Mustang Bio soars on its gene therapy data

NEJM reports ‘medical breakthrough’ in Mustang Bio cell and gene therapy

Mustang Bio (MBIO) announced that the New England Journal of Medicine has published data from St. Jude Children’s Research Hospital, the nation’s “leading hospital” for understanding, treating and curing childhood cancer and other life-threatening diseases.

Mustang Bio soars on its gene therapy data, Stockwinners

The data comes from a Phase 1/2 clinical trial of a lentiviral gene therapy for the treatment of newly diagnosed infants under two years old with XSCID, also referred to as SCID-X1 and commonly known as “bubble boy disease.”

Under a licensing agreement with St. Jude, Mustang will develop the lentiviral gene therapy for commercial use as MB-107.

The multi-center Phase 1/2 clinical trial is evaluating the safety and efficacy of a lentiviral vector to transfer a normal copy of the IL2RG gene to bone marrow stem cells in newly diagnosed infants under the age of two with XSCID, preceded by low exposure-targeted busulfan conditioning.

A total of 10 infants have received the therapy to date in this clinical trial. Among the data highlights, bone marrow harvest, busulfan conditioning and cell infusion were well tolerated.

In seven of the eight cases, normalization of naive T-cell and natural killer cell numbers occurred within three to four months after treatment, accompanied by vector marking in T, B, NK and myeloid cells and marrow progenitors.

All patients cleared previous infections and are growing normally. Seven of the eight infants treated have developed normal IgM levels to date.

Most patients were discharged from the hospital within one month.

Data Highlights:

  • Bone marrow harvest, busulfan conditioning and cell infusion were well tolerated.
  • In seven of the eight cases, normalization of CD3+, CD4+ and CD4+ naïve T-cell and natural killer (“NK”) cell numbers occurred within three to four months after treatment, accompanied by vector marking in T, B, NK and myeloid cells and marrow progenitors.
    • The eighth infant had insufficient T cells initially, but normalization of T cells occurred following an unconditioned boost of gene-corrected cells, and the patient is progressing favorably.
  • All patients cleared previous infections and are growing normally.
  • Seven of the eight infants treated have developed normal IgM levels to date.
    • Four of these seven infants have discontinued monthly infusions of intravenous immunoglobulin (IVIG) therapy to date.
    • Three of those four infants that discontinued monthly IVIG infusions have responded to vaccines to date.

MBIO closed at $2.66, it last traded at $8.91.

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Advanced Disposal sold for $4.9 billion

Waste Management to acquire Advanced Disposal Services for $33.15 per share

Advanced Disposal sold for $4.9B, Stockwinners

Waste Management (WM) and Advanced Disposal Services (ADSW) announced that they have entered into a definitive agreement under which a subsidiary of Waste Management will acquire all outstanding shares of Advanced Disposal for $33.15 per share in cash, representing a total enterprise value of $4.9B when including approximately $1.9B of Advanced Disposal’s net debt.

The per share price represents a premium of 22.1% to Advanced Disposal’s closing share price as of April 12, the last trading day prior to today’s announcement, and a premium of 20.9% to Advanced Disposal’s 30-day volume weighted average price as of the same date.


Transaction to close by the first quarter of 2020, Stockwinners

The transaction is not subject to a financing condition. Waste Management intends to finance the transaction using a combination of bank debt and senior notes.

Advanced Disposal Services provides non-hazardous solid waste collection, transfer, recycling, and disposal services. The company is involved in the curbside collection of residential refuse from small carts or containers into collection vehicles for transport to a disposal/recycling site. The company serves approximately 2.8 million residential customers; 200,000 commercial and industrial customers; and 800 municipalities in the Southeast, Midwest, and Eastern regions of the United States, as well as the Commonwealth of the Bahamas.

Following completion of the transaction, Waste Management expects to maintain a strong balance sheet and solid investment grade credit profile with a pro forma leverage ratio within the company’s long-term targeted net debt-to-EBITDA range of 2.75x to 3.0x.

The transaction, which was unanimously approved by the boards of directors of both companies, is expected to close by the first quarter of 2020, subject to the satisfaction of customary closing conditions, including regulatory approvals and approval by a majority of the holders of Advanced Disposal’s outstanding common shares.

In connection with the definitive agreement, Canada Pension Plan Investment Board, which owns approximately 19% of Advanced Disposal’s outstanding shares, has, under the terms of a voting agreement, agreed to vote its shares in favor of the transaction.

