On August 12, 2021 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, reported its financial results for the quarter ended June 30, 2021 (Press release, HTG Molecular Diagnostics, AUG 12, 2021, View Source [SID1234586443]).

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Recent Business Highlights

Total revenue increased by approximately 45% from the first quarter to the second quarter of 2021.
Commercially launched the HTG Transcriptome Panel for sale in the U.S. and Europe in kit form or as a service in HTG’s VERI/O laboratory. The HTG Transcriptome Panel, designed to measure approximately 20,000 mRNA targets using the HTG EdgeSeq technology, is currently available for use with the Illumina sequencing platforms. Through its work with Early Adopter Program collaborators in the first half of 2021, the company received its first revenue-generating commercial orders for the HTG Transcriptome Panel in the second quarter of 2021.
Announced the release of HTG EdgeSeq Reveal version 4.0.0, adding additional features and software functionalities to support, among other things, data analysis for the HTG Transcriptome Panel.
Formed a new drug discovery business unit, HTG Therapeutics, in July 2021. This business unit is expected to leverage the company’s existing capabilities and expand upon the utility of the HTG EdgeSeq platform technology in the discovery of early-stage drug candidates. By leveraging these profiling technologies earlier in the drug discovery process, HTG Therapeutics is expected to generate lead compounds faster, and with superior efficacy and toxicity profiles.
"We believe our sequential growth this quarter over the first quarter of 2021 indicates our core business is recovering. Increased sample processing activity in our VERI/O laboratory and consumable product orders from existing and new customers were the driving factors in the growth of our product and product-related services revenue. I commend our commercial team, whose commitment with existing and new customers has never wavered despite the challenges we faced since 2020," said John Lubniewski, President and CEO of HTG. "The focus of our research and development teams on development milestones and opportunities to improve upon our existing technology and expand into other RNA-related applications has resulted in significant progress this quarter. We again successfully completed our development milestones in the second quarter, which enabled us to commercially launch our HTG Transcriptome Panel on August 5th. In addition, our vision to further advance precision medicine into drug discovery is quickly coming into place, and we are excited to be building an even stronger technology platform foundation with which we can continue to grow."

Second Quarter 2021 Financial Highlights:

Total revenue for the quarter ended June 30, 2021 was $2.1 million, compared with $2.0 million for the same period in 2020.

Product and product-related services revenue for the quarter ended June 30, 2021 was $2.1 million, compared with $1.7 million for the same period in 2020 and $1.4 million for the first quarter ended March 31, 2021. This increase is due primarily to RUO sample processing services and the sale of RUO consumables products for which demand has begun to recover to pre-COVID-19 levels as customers have resumed development activities. Revenue for the quarter ended June 30, 2020 included $0.2 million of collaborative development services revenue for which the remaining contracted development tasks on our existing programs have been completed.

Net loss from operations for the quarter ended June 30, 2021 was $4.1 million, compared with $5.0 million for the same period in 2020. Net loss per share was $(0.39) for the quarter ended June 30, 2021 compared with $(1.30) for the second quarter of 2020.

Cash, cash equivalents and short-term available-for-sale securities totaled $29.8 million as of June 30, 2021, with current liabilities of approximately $7.1 million and non-current liabilities of $11.7 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

On August 12, 2021 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported that the United States Food and Drug Administration ("FDA") has recently granted Breakthrough Therapy Designation ("BTD") for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") (Press release, Coherus Biosciences, AUG 12, 2021, View Source [SID1234586462]). The FDA had earlier granted BTD for toripalimab monotherapy for patients with recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

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BTD is intended to expedite the development and regulatory review of drugs where preliminary clinical evidence demonstrates substantial improvement over existing therapies for a severe or life-threating disease. Drugs with BTD will be granted closer FDA guidance – including that from senior FDA officials – and various forms of support to avail patients with new therapy as soon as possible.

Junshi Biosciences expects to complete the biologics license application ("BLA") submission for toripalimab plus chemotherapy for 1st line NPC and for toripalimab monotherapy for 2nd or 3rd line NPC later this quarter.

"We are pleased to have received Breakthrough Therapy designation for our novel PD-1 blocking antibody, toripalimab, for nasopharyngeal carcinoma, which is an aggressive cancer with no immuno-oncology treatment options approved in the United States," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We look forward to working closely with the FDA during the BLA review process and with our partner, Coherus, to bring toripalimab to NPC patients in the U.S., if approved."

The Breakthrough Therapy designation is supported by data from the Phase 3 clinical trial "JUPITER-02" evaluating toripalimab in combination with chemotherapy for the first-line treatment of NPC. In this study, toripalimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression free survival ("PFS") compared to chemotherapy alone (assessed by a blinded independent review committee ("BIRC") per RECIST v1.1). JUPITER-02 also met secondary endpoints of PFS assessed by the investigator and objective response rate assessed by BIRC. There was also a longer duration of response, a higher disease control rate, and higher one- and two-year survival rates for the toripalimab arm. The safety profile of toripalimab is consistent with that observed in previously reported toripalimab clinical trials and the safety profile of this class of drugs. The result of JUPITER-02 was recently presented at the ASCO (Free ASCO Whitepaper) plenary session (#LBA2) and full results can be found in the August 2021 on-line edition of Nature Medicine.

About toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

On August 12, 2021 bioAffinity Technologies, a privately held company focused on early diagnostics and cancer therapeutics, announced publication in the peer-reviewed Journal of Visualized Experiments (JoVE) (Press release, BioAffinity Technologies, AUG 12, 2021, View Source [SID1234586478]). The paper, entitled Quality-Controlled Sputum Analysis by Flow Cytometry, presents an efficient and effective method to analyze sputum on a flow cytometric platform, allowing for development of high-throughput diagnostic tests for lung cancer and other lung diseases.

