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Onconova Therapeutics, Inc. Announces Closing of $28.75 Million Public Offering of
Common Stock Including Full Exercise of the Over-Allotment Option

On February 16, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the closing of its previously-announced underwritten public offering (Press release, Onconova, FEB 16, 2021, View Source [SID1234575124]). A total of 28,750,000 shares of its common stock were sold, including 3,750,000 shares of common stock following the exercise by the underwriters of their over-allotment option, at a public offering price of $1.00 per share. The gross proceeds of the offering to the Company are $28.75 million, before deducting the underwriting discounts and commissions and other estimated offering expenses.

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Guggenheim Securities is acting as sole book-running manager. Maxim Group LLC and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above were offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission ("SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on February 10, 2021 and is available on the SEC’s website at View Source A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is also available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

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

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2020 Financial Results and Provides a Corporate Update

On February 16, 2021 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the fourth quarter and fiscal year ended November 30, 2020 and provided a corporate update (Press release, Nurix Therapeutics, FEB 16, 2021, View Source [SID1234575123]).

"We begin 2021 with a positive notification from the FDA that our first Phase 1 clinical trial of NX-2127 may proceed in patients with B cell malignancies, including chronic lymphocytic leukemia," said Arthur Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We look forward to a very exciting year as we generate clinical data that can support further development of NX-2127, a first-in-class targeted protein degrader of BTK, a highly validated target for hematologic malignancies."

Recent Business Highlights

Submitted first IND application for lead program NX-2127 and received clearance by the U.S. Food and Drug Administration (FDA). Nurix expects to dose the first patient in a Phase 1a/1b trial for NX-2127 in patients with relapsed or refractory B-cell malignancies in the first quarter of 2021 (expected timing of clinical trials here and throughout the press release are based on calendar year periods).

Expanded Sanofi collaboration: On January 7, 2021, Nurix announced that Sanofi exercised its option to increase the number of targets to a total of five, up from the original three targets in the strategic collaboration signed in December 2019. The option exercise triggered a one-time $22 million payment to Nurix, adding to the previously received $55 million upfront payment. As part of the multi-year collaboration, Nurix is using its proprietary drug discovery platform, DELigase, that integrates its DNA-encoded libraries (DEL) and its portfolio of E3 ligases to create small molecules designed to induce degradation of specified drug targets. Sanofi will have exclusive rights and be responsible for clinical development and commercialization of drug candidates resulting from the work while Nurix will retain the option to co-develop and co-promote up to two products in the United States under certain conditions.

Presented Preclinical Data Highlighting Pipeline Programs: In December 2020, the Company presented IND-enabling data from its NX-2127 program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, including data in non-human primates demonstrating rapid and sustained degradation of BTK with once daily oral dosing. In October 2020, at the Targeted Protein Degradation Summit, data were presented from the Company’s NX-1607 program. NX-1607 is an inhibitor of Casitas B-lineage lymphoma proto-oncogene-B (CBL-B) that is being developed for immuno-oncology indications. The data demonstrated both single agent anti-tumor activity of NX-1607 and combination anti-tumor activity with an anti-PD-1 antibody in animal models.

Completed Initial Public Offering (IPO) in July 2020 raising approximately $238.5 million in gross proceeds: On July 23, 2020, Nurix announced the pricing of its IPO of 11,000,000 shares of common stock, at a public offering price of $19.00 per share. In addition, the underwriters subsequently exercised their option to purchase 1,550,000 additional shares of common stock. The net proceeds to Nurix from the offering were approximately $218.1 million, after deducting underwriting discounts, commissions and offering expenses.

Strengthened Leadership Team with Key Appointments. In 2020, the Company added Michael Lotze, M.D., as chief cellular therapy officer and Robert Brown, M.D., as vice president of clinical development to help advance protein modulating drug candidates and cell therapy programs into the clinic. The Company also enhanced the financial team with the addition of Jason Kantor, Ph.D., as senior vice president, finance and investment strategy.
Upcoming Program Highlights

NX-2127: The Company’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally available degrader of Bruton’s tyrosine kinase (BTK) with immunomodulatory drug (IMiD) activity for the treatment of relapsed or refractory B-cell malignancies. The Company has an open IND and anticipates dosing the first patient in a Phase 1a/1b trial for NX-2127 in the first quarter of 2021.

NX-1607: The Company’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally available inhibitor of CBL-B for immuno-oncology indications. The Company anticipates commencing a Phase 1 trial for NX-1607 in the second half of 2021.

NX-5948: The Company’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally available BTK degrader designed without IMiD activity for certain B-cell malignancies, autoimmune diseases and related diseases such as graft-versus-host disease. The Company anticipates commencing a Phase 1 trial for NX-5948 in the second half of 2021.

