**UNITED STATESSECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

 

**FORM 10-Q**

 

**ý****                                ****Quarterly report pursuant toSection 13 or 15(d) of the Securities Exchange Act of 1934.**

 

**For the quarterly period ended March 31,2004.**

 

**o****                                ****Transition report pursuant toSection 13 or 15(d) of the Securities Exchange Act of 1934.**

 

**For the transition period from                 to                 .**

 

**Commission File Number****000-29815**

 

**AllosTherapeutics, Inc.**

(Exact name of Registrant as specified in itscharter)

 
| **Delaware**                                          |   | **54-1655029**      |
|-------------------------------------------------------|--------|---------------------|
| (State or other jurisdiction of                       |   | (I.R.S. Employer    |
| incorporation or organization)                        |   | Identification No.) |
|                                                  |   |                |
| **11080 CirclePoint Road, Suite 200**                 |
| **Westminster, Colorado  80020**                 |
| **(303) 426-6262**                                    |
| (Address, including zip code, and telephone  number,  |
| including area code, of principal executive  offices) |

 

Indicate bycheck mark whether the registrant (1) has filed all reports required to befiled by Section 13 or 15(d) of the Securities Exchange Act of 1934 duringthe preceding 12 months (or for such shorter period that the registrantwas required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days.

 

Yes                            ý                                                                                    No                                o

 

Indicate bycheck mark whether the registrant is an accelerated filer (as defined in Rule12b-2 of the Exchange Act).

 

Yes                            ý                                                                                    No                                o

 

As of May 5,2004, there were 31,139,390 shares of the registrant’s Common Stock, par value$0.001 per share, outstanding.

 

This quarterly report on Form 10-Q consistsof 20 pages.

 

 

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**ALLOSTHERAPEUTICS, INC.**

 

**FORM 10-Q**

 

**TABLE OF CONTENTS**

 
| PART I.  Financial Information |                                                                                                                                                                                                         |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                                |                                                                                                                                                                                                         |
| ITEM 1.                             | Financial Statements                                                                                                                                                                                         |   |
|                                |                                                                                                                                                                                                         |   |
|                                | Balance Sheets  (unaudited) —  as of December 31, 2003 and March 31, 2004                                                                                                                |   |
|                                |                                                                                                                                                                                                         |   |
|                                | Statements of Operations (unaudited) — for the three months ended  March 31, 2003 and 2004 and the cumulative period from September 1,  1992 (date of inception) through March 31, 2004  |   |
|                                |                                                                                                                                                                                                         |   |
|                                | Statements of Cash Flows  (unaudited) — for the three months ended March 31, 2003 and 2004 and the  cumulative period from September 1, 1992 (date of inception) through  March 31, 2004 |   |
|                                |                                                                                                                                                                                                         |   |
|                                | Notes to Financial Statements (unaudited)                                                                                                                                                                    |   |
|                                |                                                                                                                                                                                                         |   |
| ITEM 2.                             | Management’s Discussion and Analysis of  Financial Condition and Results of Operations                                                                                                                  |   |
|                                |                                                                                                                                                                                                         |   |
| ITEM 3.                             | Quantitative and Qualitative Disclosures  About Market Risk                                                                                                                                                  |   |
|                                |                                                                                                                                                                                                         |   |
| ITEM 4.                             | Controls and Procedures                                                                                                                                                                                      |   |
|                                |                                                                                                                                                                                                         |
| PART II.  Other Information    |                                                                                                                                                                                                         |
|                                |                                                                                                                                                                                                         |   |
| ITEM 1.                             | Legal  Proceedings                                                                                                                                                                                           |   |
|                                |                                                                                                                                                                                                         |   |
| ITEM 2.                             | Changes  in Securities and Use of Proceeds                                                                                                                                                                   |   |
|                                |                                                                                                                                                                                                         |   |
| ITEM 3.                             | Defaults  Upon Senior Securities                                                                                                                                                                             |   |
|                                |                                                                                                                                                                                                         |   |
| ITEM 4.                             | Submission  of Matters to a Vote of Security Holders                                                                                                                                                         |   |
|                                |                                                                                                                                                                                                         |   |
| ITEM 5.                             | Other  Information                                                                                                                                                                                           |   |
|                                |                                                                                                                                                                                                         |   |
| ITEM 6.                             | Exhibits  and Reports on Form 8-K                                                                                                                                                                            |   |
|                                |                                                                                                                                                                                                         |   |
| SIGNATURES                          |                                                                                                                                                                                                         |   |

