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SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549

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FORM 10-K/A(Amendment No. 1)

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Annual Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 for the fiscal year ended June 30, 2001.

OR

Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to
 to .

Commission file number: 000-22987

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VALENTIS, INC.(Exact Name of Registrant as Specified in Its Charter)

DELAWARE

94-3156660(State or Other Jurisdiction of
Incorporation or Organization)

(I.R.S. Employer
Identification No.)


863A Mitten Road
Burlingame, California 94010(Address of Principal Executive Offices)

Registrant's
telephone number, including area code:(650) 697-1900

Securities registered pursuant to Section 12(b) of the Act:None

Securities registered pursuant to Section 12(g) of the Act:Common Stock, $0.001 par value

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Indicate
by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days. Yes /x/  No / /

Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of
registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K/A. / /

The
aggregate market value of the voting stock held by non-affiliates of the Registrant as of September 24, 2001 based on the closing sales price of the
Registrant's common stock, as reported on the Nasdaq National Market, was approximately $118,610,009. Shares of common stock held by each officer and director have been excluded in that such persons
may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

The
number of shares of Common Stock, par value $0.001 per share, of Valentis, Inc. outstanding as of September 24, 2001 was 29,908,504.

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EXPLANATORY NOTES

This Amendment No. 1 on Form 10-K/A is being filed by Valentis, Inc. as an amendment to our Annual Report on
Form 10-K for the fiscal year ended June 30, 2001 to amend and restate in its entirety Part III.

PART III

ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT

Certain Information With Respect to Directors

The following table sets forth certain information with respect to the members of our Board of Directors as of October 22, 2001.

|Name of Director                   |  | Age |  | Position                                        |  | Director Since |  | Term Expiring
|---------------------------------- |  | --- |  | ----------------------------------------------- |  | -------------- |  | -------------
|Benjamin F. McGraw, III, Pharm.D.  |  | 52  |  | President, Chief Executive Officer and Chairman |  | 1994           |  | 2001         
|Arthur M. Pappas (1)(2)            |  | 54  |  | Director                                        |  | 1999           |  | 2001         
|Stanley T. Crooke, M.D., Ph.D. (1) |  | 56  |  | Director                                        |  | 1999           |  | 2002         
|Patrick G. Enright (2)             |  | 39  |  | Director                                        |  | 1998           |  | 2002         
|Alan C. Mendelson                  |  | 53  |  | Director                                        |  | 2001           |  | 2002         
|Raju Kucherlapati, Ph.D. (1)       |  | 58  |  | Director                                        |  | 1995           |  | 2003         
|Bert W. O'Malley, M.D.             |  | 64  |  | Director                                        |  | 1999           |  | 2003         
|Mark McDade (2)                    |  | 46  |  | Director                                        |  | 2000           |  | 2003         

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Benjamin F. McGraw, III, Pharm.D.

Benjamin F. McGraw, III, Pharm.D. has served as the Company's President, Chief Executive Officer and Chairman since September 1994 when he joined
Megabios Corp. as its President, Chief Executive Officer and Chairman. In March 1999 Megabios Corp. merged with GeneMedicine, Inc. to form Valentis. In August 1999 Valentis merged with
PolyMASC Pharmaceuticals, plc. Prior to Megabios, Dr. McGraw gained experience in R&D as Vice-President, Development for Marion and Marion, Merrell Dow; in business development as
Corporate Vice-President, Corporate Development at Allergan, Inc.; and in finance as President of Carerra Capital Management. Dr. McGraw also serves on the board of directors
of ISTA Pharmaceuticals. Dr. McGraw received his Doctor of Pharmacy from the University of Tennessee Center for the Health Sciences, where he also completed a clinical practice residency.

