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Zhejiang Medicine and Ambrx Present Positive Top Line Data from a Phase 1a/1b Clinical Trial of ARX788 in Metastatic HER2 Positive Breast Cancer

On December 12, 2019 Zhejiang Medicine, NovoCodex and Ambrx reported positive interim topline data from the ongoing "111" trial (CTR20171162) evaluating ARX788, a novel anti-HER2 ADC, in heavily pretreated patients with metastatic HER2 positive breast cancer (Press release, Zhejiang Medicine, DEC 12, 2019, View Source [SID1234552312]). All patients enrolled had failed prior therapy with trastuzumab and 47% had failed therapy with trastuzumab and lapatinib.

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ARX788 was well tolerated at all dose levels with just two ≥ Grade 3 drug related reversible adverse events observed amongst 51 enrolled patients. ARX788 showed an excellent safety profile with dose escalation continuing. No DLT or MTD was observed as of the November 20, 2019 cut-off date.

Response rates correlated with increased dose levels. As of the cut-off date, the highest dose tested was 1.5mg/kg every three weeks. This cohort, which continues dosing and remains under observation, had already achieved a 63% overall response rate. Prior cohorts at 0.88, 1.1 and 1.3 mg/kg demonstrated overall response rates of 14%, 36% and 56% respectively. Further, the substantial increases in efficacy observed at higher doses was achieved with only mild increases in toxicity.

These data originate from the Fudan University Shanghai Cancer Center in China and are part of a broader global ARX788 development program (NCT03255070 and CTR20171162) that includes clinical sites in China, USA and Australia.

The 42nd Annual San Antonio Breast Cancer Symposium Poster is available at www.ambrx.com

Zhejiang Medicine licensed the commercial rights to ARX788 in China in 2013. The promising clinical data for ARX788 serves as a solid foundation to the second and more recent collaboration. Earlier this year, Ambrx and Zhejiang Medicine (via its subsidiary NovoCodex) entered into their second collaboration to develop and commercialize ARX305 in China. ARX305 is an anti-CD70 Antibody Drug Conjugate for the potential treatment of Renal Cell Carcinoma, Multiple Myeloma, and other solid tumors.

About HER2-Positive Breast Cancer

Almost 300,000 new cases of HER2 positive breast cancer may be diagnosed in 2020 in the US alone (approximately 15-20% of breast cancers are HER2 positive). HER2 positive breast cancer tends to be aggressive and more likely to recur than HER2 negative. There are currently no approved therapies demonstrating progression-free survival or overall survival benefit for the treatment of patients with HER2 positive metastatic breast cancer after progression on T-DM1 (which is not approved in China).

Aurinia Closes US$191.7 Million Public Offering of Common Shares and Full Exercise of Underwriters’ Option to Purchase Additional Common Shares

On December 12, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported the closing of its previously announced underwritten public offering of 12,782,439 common shares, including 1,667,274 common shares pursuant to the full exercise of the underwriters’ option to purchase additional common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, DEC 12, 2019, View Source [SID1234552310]). The shares were sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are approximately US$191.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

Jefferies LLC and SVB Leerink LLC acted as joint book-running managers for the Offering. H.C. Wainwright & Co. LLC, Oppenheimer & Co. Inc., and Bloom Burton Securities Inc. acted as co-managers for the Offering.

For the purposes of the TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, as well as working capital and general corporate purposes.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on March 29, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated March 26, 2018. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents are available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement are available upon request by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

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

Applied DNA Reports 2019 Year End and Fiscal Fourth Quarter Financial Results

On December 12, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic development reported consolidated financial results for the full fiscal year and quarter ended September 30, 2019 (Press release, Applied DNA Sciences, DEC 12, 2019, View Source [SID1234552309]).

"In fiscal 2019 total revenues increased 38%, and total operating expenses decreased by 5% as we sharpened our focus on our ability to produce linear DNA at scale for our tagging, diagnostics and preclinical biotherapeutic businesses," said Dr. James A. Hayward, chairman, president and CEO of Applied DNA.