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Electronics for Imaging sold for $1.7 billion

Siris Capital affiliate to acquire Electronics for Imaging for $37.00 per share

Electronics for Imaging (EFII), or EFI, announced that it has entered into a definitive agreement to be acquired by an affiliate of Siris Capital in an all-cash transaction valued at approximately $1.7B.

EFI sold for $1.7 billion, Stockwinners

Electronics for Imaging, Inc. provides industrial format display graphics, corrugated packaging and display, textile, and ceramic tile decoration digital inkjet printers worldwide. Its Industrial Inkjet segment offers VUTEk format display graphics, Nozomi corrugated packaging and display, Reggiani textile, and Cretaprint ceramic tile decoration and building material industrial digital inkjet printers; digital ultra-violet curable, light emitting diode curable, ceramic, water-based, thermoforming, and specialty inks; various textile inks, including dye sublimation, pigmented, reactive dye, acid dye, pure disperse dye, and water-based dispersed printing inks, as well as coatings; digital inkjet printer parts; and professional services. 

Under the terms of the agreement, which has been unanimously approved by EFI’s board, an affiliate of Siris will acquire all the outstanding common stock of EFI for $37.00 per share in cash.

The purchase price represents an approximately 45% premium over EFI’s 90-day volume-weighted average price ended on April 12. EFI may solicit alternative acquisition proposals from third parties during a “go-shop” period over the next 45 calendar days.

EFI will have the right to terminate the agreement to enter into a superior proposal subject to the terms and conditions of the agreement.

There is no guarantee that this process will result in a superior proposal and the agreement provides Siris with a customary right to attempt to match a superior proposal.

EFI does not intend to disclose developments with respect to the solicitation process unless and until it determines such disclosure is appropriate or is otherwise required.

EFI’s board has unanimously recommended that its shareholders adopt the agreement with Siris.

Subject to the go-shop, a special meeting of EFI’s shareholders will be held as soon as practicable following the filing of the definitive proxy statement with the U.S. Securities and Exchange Commission and subsequent mailing to shareholders.

Subject to the go-shop, the proposed transaction is expected to close by Q3 and is subject to approval by EFI’s shareholders, along with the satisfaction of customary closing conditions including antitrust regulatory approvals.

The transaction is not subject to any financing conditions. Upon completion of the acquisition, EFI will become wholly owned by an affiliate of Siris.

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Alliance Data sells Epsilon for $4.4 billion

Publicis to acquire Epsilon for $4.40B in cash

Publicis (PUBGY) announced it has entered into an agreement with Alliance Data Systems (ADS) under which Publicis will acquire Alliance Data’s Epsilon business for a net purchase price of $3.95B after tax step-up – total cash consideration of $4.40B – and build a strategic partnership with Alliance Data remaining business.


Publicis to acquire Epsilon for $4.40B in cash , Stockwinners

The acquisition gives Publicis access to Epsilon’s data capabilities. The company says, for example, it has more than 250 million unique consumers identified in the U.S. The company says it can build on top of a client’s first-party data with its own assets, like behavioral and transactional data.

The Directoire, or Management Board, and the Conseil de Surveillance, or Supervisory Board, of Publicis have unanimously approved this transaction.

Alliance Data sells Epsilon for $4.4 billion, Stockwinners

Arthur Sadoun, Chairman and CEO of Publicis, said that, “Our clients are facing increasing pressure from the rise in consumer expectations, the mainstreaming of direct-to-consumer brands and new data regulations. The only response is to deliver personalized experiences at scale. They have to transform to meet this new market imperative.”

Edward Heffernan, Alliance Data Systems’ President and CEO, added that, “I’m pleased to say today’s announcement represents a trifecta win for Alliance Data, Epsilon and Publicis Groupe.

The announcement of this transaction represents the culmination of an extensive assessment of strategic options for our Epsilon business.

With this transaction, we have found what we believe to be the right home for Epsilon’s technology, data assets and associates.

Publicis Groupe will be the ideal cultural and strategic fit for Epsilon and its Conversant business, and will help drive Publicis Groupe’s own transformation in today’s data-driven digital world.

Furthermore, the unique relationships that have been cultivated between Epsilon and our other Alliance Data businesses will remain intact, and we look forward to working with Publicis Groupe to develop an even broader relationship promoting mutual and sustainable growth going forward.”

