Alliqua Biomedical provides update to shareholders

Alliqua Biomedical (NASDAQ:ALQA) provides following updates to shareholders:

The Company completed sale of asset and rights relating to UltraMist Therapy System on May 7, 2018 to Celularity Inc.

On October 11, 2018, the Company signed merger agreement with Adynxx, Inc. The transaction is expected to close in Q1 2019.

On November 28, 2018, Alliqua announced to spin off its contract-manufacturing subsidiary Aquamed Technologies, and merge the business with TO Pharmaceuticals (OTCPK:TGLP) to establish a clinical-stage pharmaceutical company focused on commercializing cannabinoid-based therapies. The transaction will close in Q1 2019.

The company also intends to pay a special dividend in the range of $1.00 to $1.20 per share.

https://seekingalpha.com/news/3420265-alliqua-biomedical-provides-update-shareholders-shares-23-percent-premarket

Heron gains on positive pain med combo data

Heron Therapeutics (HRTX +2.6%) is up on average volume in response to its announcement of positive results from pain management study evaluating the combination of HTX-011 and over-the-counter pain meds (acetaminophen and ibuprofen) for managing postoperative pain.

90% of patients receiving the combo regimen did not need opioids for postoperative pain through 72 hours after surgery, superior to 51%, 40% and 22% of patients receiving HTX-011, bupivacaine and placebo, respectively.

81% of patients receiving the combo remained opioid-free through 28 days after surgery.

The company’s U.S. marketing application seeking approval for HTX-011 + meloxicam is currently under FDA review with an action date of April 30.

https://seekingalpha.com/news/3420463-heron-3-percent-positive-htxminus-011-data

The Ten Biggest Private Equity Deals In Healthcare In 2018

As 2018 was a banner year for venture capital funding in the healthcare sector, it was also a record for private equity deals. 715 private equity deals had closed as of mid-December for a combined value of $103.72 billion, according to PitchBook. In 2017 there were 709 deals worth $88.87 billion, and 651 deals worth $70.5 billion in 2016. That’s up from 413 deals worth $31.52 billion in 2013.

The Healthcare Research Institute of Pricewaterhousecoopers expects the trend to continue in 2019, as private equity investments have increased across the economy and the healthcare sector is in a phase of management teams looking to sell parts of a company that aren’t deemed essential to its main business. “We’ve seen a high level of divestitures, offloading a lot of non-core assets, and private equity has been there to be great partner,” says Karen Young, PwC’s U.S. pharma and life sciences leader. But the growth is from firms that have been in and around the industry making more bets, not from new players getting involved, she thinks. “They’re looking to become more of a collaborator in the industry versus just a banker, and I think that’s what’s driving a better relationship, as well as better outcomes on those transactions with higher values,” Young says.

2018’s biggest private equity deals in healthcare include such collaborations as health insurer Humana’s $4.1 billion partnership with firms TPG Capital and Welsh, Carson, Anderson & Stowe to buy Kindred Healthcare, which provides home health services and operates facilities for long-term acute care and rehabilitation. But it also includes more traditional deals such as controversial emergency room outsourcing company Envision Healthcare’s going private.

Here’s the rundown of the top ten, according to PitchBook:

1. Envision Healthcare; $9.9 billion; Kohlberg Kravis Roberts
2. Athenahealth; $5.7 billion; Veritas Capital, Evergreen Coast Capital
3. LifePoint Health; $5.6 billion; Apollo Global Management, ATP Private Equity Partners, RCCH HealthCare Partners
4. Kindred Healthcare; $4.1 billion; Welsh, Carson, Anderson & Stowe, TPG Capital, Humana
5. American Medical Response; $2.4 billion; Air Medical Group Holdings, Kohlberg Kravis Roberts, Ardian, Koch Equity Development
6. Sound Physicians; $2.15 billion; Revelstoke Capital Partners, Athyrium Capital Management, Summit Partners, Silversmith Capital Partners
7. Lifescan; $2.1 billion; Platinum Equity
8. Curo Health Services; $1.4 billion; TPG Capital, Welsh, Carson, Anderson & Stowe, Humana
9. Juice Plus; $1.235 billion; Altamont Capital Partners
10. Analogic; $1.1 billion; Altaris Capital Partners

https://www.forbes.com/sites/elliekincaid/2018/12/28/the-ten-biggest-private-equity-deals-in-healthcare-in-2018/#4571bae4773b

Digital health market ‘frothy, but it doesn’t look like a bubble’

Since Rock Health began researching and tracking funding into the digital health space in 2011, we’ve reported steady growth nearly every year. 2018 was no different, with a massive $7.9 billion in venture filling start-ups’ coffers. But the signals we’re seeing — large, late-stage rounds at high valuations and shorter periods between early rounds — are those of an investment cycle nearing its peak.

