Navidea Pharmceutical (NAVB), updated 3/29/17

A new beginning for Navidea Pharmaceutical

On February 22, 2017, NSVB agreed to pay $59 million to CRG as part of the “Settlement Amount” in a long battled lawsuit between CRG ( made up of Capital Royalty Partners II L.P., as Secured Party and as Control Agent, Capital Royalty Partners II – Parallel Fund “A” L.P., as Secured Party, and Parallel Investment Opportunities Partners II L.P., as Secured Party )
The payment were structured as below:
 $56 million will be paid by the Company out of the cash proceeds of the Transaction, and 
Cardinal Health 414 will prepay $3 million in guaranteed earnout payments that would have otherwise been payable in the third year after closing of the Transaction.
With the lawsuit behind it,   Lymphoseek® product (for lymphatic mapping, lymph node biopsy and the diagnosis of metastatic spread to lymph nodes for the staging of cancerin North America) was sold to Cardinal Health, on 3/3/17, for $83 million  and may receive up to $227 million of contingent consideration based on milestones through 2026, with $17.1 million of that amount guaranteed over the next three years.
Cardinal Health will license a portion of the acquired intellectual property back to Navidea to allow Navidea to develop and sell new immunodiagnostic and immunotherapeutic products for other indications in North America, and to produce and sell Lymphoseek, ex US.

Post sale, Navidea will have $15.6 million in cash and $3.3 million in payables.  A large portion of the payables is tied to the 4694 program which is planned to be divested in the near future.

From the Q4, 2016 financial filing released on 3/29/17;
Current focus is on imaging and therapeutic product candidates are based on the same drug delivery system that targets activated macrophages.
Two delivery systems, subcutaneous and IV, has show feasibility in humans.
Additional oral delivery approach for animals is under investigation.

Disease targets currently under investigation are
Rheumatoid Arthritis
Atherosclerosis
Zika, 
Dengue, 
Human immunodeficiency virus ("HIV"), 
Human herpesvirus 8 ("HHV8")
Leishmaniosis

Navidea Biopharm. (NAVB) Update Jan 9, 2017

The main focus of this company over the past year was the legal battles with its lender, CRG Capital.  The stock price has suffered over the past year reflecting investor’s trepidation.

With the CEO debacles, the chairman, Michael Goldberg, has taken control of the situation and struggled to move the company past this crisis.

On November 23rd, 2016, it entered into a definitive asset purchase agreement with Cardinal Health to sell its Lymphoseek product for cancer in North America.  In addition, Cardinal Health will license back to Navidea the IP for development and marketing new immunodiagnostic and immunotherapeutic products for specific purposes in North America .  It will allow Navidea to continue to produce and sell Lymphoseek, mostly under a different brand, outside of North America .

In exchange Navidea will receive $80 million at closing, and the opportunity to earn up to $230 million of contingent consideration based on certain milestones through 2026, with $20.1 million of that amount guaranteed over the next 3 years.      

Cardinal will pay to the Navidea the following additional milestone payments upon the achievement by or on behalf of Cardinal of the following milestone events:

• $10,000,000, payable after the first fiscal year ending June 30th in which annual Net Sales exceed $100,000,000

• $15,000,000, payable after the first fiscal year ending June 30th in which annual Net Sales exceed $200,000,000
• $20,000,000, payable after the first fiscal year ending June 30th in which annual Net Sales exceed $300,000,000
• $25,000,000, payable after the first fiscal year ending June 30th in which annual Net Sales exceed $400,000,000
• In no event will the aggregate of all such milestone payments exceed $70,000,000, provided, however, that more than one milestone payment can be earned in the same fiscal year

From Biotech Showcase, 9-11, 2017, San Francisco.

• Sold Lymphoseek business to Cardinal Health;
• stockholder proxy in preparation,
• awaiting SEC approval.
• Macrophage Therapeutics
• “If you can image it, you can treat it”
• Anti-activated macrophages
• CD 206 receptor only present in activated macrophage,
• M1 to M2 conversion
• Deplete activated macrophages as a therapeutic approach
• Active against Zika virus in cell culture studies.

Arena Pharm (ARNA) Update Jan 6, 2017

With the announcement of the formation of Beacon Discovery, Inc. in September 2016, the investment community is not impressed.  

This strategic move was to move away from the Belviq franchise (sales has not live up to expectations) and focus on the development of pipeline candidates; namely:

1. APD334, Etrasimod, for IBD (in Ph 2),

2. APD811,Ralinepeg, for PAH (in Ph 2),

3. APD371 for pain in Crohn’s disease (Ph 2)
4. APD791, Temanogrel in treatment of thrombotic diseases.

5. Other collaborations with Axovant Sciences (Ph 2) and Boehringer Ingelheim (Preclinical)

On 1/4/17, an amendment of its BELVIQ® (lorcaserin HCl) marketing and supply agreement with Eisai Co., Ltd. and Eisai Inc.

Under the amendment, an agreement was entered whereby Eisai is granted license to certain patents, regulatory approvals, samples, records, know-how related to BELVIQ, trademarks (including the trademarks BELVIQ, BELVIQ XR and VENESPRI), our agreements with distributors of BELVIQ.  .Assign its rights under the agreements with Ildong Pharmaceutical Co. LTD., Abic Marketing Limited and CY Biotech Company Limited to Eisai  In essence, Eisai will be solely responsible for Belviq.

