On March 5, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that Dr. Christian Hassig, Chief Scientific Officer, will present an overview of the company at the Cowen 39th Annual Health Care Conference, scheduled for 10:00 a.m. ET on Wednesday, March 13 (Press release, Sierra Oncology, MAR 5, 2019, View Source [SID1234533995]). A live audio webcast and archive of the presentation will be accessible through the Sierra Oncology website at www.sierraoncology.com.

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On March 5, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that members of its senior management team will participate at the following healthcare conferences in March (Press release, CytomX Therapeutics, MAR 5, 2019, View Source [SID1234533994]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Cowen 39th Annual Health Care Conference

Date: Monday, March 11, 2019
Time: 1:30 p.m. – 2:00 p.m. EST
Location: Boston, Massachusetts

Barclays Global Healthcare Conference

Date: Tuesday, March 12, 2019
Time: 2:05 p.m. – 2:35 p.m. EST
Location: Miami, Florida

Live audio webcast of theses presentations will be available through the "Investors & News" section of CytomX’s website. An archived replay will be available for 90 days following the event.

On March 5, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported financial results for the fourth quarter and full year 2018 (Press release, Arcus Biosciences, MAR 5, 2019, View Source [SID1234533992]). The Company also provided updates on its clinical programs.

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"Throughout 2018, we made substantial progress on multiple programs, ending the year with four product candidates in the clinic," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "Enrollment continues in our first three dose-escalation trials for AB928, in which we are evaluating AB928 in combination with either immunogenic chemotherapies or our anti-PD-1 antibody, AB122, across a number of tumor types. We plan to present early data on safety, pharmacokinetic/pharmacodynamic profile, biomarker analysis and clinical activity for the AB928 combinations in mid-2019. Following our IPO last year, we have a strong balance sheet, and we are well-positioned to execute on our research and clinical development plans into 2021."

Pipeline Updates

AB928 (dual A2aR/A2bR antagonist)

The Company continues to enroll patients in the first three AB928 combination trials:

AB928 in combination with Doxil in triple negative breast cancer (TNBC) and ovarian cancer

AB928 in combination with mFOLFOX in colorectal cancer and gastroesophageal cancer

AB928 in combination with AB122 in advanced solid tumors.

The Company expects to initiate its fourth AB928 combination trial in patients in the coming months:

AB928 in combination with carboplatin/pemetrexed with or without pembrolizumab in non-small cell lung cancer (NSCLC) after failing tyrosine kinase inhibitor (TKI) therapy.

AB122 (anti-PD-1 antibody)

The Company is enrolling the final cohort of the Phase 1 dose-escalation trial for AB122. Based on data generated to date, the Company selected 240 mg as the dose for the Q2W (every 2 weeks)

regimen for AB122. The Company continues to evaluate different doses and dosing schedules.

AB154 (anti-TIGIT antibody)

Enrollment continues in the dose-escalation portion of the ongoing Phase 1 trial for AB154 in Australia, which is evaluating AB154 as a monotherapy and in combination with AB122 in advanced solid tumors. The dose-escalation portion will be followed by the initiation of dose-expansion cohorts in solid tumors associated with high levels of TIGIT and/or CD155, the primary ligand for TIGIT, once the recommended doses for AB154 as a monotherapy and in combination with AB122 have been identified.

The Company received clearance from the FDA of its Investigational New Drug (IND) application for AB154, which enables incorporation of U.S. sites in the ongoing Phase 1 trial.

AB680 (small-molecule CD73 inhibitor)

Continued dosing in the healthy volunteer trial of AB680 (i.v. formulation) in Australia. This trial is primarily designed to determine the safety, tolerability, pharmacokinetic and pharmacodynamic profile of AB680 prior to initiating clinical testing of AB680 in cancer patients.

IND-enabling studies for an oral formulation of AB680 have continued to progress.

Corporate Updates

In January 2019, Arcus announced the transition and appointment of Jennifer Jarrett to its Board of Directors. Ms. Jarrett currently serves as Vice President, Corporate Development and Capital Markets at Uber.

Upcoming Milestones

In mid-2019, the Company expects to:

Present initial data from the dose-escalation portion of the AB928 combination trials, which will include data on safety, pharmacokinetic/pharmacodynamic profile, biomarker analysis and clinical activity for the combinations.

Initiate the first of the dose-expansion cohorts for the AB928 combination trials.

