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Exact Sciences Announces Fourth Quarter 2022 Results

On February 21, 2023 Exact Sciences Reported record revenue, expects revenue of $2,265-2,315 million and positive adjusted EBITDA for full year 2023 (Press release, Exact Sciences, FEB 21, 2023, View Source [SID1234627471]).

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Fourth quarter and 2022 highlights

Total fourth quarter revenue of $553 million, an increase of 17% or 28% excluding COVID-19 testing, with Screening revenue of $404 million and Precision Oncology revenue of $143 million
Total 2022 revenue of $2,084 million, an increase of 18% or 25% excluding COVID-19 testing, with Screening revenue of $1,425 million and Precision Oncology revenue of $601 million
Surpassed 12 million cumulative people tested for cancer, including 10 million with Cologuard
MADISON, Wis., Feb. 21, 2023 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company generated revenue of $553.0 million for the fourth quarter of 2022 and $2,084.3 million for the full year of 2022, both ended Dec. 31, 2022.

"With a strong finish in 2022 and a great start to 2023, Cologuard and Oncotype DX are setting the tone for an impactful year ahead," said Kevin Conroy, chairman and CEO of Exact Sciences. "Our financial strength, scientific capabilities, and deep partnerships with health systems put Exact Sciences in a leading position to deliver innovative tests that help prevent cancer, detect it earlier, and guide treatment to more patients globally."

Fourth quarter 2022 financial results

For the three-month period ended Dec. 31, 2022, as compared to the same period of 2021 (where applicable):

Total revenue was $553.0 million, an increase of 17 percent, or 28 percent excluding COVID-19 testing
Screening revenue was $403.5 million, an increase of 45 percent, or 42 percent excluding the PreventionGenetics acquisition
Precision Oncology revenue was $143.4 million, a decrease of 4 percent, or an increase of 1 percent excluding the divested Oncotype DX Genomic Prostate Score test and a $1.8 million foreign exchange impact
COVID-19 testing revenue was $6.0 million, a decrease of 87 percent
Gross margin including amortization of acquired intangible assets was 70 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 73 percent
Net loss was $127.7 million, or $0.72 per share, compared to a net loss of $220.6 million, or $1.28 per share
EBITDA was $(75.0) million and adjusted EBITDA was $4.9 million
Cash, cash equivalents, and marketable securities were $632.1 million at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests, PreventionGenetics, and immaterial revenue from Biomatrica and Oncoguard Liver products. Precision Oncology includes laboratory service revenue from global Oncotype DX products and therapy selection products.

2023 revenue outlook

The company anticipates revenue of $2,265-$2,315 million during 2023, assuming:

Screening revenue of $1,660-$1,690 million,
Precision Oncology revenue of $600-$620 million, and
COVID-19 testing revenue of $5 million
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, non-GAAP gross margin, non-GAAP gross profit, and normalized and constant currency growth rates in revenue. 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. Normalized and constant currency growth rates in revenue are calculated to adjust for acquisitions, divestitures and foreign currency. To exclude the impact of change in currency exchange rates from the prior period under comparison, the Company converts the current period non-U.S. dollar denominated revenue using the prior period exchange rate. 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. Additionally, adjusted EBITDA excludes a number of expense items that are included in net loss. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. 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." Information reconciling forward-looking non-GAAP measures to U.S. GAAP measures is not available without unreasonable effort.

Fourth quarter conference call & webcast
Company management will host a conference call and webcast on Tuesday, February 21, 2023, at 5 p.m. ET to discuss fourth quarter and full year 2022 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.

An archive of the webcast will be available at exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.

About Cologuard
The Cologuard test 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. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test 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 the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test 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 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 the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.

About Exact Sciences’ Precision Oncology portfolio
Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. To learn more, visit precisiononcology.exactsciences.com.

About PreventionGenetics
Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome and whole exome sequencing test, PGxome. PreventionGenetics was acquired by Exact Sciences in December 2021.

