Ltd.
Re-financed Bancolombia loan extending the maturity date from December 14, 2021 to October 26, 2026.
Purchased an additional 1,009,725 common shares through NCIB for an aggregate cash consideration of $5,258.
"I am excited to announce that for a second consecutive quarter, Knight achieved record quarterly results despite the ongoing challenges posed by the pandemic. During the last 9 months we executed on multiple fronts with our business development team closing Exelon, entering into an exclusive supply and distribution agreement with Incyte while the commercial team continuing to deliver on strong growth of our key brands and the operational teams executing on integration and systems implementation. Furthermore, we strengthened Knight’s management team by adding a Global VP Scientific Affairs, a Global VP Legal and Compliance and a Global VP Human Resources, to continue delivering on growth and operational excellence," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

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1 Adjusted EBITDA is not a defined term under IFRS, refer to the definitions below for additional details.

Revenue: For the quarter ended September 30, 2021 revenues increased by $28,101 or 62% compared to the same prior year period. On a constant currency basis, revenues increased by $27,378 or 62%. The growth in revenues on a constant currency basis is explained as following:

An estimated increase in revenues of approximately $9,200 to $11,500 driven by the increased demand of certain of our infectious diseases products to treat invasive fungal infections associated with COVID-19. Of this amount, Knight estimates approximately $3,200 to $4,200 was not utilized during the quarter.
An increase in revenues of $9,905 driven by the acquisition of Exelon.
An increase in revenues of $6,047 or 76%, from $7,918 to $13,965, driven by the growth of our recently launched products, including Cresemba, Lenvima, Halaven, Nerlynx, Trelstar and certain BGx products.
Gross margin: For the quarter ended September 30, 2021 gross margin increased from 43% to 51% explained by a change in product mix, lower inventory provision recorded in Q3-21 compared to Q3-20 offset by the re-negotiation of certain license agreements and the depreciation of the LATAM currencies. The gross margin would have been 54%, an increase of 3%, from 51% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: For the quarter ended September 30, 2021, selling and marketing increased by $2,227 or 29% and on a constant currency basis by $2,165 or 29% as compared to the same prior year period. Excluding, the allowance for expected credit losses, S&M increased by $1,857 or 25% due to increase in certain variable costs such as distribution and compensation as well as an increase in selling and marketing activities related to product launches and Exelon.

General and administrative: For the quarter ended September 30, 2021, general and administrative expenses decreased by $2,072 or 19% and on a constant currency basis by $1,814 or 18% as compared to the same period in prior year. Excluding the non-recurring costs incurred in Q3-20 related to the Unified Tender Offer of $3,490, G&A increased by $1,676 or 17%. The increase is driven by an increase in the variable compensation and certain professional fees.

Amortization of intangible assets: For the quarter ended September 30, 2021, amortization of intangible assets increased by $5,496, or 96%, mainly explained by the amortization of Exelon acquired during Q2-21 partially offset by the depreciation of LATAM currencies.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter ended September 30, 2021, interest income was $1,402, a decrease of $1,786 or 56%, compared to the same prior year period, due to a decrease in interest rates, the average cash and marketable securities balances and a lower average loan balance.

Interest expense: The interest expense relates to interest incurred on bank loans. For the quarter ended September 30, 2021 interest expenses was $959, an increase of $137 or 17% compared to the same period in the prior year due to higher interest rates.

Adjusted EBITDA: For the quarter ended September 30, 2021 adjusted EBITDA increased by $13,118 or 311% and on a constant currency basis by $13,637 or 369%, compared to Q3-20. The growth in adjusted EBITDA is driven by an increase in gross of margin of $17,901 offset by an increase in operating expenses adjusted for acquisition and transaction costs as well as non-recurring expenses.

Net loss or income: For the quarter ended September 30, 2021, net loss was $8,586 compared to net income of $17,492 for the same period last year. The variance mainly resulted from the above-mentioned items as well as a net loss on the revaluation of financial assets measured at fair value through profit or loss of $21,301 in the third quarter of 2021 versus a net gain of $12,873 in the prior year period mainly due to unrealized losses and gains on revaluation of the strategic fund investments.

Cash, cash equivalents and marketable securities: As at September 30, 2021, Knight had $156,029 in cash, cash equivalents and marketable securities, a decrease of $236,196 or 60% as compared to December 31, 2020. The variance is primarily due to cash outflows related to the acquisition of Exelon, the shares repurchased through NCIB and the repayments of bank loans offset by cash generated from operating activities.

Financial assets: As at September 30, 2021, financial assets were at $189,743, a decrease of $4,212 or 2%, as compared to the prior period, mainly due to an increase of $17,063 due to mark-to-market adjustments offset by decrease of 16,652 due to net distributions in Knight’s fund investments, loan repayments of $2,494 and disposal of equity investments of $2,624 during the period. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets. During the quarter ended September 30, 2021, the Company recorded an unrealized loss of $20,629, as a result of the share price decrease of Singular Genomics Systems, Inc. ("SGS"), an investment held within Domain Associated LLC. Should the share price of SGS remain at this level, the Company would record a life to date unrealized gain of approximately $12,929 [USD 10,550] on this investment.

Bank Loans: As at September 30, 2021, bank loans were at $36,328, a decrease of $15,442 or 30% as compared to the prior period, mainly due to loan repayment of $14,911.

Product Updates

On September 22, 2021, Knight entered into a definitive agreement with Incyte Biosciences International Sàrl, for the exclusive rights to distribute tafasitamab (sold as Monjuvi in the United States and Minjuvi in Europe) and pemigatinib (Pemazyre) in Latin America. Under the terms of the agreement Knight will be responsible for seeking the necessary regulatory approvals and distributing both products in Latin America.

Knight expects to submit tafasitamab and pemigatinib in key LATAM countries in the second half of 2022.

NCIB

During the three-month and nine-month periods ended September 30, 2021, the Company purchased 2,963,022 and 7,844,438 common shares for $15,361 and $40,907, respectively.

Subsequent to quarter-end, the Company purchased an additional 1,009,725 common shares for an aggregate cash consideration of $5,258.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its third quarter results today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.