On February 13, 2019 Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company developing novel medicines for the prostate cancer continuum of care and urology specialty pharmaceuticals, reported financial results and business highlights for its fiscal 2019 first quarter ended December 31, 2018 (Press release, Veru, FEB 13, 2019, View Source [SID1234533313]).

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Fiscal 2019 First Quarter Financial Results

Company net revenues up 146% to $6.4 million from $2.6 million in the prior-year first quarter. Company reported FC2 Female Condom / FC2 Internal Condom (FC2) sales growth in both its prescription business and in its public sector business;

Company gross profit up 254% to $4.6 million from $1.3 million in the prior-year first quarter;

Company gross margin increased to 73% from 51% in the prior-year first quarter;

FC2 prescription business net revenues up 1,500% to $2.4 million from $0.15 million in the prior-year first quarter. Compound Annual Growth Rate (CAGR) of 100% over last five quarters for net revenues of FC2 prescription business;

FC2 public sector business net revenues up 60% to $3.9 million from $2.4 million in the prior-year first quarter;

CAGR of 25% over the last five quarters for net revenues of total FC2 business;

Commercial Segment (FC2, PREBOOST and drug commercialization costs) operating income was $3.7 million versus $0.1 million in the prior-year first quarter;

Operating loss significantly narrowed by 86% to $1.0 million from $7.4 million in the fiscal 2018 first quarter (the fiscal 2018 first quarter included a $3.8 million loss for the settlement of Brazilian receivables); and

Net loss of $2.1 million, or $0.03 per share, was significantly less than $4.3 million, or $0.08 per share, in the first quarter of fiscal 2018.

"We are pleased to report strong financial results in the fiscal 2019 first quarter, including excellent topline growth, substantially higher gross profit and a significantly lower operating loss," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. "The improvement was driven by increased sales of FC2 in our prescription business as well as in our public sector business. We recently changed the sales strategy of our FC2 prescription business, which has a higher gross margin, making the growth of that part of our business particularly gratifying. Growing prescription sales of FC2 should help smooth out some of the fluctuations in total FC2 net revenues that we have historically seen due to ordering patterns related to our FC2 public sector business."

Recent Business and Operational Highlights

Announced the Company’s strategy to become known as "the prostate cancer company" and to provide a "continuum of care" for prostate cancer patients. Prostate cancer remains the second most frequent cause of cancer deaths in men and drugs to manage prostate cancer are large market opportunities. Our drug development and drug commercial activities will largely align with the clinical management of prostate cancer patients. Anticipated revenue from our urology specialty pharma business and existing commercial products will help to support these efforts; .

Initiated a Phase 1b/2 clinical trial and enrolled patients for VERU-111, a novel, proprietary, next generation, first-in-class oral selective antitubulin agent that targets and disrupts alpha and beta tubulin for advanced prostate cancer and potentially other cancers, with clinical data expected in 2019. Drugs for advanced prostate cancer currently have over $3 billion in U.S. annual sales;

Initiated a Phase 2 clinical trial and enrolled patients for zuclomiphene citrate, a novel, proprietary, oral, nonsteroidal, estrogen receptor agonist to treat hot flashes caused by androgen deprivation therapy, or hormone treatment for men with advanced prostate cancer; top line results expected Summer 2019. Based on an independent market analysis sponsored by the Company, the Company estimates the U.S. market potential for zuclomiphene citrate is over $600 million annually;

Completed a successful bioavailability and bioequivalence clinical trial for the Company’s proprietary tadalafil and finasteride combination tablet (TADFIN) for benign prostatic hyperplasia with a New Drug Application (NDA) to be submitted in 2019 and approval expected in 2020. BPH is an established multi-billion-dollar market;

Signed a multi-year exclusive supply and distribution agreement to supply the Company’s PREBOOST premature ejaculation wipes to Roman Health Ventures Inc., a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the internet;

Four abstracts accepted for presentation for VERU-111 and zuclomiphene citrate at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February 2019;

Three abstracts accepted for presentation for VERU-111 at the European Association of Urology Congress in March 2019; and

One abstract accepted for presentation for VERU-111 at the American Urological Association Annual Meeting in May 2019.

"We are focused on advancing our pipeline of drug candidates for the continuum of care for prostate cancer, which have a combined addressable market of multiple billions of dollars, noted Dr. Steiner. We continue to run a lean operation, with our existing commercial businesses helping to fund the development of our prostate cancer and our urology specialty pharmaceuticals. Even after costs associated with all of our pharmaceutical clinical development programs in the most recently completed quarter, our operating loss significantly narrowed to approximately a $1 million loss for the quarter. Anticipated strong growth in revenues from our current commercial products combined with anticipated new revenue from our TADFIN for BPH, which we expect to launch in 2020, should allow us to continue to significantly invest in our prostate cancer proprietary pharmaceuticals, to seek strong commercialization partnerships, and to access large, well-established urology and prostate cancer markets around the globe."