 

2

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# **PART I. FINANCIAL INFORMATION**

# ** **

## **ITEM 1.**                        FINANCIALSTATEMENTS

## ** **

**ALLOS THERAPEUTICS,INC.**

### **BALANCESHEETS**

**(unaudited)**

 
|                                                                                                                                                                                                                                       |   | **December 31,** |       | **March 31,** |   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------|------------|--------------------|--------|
|                                                                                                                                                                                                                                       |   | **2003**              |       | **2004**           |   |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| **ASSETS**                                                                                                                                                                                                                                 |   |                  |       |               |   |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| Current  assets:                                                                                                                                                                                                                           |   |                  |       |               |   |
| Cash and cash  equivalents                                                                                                                                                                                                                 |   | $                     | 4,642,305  |               | $      | 3,720,492 |   |
| Restricted  cash                                                                                                                                                                                                                           |   | 550,000               |       | 550,000            |   |
| Short-term  investments                                                                                                                                                                                                                    |   | 40,254,935            |       | 37,134,312         |   |
| Prepaid  research and development expenses                                                                                                                                                                                                 |   | 286,573               |       | 342,805            |   |
| Prepaid  expenses and other assets                                                                                                                                                                                                         |   | 834,249               |       | 161,721            |   |
| Total current  assets                                                                                                                                                                                                                      |   | 46,568,062            |       | 41,909,330         |   |
| Long-term  marketable securities                                                                                                                                                                                                           |   | 150,182               |       | 138,998            |   |
| Property and  equipment, net                                                                                                                                                                                                               |   | 1,455,486             |       | 1,317,722          |   |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| Total assets                                                                                                                                                                                                                               |   | $                     | 48,173,730 |               | $      | 43,366,050 |   |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| **LIABILITIES AND STOCKHOLDERS’ EQUITY**                                                                                                                                                                                              |   |                  |       |               |   |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| Current  liabilities:                                                                                                                                                                                                                      |   |                  |       |               |   |
| Accounts  payable — related parties                                                                                                                                                                                                   |   | $                     | 114,483    |               | $      | 39,705 |   |
| Trade accounts  payable and accrued expenses                                                                                                                                                                                               |   | 462,774               |       | 814,575            |   |
| Accrued  research and development expenses                                                                                                                                                                                                 |   | 1,173,856             |       | 1,445,945          |   |
| Accrued bonus  and employee benefits                                                                                                                                                                                                       |   | 1,011,340             |       | 623,401            |   |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| Total current  liabilities                                                                                                                                                                                                                 |   | $                     | 2,762,453  |               | $      | 2,923,626 |   |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| Commitments  and contingencies (Note 6)                                                                                                                                                                                                    |   |                  |       |               |   |
| Stockholders’  equity:                                                                                                                                                                                                                |   |                  |       |               |   |
| Preferred stock, $0.001 par value;  10,000,000 shares authorized at December 31, 2003 and March 31,  2004; no shares issued or outstanding                                                                                       |   | —                |       | —             |   |
| Series A Junior Participating Preferred  Stock, $0.001 par value; 1,000,000 shares designated from authorized  preferred stock at December 31, 2003 and March 31, 2004; no shares  issued or outstanding                         |   | —                |       | —             |   |
| Common stock, $0.001 par value; 75,000,000  shares authorized at December 31, 2003 and March 31, 2004;  31,103,455 and 31,138,224 shares issued and outstanding at December 31,  2003 and March 31, 2004, respectively |   | 31,104                |       | 31,138             |   |
| Additional  paid-in capital                                                                                                                                                                                                                |   | 181,415,293           |       | 181,561,574        |   |
| Deferred  compensation related to stock based compensation                                                                                                                                                                                 |   | (285,576              | )          | (254,219           | )      |
| Deficit  accumulated during the development stage                                                                                                                                                                                          |   | (135,749,544          | )          | (140,896,069       | )      |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| Total  stockholders’ equity                                                                                                                                                                                                           |   | 45,411,277            |       | 40,442,424         |   |
|                                                                                                                                                                                                                                       |   |                  |       |               |   |
| Total  liabilities and stockholders’ equity                                                                                                                                                                                           |   | $                     | 48,173,730 |               | $      | 43,366,050 |   |

 

The accompanying notes are anintegral part of these financial statements.

