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TRILLIUM ANNOUNCES CLOSING OF US$15 MILLION PUBLIC OFFERING OF
COMMON SHARE UNITS AND SERIES II NON-VOTING CONVERTIBLE FIRST
PREFERRED SHARE UNITS

On March 8, 2019 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 closed its previously announced underwritten public offering of 6,550,000 common share units (the "Common Share Units") of the Company and 12,200,000 Series II Non-Voting Convertible First Preferred Share units (the "Series II First Preferred Share Units") of the Company (Press release, Trillium Therapeutics, MAR 8, 2019, View Source [SID1234534173]).

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The Common Share Units were sold at a public offering price of US$0.80 per Common Share Unit. Each Common Share Unit is comprised of one common share of the Company (each a, "Common Share") and one Common Share purchase warrant (each a "Common Share Warrant"). Each Common Share Warrant is exercisable for one Common Share at a price of US$0.96 per Common Share Warrant, subject to adjustment, at any time until 5:00 p.m. (Toronto time) on February 28, 2024, subject to certain terms and conditions. The Series II First Preferred Share Units were sold at a public offering price of US$0.80 per Series II First Preferred Share Unit. Each Series II First Preferred Share Unit is comprised of one Series II Non-Voting Convertible First Preferred Share (each a "Series II First Preferred Share") and one Series II First Preferred Share purchase warrant (each a "Series II First Preferred Share Warrant"). Each Series II First Preferred Share Warrant is exercisable for one Series II First Preferred Share at a price of US$0.96 per Series II First Preferred Share Warrant, subject to adjustment, at any time until 5:00 p.m. (Toronto time) on February 28, 2024, subject to certain terms and conditions.

The gross proceeds to the Company from the offering were US$15 million before deducting underwriting discounts and commissions and other expenses of the offering.

The Company intends to use the net proceeds of the offering for (i) ongoing research and development activities of its SIRPaFc program; and (ii) working capital and general corporate purposes.

Cowen and Company, LLC acted as the sole book-running manager for the Offering.

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.

Exact Sciences Announces Offering of $600 Million Convertible Senior Notes Due 2027

On March 5, 2019 Exact Sciences Corporation (NASDAQ: EXAS) (the "Company") reported an underwritten public offering of $600 million aggregate principal amount of convertible senior notes due 2027 (the "Notes") pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (the "SEC") on Form S-3 (Press release, Exact Sciences, MAR 8, 2019, View Source [SID1234534174]). The Company has also granted the underwriter a 30-day option to purchase up to an additional $90.0 million aggregate principal amount of the Notes. Concurrently with this offering, in separate transactions, the Company also expects to enter into agreements with certain holders of its 1.0% Convertible Senior Notes due in January 2025 (the "2025 Notes") to exchange an aggregate of approximately 50% of the outstanding principal amount of such notes for consideration consisting of cash, shares of the Company’s common stock or a combination thereof. The terms of such agreements will be individually negotiated and will depend on the market price of the Company’s common stock and the trading price of the 2025 Notes at the time such agreements are entered into. The cash portion of such consideration will be funded from a portion of the net proceeds from this offering. The Company may also exchange or induce conversions of the 2025 Notes following completion of this offering and may fund such exchanges or conversions with the proceeds of this offering. The Company intends to use the remaining net proceeds of this offering for general corporate and working capital purposes. The Notes will be convertible into cash, shares of the Company’s common stock (and, if applicable, cash in lieu of any fractional share), or a combination thereof, at the Company’s election.

BofA Merrill Lynch is acting as sole book-running manager for the Notes offering.

An automatically effective shelf registration statement relating to the Notes was filed with the SEC on June 6, 2017. The offering of the Notes will be made only by means of the prospectus and related prospectus supplement, which have been or will be filed with the SEC. A copy of the prospectus supplement and prospectus relating to the Notes offering may be obtained free of charge on the SEC’s website at View Source or by sending a request to BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department (or by e-mail at [email protected]).

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

Medtronic Announces Cash Dividend for Fourth Quarter of Fiscal Year 2019

On March 8, 2019 The board of directors of Medtronic plc (NYSE:MDT) reported the fiscal year 2019 fourth quarter cash dividend of $0.50 per ordinary share, representing a 9 percent increase over the prior year (Press release, Medtronic, MAR 8, 2019, View Source;p=RssLanding&cat=news&id=2390745 [SID1234534169]). This quarterly declaration is consistent with the dividend announcement made by the company in June 2018. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 41 consecutive years. The dividend is payable on April 12, 2019, to shareholders of record at the close of business on March 22, 2019.