Added Dr. Hayward, "Over the past year we focused on elevating the Company’s profile for preclinical biotherapeutics and diagnostic applications. With the Company’s unique ability – approximately 130 patents and patents pending – to produce large quantities of ultra-pure linear DNA, the Company’s linear DNA manufacturing platform is a potential industry disrupter that offers therapeutic developers a replacement to plasmid DNA that we believe is cheaper, faster and easily scalable. Over the past 15 months, we developed a robust pipeline of more than 15 contract research opportunities with top cancer, gene therapy, vaccine and RNA partners, which is already generating initial revenue."

"The recent acquisition of the assets and IP of Vitatex, Inc. gives us a second compelling branch to the linear DNA story that we believe lends itself to the diagnostics, prognostics and therapeutics of invasive circulating tumor cells (iCTC). Within just three months of acquisition, we signed an agreement with Tyme Technologies, Inc. for the supply of our Vita-AssayTM iCTC capture assay and associated services for iCTC detection in their pivotal stage pancreatic cancer clinical trial. In addition, our protocols for obtaining and studying iCTCs in colorectal cancer have recently been approved by an Institutional Review Board."

Continued Dr. Hayward, "Within our product authenticity and traceability solutions segment, our textile business, led by an experienced sales team, broadened awareness and adoption of our CertainT platform. Expanding beyond our relationship with Himatsingka for cotton home textiles, we established a technology partnership that gives us entrée into the cotton apparel market. We continued the global implementation of our tagging platform by completing commercial scale pilots at approximately 20 textile manufacturing sites using varied materials throughout China, Southeast Asia and India. In synthetic textiles, brands and retailers are increasingly relying on materials that offer high performance, sustainability and transparency and the promise of circular manufacturing. Our efforts have yielded strategic alliances that position us alongside key participants along multiple points in the global textile value chain to more broadly drive adoption of our authentication technology platform. We have begun to integrate our CertainT platform to provide end-to-end material traceability to multiple related categories, including leather, wool, down and feather, specialty coatings and additives, recycled PET, viscose, and other synthetics. We believe we are well positioned for uptake by brands and retailers."

Concluded Dr. Hayward, "Looking ahead, we have set our sights on generating top-line growth from our linear DNA manufacturing platform, that should be driven by textiles and cannabis, as well as biotherapeutic and diagnostics, as we begin to convert our business-building activities in fiscal 2019 into pre-commercial and commercial revenues in fiscal 2020. Having recently completed an equity raise, re-established our compliance with the Nasdaq listing requirements, and eliminated our Going Concern opinion, we have our strongest balance sheet in years and the financial resources to support a sustainable growth trajectory."

2019 Full Fiscal Year Financial Highlights

Revenues for fiscal 2019 totaled $5.4 million, an increase of 38% from $3.9 million from the prior fiscal year. The increase in revenues was due to an increase in service revenues of $1.2 million, or 57%, and an increase in product revenues of $308 thousand, or 17%. The increase in revenue was primarily attributable to an increase of $1 million from our now terminated cannabis licensing agreement, as well as an $889 thousand increase in textiles relating to shipments of DNA concentrate to protect the cotton supply chain. These increases in revenue were offset by a decrease in consumer asset marking sales.
·Effective October 1, 2018, the Company was required to adopt Accounting Standards Update (ASU; the "Update") No. 2014-09, Revenue from Contracts with Customers (Topic 606), utilizing the modified retrospective method. Had the Company not adopted the Update, the Company would have recognized additional revenue of approximately $915 thousand during fiscal 2019. This amount was primarily comprised of the recognition of $766 thousand during the twelve-month period ended September 30, 2019, under a $1.15 million cotton order shipped in June 2018, with extended payment terms. The total cumulative impact of the Update that was recorded to opening retained earnings in fiscal 2019 was approximately $493 thousand. See Cumulative Effect Adjustment and the Impact on Current Period Financial Statements of Adopting Topic 606 attached.
·Operating expenses for the fiscal year ended September 30, 2019 decreased by $707 thousand or 5% as compared to the prior fiscal year. The decrease is primarily attributable to approximately an $890 thousand decrease in payroll, due to a realignment of the sales force and reductions in overall headcount. This decrease in payroll was offset by an increase in legal fees.
·Net loss for the twelve months ended September 30, 2019 was $8.6 million or $9.69 per share, compared with a net loss of $11.7 million or $15.86 per share for the twelve months ended September 30, 2018, an improvement of 26%.
·Excluding non-cash expenses and interest, Adjusted EBITDA for the fiscal year ended September 30, 2019 was a negative $7.6 million as compared to a negative $9.8 million for the prior fiscal year, an improvement of 22%. See below for information regarding non-GAAP measures.

