SC TO-I/A

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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

SCHEDULE TO/A
(Rule 14d-100)

TENDER OFFER STATEMENT UNDER SECTION 14(d)(1)
OR 13(e)(1) OF THE SECURITIES EXCHANGE ACT OF 1934

(Amendment No. 3)

VALENTIS, INC.
(Name of Issuer)

VALENTIS, INC. (OFFEROR AND ISSUER)
(Name of Filing Person (Identifying Status as Offeror, Issuer or Other Person))

Series A Convertible Redeemable Preferred Stock, Par Value $0.001 Per Share,
Common Stock Purchase Warrants, Class A and
Common Stock Purchase Warrants, Class B
(Title of Class of Securities)

N/A
(Cusip Number of Class of Securities)

BENJAMIN F. MCGRAW, III, PHARM.D.
863A MITTEN ROAD
BURLINGAME, CALIFORNIA 94010
(650) 697-1900
(Name, Address And Telephone Number of Person Authorized To
Receive Notices And Communications on Behalf of Filing Persons)

WITH A COPY TO:

PATRICK A. POHLEN, ESQ.
LATHAM & WATKINS
135 COMMONWEALTH DRIVE
MENLO PARK, CALIFORNIA 94025
(650) 328-4600

Check the appropriate boxes below to designate any transactions to which the statement relates.

o

third-party tender offer subject to Rule 14d-1.

ý

issuer tender offer subject to Rule 13e-4.

o

going-private transaction subject to Rule 13e-3.

o

amendment to Schedule 13D under Rule 13d-2.

Check the following box if the filing is a final amendment reporting the results of the tender offer: o

        This Amendment No. 3 amends and supplements the Tender Offer Statement on Schedule TO filed by Valentis, Inc., a Delaware corporation (the "Company," "Valentis," "us" or "we"), on May 10, 2002, as amended by Amendment No. 1 on June 5, 2002 and Amendment No. 2 on July 3, 2002. This Schedule TO is related to the Company's offer to purchase for cash 16,940 shares, or 55%, of its currently outstanding Series A Convertible Redeemable Preferred Stock, par value $0.001 per share (the "Series A Preferred Stock"), and 55% of the outstanding related Common Stock Purchase Warrants, Class A (the "Class A Warrants") and Common Stock Purchase Warrants, Class B (the "Class B Warrants", and together with the Class A Warrants, the "Warrants"), which warrants were issued to holders of Series A Preferred Stock in connection with their acquisition of Series A Preferred Stock. Fifty-five percent of the related Warrants are exercisable for an aggregate of approximately 605,980 shares of common stock, par value $0.001 per share (the "Common Stock"). The Company is offering to purchase the Series A Preferred Stock and related Warrants at a purchase price of $1,000 per share of Series A Preferred Stock and related Warrants tendered (the "Offer Consideration"), subject to the terms and conditions set forth in the Offer to Purchase dated May 10, 2002 (the "Offer to Purchase") and in the related Letter of Transmittal, which, as amended or supplemented from time to time, together constitute the offer.

        The Company has extended the period of time for which the offer is open to 9:00 p.m., Pacific Time, on October 15, 2002. The information contained in Exhibits (a)(5)(D) and (a)(5)(E) is incorporated herein by reference.

Item 12.    Exhibits.

(a)(5)(D)	Press Release, dated August 30, 2002.
(a)(5)(E)	Correction to Press Release, dated August 30, 2002.

2

SIGNATURE

        After due inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.

	VALENTIS, INC.
	By:	/s/  BENJAMIN F. MCGRAW III
		Name:	Benjamin F. McGraw III, Pharm.D.
		Title:	President and Chief Executive Officer
Dated: September 3, 2002

3

EXHIBIT INDEX

(a)(5)(D)	Press Release, dated August 30, 2002.
(a)(5)(E)	Correction to Press Release, dated August 30, 2002.

4

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Item 12. Exhibits.

