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AVEO Reports Second Quarter 2019 Financial Results and Provides Business Update

On August 8, 2019 AVEO Oncology (NASDAQ: AVEO) reported financial results for the second quarter ended June 30, 2019 and provided a business update (Press release, AVEO, AUG 8, 2019, View Source [SID1234538389]).

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"As we move toward reporting more mature interim overall survival (OS) results from our TIVO-3 study of tivozanib in advanced kidney cancer, AVEO continues to make meaningful clinical, regulatory and strategic progress across our pipeline," said Michael Bailey, president and chief executive officer of AVEO. "Notably, since the beginning of the second quarter, we presented encouraging data from ongoing clinical studies of ficlatuzumab, our HGF inhibitory antibody, closed a public offering in April, and saw the approval of FOTIVDA in New Zealand. In addition to these events, we recently announced the amendment to our license agreement with Kyowa Kirin for tivozanib non-oncology rights, which is consistent with our strategy to develop and commercialize our oncology-focused pipeline while retaining meaningful economic interest and advancing our non-oncology pipeline through partnerships. As a result of the license amendment with Kyowa Kirin and the April financing, the Company’s cash runway is now anticipated to extend into the third quarter of 2021. We expect this progress will continue to build momentum as we look forward to the next interim OS readout from our TIVO-3 study in the fourth quarter of this year."

Recent Highlights

Announced Kyowa Kirin Buy Back of Tivozanib Non-Oncology Rights from AVEO. In August 2019, AVEO and Kyowa Kirin Co., Ltd. announced that the companies’ license agreement for tivozanib has been amended to allow Kyowa Kirin to buy back the non-oncology rights of tivozanib in AVEO’s territories, which includes the U.S. and EU. Under the terms of the amended license agreement, AVEO will receive a $25 million upfront payment and a waiver of the $18 million milestone payment due to Kyowa Kirin upon AVEO obtaining U.S. market approval for tivozanib. In addition, AVEO will be eligible to receive up to $391 million in milestone payments upon the successful achievement of certain development and commercial objectives related to tivozanib formulations for the treatment of non-oncology indications. AVEO is also eligible to receive tiered royalty payments on net sales in these indications, which range from a high single-digit to low double-digit percent.

FOTIVDA (tivozanib) Approval in New Zealand for the Treatment of Advanced RCC received by AVEO’s Partner, EUSA Pharma. In July 2019, the New Zealand Medicines and Medical Devices Safety Authority approved FOTIVDA (tivozanib) for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.

Presented Tivozanib Studies at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. In June 2019, two tivozanib poster presentations reported encouraging data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois. The presentations, titled "Efficacy and safety of tivozanib in recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer" (abstract 361) and "TIVO-3: Subgroup analysis of progression-free survival of tivozanib compared to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC)" (abstract 4572), are available in the Publications & Presentations section of AVEO’s website.

$2 Million Milestone Payment from EUSA Pharma Triggered. In April 2019, AVEO announced the triggering of a $2 million milestone payment from EUSA Pharma related to the reimbursement approval and commercial launch of FOTIVDA (tivozanib) in Spain as a first-line treatment of adult patients with RCC.

Closed Public Offering of Common Stock and Warrants. In April 2019, AVEO completed an underwritten public offering of 21,739,131 shares of common stock and warrants to purchase 25,000,000 shares of common stock at the public offering price of $1.14 per share and $0.01 per warrant. The warrants have a two-year term and a strike price of $1.25 per share. Gross proceeds of the offering were approximately $25.0 million and are expected to be used for clinical and preclinical development of AVEO’s product candidates, as well as for working capital and other general corporate purposes.

