On January 23, 2020 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange in the United States, reported preliminary, unaudited financial results and select operating metrics for the fourth quarter and fiscal year ended December 31, 2019 (Press release, eHealthInsurance, JAN 23, 2020, View Source [SID1234553473]).

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"I am proud of our achievements in 2019. After raising our guidance twice in the past year, we significantly exceeded our financial and operating targets driven by consistently strong execution throughout the year. 2019 culminated with an exceptional performance by our team during the fourth quarter Medicare annual enrollment period. Our marketing and business development organizations drove record consumer demand to the eHealth platform allowing us to grow fourth quarter approved Medicare members in excess of 85%," commented Scott Flanders, chief executive officer of eHealth. "We remain excited about the Medicare market opportunity and significant growth potential ahead of us and are looking forward to sharing our outlook for 2020 as part of our fourth quarter earnings release next month."

The preliminary, unaudited financial results and selected operating metrics included in this press release are based on information available as of January 23, 2020 and management’s initial review of operations for the fourth quarter and year ended December 31, 2019. They remain subject to change based on management’s ongoing review of the company’s fourth-quarter and full year results and are forward-looking statements. eHealth assumes no obligation to update these statements. The actual results may be materially different and are affected by the risk factors and uncertainties identified in this press release and in eHealth’s annual and quarterly filings with the Securities and Exchange Commission.

As part of the year-end closing process, the company is enhancing the manner in which it estimates residual or "tail" revenue from the company’s Medicare Advantage members approved in prior periods. Since the adoption of Accounting Standards Codification (ASC) 606, the company’s cash collections for Medicare Advantage policies have in general exceeded initial lifetime value estimates. This dynamic has contributed in past quarters to the recognition of increasing amounts of residual or "tail" revenue from Medicare members approved in prior periods. Our preliminary results exclude the positive impact of changes in estimates for expected collections for Medicare Advantage members approved since our adoption of ASC 606 through the third quarter of 2019. The company plans to include the results of any such changes in estimates as well as full financial and operating results as part of its fourth quarter and full year 2019 earnings release.

Fourth Quarter and Fiscal Year 2019 Preliminary Results

Excluding any positive impact from the changes in estimates to residual revenue for Medicare Advantage members approved since our adoption of ASC 606 through the third quarter of 2019, we expect the following fourth quarter and fiscal year 2019 results:

Revenue for the fourth quarter of 2019 is expected to be in the range of $257.5 to $259.5 million with expected fourth quarter revenue from the Medicare segment in the range of $239.0 to $240.5 million.
GAAP net income for the fourth quarter of 2019 is expected to be in the range of $53.0 to $55.0 million. Adjusted EBITDA(a) for the fourth quarter of 2019 is expected to be in the range of $98.5 to $100.5 million.
Revenue for the year ended December 31, 2019 is expected to be in the range of $462.0 to $464.0 million as compared to the company’s guidance of $365.0 to $385.0 million. Revenue from the Medicare segment for the full year 2019 is expected to be in the range of $403.5 to $405.0 million as compared to the company’s guidance of $318.0 to $333.0 million.
GAAP net income for the year ended December 31, 2019 is expected to be in the range of $31.0 to $33.0 million as compared to the company’s guidance of $20.9 to $25.9 million.
Adjusted EBITDA(a) for the year ended December 31, 2019 is expected to be in the range of $89.0 to $91.0 million as compared to the company’s guidance of $65.0 to $70.0 million.

Adjusted EBITDA is calculated by adding stock-based compensation expense, depreciation and amortization expense, change in fair value of earnout liability, amortization of intangible assets, other income, net of expenses and provision for income taxes to GAAP net income. See "Non-GAAP Financial Information Reconciliations."

Approved Members

The number of approved members for all Medicare products, which includes Medicare Advantage, Medicare Supplement and Medicare Part D Prescription Drug Plans, grew 88% during the fourth quarter of 2019 compared to the fourth quarter of 2018. The number of approved members for Medicare Advantage products grew 100% over the same time period. For the full year 2019, the number of approved members for all Medicare products grew 81% compared to the full year 2018 with approved members for Medicare Advantage products growing 88% over the same time period.

The number of approved members for major medical individual and family plan (IFP) products grew 1% during the fourth quarter of 2019 compared to the fourth quarter a year ago. For the full year 2019, the number of approved members for IFP products declined 25% compared to 2018. The decline in approved IFP members reflects weaker than expected enrollment activity in the overall individual and family health insurance market as well as our continuing emphasis on the Medicare business in allocating our marketing resources.