Initiate a dose-expansion cohort to evaluate AB122 as a monotherapy to confirm that the activity of AB122 is similar to that of the approved anti-PD-1 antibodies.

Report safety, tolerability, pharmacokinetic and pharmacodynamic data from the Phase 1 trial of AB680 in healthy volunteers.

In the second half of 2019, the Company expects to:

Present additional data from the dose-escalation portion of the AB928 combination trials.

Initiate a Phase 1 trial for AB680 in patients with advanced solid tumors.

Report initial data on the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical activity of AB154 as monotherapy and in combination with AB122.

Fourth Quarter and Full Year 2018 Financial Results

Cash Position: At December 31, 2018, cash and investments (which include cash equivalents and both short-term and long-term investments) were $259.7 million, compared to $175.7 million at December 31, 2017. The increase was primarily due to $124.7 million in net proceeds from the Company’s initial public offering in March, offset by cash utilized to support its operations in 2018.

Revenues: Collaboration and license revenues for the fourth quarter ended December 31, 2018 were $1.6 million, compared to $1.3 million for the same period in 2017. For the full year 2018, collaboration and license revenues were $8.4 million, compared to $1.4 million for the same period in 2017. The increase in revenues for both periods was attributable to revenues recognized from the Option and License Agreement into which the Company entered with Taiho Pharmaceutical Co., Ltd in September 2017.

R&D Expenses: Research and development expenses for the fourth quarter ended December 31, 2018 were $11.4 million, compared to $12.1 million for the same period in 2017. The decrease was due to licensing milestone costs of $3.8 million paid to WuXi Biologics and Abmuno Therapeutics in the fourth quarter ended December 31, 2017, which were offset by increased clinical and manufacturing costs related to the Company’s four clinical-stage development programs, increased R&D headcount to support the Company’s clinical operations and other programs, and an increase in stock-based compensation expense. For the full year 2018, research and development expenses were $49.6 million, compared to $47.2 million for the same period in 2017.

G&A Expenses: General and administrative expenses for the fourth quarter ended December 31, 2018 were $3.6 million, compared to $2.4 million for the same period in 2017. The increase was primarily due to higher legal and accounting fees and additional staff in key areas required to support a public company infrastructure, higher stock-based compensation expense, as well as increased facilities and office expenses related to our expanded facility in Hayward. For the full year 2018, general and administrative expenses were $13.6 million, compared to $7.6 million for the same period of 2017.

Net Loss: Net loss for the fourth quarter ended December 31, 2018 was $12.3 million, compared to $13.2 million for the same period in 2017. The decrease in net loss was primarily attributable to the increase in revenue and changes in operating expenses noted above as well as an increase in interest income. For the full year 2018, net loss was $49.6 million, compared to $53.1 million for the same period in 2017.

Based on its current operating plan, the Company expects that its cash and investments as of December 31, 2018 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into 2021.

On March 1, 2019, TG Therapeutics, Inc. ("TG" or the "Company") entered into an underwriting agreement (the "Underwriting Agreement") with Cantor Fitzgerald & Co. (the "Underwriter"). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriter, in a firm commitment underwritten public offering, 4,100,000 shares (the "Firm Shares") of the Company’s common stock, $0.001 par value per share ("Common Stock") and 615,000 shares of the Company’s common stock, par value $0.001 per share (the "Option Shares" and together with the Firm Shares, the "Shares"), less underwriting discounts and commissions. The transactions contemplated by the Underwriting Agreement are expected to close on March 5, 2019, subject to the satisfaction of customary closing conditions (Filing, 8-K, TG Therapeutics, MAR 5, 2019, View Source [SID1234533989]). A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering.

The gross proceeds to the Company are expected to be approximately $27.7 million before deducting estimated expenses payable by the Company associated with the offering.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The offering is being made pursuant to the Company’s effective "shelf" registration statement on Form S-3 (File No. 333-218293) (the "Registration Statement") filed with the Securities and Exchange Commission (the "SEC") on May 26, 2017, which was declared effective by the SEC on June 13, 2017, as supplemented by a preliminary prospectus supplement filed with the SEC on February 28, 2019 and a final prospectus supplement filed with the SEC on March 5, 2019, pursuant to Rule 424(b) under the Securities Act.

Alston & Bird LLP, counsel to the Company, delivered an opinion as to the validity of the Shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.