Arthur M. Pappas

Arthur M. Pappas has served as a director of the Company since March 1999. From January 1995 to March 1999, Mr. Pappas served as a
director of GeneMedicine, Inc. which merged with Megabios in March 1999 to form Valentis. Mr. Pappas is Chairman and Chief Executive Officer of A. M. Pappas & Associates, LLC,
which he founded in 1994, an international advisory services, investment and venture company that works with life science companies, products and related technologies. Mr. Pappas is a director
of publicly-traded Quintiles Transnational Corp., a contract research, sales and marketing organization, Embrex, Inc., a research and development company specializing in poultry
in-the-egg delivery systems, and AtheroGenics, Inc., a biopharmaceutical company focused on research and

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development of genes that regulate atherosclerosis and cancer. Mr. Pappas received a B.S. in biology from Ohio State University and an M.B.A. in finance from Xavier University.

Stanley T. Crooke, M.D., Ph.D.

Stanley T. Crooke, M.D., Ph.D. has served as a director of the Company since March 1999. He previously served as a director of GeneMedicine, Inc. from
March 1992 to March 1996, and as Chairman of the Board of GeneMedicine from March 1996 to March 1999. Dr. Crooke has been Chief Executive Officer and a director of
Isis Pharmaceuticals, Inc., a biotechnology company, since he co-founded Isis in January 1989, and he has served as Chairman of the Board of Isis since February 1991.
Dr. Crooke is a member of the Board of Directors of Idun Pharmaceuticals, Inc., SYNSORB Biotech, Inc., Axon Instruments, Inc., EPIX Medical Inc. and Isis
Pharmaceuticals, Inc. Dr. Crooke received a Ph.D. in Pharmacology and an M.D. from Baylor College of Medicine, where he served for a number of years as Adjunct Professor of Pharmacology.
He currently serves as Adjunct Professor of Pharmacology at the University of California, San Diego.

Patrick G. Enright

Patrick G. Enright has served as a director of the Company since March 1998. Since March 1998, Mr. Enright has been a managing member of
Diaz & Altschul Group, LLC, a privately held merchant bank. From March 1995 to February 1998, Mr. Enright served in various executive positions at the Company, including
Senior Vice President, Corporate Development and Chief Financial Officer. From September 1993 to June 1994, Mr. Enright was Senior Vice President of Finance and Business
Development for Boehringer Mannheim Therapeutics, a pharmaceutical company and a subsidiary of Corange Ltd. From September 1989 to September 1993, Mr. Enright was employed
at PaineWebber Incorporated, an investment banking firm, where he became a Vice President in January 1992. Mr. Enright received his M.B.A. from the Wharton School of Business at the
University of Pennsylvania and his B.S. in biological sciences from Stanford University.

Alan C. Mendelson

Alan Mendelson has served as a director of the Company since February 2001. Mr. Mendelson is a senior partner of Latham & Watkins, a
private law firm and has been with that firm since May 2000. Previously Mr. Mendelson was with Cooley Godward LLP, a private law firm, for 27 years and served as the managing
partner of its Palo Alto office from May 1990 to March 1995 and from November 1996 to October 1997. Mr. Mendelson has served as Secretary of the Company since
March 2000. Mr. Mendelson served as Acting General Counsel of Cadence Design Systems, Inc., an electronic design automation software company, from November 1995 to
June 1996. Mr. Mendelson previously served as Secretary and Acting General Counsel of Amgen, Inc., a biopharmaceutical company from April 1990 to March 1991.
Mr. Mendelson is currently a director of Aviron, Axys Pharmaceuticals, Inc. and USSeach.com, Inc. Mr. Mendelson received his J.D. from Harvard Law School and his A.B. in
political science from the University of California, Berkeley.

Raju Kucherlapati, Ph.D.

Raju Kucherlapati, Ph.D. has served as a director of the Company since March 1995. Dr. Kucherlapati has served as the Lola and Saul Kramer
Professor and Chairman of the Department of Molecular Genetics at Albert Einstein College of Medicine since 1989. Dr. Kucherlapati is a founder of both Cell Genesys, Inc., a
biotechnology company and Millennium Pharmaceuticals, Inc., a biopharmaceutical company. Dr. Kucherlapati serves on the boards of directors of Abgenix, Inc., a biopharmaceutical
company, and Millennium Pharmaceuticals, Inc. Dr. Kucherlapati received his Ph.D. in genetics from the University of Illinois.