On January 23, 2020 Certara, the global model-informed drug development and decision support leader, reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or consulting services (Press release, Certara, JAN 23, 2020, View Source [SID1234553472]). This result affirms the pharmaceutical industry’s dedication to employing model-informed drug development approaches for informing key clinical testing decisions, resulting in reduced cost and increased speed in bringing new drugs to patients.

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"We are thrilled to participate in the modernization of drug development effort that has been spearheaded by the FDA," said Certara’s CEO Dr. William Feehery. "Certara’s Simcyp, Phoenix and Global Submit software platforms have been widely used by both the FDA and the biopharmaceutical industry during the past several years for drug development and regulatory review. In addition to the use of our technology, our expert consulting services teams supported the development of therapies for patients with cancer, central nervous system diseases, infectious diseases, and rare diseases in the class of 2019."

During her speech at the Breakthroughs in Medicine conference in Rancho Palos Verdes, CA last September, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER) spoke of the Agency’s commitment to innovation in drug development. Certara’s mission is closely aligned with that commitment, which was outlined by the Agency in its Congressional testimony on implementing the 21st Century Cures Act:

"As part of FDA’s broader innovation initiative, we are encouraging the use of state-of-the-art innovations such as adaptive trials, modeling, and simulations to allow an evaluation of a product’s safety and effectiveness…CDER and FDA’s Center for Biologics Evaluation and Research (CBER) are currently deploying these tools to help predict clinical outcomes, inform trial design, support evidence of effectiveness, and evaluate potential adverse event mechanisms."

Certara’s innovations have had a profound impact on accelerating and improving the efficiency of drug development. During the past six years, Certara’s technology and/or consulting services have been used to inform and expedite the development of about 250 novel therapies. In 2019 alone, Certara provided technology, consulting and/or regulatory writing and submission support for 11 oncology drugs, 12 drugs for orphan diseases, and 16 drugs that received priority or accelerated review. Certara’s quantitative and integrated approach to drug development has enabled sponsors to reduce the size and duration of clinical trials, develop dosing strategies for special populations, such as pediatrics, evaluate alternative formulations, seek expedited regulatory pathways, and leverage in silico models in lieu of conducting clinical trials.

On January 23, 2020 Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, reported that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase 2 clinical trial (Press release, Epizyme, JAN 23, 2020, View Source [SID1234553470]).

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"Despite industry advancements, there are limited therapeutic options for treating patients with epithelioid sarcoma who struggle with high rates of recurrence and toxicities associated with currently used therapies," said Gary K. Schwartz, M.D., chief of hematology and oncology at Columbia University and NewYork-Presbyterian Hospital, deputy director of the Herbert Irving Comprehensive Cancer Center, professor of oncology at Columbia University Vagelos College of Physicians and Surgeons and an investigator in Epizyme’s Phase 2 trial. "The TAZVERIK data from the ES cohort in Epizyme’s Phase 2 trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of TAZVERIK represents an important advancement in the treatment of patients with ES."

"Today’s accelerated approval of TAZVERIK is a landmark event for people with ES and represents our dedication to our mission of rewriting treatment for people with cancer and other serious diseases," said Robert Bazemore, president and chief executive officer of Epizyme. "TAZVERIK is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients. Our commercial launch plans are underway, and we expect to make TAZVERIK available to ES patients and treating physicians across the U.S. within 10 business days."

"For people with epithelioid sarcoma, an aggressive life threatening cancer that affects young adults, having new treatment options can offer much needed hope," added Denise Reinke, MS, NP, MBA, president and chief executive officer of the Sarcoma Alliance for Research through Collaboration (SARC) and co-founder of the Sarcoma Coalition.

Dr. Shefali Agarwal, chief medical officer, commented, "Discovering, developing and obtaining FDA approval for TAZVERIK, with its novel mechanism of action, is the result of years of work and commitment by many people, including the patients, caregivers and physicians who have participated in our clinical trials, along with the talented team at Epizyme. We are tremendously proud of this important milestone and look forward to further advancing clinical development of tazemetostat for multiple types of cancers."

Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. The company’s ongoing, global, randomized, controlled confirmatory trial assessing the combination of TAZVERIK plus doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES is underway.

In addition, Epizyme will conduct certain post-marketing activities, including clinical pharmacology evaluations to assess the effect of TAZVERIK on liver function and the effect of CYP3A inhibitors and inducers on TAZVERIK to inform aspects of the prescribing information. The company will also expand enrollment in Cohort 6 of its Phase 2 study, which has enrolled 44 patients to date, for a total of at least 60 epithelioid sarcoma patients. This expansion is intended to provide more patient experience for potential future inclusion in the label.

