On February 12, 2020 Veru Inc. (NASDAQ: VERU), The Prostate Cancer Company, an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, reported that net revenues increased 66% and gross profit rose 57% for its fiscal 2020 first quarter ended December 31, 2019 (Press release, Veru, FEB 12, 2020, View Source [SID1234554217]).

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First-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues increased 66% to $10.6 million from $6.4 million;

Gross profit increased 57% to $7.3 million from $4.6 million;

FC2 US prescription net revenues increased 148% to $6.1 million from $2.4 million;

Operating loss was $1.8 million; and

Net loss was $3.3 million, or $0.05 per share.

"Our robust fiscal 2020 first quarter net revenues and gross profit were driven primarily by the 148% growth in prescription sales of FC2," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "Both our top line and gross profit for the period exceeded last year’s first quarter, as well as the preceding quarter. Increased public sector sales of FC2 and growing demand for our PREBOOST/Roman Swipes product were also key contributors to our positive momentum. We continue to generate significant cash to invest in the clinical development of our prostate and oncology drug pipeline. We are off to a great start for fiscal 2020.

"On the clinical development front, we are on target to complete before the end of our current quarter, the Phase 1b portion and to initiate the Phase 2 portion of the clinical trial for VERU-111, our proprietary prostate cancer product. VERU-111, an oral, next generation, first-in-class, selective antitubulin, has demonstrated preliminary antitumor activity in men with metastatic castration resistant prostate cancer and appears to be well tolerated with no evidence of treatment induced 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 39 patients from 4.5 mg per day up to 81

mg per day. The study protocol called for continuing to enroll patients until a maximum tolerated dose was reached, or some safety side effect that indicates that higher doses may not be well tolerated, was observed. There have been reported side effects consistent with VERU-111’s and other antitubulins’ cytotoxic effects, such as mostly mild to moderate diarrhea, nausea, and vomiting, which appear to be dose dependent.

"Although this study was designed for determination of safety, we do see evidence of preliminary 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 3.7 months. In our Phase 1b/2 trial, 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 11.75, 10.4, 10.4 and 7.6 months. All these men have prostate-specific antigen (PSA) reductions. We have another 6 men that progressed at 4.2 months. The patient who has reached 11.75 months had a PSA reduction of -63% and has had cancerous lymph nodes shrink as measured by CT scan and confirmed by a second CT scan. We also have another patient who at the time of enrollment had progressing prostate cancer bone metastases, show improvements of these bone metastases based on a bone scan following treatment with VERU-111. There is also evidence that these anticancer effects appear to have a dose response—meaning higher doses at 3-week cycles have more activity.

"Last month, we announced positive top line data from our Phase 2 clinical study of Zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist, for the treatment of androgen deprivation hormone therapy (ADT) induced hot flashes in men who have advanced prostate cancer. The interim results at Day 42 indicate that Zuclomiphene has clinically meaningful activity against moderate to severe hot flashes and appears to be well tolerated with no reports of estrogen related side effects like breast tenderness or enlargement or venothromboembolic events. We plan to meet with the FDA to review the development plan and based on that discussion, we anticipate initiation of the pivotal Phase 3 clinical trial to evaluate Zuclomiphene for the treatment of ADT-induced moderate to severe hot flashes in men with prostate cancer by early summer.

"Our plan is also to submit by the end of next quarter an Investigational New Drug (IND) application for VERU-100, our long-acting 3-month, small volume, subcutaneous depot gonadotropin-releasing hormone (GnRH) antagonist for the treatment of hormone sensitive advanced prostate cancer.

"TADFIN (Tadalafil and Finasteride Combination Capsule), which is being developed for benign prostatic hyperplasia (BPH) and would be the first combination of a PDE5 inhibitor and 5 alpha reductase inhibitor, is collecting 12-month stability data on manufacturing batches. The Company will submit an NDA for TADFIN which is expected in the second half of 2020. Our plan is to launch this product in the U.S. via telemedicine.

"Finally, two of our scientific abstracts have been accepted for presentation at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium and are to be presented this weekend. The first presentation will provide proof of concept preclinical data on VERU-100 as a long acting GnRH antagonist subcutaneous depot. The second presentation is a survey of the impact of hot flashes on a contemporary cohort of men with advanced prostate cancer on ADT. This is the patient population that Zuclomiphene is being developed for to address this unmet medical need."

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. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register,

download and install any necessary software. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10138979, for one week.

On February 12, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that the research team lead by Dr. Jose Conejo-Garcia, Chair of the Department of Immunology at Moffitt Cancer Center, Anixa’s development partner, has completed and validated the reformulation of the viral vector necessary for its CAR-T program (Press release, Anixa Biosciences, FEB 12, 2020, View Source [SID1234554216]).

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Last year, Anixa announced, that in order to improve the potential efficacy of its CAR-T therapy, it would reformulate the viral vector used to infect and engineer each individual patient’s T-cells. The purpose was to increase the expression level of the Follicle Stimulating Hormone (FSH) on the engineered, autologous T-cells. With the successful viral vector reformulation, verification and validation, the new viral formulation is now being manufactured under Good Manufacturing Practice (GMP) conditions. This manufacturing process is expected to take approximately three months and Anixa and Moffitt remain on track to file the Investigational New Drug (IND) application in 2020.

CAR-T therapy requires the extraction and isolation of an individual’s T-cells, followed by engineering these cells to enable them to more effectively kill cancer. These cells are then expanded and reinfused into the patient. Engineering these cells is performed by using a virus that itself has been engineered. The engineered virus initially infects the T-cells. Successive to infection, the virus induces the cellular machinery of the patient’s T-cell to create on its surface, the "homing missiles" which in the case of Anixa’s therapy are FSH molecules. It is expected that a T-cell with more FSH on the surface will be more effective at targeting ovarian cancer.