Under the terms of the agreed transaction, Publicis will acquire Epsilon for a cash consideration of $4.40B, representing a net purchase price of $3.95B after deducting the benefit of acquisition-related tax step-up.

This implies an 8.2-times multiple, based on a 2018 Adjusted EBITDA of $485M.

According to Publicis, the transaction will be double digit accretive to its headline EPS and free Cash Flow per share from year one.

Publicis also said that it “remains committed” to its 45% dividend payout ratio and will put on hold its share repurchase program in the context of this acquisition.

The transaction remains subject to customary approvals and is expected to close in Q3 2019.

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Anadarko Petroleum sold for $50 billion

Chevron to acquire Anadarko for $65 per share or $33B


Anadarko sold for $50 billion, Stockwinners

Chevron Corporation (CVX) announced that it has entered into a definitive agreement with Anadarko Petroleum (APC) to acquire all of the outstanding shares of Anadarko in a stock and cash transaction valued at $33B, or $65 per share.

Based on Chevron’s closing price on April 11, and under the terms of the agreement, Anadarko shareholders will receive 0.3869 shares of Chevron and $16.25 in cash for each Anadarko share.

Chevron sees synergies of $2 billion, Stockwinners

The total enterprise value of the transaction is $50B.

“The acquisition of Anadarko will significantly enhance Chevron’s already advantaged Upstream portfolio and further strengthen its leading positions in large, attractive shale, deepwater and natural gas resource basins.

Furthermore, Western Midstream Partners, LP (WES) is a successful midstream company whose assets are well aligned with the combined companies’ upstream positions, which should further enhance their economics and execution capabilities.”

Chevron’s Chairman and CEO Michael Wirth said, “This transaction builds strength on strength for Chevron. The combination of Anadarko’s premier, high-quality assets with our advantaged portfolio strengthens our leading position in the Permian, builds on our deepwater Gulf of Mexico capabilities and will grow our LNG business.

It creates attractive growth opportunities in areas that play to Chevron’s operational strengths and underscores our commitment to short-cycle, higher-return investments.

This transaction will unlock significant value for shareholders, generating anticipated annual run-rate synergies of approximately $2 billion, and will be accretive to free cash flow and earnings one year after close,” Wirth concluded.

“The strategic combination of Chevron and Anadarko will form a stronger and better company with world-class assets, people and opportunities,” said Anadarko Chairman and CEO Al Walker.

“I have tremendous respect for Mike and his leadership team and believe Chevron’s strategy, scale and operational capabilities will further accelerate the value of Anadarko’s assets.”

The acquisition consideration is structured as 75% stock and 25% cash, providing an overall value of $65 per share based on the closing price of Chevron (CVX) stock on April 11.

In aggregate, upon closing of the transaction, Chevron will issue approximately 200M shares of stock and pay approximately $8B in cash. Chevron will also assume estimated net debt of $15B.

Total enterprise value of $50B includes the assumption of net debt and book value of non-controlling interest.

The transaction has been approved by the boards of both companies and is expected to close in the second half of the year. The acquisition is subject to Anadarko (APC) shareholder approval. It is also subject to regulatory approvals and other customary closing conditions.

Upon closing, the company will continue be led by Michael Wirth as chairman and CEO. Chevron will remain headquartered in San Ramon, California.

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Intercept falls on NASH study

Intercept falls after releasing ‘supportive data’ from Phase 3 NASH study

Intercept Pharmaceuticals (ICPT) overnight announced additional “supportive data” from its Phase 3 Regenerate study of obeticholic acid in patients with liver fibrosis due to nonalcoholic steatohepatitis.

stockwinners.com ICPT

Intercept falls after releasing ‘supportive data’ from Phase 3 NASH study, Stockwinners

Nonalcoholic steatohepatitis (NASH) is liver inflammation and damage caused by a buildup of fat in the liver. It is part of a group of conditions called nonalcoholic fatty liver disease. You may be told you have a “fatty liver.”

The new data based on additional analyses show that obeticholic acid “demonstrated robust efficacy across a range of additional histologic and biochemical parameters,” Intercept said in a statement.

The data are being presented today at the International Liver Congress in Vienna, Austria.

The primary efficacy analysis assessed efficacy at 18 months in 931 patients with stage 2 or 3 liver fibrosis due to NASH.

