Veracyte Announces Second Quarter 2020 Financial Results

On July 30, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the second quarter ended June 30, 2020 and provided an update on recent business progress (Press release, Veracyte, JUL 30, 2020, View Source [SID1234562574]).

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"We delivered solid second quarter results in the face of headwinds from the COVID-19 pandemic," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Our genomic testing volume doubled between April and June as hospitals started performing more non-emergency procedures and physician practices began to open. We have begun leveraging opportunities for new virtual sales and marketing models to increase efficiency and drive growth. We also remain on track to bring four new tests to market in 2021, further accelerating our growth. Additionally, we continued to grow our biopharmaceutical and diagnostic partnerships to fuel our global expansion with a comprehensive test menu that extends our total addressable market beyond the $40 billion for our current and pipeline products."

Second Quarter 2020 Financial Results

For the second quarter of 2020:

Total revenue was $20.7 million, comprising $16.9 million in testing and product revenue and $3.8 million in biopharmaceutical partnership and collaboration revenue;

Gross Margin was 63%;

Operating Expenses, Excluding Cost of Revenue, were $24.1 million;

Net Loss and Comprehensive Loss was $11.0 million;

Basic and Diluted Net Loss Per Common Share was $0.22;

Net Cash Used in Operating Activities was $8.4 million; and

Cash and Cash Equivalents were $147.5 million at June 30, 2020.

For the six-month period ended June 30, 2020:

Total revenue was $51.8 million, comprising $47.3 million in testing and product revenue and $4.5 million in biopharmaceutical partnership and collaboration revenue;

Gross Margin was 62%;

Operating Expenses, Excluding Cost of Revenue, were $55.2 million;

Net Loss and Comprehensive Loss was $22.7 million;

Basic and Diluted Net Loss Per Common Share was $0.45; and

Net Cash Used in Operating Activities was $13.7 million.

Second Quarter 2020 and Recent Business Highlights

Core Diagnostics Business:

Increased our reported genomic testing volume (Afirma, Percepta and Envisia), with June total volume doubling that of April.

Expanded virtual customer engagement program, conducting more than two dozen virtual educational events, email campaigns and other digital outreach to clinicians.

Strengthened our library of published clinical evidence supporting use of the Afirma Xpression Atlas (Cancer Cytopathology) and the Envisia Genomic Classifier (CHEST and AJRCCM). The AJRCCM study further demonstrates the Envisia classifier’s ability to improve diagnosis of idiopathic pulmonary fibrosis without the need for surgery.

LymphMark – Submitted De Novo classification request to the FDA for the lymphoma subtyping test, which is designed to help inform diagnosis and better treatment decisions.
On track to launch four new products in 2021: Nasal swab test for early lung cancer detection; Percepta Atlas to inform treatment decisions in lung cancer; Envisia international launch on the nCounter; and LymphMark, if the FDA grants our De Novo classification request.
Signed distributor contracts that will make Veracyte’s advanced genomic testing on the nCounter system available to laboratories throughout the Asia Pacific region, as well as in Australia and New Zealand.

Strategic Collaborations:

CareDx – Formed strategic collaboration through which CareDx has the exclusive right to develop solid organ transplant rejection tests on the nCounter Analysis System, fueling our global menu expansion.

Generated revenue from four biopharmaceutical and diagnostics partners: Eli Lilly/Loxo Oncology, Johnson & Johnson Innovation, Acerta Pharma and CareDx.

MAVIDx – Signed strategic agreement, taking an equity stake in MAVIDx, for the new company to develop COVID-19 and other infectious disease tests for ultra-high throughput testing on the nCounter system. A Harvard University report estimates the market will require 20 million tests per day in the United States alone.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

BioNTech Publishes Data from mRNA-based BNT111 FixVac Melanoma Trial in Nature

On July 30, 2020 BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), reported the publication of interim Phase 1 data for the Company’s FixVac cancer vaccine program BNT111 in the journal Nature (Press release, BioNTech, JUL 30, 2020, View Source [SID1234562573]). The Lipo-MERIT trial is a multicenter, open-label, dose-escalation Phase 1 trial (NCT02410733) to evaluate safety and tolerability of vaccinated patients with stage IIIB-C and stage IV melanoma. The publication titled "An RNA vaccine drives immunity in checkpoint-inhibitor-treated melanoma" summarizes the findings of an exploratory interim analysis (data extraction date July 29, 2019). Safety assessment was performed in 89 advanced melanoma patients treated with intravenously delivered repeated doses of mRNA-based cancer vaccine BNT111 ranging from 7.2µg to 400µg. Overall, BNT111 treatment was well tolerated with no dose limiting toxicity. Most common adverse events were mild to moderate, transient flu-like symptoms, such as pyrexia and chills. Assessment of blood cytokines showed transient upregulation of cytokines such as Interferon-alpha (IFNa), Interferon-gamma (IFNγ) and Interleukin-12 (IL12) in line with a toll-like-receptor (TLR)-mediated antiviral immune modulation critical for expansion of Th1 type antigen-specific T cells.

