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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report: September 18, 1998
Commission File Number: 0-18976
CELTRIX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 94-312146
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
3055 Patrick Henry Drive, Santa Clara, CA 95054-1815
(Address of principal executive offices and zip code)
Registrant's Telephone Number: (408) 988-2500
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ITEM 5. OTHER EVENTS
On September 18, 1998, Celtrix Pharmaceuticals, Inc., a Delaware
corporation (the "Company") announced Celtrix Restructures Company to
Concentrate on Clinical Development of SomatoKine(R). Further details regarding
this announcement are contained in the Company's news release dated September
18, 1998, attached as exhibit hereto and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) EXHIBITS
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Exhibit 21 Celtrix Pharmaceuticals, Inc. News Release dated September 18, 1998.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CELTRIX PHARMACEUTICALS, INC. (Registrant)
Date: September 18, 1998 By: /s/ Donald D. Huffman
--------------------------------------------
Donald D. Huffman
Vice President, Finance & Administration
Chief Financial Officer (Duly authorized
principal financial and accounting officer.)
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CELTRIX PHARMACEUTICALS, INC.
INDEX TO EXHIBITS
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Exhibit Number
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Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release dated September 18, 1998.
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[CELTRIX LETTERHEAD]
NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Officer
(408) 988-2500
CELTRIX RESTRUCTURES COMPANY TO CONCENTRATE
ON CLINICAL DEVELOPMENT OF SOMATOKINE(R)
MANUFACTURING ACTIVITIES DISCONTINUED
FINANCING ANNOUNCED
SANTA CLARA, CA -- September 18, 1998 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) today announced that it will restructure the company to focus on
the clinical development of SomatoKine(R) while reducing the cash burn rate. As
sufficient clinical grade SomatoKine has been accumulated for the conduct of
clinical trials over the next two years, the company will discontinue
manufacturing operations. Since the majority of current staff have been
associated with manufacturing and related functions, the restructuring will
involve a reduction in workforce of up to 90% over the next few months. The
company has also arranged additional financing to extend its cash resources into
the fourth quarter of 1999. At June 30, 1998, Celtrix had $4.5 million in cash.
"Restructuring the company at this point will reduce the annual burn rate
from approximately $13 million to $2 million while maintaining important assets
including encouraging clinical data and substantial quantities of SomatoKine
drug," said Andreas Sommer, Ph.D., Celtrix's president and chief executive
officer. "The company has secured a commitment of $2 million in additional
funding from existing investors and will concentrate on establishing corporate
partnerships and other opportunities that will enable the continued development
of SomatoKine."
Promising interim data from Phase II feasibility studies in severe
osteoporosis (recovery from hip fracture surgery) and traumatic burns have
recently been obtained. Final data from an ongoing Phase II feasibility study
in diabetes are expected by year-end. Commercial opportunities for the
treatment of severe osteoporosis, trauma and diabetes are very significant."
"I want to express our great appreciation to all of Celtrix's employees,
whose hard work, talent and dedication are the basis of the company's
accomplishments," Dr. Sommer said. "Because of their efforts, we have
substantial quantities of clinical grade drug available and promising clinical
data that will enable the company to continue its development program."
CELTRIX PHARMACEUTICALS
Celtrix is a biopharmaceutical company developing therapeutics for
seriously debilitating, degenerative conditions primarily associated with severe
trauma, chronic diseases or aging. The company's focus is on SomatoKine, the
novel IGF-BP3 complex, for treatment of a broad range of metabolic disorders.
SomatoKine is currently undergoing Phase II clinical testing for the treatment
of severe osteoporosis (recovery from hip fracture surgery), traumatic burns and
diabetes. Celtrix has also licensed rights for development of another molecule,
TGF-beta-2, to Genzyme Corporation for incorporation into their comprehensive
program for tissue repair. TGF-beta-2 is currently in Phase II clinical testing
for treatment of dermal ulcers.
-more-
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"Celtrix Restructures Company to Concentrate on Clinical Development of
SomatoKine(R)"
Page 2
This news release contains certain forward-looking statements within the
meaning of Section 21 of the Securities and Exchange Act of 1934, as amended.
Actual results may differ materially from the statements made, as a result of
various factors, including risks associated with the outcomes of future clinical
trials involving SomatoKine, failure to consummate the proposed financing and
the ability to enter into collaboration(s) with corporate partners, as well as
risks associated with future research, clinical study results, the regulatory
approval process, competitive products and other factors which are listed from
time to time in Celtrix's Securities and Exchange Commission (SEC) filings.
These forward-looking statements represent Celtrix's judgment as of the date of
this news release.
-end-
