CHELSEA, Mass.–(BUSINESS WIRE)–

Civitas Therapeutics, Inc., a biopharmaceutical company with a lead
program in Parkinson’s disease that leverages the ARCUS®
respiratory delivery platform, today announced the successful completion
of a $38 million Series B financing. Bay City Capital led the round and
was joined by new investors RA Capital and another undisclosed blue chip
public investment fund with participation from all existing investors
including Alkermes plc, Canaan Partners, Fountain Healthcare Partners,
and Longitude Capital.

“The strength and diversity of this investor group provides a robust
foundation for achieving our vision of developing proprietary ARCUS®-based
therapeutics to improve outcomes for patients,” said Glenn Batchelder,
Chief Executive Officer and Co-founder of Civitas. “We are pleased that
our new investors recognized the significant value that has been created
since our initial financing, and we are excited to have their input and
support as we further develop our lead program along with the broader
pipeline.”

Civitas plans to use the proceeds from this financing for late stage
clinical development of the company’s lead program, CVT-301, an inhaled
formulation of levodopa (L-dopa) being developed for the rapid and
reliable relief from debilitating motor fluctuations (OFF episodes)
associated with Parkinson’s disease. Civitas recently initiated a Phase
2b clinical study to evaluate the efficacy and safety of CVT-301,
self-administered by patients, in treating emergent OFF episodes during
one month of continued use. The company will report preliminary data
from this study in the first half of 2014. In addition, Civitas will
explore additional opportunities to leverage the ARCUS®
platform for other disease states where the potential to deliver a
large, precise dose of a drug — independent of inspiratory flow rate —
from a simple, breath actuated device, would provide a significant
clinical advantage.

“As we surveyed the Parkinson’s disease landscape, we found CVT-301 to
be a particularly compelling opportunity that uniquely addresses a
significant unmet need,” said Rajeev Shah, Partner at RA Capital.
“CVT-301 represents a rare combination of a large commercial opportunity
for a severe disease coupled with a highly de-risked, capital efficient
development path.”

“We are very pleased to join the Civitas investor syndicate,” said Rob
Hopfner, Partner at Bay City Capital. “Civitas, along with its
scientific and patient foundation collaborators, has made impressive
achievements in rapidly advancing the development of CVT-301 since the
company’s launch in 2011. The company’s track record of outstanding
execution gives us confidence that they are destined to deliver
important new therapies to patients.”

As part of this financing, Mr. Shah and Dr. Hopfner will join Civitas’
Board of Directors.

About CVT-301

Civitas’ lead program, CVT-301, is an inhaled formulation of L-dopa
being developed for the rapid and reliable relief from debilitating
motor fluctuations (OFF episodes) associated with Parkinson’s disease.
Oral L-dopa, used for chronic symptom management, is administered to
maintain dopamine levels in the brain above the therapeutic threshold;
however, the reliability of oral L-dopa formulations is significantly
compromised by delayed and unpredictable absorption and excessive
variability in circulating plasma drug concentrations inherent to the
oral delivery route. L-dopa remains widely recognized as the most
efficacious treatment for Parkinson’s disease symptoms in spite of this
intrinsic unreliability, which results in OFF episodes. CVT-301 is being
developed as an adjunct PRN therapy to standard oral L-dopa therapy to
address OFF episodes as they emerge and enable patients to reliably
manage their symptoms.

CVT-301 leverages the ARCUS® platform to optimally deliver a
precise dose to the deep lung for rapid and predictable L-dopa
absorption. The ARCUS® platform is uniquely able to deliver
the necessary L-dopa dose with the required precision. A Phase 1 study
in healthy volunteers showed that CVT-301 rapidly achieved target L-dopa
plasma levels with a pharmacokinetic (PK) profile supportive of its
therapeutic potential. The recently completed Phase 2a double blind
placebo controlled dose finding study (CVT-301-002) recapitulated the PK
profile in patients, produced rapid and durable improvement in motor
function when administered to patients in the OFF state, and was
generally safe and well tolerated at all doses tested. Civitas is
currently conducting a Phase 2b study to evaluate the efficacy and
safety of CVT-301 in treating emergent OFF episodes during one month of
continued use. CVT-301 clinical studies conducted to date have been
funded in part by grants from The Michael J. Fox Foundation for
Parkinson’s Research.

About Parkinson’s Disease

Over one million people in the US and six million people worldwide
suffer from Parkinson’s disease, a neurodegenerative disorder caused by
diminished production of dopamine in the substantia nigra area of the
brain, resulting in progressive impairment of motor function including
tremors, rigidity, and difficulty in moving. The unreliability of
available medications for symptomatic treatment of Parkinson’s disease
remains a significant unmet need. Even when treated with the current
standard of care, the majority of Parkinson’s patients continue to
experience motor fluctuations. These unpredictable OFF episodes reduce
patients’ ability to lead productive, independent lives and are
recognized by patients, care givers, and healthcare professionals as one
of the most troubling and debilitating issues associated with the
disease.

About ARCUS®Platform

The ARCUS® platform is a proprietary dry powder and device
combination with a unique ability to deliver a large, precise dose
independent of inspiratory flow rate from a simple, breath actuated
device. The platform is protected by a large intellectual property
estate including over 130 issued patents. The technology has
successfully delivered more than one million doses to patients and the
manufacturing technology has been scaled to accommodate a significant
commercial launch.

About Civitas Therapeutics

Civitas is a privately-held biopharmaceutical company focused on
developing a robust pipeline of inhaled therapeutics with the clinically
proven ARCUS® dry powder pulmonary delivery platform. In
addition to the lead program, CVT-301 for treating Parkinson’s disease,
other programs encompass respiratory disease, central nervous system
disorders, and infectious disease. The company is headquartered in
Chelsea, Mass. in a facility that includes both development and
commercial scale GMP manufacturing capabilities. The Company is financed
by leading investors including Alkermes plc, Bay City Capital, Canaan
Partners, Fountain Healthcare Partners, Longitude Capital and RA
Capital. For further information on Civitas, please visit www.civitastherapeutics.com.

Civitas Therapeutics
Stephanie Gillis, 617-660-4121
[email protected]
or
Media:
Suda Communications LLC
Maureen L. Suda, 585-387-9248