Announced Results from Phase 1b Ficlatuzumab-Cytarabine Trial (CyFi) in Patients with Relapsed and Refractory AML. In April 2019, AVEO announced the presentation of encouraging data from an investigator-sponsored Phase 1b expansion cohort of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29 – Apr 3, 2019 in Atlanta. Of 18 AML patients enrolled in the study, all had disease that was refractory to initial treatment, 17 were evaluable and 9 achieved a complete response. The most frequent grade 3/4 treatment emergent adverse events observed were febrile neutropenia, liver function test abnormalities, and electrolyte disturbance. There was one death from sepsis and multi-organ failure that was determined to be disease related, and one patient withdrew from the study due to grade 4 gastrointestinal bleed, determined to be likely ficlatuzumab related. A copy of the presentation is currently available in the Publications & Presentations section of AVEO’s website.

Based on these encouraging results, the Company is planning potential next steps for this program in collaboration with its ficlatuzumab development and commercialization partner, Biodesix, Inc.

Second Quarter 2019 Financial Results

AVEO ended Q2 2019 with $40.2 million in cash, cash equivalents and marketable securities as compared with $24.4 million at December 31, 2018.

Total revenue for Q2 2019 was approximately $0.7 million compared with $0.4 million for Q2 2018.

Research and development expense for Q2 2019 was $2.6 million compared with $4.9 million for Q2 2018.

General and administrative expense for Q2 2019 was $3.0 million compared with $2.8 million for Q2 2018.

Net loss for Q2 2019 was $3.1 million, or net loss of $0.02 per basic and diluted share, respectively, compared with net income of $4.0 million for Q2 2018, or income of $0.03 per basic share and a loss of $0.06 per diluted share.

Financial Guidance

AVEO believes that our approximate $40.2 million in cash, cash equivalents and marketable securities at June 30, 2019 together with the $25 million upfront payment from the Kyowa Kirin license amendment to be received in the third quarter would allow us to fund our planned operations into the third quarter of 2021. This estimate excludes, subject to our decision whether to submit an New Drug Application (NDA) for tivozanib to the U.S. Food and Drug Administration (FDA) following the availability of more mature OS results, remaining costs to prepare and filing fees in connection with a possible NDA submission, and pre-commercialization activities that we may undertake. This estimate also assumes no receipt of additional milestone payments from our partners, no funding from new partnership agreements, no additional equity financings, no debt financings, no additional sales of equity under our sales agreement with SVB Leerink and no additional sales of equity through the exercise of our outstanding warrants. Accordingly, the timing and nature of activities contemplated for the remainder of 2019 and thereafter will be conducted subject to the availability of sufficient financial resources.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, ovarian, colorectal and breast cancers.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in investigator-sponsored trials in squamous cell carcinoma of the head and neck (SCCHN), metastatic pancreatic ductal cancer (PDAC) and acute myeloid leukemia (AML).

Veru Reports Higher Net Revenues and Gross Profit for its Fiscal 2019 Third Quarter

On August 8, 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 third quarter ended June 30, 2019 (Press release, Veru, AUG 8, 2019, View Source [SID1234538384]).

Business and Operational Highlights

VERU-111. VERU-111 is an oral, first-in-class, alpha and beta antitubulin 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 we have dosed 6 cohorts (18 men total) with escalating doses of VERU-111. In clinical observations, VERU-111 is well-tolerated with a favorable safety profile and no dose limiting toxicity has been observed. In some of the men whose PSA blood level was rapidly rising at enrollment, a marker of cancer progression, we have observed that VERU-111 treatment resulted in PSA stabilizations and reductions consistent with early promising signals of anticancer efficacy. Once we have reached a dose level that has dose limiting toxicity, we will be able to select the dose that will be evaluated 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 $4.5 billion annual 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 are one of the main reasons why men want to stop androgen deprivation therapy. Approximately 100 men will be randomized in the Phase 2 clinical trial evaluating 2 doses (10mg and 50mg) of oral zuclomiphene versus placebo. Top line results expected late Summer/early Fall 2019. Based on an independent market analysis sponsored by the Company, expected U.S. sales potential for zuclomiphene citrate is estimated to exceed $600 million annually.