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 from outside the U.S. and asking to be joined into the Veru Inc. 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 10128045. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source

On February 12, 2019 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its second quarter ended December 31, 2018 (Press release, Palatin Technologies, FEB 12, 2019, View Source [SID1234533237]).

Recent Highlights and Program Updates

Female Sexual Dysfunction / Vyleesi (bremelanotide)
●Vyleesi, the trade name for bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):

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The Prescription Drug User Fee Act ("PDUFA") date for completion of FDA review of the Vyleesi New Drug Application ("NDA") was extended three months to June 23, 2019.

The U.S. Food and Drug Administration ("FDA") requested a Phase 1 study in premenopausal volunteers assessing short term daily use of Vyleesi. This study is ongoing and is being conducted by Palatin and AMAG Pharmaceuticals, our exclusive licensee for North America.

Study results are anticipated to be submitted to the FDA prior to the updated PDUFA date.

Palatin is in discussions with potential collaboration partners for certain regions outside of the licensed territories of North America, China and South Korea.

Anti-Inflammatory / Autoimmune Programs
●Melanocortin receptor 1 and 1/5 ("MC1r", "MC1/5r") agonists under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases:

PL-8177, a selective MC1r peptide agonist:

Completed subcutaneous dosing of human subjects in a Phase 1 single and multiple ascending dose clinical safety study, with no safety or tolerability concerns noted in a press release dated November 8, 2018.

A separate clinical study with oral dosing in human subjects was started during the quarter ended December 31, 2018, with data expected in the first quarter of calendar year 2019.

Program is under internal evaluation for orphan designations.

PL-8331 and PL-9643, dual MC1r and MC5r peptide agonists:

Continuing with preclinical Investigational New Drug ("IND") enabling activities.

Program is under internal evaluation for orphan designations.

Natriuretic Peptide Receptor ("NPR") System Program
●We have designed and are developing potential NPR candidate drugs that are selective for one or more different natriuretic peptide receptors, including natriuretic peptide receptor-A ("NPR-A"), natriuretic peptide receptor B ("NPR-B"), and natriuretic peptide receptor C ("NPR-C"):

PL-3994, an NPR-A agonist that has potential utility in treatment of a number of cardiovascular diseases, including genetic and orphan diseases resulting from a deficiency of endogenous active NPR-A.

Academic collaborations with several institutions ongoing.

PL-5028, a dual NPR-A and NPR-C agonist in development for cardiovascular diseases, including reducing cardiac hypertrophy and fibrosis.

Academic collaborations with several institutions ongoing.

Genetic Obesity Program
●Melanocortin receptor 4 ("MC4r") peptide PL-8905 and orally-active small molecule PL-9610 under development for the treatment of rare genetic metabolic and obesity disorders:

Program is under internal evaluation for orphan designations.

Corporate
●Decreased debt and related liabilities from $7.2 million at June 30, 2018 to $2.8 million at December 31, 2018.

Second Quarter Fiscal 2019 Financial Results
Palatin reported a net loss of $(5.0) million, or $(0.02) per basic and diluted share, for the quarter ended December 31, 2018, compared to net income of $3.0 million, or $0.02 per basic and $0.01 per diluted share, for the same period in 2017.

The difference in financial results between the three months ended December 31, 2018 and 2017 was primarily attributable to the recognition of $10.6 million in license and contract revenue during the 2017 period pursuant to our license agreement with AMAG.

Revenue
There were no revenues recorded in the quarter ended December 31, 2018.

For the quarter ended December 31, 2017, 100% of the revenue Palatin recognized was related to our license agreement with AMAG.

Operating Expenses
Total operating expenses for the quarter ended December 31, 2018 were $5.1 million compared to $7.7 million for the comparable quarter of 2017. The decrease in operating expenses was mainly attributable to the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA in HSDD in March 2018.

Other Income/Expense
Total other income, net was $7,871 for the quarter ended December 31, 2018 compared to total other expenses, net $(0.3) million for the quarter ended December 31, 2017. The difference is related primarily to the decrease in interest expense related to Palatin’s venture debt.

Income Tax
There was no income tax expense, or benefit, recorded in the quarter ended December 31, 2018.

