<PAGE>
-----------------------------
-----------------------------
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 (Date of earliest
event reported):
May 29, 1997
XYTRONYX, INC.
----------------------------------
(Exact name of registrant as specified in its charter)
DELAWARE
--------------------------
(State or other jurisdiction of incorporation)
0-14838 36-3258753
---------------------- ----------------------------------
(Commission File Number) (IRS Employer Identification Number)
6730 Mesa Ridge Rd.
Suite A
San Diego, California 92121
----------------------------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (619) 550-3900
---------------
<PAGE>
Item 5. Other Events.
News release dated June 6, 1997, (the "PMA News Release") announcing that the
Company received an approvable letter from the U.S. Food and Drug Administration
(FDA) for a premarket application (PMA) for the Periodontal Tissue Monitor
(PTM). The approval is contingent upon certain manufacturing requirements and
labeling issues. The PMA News Release filed as Exhibit 99.57 hereto, is hereby
incorporated into this Report by reference.
News release dated May 29, 1997, (the "Steri-Oss News Release") announcing that
the Company signed a letter of intent with Steri-Oss, a leading dental implant
company, for the distribution of the Company's Periodontal Tissue Monitor (PTM).
Under the proposed five year agreement, Steri-Oss would be the exclusive
distributor of PTM in North America and other countries, excluding Europe and
Japan. The Steri-Oss News Release filed as Exhibit 99.58 hereto, is hereby
incorporated into this Report by reference.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) EXHIBITS. The following exhibit accompanies this Report:
Exhibit
Number Exhibit Description
------- -------------------
99.57 News release dated June 6, 1997, (the "News Release")
announcing that the Company received an approvable
letter from the U.S. Food and Drug Administration
(FDA) for a premarket application (PMA) for the
Periodontal Tissue Monitor (PTM). The approval is
contingent upon certain manufacturing requirements
and labeling issues.
99.58 News release dated May 29, 1997, (the "News Release")
announcing that the Company signed a letter of intent
with Steri-Oss, a leading dental implant company, for
the distribution of the Company's Periodontal Tissue
Monitor (PTM). Under the proposed five year agreement,
Steri-Oss would be the exclusive distributor of PTM in
North America and other countries, excluding Europe and
Japan.
2
<PAGE>
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 hereunto duly authorized.
XYTRONYX, INC.
By: /s/ James Hertzog
-----------------------
James Hertzog
Date: June 10, 1997 Controller-Principal Accounting Officer
3
<PAGE>
INDEX TO EXHIBITS
Exhibit Sequentially
Number Description Of Exhibit Numbered Page
- ------- ---------------------- -------------
99.57 News release dated June 6, 1997, (the "PMA
News Release") announcing that the Company
received an approvable letter from the U.S. Food
and Drug Administration (FDA) for a premarket
application (PMA) for the Periodontal Tissue
Monitor (PTM). The approval is contingent upon
certain manufacturing requirements and labeling
issues.
99.58
News release dated May 29, 1997, (the "Steri-Oss
News Release") announcing that the Company signed
a letter of intent with Steri-Oss, a leading
dental implant company, for the distribution of
the Company's Periodontal Tissue Monitor (PTM)
which is under FDA review. Under the proposed
five year agreement, Steri-Oss would be the
exclusive distributor of PTM in North America
and other countries, excluding Europe and Japan.
4
<PAGE>
Exhibit 99.57
FOR IMMEDIATE RELEASE
Contact: Jim Hertzog Rhonda Chiger (investors)
Xytronyx Inc. Patricia Gitt (media)
619/550-3900 Dewe Rogerson Inc.
212/688-6840
XYTRONYX RECEIVES APPROVABLE LETTER FROM
FDA FOR PERIODONTAL TISSUE MONITOR
San Diego, CA, June 6, 1997 --- Xytronyx, Inc. (AMEX: XYX) today announced that
it has received an approvable letter from the U.S. Food and Drug Administration
(FDA) for a premarket application (PMA) for the Periodontal Tissue Monitor
(PTM). The approval is contingent upon certain manufacturing requirements and
labeling issues. The Company has signed a letter of intent with Steri-Oss, a
leading dental implant company, for distribution of PTM in North America and
other countries. PTM is currently being marketed by Hawe-Neos Dental in Europe
and will be marketed by Shofu upon regulatory approval in Japan.
PTM is a chairside test which can be used at the dentist's office for the
detection and monitoring of periodontitis, a severe form of periodontal disease.
According to the American Dental Association, periodontitis affects 24% of
18 - 64 year olds in the U.S. each year and 33% of the world-wide population.
