On December 13, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Claus Møller, MD, Ph.D., Chief Executive Officer of Y-mAbs Therapeutics will provide an overview and update on the company’s business at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Y-mAbs Therapeutics, DEC 13, 2018, View Source [SID1234532065]). The presentation will take place on Thursday, January 10, 2019, at 8:00 AM Pacific Standard Time.

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On December 13, 2018 Veru Inc. (NASDAQ: VERU) reported its financial results for the fiscal (FY) 2018 fourth-quarter and full-year ended September 30, 2018 (Press release, Veru, DEC 13, 2018, View Source [SID1234532047]).

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"Our fiscal 2018 fourth-quarter and full-year financial results improved significantly driven by increased US demand for the FC2 Female Condom / FC2 Internal Condom (FC2) and improving gross profit," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. For the fiscal 2018 fourth quarter, net revenues increased 41% to $5.2 million and gross profit grew by 78% to $3.2 million over the prior-year period."

"We continue to see increasing US Rx demand and related improving gross profit for our FC2 product through the first two months of the current fiscal quarter as well. For example, US FC2 Rx net revenues were 15% of total global FC2 net revenues in all channels for FY 2018. Q4 FY 2018 US FC2 Rx net revenues were 67% of total US FC2 Rx net revenues for the full FY 2018. Already through the first two months of the current fiscal year 2019, US FC2 Rx net revenues are at 120% of Q4 FY 2018 US FC2 Rx net revenues.

The Company also was granted a significant tender award for FC2 from the Republic of South Africa, which could generate approximately $30 million of future net revenues spread over a three-year period. No orders from this new South African tender are reflected in the FY 2018 financial results.

"Importantly, Veru is rapidly transforming into a biopharmaceutical company with a strong focus on prostate cancer with several drugs under development to provide a continuum of care for these cancer patients. To that end, earlier this quarter we announced that we have begun enrolling patients for our zuclomiphene citrate Phase 2 clinical trial for the treatment of hot flashes caused by androgen deprivation therapy for men with advanced prostate cancer with "top line" results, or general summary data, expected in the first half of FY 2019.

"In addition, in November, we submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for VERU-111 (bisindole), a first-in-class, next generation, proprietary, oral tubulin inhibitor for the treatment of metastatic prostate cancer. We expect this drug to advance into an open label Phase 1b/2 clinical trial by no later than early January 2019. We also announced earlier this month that the first patient was dosed in our bioequivalence study of Tadalafil (Cialis) and Finasteride (PROSCAR) combination tablet for benign prostatic hyperplasia (BPH). This combination tablet is designed to improve patient compliance and convenience with bioequivalency results expected in January 2019.

"Regarding our existing portfolio of commercial products, we have expanded our FC2 presence in the US market by partnering with a leading telemedicine marketing and sales channel, as well as utilizing a contracted independent sales force. For PREBOOST we recently entered into a US distributor agreement with a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the internet."

"In early October, just after the close of our fiscal year, we strengthened our balance sheet, completing an underwritten public stock offering that generated $9.2 million of net proceeds. We intend to use the proceeds for working capital and general corporate purposes, including research and development, clinical trials and marketing expenditures."

"In summary, our accomplishments over the past year further solidify our foundation and position Veru for future success. In the coming year, we look to build on these achievements with the planned submission to the FDA of New Drug Applications for Tadalafil and Finasteride combination tablets and Tamsulosin XR capsules and sprinkles. We look to continue our transformation into a biopharmaceutical company with a strong focus on prostate cancer treatment and prostate cancer supportive care with several drugs to provide a continuum of care for these patients."

Fiscal 2018 Fourth-Quarter Results

For the fiscal 2018 fourth-quarter, net revenues, which were primarily derived from sales of FC2, rose 41% to $5.2 million from $3.7 million for the fourth-quarter of fiscal 2017. Gross profit increased by 78% to $3.2 million, or 61% of net revenues, compared with $1.8 million, or 49% of net revenues, for the fourth-quarter of fiscal 2017. Operating expenses were $7.0 million compared with $4.6 million for the fourth-quarter of fiscal 2017. Non-operating income was $63 thousand compared with non-operating expenses of $32 thousand for the fourth-quarter of fiscal 2017. Income tax expense was $4.2 million compared with an income tax benefit of $0.1 million in the fourth-quarter of fiscal 2017. Net loss was $7.9 million, or $0.14 per share, compared with net loss attributable to common stockholders of $4.7 million, or $0.10 per share, for the fourth-quarter of fiscal 2017.

Fiscal 2018 Full-Year Results

For the fiscal 2018 full-year, net revenues, which were primarily derived from sales of FC2, climbed 16% to $15.9 million from $13.7 million for fiscal 2017. Gross profit increased 23% to $8.8 million, or 55% of net revenues, compared with $7.0 million, or 51% of net revenues, for fiscal 2017. Operating expenses were $29.7 million compared with $15.5 million for fiscal 2017. Non-operating expenses were $2.2 million compared with $0.1 million for fiscal 2017. Income tax expense was $0.9 million compared with an income tax benefit of $2.0 million in fiscal 2017. Net loss was $23.9 million, or $0.44 per share, compared with net loss attributable to common stockholders of $8.6 million, or $0.25 per share, for fiscal 2017.