In exchange Arena (via it’s wholly owned subsidiary, 356 Royalty Inc.) will

1. Receive royalty payments as follows:
1. Royalty rates range from:
1. 9.5% on annual global net sales less than or equal to $175 million,
2. 13.5% on annual global net sales greater than $175 million but less than or equal to $500 million and
3. 18.5% on annual global net sales greater than $500 million.
2. Eligible to receive milestone payments of $25M for Sales (reaching $250M in any 12 mo) and $1M for regulatory approval in Brazil (which was approved in 12/19/16 by  Brazilian Health Surveillance Agency (ANVISA)
3. Arena will have estimated costs savings of $80M related to Lorcaserin development obligations

Arena Pharm (ARNA) progress Updated Aug 10, 2016

ARNA Pipeline Progress as of 8/10/16

ATHX Bulls vs Bears 10/18/15

Bulls vs Bears updated 8/6/2015

Bullish

• Even though exploratory Phase 2 stroke trial failed to meet prim. endpoint, study indicate promising result at earlier time-point( < 36 h );
• Completed additional analyses of data from Phase 2 clinical study of MultiStem^® therapy to treat ischemic stroke 
• Advanced launch activities for grant-supported Phase 2 clinical study to evaluate the administration of MultiStem cells to patients who have suffered a severe, non-ST-elevated AMI;target remains to generate top-line data in 2016;
• Acute MI favorable phase 1, plan Phase 2 in Q2 2015;
• Received FDA authorization for grant-supported clinical study exploring MultiStem treatment of acute respiratory distress syndrome ("ARDS")
• Hematopoietic Stem Cell Transplant for radiation patients, Ph 1 completed
• Director Traub bought 30K@$1.27 on 6/10/15

Bearish

• Exploratory Phase 2 trial failed to meet prim. endpoint on 4/14/15
• No near term price catalyst
• As of 6/2/15 Insider sell 3 mo (-128611_Sell/Tot 17/0; 12 mo (-12673, Buy/Tot 57/63 net trades) 
• Inflammatory Bowel Syndrome - Phase 2 results show no efficacy. Pfizer to terminate effective July 2015 
• Will Chugai pay $7M to continue collaborate on ischemic stroke?
• From Q1 2015 call, stroke Phase 2b trial will happen after summer 

NAVB Q3 Lymphoseek revenue projection 10/17/15 ver 1.1

Based on Q2 results and projections made in Q1, the sales for Q3 must be a significant beat, hopefully from the new NAVB' own sales force.  The probability is ...

Note that in Q2, Lymphoseek sales were lower than hoped, assuming a straight 28.7% sales projection.  Hopefully, for the bulls, the added sales rep will rectify this shortfall.

		Qtr 1 2014	Qtr 2 2014	Qtr 3 2014	Qtr 4 2014	Yr 2014	Qtr 1 2015	Qtr 2 2015	Qtr 3 2015
REVENUE
	Actual Lymphoseek Revenue	$626,631	$1,046,257	$1,101,071	$1,426,041	$4,200,000	$1,835,422	$1,963,548
	Projected Annual Lymphoseek revenue ($)	5-6M	5-6M	5-6M	4M	Lowered from 5-6M to 4M	10-12M for Yr 2015	?	?
	Lymphoseek revenue projection based on Q4 2014 to Q1 2015 growth rate					Q1 2015 to Q4 2014 increase	28.7%	$2,362,326	$3,040,491

NAVB Bulls vs Bears 9/19/15

Bulls vs Bears updated 9/19/15

Bullish

• Manocept-Doxorubicin (MT-1001) conjugate selectively targets tumor-associated macrophages and kills cells via apoptosis
• Gross margins on Lymphoseek grew to 83% for the second quarter of 2015 compared to 74%
• Dual listing in TASE; started trading on 9/8/15
• Maintain goal to achieve break-even cash flow in first quarter 2016 
• Reiterate guidance for Lymphoseek revenue in 2015 is $10 million to $12 million ($4.2 million in Y 2014); over 100% increase. 
• Awarded NIH grants to explore new applications of the ManoceptTM platform for cardiovascular disease and rheumatoid arthritis (RA) totaling up to $2.0 million
• Lymphoseek injection is statistically less painful to patients compared to filtered Tc-99m Sulfur Colloid (fTcSC) as published 8/20/15;
• Incentive plan for new CEO tied to stock price (see news dated 10/15/14)
• Lymphoseek®Phase 3 NEO3-06 Clinical Trial in Oral Cavity Cancer of the Head and Neck met primary goal; 

Bearish

• Actual Q2 2015 Lymphoseek sales ($1.9M) did not track anticipated 28%  increase(or $2.8M);
• Expensive term loan ($50 million) with CRG (A term of six years, an interest only period for the first four years, and a 14% annual interest rate) see news dated 5/11/15, 
• NAV 4694 F-18 PET for AD on hold pending partner 
• NAV5001 (I-123) radiolabeled SPECT for PD, program terminated with Alseres Pharm.