Veracyte Announces Fourth Quarter and Full-Year 2020 Financial Results

On February 17, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent business progress (Press release, Veracyte, FEB 17, 2021, View Source [SID1234575188]).

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"Our revenue and genomic testing and product volume continued to rebound from the pandemic during the fourth quarter and we entered 2021 with strong momentum across our business," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We are on track to launch multiple new products this year, including our noninvasive nasal swab test and Percepta Genomic Atlas in lung cancer.

"Additionally, we expect our pending acquisition of Decipher Biosciences, with its market-leading products in urologic cancers, will significantly accelerate our revenue growth by expanding our reach into seven of the ten most common cancers, further solidifying our global leadership in cancer genomic diagnostics. We look forward to welcoming Decipher’s employees when the transaction closes and to strengthening our executive leadership team with the addition of Dr. Tina Nova, Decipher’s president and CEO."

Fourth Quarter 2020 Financial Results

For the three months ended December 31, 2020, compared to the prior year:

Total Revenue was $34.5 million, an increase of 16%;
Gross Margin was 68%, an increase of 2 percentage points;
Operating Expenses, Excluding Cost of Revenue, were $31.4 million, an increase of 13%;
Net Loss and Comprehensive Loss was $8.0 million, compared to $7.5 million;
Basic and Diluted Net Loss Per Common Share was $0.14, versus $0.15;
Net Cash Provided by Operating Activities was $2.3 million, compared to $1.8 million; and
Cash and Cash Equivalents were $349.4 million at December 31, 2020.
For the year ended December 31, 2020, compared to the prior year:

Total Revenue was $117.5 million, a decrease of 2%;
Gross Margin was 65%, a decrease of 5 percentage points;
Operating Expenses, Excluding Cost of Revenue, were $111.4 million, an increase of 13%;
Net Loss and Comprehensive Loss was $34.9 million, compared to $12.6 million;
Basic and Diluted Net Loss Per Common Share was $0.66, versus $0.27; and
Net Cash Used in Operating Activities was $9.7 million, compared to $3.2 million.
2020 Full-Year and Recent Business Highlights

Commercial Growth

Grew revenue to $34.5 million in the fourth quarter, an increase of 16% compared to the same period in 2019.
Product revenue grew to $9.8 million for 2020, exceeding our expectations.
Achieved genomic testing and product volume of 13,130 tests in the fourth quarter, a 14% increase compared to the fourth quarter of 2019.
Received new Medicare reimbursement rate of $5,500 for the Envisia Genomic Classifier, which went into effect on October 1, 2020, following the test’s designation by the Centers for Medicare & Medicaid Services as an Advanced Diagnostic Laboratory Test (ADLT).
Received reimbursement approval from the German government for the Prosigna Breast Cancer Gene Signature Assay, making the test accessible for all breast cancer patients in Germany with HR+/HER2- early-stage breast cancer.
Evidence Development

Published ten studies in leading peer-reviewed journals supporting our genomic tests in four disease areas (lung cancer, breast cancer, thyroid cancer and interstitial lung diseases, including idiopathic pulmonary fibrosis).
Launched the PROCURE study, led by an independent scientific committee of breast cancer experts and including input from 180 clinicians throughout Europe, to help achieve consensus on the evidence supporting the most frequently used breast cancer genomic tests, including Prosigna.
Pipeline Advancement/Collaborations

Unveiled new preliminary performance data at an R&D Day event for our noninvasive nasal swab test for early lung cancer detection and our Percepta Genomic Atlas for informing treatment decisions at the time of lung cancer diagnosis.
Expanded our strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson to include a focus on the NOBLE trial. The 9,000-patient, prospective, multicenter clinical study is designed to distinguish genomic and other differences in lung cancer development, which may fuel Veracyte’s development of future tests.
Decipher Acquisition

