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TRILLIUM ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON SHARES AND SERIES II NON-VOTING CONVERTIBLE FIRST PREFERRED SHARES

On January 22, 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 commenced a public offering of common shares (the "Common Shares") of the Company and Series II Non-Voting Convertible First Preferred Shares (the "Series II First Preferred Shares") of the Company (the "Offering") (Press release, Trillium Therapeutics, JAN 22, 2020, View Source [SID1234553412]). In addition, Trillium intends to grant the underwriters a 30-day option to purchase up to an additional amount of Common Shares equal to 15% of the Common Shares and Series II First Preferred Shares offered in the Offering.

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

Cowen is acting as the sole book-running 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, or the actual size or terms of the Offering. 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.

Tetraphase Pharmaceuticals Announces $17.5 Million of Financings Priced At-the-Market

On January 22, 2020 Tetraphase Pharmaceuticals, Inc. (Nasdaq: TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVATM (eravacycline for injection) to treat serious and life-threatening infections, reported that it has entered into a definitive agreement with Armistice Capital, LLC, a healthcare-focused institutional investor, for the purchase, in a private placement priced at-the-market under Nasdaq rules, of (i) 1,270,000 shares of common stock and accompanying warrants to purchase an aggregate of 1,270,000 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 2,063,334 shares of common stock and accompanying warrants to purchase up to an aggregate of 2,063,334 shares of common stock (Press release, Tetraphase, JAN 22, 2020, View Source [SID1234553411]). Each share of common stock and accompanying common stock warrant are being sold together at a combined price of $3.00, and each pre-funded warrant and accompanying common stock warrant are being sold together at a combined price of $2.999, for gross proceeds of approximately $10 million. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. Each common stock warrant will have an exercise price of $2.87 per share, will be exercisable immediately and will expire five years from the date of issuance.

In addition, the Company has entered into a definitive agreement with certain healthcare-focused institutional investors for the purchase, in a registered direct offering priced at-the-market under Nasdaq rules, of (i) 2,380,105 shares of common stock and accompanying warrants to purchase up to an aggregate of 2,380,105 shares of common stock, and (ii) pre-funded warrants to purchase up to an aggregate of 120,000 shares of common stock and accompanying warrants to purchase up to an aggregate of 120,000 shares of common stock. Each share of common stock and accompanying common stock warrant are being sold together at a combined price of $3.00, and each pre-funded warrant and accompanying common stock warrant are being sold together at a combined price of $2.999, for gross proceeds of approximately $7.5 million. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. Each common stock warrant will have an exercise price of $2.87 per share, will be exercisable immediately and will expire five years from the date of issuance.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement and the registered direct offering.

The gross proceeds to the Company from the registered direct offering and the concurrent private placement, before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, will be approximately $17.5 million. The Company intends to use the net proceeds from the registered direct offering and concurrent private placement for the commercialization of XERAVA as well as for working capital and other general corporate purposes. The registered direct offering and concurrent private placement are expected to close on or about January 24, 2020, subject to the satisfaction of customary closing conditions. The closing of the registered direct offering is also conditioned upon the closing of the concurrent private placement.

A shelf registration statement relating to the securities offered in the registered direct offering described above was filed with the Securities and Exchange Commission (the "SEC") on January 25, 2018 and declared effective by the SEC on February 5, 2018. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement, final prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and may be obtained, when available, for free by visiting EDGAR on the SEC website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Tetraphase has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the warrants issued in the private placement (the "Private Placement Securities").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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. Any offering of the Private Placement Securities under the resale registration statement will only be by means of a prospectus.

JOHNSON & JOHNSON REPORTS 2019 FOURTH-QUARTER AND FULL YEAR RESULTS

On January 22, 2020 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2019 (Press release, Johnson & Johnson, JAN 22, 2020, View Source [SID1234553410]). "We delivered strong underlying sales and earnings growth in 2019, driven by the strength of our Pharmaceutical business, accelerating performance in our Medical Devices business and improved profitability in our Consumer business," said Alex Gorsky, Chairman and Chief Executive Officer. "As we enter into 2020 and this next decade, our strategic investments focused on advancing our pipelines and driving innovation across our entire product portfolio, position us well to deliver long-term sustainable growth and value to our shareholders."

Mr. Gorsky continued, "I am extremely proud of our talented and dedicated colleagues who live Our Credo values each and every day, and are inspired to deliver transformative healthcare solutions that improve the lives of our patients and consumers around the world."
OVERALL FINANCIAL RESULTS:
q4chart1.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items

REGIONAL SALES RESULTS:

q4chart2.jpg

q4chart3.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT SALES RESULTS:

q4chart4.jpg

q4chart5.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

FULL-YEAR 2019 SEGMENT COMMENTARY:

Consumer
Consumer worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 1.4%* driven by NEUTROGENA beauty products and over-the-counter products including TYLENOL and MOTRIN analgesics, partially offset by lower sales of baby care products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 5.8%* driven by STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, and ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer. This growth was partially offset by biosimilar and generic competition, primarily declines in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer and international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 3.9%* driven by electrophysiology products in the Interventional Solutions business, international energy and endocutter products in the Advanced Surgery business, and ACUVUE contact lenses in the Vision business.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the company’s website at news releases.
Regulatory
Approvals