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Efficacy was evaluated in a subset of 42 checkpoint-inhibitor (CPI)-experienced patients with radiologically evaluable melanoma assessed by imaging of metastatic lesions before and after vaccination. At the data extraction date, three patients out of 25 patients in the BNT111 monotherapy group experienced a partial response, seven patients showed stable disease and one patient showed a complete metabolic remission of metastatic lesions. Of the 17 patients treated with the combination of BNT111 with anti-PD-1, six patients developed a partial response. Treatment with BNT111 resulted in the expansion and activation of circulating tumor-antigen-specific T cells with memory-function that exhibited strong cytotoxic activity against tumor cells. Vaccine-induced T cells displayed a Th1 phenotype which is of importance for cell-mediated immune responses such as activation of antigen-specific cytotoxic T cells.

This interim data shows that BNT111 alone and in combination with PD-1 checkpoint blockade, while being well tolerated, mediates durable objective responses in melanoma patients that had progressed after prior checkpoint blockade. Vaccine-induced antigen-specific memory T cells persisted for more than one year under continuous monthly vaccination.

BNT111 is composed of four melanoma antigens (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE) and is the most advanced of five clinical-stage FixVac product candidates within BioNTech’s broader development pipeline. The FixVac platform is an off-the-shelf mRNA immunotherapy approach that targets a fixed combination of shared non-mutated tumor-associated antigens specific to each cancer type.

Further FixVac cancer vaccine candidates are currently investigated in Phase 1 clinical trials for prostate cancer (BNT112) (Clinicaltrials.gov Identifier NCT04382898), HPV16-positive cancers (BNT113) (Clinicaltrials.gov Identifier NCT03418480), triple negative breast cancer (BNT114) (Clinicaltrials.gov Identifier NCT02316457) and ovarian cancer (BNT115) (Clinicaltrials.gov Identifier NCT04163094).

About FixVac

BioNTech’s FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared within specific cancer types. They feature the Company’s proprietary RNA-lipoplex delivery formulation which is designed to enhance stability and translation of the mRNA cargo as well as specifically target dendritic cells to trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigen.

Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2020 Financial Results

On July 30, 2020 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the second quarter ended June 30, 2020 (Press release, Corvus Pharmaceuticals, JUL 30, 2020, View Source [SID1234562572]).

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"In the second quarter, we advanced each of our three clinical oncology programs, highlighted by the presentation of new data at ASCO (Free ASCO Whitepaper) on the identification of a refined biomarker that enriches for responding patients with renal cell cancer treated with our lead candidate, ciforadenant," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "Based on this data, we are planning to meet with the U.S. Food & Drug Administration (FDA) to discuss the initiation of a pivotal study of ciforadenant in renal cell cancer. For CPI-006 and CPI-818, we have largely completed enrollment in the current portions of their Phase 1/1b studies and expect to report updated results at medical meetings later this year."

"We also added a fourth program utilizing our novel immunomodulatory antibody CPI-006 for treatment of patients with mild-to-moderate COVID-19. Our unique approach is based on the ability of CPI-006 to activate B cells, leading to the production of anti-SARS-CoV-2 IgM and IgG antibodies and memory B cells, which has the potential to shorten recovery time and improve long-term protective immunity. The study is advancing on track with the first cohort of five patients fully enrolled and four of five patients now enrolled in the second cohort. We expect to report anti-SARS-CoV-2 antibody and memory B cell results from our study later this year."

Recent Achievements

Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

Presented updated data from the Phase 1b/2 clinical trial of ciforadenant in patients with refractory renal cell carcinoma (RCC) at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. The data covered 51 patients and showed an objective response rate (ORR) of 17% by RECIST criteria in Adenosine Gene Signature positive patients (n=31) and 0% ORR in the Adenosine Gene Signature negative group (n=20). The ORR improved to 27% with a refined version of the test, which is based on the measurement of CD68 positive myeloid cells, the downstream target of adenosine.
CPI-006: Anti-CD73 Antibody with Immunomodulatory Activity

Initiated an open-label, Phase 1 study of CPI-006 in COVID-19 patients with mild to moderate symptoms. Patients will receive a single dose of CPI-006, with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg, escalating in four cohorts as the study progresses. Patients will receive medications, therapies, and interventions per standard treatment protocols for COVID-19 for the duration of the study. The primary efficacy endpoint is the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28. The study will also examine safety and effects on anti-viral memory B cells and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization.