"We are pleased to have received the approvable letter from the FDA and will now
move PTM towards final approval and commercialization. We look forward to
turning our attention to our proprietary Cancer Immunotherapy Program (PDIT-TM-)
and Boronated Porphyrin Compounds (BOPP) for the treatment of cancer," said H.
Laurence Shaw, M.D., president and chief executive officer at Xytronyx. "Within
the last five months, Xytronyx has put together a new management team and raised
$10 million in capital to pursue our new strategic mission of being a licensing,
research and development company."
This news release contains forward looking statements. The actual results could
vary from those expected due to a variety of risks set forth from time to time
in the Company's filings with the Securities and Exchange Commission, including
but not limited to its report on Form 10-Q for the quarters ended June 30,
September 30 and December 31, 1996 and its report on Form 10-K for the year
ended March 31, 1996. The Company can provide no assurances as to when or if
the Company will receive final approval from the FDA for the PMA for PTM. The
Company undertakes no obligation to publicly release the results of any of these
forward-looking statements which may be made to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events.
Xytronyx Inc. is a licensing, research and development company for healthcare
products. The Company actively seeks products in order to manage their further
development and licensing opportunities. Xytronyx is currently engaged in the
development of cancer related technologies, Cancer Immunotherapy (PDIT-TM-) for
the treatment of metastatic cancer and Boronated Porphyrin Compounds (BOPP) for
cancer and other proliferative disorders.
# # #
<PAGE>
Exhibit 99.58
IMMEDIATE RELEASE
Contact: Jim Hertzog Kate de Santis (investors)
Xytronyx Inc. Susan Farley (media)
619/550-3900 Dewe Rogerson Inc.
212/688-6840
XYTRONYX SIGNS LETTER OF INTENT FOR MARKETING OF ITS
PERIODONTAL TISSUE MONITOR
San Diego, CA May 29, 1997 --- Xytronyx, Inc. (AMEX: XYX) today announced that
it has signed a letter of intent with Steri-Oss, a leading dental implant
company, for the distribution of its Periodontal Tissue Monitor (PTM) which is
under FDA review. Under the proposed five year agreement, Steri-Oss would be
the exclusive distributor of PTM in North America and other countries, excluding
Europe and Japan. PTM is currently being marketed by Hawe-Neos Dental in Europe
and will be marketed by Shofu upon regulatory approval in Japan.
PTM is a chairside test which can be used at the dentist's office for the
detection and monitoring of periodontitis, a severe form of periodontal disease.
According to the American Dental Association, periodontitis affects 33% of the
world-wide population and 24% of 18 to 64 year olds in the U.S. each year.
"We chose Steri-Oss due to their leadership position in the dental market and
strong sales force with periodontal products," said H. Laurence Shaw, M.D.,
chairman, president and chief executive officer. "With these relationships in
place, we look forward to being able to focus our efforts on developing our
product pipeline in the cancer area; first with our ongoing programs utilizing
our Photodynamic Immunotherapy Technology (PDIT) and Boronated Porphyrin
Compounds (BOPP) technology, then by in-licensing later stage products for
further development."
Recently, Xytronyx announced that its proprietary immunotherapy treatment
(PDIT-TM-) showed positive results as an effective treatment for the destruction
of malignant tumors in rats, as was reported in the current issue of CANCER
LETTERS. In that study, the PDIT-TM- technology destroyed targeted tumor in
both primary and metastatic tumors minimizing local non-tumor tissue damage and
created resistance in successfully treated rats to tumor rechallenge.
This news release contains forward looking statements. The consummation of the
proposed transaction with Steri-Oss is subject to several conditions, including
the negotiation and execution of definitive agreements and the actual results
could vary from those expected due to a variety of risks set forth from time to
time in the Company's filings with the Securities and Exchange Commission,
including but not limited to its report on Form 10-Q for the quarters ended June
30, September 30 and December 31, 1996 and its report on Form 10-K for the year
ended March 31, 1996. The Company undertakes no
<PAGE>
obligation to publicly release the results of any of these forward-looking
statements which may be made to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
Xytronyx Inc. is a biotechnology research, development and licensing company.
The Company actively seeks products in the later stages of development in order
to manage their further development and licensing opportunities. The Company
is currently engaged in the development of two cancer related technologies,
Photodynamic Immunotherapy-TM- (PDIT-TM-) for the treatment of metastatic cancer
and Boronated Porphyrin Compounds (BOPP) for hyperproliferative diseases,
including brain cancer.
# # #
