On March 7, 2019 ArQule, Inc. (Nasdaq: ARQL) reported its financial results for the fourth quarter and full year of 2018 (Press release, ArQule, MAR 7, 2019, View Source [SID1234534077]).

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For the quarter ended December 31, 2018, the Company reported a net loss of $8,487,000 or $0.08 per share, compared with net loss of $7,760,000 or $0.09 per share, for the quarter ended December 31, 2017. The Company reported a net loss of $15,482,000 or $0.16 per share, for the year ended December 31, 2018, compared with a net loss of $29,203,000 or $0.39 per share, for the year ended December 31, 2017.

As of December 31, 2018, the Company had a total of approximately $99,558,000 in cash, equivalents, and marketable securities.

Key Highlights from 2018

ARQ 531, our potent and reversible dual inhibitor of both wild-type and C481S-mutant BTK. Successfully progressedrecruitment in our ongoing phase 1 dose escalation trial in 2018, enrolling over 20 patients at 7 dose cohorts ranging from 5mg to 65mg QD. Data from this trial was presented at 3 major conferences (AACR, EHA (Free EHA Whitepaper), ASH (Free ASH Whitepaper)) in 2018 and demonstrated a good safety profile, profound target engagement and encouraging signs of dose-dependent clinical activity in both lymphomas and C481S-mutant CLL
Miransertib, our potent and selective first-generation AKT inhibitor. Presented first-of-its kind clinical data in Proteus syndrome and PROS at the American Society of Human Genetics (ASHG), received FDA Fast Track Designation in PROS, and worked with regulators to define registrational trial designs for both indications
ARQ 751, our highly potent and selective next-generation AKT inhibitor. Progressed the phase 1 basket trial in R/R or metastatic cancer patients harboring an AKT, PI3K or PTEN mutation, identified a recommended phase 2 dose of 75mg QD and presented data at the EORTC/AACR/NCI congress in November
Derazantinib, our FGFR inhibitor, partnered with Basilea and Sinovant, in a registrational trial for intrahepatic cholangiocarcinoma. Continued the timely recruitment and transfer of clinical and other responsibilities to Sinovant and Basilea following the outlicensing to both companies in February and April of last year, respectively
Capital Structure. Strengthened our capital structure through business development activities, which included funding from our collaborators and a successful offering of our common stock which raised gross proceeds of about $70 million
Stock Index Inclusions. Added to the family of Russell 2000 Index companies in June and the NASDAQ Biotechnology Index in December
Key Catalysts & Goals for 2019

ARQ 531: Dual BTK Inhibitor in B-Cell Malignancies

Complete the dose escalation portion of phase 1 trial
Determine a recommended phase 2 dose and initiate expansion cohort(s)
Present results of dose escalation phase 1 trial at major industry conference(s)
Miransertib: AKT Inhibitor in Proteus syndrome and PROS

Finalize regulatory interactions with the FDA
Initiate registrational trial cohorts in both Proteus syndrome and PROS
ARQ 751 (and Miransertib): AKT Inhibitors in Oncology

Complete recruitment in ongoing clinical trials
Present data sets at major medical conferences this year
Derazantinib: FGFR Inhibitor in iCCA

Complete the orderly and timely transfer of all clinical, manufacturing and regulatory responsibilities to our partners, Basilea and Sinovant
"2018 was a watershed year for ArQule," remarked Paolo Pucci, Chief Executive Officer. "The clinical progress we made across the entire portfolio positions us well for an even more transformational 2019. Specifically in rare disease, we now have the ability to expand the scope of the miransertib registrational trial beyond Proteus syndrome to the PROS family of overgrowth spectrum disorders which represents a particularly exciting opportunity because of their significantly larger prevalence."

Dr. Brian Schwartz, Chief Medical Officer, added "We made tremendous progress in 2018, enrolling over 20 patients across 7 cohorts in our dose escalation study with ARQ 531 which is now positioned as the first and best in class drug candidate to address the emerging medical need in BTK mutated malignancies. We are looking forward to advance ARQ 531, miransertib and ARQ 751 respectively into the next phase of development. I want to thank our collaborators such as the Ohio State University, the National Institute of Health and Bambino Gesu’, and others for their continued support in advancing these programs."

Revenues and Expenses

Revenues for the quarter ended December 31, 2018, were $2,941,000 compared with revenues of zero for the quarter ended December 31, 2017. Revenues for the year ended December 31, 2018 were $25,764,000 compared with revenues of zero for the year ended December 31, 2017. Research and development revenue increased in 2018 due to revenue of $5.9 million from our February 2018 Sinovant licensing agreement, $18.5 million from our April 2018 Basilea licensing agreement and $1.3 million from a non-exclusive license agreement for certain of our library compounds.

