On May 15, 2019 AC Immune SA (NASDAQ: ACIU), a Swiss-based, biopharmaceutical company with a broad clinical-stage pipeline focused on pioneering Precision Medicine in neurodegenerative diseases, reported financial results for the first quarter ended March 31, 2019 (Press release, AC Immune, MAY 15, 2019, View Source [SID1234536344]).

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Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "Our CHF 300 million cash position, funds operations through Q3 2023, allowing us to achieve multiple potentially transformative goals. This is thanks to SupraAntigen and Morphomer, our proprietary discovery platforms, which already have generated multiple clinical and preclinical product-candidates and about CHF 300 million in partnering revenues for rights to our industry-leading therapeutic candidates to treat neurodegenerative diseases. We expect multiple developments in 2019, including initiation of a Phase 1 trial of small molecule Tau Morphomer, as we advance our new partnership with Eli Lilly, and the interim Phase 1b data on ACI-24 to treat Alzheimer’s disease (AD) in Down syndrome."

"Our key near- to medium-term focus is on developing our Tau therapies to treat early and moderate AD based on the growing body of clinical evidence that Tau pathology drives disease progression," added Dr Pfeifer. "As the key opinion leaders have advised, we also are continuing testing of Abeta therapeutics, like ACI-24 and crenezumab, in carefully selected more homogeneous populations for early treatment and prevention, such as AD in Down syndrome patients and familial AD, respectively. The Roadmap to successful therapies for neurodegenerative diseases like Alzheimer’s requires that we treat earlier in the course of disease and select more homogenous populations using Precision Medicine and, as soon as practical, combination therapies."

Financial Highlights Q1 2019

Enhanced cash position of more than CHF 300 million as of Q1 2019, following receipt of CHF 80 million upfront payment and USD 50 million convertible equity note as a result of license agreement with Eli Lilly, effective in January 2019.
Strategic R&D expenditures increased by CHF 1.5 million (+15%) supporting an ongoing ramp-up in R&D activities, primarily driven by investments in our neurodegenerative disease therapeutics development and discovery programs, most notably ACI-35.
IFRS net income of CHF 63.6 million and Non-IFRS income of CHF 60.7 million.

Research & Development Highlights Q1 2019

License agreement signed with Lilly to research and develop Tau aggregation inhibitor small molecules for the potential treatment of Alzheimer’s disease and other neurodegenerative diseases. The terms include upfront payment of CHF 80 million, USD 50 million convertible equity note, CHF 60 million in potential near-term milestones, as well as other milestones up to approximately CHF 1.68 billion, and tiered royalty payments in the low double digits.
Presented new data on alpha-synuclein PET Tracer at the Alzheimer’s and Parkinson’s Diseases Congress (AD/PD) Lisbon, Portugal, March 26–31, 2019.
New clinical data on AC Immune’s novel next generation Tau PET-Tracer presented by licensing partner, Life Molecular Imaging, at AD/PD.
Genentech, a member of Roche Group, commenced recruitment for a second Phase 2 trial of AC Immune’s anti-Tau monoclonal antibody, RG6100 (MTAAU9937A, RO7105705), in moderate AD, supplementing a separate Phase 2 trial to evaluate its efficacy and safety in participants with prodromal to mild AD.
Roche discontinued CREAD 1 and CREAD 2, Phase 3 studies of crenezumab and presented an interim analysis of CREAD studies at AD/PD on March 27, 2019.
The landmark Alzheimer’s Prevention Initiative (API) trial of crenezumab, for which data are expected in Q1 of 2022, is continuing in cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at high risk of developing familial AD.

Analysis of Financial Statements for the Three Months Ended March 31, 2019

Revenues

Revenues for the first quarter of 2019 increased CHF 73.6 million compared to 2018, driven by recognition of CHF 73.9 million from the right-of-use license and research and development activities. Revenues fluctuate as a result of payments associated with our collaborations with current and potentially new partners, the timing of milestone achievements and the size of each milestone payment.
Research & Development (R&D) Expenses

Total R&D expenditures increased CHF 1.5 million (+15%) for the three months ended March 31, 2019 compared to 2018.
General & Administrative (G&A) Expenses

For the three months ended March 31, 2019, G&A increased CHF 0.6 million (+22%) to CHF 3.3 million. Increase driven by rental and personnel expenses.
IFRS Income/(Loss) for the period