Pursuant to the license agreements with Fosun and Kwangdong, $500,000 and $82,500, respectively, was withheld in accordance with tax withholding requirements in China and the Republic of Korea, respectively, and was recorded as an expense during the fiscal year ended June 30, 2018. For the quarter ended December 31, 2017, Palatin recorded $100,880 in income tax expense related to those withholding amounts utilizing an estimated effective annual income tax rate applied to income for the quarter and the remaining balance of $256,365 was included in prepaid expenses and other current assets at December 31, 2017. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin’s valuation allowance. The $100,880 of income tax expense was offset by a $500,000 tax benefit that Palatin recorded in the quarter ended December 31, 2017 related to the release of a valuation allowance against Palatin’s federal alternative minimum tax credit as a result of the Tax Cuts and Jobs Act signed in December 2017. Accordingly, $500,000 was included in other long-term assets at December 31, 2017.

Cash Position
Palatin’s cash, and cash equivalents were $24.7 million as of December 31, 2018, compared to cash and cash equivalents of $38.0 million at June 30, 2018. Current liabilities were $4.5 million as of December 31, 2018, compared to $10.8 million as of June 30, 2018.

Palatin believes that existing capital resources will be sufficient to fund our planned operations through at least March 31, 2020.

Palatin Drug Discovery Programs
In the conference call and webcast, management will update and discuss next steps in Palatin’s portfolio of drug development programs. These include Palatin’s MC1r and MC1/5r agonist peptides for treatment of anti-inflammatory and autoimmune indications, MC4r peptide and small molecule agonists for the treatment of genetic obesity indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and pulmonary indications.

Conference Call / Webcast
Palatin will host a conference call and webcast on February 12, 2019 at 11:00 a.m. Eastern Time to discuss the quarter ended December 31, 2018 results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-877-260-1479 (US/Canada) or 1-334-323-0522 (international), conference ID 4414047. The webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 4414047. The webcast and telephone replay will be available through February 19, 2019.

On February 12, 2019 Provectus (OTCQB: PVCT) reported that orphan drug designation (ODD) status was granted by the U.S. Food and Drug Administration (FDA) to small molecule oncolytic immunotherapy PV-10 for the treatment of ocular melanoma (to include all melanoma disease affecting the eye and orbit) (Press release, Provectus Biopharmaceuticals, FEB 12, 2019, View Source [SID1234533258]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death (ICD) in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.1-4

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Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.

Preliminary data from Provectus’ uveal melanoma expansion cohort of its Phase 1 "basket study" of PV-10 for the treatment of cancers metastatic to the liver were presented in a poster presentation at the 15th International Congress of the Society for Melanoma Research (SMR 2018 Congress) in late-2018: a total of four patients had received PV-10 for at least one uveal melanoma liver tumor, two patients had received a second round of PV-10 treatment to an additional liver tumor, and one patient initiated standard of care immunotherapy (Opdivo + Yervoy) between PV-10 treatments; treatment-related adverse events were consistent with established patterns; and, tumor reduction was observed in 5 of 6 PV-10-injected tumors. A copy of the poster presentation is available on the Company’s website.

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. ODD status qualifies companies for benefits that include seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.

ODD status previously was granted to PV-10 for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, and neuroblastoma in 2018.

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

On February 12, 2019 Anchiano Therapeutics Ltd. (Nasdaq and TASE: ANCN) ("Anchiano") reported that it has priced its initial public offering of 2,652,174 of its American Depositary Shares ("ADSs"), each representing five ordinary shares of Anchiano, at $11.50 per ADS, less underwriting discounts and commissions (Press release, Anchiano Therapeutics, FEB 12, 2019, View Source [SID1234533277]). The ADSs are expected to begin trading on the Nasdaq Capital Market ("Nasdaq") under the symbol "ANCN" on February 12, 2019, and the offering is expected to close on or about February 14, 2019.

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The underwriters have been granted a 30-day option to purchase up to an additional 397,826 ADSs offered by Anchiano to cover over-allotments, if any.

In the offering, Oppenheimer & Co. Inc. is acting as the sole book-running manager, Ladenburg Thalmann is acting as lead manager and LifeSci Capital LLC is acting as co-manager.

The offering is being made only by means of a prospectus, copies of which can be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at [email protected].

A registration statement relating to these securities was filed with and declared effective by the U.S. Securities and Exchange Commission on February 11, 2019. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 their registration or qualification under the securities laws of any such state or jurisdiction

On February 12, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its fourth quarter/fiscal year 2018 financial results on Tuesday, February 26, 2019, before the open of the U.S. financial markets (Press release, Clovis Oncology, FEB 12, 2019, View Source [SID1234533259]). Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss Q4/FY 2018 results on Tuesday, February 26, at 8:30am ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.393.4306, International participants 734.385.2616, conference ID: 6675335.