On February 11, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $295.6 million for the fourth quarter ended Dec. 31, 2019 and $876.3 million for the full year ended Dec. 31, 2019, including Precision Oncology revenue of $66.2 million for the period Nov. 8, 2019 through Dec. 31, 2019, following the close of the Genomic Health combination (Press release, Exact Sciences, FEB 11, 2020, View Source [SID1234554155]).

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"The Exact Sciences team delivered another strong quarter to end a transformative year for the company," said Kevin Conroy, chairman and CEO of Exact Sciences. "The strong foundation we’ve built for Cologuard and Oncotype DX and the capabilities of our combined team position us well to continue to grow our core business and deliver more innovative cancer tests to people in need."

Fourth-Quarter 2019 Financial Results

For the three-month period ended December 31, 2019, as compared to the same period of 2018 (where applicable):

Total revenue was $295.6 million
Screening revenue was $229.4 million, an increase of 60 percent
Cologuard test volume was 477,000, an increase of 63 percent
Average Cologuard recognized revenue per test was $481
Average Cologuard cost per test was $123, an improvement of $6
Precision Oncology revenue was $66.2 million for the period Nov. 8, 2019 through Dec. 31, 2019, following the close of the Genomic Health combination
Precision Oncology proforma revenue for the full fourth quarter was $119.1 million, an increase of 14 percent from proforma 2018 revenue, assuming Genomic Health were a standalone entity
Oncotype DX test volume for the full fourth quarter was 41,000, an increase of 14 percent
Gross margin including amortization of acquired intangibles was 72 percent, and non-GAAP gross margin excluding amortization of acquired intangibles was 76 percent
Transaction-related costs for the Genomic Health combination were $15.7 million, and integration-related costs were $38.0 million, which are included in general and administrative operating expenses
Income tax benefit was $184.6 million due to a change in the deferred tax asset valuation allowance resulting from the Genomic Health combination
Net income was $77.9 million, or $0.56 per basic share and $0.54 per diluted share, compared to a net loss of $54.0 million, or $0.44 per basic and diluted share
EBITDA was $(70.0) million and adjusted EBITDA was $9.7 million
Non-cash interest expense related to convertible debt was $11.5 million, compared to $8.4 million
Cash, cash equivalents and marketable securities were $323.7 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 DX products.

2020 Outlook

The Company anticipates revenue of $1.61-$1.645 billion during 2020, including Screening revenue of $1.125-$1.15 billion and Precision Oncology revenue of $485-$495 million.
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projects. See the cautionary information about forward-looking statements in the "Forward-Looking Statements" section of this news release.

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. Adjusted EBITDA consists 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."

Fourth-Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Tuesday, February 11, 2020, at 5 p.m. ET to discuss fourth-quarter and full-year 2019 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.

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 416-621-4642 internationally. The access code for the replay of the call is 3280195. 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.

On February 11, 2020 Fennec Pharmaceuticals Inc. (Nasdaq:FENC; TSX: FRX), a specialty pharmaceutical company, reported it has completed its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARKTM (a unique formulation of sodium thiosulfate) for intravenous use and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined) (Press release, Fennec Pharmaceuticals, FEB 11, 2020, View Source [SID1234554154]). The PEDMARKTM indication requested is for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.

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Fennec’s PEDMARK regulatory submissions follow: a pre-NDA meeting with the FDA in December 2018 after which Fennec initiated a rolling NDA; and pre-submission meetings with the EMA and an approved pediatric investigation plan (PIP). Both applications are based upon clinical results from two pivotal Phase 3 clinical trials:

·SIOPEL 6 conducted by the International Childhood Liver Tumor Strategy Group (SIOPEL) with results published in the New England Journal of Medicine in June 2018

and

·ACCL0431 conducted by the Children’s Oncology Group (COG) with results published in Lancet Oncology in 2016.

"At Fennec, we are dedicated to the development of PEDMARK for the prevention of ototoxicity in children. The completion of these regulatory submissions to the FDA and EMA are the culmination of many years of hard work, bringing us one step closer to achieving our mission," said Rosty Raykov, chief executive officer of Fennec. "Fennec would like to thank the many parents, children and investigators who participated in the clinical trials, as well as our dedicated employees who helped us reach this important milestone. We are well underway with commercialization readiness activities to support the potential launch of PEDMARK and our transition to becoming a commercial-stage organization."

1 PEDMARK is US proposed tradename. European tradename is under evaluation.

The FDA has a 60-day review period to determine whether the PEDMARK NDA is acceptable for filing. PEDMARK has been granted Orphan Drug, Breakthrough Therapy, and Fast Track designations from the FDA. If PEDMARK is granted a priority review, the Prescription Drug User Fee Act (PDUFA) action date is expected in the third quarter of 2020.