Fiscal Fourth Quarter 2019 Financial Results:

·Revenues increased 40% for the fourth quarter of fiscal 2019 to $1.7 million, compared with $1.2 million reported in the same period of the prior fiscal year and decreased 19% from $2.1 million for the third quarter of fiscal 2019. The increase in revenues year over year was due primarily to an increase in product revenues from shipments of DNA concentrate to protect the cotton supply chain. The decrease in revenue quarter over quarter was due to the recognition of $1 million in revenue from a licensing agreement in the cannabis industry during the third fiscal quarter of fiscal 2019.
·Total operating expenses decreased to $3.2 million for the fourth fiscal quarter of 2019, compared with $4.4 million in the prior fiscal year’s fourth quarter. This decrease is primarily attributable to an approximate $231 thousand decrease in payroll, due to a realignment of the sales force and reductions in overall headcount as well as a decrease of $954 thousand in stock-based compensation expense.
·Net loss for the quarter ended September 30, 2019 was $1.2 million, or $1.44 per share, compared with a net loss of $3.5 million, or $4.62 per share, for the quarter ended September 30, 2018, an improvement of 69%, and a net loss of $1.5 million, or $1.60 per share, for the quarter ended June 30, 2019.
·Excluding non-cash expenses, Adjusted EBITDA was negative $1.6 million and a negative $2.2 million for the quarters ended September 30, 2019 and 2018, respectively. See below for information regarding non-GAAP measures.

Select Recent Operational Highlights:

·On November 26, Applied DNA’s majority-owned subsidiary focused on next-generation biotherapeutics and diagnostics, LineaRx, signed a definitive agreement with Tyme Technologies, Inc. to supply the Company’s Vita-AssayTM invasive Circulating Tumor Cell (iCTC) capture assay and associated services for use in the pivotal stage of the TYME-88-PANC clinical trial for patients with third-line pancreatic cancer. The potential value of the Agreement is the largest contract to-date for LineaRx, and we believe the largest in the development history of the iCTC assay;
·On November 12, the Company announced the successful DNA tagging of leather at one of the world’s largest tanneries based in Asia. The work follows a successful research project undertaken within the UK that demonstrated SigNature DNA could be successfully used to trace the hide of an animal from a farm to the product in a store;
·On October 16, Applied DNA announced that it had entered into a partnership with Molecular Isotope Technologies, LLC ("MIT LLC"), a pioneer and leader in the application of natural-abundance stable-isotopic analysis provided under the trademarks Nature’s Fingerprint and IsoPedigree. MIT LLC’s technology utilizes stable isotopic "fingerprints" as a method for verification of product origin and supply chain processing to support product claims. MIT LLC’s technology will be offered by Applied DNA as an additional component of its CertainT platform to tag, test and track raw materials and finished goods. MIT LLC will support and promote the CertainT platform as a service complementary to its own;
·On October 1, LineaRx announced that its invasive Circulating Tumor Cells (iCTCs) platform demonstrated superior correlation over Prostate Specific Antigen (PSA) in an ongoing Phase II trial in recurrent prostate cancer. The Company believes that the study shows that iCTCs may be used to accurately follow therapy success in prostate cancer while also providing new tools for cell and gene therapy design and production;
·On September 24, the Company announced that it received a $1 million order to supply SigNature T taggant for cotton in the upcoming 2019 – 2020 ginning season that began in October. The Company’s SigNature T technology, paired with its genotyping and digital systems, will be used to tag, test and track the Pima cotton variety grown in the San Joaquin Valley, California that is sold under the PimaCott brand nationwide and online by the largest home goods retailer in the U.S. Since 2014, and including the cotton tagged with this order, over 250 million pounds of cotton will have been tagged as the key to a total end-to-end traceability solution that is substantiated by forensic test data;
·On September 19, LineaRx announced that its collaborators Takis/Evvivax have completed pre-clinical animal studies of two vaccine candidates produced with linear DNA. Tests of both vaccines in mouse models demonstrated their ability to eliminate tumors in vivo, and to potentially prevent initial occurrence. Clinical data accumulated from linear DNA vaccines for companion animals can be used to accelerate translation to human therapies by Evvivax and Takis;
·On September 5, Applied DNA announced a sales and marketing partnership with Navarpluma that extends the Company’s Textiles business to include the global down and feather supply chain. Navarpluma S.L., one of the world’s premier suppliers of down and feathers to the textile industry, will be the first to offer this new system to its customer base that counts some of the world’s most prestigious brands as clients.

