Market Overview

Dance Biopharm Achieves Growth and Organizational Milestones in 2018 with Continued Development of Inhaled Biologics Pipeline

Share:

Late-stage biopharmaceutical company leverages capital investment to
advance their soft mist inhaled insulin product towards Phase III trials
and build leadership team

Dance
Biopharm Holdings Inc.
("Dance"), a privately-held biotechnology
company focused on the development of novel soft mist inhalable
formulations of biologics currently available as injections, announces
significant 2018 milestones as it prepares to host investor meetings
around the J.P. Morgan Healthcare Conference January 7-10, 2019 in San
Francisco. Among the company's most notable achievements is the
completion of its Phase I/IIa trial (Samba 04) for Dance 501, its
flagship inhaled insulin product delivered via a smart handheld soft
mist inhaler. Dance began its final two confirmatory Phase II studies of
Dance 501 in type 1 and 2 diabetes patients, and plans to initiate two
Phase III programs in type 2 diabetes patients in 2019.

Investment Drives Operational Growth and Leadership

Dance expects this positive momentum to continue as it celebrates the
past year of accomplishments. These include significant investments from
industry leaders, notable executive board appointments, new partnerships
and strong progression on the development of its soft mist inhaled
insulin product and inhaled biologics pipeline.

Key Funding from Industry Leaders

In June, the company completed a new private equity financing round
securing $24.5 million. SternAegis Ventures, through Aegis Capital
Corp., ("SternAegis") acted as the exclusive placement agent for this
offering. Molex Ventures, LLC, a subsidiary of Koch Industries ("Molex
Ventures") also made a substantial equity investment in Dance and helped
anchor the round. Dance is using this financing to fund human clinical
studies, manufacture drug and devices for clinical studies, and develop
the organization's capability to execute on clinical trials.

Lily Yeung, vice president, Molex Ventures and Dance Biopharm board
observer adds, "Congratulations to Dance team on a terrific year of
growth. This company is well positioned to transform diabetes care by
taking the complexity out of insulin delivery and addressing the
specific needs of an industry that is experiencing a 9% global growth in
new diabetic patients each year."

Leadership and Board Appointments

Anne Whitaker, an accomplished pharmaceutical and biotech executive,
joined Dance this year as Director and Chief Executive Officer. Ms.
Whitaker has worked with branded diabetes pharmaceutical products at all
stages of the product lifecycle, and she will lead the company's
transition from late stage development to preparing its lead clinical
asset, Dance 501, for commercialization.

New Dance Board of Directors appointments include: Matt Jennings,
currently serving as CEO and President of Phillips-Medisize, a Molex
company that provides design and manufacturing services for medical
devices and diagnostics, along with Benjamin Wolin, a co-founder and
former CEO of Everyday Health (NYSE:EVDY), a leading digital marketing
and communication platform for consumers, doctors and healthcare.

Strong Product Pipeline Progress

Building on the 28+ years of drug and development experience of its
executive team, Dance continued the aggressive expansion of its novel
product portfolio in 2018. The company looks forward to Dance 501 data
from Samba 04 trials being presented at an upcoming diabetes scientific
conference and to completing its Phase II clinical trials in 2019. Also
of note are Dance's pipeline assets that are advancing towards human
clinical trials including a soft mist inhaled GLP-1 analogue for the
treatment of diabetes and obesity.

Agile Manufacturing and Supply Chain Partners

Dance operates a lean and agile organization that engages with key
partners across the value chain. Throughout 2018, the company continued
to fortify its relationship with partners such as Dongbao Pharma, its
insulin API provider and development joint venture partner in China.
Dongbao has committed to equally sharing the development cost of Dance
501 in China. With this approach to strategic partnerships, Dance avoids
the capital investment usually required for staffing and building
manufacturing facilities.

2019 – Continuing the Road to Commercialization and Transforming
Patient Care

According to Ms. Whitaker, "Dance is at an exciting stage, and we are
preparing the market for Dance 501 by building awareness of our company
innovations, value to patients and healthcare providers, and our product
IP. We also seek to demonstrate patient preference for our soft mist
inhaled medicine over injections and how this new generation of inhaled
drug delivery has the potential to improve medication adherence and
patient outcomes."

Dance 501 – Novel Soft Mist Inhaled Insulin Product

Inhaled insulin delivery offers a potentially promising needle-free
alternative. As the company's most advanced clinical candidate currently
studied for the treatment of type 1 and 2 diabetes, Dance 501 is a
transformative drug device combination product, which includes a novel,
preservative-free formulation of inhaled recombinant human insulin
delivered via a proprietary, smart, handheld soft mist device. Dance 501
has been designed to enable convenient and confident delivery of insulin
into a patient's lungs in just a few breaths, yielding high lung
deposition and distribution.

Diabetes, A Global Epidemic Affecting an Estimated 425 Million People
Worldwide

The International Diabetes Federation's (IDF) Diabetes Atlas eighth
edition estimates that approximately 425 million adults were living with
diabetes in 2017. According to Atlas, 325 million people were at risk of
developing type 2 diabetes in 2017. And $727 billion dollars was
attributed to the treatment of patients with diabetes in 2017. IDF
forecasts the number of adult patients with diabetes to grow to
approximately 629 million by 2045. For most patients with diabetes, the
disease leads to serious medical complications.

About Dance Biopharm Holdings, Inc.

Dance Biopharm Holdings, Inc., is a private company focused on
developing novel inhaled formulations of medicines to treat diabetes and
other serious chronic diseases. The company began operations in 2010,
founded by Dr. John Patton, who has more than 28 years of experience
developing inhaled insulin and other inhaled therapies. For more
information, please visit www.dancebiopharm.com.

FORWARD-LOOKING STATEMENTS

All statements other than statements of historical fact included in this
press release are forward-looking statements that are subject to certain
risks, trends and uncertainties that could cause actual results and
achievements to differ materially from those expressed in such
statements. We have based these forward-looking statements upon
information available to management of Dance as of the date of this
release and management's expectations and projections about certain
future events. It is possible that the assumptions made by management
for purposes of such statements may not materialize. Actual results may
differ materially from those projected or implied in any forward-looking
statements. Such statements may involve risks and uncertainties,
including but not limited to those relating to our limited operating
history, our ability to successfully develop Dance 501, the cost and
uncertainty of obtaining regulatory approvals, our ability to bring
Dance 501 to multiple markets and our ability to develop inhaled
formulations of other medicines.

View Comments and Join the Discussion!