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Bert W. O'Malley, M.D.

Bert W. O'Malley, M.D. has served as a director of the Company since March 1999. Dr. O'Malley co-founded GeneMedicine, Inc. and served as one of
its directors from April 1998 to March 1999. Dr. O'Malley has been Chairman of the Department of Molecular and Cellular Biology at Baylor College of Medicine and a Director of the
Baylor Center for Population Research and Reproductive Biology since 1973. He is a member of the National Academy of Science and the Institute of Medicine and is the author of more than 500 scientific
publications. Dr. O'Malley's scientific work has included major achievements in the areas of medical endocrinology and reproduction with potentially broad application to the diagnosis of human
genetic diseases and the treatment of breast and prostatic cancer. His work includes the invention of the Company's proprietary GeneSwitch technology for the genetic regulation of
therapeutic proteins. Dr. O'Malley holds a B.S. in psychology/chemistry and an M.D. degree from the University of Pittsburgh.

Mark McDade

Mark McDade has served as a director of the Company since May 2000. Since January 2001, Mr. McDade has been the Chief Executive Officer of
Signature BioScience, Inc., a privately-held company focused on drug discovery. Mr. McDade was the President and Chief Operating Officer of Corixa Corporation, a developer of
immunotherapeutic products through 2000. As a co-founder of Corixa in September 1994, he served as its Chief Operating Officer since that company's inception. Prior to Corixa,
Mr. McDade held various management positions at Boehringer Mannheim and Sandoz Ltd. Mr. McDade serves on the board of directors of Corixa. Mr. McDade earned an M.B.A. from
the Harvard University Graduate School of Business and a B.A. in history from Dartmouth College.

Certain Information With Respect to Executive Officers

The executive officers of our company as of October 22, 2001 are as follows:

|Name                              |  | Age |  | Position                                                   
|--------------------------------- |  | --- |  | -----------------------------------------------------------
|Benjamin F. McGraw, III, Pharm.D. |  | 52  |  | President, Chief Executive Officer and Chairman            
|Bennet L. Weintraub               |  | 47  |  | Chief Financial Officer and Vice President, Finance        
|J. Tyler Martin, Sr., M.D.        |  | 42  |  | Senior Vice President, Development                         
|Alain Rolland, Pharm.D., Ph.D.    |  | 41  |  | Senior Vice President, Preclinical Research and Development
|Margaret M. Snowden               |  | 42  |  | General Counsel                                            

The
principal occupations and positions for the past five years, and in some cases prior years, of the executive officers named above, are as follows:

Benjamin F. McGraw, III, Pharm.D.

Benjamin F. McGraw, III, Pharm.D. has served as the Company's President, Chief Executive Officer and Chairman since September 1994 when he joined
Megabios Corp. as its President, Chief Executive Officer and Chairman. In March 1999 Megabios Corp. merged with GeneMedicine, Inc. to form Valentis. In August 1999 Valentis merged with
PolyMASC Pharmaceuticals, plc. Prior to Megabios, Dr. McGraw gained experience in R&D as Vice-President, Development for Marion and Marion, Merrell Dow; in business development as
Corporate Vice-President, Corporate Development at Allergan, Inc.; and in finance as President of Carerra Capital Management. Dr. McGraw also serves on the board of directors
of ISTA Pharmaceuticals. Dr. McGraw received his Doctor of Pharmacy from the
University of Tennessee Center for the Health Sciences, where he also completed a clinical practice residency.

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Bennet L. Weintraub

Bennet L. Weintraub has served as Chief Financial Officer and Vice President Finance of the Company since May 1998. From March 1996 to
May 1998, Mr. Weintraub was Chief Financial Officer and Vice President Finance and Administration for Technology Modeling Associates, a software company. From September 1993 to
March 1996, he was employed as Director of Finance by Metra Biosystems, a bone diagnostics company, and from September 1987 to September 1993, he was Controller at Advanced
Polymer Systems, a drug delivery company. Mr. Weintraub received his M.B.A. from Harvard University Graduate School of Business and his B.A. in mathematical economics from Pomona College, and
is a certified public accountant in California.