In addition to approving the dividend, the board today authorized the expenditure of funds for share repurchases. Given the remaining amount under the board’s June 2017 $5.0 billion authorization had been reduced to $1.3 billion by the end of the last fiscal quarter, the board today authorized an incremental $6.0 billion for share repurchases. The company noted that there is no specific time period associated with today’s repurchase authorization.

Mersana Therapeutics Announces Fourth Quarter and Full Year 2018 Financial Results and Provides Business Updates

On March 8, 2019 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results and a business update for the fourth quarter and full year ended December 31, 2018 (Press release, Mersana Therapeutics, MAR 8, 2019, View Source [SID1234534166]).

"In 2018 we made significant progress with XMT-1536, our first-in-class ADC candidate targeting NaPi2b. We remain encouraged by the safety, tolerability, and early signs of activity seen in heavily pretreated, unselected patients in the dose escalation trial. Within the second quarter of 2019 we plan to report data from the dose escalation portion of the study, select a go forward dose and initiate the Phase 1 expansion cohorts," said Anna Protopapas, President and CEO of Mersana Therapeutics. "More recently, we strengthened our balance sheet through an equity financing that provides us with the capital necessary to advance XMT-1536 and our potential next ADC candidate through to important future value inflection points."

Recent Highlights and Updates

Clinical Program

Continued the Phase 1 dose escalation study of XMT-1536 for the treatment of NaPi2b-expressing cancers. XMT-1536 is a first-in-class Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-squamous non-small cell lung cancer (NSCLC) adenocarcinoma. The data to date from the ongoing XMT-1536 dose escalation study indicate that the trial has reached clinically relevant dose levels, starting at 20 mg/m2 but has not yet reached a maximum tolerated dose. The once-every-three-week dosing regimen has been fully explored. In the once-every-four-week dosing regimen, the Company has completed dosing patients in the 20 mg/m2 and 30 mg/m2 dose cohorts. Both dosing regimens have thus far been well tolerated and dosing of the 36 mg/m2 cohort has been initiated. The Company is planning to report data from the dose escalation portion of the study in the second quarter of 2019.
Discovery & Platform Progress

On track to disclose its next ADC clinical candidate in the second half of 2019 further strengthening its scientific leadership in ADC development.

Presented data on two new platforms at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in November 2018. Details of the abstracts are below:
º The first abstract, titled "Discovery of the novel, homogeneous payload platform Dolasynthen for Antibody-Drug Conjugates" characterized Dolasynthen, a next-generation platform allowing for drug homogeneity and precise control of the Drug-to- Antibody ratio of an ADC.
º The second abstract, titled "Indole-Biaryl Pyrrolobenzodiazepines (I-BiPs): A potent and well-tolerated class of DNA mono-alkylating payload for antibody-drug conjugates (ADCs)" characterized Alkymer, a DNA damaging platform demonstrating superiority to existing DNA damaging platforms.
Corporate Updates

Appointed Dirk Huebner, M.D., as Chief Medical Officer. Dr. Huebner’s 25 years of drug development experience, including significant experience in the development and approval of ADCs, will contribute to Mersana’s leading clinical development organization.
Strengthened balance sheet through important equity financing. On March 5, 2019, the Company announced the closing of a public offering of approximately 24.4 million shares of its common stock at the price of $4.00 per share. Aggregate gross proceeds from the offering were approximately $97.8 million.
Upcoming Events

Mersana will give a corporate presentation at the Cowen & Co. Annual Health Care Conference on March 13, 2019, in Boston, MA.
Mersana will present on the Dolasynthen platform as well as a dual payload ADC containing both a microtubule inhibitor and a DNA alkylator, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from March 29 – April 3, 2019, in Atlanta, GA.
2018 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2018, were $70.1 million, compared to $125.2 million as of December 31, 2017.