AC Immune had net income after taxes of CHF 63.6 million in 2019 compared with a net loss of CHF 11.6 million for the comparable period in 2018.
Balance Sheet

The Company had a total cash balance of CHF 302.1 million comprised of CHF 222.1 million in cash and cash equivalents and CHF 80.0 million in short-term financial assets. This compares to CHF 186.5 million as of December 31, 2018. The increase of CHF 115.6 million is principally due to the CHF 80 million upfront payment and USD 50 million convertible equity note with Lilly. Further details are available in our Statements of Cash flows on the accompanying Form 6-K.
The Company’s strong cash balance provides enough capital resources to progress through at least Q3 2023, not considering any incoming milestones.
The total shareholders’ equity position increased from December 31, 2018 to CHF 241.9 million from CHF 177.6 million. Further details are available in our corresponding Financial Statements filed on the accompanying Form 6-K.

On May 15, 2019 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the first quarter ended March 31, 2019 (Press release, Cleveland BioLabs, MAY 15, 2019, View Source [SID1234536339]).

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Cleveland BioLabs reported a net loss of $(0.9) million, excluding minority interests, for the first quarter of 2019, or $(0.08) per share, compared to a net loss, excluding minority interests, of $(1.2) million, or $(0.11) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced research and development activity due to previously disclosed vendor delays in in the analytical analyses required to complete the biocomparability study and a decrease in General and Administrative costs partially offset by an increase in the non-cash adjustment to our warrant liabilities. The biocomparability study was completed during the first quarter.

As of March 31, 2019, the Company had $3.3 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into December 2019.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The development, pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our top priority.

Further Financial Results

Revenue for the first quarter of 2019 decreased to $0.20 million compared to $0.23 million for the first quarter of 2018. The net decrease was primarily attributable to decreased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure partially offset by increased revenue from our service contract with Incuron.

Research and development costs for the first quarter of 2019 decreased to $0.5 million compared to $1.3 million for the first quarter of 2018. The reduction in research and development costs is due to a $0.57 million reduction in spending for biodefense applications of entolimod, $0.26 million decrease in expenses related to the oncology applications of the entolimod family of compounds, and a $0.04 million reduction in spending on Panacela’s product candidates partially offset by a $0.05 million increase in expenses related to the Curaxins.

General and administrative costs for the first quarter of 2019 decreased to $0.47 million compared to $0.73 million for the first quarter of 2018. This decrease was primarily attributable to $0.15 million decrease in property tax expense, $0.06 million decrease in expense relating to a one-time settlement for the previously completed research contracts with the Russian Ministry of Trade, and $0.05 million decrease in legal and professional fees.

On May 15, 2019 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported financial results for the quarter ended March 31, 2019 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein (Press release, Celsion, MAY 15, 2019, View Source [SID1234536338]). The Company’s lead program is ThermoDox, which is currently in Phase III development for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer. The Company’s immunotherapy candidate, GEN-1, is currently in Phase I/II development for the localized treatment of newly diagnosed Stage III/IV ovarian cancer.

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"Celsion continues to make significant progress with our two ongoing clinical development programs for ThermoDox and GEN-1. With sound fundamentals and a strong balance sheet, we are well positioned to see our clinical programs through transformative milestones over the next year. We are looking forward to the first of two preplanned, interim efficacy analyses for the Phase III OPTIMA Study expected in the second half of 2019 and mid-2020, respectively. This global, pivotal study completed patient enrollment in August 2018 at over 65 clinical sites in 14 different countries, including all of the markets where primary liver cancer is a major problem," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Our Phase I/II OVATION 2 Study in newly diagnosed ovarian cancer is now recruiting patients and continues to work through the activation of up to 31 clinical sites by the end of this year. Importantly, enrollment of patients in the Phase I portion of the study is expected to be complete and initial data reported by the end of 2019. This promising clinical development program in immunotherapy has generated impressive results in previous trials."

Recent Developments

ThermoDox

Issuance of New U.S. Patent for ThermoDox. On April 17, 2019, the Company announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,251,901 B2 – Thermosensitive Nanoparticle Formulations and Method of Making the Same, which is directly applicable to the method of treating cancer using a new ThermoDox formulation. The claim covers a method for preparing (as well as the composition of) a doxorubicin sulfate temperature-sensitive liposome and extends coverage time over ThermoDox’s current patent portfolio to 2033. This new patent broadens our intellectual property portfolio providing for life cycle management of ThermoDox well into the future.