Announced we have entered into an agreement to acquire Decipher Biosciences, a commercial-stage precision oncology company focused on urologic cancers, further solidifying Veracyte’s global leadership in the genomic cancer diagnostics market while accelerating revenue growth.
Under terms of the acquisition agreement and following Veracyte’s exercise of an option to substitute cash for the entire stock portion of the consideration, the company will pay Decipher security holders $600 million in cash, subject to customary purchase price adjustments.
The acquisition is expected to close on or before April 1, 2021, subject to regulatory approval and the satisfaction of other customary conditions.
Financing

Issued and sold 8,547,297 shares of common stock, including 1,114,864 shares sold upon full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $74.00 per share. The net proceeds to Veracyte from the offering were approximately $593.8 million.
Veracyte intends to use a portion of the net proceeds from the offering, together with its existing cash and cash equivalents, to finance its acquisition of Decipher and intends to use the remaining net proceeds of the offering for working capital and other general corporate purposes, including to acquire or invest in complementary businesses, technologies or other assets.
2021 Outlook

Pending the completion of the acquisition of Decipher Biosciences, which is assumed to occur by April 1, 2021, Veracyte expects total combined revenue in 2021 to be approximately $190 million to $200 million, representing growth of approximately 65% over 2020 at the midpoint of the range.

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

Molecular Templates, Inc. Announces Proposed Public Offering of Common Stock

On February 17, 2021 Molecular Templates, Inc. (Nasdaq: MTEM) (the "Company" or "Molecular"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer and other serious diseases, reported that it has commenced an underwritten public offering of its common stock (Press release, Molecular Templates, FEB 17, 2021, View Source [SID1234575187]). Molecular also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering on the same terms and conditions. All of the shares in the offering are to be sold by Molecular.

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Molecular intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund: its Phase II clinical studies for MT-3724 and/or development of other CD20-targeted molecules; its ongoing Phase I clinical study of MT-5111; its share of development expenses in its CD38 collaboration with Takeda; its PD-L1 program (including its anticipated upcoming Phase I clinical study for MT-6402); further preclinical development and drug discovery activities in its other programs; and for working capital and general corporate purposes. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

BofA Securities, Cowen, Evercore ISI and Barclays are acting as joint book-running managers for the offering.

The securities are being offered by Molecular pursuant to a shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A preliminary prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained from BofA Securities, Inc., c/o BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or via e-mail at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or via telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, via telephone at (888) 474-0200, or via e-mail at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at (888) 603-5847, or via e-mail at [email protected][email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Nkarta Announces February and March 2021 Investor Conference Schedule

On February 17, 2021 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported its participation at these upcoming investor conferences (Press release, Nkarta, FEB 17, 2021, View Source [SID1234575186]):

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SVB Leerink 10TH Annual Global Healthcare Conference
February 26, 2021
Fireside chat presentation: 1:40 p.m. ET

Cowen 41ST Annual Health Care Conference
March 3-4, 2021
No presentation

Barclays Global Healthcare Conference
March 11, 2021
Fireside chat presentation: 10:20 a.m. ET

Live audio webcasts of the presentations will be available on the Investors section of Nkarta’s website, www.nkartatx.com. Replays of the webcasts will be archived on the website for approximately four weeks.

Ultragenyx to Present at Upcoming Investor Conferences

On February 17, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, FEB 17, 2021, View Source [SID1234575185]):

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SVB Leerink 10th Annual Global Healthcare Conference on Wednesday, February 24, 2021 at 2:20 PM ET.

Cowen 41st Annual Health Care Conference on Monday, March 1, 2021 at 2:00 PM ET.
The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

Salarius Completes Dose-Escalation Stage of Phase 1/2 Clinical Trial in Relapsed and Refractory Ewing Sarcoma Patients, Initiates Expansion Stage in Ewing and Ewing-related Sarcoma Patients

On February 17, 2021 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for patients with pediatric cancers, solid tumors, and other cancers, reported that it has completed the dose-escalation stage and established the recommended Phase 2 dose (RP2D) for its ongoing Phase 1/2 clinical trial in relapsed/refractory (R/R) Ewing sarcoma (Press release, Salarius Pharmaceuticals, FEB 17, 2021, View Source [SID1234575184]).