COVID-19 Study Update: Since the announcement of the study and enrollment of the first cohort of five patients in early July, four of five patients in the second cohort have been enrolled in the study. As of the cutoff date of July 30, 2020, no dose limiting toxicities had been noted and early anti-SARS-CoV-2 antibody response data was encouraging with relatively high titers of IgG and IgM to both spike and receptor binding domain (RBD) viral proteins observed. In the first two patients receiving the lowest dose of CPI-006 and tested at an early Day 7 time point, IgG titers to spike protein were > 1:25,000 and > 1:50,000. One of these patients has also completed Day 14 testing, which showed the titers to viral spike protein and RBD had increased to > 1:100,000. Significant levels of IgM antibodies were also detected. The Company remains on track to report 28-day follow up results from the Phase 1 study later this year.

Completed enrollment in three dose escalation arms of the CPI-006 Phase 1/1b cancer clinical trial: monotherapy, combination with ciforadenant and combination with pembrolizumab and we continue to enroll the triplet combination dose escalation arm with ciforadenant and pembrolizumab. Updated clinical data from the Phase 1/1b oncology clinical trial is targeted to be presented later this year.
CPI-818: A small molecule ITK inhibitor

Completed enrollment in the dose escalation portion (N=16) of the CPI-818 Phase 1/1b clinical trial, which included patients with several types of advanced, refractory T-cell lymphomas. Based on results from this portion of the study, including a confirmed complete response in one patient with peripheral T-cell lymphoma (PTCL) who previously failed chemotherapy and high dose chemotherapy with autologous bone marrow transplantation, the Company selected the CPI-818 optimum dose and began the next portion of the study with a focus on patients with PTCL and cutaneous T-cell lymphoma (CTCL).
Anticipated Future Events

Data from the Phase 1 trial of CPI-006 used to treat COVID-19 patients later this year.

The Company plans to meet with the FDA to discuss the study design and plans for a ciforadenant pivotal study in advanced refractory RCC using the Adenosine Gene Signature as a biomarker.

Updated clinical data from the CPI-006 Phase 1/1b oncology clinical trial is planned to be presented later this year.

Updated clinical data from the CPI-818 Phase 1/1b clinical trial is planned to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020.
Financial Results
At June 30, 2020, Corvus had cash, cash equivalents and marketable securities totaling $59.3 million, as compared to cash, cash equivalents and marketable securities of $78.0 million at December 31, 2019. Corvus expects net cash used in operating activities for the second half of 2020 to be between $12 million and $14 million resulting in a cash balance of between $47 million and $45 million at December 31, 2020.

Research and development expenses for the three months ended June 30, 2020 totaled $7.9 million compared to $10.6 million for the same period in 2019. The decrease of $2.7 million was primarily due to a $0.5 million decrease in ciforadenant clinical trial expenses, a $1.7 million decrease in CPI-006 drug manufacturing costs, a $0.5 million decrease in CPI-818 drug manufacturing costs and a $0.8 million decrease in outside service costs, partially offset by a $1.1 million increase in CPI-006 clinical trial expenses.

The net loss for the three months ended June 30, 2020 was $10.6 million, compared to a net loss of $13.0 million for the same period in 2019. Total stock compensation expense for the three months ended June 30, 2020 was $1.4 million compared to $1.9 million of total stock compensation expense for the same period in 2019.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, July 30, 2020, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2020 financial results. The conference call can be accessed by dialing 1-855-327-6837 (toll-free domestic) or 1-631-891-4304 (international) and using the conference ID 10010533. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

Lantern Pharma Reports Second Quarter 2020 Financial Results and Continued Corporate Progress

On July 30, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biotechnology company using its proprietary RADR artificial intelligence ("A.I.") platform to improve drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, reported its financial results for the second quarter ended June 30, 2020, and provided an update on its R&D pipeline and other corporate developments (Press release, Lantern Pharma, JUL 30, 2020, View Source [SID1234562571]).

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"Lantern Pharma achieved important scientific and operational milestones during the quarter that have us well positioned for growth as we focus on being the leader in A.I.-enabled oncology drug development," said Panna Sharma, CEO and President of Lantern Pharma. "Our proprietary RADR platform recently surpassed 500 million data points, further accelerating our path to one billion curated oncology data points in the next few quarters. We have also advanced our manufacturing capabilities and network for our upcoming clinical trials for LP-300 in non-small cell lung cancer among never smokers, and for LP-184 in genomically defined solid tumors and glioblastoma. On June 15, we completed a successful IPO, raising gross proceeds of $26.3 million, significantly strengthening the Company’s balance sheet and provides additional resources to support the continued development of our promising and growing pipeline of targeted cancer therapies. Our approach and vision is to bring cancer therapies to market faster and with reduced cost and risk and ultimately improve patient outcomes. We are entering what I believe is the Golden Age of A.I. where industries will continue to be rapidly transformed and massive advancements made that can benefit medicine, health and those willing to invest in and develop these disruptive opportunities."