 

3

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**ALLOSTHERAPEUTICS, INC.**

### **STATEMENTSOF OPERATIONS**

**(unaudited)**

 
|                                                                  |   | **Three  Months Ended  March 31,** |       | **Cumulative  Period  From September 1, 1992   (date of inception)  through March 31,** |   |
|-----------------------------------------------------------------------|--------|-----------------------------------------|------------|---------------------------------------------------------------------------------------------------|--------|
|                                                                  |   | **2003**                                |       | **2004**                                                                                          |   | **2004** |   |
|                                                                  |   |                                    |       |                                                                                              |   |   |   |
| Operating expenses:                                                   |   |                                    |       |                                                                                              |   |   |   |
| Research and development                                              |   | $                                       | 3,405,572  |                                                                                              | $      | 1,988,567 |   | $ | 74,147,833 |   |
| Clinical manufacturing                                                |   | 2,080,207                               |       | 782,571                                                                                           |   | 23,319,012 |   |
| Marketing, general and administrative                                 |   | 2,019,254                               |       | 2,513,002                                                                                         |   | 52,557,769 |   |
| Restructuring costs                                                   |   | —                                  |       | —                                                                                            |   | 638,070 |   |
|                                                                  |   |                                    |       |                                                                                              |   |   |   |
| Total operating expenses                                              |   | 7,505,033                               |       | 5,284,140                                                                                         |   | 150,662,684 |   |
|                                                                  |   |                                    |       |                                                                                              |   |   |   |
| Loss from operations                                                  |   | (7,505,033                              | )          | (5,284,140                                                                                        | )      | (150,662,684 | ) |
| Gain on settlement claims                                             |   | —                                  |       | —                                                                                            |   | 5,110,083 |   |
| Interest and other income, net                                        |   | 371,684                                 |       | 137,615                                                                                           |   | 14,269,507 |   |
|                                                                  |   |                                    |       |                                                                                              |   |   |   |
| Net loss                                                              |   | (7,133,349                              | )          | (5,146,525                                                                                        | )      | (131,283,094 | ) |
|                                                                  |   |                                    |       |                                                                                              |   |   |   |
| Dividend related to beneficial conversion  feature of preferred stock |   | —                                  |       | —                                                                                            |   | (9,612,975 | ) |
|                                                                  |   |                                    |       |                                                                                              |   |   |   |
| Net loss attributable to common  stockholders                         |   | $                                       | (7,133,349 | )                                                                                                 | $      | (5,146,525 | ) | $ | (140,896,069 | ) |
|                                                                  |   |                                    |       |                                                                                              |   |   |   |
| Net loss per share:                                                   |   |                                    |       |                                                                                              |   |   |   |
| Basic and diluted                                                     |   | $                                       | (0.28      | )                                                                                                 | $      | (0.17 | ) |   |   |
|                                                                  |   |                                    |       |                                                                                              |   |   |   |
| Weighted average common shares:                                       |   |                                    |       |                                                                                              |   |   |   |
| Basic and diluted                                                     |   | 25,880,216                              |       | 31,109,944                                                                                        |   |   |   |

 

The accompanying notes are an integral partof these financial statements.

 