J. Tyler Martin, Sr., M.D.

J. Tyler Martin, Sr., M.D. has served as our Senior Vice President, Development since July 2001. Dr. Martin joined Valentis as Vice President,
Clinical Development and Regulatory Affairs in July 2000. From December 1997 to July 2000, Dr. Martin was Executive Director, Clinical Research and Development at the
SyStemix/GTI unit of Novartis, AG. Prior to SyStemix/GTI, Dr. Martin served as Director, Antiviral Clinical Research at Parke-Davis Inc. from April 1997 to November 1997
and Associate Director of Clinical Research at Chiron Corp. from February 1994 to April 1997. Dr. Tyler received an M.D. from the University of Nebraska and a B.S. in chemistry
from the University of Nebraska (Kearney).

Alain Rolland, Pharma.D., Ph.D.

Alain Rolland, Pharm.D., Ph.D. has served as our Senior Vice President, Preclinical Research and Development since April 2001. Dr. Rolland joined
Valentis as Vice President, Research and Development and Center Head, The Woodlands, upon completion of the merger with GeneMedicine, Inc. in March 1999. Dr. Rolland previously
had been Vice President, Research of GeneMedicine since February 1998, Vice President, Gene Delivery Sciences from November 1996 to February 1998 and Director, Gene Delivery
Sciences from June 1993 to November 1996. Prior to joining GeneMedicine in 1993, Dr. Rolland worked in drug delivery research at Ciba-Geigy Pharmaceuticals and more
recently was Head of the Formulation Research Group at the International Centre for Dermatological Research (CIRD Galderma) in France. Dr. Rolland has received numerous international and
national awards for scholarship. Dr. Rolland holds a Pharm.D. and a Ph.D. degree in
pharmaceutical sciences and a D.E.A. in pharmacokinetics and biopharmaceutics from Rennes University in France.

Margaret M. Snowden

Margaret M. Snowden has served as General Counsel since October 2001. From March 2000 to October 2001 Ms. Snowden served as Vice
President, Intellectual Property and Legal Affairs of the Company. Ms. Snowden joined the Company in April 1996 and served previously as Corporate Counsel, Intellectual Property and
Licensing. From October 1993 to April 1996, Ms. Snowden was Patent Attorney with SyStemix, Inc., a biotechnology company and a subsidiary of Sandoz, Ltd.
Ms. Snowden received her J.D. from Boalt Hall School of Law at the University of California, Berkeley, and her B.S. and M.S. in cell and molecular biology from Florida Institute of Technology.

Compliance With Section 16(a) Under the Securities Exchange Act of 1934

Section 16(a) of the Exchange Act requires that our executive officers and directors, and persons who own more than ten percent of a registered class of
our equity securities, file reports of ownership and changes in ownership (Forms 3, 4 and 5) with the Securities and Exchange Commission. Executive officers, directors and
greater-than-ten-percent holders are required to furnish us with copies of all of these forms which they file.

Based
solely on our review of these reports or written representations from certain reporting persons, we believe that during the fiscal year ended June 30, 2001, all filing
requirements applicable to our officers, directors, greater-than-ten-percent beneficial owners and other persons subject to Section 16(a) of the Exchange Act
were met.