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The Phase 1/2 clinical trial of seclidemstat in patients with Ewing sarcoma was designed as an open-label, multi-center, dose-finding study. The primary objectives of the study were to determine the safety and tolerability of seclidemstat. Secondary objectives were to assess the maximum-tolerated dose (MTD), the RP2D, preliminary anti-tumor activity, pharmacokinetics (PK), and pharmacodynamics.

Data from patients treated in the dose-escalation portion of the trial demonstrated seclidemstat had a manageable safety profile. The RP2D for the expansion stage has been established and, importantly, PK data from the dose-escalation portion of the trial indicated that treatment at the RP2D achieved plasma concentrations above levels where seclidemstat demonstrated activity in preclinical studies. Salarius is preparing to submit the full findings from the dose-escalation trial, including details on safety, dosing, and initial efficacy signals, for presentation at an upcoming medical conference. Conference embargo rules prevent additional disclosures at this time.

"The completion of dose escalation in Ewing sarcoma patients and establishment of the RP2D represent important milestones in our clinical development of seclidemstat," stated David Arthur, President and CEO of Salarius Pharmaceuticals. "We are encouraged by data from the dose-escalation phase and look forward to continuing development of seclidemstat for difficult to treat cancers."

Salarius is evaluating its lead drug candidate, seclidemstat, in patients with R/R Ewing sarcoma, a rare and deadly pediatric bone and soft tissue cancer and in a Phase 1/2 trial enrolling patients with Advanced Solid Tumors (AST). Seclidemstat is a novel, oral reversible inhibitor of the lysine-specific histone demethylase 1 enzyme (LSD1), an enzyme that has been shown to play a key role in the development and progression of certain cancers.

As previously reported, a refractory Ewing sarcoma patient treated with single-agent seclidemstat for six cycles (a cycle is 28 days), demonstrated a reduction in prospectively defined target lesions starting at end of cycle 2 with further target lesion tumor shrinkage through end of cycle 4 and cycle 6 (over 75% tumor shrinkage). The appearance of new non-target lesion at the end of cycle 2 resulted in classification of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Salarius believes this data demonstrates preliminary drug activity in a patient with refractory Ewing sarcoma. Additional data from the dose-escalation portion of the Ewing sarcoma trial has demonstrated further evidence of drug activity, which Salarius hopes to expand upon during the upcoming dose-expansion portion of the trial by treating R/R Ewing sarcoma patients with seclidemstat.

In addition to treating R/R Ewing sarcoma patients, the expansion portion of the Phase 1/2 trial will enroll patients with additional select sarcomas that share a similar biology to Ewing sarcoma. Fusions of similar oncogenes to those that are translocated in Ewing sarcoma occur in tumors, such as myxoid liposarcoma, desmoplastic small round cell tumors, and others known as Ewing-related sarcomas or FET-translocated sarcomas. The decision to include Ewing-related sarcoma patients was supported by preclinical data and encouraging clinical data in Salarius’ AST trial. Of the small subset of Ewing-related sarcoma patients with progressive disease that enrolled in the AST trial, all patients demonstrated preliminary evidence of seclidemstat drug activity at levels below the RP2D. Encouragingly, in this subset of seclidemstat treated patients, the median time to progression was above the benchmarks established for single-agent activity in the advanced, relapsed soft tissue sarcoma setting. Ewing-related sarcoma patients will continue to be treated with single-agent seclidemstat to generate more safety and early efficacy activity in this patient population. Safety and efficacy results from the AST trial are planned for presentation at an upcoming medical conference. Conference embargo rules prevent further disclosure at this time.

This study will continue to evaluate safety and antitumor activity with data readouts expected towards the end of this year and early next year.

Mr. Arthur concluded, "We are encouraged by the preliminary results from the Ewing sarcoma trial and the Advanced Solid Tumor trial that have demonstrated antitumor activity in patient populations with advanced disease. Based on the totality of the data accumulated thus far, we are optimistic about the potential of seclidemstat in multiple cancers."