On May 8, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders,reported financial results for the first quarter ended March 31, 2018, and provided an update on recent developments(Press release, Bellicum Pharmaceuticals, MAY 8, 2018, View Source [SID1234526254]).

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"We remain very encouraged with interim results from our BPX-501 program in malignant and nonmalignant pediatric patients, and remain on track for filing of MAAs in the European Union in 2019," said Bellicum’s President & CEO Rick Fair. "We are also working to expand the BPX-501 opportunity into the U.S. and into the adult stem cell transplant population with the planned initiation of two new clinical trials later this year. In our BPX-601 GoCAR-T program, we reported early promising first-in-human data on CAR-T cell expansion with the use of our iMC activation switch. We look forward to sharing data readouts on all our clinical programs during 2018, and providing further guidance on our plans to advance two new dual-switch controllable CAR-T candidates into clinical studies."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

Clinical Hold Lifted by FDA on U.S. Studies of BPX-501
The Company is now working with U.S. clinical sites to resume patient recruitment based on amended study protocols, including guidance on monitoring and management of neurologic adverse events. The FDA clinical hold did not affect the BP-004 registration trial in Europe.

BPX-501 E.U. Registration Trial Enrollment Complete
Enrollment was recently completed in the treatment arm of the BP-004 E.U. registration trial in malignant and nonmalignant pediatric patients undergoing haploidentical hematopoietic stem cell transplant (haplo-HSCT). The Company expects to have topline data at the end of 2018, followed by a readout of comparative data from its ongoing C-004 observational study in children receiving a matched unrelated donor (MUD) transplant without BPX-501. Bellicum expects to file for E.U. approvals of BPX-501 and rimiducid in 2019.

BPX-501 Interim Survival Results Reported
In March, the Company announced favorable interim results in pediatric patients with acute myeloid leukemia (AML), with overall survival of 97.3% in patients with a median follow-up of over one year. The Company also reported new updated interim data in pediatric patients with primary immunodeficiencies (PIDs) undergoing a curative haplo-HSCT with BPX-501. Abstracts providing more comprehensive interim data on these patients have been accepted for presentation at the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held in Stockholm in June.

CAR-T and TCR Phase 1 Studies Enrolling
Bellicum and its collaborators are currently enrolling Phase 1 clinical trials of three CAR-T and TCR programs featuring its industry-leading cellular control technology: BPX-601, BPX-701, and an academic collaborator’s CaspaCIDe-enabled CD19 CAR-T. The Company expects to report preliminary findings from all three studies at medical meetings later this year. BPX-601, the Company’s first GoCAR-T product candidate—differentiated by the inclusion of its proprietary iMC activation switch—is the first controllable CAR-T to enter clinical trials and is being studied in adults with nonresectable pancreatic cancer who test positive for prostate stem cell antigen (PSCA). The Company recently reported that the first patient dosed with rimiducid in the BPX-601 trial showed a robust expansion of circulating BPX-601 cells following a single dose of rimiducid, providing initial clinical proof of concept of the iMC activation switch. As enrollment continues, the Company is preparing to amend the trial to include additional PSCA-expressing tumors. In the Phase 1 study with BPX-701, Bellicum is working to add clinical sites to accelerate enrollment.

Progressing Next-Generation Dual-Switch Preclinical Programs
Leveraging its innovative technology platform, Bellicum has created next-generation controllable CAR-Ts that incorporate both activation and safety switches in the same T cell. At the AACR (Free AACR Whitepaper) Annual Meeting in April, the Company presented promising preclinical results highlighting the ability to manage expansion, persistence and safety of tumor antigen-specific CAR-T cells, potentially allowing for more aggressive anti-tumor therapies. The Company has nominated two new dual-switch CAR-Ts for clinical trials next year, and will provide additional details on these programs later this year.

Underwritten Public Offering of Common Stock
In April, Bellicum completed a public offering of 9.2 million shares, including 1.2 million shares sold under the underwriters’ option to purchase additional shares, at $7.50 per share. The aggregate offering size was $69.0 million before deducting the underwriting discounts and commissions and other offering expenses.

First Quarter 2018 Financial Results

Cash Position and Guidance: Bellicum ended the quarter on March 31, 2018 with cash, restricted cash and investments totaling $88.0 million, compared to $106.5 million at December 31, 2017. Based on current operating plans, Bellicum expects that current cash resources, including proceeds from its April 2018 public offering, will be sufficient to meet operating requirements through the end of 2019.