Patients with biopsy proven NASH with fibrosis were randomized 1:1:1 to receive placebo, OCA 10 mg or OCA 25 mg once daily.

A repeat biopsy was conducted after 18 months for histologic endpoint assessment.

Overall, study discontinuations in the primary efficacy analysis population were balanced across treatment groups.

As previously reported, in the primary efficacy analysis, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement with no worsening of NASH in 23.1% of patients compared to 11.9% of placebo patients at the planned 18-month interim analysis, the company said.

In the primary efficacy analysis, a numerically greater proportion of patients in both OCA treatment groups compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis; however, this did not reach statistical significance.

As agreed with the FDA, in order for the primary objective to be met, the study was required to achieve one of the two primary endpoints, it added.

Additional supportive efficacy analyses were conducted using the per protocol population.

Approximately three-fold more patients in the OCA 25 mg group achieved an improvement of fibrosis by greater than or equal to 2 stages compared to placebo, Intercept reported.

ICPT is down 12%, or $14.14, to $106.54.

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Orthofix reports positive results of its artificial cervical disc

Orthofix announces full two-year outcomes from IDE study of M6 cervical disc

Orthofix reports positive results of its artificial cervical disc, Stockwinners

Orthofix Medical (OFIX) announced the full two-year outcomes from its U.S. Investigational Device Exemption study of the M6-C artificial cervical disc.

Currently, the most common form of surgery for treating cervical degenerative disc disease is an anterior cervical discectomy and fusion (ACDF). More than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots. Spinal fusion surgery creates a solid union between two or more vertebrae to help strengthen the spine and alleviate chronic neck pain. There are several types of spinal fusion surgery, as well as varied instrumentation used to secure the fusion.

The data demonstrates that patients treated with the M6-C artificial cervical disc had significant improvements in neck and arm pain, function and quality of life scores.

Additionally, these patients had a significant difference in the reduction of pain and opioid medications use when compared to anterior cervical discectomy and fusion patients.

At 24 months, patients in the ACDF group who were still using pain medications had a seven times higher rate of opioid use than those in the M6-C disc group.

A prospective, non-randomized, concurrently controlled clinical trial, the M6-C IDE study was conducted at 23 sites in the United States with an average patient age of 44 years.

The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single level symptomatic cervical radiculopathy with or without cord compression.

The overall success rate for the protocol-specified primary endpoint for the M6-C disc patients was 86.8 percent at 24 months and 79.3 percent in the control group.

This data statistically demonstrates that cervical disc replacement with the M6-C disc is not inferior to treatment with ACDF. Secondary outcomes at 24 months include: Patients who received the M6-C disc demonstrated statistically significant improvement in the Neck Disability Index as measured at week six and months three, six, 12 and 24.

Meaningful clinical improvement was seen in the following pain scores: 91.2 percent of patients who received the M6-C disc reported an improvement in neck pain compared to 77.9 percent in patients who underwent the ACDF procedure.

90.5 percent of the M6-C patients reported improvement in arm pain scores compared to 79.9 percent in ACDF patients. Prior to surgery, 80.6 percent of the M6-C disc patients and 85.7 percent of the ACDF patients were taking some type of pain medication for the treatment of their cervical spine condition. At 24 months, the rate of M6-C patients who were still taking some type of pain medication dropped to 14.0 percent compared to 38.2 percent of the ACDF patients.

Of these, there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.

There was a statistically significant difference in the average mean surgery time – 74.5 minutes for patients receiving the M6-C disc versus 120.2 minutes for those patients having the ACDF procedure.

In addition, there was a statistically significant difference in the mean length of hospital stay – 0.61 days for the M6-C patients versus 1.10 days for ACDF patients. Subsequent surgery at the treated level was needed in 4.8 percent of the ACDF patients compared to 1.9 percent of the M6-C disc patients.

There were no device migrations reported in the study. Overall patients receiving the M6-C disc reported a 92-percent satisfaction rate with the surgery, and 93 percent said they would have the surgery again.

There were 3.8 percent serious adverse events related to the device or procedure in the M6-C disc group versus 6.1 percent in the ACDF group.

The M6-C disc received FDA approval in February 2019 based on the results of this study.