Research and development expenses in the fourth quarter of 2018 were $8,850,000 compared with $4,721,000 for the fourth quarter 2017. Fiscal 2018 research and development expenses were $28,710,000 compared with $19,468,000 for fiscal 2017. The $4.1 million increase in research and development expense in the fourth quarter of 2018 compared with the fourth quarter of 2017 was primarily due to higher outsourced preclinical, clinical and product development costs of $3.5 million and $0.6 million from labor and related costs.

The $9.2 million increase in research and development expense in 2018 was primarily due to higher outsourced preclinical, clinical and product development costs of $8.5 million and $0.7 million from labor and related costs.

General and administrative expenses in the fourth quarter of 2018 were $2,739,000, compared with $1,849,000 for the fourth quarter of 2017. General and administrative expenses for fiscal 2018 were $10,753,000, compared to $7,551,000 for fiscal 2017. The $0.9 million increase in general and administrative expense in the fourth quarter of 2018 compared with the fourth quarter of 2017 was principally due to higher consulting and professional fees of $0.4 million and labor and related costs of $0.5 million. The $3.2 million increase in general and administrative expense in 2018 was principally due to higher consulting and professional fees of $2.1 million and labor and related costs of $1.1 million.

2019 Financial Guidance

For 2019, ArQule expects revenue to range between $3 and $5 million. Net loss is expected to range between $40 and $43 million, and net loss per share to range between $(0.37) and $(0.39) for the year. ArQule expects to end 2019 with between $60 and $63 million in cash and marketable securities.

Conference Call and Webcast

ArQule will hold its fourth quarter and full year financial results call today, March 7, 2019 at 9:00 a.m. ET. The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations."

On March 7, 20019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and full year of 2018 (Press release, Navidea Biopharmaceuticals, MAR 7, 2019, View Source [SID1234534123]). Navidea reported total revenues for the quarter of $119,000. Net loss attributable to common stockholders was $3.2 million.

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"Navidea had a productive quarter as we advanced the business and our novel imaging pipeline," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "While we had many successes this past quarter, we will continue to work hard to advance the science and seek the go ahead from the FDA to commence our pivotal RA diagnostic trials. Our newly reconstituted board and the addition of our new Chief Medical Officer have reinvigorated our efforts to make this company a success."

Fourth Quarter 2018 Highlights and Subsequent Events

Filed a comprehensive three-part clinical trial proposal for imaging of rheumatoid arthritis with the U.S. Food and Drug Administration ("FDA"), following end-of-Phase 2 discussions

Presented corporate overviews at the 2018 BIO Investor Forum and the 2018 LD Micro Annual Event

Presented data on the Manocept platform at the 2018 ACR Annual Meeting and at the 2018 Radiological Society of North American Scientific Assembly and Annual Meeting

Received notification of acceptance by the NYSE American of the Company’s plan to regain compliance with continued listing standards; also received an extension of the deadline to remedy the low stock price to March 31, 2019

Won dismissal of Platinum litigation

Announced release of a letter by the FDA to the U.S. Patent and Trademark Office ("USPTO") indicating that the USPTO is allowed to extend the patent for Lymphoseek through May 2025

Appointed Adam D. Cutler and S. Kathryn Rouan, Ph.D. to the Navidea Board of Directors

Hired Michael S. Rosol, Ph.D. as Navidea’s Chief Medical Officer

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414, LLC in March 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

Total revenues for the fourth quarter of 2018 were $119,000, compared to $395,000 in the same period of 2017. The decrease was primarily due to a reduction in grant revenue related to SBIR grants from the NIH supporting Manocept development. Total revenues for the full year of 2018 were $1.2 million, compared to $1.8 million in 2017. The decrease was primarily due to a reduction in grant revenue, offset by increased license revenue related to the sublicense of NAV4694 to Meilleur. Revenue in both years included other revenue from our marketing partners in Europe and China related to development work performed at their request.

Research and development ("R&D") expenses for the fourth quarter of 2018 were $854,000, compared to $1.7 million in the same period of 2017. R&D expenses for the full year of 2018 were $4.2 million, compared to $4.5 million in 2017. The decrease in both periods was primarily due to net decreases in Manocept development costs for clinical trials, coupled with decreased compensation costs resulting from headcount reduction.

Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2018 were $1.4 million, compared to $2.2 million in the same period of 2017. SG&A expenses for the full year of 2018 were $7.7 million, compared to $11.2 million during 2017. The net decrease in both periods was primarily due to decreased legal and professional services, as well as decreased general office, insurance, depreciation, rent, and travel expenses, offset by termination costs associated with the resignation of our former CEO in 2018.

Navidea’s net loss attributable to common stockholders for the fourth quarter of 2018 was $3.2 million, or $0.02 per share (basic), compared to a net loss attributable to common stockholders of $4.1 million, or $0.03 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the full year of 2018 was $16.1 million, or $0.09 per share (basic), compared to net income attributable to common stockholders of $74.9 million, or $0.47 per share, in 2017.

Navidea ended the fourth quarter of 2018 with $4.3 million in cash and investments.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

Event:

Fourth Quarter 2018 Earnings and Business Update Conference Call

Date:

Thursday, March 7, 2019

Time:

5:00 pm (Eastern Time)

U.S. & Canada Dial-in:

877-407-0312

Conference ID:

13687788

Webcast Link:

View Source

The recorded conference call can be replayed and will be available for 90 days following the call, available on the investor relations page of Navidea’s corporate website at www.navidea.com.

On March 7, 2018 Amgen (NASDAQ:AMGN) reported its Board of Directors declared a $1.45 per share dividend for the second quarter of 2019. The dividend will be paid on June 7, 2019, to all stockholders of record as of the close of business on May 17, 2019 (Press release, Amgen, MAR 7, 2019, View Source;p=RssLanding&cat=news&id=2390572 [SID1234534167]).

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On March 7, 2019 Apellis Pharmaceuticals, Inc., (Nasdaq:APLS) a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, reported the pricing of its underwritten public offering of 6,000,000 shares of its common stock at a public offering price of $17.00 per share, for total gross proceeds of $102 million, before deducting underwriting discounts and commissions and expenses payable by Apellis (Press release, Apellis Pharmaceuticals, MAR 7, 2019, View Source [SID1234534062]). All of the shares in the offering are being sold by Apellis. In addition, Apellis has granted the underwriters a 30-day option to purchase up to 900,000 additional shares of its common stock at the public offering price, less the underwriting discount and commissions. The offering is expected to close on March 11, 2019, subject to customary closing conditions.

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Citigroup, J.P. Morgan and Cowen are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. is acting as lead manager for the offering.

The shares are being offered by Apellis pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC") on December 28, 2018 and amended on February 26, 2019. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (631) 274-2806.

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

On March 7, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that members of the Company’s management team will participate at several upcoming conferences (Press release, Atara Biotherapeutics, MAR 7, 2019, View Source [SID1234534078]):

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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 and Company 39th Annual Health Care Conference

Isaac Ciechanover, M.D., the Company’s President and Chief Executive Officer, will give a presentation on Tuesday, March 12, 2019 at 10:00 a.m. EDT. The conference will be held at the Boston Marriott Copley Place in Boston, MA.
Memorial Sloan Kettering 3rd Annual Clinical Application of CAR T Cells Conference

Chris Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will participate in the Industry Session on Thursday, March 14, 2019 at 4:35 p.m. EDT. The conference will be held at the Zuckerman Research Center in New York, NY.
William Blair 9th Annual Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper)

Chris Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will present on Wednesday, March 20, 2019 at 11:00 a.m. EDT. The conference will be held at the Apella Event Space Alexandria Center in New York, NY.
Alliance for Regenerative Medicine 7th Annual Cell & Gene Therapy Investor Day

Chris Haqq, M.D., Ph.D., the Company’s Executive Vice President of Research and Development and Chief Scientific Officer, will participate in a panel titled "Cell Therapy for Solid Tumors" on Thursday, March 21, 2019 at 1:30 p.m. EDT. The Conference will be held at the Metropolitan Club in New York, NY.
Jefferies 6th Annual IO Cell Therapy Summit

Dietmar Berger, M.D., Ph.D., the Company’s Global Head of Research and Development, will present on Friday, April 5, 2019. The conference will be held at the Boston Harbor Hotel in Boston, MA and the time of the presentation will be available on Atara’s investor events webpage by March 29.
Live audio webcasts of the presentations at the Cowen and Company 39th Annual Health Care Conference and Alliance for Regenerative Medicine 7th Annual Cell & Gene Therapy Investor Day will be available by visiting the Investor Events and Presentations section of the Atara website. An archived replay of each webcast will be available on the Company’s website for 14 days following the conclusion of each presentation.