Fiscal Fourth Quarter 2019 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal fourth quarter-end 2019 results on Thursday, December 12, 2019 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free:1-844-887-9402
·Participant Toll: 1-412-317-6798
Please ask to be joined to the Applied DNA Sciences call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through December 19, 2019):

·Participant Toll Free: 1-877-344-7529
·Participant Toll: 1-412-317-0088
·Participant Passcode: 10136194
·Webcast replay: View Source

For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

Entry into a Material Definitive Agreement

On December 12, 2019, Amgen reported that it entered into a second amended and restated revolving credit agreement with Citibank, N.A., as administrative agent ("Citibank"), JPMorgan Chase Bank, N.A., as syndication agent, and the other banks party thereto, for a total commitment of $2.5 billion (Filing, 8-K, Amgen, DEC 12, 2019, View Source [SID1234552308]). Financing under the revolving credit agreement is available for general corporate purposes, including as a liquidity backstop to our commercial paper program. The commitments under the revolving credit agreement may be increased by up to $750 million in the aggregate upon our request at the discretion of the banks and subject to certain customary requirements. The commitments of each bank under the revolving credit agreement have an initial term of five years and may be extended for up to two additional one year periods upon our request at the discretion of the respective bank, subject to certain customary requirements. The revolving credit agreement amends and restates our existing revolving credit agreement dated as of July 30, 2014.

Advances under the revolving credit agreement will bear interest at an annual rate of, at our option, either (i) the applicable LIBOR rate (or EURIBOR rate for certain advances denominated in Euros) plus between 0.700% and 1.125%, depending on the rating of our senior long-term unsecured debt or (ii) the highest of (A) Citibank’s base commercial lending rate, (B) the overnight federal funds rate plus 0.50% and (C) one month LIBOR plus 1.00%, plus between 0.000% and 0.125%, depending on the rating of our senior long-term unsecured debt. The revolving credit agreement contains provisions relating to the determination of successor rates to address the possible phase-out or unavailability of designated reference rates under the revolving credit agreement. We have also agreed to pay a fee for committed funds under the revolving credit agreement, whether used or unused, of between 0.05% and 0.125% per annum depending on the rating of our senior long-term unsecured debt. The revolving credit agreement includes a $300 million sub-limit for issuances of letters of credit.

The revolving credit agreement contains customary affirmative and negative covenants, including limitations on mergers, consolidations and sales of assets; limitations on liens and sales and leasebacks; limitations on transactions with affiliates and limitations on subsidiary indebtedness. In addition, the revolving credit agreement requires maintenance of a minimum consolidated interest coverage ratio of EBITDA to total interest expense, each on a consolidated basis.

The description of the revolving credit agreement above does not purport to be complete and is qualified in its entirety by reference to the revolving credit agreement, which is filed as Exhibit 10.1 to this report.

Veru Reports Fiscal 2019 Full-Year Net Revenues Doubled, Gross Profit Up 147%

On December 12, 2019 Veru Inc. (NASDAQ: VERU), The Prostate Cancer Company, an oncology and urology biopharmaceutical company developing novel medicines for the management of prostate cancer, reported that its fiscal 2019 full-year net revenues doubled to $31.8 million and gross profit increased 147% to $21.7 million (Press release, Veru, DEC 12, 2019, View Source [SID1234552306]).

"For both the fiscal 2019 fourth quarter and full year, we continue to generate impressive increases to net revenues and gross profit compared with the prior year," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "The robust ramp up of prescription as well as global public sector sales of FC2 and increased consumer demand for our PREBOOST/Roman Swipes product drove the significantly improved financial performance."