VERU-100. VERU-100 is a long-acting gonadotropin-releasing hormone (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. Recently, we added this proprietary internally developed peptide drug candidate to the Company’s late-stage drug development pipeline. Based on regulatory clarity obtained in the preIND meeting with FDA in May 2019, we plan to initiate a Phase 2 clinical study in early 2020 after GMP manufacturing of VERU-100. Androgen deprivation therapy for advanced prostate cancer is an established multi-billion-dollar global market.

TADFIN (Tadalafil and Finasteride Combination Capsule). TADFIN is being developed for BPH and would be the first combination of a PDE5 inhibitor and 5 alpha reductase inhibitor. The Company had a successful preNDA meeting with 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 Summer of 2020. BPH is an established multi-billion-dollar market.

"We are delivering on our strategy of providing multiple prostate cancer and prostate cancer supportive care medicines for the continuum of prostate cancer care," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "We are pleased with the clinical progress we are making in advancing our product development program and in adding a high value, late stage drug candidate that complements our existing portfolio."

Highlights Third-Quarter Financial Results: Fiscal 2019 vs Fiscal 2018

Net revenues increased 77% to $9.7 million from $5.5 million;

Gross profit more than doubled to $6.6 million, or 68% of net revenues, from $3.1 million, or 56% of net revenues;

FC2 US prescription net revenues increased more than tenfold to $4.4 million from $0.4 million;

Operating loss significantly narrowed to $1.8 million from $5.0 million; and

Net loss was $2.8 million, or $0.04 per share, compared with $7.9 million, or $0.15 per share.

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

Net revenues rose 116% to $23.1 million from $10.7 million;

Gross profit climbed 183% to $15.8 million, or 69% of net revenues, from $5.6 million, or 52% of net revenues;

FC2 US prescription net revenues increased over tenfold to $9.4 million from $0.83 million;

FC2 public sector net revenues were $13.0 million, a 33% increase from $9.8 million;

Operating loss significantly narrowed to $5.0 million from $17.1 million (fiscal 2018 year to date included a $4.0 million loss for the settlement of Brazilian receivables); and

Net loss was $9.0 million, or $0.14 per share, compared with $16.0 million, or $0.30 per share.

"For the fiscal 2019 third quarter, we had impressive increases to net revenues and to gross profit which combined to substantially improve our bottom line," said Dr. Steiner. "Key contributors to the quarter’s performance included the continued significant ramp up of prescription sales of FC2 and the increased consumer demand for our PREBOOST/Roman Swipes. As our revenue base has grown to include increased FC2 prescription sales, our gross profit has risen substantially. The robust growth of the US FC2 prescription business remains noteworthy as it allows us to be less reliant on traditional intermittent ordering patterns typically seen in our FC2 public sector business. All of these factors combined to significantly narrow our operating loss for the quarter compared with the prior year period, which allows us to continue to invest in our multiple prostate cancer drug candidate clinical development efforts."

Financial Outlook

The Company reiterated its fiscal 2019 full year guidance of net revenues between $29 and 32 million, which represents a 95% increase over full year fiscal 2018, and gross margin of approximately 66%.

The Company does not expect to update the guidance for the full year fiscal 2019 provided above before the release announcing results for its fiscal 2019 year end. The Company notes that the statements of future performance made in this release, including the guidance for the full year fiscal 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 U.S. callers, or 412-317-0088 from outside the U.S., passcode 10133960. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source

Sutro Biopharma to Present at the 2019 Wedbush PacGrow Healthcare Conference

On August 8, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that its Chief Business Officer, Stephen Worsley, will present at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, Aug. 13 at 1:20 p.m. EDT in New York City (Press release, Sutro Biopharma, AUG 8, 2019, View Source [SID1234538383]).

A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section on the company’s website at www.sutrobio.com. A replay of the webcast will be available following the event for approximately 30 days.