DeTIL-0255: The Company’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. The Company anticipates commencing a Phase 1 trial for DeTIL-0255 in the second half of 2021.
Fiscal Fourth Quarter and Full Year 2020 Financial Results

Collaboration revenue for the three months and twelve months ended November 30, 2020 was $6.7 million and $17.8 million, respectively, compared with $1.9 million and $31.1 million for the three and twelve months ended November 30, 2019. The decrease in collaboration revenue for the full year was attributable to the termination of a collaboration agreement with Celgene Corporation in June 2019, which resulted in no revenue recognition in 2020, offset by revenue recognized related to the Company’s collaboration agreements with Gilead Sciences, Inc. and Sanofi S.A. that were established in July and December 2019, respectively.

Research and development expenses for the three months and twelve months ended November 30, 2020 were $20.4 million and $66.5 million, respectively, compared with $12.8 million and $45.0 million for the three and twelve months ended November 30, 2019. The increase was primarily related to increases in preclinical development activities and drug discovery research as well as increased expenses related to higher headcount.

General and administrative expenses for the three months and twelve months ended November 30, 2020 were $6.3 million and $16.3 million, respectively, compared with $2.6 million and $8.3 million for the three and twelve months ended November 30, 2019. The increase was primarily related to higher headcount and increased legal and accounting expenses associated with becoming a public company.

Net loss attributed to common stockholders for the three months and twelve months ended November 30, 2020 was $19.9 million or ($0.51) per share and $43.2 million or ($2.76) per share, respectively, compared with $13.5 million or ($3.55) per share and $21.7 million or ($6.59) per share, respectively, for the three and twelve months ended November 30, 2019.

Cash, Cash Equivalents and Investments: As of November 30, 2020, the Company had cash, cash equivalents and investments of $372.0 million, compared with $38.2 million as of November 30, 2019.

Myriad Genetics to Announce December 2020 Quarterly Financial Results on February 23, 2021

On February 16, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported that it will hold its quarterly earnings conference call for the period ending December 30, 2020 with investors and analysts at 4:30 p.m. EST on Tuesday, February 23, 2021 (Press release, Myriad Genetics, FEB 16, 2021, View Source [SID1234575122]). During the call, Paul J. Diaz, president and CEO, and R. Bryan Riggsbee, Chief Financial Officer, will provide a financial overview and business update of Myriad’s performance for the quarter.

The dial-in number for domestic callers is 1-800-584-2088. International callers may dial 1-212-231-2924. All callers will be asked to reference reservation number 21990097. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call along with a slide presentation will be available through a live webcast at www.myriad.com.

Dynavax to Present at the Cowen 41st Annual Health Care Conference

On February 16, 2021 Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, reported that Ryan Spencer, Chief Executive Officer, will present at the Cowen 41st Annual Health Care Conference on Monday, March 1, at 3:20 p.m. E.T (Press release, Dynavax Technologies, FEB 16, 2021, https://investors.dynavax.com/news-releases/news-release-details/dynavax-present-cowen-41st-annual-health-care-conference [SID1234575121]).

The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "investors" section of the Company’s website at View Source

Exact Sciences Announces Fourth Quarter 2020 Results

On February 16, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $466.3 million for the fourth quarter ended Dec. 31, 2020 and $1,491.4 million for the full year ended Dec. 31, 2020 (Press release, Exact Sciences, FEB 16, 2021, View Source [SID1234575120]).

"Exact Sciences finished another transformative year by delivering strong fourth quarter results against a challenging backdrop because of the pandemic," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are a leader in cancer diagnostics because of our people, scientific platform, and market-leading Cologuard and Oncotype tests. We aim to extend this leadership throughout the cancer continuum and bring additional tests to patients to help improve cancer outcomes."

Fourth Quarter 2020 Financial Results

For the three-month period ended December 31, 2020, as compared to the same period of 2019 (where applicable):

Total revenue was $466.3 million
Screening revenue was $249.7 million, an increase of 9 percent
Precision Oncology revenue was $117.6 million
COVID-19 testing revenue was $99.1 million
Gross margin including amortization of acquired intangible assets was 74 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 79 percent
During the fourth quarter of 2020, the Company acquired Base Genomics, which was treated as an asset acquisition under U.S. GAAP and resulted in a $412.6 million charge to research and development expense
Net loss was $(436.8) million, or $(2.79) per share, compared to net income of $78.0 million, or $0.56 and $0.54 per basic and diluted share.
EBITDA was $(375.5) million and adjusted EBITDA was $87.9 million
Non-cash interest expense related to convertible debt was $21.3 million, compared to $11.5 million
Cash, cash equivalents and marketable securities were $1,840.0 million at the end of the quarter
Screening includes laboratory service revenue from Cologuard and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products.

Non-GAAP Disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

Fourth Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Tuesday, February 16, 2021, at 5 p.m. ET to discuss fourth quarter and full-year 2020 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-235-7650 and international callers should dial +1-647-689-4171. The access code for both domestic and international callers is 2892148.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 2892148. The webcast, conference call and replay are open to all interested parties.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.