"I would like to highlight on the clinical development front, VERU-111 — our proprietary, oral, next generation, first-in-class, selective antitubulin – as it continues to show antitumor activity and no dose related toxicity in men with metastatic castration resistant prostate cancer. VERU-111 appears to be well tolerated with no evidence of neutropenia, neurotoxicity or allergic (hypersensitivity) reactions that typically occur with IV taxane chemotherapy. To date, our Phase 1b/2 clinical study has enrolled and dosed 33 patients from 4.5 mg per day up to 81 mg per day. The study will continue to enroll patients using increasing doses of VERU-111 until maximum tolerated dose is observed.

"Although this study was designed for determination of safety, we do see evidence of significant antitumor activity. Historical controls from the literature report that the time to imaging based tumor progression in men like those enrolled in our study averages about 2-3 months. In our Phase 1b/2, we have 20 men in the study that had the potential to be treated for 4.5 months. Even without having an optimal dose or dose schedule yet determined, there are 4 men who are still ongoing in the trial with no progression at 9.75, 8.4, 8.4 and 5.6 months. All of these men have prostate-specific antigen (PSA) reductions. We have another 6 men that progressed at 4.2 months. The patient who has reached 9.75 months had a PSA reduction of -63% and has had 2 of his cancerous lymph nodes shrink as measured by CT scan. Another patient in the study with stable disease stopped losing weight, reported that his fatigue resolved, and had a PSA reduction."

"Based on reports in the scientific literature, it appears that just like cabazitaxel, VERU-111 is a very active compound in metastatic castration resistant prostate cancer, and it seems to perform better than adding another androgen blocking agent in a similar patient population. VERU-111 appears to be well tolerated with a wide safety margin. Wide safety margin means that we are seeing anticancer activity at doses where we are not seeing drug toxicity. We plan to present full clinical results for this ongoing Phase 1b/2 at a future major scientific meeting.

Dr. Steiner added: "Since VERU-111 has signs of antitumor activity and an acceptable safety profile, we plan to expand and initiate in early 2020 three additional Phase 2 studies where we had demonstrated significant preclinical anticancer activity: metastatic pancreatic cancer, metastatic breast cancer and postchemotherapy (taxane) metastatic castration resistant prostate cancer. This clearly positions Veru as an oncology company with a novel oral agent that selectively targets alpha and beta subunits of tubulin."

"We also plan to submit the Investigation New Drug (IND) application for VERU-100 – our long-acting 3-month subcutaneous depot gonadotropin-releasing hormone (GnRH) antagonist for the treatment of hormone sensitive advanced prostate cancer – in early 2020. Regarding our Phase 2 clinical trial of zuclomiphene citrate, our proprietary drug to treat hot flashes caused by androgen deprivation therapy in men with advanced prostate cancer, we expect top line clinical data by no later than next month."

"Growing strong revenues from our base business will continue to support not only the current Phase 1b/2 VERU-111 oral selective antitubulin clinical trial and other VERU-111 Phase 2 clinical trials for different tumor types, but also the completion of the Phase 2 zuclomiphene citrate trial, and the planned Phase 2 VERU-100 3-month depot GnRH antagonist clinical trial in 2020. We are very pleased with the significant clinical progress we are making in advancing our entire product development program."

Full-Year Financial Highlights: Fiscal 2019 vs Fiscal 2018

Net revenues rose 100% to $31.8 million from $15.9 million;

Gross profit climbed 147% to $21.7 million, or 68% of net revenues, from $8.8 million, or 55% of net revenues;

FC2 US prescription revenue increased more than five-fold to $14.1 million from $2.4 million;

FC2 public sector net revenues were $16.8 million, a 25% increase from $13.5 million;

Operating loss significantly narrowed to $6.4 million from $20.9 million;

Net loss was $12.0 million, or $0.19 per share, compared with $23.9 million, or $0.44 per share; and,

At September 30, 2019, cash and accounts receivable were $11.3 million, an increase of $3.6 million from $7.7 million at the end of the prior year.