4

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**ALLOSTHERAPEUTICS, INC.**

### **STATEMENTSOF CASH FLOWS**

**(unaudited)**

 
|                                                                                                           |   | **Three  Months Ended  March 31,** |       | **Cumulative  Period From  September 1, 1992  (date of inception)  through** |   |
|----------------------------------------------------------------------------------------------------------------|--------|-----------------------------------------|------------|-----------------------------------------------------------------------------------|--------|
|                                                                                                           |   | **2003**                                |       | **2004**                                                                          |   | **March 31,  2004** |   |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Cash Flows  From Operating Activities:                                                                         |   |                                    |       |                                                                              |   |   |   |
| Net loss                                                                                                       |   | $                                       | (7,133,349 | )                                                                                 | $      | (5,146,525 | ) | $ | (131,283,094 | ) |
| Adjustments to reconcile net loss to net  cash used in operating activities:                                   |   |                                    |       |                                                                              |   |   |   |
| Depreciation and amortization                                                                                  |   | 149,447                                 |       | 142,562                                                                           |   | 1,986,083 |   |
| Stock-based compensation                                                                                       |   | (365,379                                | )          | 90,802                                                                            |   | 21,525,814 |   |
| Write-off of long-term investment                                                                              |   | —                                  |       | —                                                                            |   | 1,000,000 |   |
| Other                                                                                                          |   | —                                  |       | —                                                                            |   | 98,384 |   |
| Changes in operating assets and  liabilities:                                                                  |   |                                    |       |                                                                              |   |   |   |
| Prepaids and other assets                                                                                      |   | (371,413                                | )          | 616,296                                                                           |   | (494,527 | ) |
| Interest receivable on investments                                                                             |   | 125,582                                 |       | 15,995                                                                            |   | (607,911 | ) |
| Accounts payable – related parties                                                                        |   | 30,152                                  |       | (74,778                                                                           | )      | 3,397,970 |   |
| Trade accounts payable and accrued expenses                                                                    |   | 8,996                                   |       | 351,801                                                                           |   | 814,575 |   |
| Accrued research and development expenses                                                                      |   | 677,029                                 |       | 272,089                                                                           |   | (1,912,319 | ) |
| Accrued bonus and employee benefits                                                                            |   | (746,330                                | )          | (387,939                                                                          | )      | 623,401 |   |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Net cash used in operating activities                                                                          |   | (7,625,265                              | )          | (4,119,697                                                                        | )      | (104,851,624 | ) |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Cash Flows From Investing Activities:                                                                          |   |                                    |       |                                                                              |   |   |   |
| Acquisition of property and equipment                                                                          |   | (127,619                                | )          | (4,798                                                                            | )      | (3,049,062 | ) |
| Purchases of marketable securities                                                                             |   | (284,282                                | )          | (6,884,188                                                                        | )      | (290,043,251 | ) |
| Proceeds from sales of marketable  securities                                                                  |   | 13,845,000                              |       | 10,000,000                                                                        |   | 253,377,852 |   |
| Purchase of long-term investment                                                                               |   | —                                  |       | —                                                                            |   | (1,000,000 | ) |
| Payments received on notes receivable                                                                          |   | —                                  |       | —                                                                            |   | 49,687 |   |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Net cash provided by (used in) investing  activities                                                           |   | 13,433,099                              |       | 3,111,014                                                                         |   | (40,664,774 | ) |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Cash Flows From Financing Activities:                                                                          |   |                                    |       |                                                                              |   |   |   |
| Principal payments under capital leases                                                                        |   | —                                  |       | —                                                                            |   | (422,088 | ) |
| Proceeds from sales leaseback                                                                                  |   | —                                  |       | —                                                                            |   | 120,492 |   |
| Pledging restricted cash                                                                                       |   | —                                  |       | —                                                                            |   | (550,000 | ) |
| Proceeds from issuance of convertible  preferred stock, net of issuance costs                                  |   | —                                  |       | —                                                                            |   | 40,285,809 |   |
| Proceeds from issuance of common stock,  associated with  stock options and  employee stock purchase plan |   | 48,273                                  |       | 94,062                                                                            |   | 906,978 |   |
| Proceeds from issuance of common stock, net  of issuance costs                                                 |   | —                                  |       | (7,192                                                                            | )      | 108,895,699 |   |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Net cash provided by financing activities                                                                      |   | 48,273                                  |       | 86,870                                                                            |   | 149,236,890 |   |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Net increase (decrease) in cash and cash  equivalents                                                          |   | 5,856,107                               |       | (921,813                                                                          | )      | 3,720,492 |   |
| Cash and cash equivalents, beginning of  period                                                                |   | 3,756,951                               |       | 4,642,305                                                                         |   | — |   |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Cash and cash equivalents, end of period                                                                       |   | $                                       | 9,613,058  |                                                                              | $      | 3,720,492 |   | $ | 3,720,492 |   |
|                                                                                                           |   |                                    |       |                                                                              |   |   |   |
| Supplemental  Schedule of Non-cash Operating and Financing Activities:                                    |   |                                    |       |                                                                              |   |   |   |
| Cash paid for interest                                                                                         |   | $                                       | —     |                                                                              | $      | — |   | $ | 1,033,375 |   |
| Issuance of stock in exchange for license  agreement                                                           |   | —                                  |       | —                                                                            |   | 40,000 |   |
| Capital lease obligations incurred for  acquisition of property and equipment                                  |   | —                                  |       | —                                                                            |   | 422,088 |   |
| Issuance of stock in exchange for notes  receivable                                                            |   | —                                  |       | —                                                                            |   | 139,687 |   |

 

The accompanying notes are an integral partof these financial statements.