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"Sputum provides a superior sample in which to analyze cellular content and other microenvironmental features. Analysis of sputum by the method we describe opens a new and exciting window of opportunity for determining the health of an individual’s lungs," bioAffinity President and CEO Maria Zannes said. "The processing method provided in JoVE describes an innovative and highly efficient method to process sputum for use with flow cytometry, an approach that can rapidly analyze a sample for the presence of diseases such as COPD, asthma and lung cancer."

bioAffinity Technologies has developed CyPath, a platform technology to diagnose cancer. The Company’s first product is CyPath Lung, a non-invasive and cost-effective test for the early detection of lung cancer that allows patients to collect their sputum sample at home.

bioAffinity Technologies recently completed a test validation trial of CyPath Lung evaluating sputum from people at high risk for lung cancer, including patients with the disease and others who were cancer-free. The trial resulted in 92% sensitivity and 87% specificity in the group of patients who had no or smaller than 2 cm nodules in the lung.

CyPath Lung uses flow cytometry, a method able to interrogate an individual cell in a fraction of seconds, and automated analysis to identify parameters indicative of cancer. Unlike genomic or other molecular markers used in many liquid biopsies, bioAffinity’s CyPath technology does not collect genetic material for evaluation. CyPath uses flow cytometry to investigate the lung micro-environment by identifying cell populations including those preferentially labeled by the porphyrin TCPP that are indices of cancer.

On August 12, 2021 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and second quarter financial results (Press release, Kronos Bio, AUG 12, 2021, View Source [SID1234586517]).

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"At our virtual R&D Day in May, we outlined our vision for expanding and driving progress in our pipeline of clinical programs that target dysregulated transcription factors and the regulatory networks within cancerous cells. This included unveiling the development strategy for our SYK inhibitor portfolio, which comprises entospletinib (ENTO) and LANRA. These differentiated clinical-stage investigational development candidates have the potential to address the mutations that are present in more than two-thirds of patients with AML," said Norbert Bischofberger, Ph.D., president and CEO. "We are poised to initiate our registrational Phase 3 trial later this year to support potential accelerated approval of ENTO in patients newly diagnosed with NPM1-mutated AML. With the recent FDA clearance of our IND for LANRA in relapsed or refractory FLT-3 mutant AML, we plan to launch our second SYK inhibitor clinical trial in the fourth quarter of 2021, when we also expect to report initial Phase 1 data from our trial of KB-0742, our potent oral, highly selective cyclin dependent kinase 9 inhibitor. I am proud of our Company’s momentum and anticipate multiple important inflection points in the coming months."

Recent Company Highlights

Received clearance from U.S. Food and Drug Administration (FDA) for the IND application of LANRA, a next-generation spleen tyrosine kinase (SYK) inhibitor. The first of two planned Phase 1/2 clinical trials is expected to initiate in Q4 2021 in patients with relapsed or refractor FLT3-mutated AML and will include a dose-escalation and an expansion cohort study design. The first stage will evaluate initial safety, pharmacokinetic (PK) and anti-leukemic activity of escalating once-daily doses of LANRA in combination with gilteritinib. Initial data from this first stage of the trial are anticipated to be available in the second half of 2022.
On track to initiate the Phase 3 trial of ENTO in the second half of 2021 with a pivotal data readout expected in the second half of 2023.
This trial will assess measurable residual disease (MRD) negative complete response (CR) as the primary endpoint to support potential accelerated approval in patients newly diagnosed with NPM1-mutated AML.
Anticipates reporting initial safety, PK and pharmacodynamic (PD) data from Phase 1 trial of KB-0742, a highly selective, orally bioavailable cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors, in the fourth quarter of 2021. The company presented preclinical data for KB-0742 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021, which showed CDK9 inhibition on an intermittent dosing schedule with KB-0742 resulted in sustained inhibition of tumor growth in multiple types of solid tumors. The findings suggest that genomic amplification of MYC, a well-characterized transcription factor and a long-recognized driver of cancer, is a key factor of sensitivity to CDK9 inhibition.
Hosted a virtual R&D Day in May 2021 to discuss the company’s development strategy for the SYK inhibitors ENTO and LANRA, expectations for the upcoming Phase 1 data readout for KB-0742 and potential populations for expansion cohorts of a Phase 1/2 trial, along with an overview of the company’s differentiated drug discovery platform and future pipeline programs.
Second Quarter Financial Highlights

Cash, Cash Equivalents and Investments: As of June 30, 2021, cash, cash equivalents and investments totaled $419.3 million.

R&D Expenses: Research and development expenses were $19.8 million for the second quarter of 2021, which includes non-cash stock-based compensation expense of $3.4 million.

G&A Expenses: General and administrative expenses were $9.3 million for the second quarter of 2021, which includes non-cash stock-based compensation expense of $3.0 million.

Net Loss: Net loss for the second quarter of 2021 was $29.1 million, or $0.53 per share, including non-cash stock-based compensation expense of $6.4 million.

On August 12, 2021 Scandion Oncology A/S reported that it will publish its Half-year report on Thursday, 19 August 2021 before 09:00 CET (Press release, Scandion Oncology, AUG 12, 2021, View Source,c3395664 [SID1234586412]).

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Scandion Oncology’s executive management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

The information was provided by the contact person above for publication on 12 August 2021.