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Aradigm Announces Second Quarter 2018 Financial Results

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Aradigm Corporation (NASDAQ:ARDM) (the "Company") today
announced financial results for the second quarter and six months ended
June 30, 2018.

Second Quarter 2018 Financial Results

The Company recorded $256,000 in revenue in the second quarter of 2018
compared with $7.7 million in revenue in the second quarter of 2017. The
Company recognized $96,000 in contract revenue – related party, $95,000
in government contract revenue and $65,000 in government grant revenue
for the second quarter of 2018, as compared to $7.5 million in contract
revenue – related party, $196,000 in government contract revenue and
$7,000 in government grant revenue for the second quarter of 2017.

Total operating expenses for the second quarter of 2018 were $3.0
million, compared with total operating expenses of $5.7 million for the
second quarter of 2017. The decrease in research and development
expenses of $2.1 million was due to a decrease in spend in support of
the Linhaliq regulatory process towards US and EU approvals for market
authorization and lower employee-related expenses due to a reduction in
headcount. The decrease in general and administrative expenses of $0.5
million was primarily related to lower legal expenses, lower expenses
for Board of Director fees and lower employee-related expenses due to a
reduction in headcount.

Net loss for the second quarter of 2018 was $3.8 million or $(0.25) per
share, compared with a net income of $1.0 million or $0.07 per share in
the second quarter of 2017. For the quarter ended June 30, 2018, the
shift to a net loss from net income resulted primarily from a decrease
in revenue of $7.4 million and a decrease in operating expenses of $2.7
million.

Liquidity and Capital Resources and Related Matters

As of June 30, 2018, the Company reported cash and cash equivalents of
$2.1 million.

In January, Aradigm received a Complete Response Letter (CRL) from the
FDA regarding the New Drug Application (NDA) for Linhaliq as a treatment
for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic
lung infections with Pseudomonas aeruginosa (P. aeruginosa).

The CRL states that the FDA has determined that it cannot approve the
NDA in its present form and provides specific reasons for this action
along with recommendations needed for resubmission; the areas of concern
include clinical data, human factor validation study and product
quality. We remain confident in the efficacy, safety and quality of
Linhaliq (now named Apulmiq for the FDA) and are formally interacting
with the FDA to discuss the topics covered in the CRL with the goal of
developing plans to move towards resubmission of the Linhaliq NDA as
soon as possible. We are committed to continuing to work on obtaining
regulatory approval of Linhaliq in the US for (NCFBE) patients who
suffer from this very severe disease which carries a burden of high
morbidity and mortality with no treatment options.

The Aradigm Board of Directors approved temporary measures on February
9, 2018 intended to preserve the Company's cash resources.

During the quarter ended June 30, 2018 Aradigm raised $4.0 million
through the issuance of bridge notes and obtained commitments for
additional monthly funding through September of 2018 totaling
approximately $3.0 million. This $3.0 million along with the cash
balance of $2.1 million will be sufficient to fund operations through
the third quarter of 2018.

Aradigm is pursuing potential alternatives to resolve our cash position
in the short term as well as developing strategic options that would
provide for our long term viability. We feel it is very important to
bring Linhaliq to commercialization in as many countries as possible to
allow patients suffering from (NCFBE) to receive the benefits of
Linhaliq. Patients, patient advocacy groups and key opinion leaders have
expressed support for regulatory approval of Linhaliq as we work towards
this goal. The MAA was filed on March 8, 2018 followed by the EMA
validation of the MAA. The EMA review of the MAA for Linhaliq will be
according to standard timelines, with an opinion of the Committee for
Medicinal Products for Human Use (CHMP) expected within 210 days from
the formal procedural start date of March 29, 2018. The time needed by
us to respond to EMA questions during the MAA review will trigger formal
clock-stops of the procedure and may add several months to the nominal
210 day duration, until the final CHMP opinion will be issued.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal
dilatation of the bronchi and bronchioles, frequently associated with
chronic lung infections. It is often a consequence of a vicious cycle of
inflammation, recurrent lung infections, and bronchial wall damage.
NCFBE represents an unmet medical need with high morbidity and mortality
that affects more than 150,000 people in the US and over 200,000 people
in Europe. There is currently no drug approved for the treatment of this
condition.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the
development and commercialization of drugs for the prevention and
treatment of severe respiratory diseases. Aradigm has completed two
Phase 3 trials with Linhaliq, an investigational proprietary formulation
of ciprofloxacin for inhalation for the treatment of non-cystic fibrosis
BE and submitted an NDA to the FDA on July 27, 2017 for this indication.
The FDA responded with a CLR regarding the NDA. As stated previously, we
are committed to continuing to work on obtaining regulatory approval of
Linhaliq in the US. On March 8, 2018 Aradigm submitted a MAA to the EMA
for the same indication which is validated and under review according to
standard timelines. Aradigm's inhaled ciprofloxacin formulations include
Linhaliq and Lipoquin which are also product candidates for treatment of
patients with cystic fibrosis and non-tuberculous mycobacteria, and for
the prevention and treatment of high threat and bioterrorism infections,
such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and
inhaled anthrax.