R&D Expenses: Research and development expenses were $16.5 million for the quarter ended March 31, 2018, compared to $15.3 million for the comparable period in 2017. The increase of approximately $1.2 million is primarily due to increased general research and development and collaboration costs of $1.9 million and increased costs related to BPX-701 of $0.2 million, partially offset by reduced costs related to BPX-501 of $0.9 million. Costs related to BPX-601 were comparable in each of the three-month periods.

G&A Expenses: General and administrative expenses were $5.7 million for the first quarter ended March 31, 2018, compared to $5.9 million during the comparable period in 2017. The decrease in G&A expenses in 2018 is primarily due to severance costs related to former executive officers incurred in the three months ended March 31, 2017.

Net Loss: Bellicum reported a net loss of $22.8 million during the first quarter of 2018 and $22.0 million during the comparable period in 2017. The results include non-cash, share-based compensation charges and depreciation of $5.0 million and $4.1 million in the first quarters of 2018 and 2017, respectively.

Shares Outstanding:

Bellicum had 34,288,556 and 42,873,045 shares of common stock outstanding as of March 31, 2018 and April 30, 2018, respectively. The increase in the number of outstanding shares was primarily attributable to the public offering of 9.2 million shares in April.

About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.

About BPX-601
BPX-601 is a GoCAR-T product candidate containing Bellicum’s proprietary inducible MyD88/CD40, or iMC, activation switch, designed to treat solid tumors expressing prostate stem cell antigen, or PSCA. Preclinical data show enhanced T cell proliferation, persistence and in vivo anti-tumor activity compared to traditional CAR-T therapies. In addition to pancreatic cancer, PSCA is expressed in several other solid tumor indications, including: gastric, esophageal, cholangiocarcinoma, glioblastoma, prostate and bladder cancers. The Company plans to expand the clinical development of BPX-601 to include additional PSCA expressing cancer types.

About BPX-701
BPX-701 is a high affinity T cell receptor product candidate designed with the CaspaCIDe safety switch. In preclinical studies, PRAME-specific clones showed high reactivity against a panel of PRAME positive tumor cell lines, metastatic melanoma, sarcomas and neuroblastoma tissues. In vitro study data showed that BPX-701 demonstrated strong affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells, as well as complete elimination of BPX-701 cells in response to rimiducid.

On May 8, 2018 Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal third-quarter 2018, provided an update on recent business highlights and raised its fiscal year 2018 financial guidance (Press release, Myriad Genetics, MAY 8, 2018, View Source [SID1234526272]).

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"We saw strong results in the third quarter with financial performance once again exceeding our expectations due to better than anticipated hereditary cancer volumes, strong new product volume growth and the success of our Elevate 2020 program," said Mark C. Capone, president and CEO, Myriad Genetics. "Our diversification efforts achieved record results in the third quarter, with new products now representing 71 percent of sample volume and 36 percent of revenue. And the landmark GeneSight clinical trial results have led to our first commercial coverage decision. Given that this new product growth is being built upon a solid hereditary cancer foundation, we are raising our financial guidance for fiscal year 2018."

Business Highlights

Hereditary Cancer

Achieved the fifth consecutive quarter of year-over-year hereditary cancer volume growth with total hereditary cancer volume exceeding our three percent growth target on a year-over-year basis.

riskScore led to accelerating growth in our preventive care segment over the last two quarters.

GeneSight

Revenue increased 27 percent year-over-year to $30.4 million with record volumes in the quarter.

Myriad has been notified of a commercial coverage decision from a top-20, mid-Atlantic payer.

Presented data from the largest-ever pharmacogenomics clinical study in patients with moderate-to-very severe depression at the American Psychiatric Association annual meeting in New York City, demonstrating that patients were 50 percent more likely to achieve remission and 30 percent more likely to respond to treatment when their medication selection was guided by the GeneSight Psychotropic genetic test.

Submitted the randomized controlled trial study manuscript to a peer-reviewed journal and anticipate publication around the end of fiscal year 2018.

Submitted manuscripts for the IMPACT study and a second major health economic study utilizing the

Optum Healthcare Solutions dataset.

Vectra DA

Revenue increased 34 percent year-over-year in the quarter with volumes growing in the double-digits on a sequential basis.