Does this peak signal a “bubble?” The so-called b-word has been sneaking into conversations with our fellow investors, so we dedicated our year-end number crunching to measuring the froth.

In our view, digital health is not in a bubble. But we’ve heard opposing views on that from other investors, and so we welcome a healthy debate as this cycle unfolds.

Will investors keep backing digital health?

Rock Health

Digital health funding from 2011 to 2018

Future venture capital funding for digital health largely rests on two factors: the health of the economy as a whole, and the dynamics driving investment in health care innovation.

First, where the broader venture capital market goes, digital health will go. Digital health’s growth over the past five years mirrors venture investment growth overall: Both hit decade-high deal values in 2018.

But of course, the ongoing public market pullback could trigger investor wariness that spills into venture capital.

For the second factor, we validated a simple framework with fellow investors to assess the current “bubbliness” of digital health against six attributes. We hope this approach moves the bubble discussion to a more data-driven place and helps entrepreneurs identify strategies to weather a potentially tighter capital market.

Rock Health

Is digital health in a bubble? Maybe.

1. Hype supersedes business fundamentals: Technology’s potential to fundamentally transform the $3.5 trillion healthcare market drives excitement for digital health, not irrational hype. While startups must overcome long sales cycles and byzantine reimbursement models, investors and entrepreneurs are actively learning and moving toward sustainable business models: risking payment on clinical outcomes and pursuing strong validation pathways for reimbursement. Verdict: not bubbly.

2. High cash burn rates: This is perhaps the “bubbliest” attribute of digital health—many well-funded startups are raising cash quickly. A median Series A, or first institutional, round of funding increased by a third in recent years, and since 2011, time to raise between seed and that Series A has been cut roughly in half. Savvy entrepreneurs will find ways to reduce the need for fresh capital while reaching growth milestones. As Kaiser Permanente Ventures’ Liz Rockett pointed out to us, “With sales cycles being as long as they are, you have to burn a fair amount of capital without a known endpoint to figure out where you’re headed. The CEOs who figure out how to do that as efficiently as possible will be able to retain a lot more ownership in their companies and give themselves more flexibility at exit.” Verdict: moderately bubbly.

3. Unclear exit pathways: M&A for digital health companies has been flat for the past few years, and there hasn’t been an IPO since 2016. Over half of acquirers in 2018 were digital health companies themselves, primarily looking to acquire for scale and to build out their offerings. Incumbent shake-ups and the entry of tech giants will drive more demand for innovation—and opportunities for consolidation. Verdict: moderately bubbly.

4. Surge of cash from new investors: Our data shows repeat investors have outnumbered new investors for the past four years, and the spread is growing. Commitment from those who know the space well is a good sign—particularly as they encourage companies to pace growth and develop a long-term fundraising plan that doesn’t hinge on an annual influx of cash. Verdict: not bubbly.

5. High valuations decoupled from fundamentals: With bigger, more frequent rounds, some valuations are soaring. Bessemer Venture Partners’ Steve Kraus cautions, “I’m not a big fan of the obsession with unicorn valuations. The focus should be on building a ‘unicorn product’ in healthcare and then the rest will take care of itself.” He sees startups hiking up valuations via large investments rather than taking a measured approach of raising less cash and selling at a lower, but good, multiple. Fortunately, this isn’t an inevitability—startups can avoid overvaluation by taking smart, not big, money. Verdict: moderately bubbly.

6. Fraud or misuse of funds: Before it pops, a bubble can tempt market participants with massive returns and lead to fraud. Could Outcome Health and Theranos be indicative of a wider trend in health tech? We don’t think so. There hasn’t been further evidence of fraudulent behavior infecting the sector. Verdict: Not bubbly.

Rock Health

Rock Health’s data on the distribution of digital health investors

While the future is not yet written, it seems unlikely that capital will continue to flow at the current rate. We anticipate a possible pullback in VC funding for digital health in future periods—not a bubble pop. The next stage will be shaped by how entrepreneurs and investors reset for a tighter market in 2019. Doing so will safeguard against future market corrections—and allow the digital health community to continue making healthcare massively better for every human being.

https://www.cnbc.com/2019/01/02/is-digital-health-in-a-bubble-weve-been-tracking-it-since-2011-and-were-not-so-sure.html

Newstrike Brands recalls cannabis sold in Alberta over contamination concern

A Toronto-based company has ordered a recall of a cannabis product sold in Alberta due to contamination concerns.

Newstrike Brands and its Up Cannabis subsidiary say the recall is a precaution because tests have found mould and microbial contaminates that exceed acceptable limits.

The recall involves 1,428 units of one lot of Up Cannabis seven gram dried cannabis jars sold to the Alberta Gaming Liquor & Cannabis Commission.