Fourth-Quarter Financial Highlights: Fiscal 2019 vs Fiscal 2018

Net revenues increased 68% to $8.7 million from $5.2 million;

Gross profit increased to $5.8 million, or 67% of net revenues, from $3.2 million, or 61% of net revenues;

FC2 US prescription net revenues increased nearly three-fold to $4.7 million from $1.6 million;

Operating loss significantly narrowed to $1.5 million from $3.8 million; and

Net loss was $3.1 million, or $0.05 per share, compared with $7.9 million, or $0.14 per share.

Based on our resources on hand and the anticipated performance of our commercial businesses together with already existing sources of capital, the Company believes that it has sufficient resources to execute our clinical drug trial programs through year end 2021.

Pharmaceutical Products Development Program Highlights

VERU-111. VERU-111 is an oral, next generation, first-in-class, selective small molecule that targets and binds to the alpha and beta antitubulin subunits of microtubules in cells. VERU-111 is being evaluated in a Phase 1b/2 clinical trial in men who have metastatic prostate cancer and whose disease is resistant to both castration and novel androgen blocking agents (abiraterone or enzalutamide). The objective of this clinical trial is to determine the dose limiting toxicity of VERU-111. At this point, 33 men in total have received doses of VERU-111, with each separate cohort receiving a higher dose. In clinical observations, VERU-111 has been well-tolerated with a favorable safety profile, and no dose limiting toxicity has been observed. There has been no neutropenia, neurotoxicity, or allergic (hypersensitivity) reactions which typically occur with IV taxane chemotherapy. In some of the men whose PSA blood levels were rapidly rising, a marker of cancer progression, as well as bone scans and/or CT scans showing cancer lesions progression at enrollment, treatment with VERU-111 resulted in PSA stabilizations and reductions consistent with early promising signals of anticancer efficacy. Furthermore, some patients have also demonstrated arrested progression of CT and/or bone scan cancer lesions beyond 8 and 9 months. Once a dose limiting toxicity level has been reached, a dose will be selected for evaluation in the Phase 2 clinical study. There are no drugs that are FDA approved to treat men who have both castration and novel androgen blocking agent resistant prostate cancer and which are also prechemotherapy (chemotherapy naïve), representing an estimated global market of $4.5 billion annually. As VERU-111 has signs of antitumor activity and an acceptable safety profile, the Company plans to expand and initiate in early 2020 three additional Phase 2 studies where we had demonstrated significant preclinical anticancer activity: metastatic pancreatic cancer, metastatic breast cancer and postchemotherapy (taxane) metastatic castration resistant prostate cancer.

VERU-100. VERU-100 is a long-acting 3-month subcutaneous depot GnRH antagonist for the treatment of hormone sensitive advanced prostate cancer. Currently, there are no GnRH antagonists commercially approved beyond 1 month, which would make VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot. Based on regulatory clarity obtained in the pre-IND meeting with the FDA in May 2019, the Company plans to submit the IND application for VERU-100 in early 2020. Androgen deprivation therapy for advanced prostate cancer is an established multi-billion-dollar global market.

Zuclomiphene Citrate. Zuclomiphene citrate is a novel, proprietary, oral, nonsteroidal, estrogen receptor agonist being evaluated as a treatment for hot flashes caused by androgen deprivation therapy for men with advanced prostate cancer. Hot flashes, also known as vasomotor symptoms, are one of the main reasons why men want to stop androgen deprivation therapy. There have been no reports of gynecomastia, breast pain, or venothromboembolic events (blood clots in legs or lungs, or stroke) in the Intent to Treat safety database in the Phase 2 clinical study which are side effects commonly seen with off label use of steroidal estrogens and progestins for hot flashes in these patients. Top line clinical data results are expected by no later than next month. An independent market analysis sponsored by the Company estimates potential U.S. sales for zuclomiphene citrate to be between $600-800 million annually.

TADFIN (Tadalafil and Finasteride Combination Capsule). TADFIN is being developed for benign prostatic hyperplasia (BPH) and would be the first combination of a PDE5 inhibitor and 5 alpha reductase inhibitor. The Company had a successful preNDA meeting with the FDA in May 2019. After the Company has 12-month stability data on manufacturing batches, the Company will submit an NDA for TADFIN which is expected in the second half of 2020. BPH is an established multi-billion-dollar market.

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 U.S. callers, or 412-317-0088 from outside the U.S., passcode 10136891. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source