Phase 2 Epithelioid Sarcoma Cohort Efficacy Data
The efficacy of TAZVERIK was evaluated in an open-label, single-arm cohort (Cohort 5) of a multi-center study (Study EZH-202, NCT02601950) in patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma. Patients were required to have INI1 loss, detected using local tests, and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. Patients received TAZVERIK 800 mg orally twice daily until disease progression or unacceptable toxicity. Tumor response assessments were performed every 8 weeks. The major efficacy outcome measures were confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR) and duration of response (DOR). Median duration of follow-up was 14 months (range 0.4 to 31).

Among the 62 patients who received TAZVERIK, median age was 34 years (range 16 to 79); 63% were male, 76% were White, 11% were Asian, 44% had proximal disease, 92% had an ECOG PS of 0 or 1, and 8% had an ECOG PS of 2. Prior surgery occurred in 77% of patients; 61% received prior systemic chemotherapy.

In the total 62 patients treated, the ORR (95% confidence interval) was 15% (7%, 26%), with 1.6% of patients achieving a complete response and 13% achieving a partial response. Among responders in the trial, 67% had a duration of response of six months or longer.

Serious adverse reactions occurred in 37% of patients receiving TAZVERIK. Serious adverse reactions in ≥3% of patients who received TAZVERIK were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress.

One patient (2%) permanently discontinued TAZVERIK due to an adverse reaction of altered mood.

Dosage interruptions due to an adverse reaction occurred in 34% of patients who received TAZVERIK. The most frequent adverse reactions requiring dosage interruptions in ≥3% were hemorrhage, increased alanine aminotransferase (ALT), and increased aspartate aminotransferase (AST).

Dose reduction due to an adverse reaction occurred in one (2%) patient who received TAZVERIK; the dose was reduced in this patient for decreased appetite.

The most common adverse reactions (≥20%) were pain, fatigue, nausea, decreased appetite, vomiting and constipation.

View the U.S. Full Prescribing Information here: Epizyme.com

About TAZVERIK
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Dosage and Administration
The recommended dosage of TAZVERIK is 800 mg taken orally twice daily with or without food.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 668 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.6% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T-LBL).
Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0-45h]) at the 800 mg twice daily dose.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.
Adverse Reactions

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurring in >3% were hemorrhage, pleural effusion, skin infection, dyspnea and pain. The most common (≥20%) adverse events were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%) and constipation (21%).
Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.
Avoid coadministration of strong or moderate CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.
Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.
Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.
Investor Conference Call
Epizyme will host an investor conference call and webcast tonight at 5:30 p.m. ET. To participate in the call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 2339029. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast will be archived on the website for 60 days.

On January 23, 2020 Freenome, a privately-held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection through a routine blood draw, reported that is presenting data from their prospective, multi-center clinical study AI-EMERGE (Press release, Freenome, JAN 23, 2020, View Source [SID1234553469]). The colorectal cancer (CRC) study will be featured at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium (ASCO GI) on Saturday, January 25th in San Francisco. "We’re delighted to present results from the first prospective clinical study with our multiomics blood test that achieved high sensitivity and specificity in early-stage CRC," said Gabriel Otte, Chief Executive Officer of Freenome. "This represents a significant step forward in our efforts to bring an effective early detection test to as many people as possible."

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Freenome to present promising prospective data of its multiomics blood test for CRC screening at the ASCO (Free ASCO Whitepaper) 2020 Gastrointestinal Cancers Symposium

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Freenome’s poster, Blood-Based Detection of Early-Stage Colorectal Cancer Using Multiomics and Machine Learning, highlights the performance of their multiomics blood test, which combines tumor- and non-tumor-derived (such as immune) signals from cell-free DNA (cfDNA), epigenetic, and protein biomarkers into a machine learning-based classifier, to detect early-stage CRC. This study, which included average-risk screening and case-control subjects (n=574) and an analyte training set (n=17) drawn from a statistically-driven subset of AI-EMERGE, demonstrated a sensitivity of 94% and specificity of 94% for early-stage (I/II) colorectal adenocarcinoma. "The current study shows exciting multiomics data demonstrating high sensitivity and specificity for detecting early-stage CRC," said Aasma Shaukat, MD, MPH, GI Section Chief at Minneapolis VAHCS and Professor of Medicine, University of Minnesota. "Early detection is key to improving survival and these results give us hope that in the future we may have a highly sensitive and specific blood test to screen patients for early disease." The Company expects to validate these results in a prospective, multi-center registrational study that will begin enrollment this year.