As of September 30, 2018, cash (including restricted cash) was $3.8 million. Subsequent to September 30, 2018, the Company completed a stock offering that generated net proceeds of approximately $9.2 million after deducting underwriting discounts and commissions and expenses payable by the Company.

Conference Call Event Details

Veru Inc. will host a conference call today at 8 a.m. ET to review the company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706, and asking to be joined into the call.

In addition, investors may access a replay of the conference call the same day beginning at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for US callers, or 412-317-0088 from outside the U.S., passcode 10126693. The replay will be available for one week, after which, the recording will be available via the company’s website at View Source

On December 13, 2018 XBiotech Inc. (NASDAQ: XBIT) reported the publication of findings on key biomarker analysis of colorectal cancer patients treated with bermekimab in its European Phase III study (Press release, XBiotech, DEC 13, 2018, View Source;p=RssLanding&cat=news&id=2380559 [SID1234532049]). The manuscript, entitled, "Interleukin-1 Receptor Antagonist (IL-1ra) Levels Predict Favorable Outcome after Bermekimab, a First-in-Class True Human Interleukin-1α Antibody, in a Phase III Randomized Study of Advanced Colorectal Cancer", has been published online in the journal OncoImmunology.

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The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—which tend to worsen with advanced cancer, to assess whether these symptoms stabilized or improved with treatment. Patients that achieved the primary endpoint in the Phase III study had one-fifth as many serious adverse events, were twice as likely to have no tumor growth, improved significantly with all life quality measures, and had almost three-fold increase in survival compared to failures.

Results from Dr. Razelle Kurzrock’s analysis found that for patients with relatively low IL-1ra levels at the start, 41% of those treated with bermekimab achieved the primary endpoint, compared to only 33% of patients for the entire bermekimab treatment group (19% of placebo patients achieved the primary endpoint). However, in the publication it is reported that for those with relatively low pretreatment levels of both IL-1ra and IL-6, 46% of patients in the bermekimab group versus only 17% in placebo achieved the primary endpoint (p<0.01). About 28% of patients in the study met the criteria of low IL-1ra and low IL-6.

Dr. Razelle Kurzrock, lead author of the publication, is Chief, Division of Hematology and Oncology, and Director, Center of Personalized Cancer Therapy at Moores Cancer Center UC San Diego. Dr. Kurzrock commented, "These findings help us better identify patients with advanced cancer who can benefit from a targeted therapy that interrupts the inflammatory process, thereby decreasing tumor growth and cancer-related morbidity. We hope that these results will help lead us to the effective use of bermekimab in cancer therapy."

About Razelle Kurzrock, M.D.
Dr. Kurzrock is a medical oncologist and a renowned expert in precision medicine. She is a thought leader in the use of anti-cytokine therapies for the treatment of cancer and one of the first to recognize the importance of the interleukin-1 pathway in cancer. While at the University of Texas MD Anderson Cancer Center, Dr. Kurzrock built one of the most successful Phase 1 clinical trials programs in the nation, and was the senior author in the pioneering study for XBiotech’s colorectal cancer study. Dr. Kurzrock currently serves as: Senior Deputy Director for Clinical Science, Murray Professor of Medicine, Director for the Center for Personalized Cancer Therapy and Clinical Trials Office, and a Team Leader for Experimental Therapeutics at the Moores Cancer Center at UC San Diego. Dr. Kurzrock is also Chief of the Hematology & Oncology Division in the UC San Diego School of Medicine. Dr. Kurzrock serves on XBiotech’s Scientific Advisory Board.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On December 13, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported the pricing of an underwritten public offering of 3,000,000 shares of its common stock at a price to the public of $10.00 per share (Press release, Tocagen, DEC 13, 2018, View Source;p=RssLanding&cat=news&id=2380494 [SID1234532050]). The gross proceeds from the offering are expected to be approximately $30.0 million, before deducting the underwriting discounts and commissions and other offering expenses. The offering is expected to close on or about December 17, 2018, subject to customary closing conditions. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 450,000 shares of Tocagen’s common stock at the public offering price, less the underwriting discounts and commissions.

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Citigroup and Leerink Partners are acting as joint book-running managers for the offering.

The securities described above are being offered by Tocagen pursuant to a shelf registration statement on Form S-3 filed by Tocagen with the Securities and Exchange Commission (SEC), which was declared effective on May 23, 2018. A preliminary prospectus supplement and accompanying prospectus related to the offering was filed with the SEC and is available for free on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus related to this offering, when available, may be obtained from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the 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 Decembber 13, 2018 Incyte Corporation (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of January (Press release, Incyte, DEC 13, 2018, View Source [SID1234532052]):

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Goldman Sachs 11th Annual Healthcare CEOs Unscripted: A View from the Top Conference on Thursday, January 3, 2019 at 11:00 am (EST) in New York; and
J. P. Morgan 37th Annual Healthcare Conference on Monday, January 7, 2019 at 1:30 pm (PST) in San Francisco
The presentations will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcast should log on before the start time in order to download any software required.