Initiated plans to move the Vectra DA customer service group and commercial laboratory to our Salt Lake City headquarters with plans to complete both moves by the end of fiscal year 2019.

Prolaris

Revenue in the quarter increased 91 percent year-over-year to $6.5 million and test volumes grew 10 percent sequentially.

NCCN issued new guidelines supporting Prolaris as standard of care for treatment decisions in patients with low and favorable-intermediate risk prostate cancer. The guidelines also support the broad use of hereditary cancer testing in 40,000 specific prostate cancer patients diagnosed every year in the United States and support the use of biomarkers such as myChoice HRD Plus to identify prostate cancer patients for targeted therapies.

American Association of Clinical Urology and the Large Urology Group Practice Association, that represent 70 percent of urologists in the country, issued a position paper supporting the new NCCN guidelines.

Received positive medical policy recommendations for Prolaris in the quarter from 14 Medicaid states, first Blue Cross Blue Shield plan and several regional payers.

EndoPredict

Reported $2.3 million in the quarter an increase of 15 percent sequentially.

Received final Medicare local coverage decision from Noridian which became effective on January 30 increasing total coverage to approximately 90 percent of the United States market.

One of the largest private insurers in the United States has expanded its coverage policy on EndoPredict to aid in the clinical decision of whether or not to extend adjuvant hormonal therapy beyond five years of treatment.

Companion Diagnostics

Received Food and Drug Administration approval for BRACAnalysis CDx as a companion diagnostic in conjunction with AstraZeneca’s Lynparza (olaparib) for HER2- metastatic breast cancer.

Launched BRACAnalysis CDx to approximately 3,000 oncologists who treat greater than two-thirds of metastatic breast cancer and saw a 70 percent increase in metastatic breast cancer testing in the third quarter compared to the second quarter.

International

Received a revised draft guidance document from the United Kingdom’s National Institute for Health and Care Excellence (NICE) which includes EndoPredict as one of three approved breast cancer prognostic tests.

Initiated a restructuring to shift all laboratory developed testing to United States laboratories which will lead to closing the laboratory in Munich Germany and the sale of the German Clinic.

Received pre-market approval from the Japanese Ministry of Health, Labor, and Welfare for our BRACAnalysis CDx test for HER2- metastatic breast cancer.

Conference Call and Webcast

A conference call will be held today, Tuesday, May 8, 2018, at 7:30 a.m. EST to discuss Myriad’s financial results for the fiscal third-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-699-0623. International callers may dial 1-303-223-4362. All callers will be asked to reference reservation number 21887258. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On May 7, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 7, 2018, View Source [SID1234526147]). The FDA is expected to make a decision on approval by 5 September 2018. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

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"Our phase III results showed TECENTRIQ in combination with Avastin, paclitaxel and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are working closely with the FDA to bring this treatment regimen to people with this type of lung cancer as soon as possible."

This sBLA is based on results from the Phase III IMpower150 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with advanced non-squamous NSCLC. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.

TECENTRIQ is currently approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK and EGFR mutations.

About the IMpower150 study
IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and paclitaxel with or without Avastin in people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people, of which those with ALK and EGFR mutations were excluded from the primary intention-to-treat (ITT) analysis. People were randomised (1:1:1) to receive:

TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
TECENTRIQ and Avastin plus carboplatin and paclitaxel (Arm B), or
Avastin plus carboplatin and paclitaxel (Arm C, control arm)
The co-primary endpoints were OS and PFS, as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). The primary analysis of the co-primary PFS endpoint in IMpower150 was assessed in two populations: all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type) and in a subgroup of people who had a specific biomarker (T-effector "Teff" gene signature expression). The co-primary OS endpoint was assessed in all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type). Key secondary endpoints included investigator-assessed PFS and OS, safety in the ITT population and in EGFR and ALK mutation subgroups.

About NSCLC
Lung cancer is the leading cause of cancer death globally1. Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day2. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases2.

About the TECENTRIQ and Avastin combination
There is a strong scientific rationale to support further investigation of TECENTRIQ plus Avastin in combination. We are investigating this combination in a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity by inhibiting VEGF-related immunosuppression, promoting T cell tumour infiltration and enabling priming and activation of T cell responses against tumour antigens.

About TECENTRIQ
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.