Dr. Amit Kumar, President and CEO of Anixa stated, "We are pleased to have completed this first milestone in our development program and remain confident in our previously stated development timeline."

"Our laboratory completed the reformulation of the viral vector, and we have demonstrated its ability to increase the concentration of FSH on the surface of transformed human T-cells. We expect the increased expression of FSH to provide better efficacy of our drug for ovarian cancer patients. We are looking forward to taking this therapy into the clinic as soon as possible," stated Dr. Conejo-Garcia.

On February 12, 2020 Fortress Biotech, Inc. (Common Stock: Nasdaq: FBIO) (Preferred Stock: Nasdaq: FBIOP) ("Fortress"), an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, reported that it has priced an underwritten public offering of 625,000 shares of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock at a price of $20 per share, with expected gross proceeds to Fortress of $12.5 million (Press release, Fortress Biotech, FEB 12, 2020, View Source [SID1234554215]). In addition, Fortress has granted the underwriters a 45-day option to purchase up to 93,750 additional shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about February 14, 2020, subject to customary closing conditions.

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The Benchmark Company, LLC and ThinkEquity, a division of Fordham Financial Management, Inc. are acting as joint bookrunning managers for the offering.

Fortress intends to use the net proceeds from the public offering for its operations, including, but not limited to, general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

The offering is being made by Fortress pursuant to an effective shelf registration statement on Form S-3 (File 333-226089) previously filed with the Securities Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and related prospectus supplement that form a part of the registration statement. A copy of the final prospectus supplement and accompanying prospectus related to this offering may be obtained from any of the underwriters, including the offices of The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: [email protected], and the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected]. You may also obtain these documents for free when they are available by visiting the SEC’s website at www.sec.gov.

On February 12, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the commencement of a registered underwritten public offering of $250.0 million in shares of its common stock (Press release, Deciphera Pharmaceuticals, FEB 12, 2020, View Source [SID1234554213]). In addition, Deciphera intends to grant the underwriters a 30-day option to purchase up to $37.5 million in shares of its common stock.

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J.P. Morgan, Piper Sandler and Jefferies are acting as joint book-running managers for the offering. Guggenheim Securities is acting as lead manager for the offering. SunTrust Robinson Humphrey is acting as co-manager for the offering.

Deciphera intends to use the net proceeds from the offering to fund general corporate purposes, which may include research and development and clinical development costs to support the advancement of its drug candidates, including the continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; the conduct of clinical trials and preclinical research and development activities; working capital; capital expenditures; general and administrative expenses; and other general corporate purposes.

An automatic shelf registration statement (including a prospectus) relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on February 12, 2020 and became effective upon filing. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does 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 registration or qualification under the securities laws of any such state or jurisdiction.

On February 12, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) seeking approval for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST) (Press release, Deciphera Pharmaceuticals, FEB 12, 2020, View Source [SID1234554212]). The FDA granted Priority Review for the NDA, which provides for a six-month review, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2020.

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"The FDA’s acceptance of our NDA brings us one step closer to our goal of providing patients with advanced GIST a potential new treatment option," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "With commercial preparations already underway, we believe we will be well positioned for a potential U.S. launch in 2020. We look forward to working with the FDA during their review of this application."

Priority Review designation is for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Under the PDUFA, a Priority Review targets a review time of six months compared to a standard review time of ten months. The FDA previously granted Breakthrough Therapy Designation (BTD) for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. BTD is designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy.

The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program. This pilot program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality. Additional information about RTOR can be found at: View Source

In addition, the Company has submitted additional marketing applications in Canada and Australia for ripretinib in advanced GIST. These submissions are part of the FDA’s Project Orbis pilot program and both received Priority Review designations. The Project Orbis pilot program, an initiative of the FDA Oncology Center of Excellence, is designed to provide a framework for concurrent submission and review of oncology products among international partners. Additional information about Project Orbis can be found at: View Source

The NDA submission is supported by positive results from the Company’s INVICTUS pivotal Phase 3 study of ripretinib in advanced GIST. INVICTUS is a randomized (2:1), double-blind, placebo-controlled, international, multicenter study designed to evaluate the efficacy and safety of ripretinib compared to placebo in 129 patients with advanced GIST whose previous therapies have included at least imatinib, sunitinib, and regorafenib. As previously reported, the study achieved its primary endpoint of improved progression free survival compared to placebo in patients with fourth-line and fourth-line plus GIST, as determined by blinded independent central radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

About Ripretinib

Ripretinib is an investigational tyrosine kinase switch control inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a unique dual mechanism of action that regulates the kinase switch pocket and activation loop. Ripretinib is currently in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, or GIST, systemic mastocytosis, or SM, and other cancers. Ripretinib inhibits initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary exon 17 D816V mutation involved in SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST. Ripretinib has been granted Fast Track Designation and Breakthrough Therapy Designation by the FDA for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. The FDA also granted Priority Review for the NDA for ripretinib, and assigned a PDUFA target action date of August 13, 2020. In addition, ripretinib has been granted Orphan Drug Designation for the treatment of GIST by the FDA and European Medicines Agency (EMA). For more information about the Company’s clinical trials with ripretinib, please visit www.clinicaltrials.gov.

Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization of ripretinib in Greater China (MainlandChina, Hong Kong, Macau, and Taiwan). Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.