This Current Report on Form 8-K is being filed to incorporate the Underwriting Agreement and opinion by reference into such Registration Statement. The foregoing summary description of the offering and the documentation related thereto, including without limitation, the Underwriting Agreement, does not purport to be complete and is qualified in its entirety by reference to such Exhibits.

The Underwriting Agreement has been included to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the Underwriting Agreement and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Underwriting Agreement, and this subsequent information may or may not be fully reflected in the Company’s public disclosures.

Debt Financing

On February 28, 2019 (the "Closing Date"), the Company ("Borrower") entered into a term loan facility of up to $60.0 million ("Term Loan") with Hercules Capital, Inc., ("Hercules"), the proceeds of which will be used for its ongoing research and development programs and for general corporate purposes. The Term Loan is governed by a loan and security agreement, dated February 28, 2019 (the "Loan Agreement"), which provides for up to four separate advances. The first advance of $30.0 million was drawn on the Closing Date. Two additional advances of $10.0 million may be drawn at the Borrower’s option but subject to the clinical trial milestones, and the fourth advance of $10.0 million, available in minimum increments of $5.0 million, is available through December 15, 2020 subject to the approval of Hercules’ investment committee.

The Term Loan will mature on March 1, 2022 (the "Loan Maturity Date"). Each advance accrues interest at a per annum rate of interest equal to the greater of either (i) the "prime rate" as reported in The Wall Street Journal plus 4.75%, and (ii) 10.25%. The Term Loan provides for interest-only payments until October 1, 2020. The interest-only period may be extended to April 1, 2021 if the Borrower, on or before September 30, 2020, achieves either the third milestone or the Company has raised at least an amount equal to $150.0 million in unrestricted net cash proceeds from one or more equity financings, subordinated indebtedness and/or upfront proceeds from business development transactions permitted under the Loan Agreement, in each case after February 7, 2019, and prior to September 30, 2020. Thereafter, amortization payments will be payable monthly in eighteen installments (or, if the period requiring interest-only payments has been extended to April 1, 2021, in twelve installments) of principal and interest (subject to recalculation upon a change in prime rates). At its option upon seven business days’ prior written notice to Hercules, the Company may prepay all or any portion greater than or equal to $5.0 million of the outstanding advances by paying the entire principal balance (or portion thereof), all accrued and unpaid interest, subject to a prepayment charge of 3.0%, if such advance is prepaid in any of the first twelve months following the Closing Date, 1.5%, if such advance is prepaid after twelve months following the Closing Date but on or prior to twenty-four months following the Closing Date, and 0% thereafter. In addition, a final payment equal to 3.5% of the aggregate principal amount of the loan extended by Hercules is due on the maturity date. Amounts outstanding during an event of default shall be payable on demand and shall accrue interest at an additional rate of 4.0% per annum of the past due amount outstanding.

The Term Loan is secured by a lien on substantially all of the assets of the Borrower, other than intellectual property and contains customary covenants and representations, including a liquidity covenant, financial reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries.

The events of default under the Loan Agreement include, without limitation, and subject to customary grace periods, (1) the Borrower’s failure to make any payments of principal or interest under the Loan Agreement, promissory notes or other loan documents, (2) the Borrower’s breach or default in the performance of any covenant under the Loan Agreement, (3) the occurrence of a material adverse effect, (4) the Borrower making a false or misleading representation or warranty in any material respect, (5) the Borrower’s insolvency or bankruptcy, (6) certain attachments or judgments on the Borrower’s assets, or (7) the occurrence of any material default under certain agreements or obligations of the Borrower involving indebtedness in excess of $750,000. If an event of default occurs, Hercules is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement.

The Loan Agreement also contains warrant coverage of 2% of the total amount funded. A warrant (the "Warrant") was issued by Borrower to Hercules to purchase 147,058 shares of common stock with an exercise price of $4.08. The Warrant shall be exercisable for seven years from the date of issuance. Hercules may exercise the Warrant either by (a) cash or check or (b) through a net issuance conversion. The shares will be registered and freely tradeable within six months of issuance.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On March 5, 2019 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the Cowen 39th Annual Health Care Conference in Boston, MA on Tuesday, March 12, 2019 at 11:20 a.m., ET (Press release, Alexion, MAR 5, 2019, https://news.alexionpharma.com/press-release/financial-news/alexion-present-cowen-39th-annual-health-care-conference [SID1234533987]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.