Publication of ThermoDox Study Results in the Peer-Reviewed Journal, Radiology. On January 17, 2019, the Company announced that results from the Phase I TARDOX trial of ThermoDox conducted at the University of Oxford, United Kingdom, were published in the peer-reviewed journal, Radiology. The findings published in Radiology serve as a companion paper to the groundbreaking work published in Lancet Oncology in July 2018. This was the first published study to evaluate ThermoDox when combined with high-intensity focused ultrasound (HIFU). The Radiology publication was accompanied by an editorial highlighting the significance of utilizing HIFU to safely deliver oncologically relevant concentrations of doxorubicin with ThermoDox.

The article, titled, "Focused Ultrasound Hyperthermia for Targeted Drug Release from Thermosensitive Liposomes: Results from a Phase I Trial," included an evaluation of the TARDOX results and the safety, efficacy and utility of treatment with ThermoDox plus targeted, non-invasive ultrasound in patients with solid liver tumors, with treatment plans based on patient-specific modeling.

The Phase I TARDOX study was carried out as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering, the Oncology Clinical Trials Office (OCTO) and the Oxford University Hospitals NHS Foundation Trust and evaluated patients with inoperable primary or secondary liver tumors who had previously received chemotherapy. In this trial, 10 patients received a single intravenous dose of 50 mg/m2 of ThermoDox, and ultrasonic heating of target tumors was monitored in six participants using a minimally invasive temperature sensor, while four patients were treated without real-time thermometry. The study demonstrated that focused ultrasound exposure with ThermoDox resulted in increased chemotherapy concentrations within liver tumors that were an average of 3.7 times greater than preheating levels across all 10 patients in the study.

Safety was assessed by analysis of magnetic resonance imaging (MRI) and biopsy specimens for evidence of thermal ablation, as well as adverse event monitoring. There was no evidence of focused ultrasound-related adverse effects, including thermal ablation.GEN-1 Immunotherapy

Presentation of GEN-1 Clinical Development Program at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. On March 4, 2019, the Company announced the oral presentation of data highlighting the safety, clinical response and translational data from the OVATION I Study by Premal H. Thaker, M.D., M.S., a nationally recognized expert in gynecologic oncology, Associate Professor of Obstetrics and Gynecology at the Siteman Cancer Center at the Washington University School of Medicine in St. Louis at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium.

Dr. Thaker’s presentation highlighted the following:

●The Phase IB OVATION I Study, which evaluated escalating doses of GEN-1 (36 mg/m2, 47 mg/m2, 61 mg/m2 and 79 mg/m2) administered intraperitoneally in combination with three cycles of neoadjuvant chemotherapy (NAC) prior to interval debulking surgery, followed by three cycles of NAC in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer, demonstrated median PFS of 21 months in patients treated per protocol (n=14) and 17.1 months for the intent-to-treat population (n=18) for all dose cohorts, including three patients who dropped out of the study after 13 days or less, each of which compared favorably to the PFS historical average of 12 months for women with Stage III/IV ovarian cancer.
● Of the 14 patients who were evaluable for response, 100% of patients administered NAC plus the two higher doses of GEN-1 experienced an objective tumor response (defined as a partial or complete response) compared to only 60% of patients given the two lower doses.
●Patients in the two higher dose cohorts also had a high surgery success rate, with 88% of these patients achieving the optimal outcome of a complete (R0) resection. 100% of patients treated at the highest dose cohort had a complete R0 resection.
●Pre- and post-treatment levels of key ovarian cancer biomarkers were also measured as part of this study and showed marked reduction in immunosuppressive response across multiple biomarkers post-treatment, including FOXP3 and IDO-1 – an outcome not previously observed with NAC treatment alone.

Corporate Development

Celsion Participated in Two Investor Conferences. During May 2019, the Company attended the ThinkEquity Conference on May 2, 2019 at The Mandarin Oriental Hotel in New York City and the Deutsche Bank 44th Annual Health Care Conference on May 7-8, 2019 at The InterContinental Hotel in Boston. A webcast of Celsion’s presentation at the ThinkEquity Conference may be accessed by visiting the "News & Investors" section of Celsion’s corporate website. The format of the Deutsche Bank Health Care Conference was comprised of one-on-one and small group meetings with leading institutional investors.