Mersana Therapeutics Announces Second Quarter 2019 Financial Results and Provides Business Updates

On August 8, 2019 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results and a business update for the second quarter ended June 30, 2019 (Press release, Mersana Therapeutics, AUG 8, 2019, View Source [SID1234538382]).

"In the second quarter, we reported encouraging clinical activity and tolerability for our first-in-class, wholly-owned ADC candidate, XMT-1536, in heavily pretreated cancer patients without selection for NaPi2b expression," said Anna Protopapas, President and CEO of Mersana Therapeutics. "We are on track with the execution of our 2019 goals, including selecting a dose and initiating enrollment in the Phase 1 expansion study of XMT-1536 and bringing forward our next ADC candidate."

Recent Highlights and Updates

Clinical Program

·Presented interim Phase 1 data for XMT-1536 at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. XMT-1536 is a first-in-class, wholly-owned Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma. These data showed that XMT-1536 is clinically active at well-tolerated doses in heavily pretreated and unselected patients. As of May 10, 2019, the data cutoff date for the ASCO (Free ASCO Whitepaper) disclosure, XMT-1536 was well-tolerated at doses up to 30 mg/m2, with observation of objective responses at 20 mg/m2 and higher. Patients (N=37) were heavily pretreated, with a median of four prior lines of treatment (range 1-13) for all patients and a median of five lines of prior treatment in ovarian cancer patients (range 1-11). Interim results included:

·The most common treatment-related adverse events (TRAEs) were Grade 1-2 nausea, fatigue, and headache, and the most frequent Grade 3 TRAE was transient AST elevation without associated changes in bilirubin.

.In patients with tumor types selected for the planned expansion phase (platinum-resistant ovarian cancer and NSCLC adenocarcinoma) treated at >20 mg/m2 (N=18), three (17%) achieved partial responses (PRs) and eight (44%) achieved stable disease (SD) for a disease control rate (DCR) of 11/18 (61%), and a treatment duration lasting beyond 16 weeks in 9 patients (50%).

·In ovarian cancer patients treated at >30 mg/m2 (N=7), two (28%) achieved partial responses (PRs) and three (43%) achieved stable disease (SDs) for a disease control rate (DCR) of 5/7 (71%), and three of these patients (43%) were treated on study for more than 16 weeks.

·The Phase 1 dose escalation study of XMT-1536 for the treatment of NaPi2b-expressing cancers remains ongoing. The Company continues to evaluate patients in the 36 mg/m2 once-every-four-week dosing cohort and the maximum tolerated dose has not yet been reached. The Company expects to select a dose and initiate expansion cohorts in the third quarter of 2019.

·Site initiation continues for the dose expansion portion of the XMT-1536 Phase 1 study. Mersana continues to add sites in anticipation of dosing patients in the expansion groups in the third quarter of 2019. In the first group, the Company plans to enroll platinum-resistant ovarian cancer patients who have failed standard therapy. The second patient group will enroll NSCLC adenocarcinoma patients who have failed front line platinum-based chemotherapy with anti-PD-1 or anti-PD-L1 therapy.

Discovery & Platform Progress

·Mersana expects to disclose its next ADC clinical candidate around year end, further strengthening its scientific leadership in ADC development. The Company is targeting the filing of its next Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2020.

Corporate Updates

·Completed non-dilutive debt financing for additional financial flexibility. On May 8, 2019, the Company completed a non-dilutive debt financing with Silicon Valley Bank (SVB) that provides Mersana with the ability to draw up to $20.0 million, the proceeds of which will be used for general corporate and working capital purposes.

·Added significant strategic and operational expertise in oncology to Mersana’s leadership team. On June 12, 2019, the Company announced the appointment of Brian C. DeSchuytner as Senior Vice President of Finance and Product Strategy. Mr. DeSchuytner is an accomplished life science professional with nearly two decades of experience spanning corporate strategy, finance, product development, and commercial launch. Most recently, Mr. DeSchuytner was Vice President responsible for ZEJULA (niraparib) commercialization in ovarian cancer at TESARO. Prior to that he was Vice President responsible for the NINLARO (ixazomib) global launch at Takeda Oncology. Earlier in his career, Brian held corporate development and strategy roles of increasing responsibility at Takeda Oncology and was a leader in the life sciences practice of L.E.K. Consulting.

