On October 29, 2020 Cancer Genetics, Inc. (Nasdaq: CGIX) ("Cancer Genetics"), a leader in drug discovery and preclinical oncology and immuno-oncology services, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 1,363,637 shares of common stock of the Company at a price to the public of $2.20 per share, less underwriting discounts and commissions (Press release, Cancer Genetics, OCT 29, 2020, View Source [SID1234569235]). The offering is expected to close on or about November 2, 2020, subject to satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company has also granted to the underwriter a 30-day option to purchase up to an additional 204,545 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds of the offering are expected to be approximately $3.0 million, prior to deducting underwriting discounts and commissions and offering expenses and excluding the underwriter’s option to purchase additional shares. Cancer Genetics intends to use the net proceeds to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on July 21, 2020. A preliminary prospectus supplement describing the terms of the offering was filed with the SEC on October 28, 2020, and is available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On October 28, 2020 Biodesix, Inc. (Nasdaq: BDSX) a leading data-driven diagnostic solutions company with a focus in lung disease, reported publication of an analysis of the company’s Nodify XL2 lung nodule test (Press release, Biodesix, OCT 28, 2020, View Source [SID1234572011]). The test supports clinical decision-making for suspicious nodules by more accurately identifying patients with a very low risk of malignancy and shifting those patients into surveillance, thereby minimizing invasive procedures on those with benign nodules.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In previously published findings from the Pulmonary Nodule Plasma Proteomic Classifier (PANOPTIC) Trial, the Nodify XL2 test was shown to accurately identify patients with lung nodules who have a pre-test risk of malignancy less than 50% as "likely benign." After one year of follow-up, the test demonstrated a sensitivity of 97%, specificity of 44%, and negative predictive value of 98%, which is more accurate than other commonly used lung nodule risk assessment calculators.

The new paper, published in the American College of Chest Physicians (CHEST) Journal, presents findings that all nodules in the study group that were established as benign after one year remained benign after two years of follow-up. This data confirms the performance of the Nodify XL2 test over the guideline-recommended two-year surveillance period to radiologically confirm a benign diagnosis. Additionally, a new analysis suggests that the classifier performs similarly regardless of the whether the nodule of concern was solitary or there were other nodules present.

"This assessment demonstrates our commitment to providing long-term follow-up for patients and to continuously study the performance of our tests," said Scott Hutton, CEO of Biodesix. "Central to our mission is the drive to improve patient outcomes while reducing ineffective and unnecessary treatments and procedures. Nodify XL2 exemplifies this. With this test, part of our Nodify LungTM testing strategy, physicians are equipped with vital and time-sensitive information to help efficiently determine the appropriate course of treatment for each patient."

About Nodify XL2 Lung Nodule Test

The Nodify XL2 blood-based proteomic test t helps identify patients who have a suspicious lung nodule that is likely benign or at a reduced risk of being cancerous. Results help physicians to identify patients who may be better candidates for routine CT surveillance to monitor for growth or shrinkage of the nodule over time instead of an invasive diagnostic procedure. The Nodify XL2 test is used for patients who are 40 years or older, have nodules between 8 and 30mm, and have a pre-test risk of lung cancer of less than or equal to 50%.

The test is performed in Biodesix’s COLA-accredited laboratory in De Soto, Kansas.

On October 28, 2020 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the third quarter ended October 4, 2020 (Press release, PerkinElmer, OCT 28, 2020, View Source [SID1234570413]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company reported GAAP earnings per share from continuing operations of $1.57, as compared to GAAP earnings per share from continuing operations of $0.53 in the third quarter of 2019. GAAP revenue for the quarter was $964.0 million, as compared to $706.9 million in the third quarter of 2019. GAAP operating income from continuing operations for the quarter was $248.0 million, as compared to $78.7 million for the same period a year ago. GAAP operating profit margin was 25.7% as a percentage of revenue, as compared to 11.1% in the third quarter of 2019.

Adjusted earnings per share from continuing operations for the quarter was $2.09, as compared to $1.06 in the third quarter of 2019. Adjusted revenue for the quarter was $964.2 million, as compared to $707.1 million in the third quarter of 2019. Adjusted operating income from continuing operations for the quarter was $304.3 million, as compared to $152.5 million for the same period a year ago. Adjusted operating profit margin was 31.6% as a percentage of adjusted revenue, as compared to 21.6% in the third quarter of 2019.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"I remain humbled by and immensely proud of how everyone within PerkinElmer has rallied together to tackle this year’s challenges," said Prahlad Singh, president and chief executive officer of PerkinElmer. "As we look to 2021 and beyond, the environment will undoubtedly be different from the future we imagined a year ago. However, I could not be more confident that we as an organization are headed in the right direction and better positioned to tackle the challenges of tomorrow."