TECENTRIQ is already approved in the European Union, United States and more than 60 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On May 7, 2018 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that the May 3rd presentation from David Hansen, MabVax’s President and Chief Executive Officer, at VirtualInvestorConferences.com is now available for on-demand viewing at VirtualInvestorConferences.com (Press release, MabVax, MAY 7, 2018, View Source [SID1234526150]).

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Mr. Hansen provided a corporate overview, as well as a clinical update and outlined anticipated milestones for its Phase 1 clinical programs including the MVT-5873 clinical trial in combination with a standard of care chemotherapy as a first line therapy for patients newly diagnosed with pancreatic cancer, and the MVT-1075 radioimmunotherapy clinical trial for the treatment of pancreatic, colon and lung cancers.

MabVax Therapeutics’ presentation will be available for 90 days. Investors and advisors may download additional information and materials from the "virtual trade booth" for the next three weeks.

About VirtualInvestorConferences.com

Since 2010, VirtualInvestorConferences.com, created by BetterInvesting (NAIC) and PRNewswire, has been the only monthly virtual investor conference series that provides an interactive forum for presenting companies to meet directly with investors using a graphically-enhanced online platform.

Designed to replicate the look and feel of location-based investor conferences, Virtual Investor Conferences unites PR Newswire’s leading-edge online conferencing and investor communications capabilities with BetterInvesting’s extensive retail investor audience network. To learn more, please visit www.VirtualInvestorConferences.com.

On May 7, 2018 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the first quarter ended March 31, 2018 (Press release, Lipocine, MAY 7, 2018, View Source [SID1234526168]).

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First Quarter and Recent Corporate Highlights

The Company received $10 million through a Loan and Security Agreement with Silicon Valley Bank ("SVB Loan").
·The Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") met to discuss the New Drug Application ("NDA") for TLANDO, Lipocine’s oral testosterone product candidate for the proposed indication of testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
BRUDAC voted six in favor and thirteen against the acceptability of the overall benefit/risk profile to support approval of TLANDO as a testosterone replacement therapy ("TRT").
·The Company and the other defendants entered into a memorandum of understanding to settle the purported securities class action litigation captioned In re Lipocine Inc. Securities Litigation.
·The Company initiated a phlebotomy clinical study under the TLANDO investigational new drug ("IND") Application to confirm no ex-vivo conversion of testosterone undecanoate to testosterone.
·The Company submitted a draft protocol for an ambulatory blood pressure monitoring ("ABPM") clinical study to the FDA for review under the TLANDO IND.
The FDA’s assigned Prescription Drug User Fee Act ("PDUFA") goal date for the TLANDO NDA is May 8, 2018.

"We look forward to learning the FDA outcome on our PDUFA goal date for TLANDO. We continue to believe that as an oral drug TLANDO offers significant benefits to patients compared to topical gels and injections. These benefits include overcoming the inadvertent testosterone transference risk to children and partners that exist with topical gels," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.

First Quarter 2018 Financial Results

Lipocine reported a net loss of $2.7 million, or ($0.13) per diluted share, for the quarter ended March 31, 2018, compared with a net loss of $4.9 million, or ($0.26) per diluted share, in the quarter ended March 31, 2017.

License revenues were $428,000 during the three months ended March 31, 2018, compared to no revenue being received during the three months ended March 31, 2017. License revenue relates to royalty payments received from Spriaso, LLC under a licensing agreement for the cough and cold field.

Research and development expenses were $1.4 million in the quarter ended March 31, 2018, compared with $3.1 million in the quarter ended March 31, 2017. The decrease in research and development expenses was primarily due to reduced contract research organization costs for TLANDO and lower personnel costs offset by increased outside service costs primarily related to the TLANDO BRUDAC meeting in January 2018 and increased contract manufacturing costs for LPCN 1107.

General and administrative expenses were $1.7 million in the quarter ended March 31, 2018, compared with $1.8 million in the quarter ended March 31, 2017. The decrease in general and administrative expenses was primarily due to decreased personnel costs and overhead costs offset by increased professional fees related to legal, intellectual property and commercial activities.

As of March 31, 2018, the Company had cash, cash equivalents, and marketable securities of $27.8 million, compared to cash, cash equivalents, and marketable securities of $21.5 million at December 31, 2017. In the event TLANDO is not approved by the FDA on or prior to May 31, 2018, the SVB loan requires $5.0 million of cash to be restricted and held as cash collateral until such time as TLANDO is approved by the FDA.