Fourth Quarter 2018

Collaboration revenue for the fourth quarter 2018 was approximately $1.2 million, compared to $3.3 million for the same period in 2017. The decrease was largely the result of a decrease in efforts to support partnered programs.
Research and development expenses for the fourth quarter 2018 were approximately $19.8 million, compared to $14.6 million for the same period in 2017, driven primarily by an increase in clinical and regulatory expenses due to the progress of our XMT-1536 program and manufacturing costs to support the future clinical development of XMT-1536.
General and administrative expenses for the fourth quarter 2018 were approximately $4.2 million, compared to $3.1 million for the same period in 2017, driven primarily by increased employee-related expenses due to an increase in headcount and increased professional fees.
Net loss for the fourth quarter 2018 was $22.4 million, or $0.97 per share, compared to a net loss of $14.0 million, or $0.61 per share, for the same period in 2017. Weighted average common shares outstanding for the years ended December 31, 2018 and December 31, 2017, were 23,184,459 and 22,750,425, respectively.
Full Year 2018

Collaboration revenue for the full year 2018 was approximately $10.6 million, compared to $17.5 million for the full year 2017. The decrease was primarily the result of a decrease in efforts to support partnered programs and a change in total projected efforts associated with timelines used to measure XMT-1522 revenue under ASC 606.
Research and development expenses for the full year 2018 were approximately $59.9 million, compared to $46.7 million for the full year 2017. The increase was primarily due to an increase in pre-clinical platform development, clinical and regulatory expenses due to the progress of XMT-1536 and XMT-1522, and manufacturing costs to support future clinical development.
General and administrative expenses for the full year 2018 were approximately $16.3 million, compared to $10.5 million for the full year 2017, driven primarily by increased employee-related expenses due to an increase in headcount and increased professional fees.
Net loss for the full year 2018 was $64.3 million, or $2.79 per share, compared to a net loss of $38.7 million, or $3.22 per share, for the full year 2017. Weighted average common shares outstanding for the periods ended December 31, 2018 and December 31, 2017, were 23,032,250 and 12,022,733, respectively.
2019 Financial Update

On March 5, 2019 the Company completed a public equity offering with gross proceeds of $97.8 million. The Company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into at least mid-2021.
Associated with the discontinuation of the XMT-1522 program, the Company expects to recognize remaining deferred revenue under ASC 606 in the first quarter of 2019 to reflect termination of the Takeda agreement. Mersana announced the discontinuation of the development of XMT-1522 due to the competitive landscape and to prioritize its resources on advancing XMT-1536. In line with this decision, the Company and its partner, Takeda, have terminated their research and development partnerships.
Conference Call

Mersana Therapeutics will host a conference call and webcast at 8:00 a.m. ET on March 8, 2019 to report financial results for the fourth quarter and full year 2018 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 1969536. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

About XMT-1536

XMT-1536 is a Dolaflexin ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLock payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody. NaPi2b is an antigen highly expressed in the majority of non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC adenocarcinoma and other cancers. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

Bayer submits European marketing authorization application for darolutamide (for specialized target groups only)

On March 8, 2019 Bayer reported that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Bayer, MAR 8, 2019, View Source [SID1234534165]).

"Men are typically asymptomatic at this stage of prostate cancer. Therefore, it is critical that they have treatment options, which not only delay the development of metastases, but also limit burdensome side effects of therapy, so that these men can continue with their day-to-day lives," said Scott Z. Fields, M.D., senior vice president and head of Oncology Development of Bayer AG’s Pharmaceutical Division. "With this submission, we are taking an important step toward providing patients, caregivers, and physicians with a potential new treatment option for nmCRPC."

The submission to the EMA is based on data from the Phase III ARAMIS trial in men with nmCRPC, which were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine, showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT).(1)

Bayer recently completed the rolling submission of a New Drug Application to the United States Food and Drug Administration (FDA) and submitted an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan. Bayer is also in discussions with other health authorities regarding submissions.

The compound is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About ARAMIS
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.

About darolutamide
Darolutamide is a non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. In preclinical studies, darolutamide demonstrated lower blood-brain barrier penetration compared to other currently available AR antagonists.(2)

In addition to the Phase III trial ARAMIS in men with nmCRPC, darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at www.clinicaltrials.gov.

Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.(3) In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.(3) Prostate cancer is the fifth leading cause of death from cancer in men.(3) Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man´s reproductive system.(4) It mainly affects men over the age of 50, and the risk increases with age.(5) Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.(6) However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.(7)

CRPC is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly, but until recently, there have been no approved treatment options for CRPC patients who have rising prostate-specific antigen (PSA) levels while on ADT and no detectable metastases. In men with progressive nmCRPC, a rapid PSA doubling time has been consistently associated with reduced time to first metastasis and death.(8)