Financial Overview by Reporting Segment for the Third Quarter

Discovery & Analytical Solutions

Third quarter 2020 revenue was $423.6 million, as compared to $426.9 million for the third quarter of 2019. Reported revenue decreased 1% and organic revenue decreased 3% as compared to the third quarter of 2019.
Third quarter 2020 operating income from continuing operations was $42.7 million, as compared to $52.3 million for the comparable prior period.
Third quarter 2020 adjusted operating income was $62.5 million, as compared to $86.2 million for the third quarter of 2019.

Diagnostics

Third quarter 2020 revenue was $540.4 million, as compared to $280.0 million for the third quarter of 2019. Reported revenue increased 93% and organic revenue increased 92% as compared to the third quarter of 2019.
Third quarter 2020 operating income from continuing operations was $223.8 million, as compared to $47.4 million for the comparable prior period.
Third quarter 2020 adjusted operating income was $260.3 million, as compared to $79.7 million for the third quarter of 2019.
Fourth Quarter 2020 Guidance

For the fourth quarter of 2020, the Company forecasts GAAP revenue in the range of $1.12 billion to $1.23 billion, GAAP earnings per share from continuing operations of $2.27 to $2.67 and, on a non-GAAP basis, which is expected to include the adjustments noted in the attached reconciliation, adjusted earnings per share of $2.60 to $3.00.

Conference Call Information

The Company will discuss its third quarter 2020 results and its outlook for business trends in a conference call on October 28, 2020 at 5:00 p.m. Eastern Time. To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 6884834.

A live audio webcast of the call will be available on the Investors section of the Company’s Web site, www.perkinelmer.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Company’s Web site for a two-week period beginning approximately two hours after the call.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

Factors Affecting Future Performance

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes," "intends," "anticipates," "plans," "expects," "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) the effect of the COVID-19 pandemic on our sales and operations; (3) fluctuations in the global economic and political environments; (4) our failure to introduce new products in a timely manner; (5) our ability to execute acquisitions and license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (6) our failure to adequately protect our intellectual property; (7) the loss of any of our licenses or licensed rights; (8) our ability to compete effectively; (9) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (10) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (11) disruptions in the supply of raw materials and supplies; (12) the manufacture and sale of products exposing us to product liability claims; (13) our failure to maintain compliance with applicable government regulations; (14) regulatory changes; (15) our failure to comply with healthcare industry regulations; (16) economic, political and other risks associated with foreign operations; (17) our ability to retain key personnel; (18) significant disruption in our information technology systems, or cybercrime; (19) our ability to obtain future financing; (20) restrictions in our credit agreements; (21) discontinuation or replacement of LIBOR; (22) the United Kingdom’s withdrawal from the European Union; (23) our ability to realize the full value of our intangible assets; (24) significant fluctuations in our stock price; (25) reduction or elimination of dividends on our common stock; and (26) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

On October 28, 2020 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell related diseases, reported the pricing of its previously announced underwritten public offering (Press release, Allakos, OCT 28, 2020, View Source [SID1234569696]). The size of the offering is $250 million of shares of its common stock. The Company is offering 3,048,781 shares at a public offering price of $82.00 per share. The offering is expected to close on November 2, 2020, subject to the satisfaction of customary closing conditions. In connection with the offering, the Company has granted the underwriters a 30-day option to purchase up to 457,317 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Offering Summary

Jefferies, BofA Securities and SVB Leerink are acting as joint book-running managers for the offering.

LifeSci Capital LLC and William Blair are acting as the co-managers for the offering.

The Company currently expects to use the net proceeds from the offering for general corporate purposes.

An effective registration statement relating to the securities sold in this offering was filed with the Securities and Exchange Commission ("SEC") on August 5, 2019. Copies of the registration statement, the preliminary prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus will be filed with the SEC and will be accessible through the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus supplement and the accompanying prospectus. When available, copies of the final prospectus supplement and accompanying prospectus may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 1-877-547-6340, or by email at [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, 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.

On October 28, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that it will release results for its third quarter ended September 30, 2020, after the market close on November 5, 2020 (Press release, Natera, OCT 28, 2020, View Source [SID1234569439]). Natera will host a conference call and webcast at 1:30 p.m. PT (4:30 p.m. ET) to discuss its financial results, business activities, and financial outlook.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!