Kadmon Provides Business Update and Reports Second Quarter 2017 Financial Results

NEW YORK–(BUSINESS WIRE)– Kadmon Holdings, Inc. (NYSE:KDMN) (“Kadmon” or the “Company”) today
provided a business update and reported financial and operational
results for the three and six months ended June 30, 2017.

“This is an exciting time for Kadmon as we execute on clinical
milestones for KD025, our ROCK2 inhibitor in Phase 2 development. We
recently announced positive clinical data in chronic graft-versus-host
disease (cGVHD), with additional milestones expected in the second half
of 2017, including further cGVHD data as well as results from an ongoing
trial in idiopathic pulmonary fibrosis,” said Harlan W. Waksal, M.D.,
President and Chief Executive Officer of Kadmon. “In parallel, we
continue to focus our development capabilities on our ROCK inhibitor
platform for the treatment of autoimmune, fibrotic and neurodegenerative
diseases.”

Clinical and Research Update

KD025 in Autoimmune and Fibrotic Diseases

The Company is conducting three ongoing Phase 2 clinical trials as
follows:

• Open-label, dose-finding clinical trial in cGVHD – additional study
  results submitted for presentation at upcoming scientific conferences
• Randomized, open-label clinical trial in idiopathic pulmonary fibrosis
  – initial data expected Q4 2017
• Randomized, placebo-controlled clinical trial in moderate to severe
  psoriasis – approximately 50% enrolled

Additional Clinical Updates

In Q3 2017, the Company expects to initiate a randomized, double-blind,
placebo-controlled Phase 2 clinical trial of tesevatinib in autosomal
dominant polycystic kidney disease (PKD) and a dose-finding Phase 1
clinical trial of tesevatinib in autosomal recessive PKD. Enrollment
continues in the Company’s ongoing Phase 2 clinical trials of
tesevatinib in glioblastoma and in non-small cell lung cancer with brain
or leptomeningeal metastases.

The U.S. Food and Drug Administration (FDA) provided a Generic Drug User
Fee Amendments of 2012 (GDUFA) goal date of January 30, 2018, to review
the Company’s Abbreviated New Drug Application (ANDA) for KD034, its
generic trientine hydrochloride formulation for the treatment of
Wilson’s disease, in blister packaging that offers room temperature
stability. The Company submitted its first ANDA for its bottled generic
trientine hydrochloride formulation in December 2016.

Financial Results

Second Quarter 2017 Results

Loss from operations for the three and six months ended June 30, 2017
was $17.6 million and $31.6 million, respectively, compared to $22.2
million and $42.6 for the respective periods in 2016.

Revenue was $3.0 million and $8.5 million for the three and six months
ended June 30, 2017, respectively, compared to $6.4 million and $16.1
million for the respective periods in 2016. The Company expects sales of
its ribavirin portfolio of products to contribute insignificantly to
revenue in 2017 and beyond.

Research and development expenses were $10.1 million and $18.5 million
for the three and six months ended June 30, 2017, respectively, compared
to $8.6 million and $17.7 million for the respective periods in 2016.

SG&A expenses were $9.9 million and $20.0 million for the three and six
months ended June 30, 2017, respectively, compared to $19.1 million and
$42.8 million for the respective periods in 2016. The decrease in SG&A
expenses for the second quarter of 2017 is primarily related to a
decrease in legal expenses of $2.7 million, salary and salary-related
expense of $1.2 million, consulting expense related to an advisory
agreement of $0.8 million and amortization of intangible assets of $3.4
million.

Liquidity and Capital Resources

As of June 30, 2017, Kadmon’s cash and cash equivalents totaled $26.2
million, compared to $36.1 million as of December 31, 2016. In March
2017, Kadmon completed a private placement equity financing pursuant to
which Kadmon received gross proceeds of approximately $23 million from
the issuance of 6,767,855 shares of Kadmon’s common stock, at a price of
$3.36 per share, and warrants to purchase 2,707,138 shares of Kadmon’s
common stock at an initial exercise price of $4.50 per share for a term
of 13 months from the date of issuance. If these warrants are exercised,
the Company would receive approximately $12.2 million.

About Kadmon Holdings, Inc.

Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company
developing innovative products for significant unmet medical needs. We
have a diversified product pipeline focused on autoimmune and fibrotic
diseases.

Forward Looking Statements

This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”), and Section 21E of the Securities Exchange Act of
1934, as amended. Such statements may be preceded by the words “may,”
“will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,”
“targets,” “projects,” “contemplates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negative of these terms or
other similar expressions. Forward-looking statements involve known and
unknown risks, uncertainties and other important factors that may cause
our actual results, performance or achievements to be materially
different from any future results, performance or achievements expressed
or implied by the forward-looking statements. We believe that these
factors also include, but are not limited to, (i) the initiation,
timing, progress and results of our preclinical studies and clinical
trials, and our research and development programs; (ii) our ability to
advance product candidates into, and successfully complete, clinical
trials; (iii) our reliance on the success of our product candidates;
(iv) the timing or likelihood of regulatory filings and approvals; (v)
our ability to expand our sales and marketing capabilities; (vi) the
commercialization of our product candidates, if approved; (vii) the
pricing and reimbursement of our product candidates, if approved; (viii)
the implementation of our business model, strategic plans for our
business, product candidates and technology; (ix) the scope of
protection we are able to establish and maintain for intellectual
property rights covering our product candidates and technology; (x) our
ability to operate our business without infringing the intellectual
property rights and proprietary technology of third parties; (xi) costs
associated with defending intellectual property infringement, product
liability and other claims; (xii) regulatory developments in the United
States, Europe and other jurisdictions; (xiii) estimates of our
expenses, future revenues, capital requirements and our needs for
additional financing; (xiv) the potential benefits of strategic
collaboration agreements and our ability to enter into strategic
arrangements; (xv) our ability to maintain and establish collaborations
or obtain additional grant funding; (xvi) the rate and degree of market
acceptance of our product candidates; (xvii) developments relating to
our competitors and our industry, including competing therapies; (xviii)
our ability to effectively manage our anticipated growth; (xix) our
ability to attract and retain qualified employees and key personnel;
(xx) our ability to achieve cost savings and other benefits from our
efforts to streamline our operations and to not harm our business with
such efforts; (xxi) our expectations regarding the period during which
we qualify as an emerging growth company under the JOBS Act; (xxii)
statements regarding future revenue, hiring plans, expenses, capital
expenditures, capital requirements and share performance; (xxiii)
litigation, including costs associated with prosecuting or defending
pending or threatened claims and any adverse outcomes or settlements,
whether or not covered by insurance; (xxiv) the use of proceeds from our
recent private placement; (xxv) the future trading price of the shares
of our common stock and impact of securities analysts’ reports on these
prices; and/or (xxvi) other risks and uncertainties. More detailed
information about Kadmon and the risk factors that may affect the
realization of forward-looking statements is set forth in the Company’s
filings with the U.S. Securities and Exchange Commission (SEC),
including the Company’s Quarterly Report on Form 10-Q filed pursuant to
Section 13 of the Securities Exchange Act of 1934, as amended, with the
SEC on the date hereof. Investors and security holders are urged to read
these documents free of charge on the SEC’s web site at www.sec.gov.
The Company assumes no obligation to publicly update or revise its
forward-looking statements as a result of new information, future events
or otherwise.

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