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ITEM 11. COMPENSATION OF EXECUTIVE OFFICERS

Summary Compensation Table

The following table shows for the fiscal years ended June 30, 2001, 2000 and 1999, compensation awarded or paid to, or earned by, the Company's Chief
Executive Officer and its other four most highly compensated executive officers at June 30, 2001 (the "Named Executive Officers"):

|                                                                                           |  |                |  | Annual Compensation |                         | Long-Term
Compensation |   |                     
|------------------------------------------------------------------------------------------ |  | -------------- |  | ------------------- | ----------------------- | ---------------------- | - | --------------------
|
|Benjamin F. McGraw, III, Pharm.D.
President, Chief Executive
Officer and Chairman          |  | 2001
2000
1999 |  | $                   | 322,081
304,484
318,425 |                        | $ | 91,155
50,000
30,000
|Bennet L. Weintraub
Chief Financial Officer and
Vice President, Finance                    |  | 2001
2000
1999 |  | $                   | 189,176
182,379
172,622 |                        | $ | 30,317
20,000
     
|J. Tyler Martin, Sr., M.D.
Senior Vice President,
Development (3)                          |  | 2001           |  | $                   | 199,013                 |                        |   |                    
|Alain Rolland, Pharm.D., Ph.D.
Senior Vice President,
Preclinical Research
and Development |  | 2001
2000
1999 |  | $                   | 235,065
216,633
50,372  | (4)                    | $ | 41,663

20,000     
|Margaret M. Snowden
General Counsel                                                        |  | 2001
2000
1999 |  | $                   | 185,300
151,013
125,525 |                        | $ | 24,663

          

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STOCK OPTION GRANTS AND EXERCISES

The Company grants options to its executive officers under its Incentive Plan. As of September 30, 2001, options to purchase a total of 3,825,156 shares
were outstanding under the Incentive Plan and options to purchase 4,722,760 shares remained available for grant thereunder.

The
following tables show for the fiscal year ended June 30, 2001, certain information regarding options granted to, exercised by, and held at year end by, Named Executive
Officers:

Option Grants in Fiscal Year Ended June 30, 2001

|                                  |  | Individual Grants          |  |                    |   |   |                     | Potential Realizable Value
at Assumed Annual
Rates of Stock Price
Appreciation for
Option Term (1)
|--------------------------------- |  | -------------------------- |  | ------------------ | - | - | ------------------- | --------------------------------------------------------------------------------------------------
|
|
|
|Benjamin F. McGraw, III, Pharm.D. |  | 20,792
74,208              |  | 1.56
5.58          | % | $ | 9.25
9.25           |                                                                                                   
|Bennet L. Weintraub               |  | 16,752
13,248              |  | 1.26
1.00          |   |   | 9.25
9.25           |                                                                                                   
|J. Tyler Martin, Sr., M.D.        |  | 47,056
122,944             |  | 3.54
9.24          |   |   | 8.50
8.50           |                                                                                                   
|Alain Rolland, Pharm.D, Ph.D.     |  | 9,375
20,625
19,436
25,564 |  | .70
1.55
1.46
1.92 |   |   | 4.56
4.56
9.25
9.25 |                                                                                                   
|Margaret M. Snowden               |  | 1,459
8,541                |  | .11
 .64           |   |   | 9.25
9.25           |                                                                                                   

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Aggregated Option Exercises in Last Fiscal Year and Fiscal Year End Option Values

|Name                              |  | Shares
Acquired on
Exercise (#) |  | Value Realized
($) (1) |  | Number of Securities
Underlying Unexercised
Options at June 30, 2001 (#)
Exercisable/Unexercisable |  | Value of Unexercised
In-the-Money Options at
June 30, 2001 (2) ($)
Exercisable/Unexercisable
|--------------------------------- |  | ------------------------------- |  | ---------------------- |  | -------------------------------------------------------------------------------------------------- |  | --------------------------------------------------------------------------------------------
|Benjamin F. McGraw, III, Pharm.D. |  |                                |  |                       |  | 103,656 / 158,844                                                                                  |  | $62,582 / $40,544                                                                           
|Bennet L. Weintraub               |  |                                |  |                       |  | 86,459 / 62,916                                                                                    |  | $18,595 / $10,937                                                                           
|J. Tyler Martin, Sr., M.D.        |  |                                |  |                       |  | 0 / 170,000                                                                                        |  | $0 / $0                                                                                     
|Alain Rolland, Pharm.D., Ph.D.    |  |                                |  |                       |  | 116,733 / 119,953                                                                                  |  | $66,661 / $93,307                                                                           
|Margaret M. Snowden               |  |                                |  |                       |  | 26,332 / 41,334                                                                                    |  | $37,346 / $22,168                                                                           

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Compensation of Directors

Each non-employee director of the Company receives a quarterly retainer of $3,000 and a per meeting fee of $1,000. The members of the Board of
Directors are also eligible for reimbursement for their expenses incurred in connection with attendance at Board meetings in accordance with Company policy.