Newstrike says the affected cannabis has a Nov. 28, 2018, packaging date and was sold only in Alberta.

It says to date there have been no complaints or adverse reactions to the pot.

People can return it to where it was sold for replacement or a refund.

https://www.marketscreener.com/NEWSTRIKE-BRANDS-LTD-45109427/news/Newstrike-Brands-Pot-company-recalls-cannabis-product-sold-in-Alberta-over-contamination-concern-27829329/

Gritstone Oncology Updated Presentation Time at J.P. Morgan

Gritstone Oncology(Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, today announced that Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer, will present a company overview on Tuesday, Jan. 8, 2019 at 10:00 a.m. PST during the 37th Annual J.P. Morgan Healthcare Conference in San Francisco. The company will hold a question and answer session immediately following the presentation.

A live audio webcast will be available within the Investors & Media section of the Gritstone Oncology website at https://ir.gritstoneoncology.com/investors/events. An archived replay will be accessible for 30 days following the event.

https://www.marketscreener.com/GRITSTONE-ONCOLOGY-INC-46372061/news/Gritstone-Oncology-Announces-Updated-Presentation-Time-at-the-37th-Annual-J-P-Morgan-Healthcare-C-27829311/

Zymeworks 2018 Achievements, 2019 Priorities

Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reviewed its key 2018 accomplishments and outlined the Company’s priorities for 2019.

“With our clinical, preclinical, and business development achievements in 2018, along with a robust balance sheet, we believe we are in a strong position to continue delivering on our corporate objectives in 2019 and beyond,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “Our priorities include aggressively advancing our clinical and preclinical programs and continuing the development of our therapeutic platforms, which not only underpin our in-house pipeline but have also served as the basis of eight major pharmaceutical partnerships. We remain committed to our mission of creating novel biotherapeutics that allow patients worldwide to return home to their loved ones, disease free.”

2018 Achievements

• Presented Expanded ZW25 Data, Underscoring its Anti-Tumor Activity and Tolerability
  Zymeworks reported clinical results for ZW25, a novel Azymetric™ bispecific HER2-targeting antibody, at multiple medical meetings. Data continues to demonstrate ZW25’s robust single-agent anti-tumor activity and tolerability in heavily pretreated patients across a variety of HER2-expressing cancers.

• ZW49 Investigational New Drug (IND) Application Accepted by the FDA
  ZW49, Zymeworks’ second clinical candidate, is a novel bispecific HER2-targeting antibody drug conjugate. IND-enabling studies demonstrated promising efficacy and tolerability, suggesting a wide therapeutic window.

• New Corporate Partnerships Established and Existing Ones Expanded
  Zymeworks entered into new collaborations with BeiGene, which includes a licensing agreement in the Asia Pacific region (excluding Japan) for ZW25 and ZW49, and with LEO Pharma, which expands Zymeworks’ pipeline into new disease areas. The Company also expanded its existing collaborations with Daiichi Sankyo and Celgene. Zymeworks currently has eight active collaborations that offer up to US$7.6 billion in potential milestone payments plus royalties.

• Drug Candidate from First Corporate Partnership Poised to Enter Clinical Studies
  Eli Lilly submitted an IND application for one of its bispecific antibodies enabled by Zymeworks’ Azymetric platform resulting in a milestone payment to the Company.

• Introduced Robust Immune Oncology (IO) Preclinical Pipeline
  Zymeworks unveiled a number of IO programs showcasing the versatility of its platform technologies. Leveraging the Azymetric platform, Zymeworks showed how optimizing bispecific geometry and formats can maximize activity, potentially creating new classes of precision therapeutics.

• Expanded Executive Leadership Team
  Tony Polverino, Ph.D., joined Zymeworks as Executive VP of Early Development and CSO. In this newly created role, he oversees the Company’s R&D strategy and advances product candidates from discovery through translational research/early development.

• Built Strong Balance Sheet
  Zymeworks completed a US$97.8 million public financing and added non-dilutive capital from its corporate partnerships totaling US$89 million in 2018.

2019 Corporate Priorities

Zymeworks will focus on achieving the following in 2019:

• Initiating multiple Phase 2 studies for ZW25
• Expanding the global clinical development of ZW25 into Asia and Europe
• Reporting ZW25 data from combination studies (chemotherapy and/or targeted agents)
• Reporting data from the Phase 1 trial for ZW49
• Establishing additional drug development collaborations with a focus on new platforms

In addition, Zymeworks expects its pharmaceutical partners to continue nominating new Azymetric bispecific antibody therapeutic candidates for clinical development in 2019.

https://www.marketscreener.com/ZYMEWORKS-INC-34658200/news/Zymeworks-Highlights-2018-Achievements-and-Announces-2019-Priorities-27829278/