Celsion Completed an Amendment to the Asset Purchase Agreement with EGEN, Inc. On March 28, 2019, the Company entered into an amendment to the June 6, 2014 Asset Purchase Agreement for the acquisition of substantially all of the assets of EGEN, Inc. The Amendment provides that payment of the $12.4 million earnout milestone liability under the Asset Purchase Agreement related to the Ovarian Cancer Indication can be made, at the Company’s sole discretion, in the following manner:

a)7.0 million in cash to EGWU within 10 business days of achieving the milestone; or

b)$12.4 million to EGWU, which is payable in cash, common stock of the Company, or a combination of either, within one year after achieving the milestone.

Additionally, the Amendment extends the Earnout Term as it applies to the Ovarian Cancer Milestone from seven (7) years to eight (8) years from the original signing date of the Asset Purchase Agreement. As consideration for entering into the Amendment, the Company will issue to EGWU 200,000 warrants to purchase common stock with an exercise price of $0.01 per share. The Company recorded this transaction in the first quarter of 2019.

Financial Results

For the quarter ended March 31, 2019, Celsion reported a net loss of $2.3 million ($0.12 per share) compared to a net loss of $4.5 million ($0.25 per share) for the quarter ended March 31, 2018. Operating expenses were $5.0 million for the quarter ended March 31, 2019, which represented a $0.6 million (13.6%) increase, from $4.4 million in the same period of 2018. During the first quarter of 2019, the Company incurred $0.7 million in non-cash stock option expense compared to $0.2 million in the comparable prior-year period.

Cash, cash equivalents, short-term investments and interest receivable at March 31, 2019 was $23.8 million. Cash provided by financing activities was approximately $1.8 million during the quarter ended March 31, 2019. Net cash used for operating activities was $5.5 million for the quarter ended March 31, 2019, compared to $4.6 million in the comparable prior-year period.

Research and development costs were $2.8 million for the quarter ended March 31, 2019 compared to $2.7 million for the quarter ended March 31, 2018. Clinical development costs for the Phase III OPTIMA Study were $0.9 million for the current quarter compared to $1.3 million for the same period of 2018. This $0.4 million decrease resulted from the completion of enrollment for this 556-patient trial in August 2018. Costs associated with the OVATION studies were $0.1 million for each of the quarters ended March 31, 2019 and 2018. The Company announced the completion of enrollment of all cohorts of the OVATION I Study in 2017 and the initiation of the follow-on Phase I/II OVATION 2 Study during 2018. Costs associated with Celsion’s wholly-owned subsidiary, CLSN Laboratories, Inc. (which includes research and development activities for GEN-1, TheraPlas and TheraSilence) were $0.6 million in each of the quarters ended March 31, 2019 and 2018 as the Company continues to expand its manufacturing capabilities and implemented programs to reduce manufacturing costs for GEN-1. In the first quarter of 2019, other clinical costs included an increase of $0.2 million in non-cash stock compensation expense compared to the same period of 2018.

General and administrative expenses were $2.2 million for the quarter ended March 31, 2019, compared to $1.7 million for the quarter ended March 31, 2018. This $0.5 million increase was due to higher compensation expenses totaling $0.5 million in 2019 compared to 2018. Compensation expenses include costs associated with new personnel additions as well as an increase of $0.3 million related to non-cash stock option compensation expense in 2019 compared to the prior year.

Other expenses included a non-cash gain of $2.7 million, net of charge a $0.4 million for the 200,000 warrant issuance related to an amendment for the potential milestone payments for the GEN-1 ovarian product candidate during the quarter ended March 31, 2019, compared to a non-cash charge of $270,000 for the quarter ended March 31, 2018. The Company realized $0.1 million of interest income from its short-term investments during the first quarter of 2019 and 2018. In connection with the Company’s new venture debt facility with Horizon in June 2018, the Company incurred interest expense of $0.4 million during the first quarter of 2019 compared to no interest expense in the first quarter of 2018.
First Quarter Conference Call

The Company is hosting a conference call to provide a business update and discuss its first quarter 2019 financial results at 11:00 a.m. EDT on Wednesday, May 15, 2019. To participate in the call, interested parties may dial 1-800-263-0877 (Toll-Free/North America) or 1-646-828-8143 (International/Toll) and ask for the Celsion Corporation First Quarter 2019 Earnings Call (Conference Code: 1231968) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at www.celsion.com. The call will be archived for replay on Wednesday, May 15, 2019 and will remain available until May 29, 2019. The replay can be accessed at 1-719-457-0820 or 1-888-203-1112 using Conference ID: 1231968. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. EDT Wednesday, May 15, 2019.