Freenome’s multiomics blood test sensitivity and specificity by early (I/II) and late (III/IV) stage CRC

Sensitivity

Specificity

Early (Stage I/II)

Late (Stage III/IV)

94%

94%

91%

Freenome’s multiomics blood test was also compared to a leading fecal immunochemical test (FIT). Subjects enrolled in the study were asked to provide both a blood and stool sample for a head-to-head comparison. However, only 52% of study subjects provided a stool sample for analysis, reinforcing the well-characterized challenges with patient willingness to perform stool-based testing. In subjects with paired blood and stool samples, Freenome’s multiomics blood test demonstrated 100% sensitivity and 96% specificity for CRC, whereas FIT achieved 67% sensitivity and 96% specificity. "The performance of FIT in our study is consistent with that shown in other large prospective studies, which makes our results even more encouraging," said Girish Putcha, MD, PhD, Chief Medical Officer of Freenome, "since we believe such a blood test can help more people get screened for CRC than existing options, which will improve the detection of early disease and enable better clinical outcomes."

Posters will be available online at View Source at the time of presentation. The following information provides details to all of the posters Freenome will be presenting at the conference:

Abstract 66:

Presenter and Title: Girish Putcha et al., Blood-based detection of early-stage colorectal cancer using multiomics and machine learning.

Poster Session C: Anal and Colorectal Cancer: Saturday, January 25: 6:30 am – 7:55 am and 12:15 pm – 1:45 pm

Poster Walk: Novel Diagnostics and Population Health: Saturday, January 25: 12:30 pm – 1:15 pm

Poster Board C16

Abstract 207:

Presenter and Title: Francesco Vallania et al., Exploratory longitudinal analysis of cfDNA to reveal potential biomarkers of CRC progression and treatment response.

Poster Session C: Anal and Colorectal Cancer Saturday, January 25, 6:30 am – 7:55 am and 12:15 pm – 1:45 pm

Poster Board K7

About Colorectal Cancer and AI-EMERGE

Despite population screening efforts and the availability of several stool-based, non-invasive tests, more than one-third of eligible adults remain unscreened for colorectal cancer (CRC), which is the second deadliest form of cancer in the U.S. However, when detected at an early stage, the five-year relative survival rate for CRC is 90% versus 14% when detected at a late stage according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program. AI-EMERGE is a clinical study that will advance the development of a blood-based test to detect colorectal cancer early. The study is a prospective, multi-center CRC screening clinical study being conducted in patients ages 50-84 that are at average risk for CRC. The study collected blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. The study has recently closed enrollment.

On January 23, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has priced its previously announced underwritten public offering of 35,731,818 common shares (the "Common Shares") of the Company and 1,250,000 Series II Non-Voting Convertible First Preferred Shares (the "Series II First Preferred Shares") of the Company (the "Offering") (Press release, Trillium Therapeutics, JAN 23, 2020, View Source [SID1234553468]). The Common Shares are being sold at a public offering price of US$2.75 per Common Share and the Series II First Preferred Shares are being sold at a public offering price of US$2.75 per Series II First Preferred Share.

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In connection with the Offering, Trillium has granted the underwriters a 30-day option to purchase up to an additional 5,547,272 Common Shares.

The Series II First Preferred Shares are being offered to investors whose purchase of Common Shares in the Offering may result in such investor, together with its affiliates and certain related parties, beneficially owning more than 4.99% of the Company’s outstanding common shares following the consummation of the Offering.

The gross proceeds to the Company from the Offering are expected to be approximately US$101,700,000, before deducting underwriting discounts and commissions and other estimated offering expenses. The Offering is expected to close on or around January 28, 2020, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds of the Offering for: (i) the clinical development of its CD47 programs; and (ii) research, manufacturing and regulatory activities, and working capital and general corporate purposes.

Cowen is acting as the sole book-running manager for the Offering. Bloom Burton Securities Inc. is acting as co-manager for the Offering.

No Common Shares or Series II First Preferred Shares will be offered or sold in Canada as part of this Offering. The Offering is subject to market conditions, as well as a number of closing conditions, including NASDAQ Capital Market ("NASDAQ") and Toronto Stock Exchange ("TSX") approvals, and there can be no assurance as to whether or when the Offering may be completed. For the purposes of TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ.

The Offering is being made to purchasers outside of Canada pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on January 8, 2018 (the "Registration Statement") and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated January 5, 2018. A preliminary prospectus supplement dated January 22, 2020 has been filed relating to the Offering and a final prospectus supplement relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta, Manitoba, Ontario and Nova Scotia in Canada, and with the SEC in the United States.

The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request by contacting Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926.

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