Upcoming Events

·The Company will give a corporate presentation on August 13, 2019, at the 2019 Wedbush PacGrow Healthcare Conference in New York City.

·The Company will give a corporate presentation on September 4, 2019, at the Baird Healthcare Conference in New York City.

·The Company will give a corporate presentation at the H.C. Wainwright Healthcare Conference in New York City taking place from September 8 to 10, 2019.

· The Company will present preclinical data from its proprietary, novel Immunosynthen platform at the upcoming 10th Annual World ADC conference on October 9, 2019 in San Diego, CA.

2019 Financial Results

·Cash, cash equivalents and marketable securities as of June 30, 2019, were $128.2 million, compared to $70.1 million as of December 31, 2018. On March 5, 2019 the Company completed a public equity offering with gross proceeds of $97.8 million. On May 8, 2019, the Company completed a non-dilutive debt financing with Silicon Valley Bank (SVB) that provides Mersana with the ability to draw up to $20.0 million. The Company drew $5.0 million upon the execution of the agreement. The Company used net cash of $14.2 million in operations in the second quarter of 2019. The Company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into at least mid-2021.

Second Quarter 2019

·Collaboration revenue for the second quarter 2019 was approximately $0.2 million, compared to $4.2 million for the same period in 2018. The decrease in collaboration revenue was primarily a result of the termination of the XMT-1522 collaboration with Takeda, the timing of efforts to support partner programs, and the recognition of a milestone payment during the three months ended June 30, 2018.

·Research and development expenses for the second quarter 2019 were approximately $13.8 million, compared to $12.7 million for the same period in 2018, driven primarily by an increase in external costs for the Company’s next clinical candidate as well as modest increases in headcount and facilities costs. The increase was offset by a decrease in external clinical and regulatory expenses due to the discontinuation of the XMT-1522 clinical program and timing of manufacturing costs for XMT-1536.

·General and administrative expenses for the second quarter 2019 remained flat at $4.2 million, compared to the same period in 2018. An increase in employee-related expenses was primarily due to an increase in headcount, but that increase was offset by a decrease in consulting and professional fees.

·Net loss for the second quarter 2019 was $17.1 million, or $0.36 per share, compared to a net loss of $12.4 million, or $0.54 per share, for the same period in 2018. Weighted average common shares outstanding for the quarters ended June 30, 2019 and June 30, 2018, were 47,708,085 and 22,966,314 respectively.

Conference Call

Mersana Therapeutics will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the second quarter of 2019 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 5554418. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

About XMT-1536

XMT-1536 is a Dolaflexin ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLock payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody. NaPi2b is an antigen expressed in the majority of non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, NSCLC adenocarcinoma and other cancers. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

Agenus Milestone Triggers $7.5M Payment

On August 8, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, reported that the FDA has accepted the company’s IND filing for AGEN2373, a milestone in its partnership with Gilead Sciences, Inc (Press release, Agenus, AUG 8, 2019, View Source [SID1234538381]). This milestone triggers a cash payment of $7.5M. Agenus is eligible to receive additional milestone payments this year and beyond.

"This IND clearance underscores our continued commitment to delivering novel and best-in-class therapies to patients with cancer with the utmost urgency," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "AGEN2373 has unique binding properties and is designed to mitigate the toxicity observed with competitor molecules; we believe that this molecule has great potential for patients with cancer."

The collaboration between the two companies was announced in December 2018. Under the terms of the agreement, Agenus received $150 million in upfront cash payment and equity investment and is eligible for approximately $1.7 billion in future fees and milestones.

AGEN2373 is an investigational agent that has not been approved for any uses. Efficacy and safety have not been established.