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and is particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated annually that over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

On February 11, 2020 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it will be featured as a presenting company at the BIO CEO & Investor Conference conference taking place February 10-11 at the New York Marriott Marquis in New York, N.Y (Press release, AIVITA Biomedical, FEB 11, 2020, View Source [SID1234554153]). Dr. Hans S. Keirstead, AIVITA’s Chairman and CEO, will present at the following time and location:

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Date: Monday, February 10, 2020
Time: 11:15 AM ET
Location: Ziegfeld Room

The BIO CEO & Investor Conference is one of the largest independent investor conferences focused on established and emerging publicly traded and select private biotech companies. Dr. Keirstead will be presenting details on AIVITA’s platform cancer technology, a next generation immunotherapy targeting the tumor-initiating stem cells, with strong clinical data evidencing 72% survival at 2-years, and 54% survival at 5-years post-treatment. AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

On February 11, 2020 BrainCool AB, a Swedish medical device innovator, and a world leader in medical cooling technology for therapeutic hypothermia (brain cooling) and oncology, is reported that it has completed patient recruitment in the Scandinavian multi-center pivotal trial of 180 patients to investigate the patented Cooral System for prevention of Oral Mucositis (OM), one of the most debilitating side-effects of both standard and high-dose chemotherapeutic oncology treatments (Press release, BrainCool, FEB 11, 2020, View Source [SID1234554152]).

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In the United States (U.S.), BrainCool is conducting a De Novo 510 k regulatory process, with the aim of obtaining product and market clearance for the Cooral System in the U.S. by the Food and Drug Administration (FDA). The De Novo process was introduced by the FDA for instances where a device is novel and there is therefore no suitable predicate device to support a standard 510(k) submission. To qualify for the De Novo pathway, the new device must also present no more than moderate risk.

BrainCool has been granted FDA "Expedited Access Pathway" (EAP) status and will be given priority review for the Cooral System. EAP projects address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), or are eligible for de novo requests.

"With full patient recruitment for our pivotal trial, we are opening an important new door in cancer care and treatment," said Martin Waleij, CEO BrainCool AB. "Conclusive validation that cryotherapeutic intervention with the Cooral System can safely and effectively prevent the excruciating side-effects of oral mucositis is not just a major medical milestone, it’s actually a matter of life and death."

The Cooral System intra-oral cooling device includes a disposable and thermostatically controlled mouthpiece that fills with a hypothermic liquid, which circulates through the system’s channels. As the coolant gradually reaches and maintains a consistently controlled temperature, the system reduces blood flow and exposure of tissue to radiation or chemotherapeutic agents, thus preventing adverse mucosal erythema and ulcerative reactions.

Details of the Clinical Study and the Expedited Access Pathway (EAP)

The Nordic clinical trial of 180 patients has been selected by the U.S. FDA as part of the De Novo 510 process for obtaining market clearance in the U.S. Patients have been recruited over a period of two years across five important medical centers, including the lead site, Karolinska Universitetsjukhuset in Stockholm, Sweden.

Clinical data from the Nordic trial will be applicable for FDA submission. BrainCool is currently working on a module-based application wherein the first two modules contain quality routines for product development and manufacturing. The third and final module will contain clinical data from the completed Pivotal trial and will be submitted as soon as the results are available. Thereafter FDA will review the documentation and decide on a product and market approval.

About Oral Mucositis (OM)

Oral Mucositis significantly affects the quality of life for cancer patients in terms of pain, ability to eat, swallow and talk. The symptoms are often of such severity that they result in an interruption and curtailment of therapy. OM can also lead to dose reduction of the cancer therapy and treatment delays. In many cases these patients require hospitalization. OM has a direct and significant effect on the duration of disease remission and cure rates due to its dose-limiting toxicity. In some cases, risk for infection threatens survival, and there is a significant impact on quality of life and cost of care. The presence of OM is a major driver of health-care cost. Read more: View Source

On February 11, 2020 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") is reported that it has closed its offering (the "Offering") of 16,317,000 units (the "Units") at a price of C$0.50 per Unit (the "Offering Price") for gross proceeds of C$8,158,500 (Press release, IntelGenx, FEB 11, 2020, View Source [SID1234554151]).

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Each Unit consists of one share of common stock (the "Offered Shares") and one warrant (a "Warrant") entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share (a "Warrant Share"). The Warrants are exercisable immediately and will expire on the third anniversary of the date of their issuance.

The Units were distributed under a short form prospectus dated January 27, 2020 filed by the Company in connection with the Offering and available on SEDAR at www.sedar.com and have been registered with the United States Securities and Exchange Commission pursuant to a Form S-1 Registration Statement that was declared effective on January 31, 2020 (the "Registration Statement"). The Offering was conducted, on a best efforts basis, by Echelon Wealth Partners Inc. (the "Agent"). In consideration for the services rendered by the Agent, the Company has paid the Agent an agency fee equal to 7% of the gross proceeds of the Offering and has issued the Agent a number of warrants (the "Agent Warrants") equal to 7% of the number of Units issued under the Offering, each Agent Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share until the third anniversary of the date of their issuance. After the payment of the Agent’s commissions and the reimbursement of certain of the Agent’s Offering expenses and the payment of other Offering expenses, the Company expects the net proceeds from the Offering to be approximately C$7.4 million.

The Company has granted the Agent an over-allotment option exercisable, in whole or in part, at the sole discretion of the Agent, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the date hereof, to offer and sell up to an additional number of Units representing 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.

The TSX Venture Exchange (the "TSXV") has conditionally approved the listing of the Warrants and the common stock that will be issued by the Company in the Offering, including the shares of common stock issuable upon the exercise of the Warrants and the Agent Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 15 days of the closing of the Offering.

The Warrants will be listed on the TSXV under the symbol "IGX.WT" and will commence trading effective at the opening of the market on Thursday, February 13, 2020.

The Company intends to use the net proceeds from the Offering for its Phase 2A Montelukast Study and general working capital requirements.