On May 15, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Leap Therapeutics, MAY 15, 2019, View Source [SID1234536337]).

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"In the first quarter, we presented important new data for both of our programs. DKN-01’s activity continues to be impressive in biomarker targeted patient populations, with single agent partial responses in patients with endometrial cancer. In addition, TRX518 achieved a first partial response as a monotherapy and as a combination therapy with gemcitabine," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "We are looking forward to presenting additional clinical data from both programs in the second half of the year."

Recent Developments

·DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented clinical data from its study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. The overall response rate and disease control rate has been higher in patients with higher DKK1 expression as measured by in situ hybridization RNAscope. Enrollment in this study is complete.

·DKN-01 in GYNECOLOGICAL CANCERS: At the Society for Gynecologic Oncology 50th Annual Meeting on Women’s Cancer, Leap presented an update on its clinical study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers. DKN-01 monotherapy has generated two partial responses in patients with endometrial cancer, and DKN-01 plus paclitaxel has generated a partial response in a patient with carcinosarcoma. An additional DKN-01 monotherapy patient was initially reported by the treating investigator to have experienced a partial response; however, further follow-up identified that the patient has a tumor reduction that does not meet the threshold for a partial response and remains on treatment with ongoing clinical benefit. Eighty-seven patients have been enrolled in the study, and enrollment is ongoing.

·DKN-01 in PROSTATE CANCER: The first patient has been enrolled in an investigator-initiated study of DKN-01 as a monotherapy and in combination with docetaxel in DKK1-positive metastatic prostate cancer patients.

·TRX518 MONOTHERAPY: A non-virally mediated hepatocellular cancer patient, who has been treated with single agent TRX518 for two years, achieved a partial response. With recent disease progression, this patient now continues on treatment for clinical benefit.

· TRX518 COMBINATION THERAPY: Leap presented data from its clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA or OPDIVO (nivolumab), with patients from each combination arm experiencing responses and durable stable disease. Eighteen patients have been enrolled in the TRX518/KEYTRUDA expansion cohort, and enrollment is ongoing.
Selected First Quarter 2019 Financial Results

Net loss was $8.6 million for the first quarter 2019, compared to $10.6 million for the same period in 2018. This decrease was primarily due to a non-cash charge based on the change in the fair value of the warrant liability in the first quarter 2018, offset by an increase in clinical development expense.

Research and development expenses were $6.8 million for the first quarter 2019, compared to $4.2 million for the same period in 2018. This increase was primarily due to an increase in clinical trial expenses associated with an increase in patient enrollment and an increase in consulting fees and payroll expenses, partially offset by a decrease in manufacturing costs related to clinical trial material.

General and administrative expenses were $2.0 million for the first quarter 2019, compared to $2.1 million for the same period in 2018. This decrease was primarily due to a decrease in compensation expense as a result of senior management not accepting the cash bonus awarded to them by the compensation committee, partially offset by an increase in stock-based compensation expense.

Cash, cash equivalents and marketable securities totaled $21.7 million at March 31, 2019. Research and development incentive receivables, current and long term, totaled approximately $0.9 million at March 31, 2019.

On May 15, 2019 Veru Inc. (NASDAQ: VERU) an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer treatment and prostate cancer supportive care, reported its financial results for its fiscal 2019 second quarter ended March 31, 2019 (Press release, Veru, MAY 15, 2019, View Source [SID1234536336]).

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Business and Operational Highlights

VERU-111: Our oral, next-generation, first-in-class, alpha and beta antitubulin is being evaluated in men who have metastatic prostate cancer and whose disease is resistant to both castration and novel androgen blocking agents (abiraterone or enzalutamide). The open label Phase 1b clinical trial being conducted to determine the maximally tolerated dose is progressing. The open label Phase 2 clinical study is expected to commence in the Fall of 2019. Oral drugs for advanced prostate cancer, abiraterone and enzalutamide, had over $3 billion in U.S. annual sales in 2018 and $6 billion in 2018 global revenue. Men with metastatic castration resistant prostate cancer who have failed these novel androgen blocking agents is the population that VERU-111 is targeting which represents an estimated $4.5 billion annual global market.