DARZALEX (daratumumab) – European Commission Approves Combination with Bortezomib, Thalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible1
(press release)
SPRAVATO (esketamine) Nasal Spray – Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder
(press release)
DARZALEX (daratumumab) – European Commission Approves Combination with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible
(press release)
STELARA (ustekinumab) – U.S. FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
(press release)
Regulatory
Submissions
SPRAVATO (esketamine) – Submission of a Type II Variation Application to the European Medicines Agency (EMA) Seeking Expanded Use as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent1
(press release)
IMBRUVICA (ibrutinib) – Supplemental NDA Submitted to U.S. FDA and Type II Variation Submitted to EMA1 Seeking Approval of Combination with Rituximab for Previously Untreated Patients with CLL
(press release)
(press release)
Ebola Vaccine Regimen – Submission of MAA to EMA for Prevention of Ebola Virus Disease (EVD) caused by Zaire Ebolavirus Species.
(press release)
TREMFYA (guselkumab) – Submission of a Type II Variation Application to the EMA Seeking to Expand Use in the Treatment of Adults with Active Psoriatic Arthritis
(press release)
Other
Completion of Acquisition of Bermekimab, an investigational compound for multiple dermatological indications, from XBiotech Inc. 1
(press release)
Rilpivirine and Cabotegravir – U.S. FDA issues Complete Response Letter Issued for Investigational Two-Drug Long-Acting HIV Regimen
(press release)
Completion of Acquisition of TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer
(press release)
Agreement Announced to Acquire Remaining Stake in Verb Surgical Inc.
(press release)
BCMA CAR-T Therapy Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma
(press release)
J&J Vision Introduces TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients with Astigmatism
(press release)
Ethicon Launches VISTASEAL Fibrin Sealant (Human) To Manage Bleeding During Surgery
(press release)
New Cervical Spine System from DePuy Synthes Advances Treatment Options for Patients with Complex Cervical Spine Disorders
(press release)
1 Subsequent to the quarter

FULL-YEAR 2020 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: January 2020 = $1.11 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:00 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.

ImmunoGen Announces Proposed Public Offering of Common Stock

On January 22, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, ImmunoGen, JAN 22, 2020, View Source [SID1234553409]). ImmunoGen also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the number of shares of common stock offered in the public offering. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen.

ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization activities, capital expenditures, and working capital.

Jefferies, Cowen and William Blair are acting as joint book-running managers for the proposed offering.

The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 274-2806; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by e-mail at [email protected] or by telephone at (800) 621-0687.

GW Cancer Center Expands Clinical Trial Offerings for Patients with High Risk Cutaneous Squamous Cell Carcinoma

On January 22, 2020 The Cutaneous Oncology Program at the George Washington University (GW) Cancer Center reported that it was selected as the first global site for a clinical trial for patients with high-risk cutaneous squamous cell carcinoma (Press release, The George Washington University, JAN 22, 2020, View Source [SID1234553408]). This designation highlights the GW Cancer Center’s growing regional and global reputation for treating patients with advanced squamous cell carcinoma, the second most common form of skin cancer behind basal cell carcinoma. The study, sponsored by Regeneron, will examine outcomes for patients treated with Libtayo (cemiplimab) — an immunotherapy treatment — prior to surgery and radiation therapy.

In June 2019, the GW Cancer Center was selected as the first global site for a related clinical trial on the effectiveness of Libtayo given after primary surgery and radiation therapy. This new study will focus on the impact of Libtayo on tumors prior to surgery, with the goal to help shrink the tumor and potentially prevent the cancer from returning or metastasizing. Preliminary results from a similar trial at MD Anderson Cancer Center showed promising responses to pre-surgical checkpoint inhibitors in patients with advanced cutaneous squamous cell carcinoma of the head and neck.

"By being selected as the first global site for not one, but two clinical trials in 2019, we are continuing to grow our reputation as one of the most innovative programs for patients with advanced cutaneous squamous cell carcinoma," said Vishal A. Patel, MD, FAAD, FACMS, director of the Cutaneous Oncology Program at the GW Cancer Center and principal investigator of the study. "Our growth means even more patients in our region will have access to the latest potentially promising treatments and therapies."

The phase II trial is intended to investigate the safety and effectiveness of Libtayo in helping reduce the size of tumors and prevent recurrence in high risk cutaneous squamous cell carcinoma, particularly when given early. The study, currently only available at the GW Cancer Center, is estimated to enroll over 75 participants.

"This clinical trial fits clearly within our mission to drive transformational research and personalized therapy," said Eduardo M. Sotomayor, MD, Dr. Cyrus Katzen Family Director of the GW Cancer Center and professor of medicine at the GW School of Medicine and Health Sciences. "Our role as an academic cancer center means we are uniquely positioned to get the latest therapies from bench to bedside, and expanding our clinical trial offerings highlights our commitment to advancing both cancer research and patient care."

Libtayo was approved by the U.S. Food and Drug Administration in September 2018 as cemiplimab-rwlc to treat patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The immunotherapy treatment is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and was the first treatment approved and available in advanced cutaneous squamous cell carcinoma in the U.S. Current treatment options for the disease include surgery, such as Mohs micrographic surgery, radiation therapy, and systemic chemotherapy for metastatic disease. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

"Clinical investigations like this one are critical to expanding the treatment options available to patients," said Mitchell Smith, MD, PhD, associate center director for clinical investigations at the GW Cancer Center. "By examining neoadjuvant applications of immunotherapy drugs like Libtayo, the hope is that patients will be able to be treated with less invasive surgeries or avoid surgery altogether."

The Cutaneous Oncology Program at the GW Cancer Center brings together dermatologists; dermatologic surgeons; medical, surgical, and radiation oncologists; and dermato-pathologists to provide comprehensive and personalized skin cancer care to patients. The program also houses the Supportive Oncodermatology and Cutaneous T-Cell Lymphoma multidisciplinary clinics.
The potential use of Libtayo in neoadjuvant cutaneous squamous cell carcinoma is investigational, and its safety and efficacy have not been evaluated by any regulatory authority for this use.