Corporate and Scientific Highlights

●Closed initial public offering – In June 2020, Lantern Pharma closed its initial public offering of 1,750,000 shares of its common stock at a public offering price of $15.00 per share, for gross proceeds of $26,250,000, before deducting underwriting discounts, commissions and offering expenses.

●Initiated multiple preclinical studies for LP-184 in genomically defined solid tumors and Glioblastoma (GBM) – The studies aim to further validate the genomic signature of LP-184 and help to inform IND development efforts. The data generated in these studies will also support the continued expansion of our RADR (Response Algorithm for Drug Positioning and Rescue) A.I. platform.

●RADR surpasses 500 million data points – Lantern Pharma is ahead of its initial platform development schedule of reaching 400 million data points by the end of 2020. The Company is now on track to reach over 1 billion data points within the next several quarters.

●Presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) – Two presentations that detailed Lantern Pharma’s use of its RADR A.I. platform in the development of LP-184, a molecule with nanomolar potency and strong activity in cancers with KEAP1 and KRAS mutations. LP-184 is one of three cancer drug candidates in Lantern Pharma’s pipeline.

●Advanced manufacturing capabilities and network to support LP-300 and LP-184 trials – the Company established a manufacturing network in preparation for its Phase 2 clinical trial of LP-300 in non-small cell lung cancer among never smokers and for LP-184 in preclinical development for genomically defined solid tumors that overexpress certain RNA as well as for glioblastoma multiforme.

●Continue to advance our collaborations with leading academic and cancer research centers – for the purposes of examining additional potential cancer indications for our drugs, improving and validating the existing genomic signatures that correspond to patient response, establishing sites, and recruiting potential investigators for upcoming clinical trials.

Q2 2020 Financial Highlights

Cash Position: Cash and cash equivalents were $23.8 million as of June 30, 2020, compared to $1.2 million as of December 31, 2019. The increase was primarily due to proceeds from the IPO in June 2020.

R&D Expenses: Research and development expenses were $157,023 for the quarter ended June 30, 2020, compared to $361,273 for the quarter ended June 30, 2019. The decrease was primarily attributable to reductions in product candidate manufacturing related expenses reflecting completion of process development and scale-up studies conducted in the prior year period.

G&A Expenses: General and administrative expenses were $676,399 for the quarter ended June 30, 2020, compared to $268,120 for the quarter ended June 30, 2019. This increase was primarily due to an increase in expenses associated with transitioning to and becoming a public company.

Net Loss: Net loss was $833,422 for the quarter ended June 30, 2020, compared to a net loss of $629,393 for the quarter ended June 30, 2019.

Sharma continued, "Developing drugs by leveraging artificial intelligence is central to transforming the cost and efficiency of the pharma industry and improving the personalization of therapies for cancer patients. By identifying clinical candidates, together with relevant genomic, clinical and phenotypic data, we believe our approach will help us design more efficient pre-clinical studies and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. RADR is central to our process in achieving this outcome rapidly and with reduced costs. We currently have three compounds in development, one in a Phase 2 trial in prostate cancer with our partner, Oncology Venture, one that is preparing to enter into a Phase 2 trial, and one in preclinical development,"

"We believe we have developed a sustainable and scalable biopharma business model by combining a unique, oncology-focused big-data platform that leverages artificial intelligence and machine learning with active clinical and preclinical programs that are being advanced in targeted cancer therapeutic areas with significant clinical needs," concluded Sharma.

Conference Call:

Lantern Pharma will host a conference call and webcast today at 8:00 a.m. ET.

Conference Call & Webcast Details

●Toll-free Domestic & Canada: 800.791.4813 – conference ID 10552

●International: 785-424-1102 – conference ID 10552

●US and Canada callers one touch dial: +1.800.791.4813,,10552#

The webcast will be available in the "Investors" section of the company website at View Source under the News & Events page.

Replay Details

A replay of the conference call will be available for replay until 11:59 pm ET August 30, 2020.

Replay Number: 1-888-567-0053, no passcode will be needed.

A live audio-only webcast and related presentation materials will also be accessible on the Lantern Pharma corporate website: View Source. Web participants are encouraged to register 15 minutes prior to the start of the call. The webcast will be archived on the Lantern Pharma website for 6 months.

Dynavax to Report Second Quarter 2020 Financial Results and Host Conference Call on August 6, 2020

On July 30, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that it will report second quarter 2020 financial results on Thursday, August 6, 2020, after the U.S. financial markets close (Press release, Dynavax Technologies, JUL 30, 2020, View Source [SID1234562570]).

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Dynavax will host a conference call and live audio webcast on Thursday, August 6, 2020 at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial (866) 420-4066 (domestic) or (409) 217-8237 (international) and refer to conference ID 8187870. A replay of the webcast will be available for 30 days following the live event.