SIGNATURE
EXHIBIT INDEX

EX-99.(A)(5)(D)

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Exhibit (a)(5)(D)

Valentis Extends Tender Offer to October 15, 2002

BURLINGAME, CA, August 30, 2002—Valentis, Inc. (NASDAQ: VLTS) today announced that it will extend the tender period of its previously announced tender offer to purchase 16,940 shares, or 55%, of its outstanding shares of Series A Convertible Redeemable Preferred Stock and 55% of the related outstanding Common Stock Purchase Warrants, Class A and Common Stock Purchase Warrants, to October 15, 2002. The Company will pay $1,000 per share of Series A Preferred Stock and related Class A and Class B Warrants tendered. The tender period is being extended to allow additional time for the satisfaction of certain conditions to the tender offer, which are described in the Offer to Purchase filed with the Securities and Exchange Commission on May 10, 2002.

As a result of the extension, holders of the Series A Preferred Stock will have until 9:00 p.m. Pacific Time on October 15, 2002 to validly tender their shares of Series A Preferred Stock and related Class A and Class B Warrants to Valentis, in exchange for which Valentis will pay $1,000 per share of Series A Preferred Stock and related Class A and Class B Warrants tendered.

This press release is neither an offer to purchase nor the solicitation of an offer to sell any securities of Valentis. Investors are urged to read the relevant tender offer documents that have been filed with the Securities and Exchange Commission by Valentis because they contain important information concerning the offer. You are able to obtain a free copy of the documents filed with the Commission by Valentis at the Commission's website at http://www.sec.gov.

Valentis is Converting Biologic Discoveries into Innovative Products. Valentis has three product platforms for the development of novel therapeutics: the GeneMedicine, GeneSwitch® and DNA vaccine platforms. The GeneMedicine platform includes a comprehensive array of proprietary nucleic acid delivery systems, including the broad cationic lipid portfolio, from which appropriate formulations and modalities may be selected and tailored to fit selected genes, indications, and target tissues. The del-1 GeneMedicine therapeutic is the lead product for the GeneMedicine platform of non-viral gene delivery technologies. Del-1 is an angiogenesis gene that is being developed for peripheral arterial disease and ischemic heart disease. The EpoSwitch™ therapeutic for anemia is the lead product for the GeneSwitch® platform and is being developed to allow control of erythropoietin protein production from an injected gene by an orally administered drug. We have developed synthetic vaccine delivery systems based on several classes of polymers. Our proprietary PINC™ polymer-based delivery technologies for intramuscular administration provide for higher and more consistent levels of antigen production. Additional information is available at http://www.valentis.com.

Statements in this press release that are not strictly historical are "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. The words "believes," "expects," "intends," "anticipates," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could affect Valentis' actual results include the need for additional capital, the early stage of product development, uncertainties related to clinical trials, and uncertainties related to patent position. There can be no assurance that Valentis will be able to develop commercially viable gene-based therapeutics or PEGylated biopharmaceuticals, that any of the Company's programs will be partnered with pharmaceutical partners, that necessary regulatory approvals will be obtained, or that any clinical trial will be successful. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the company's operations and business environments. These are described more fully in the Valentis Annual Report on Form 10-K for the period ended June 30, 2001 and Quarterly Report on Form 10-Q for the period ended March 31, 2002, each as filed with the Securities and Exchange Commission.

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Exhibit (a)(5)(D)

EX-99.(A)(5)(E)

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Exhibit (a)(5)(E)

Press Release Source: Valentis, Inc.

Correction—Valentis, Inc.

Friday August 30, 10:30 pm ET

In SFF020, Valentis (Nasdaq: VLTS-News) Extends Tender Offer to October 15, 2002, moved earlier today, we are advised by the company that the following is an addition to the end of the second graph, "As of August 30, 2002, 4,300 shares of Series A Preferred Stock, 111,870 Class A Warrants and 41,951 Class B Warrants have been validly tendered and not withdrawn."

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Exhibit (a)(5)(E)