Kinnate Biopharma Inc. Announces Acquisition of Ownership Stake from Series A Investors of the China Joint Venture, Kinnjiu Biopharma Inc., and Initiation of Phase 1 Clinical Trial for Exarafenib (KIN-2787) in People’s Republic of China

On February 21, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported that it has acquired ownership stake of Kinnjiu Biopharma Inc. ("Kinnjiu") previously held by the Series A investors using a combination of Kinnate shares and cash (Press release, Kinnate Biopharma, FEB 21, 2023, View Source [SID1234627465]). Kinnate retains Kinnjiu’s cash, intellectual property and other assets, including key personnel and the legal entity structure. The transaction does not impact Kinnate’s cash runway, with current cash, cash equivalents and investments expected to fund current operations into mid-2024. The company also announced that KN-8701, a Phase 1 clinical trial evaluating its pan-RAF inhibitor, exarafenib, was initiated in the People’s Republic of China (PRC), with trial sites now open in PRC and Taiwan.

Nima Farzan, chief executive officer, Kinnate Biopharma Inc., commented, "We believe retaining the Kinnjiu structure will enable Kinnate to continue to invest in innovation and clinical development of its kinase inhibitors in the People’s Republic of China, Hong Kong, Macau and Taiwan. We are pleased with the progress to date across our programs, including initiating our Phase 1 clinical trial for exarafenib in the region, with sites now open in People’s Republic of China and Taiwan, and initiating the Phase 1 trial for KIN-3248, our pan-FGFR inhibitor, in Taiwan. We plan to continue advancing our novel targeted oncology pipeline globally."

Transaction Background and Terms

Kinnjiu was formed in 2021 as part of Kinnate’s joint venture to develop and commercialize its most advanced kinase inhibitors in the PRC, Hong Kong, Macau and Taiwan. In the transaction, Kinnate purchased all issued and outstanding Series A preferred shares of Kinnjiu from funds affiliated with OrbiMed and Foresite Capital Management for $24 million, using a combination of cash and shares of common stock of Kinnate. The transaction was approved by the independent directors of Kinnate.

KN-8701 Clinical Trial Background

KN-8701 is an ongoing, global Phase 1 clinical trial (NCT04913285) evaluating exarafenib in patients with advanced solid tumors harboring BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma. The trial is enrolling patients at more than 30 sites across the globe. KN-8701 contains a two-part dose escalation: in Part A1, exarafenib is being evaluated as a monotherapy across BRAF alterations and tumor types and Part A2 is evaluating exarafenib in combination with binimetinib, a MEK inhibitor. Part B, dose expansion, will evaluate exarafenib at a selected dose in cancers driven by BRAF Class II or Class III alterations.

VolitionRx Limited Announces Proposed Underwritten Public Offering of Common Stock

On February 21, 2023 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition" or the "Company"), a multi-national epigenetics company, reported that it has commenced an underwritten public offering of shares of its common stock. In addition, Volition intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions (Press release, VolitionRX, FEB 21, 2023, View Source [SID1234627469]). All of the shares of common stock in the offering are being offered by Volition. The final terms of the proposed offering will depend on 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.

Volition intends to use the net proceeds from the offering for research and continued product development, clinical studies, product commercialization, working capital and other general corporate purposes, including potential strategic acquisitions.
Newbridge Securities Corporation is acting as the sole book-running manager of the offering.

The securities are being offered by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-259783) previously filed with the Securities and Exchange Commission (the "SEC") on September 24, 2021, as amended on November 4, 2021, and declared effective by the SEC on November 8, 2021. The offering is being made only by means of a prospectus supplement and an accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. A preliminary prospectus supplement and an accompanying base prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the offering will be filed with the SEC and will also be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, the final prospectus supplement and the accompanying base prospectus relating to the offering can also be obtained, when available, from Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected], or by telephone at (877) 447-9625.

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

Entry into a Material Definitive Agreement.

On February 21, 2023 Propanc Biopharma, Inc. (the "Company"), reported that it has entered into a securities purchase agreement (the "Purchase Agreement") with ONE44 Capital LLC ("ONE44"), pursuant to which ONE44 purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $111,111, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of ONE44 (Filing, 8-K, Propanc, FEB 21, 2023, View Source [SID1234627467]). The transaction contemplated by the Purchase Agreement closed on February 16, 2023. The Company intends to use the net proceeds ($100,000) from the Note for general working capital purposes. The Note contains an original issue discount amount of $11,111.