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Altaba to dissolve itself

Altaba board approves plan of complete liquidation and dissolution

Altaba to dissolve itself, Stockwinners

Altaba (AABA) announced last night that the fund’s board of directors has approved the liquidation and dissolution of the fund pursuant to a plan of complete liquidation and dissolution, subject to stockholder approval.

Altaba Inc. is a non-diversified, closed-end management investment company based in New York City that was formed from the remains of Yahoo! Inc. after Verizon acquired Yahoo’s Internet business  The company that remained after the purchase changed its name to Altaba Inc. on June 16, 2017.

Verizon completed its acquisition of Yahoo!’s core internet business on June 13, 2017, and put the assets under a new subsidiary named Yahoo! Holdings within its newly created division, Oath.

The only Yahoo!-branded interest held by Altaba was its stake in the joint venture Yahoo! Japan but this stake has since been sold to SoftBank Group.

The fund intends to file a proxy statement with the U.S. Securities and Exchange Commission with respect to a special meeting of stockholders to seek stockholder approval of the liquidation and dissolution pursuant to the plan.

Altaba said the fund “has pursued a number of strategies with the goal of achieving its investment objective, including by repurchasing the shares, both in the open market and through an exchange offer of American Depository Shares of Alibaba Group Holding Limited (BABA) and cash for shares, the simplification of the fund through the disposition of assets other than its position in Alibaba and the resolution of certain actual and contingent liabilities, and through other means.

After carefully considering the risks, timing, viability and potential impact on the fund’s stockholders of additional strategies potentially available to the fund to achieve its investment objective, as well as the recommendation of management, and in consultation with the fund’s advisors, the board unanimously determined that the liquidation and dissolution pursuant to the plan is advisable and in the best interests of the fund and its stockholders.

” If the liquidation and dissolution pursuant to the plan is approved by the fund’s stockholders, the fund expects to sell or otherwise dispose of all of the remaining ordinary shares and ADSs of Alibaba held by the fund, other than Alibaba ADSs, if any, to be distributed in kind, and its equity interests in Excalibur IP, to the extent any such assets have not been sold or disposed of by the fund before the special meeting, Altaba stated.

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FDA to hold hearing on cannabis products

FDA to hold hearing on potential regulatory pathways for cannabis products

FDA to evaluate cannabis use, Stockwinners

The FDA issued a statement from outgoing Commissioner Scott Gottlieb on new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products, in which he stated in part:

“In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis and its components, including cannabidiol, or CBD…We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products.”

The FDA is announcing a number of new steps and actions to advance its consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under its existing authorities, Gottlieb said.

These new steps include:

A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety;

The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health;

Updates to its webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products;

and the issuance of multiple warning letters to companies marketing CBD products with “egregious and unfounded claims that are aimed at vulnerable populations.”

Publicly traded companies in the cannabis space include Aphria (APHA), Aurora Cannabis (ACB), CV Sciences (CVSI), CannTrust Holdings (CNTTF), Canopy Growth (CGC), Cronos Group (CRON), General Cannabis (CANN), India Globalization Capital (IGC), MediPharm Labs (MLCPF) and Tilray (TLRY).

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Quantenna sold for $1.07 billion

ON Semiconductor to acquire Quantenna for $24.50 per share

Quantenna sold for $1.07 billion, Stockwinners

ON Semiconductor Corporation (ON) and Quantenna Communications, Inc. (QTNA) announced that they have entered into a definitive agreement for ON Semiconductor to acquire Quantenna for $24.50 per share in an all cash transaction.

The acquisition consideration represents equity value of approximately $1.07B and enterprise value of approximately $936M, after accounting for Quantenna’s net cash of approximately $136M at the end of fourth quarter of 2018.

The acquisition significantly enhances ON Semiconductor’s connectivity portfolio with the addition of Quantenna’s industry leading Wi-Fi technology and software capabilities.

Following consummation, the transaction is expected to be immediately accretive to ON Semiconductor’s non-GAAP earnings per share and free cash flow, excluding any non-recurring acquisition related charges, the fair value step-up inventory amortization, and amortization of acquired intangibles.

The transaction is not subject to a financing condition. ON Semiconductor intends to fund the transaction through cash on hand and available capacity under its existing revolving credit facility.

Completion of the transaction is subject to approval by Quantenna’s stockholders, regulatory approvals and other customary closing conditions.

The transaction has been approved by ON Semiconductor’s and Quantenna’s boards of directors and is expected to close in the second half of 2019.

