On August 12, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the second quarter ended June 30, 2021 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, AUG 12, 2021, View Source [SID1234586381]).

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"We have had an extremely productive second quarter, marked by significant clinical and regulatory advances that were outlined in our mid-year review in June. The data presented continue to support our candidates’ potential for best-in-class positioning – both as monotherapies and in combinations – for an array of difficult-to-treat cancers," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Of note, our lead candidate, ZN-c3, demonstrated additional deepening and durable tumor responses, and based on this maturing data presented in June, we have identified potential accelerated approval paths for this candidate in USC and a biomarker-driven setting, with the Phase 2 trial in USC already underway."

Continued Dr. Sun, "Furthermore, this momentous period for Zentalis was reinforced by the completion of a recent upsized public offering in which we raised approximately $173 million in gross proceeds. This financing ensures we are well-positioned to fund all upcoming key milestones, with the goal of delivering differentiated cancer treatments to patients globally."

Program Highlights:

In June 2021, Zentalis hosted a mid-year update webcast, providing key clinical and regulatory updates across its pipeline. Clinical highlights from the update included: five confirmed Partial Responses (PRs) and one unconfirmed PR in the Phase 1 monotherapy trial of ZN-c3 in a range of heavily pre-treated solid tumors; plans for two potentially registrational trials for ZN-c3 in USC and a biomarker-driven setting; an oral dose of 50 mg QD demonstrating a Clinical Benefit Rate of 40% in the Phase 1 monotherapy trial of ZN-c5 in ER+/HER2- breast cancer. For more information on the clinical results reported, click here.

In July 2021, the Company dosed the first patient in a Phase 2 trial of ZN-c3 in women with recurrent or persistent USC. Following an end-of-Phase 1 meeting, the U.S. Food and Drug Administration (FDA) agreed in principle that ZN-c3 has the potential for an accelerated approval pathway based on the Phase 2 global study design in USC.

In June 2021, the Company received orphan drug and rare pediatric disease designations from the FDA for ZN-c3 in combination with chemotherapy for the treatment of osteosarcoma. Zentalis expects to initiate a Phase 1/2 trial in 3Q 2021.

In April 2021, Zentalis reported initial results from the Phase 1 portion of a Phase 1/2 trial of ZN-c3 in advanced solid tumors in a late-breaking session at the AACR (Free AACR Whitepaper) Annual Meeting, which was further discussed at a webcast event with Key Opinion Leaders.

In April 2021, Zentalis entered into a Clinical Trial Collaboration and Supply Agreement with GSK to investigate the combination of ZN-c3 and niraparib, GSK’s poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer. The Company expects to initiate a Phase 1b trial with this combination in the second half of 2021.
Zentera Highlights:

In July 2021, Zentera, a Shanghai-based clinical-stage biopharmaceutical company formed by Zentalis, announced the completion of a $75 million Series B financing. The proceeds will be used to advance the clinical development of three Zentalis-discovered candidates, ZN-c3, ZN-c5 and ZN-d5, in China, in addition to business development opportunities for pipeline expansion.

As of July 2021, Zentera had received CTA acceptances in China for ZN-c3, ZN-c3 in combination, ZN-c5 and ZN-d5. Two clinical trials are ongoing with plans to initiate one more trial by year-end 2021.
Corporate Highlights:

In July 2021, Zentalis closed an underwritten public offering of 3,565,000 shares of its common stock at a public offering price of $48.50 per share. The total gross proceeds were approximately $172.9 million, before deducting underwriting discounts and commissions and offering expenses payable by Zentalis.
Second Quarter 2021 Financial Results

Cash and Marketable Securities Position: As of June 30, 2021, Zentalis had cash, cash equivalents and marketable securities of $250.9 million. We believe that our existing cash, cash equivalents and marketable securities as of June 30, 2021, together with the net proceeds from our July 2021 follow-on offering, will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2023.

Research and Development Expenses: Research and development expenses for the three months ended June 30, 2021 were $44.8 million, compared to $17.5 million for the three months ended June 30, 2020. The increase of $27.3 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials for ZN-c3 and ZN-c5. In addition, in the three months ended June 30, 2021, we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials.

General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2021 were $10.4 million, compared to $9.9 million during the three months ended June 30, 2020. This increase of $0.5 million was primarily attributable to an increase of $2.0 million in employee-related and supply costs, partially offset by a reduction in allocable overhead facility expenses.

Net Loss: Net loss was $55.1 million for three months ended June 30, 2021, compared to $27.3 million for the three months ended June 30, 2020. The $27.8 million increase in net loss was primarily the result of the increases in research and development and general and administrative expenses discussed above.

Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.

On August 12, 2021 Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported second quarter 2021 financial results and provided a business update (Press release, Checkmate Pharmaceuticals, AUG 12, 2021, View Source [SID1234586427]).

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"We remain excited about the prospects for vidutolimod in melanoma, based upon compelling clinical data to date, as well as our expansion into new tumor types. We are focused squarely on execution of our clinical trials to deliver upon these opportunities, and we anticipate multiple clinical data readouts in 2022," said Barry Labinger, President and Chief Executive Officer of Checkmate.

Second Quarter Business Update

Advancing patient recruitment activities and enrollment across our ongoing clinical trials evaluating vidutolimod, including:
A Phase 2 trial of vidutolimod in combination with nivolumab in anti-PD-1 refractory advanced melanoma, supported by a clinical collaboration with Bristol Myers Squibb.
A randomized Phase 2/3 trial of vidutolimod in combination with nivolumab vs. nivolumab monotherapy in first-line metastatic or unresectable melanoma, also supported by the clinical collaboration with Bristol Myers Squibb.
A Phase 2 trial of vidutolimod in combination with pembrolizumab in recurrent or metastatic squamous cell head and neck cancer. Interim data readouts anticipated beginning 1H 2022 and maturing throughout 2022.
Ongoing start-up activities for the planned expansion of the development program for vidutolimod into cutaneous squamous cell carcinoma and Merkel cell carcinoma, supported by a clinical collaboration with Regeneron to evaluate the combination of vidutolimod and Libtayo (cemiplimab).
Second Quarter 2021 Financial Results

Research and development expenses (R&D): R&D expenses for the three months ending June 30, 2021 were $14.9 million, compared to $6.5 million for the same period in the prior year. This increase reflected a milestone payment of $4.0 million in the second quarter of 2021 triggered by initiation of patient dosing in our refractory melanoma trial, as well as increases in personnel and operating expense for the planning and execution of additional clinical trials with vidutolimod.
General and administration expenses (G&A): G&A expenses for the three months ending June 30, 2021 were $4.1 million, compared to $1.8 million for the same period in the prior year. This increase was primarily attributable to increases in personnel and operating expense incurred in connection with Checkmate operating as a publicly traded company.
Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $95.6 million as of June 30, 2021.

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.