Zuclomiphene Citrate: Enrollment of approximately 100 men in the Phase 2 clinical trial is progressing in approximately 17 clinical sites in the US. Top line results of the study are expected Summer 2019. Zuclomiphene Citrate is 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. Based on an independent market analysis sponsored by the Company, the expected U.S. sales potential for zuclomiphene citrate is estimated to exceed $600 million annually.

TADFIN (Tadalafil and Finasteride Combination Tablet): As previously announced, the Company completed a successful bioavailability and bioequivalence clinical trial for TADFIN for benign prostatic hyperplasia. The Company filed patent applications that, if issued, would have an expiry of 2040. NDA submission expected late 2019 to early 2020 with anticipated approval in 2020. BPH is an established multi-billion-dollar market.

"The clinical development of our proprietary drug pipeline is advancing," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "In clinical observations, VERU-111 appears to be well tolerated, with no documented complaints or evidence of neurotoxicity or neutropenia. Moreover, in a number of men whose PSA was rising prior to enrollment into the Phase 1b clinical trial, we are seeing some evidence of PSA stabilizations and reductions even at the lowest doses of VERU-111 being tested, which is a promising early indication of efficacy. As for our zuclomiphene citrate product, based on the blinded aggregate preliminary clinical data from our placebo-controlled trial, we can make the following general clinical observations: men are experiencing reductions in hot flashes; and as for safety, zuclomiphene citrate appears to be well tolerated."

Fiscal 2019 Second Quarter vs Fiscal 2018 Second Quarter Financial Results

Net revenues up 171% to $7.0 million from $2.6 million. Company reported FC2 sales growth in both its public sector and its US prescription channels;

Gross profit up 285% to $4.6 million, or 66% of net revenues, from $1.2 million, or 47% of net revenues;

FC2 US prescription channel net revenues up 753% to $2.6 million from $0.3 million;

FC2 public sector channel net revenues up 88% to $4.2 million from $2.3 million;

Financial results do not reflect the new tender orders that will be coming from South Africa. We expect new orders from South Africa to commence shipping during the third quarter of this fiscal year;

Commercial segment, which includes FC2, PREBOOST and drug commercialization costs, generated operating income of $3.2 million versus an operating loss of $163,000;

Operating loss significantly narrowed to $2.1 million from $4.7 million; and

Net loss was $4.0 million, or $0.06 per share, compared with $3.8 million, or $0.07 per share.

Fiscal 2019 Year-to-Date vs Fiscal 2018 Year-to-Date Financial Results

Net revenues up 159% to $13.3 million from $5.2 million;

Gross profit up 268% to $9.3 million, or 69% of net revenues, from $2.5 million, or 49% of net revenues;

Net revenue from the US prescription channel was up 1,000% to $5.0 million from $458,000 in the prior-year period;

Net revenue for the public sector channel was up 73% to $8.1 million from $4.7 million in the prior-year period;

Net revenue for PREBOOST/ Roman Swipes was $180,000 compared to $4,600 in the prior-year period; an increase of 3800%;

Operating loss down 74% to $3.1 million from $12.1 million (fiscal 2018 year to date included a $3.8 million loss for the settlement of Brazilian receivables); and

Net loss was $6.2 million, or $0.10 per share, compared with $8.1 million, or $0.15 per share.

"We have achieved strong operating results through the first two quarters of fiscal 2019," said Dr. Steiner. "Positive financial growth continued into our second quarter, with sequential quarterly increases to net revenues from both our FC2 US prescription and public sector channels. Growth of our US FC2 prescription channel is particularly noteworthy as it appears to be less reliant on traditional intermittent ordering patterns present in our FC2 public sector channel."

Financial Guidance

Management expects net revenues will grow to $29-32 million for the full year FY2019 which represents a 95% increase over the full year FY2018, and management expects gross margin will be approximately 66% in FY2019 compared to 55% in FY2018.

"Based on current cash on hand and expected cash from current sales forecasts, along with existing sources of capital, the Company does not anticipate the need for a new equity financing until at least fiscal 2021," said Dr. Steiner.

The Company does not expect to update the guidance for the full year fiscal 2019 provided above before the release announcing results for the next fiscal quarter. The Company notes that the statements of future performance made in this release, including the guidance for the full fiscal year 2019, are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the "Safe Harbor" Statement below.

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 noon Eastern Time by dialing 877-344-7529 for US callers, or 412-317-0088 from outside the U.S., passcode 10130716. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source