More information about Aradigm can be found at www.aradigm.com.

Forward-Looking Statements

Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including the risk that Linhaliq may not receive
regulatory approval or be successfully commercialized, as well as the
other risks detailed from time to in the Company's filings with the
Securities and Exchange Commission (SEC), including the Company's Annual
Report on Form 10-K for the year ended December 31, 2017 filed with the
SEC on March 23, 2018, and the Company's Quarterly Reports on Form 10-Q.

Aradigm and the Aradigm Logo are registered trademarks of Aradigm
Corporation. Linhaliq is a registered trademark of Grifols, S.A.

 

ARADIGM CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME/(LOSS)

(In thousands, except per share data)

(Unaudited)

   

Three months ended
June 30,

Six months ended
June 30,

2018   2017 2018   2017
 
Revenues $ 256     $ 7,675   $ 1,729     $ 9,368  
Operating expenses:
Research and development 1,602 3,794 5,170 6,568
General and administrative 1,388 1,911 3,102 3,589
           
Total operating expenses   2,990       5,705     8,272       10,157  
 
Income (Loss) from operations (2,734 ) 1,970 (6,543 ) (789 )
 
Interest income 5 22 20 50
Interest expense (1,038 ) (959 ) (2,042 ) (1,912 )
Other income (expense) (35 ) 2 (39 ) 8
           
Net income (loss) and comprehensive income (loss) $ (3,802 )   $ 1,035   $ (8,604 )   $ (2,643 )
Basic and diluted net income (loss) per common share $ (0.25 )   $ 0.07   $ (0.57 )   $ (0.18 )
Shares used in computing basic net income (loss) per common share   15,169       14,847     15,109       14,823  
Shares used in computing diluted net income (loss) per common share 15,169 14,848 15,109 14,823
 

ARADIGM CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

   

June 30,
2018

December 31,
2017

(Unaudited)   *
ASSETS
Current assets:
Cash and cash equivalents $ 2,099 $ 7,095
Receivables 80 200
Prepaid and other current assets 622 389
     
Total current assets 3,116 7,684
Property and equipment, net 223 289
Other assets 92 92
     
Total assets $ 3,116     $ 8,065  
LIABILITIES AND SHAREHOLDERS' DEFICIT
Current liabilities:
Accounts payable 506 903
Accrued clinical and cost of other studies 81 274
Accrued compensation 599 1,643
Deferred revenue – related party, current 579 1,900
Deferred revenue – other 59 183
Other accrued liabilities   475       563  
 
Total current liabilities 2,299 5,466
Deferred rent 50 32
Deferred revenue – related party, non-current - 90
Debt – non-current, net of discount 999 -
Debt – related party, non-current, net of discount 2,926 -
Convertible debt – non-current, net of discount 2,575 2,382
Convertible debt – related party, non-current, net of discount   14,369       12,626  
Total liabilities   23,218       20,596  
Shareholders' deficit (20,102 ) (12,531 )
     
Total liabilities and shareholders' deficit $ 3,116     $ 8,065  
 

* The balance sheet at December 31, 2017 has been derived from the
audited financial statements at that date.

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