Under
the Company's 1998 Non-Employee Directors' Stock Option Plan, on the date of the annual stockholders' meeting of each year, each member of the Company's Board of
Directors who is not an employee of the Company will automatically be granted, without further action by the Company, its stockholders or the Board of Directors, an option to purchase 10,000 shares of
the Company's Common Stock. In addition, each new non-employee director will receive a one time grant to purchase 25,000 shares of Common Stock on the date of the annual stockholders'
meeting at which such new director is elected to the Board of Directors. The exercise price of the options granted to the non-employee directors is 100% of the fair market value of the
Common Stock subject to the option on the date of the option grant.

Compensation Committee Interlocks and Insider Participation

During the year ended June 30, 2001, none of the Company's executive officers served on the board of any entities whose directors or officers serve on
the Company's Compensation Committee. No current or former executive officer or employee of the Company serves on the Compensation Committee.

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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table sets forth certain information regarding the beneficial ownership of the Company's Common Stock as of October 8, 2001 by:
(i) each director and nominee for director; (ii) each of the executive officers named in the Summary Compensation Table; (iii) all executive officers and directors of the Company
as a group; and (iv) all those known by the Company to be beneficial owners of more than five percent of its Common Stock.

BENEFICIAL OWNERSHIP

Beneficial Ownership(1)Name and Address of Beneficial Owner

Number of Shares

Percent of TotalStanley T. Crooke, M.D., Ph.D. (2)

52,962

*Patrick G. Enright (3)

328,665

1.10Alan C. Mendelson (4)

2,100

*Raju Kucherlapati, Ph.D. (5)

50,832

*Mark McDade (6)

19,061

*Benjamin F. McGraw, III, Pharm.D. (7)

526,362

1.76Bert W. O'Malley, M.D. (8)

78,412

*J. Tyler Martin, Sr., M.D. (9)

75,780

*Arthur M. Pappas (10)

39,829

*Alain Rolland, Pharm.D., Ph.D. (11)

172,031

*Margaret M. Snowden (12)

44,096

*Bennet L. Weintraub (13)

126,246

*All executive officers and directors as a group (12 persons)

1,516,376

5.07


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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

In December 2000, the Company paid a fee of $785,000 and issued a warrant to purchase 105,000 shares of Common Stock to Diaz & Altschul Group,
LLC, in consideration for its services as a financial advisor and placement agent in connection with the private placement of an aggregate of $31,500,000 worth of the Company's Series A
Convertible Redeemable Preferred Stock. Mr. Enright, one of the Company's directors, is a managing member of Diaz & Altschul Group, LLC.

For
the fiscal year ended June 30, 2001, the Company paid an aggregate of $291,280 to the law firm of Latham & Watkins for the provision of legal services during that
period. Mr. Mendelson, one of the Company's directors, is a partner of Latham & Watkins.

The
Company has entered into indemnity agreements with certain officers and directors which provide, among other things, that the Company will indemnify such officer or director,
under the circumstances and to the extent provided for therein, for expenses, damages, judgments, fines and settlements he or she may be required to pay in actions or proceedings which he or she is or
may be made a party by reason of his or her position as a director, officer or other agent of the Company, and otherwise to the full extent permitted under Delaware law and the Company's
By-laws.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.

| |  | VALENTIS, INC.         
| |  | -----------------------
| |  | /s/ Bennet L. Weintraub
| |  | By:                    
| |  | Its:                   

Date:
October 26, 2001

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