The maturity date of the Note is February 14, 2024 (the "Maturity Date"). The Note bears interest at a rate of 10% per annum. Interest is payable only in shares of Company’s common stock (the "Common Stock") and is due and payable only contemporaneously with a payment of principal, whether at the Maturity Date or upon acceleration or by prepayment, as described below. ONE44 is entitled, at its option, at any time after the six-month anniversary of the Note, to convert all or any amount of the principal face amount of this Note then outstanding into shares of Common Stock at a per-share price equal to 60% of the lowest trading price of the Common Stock, as reported by the OTC Markets Group (if the shares of the Common Stock are then quoted thereon) or by any securities exchange upon which the Common Stock is then listed, for the ten prior trading days including the day upon which a Notice of Conversion is received by the Company. In the event the Company experiences a DTC "Chill" on its shares, the conversion price shall then be decreased to 50% instead of 60% while that "Chill" is in effect. Notwithstanding the foregoing, ONE44 shall be restricted from effecting a conversion if such conversion, along with other shares of Common Stock then beneficially owned by ONE44 and its affiliates, exceeds 4.99% of the outstanding shares of Common Stock (which may be increased up to 9.9% of the outstanding shares of Common Stock upon 60 days’ prior written notice by ONE44 to the Company).

The Company may prepay the principal of the Note and accrued interest until 180 days from the issuance date (August 13, 2023). If the Note is prepaid within 60 days of the issuance date (April 15, 2023), then the prepayment premium shall be 120% of the face amount plus any accrued interest. If the Note is prepaid after 60 days from the issuance date, but less than 120 days from the issuance date (June 14, 2023), then the prepayment premium shall be 130% of the face amount plus any accrued interest. If the Note is prepaid after 120 days from the issuance date, up to 180 days from the issuance date (August 13, 2023), then the prepayment premium shall be 135% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from ONE44, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.

Other than as described above, the Note contains certain events of default, including failure to issue shares timely upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations, or warranties, insolvency, bankruptcy, liquidation, and failure by the Company to pay the principal and interest due under the Note. Upon the occurrence and during the continuation of certain events of default, the Note will accrue an annual interest rate of 24% or, if such rate is usurious or not permitted by current law, then at the highest rate of interest permitted by law.

The Note was issued, and any shares of Common Stock to be issued pursuant to any conversion of the Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing descriptions of the Note and the Purchase Agreement do not purport to be complete and each is qualified in its entirety by reference to the full text of the Note and the Purchase Agreement, which are filed as Exhibits 4.20 and 10.41, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

PDX Pharma awarded two-year $1.87M phase II SBIR grant from the National Cancer Institute (NCI) for the development of ARAC-02, a novel lung cancer treatment

On February 21, 2023 PDX Pharma reported that it has been awarded a phase II SBIR grant of $1.87M for 2 years from the National Cancer Institute (NCI) focusing on the development of a new nano-immunotherapy ARAC-02 (Antigen Release Agent and Checkpoint Inhibitor) for lung cancer treatment (Press release, PDX Pharmaceuticals, FEB 21, 2023, View Source [SID1234627466]). ARAC-02 – nanoparticle co-delivering a PD-L1 antibody, a polo-like kinase 1 (PLK1) inhibitor, and an immune-stimulant CpG – provides effective antitumor immune response via CD8+ T cell activities. The original grant application of ARAC-02 had high merit and received a rare perfect score from the NIH. We met all phase I SBIR milestones on formulation optimization and initial efficacy and safety studies in cells and in mice, which leads to phase II SBIR grant awarded for ARAC-02’s evaluation in multiple lung cancer models. Many cancers including lung cancer depend on PLK1 for cell division and growth, and PLK1 inhibition by ARAC-02 will lead to cell death. After PLK1 inhibition, ARAC-02 transiently upregulates PD-L1 expression, rendering the cancer (which may originally have low PD-L1 expression and are not eligible for immune checkpoint inhibitors, ICIs) more sensitive to PD-L1 antibody serving as the ICI and cancer homing agent on ARAC-02. We also show that CpG on ARAC-02, which recruits and activates antigen-presenting cells, enhance CD8+ T cell population and activities. Our current data suggest that ARAC-02 will have broad efficacy in lung and other cancer types (e.g., breast, liver, and pancreatic cancer) regardless of mutational status. ARAC-02 is anticipated to reach clinical trials next year. Data on first gen ARAC (without CpG) was published in Nature Communications in 2022. A US patent (US11224573B2) on the ARAC technology was also issued in Jan, 2022.