No approval of the stockholders of ON Semiconductor is required in connection with the proposed transaction.

Note that QNTA was featured by Stockwinners on February 22 at $18.00.

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Zoosk sold for $255 million

Spark Networks to acquire Zoosk, sees adjusted EBITDA to exceed $50M in 2020

Spark Networks (LOV) announced its entry into a definitive agreement to acquire Zoosk.

Zoosk shareholders will receive $95 million in cash, Stockwinners

The combination will drive a meaningful increase in Spark’s scale, with over one million monthly paying subscribers across the two platforms. Spark expects the transaction to drive meaningful margin expansion in 2020 and beyond.

“Zoosk is one of the strongest dating apps in the North American market, which comprises half of the $5B global online dating opportunity,” said Jeronimo Folgueira, Chief Executive Officer of Spark Networks SE.

“Similarly, North America has been a key strategic market for Spark, and the focal point for our growth initiatives. Our deal with Zoosk creates the second largest online dating platform in North America and the second largest publicly-listed dating company in the world.

Spark buys Zoosk for $255 million, Stockwinners

Over the past 18 months, our management team has successfully integrated acquisitions and developed new brands. As a result of these efforts, our brand portfolio now includes SilverSingles, which continues to exceed our expectations, and the Christian Mingle, Jdate and JSwipe brands, which have all shown significant improvement since they were acquired in late 2017.

Our acquisition of Zoosk is the most transformative deal in our history, and we expect the transaction to immediately strengthen our position in the online dating market. With the increased scale that results from the combination, we see a clear path to profitability improvements and greater opportunity to invest in innovation and growth initiatives that will drive shareholder value.”

With the addition of Zoosk, Spark will more than double in size and the combined business will be considerably more valuable than the two stand-alone entities: Following the completion of its integration plans, Spark expects to drive significant Adjusted EBITDA margin expansion.

In 2020, Spark expects Adjusted EBITDA to exceed $50M. Under the terms of the agreement, Spark will acquire 100% of Zoosk’s shares with a combination of cash and stock valuing the company at approximately $255M based on the closing price of Spark Networks SE stock on March 20.

Spark will issue 12.98M American Depository Shares valued at approximately $150M based on the closing price of Spark Networks SE stock of $11.53 on March 20.

Additionally, Zoosk shareholders will receive net cash consideration of $95M at closing and $10M via a deferred cash payment in December 2020, which will be funded through a new $120M senior secured debt facility.

The transaction is expected to close early in the third quarter of 2019.

LOV closed at $11.90.

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Tribune to buy nineteen stations from Nexstar

Nexstar enters agreements to divest nineteen stations for $1.32B

Nexstar to sell 19 stations, Stockwinners

Nexstar Media Group (NXST) and Tribune Media Company (TRCO) announced that Nexstar has entered into definitive agreements to sell a total of nineteen stations in fifteen markets for an aggregate $1.32B in cash following the acquisition of Tribune Media by Nexstar.

Under the terms of the agreements, TEGNA Inc. (TGNA) will acquire eleven stations in eight markets for $740M and The E.W. Scripps Company (SSP) will acquire eight stations in seven markets for $580M.

Separately, Nexstar remains engaged in active negotiations to divest two stations in Indianapolis, Indiana. On December 3, 2018, Nexstar and Tribune Media entered into a definitive merger agreement whereby Nexstar will acquire all outstanding shares of Tribune Media.

Nexstar agrees to acquire Tribune Media, Stockwinners
Nexstar agrees to sell stations from Tribune, Stockwinners

The planned divestiture of nineteen stations reflects Nexstar’s stated intention to divest certain television stations in order to comply with the FCC local and national television ownership rules and to obtain FCC and Department of Justice approval of the proposed Nexstar / Tribune Media transaction.

Nexstar intends to use the net proceeds from the divestitures to fund the Tribune acquisition and to reduce debt.

Given that the net proceeds from the divestitures exceed those initially estimated at the time the transaction was announced, Nexstar now estimates that net leverage at the closing of the transaction will be reduced to approximately 5.1x.

The planned divestiture of the nineteen stations is subject to FCC approval, other regulatory approvals, the closing of the Nexstar / Tribune Media transaction and other customary closing conditions and is expected to be completed on, or about the time of, the closing of the Nexstar / Tribune Media transaction, which is expected later this year.

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Dare Bioscience posts positive data, shares jump

Dare Bioscience announces publication of clinical findings for DARE-VVA1

Dare Bioscience publishes positive data on tamoxifen, Stockwinners

Dare Bioscience (DARE) announced the publication of clinical findings for vaginally-administered tamoxifen in Clinical and Experimental Obstetrics and Gynecology, an international journal for publication of research focused on the development of new therapeutic interventions for obstetrics and gynecology.

Dare’s product candidate, DARE-VVA1, incorporates tamoxifen in a proprietary formulation designed for vaginal delivery.

Dare holds the exclusive worldwide rights to patents issued in the U.S. and Japan covering the use and delivery of DARE-VVA1 for vulvar and vaginal atrophy, or VVA, and a U.S. patent covering composition, use and delivery of DARE-VVA1 for VVA.

The publication reported that a self-administered vaginal suppository containing tamoxifen, dosed daily for one week followed by twice weekly for three months, administered to four healthy postmenopausal women with VVA showed significant improvements in reducing vaginal pH and vaginal dryness without significant systemic absorption of tamoxifen.

This exploratory study demonstrated that tamoxifen was effective when delivered intravaginally for three months in postmenopausal women suffering with VVA.

The median vaginal pH at the time of enrollment was 7.1. At the end of month 3, the median vaginal pH was 5.0. The median paired difference between baseline and month 3 was -2.0, with a range of -2.5 to -1.5.

The self-assessment of vaginal dryness improved between baseline and month 3. Vaginal dryness was rated using a visual analogue scale, or VAS, that ranged from 0 to 10.


Tamoxifen commonly is used as a breast cancer treatment

At baseline, the median vaginal dryness rating was 8.0, with a range of 7.5 to 9.0. At the end of month 3, the median vaginal dryness rating was 3.0, with a range of 2.0 to 3.0. The median change between baseline and month 3 was -5.5.

In addition, systemic exposure was at least an order of magnitude lower following vaginal administration compared with oral tamoxifen. After eight weeks of study treatment, median plasma concentration of tamoxifen was 5.8 ng/ml, with a range of 1.0 to 10.0 ng/ml.

In comparison, after three months of oral administration of 20-mg tamoxifen once daily, the average steady state plasma concentration of tamoxifen is 122 ng/ml, with a range of 71 to 183 ng/ml. VVA is an inflammation of the vaginal epithelium due to the reduction in levels of circulating estrogen. Historically, estrogen-based therapies delivered through creams, rings and tablet supplements have been prescribed for the treatment of VVA symptoms.

However, estrogen-based products can be worrisome for women undergoing treatment for hormone-receptor positive breast cancer and are often contraindicated in such breast cancer patients and in patients with a genetic predisposition or history of familial disease, because of the concern that estrogen use will promote recurrence of disease.

Many breast cancer survivors undergo menopausal symptoms as a direct consequence of cancer treatment.

Breast cancer patients treated with aromatase inhibitors refer to VVA as one of the most unpleasant side effects of treatment. Tamoxifen has been a commonly used treatment for breast cancer and is systemically metabolized to active metabolite 4-hydroxy-N-desmethyl-tamoxifen, otherwise known as endoxifen. In breast tissue, tamoxifen acts as an estrogen antagonist.

In other tissue, including vaginal tissue, tamoxifen has been reported to exert an estrogen-like response on vaginal cytology by a mechanism yet to be understood and not expected based upon its an anti-estrogen activity.

This exploratory study demonstrated that vaginal administration of tamoxifen for three months in postmenopausal women with VVA is a possible new, non-estrogen-based treatment approach.

Dare is currently conducting activities in preparation for future clinical work with DARE-VVA1, its proprietary vaginal formulation of tamoxifen.

If successful, DARE-VVA1 could be the first and only vaginally administered tamoxifen product approved by the FDA for the treatment of VVA in hormone-receptor positive breast cancer patients.

DARE closed at $0.90, last traded at $2.70.

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Ascendis Pharma reports positive data, shares jump

Phase 3 heiGHt trial met primary objective in children with pediatric growth hormone deficiency

Ascendis Pharma (ASND) announced positive top-line results from the phase 3 heiGHt Trial, a randomized, open-label, active-controlled trial that compared once-weekly TransCon Growth Hormone to a daily growth hormone in children with pediatric growth hormone deficiency.

Ascendis Pharma reports positive data, shares jump, Stockwinners

The trial met its primary objective, demonstrating that TransCon hGH was observed to be non-inferior and, additionally, superior to the daily hGH on the primary endpoint of annualized height velocity at 52 weeks.

In the primary analysis of the intent-to-treat population using ANCOVA, TransCon hGH demonstrated an AHV of 11.2 cm/year compared to 10.3 cm/year for the daily hGH.

The treatment difference was 0.86 cm/year with a 95% confidence interval of 0.22 to 1.50 cm/year.

The AHV for TransCon hGH was significantly greater than the daily hGH.

The AHV was greater for TransCon hGH than for the daily hGH at each visit, with the treatment difference reaching statistical significance from and including week 26 onward.

The incidence of poor responders was 4% and 11% in the TransCon hGH and daily hGH arms, respectively. All sensitivity analyses completed from the trial support the primary outcome, indicating the robustness of these results.

Results from the trial indicate that TransCon hGH was generally safe and well-tolerated, with adverse events consistent with the type and frequency observed with daily hGH therapy and comparable between arms of the trial.

ASND is up $44.64 to $113.95.

Cantor Fitzgerald analyst Alethia Young raised her price target for Ascendis Pharma to $185 from $100 as she was “positively surprised” that the TransCon hGH study for growth hormone achieved a superior result on annualized growth velocity of .86cm.

The analyst thinks that the expectation had been non-inferiority with a slightly favorable numerical trend. Young also thinks safety was clean as well, which has been a challenge with other long acting growth hormones.

She would expect shares to trade up 50%-100% based on her model, and sees continued upside from shares as additional programs, such as TransCon PTH, achieve proof of concept and more candidates from the proprietary TransCon platform enter the clinic. The analyst reiterates an Overweight rating on the shares.

Growth hormone (GH) has been available for management of the short stature associated with growth hormone deficiency (GHD) for more than 60 years; recombinant DNA-derived human growth hormone (rhGH) has been available since 1985. While availability is no longer a problem, there still remains a number of difficulties with the diagnosis of GHD, resulting mainly from the lack of appropriate tools to make (or exclude) the diagnosis reliably.

The incidence of short stature associated with GHD has been estimated to be about 1:4000 to 1:10000 . It is the primary indication for GH treatment in childhood, which presently requires daily subcutaneous injections for the patient and substantial cost for the healthcare system. Based on these premises, it is clear that an accurate diagnosis is essential

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Kforce Government Solutions sold for $115 million

ManTech to acquire Kforce Government Solutions for $115M

KForce sold for $115 million, Stockwinners

ManTech (MANT) announced that it has signed a definitive agreement to acquire Kforce Government Solutions, or KGS, formerly a wholly-owned subsidiary of Kforce (KFRC) for $115M in cash.

Headquartered in Fairfax, Virginia, KGS provides technology solutions, transformation management, data management and analytics in support of federal health and defense missions.

KGS has built a legacy of success with its customers particularly within the Department of Veterans Affairs, or VA.

The acquisition adds over 500 employees to the ManTech team. In 2018, KGS generated approximately $98M of revenue and has profitability comparable to ManTech.

The combination will substantially increase ManTech’s footprint at the VA and enable ManTech to deliver services through the VA’s Transformation Twenty-One Total Technology Next Generation, or T4NG, program.

The T4NG program is a 10-year indefinite delivery, indefinite quantity contract awarded by the VA Technology Acquisition Center to help the VA transform its information technology programs.

ManTech will fund the acquisition from cash on hand with additional funding from its existing line of credit. ManTech expects the acquisition to be slightly accretive to earnings per share in 2019.

The acquisition is subject to various closing conditions and approvals, including approval under the Hart-Scott-Rodino Act, and is expected to be completed in March.

David L. Dunkel, Chairman and Chief Executive Officer commented, “Our federal government solutions business has been a meaningful part of our business since our initial government acquisition in 2006. I am immensely proud of the success that our KGS management team has had in growing and positioning this business for continued future success despite the competitive challenges it has faced, given its scale.

We are excited for our KGS management team and associates to join forces with ManTech, which we expect will enhance KGS’s competitive positioning and leverage its deep and long-standing customer relationships to drive further growth. We firmly believe in the strong secular drivers within the commercial technology space and, with this divestiture, virtually all of our revenues are derived from domestic professional and technical staffing services and solutions.”


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