 

5

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**ALLOS THERAPEUTICS,INC.**

### **NOTESTO FINANCIAL STATEMENTS**

**(unaudited)**

 

**1.****              Basisof Presentation**

 

The unaudited financial statements of Allos Therapeutics, Inc., acompany in the development stage (referred to herein as the “Company,” “we,”“us” or “our”), included herein reflect all adjustments, consisting only ofnormal recurring adjustments, which in the opinion of management are necessaryto fairly present the financial position, results of operations and cash flowsof the Company for the periods presented. Certain information and footnotedisclosures normally included in audited financial information prepared inaccordance with accounting principles generally accepted in the United Statesof America have been condensed or omitted pursuant to the Securities andExchange Commission’s rules and regulations. The results of operations for theperiod ended March 31, 2004 are not necessarily indicative of the resultsto be expected for any subsequent quarter or for the entire fiscal year endingDecember 31, 2004. These financial statements should be read inconjunction with the audited financial statements and notes thereto which areincluded in our Annual Report on Form 10-K, as amended, for the year ended December 31,2003 for a broader discussion of our business and the opportunities and risksinherent in such business.

 

Based upon the current status of our product development andcommercialization plans, we believe that our existing cash, cash equivalentsand investments will be adequate to satisfy our capital needs through at leastthe first half of fiscal 2005. We anticipate continuing our current developmentprograms and beginning other long-term development projects on new products ortechnologies. These projects will require many years and substantialexpenditures to complete and may ultimately be unsuccessful. We will requiresignificant amounts of additional capital beyond the first half of fiscal 2005from outside sources to continue research and development activities, fundoperating expenses, pursue regulatory approvals and build sales and marketingcapabilities, as necessary. Our actual capital requirements will depend on manyfactors, including the status of product development; the time and cost involvedin conducting clinical trials and obtaining regulatory approvals; the time andcost involved in filing, prosecuting and enforcing patent claims; competingtechnological and market developments; and our ability to market and distributeour future products and establish new collaborative and licensing arrangements.

 

We intend to raise additional capital in the future through eitherequity or debt financings, collaborative arrangements with corporate partnersor from other sources, including product sales, if any. Such arrangements maybe dilutive to our existing stockholders. In addition, in the event thatadditional funds are obtained through arrangements with collaborative partnersor other sources, such arrangements may require us to relinquish rights to someof our technologies, product candidates or products under development that wewould otherwise seek to develop or commercialize ourselves. There is noassurance that we will be successful in consummating any such arrangements. Inthe event we are not able to raise sufficient additional funds, we may berequired to delay, scale back, or eliminate one or more of our productdevelopment programs and our business and future prospects for revenue andprofitability may be harmed.

 

6

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**2.****              Cash and CashEquivalents, Short-term Investments and Marketable Securities**

 

All highly liquid investments with a maturity of three months or lessare considered to be cash equivalents. The carrying values of our cashequivalents and short-term and long-term marketable securities approximatetheir market values based on quoted market prices. We account formarketable securities in accordance with Statement of Financial AccountingStandards (“SFAS”) No. 115, *Accounting forCertain Investments in Debt and Equity Securities* (“SFAS 115”).Short-term and long-term marketable securities are classified as held tomaturity and are carried at cost plus accrued interest and consist ofcommercial paper, government obligations and corporate notes having maturitiesof longer than three months, held at financial institutions.

 

In accordance with SFAS 115, investments that we have the positiveintent and ability to hold to maturity are reported at amortized cost, whichapproximates fair market value, and are classified as held-to-maturity.Substantially all of our marketable securities are held in corporate notes withmaturities ranging from three months to four years. Certain reclassificationshave been recorded to the December 31, 2003 balance sheet.

 

**3.****              Accrued Research andDevelopment Expenses**

 

We record accruals for contracted third-party development activity,including estimated clinical study costs, which will be invoiced to us in asubsequent accounting period. Clinical study costs represent costs incurred byclinical research organizations and clinical sites. These costs are recorded asa component of research and development expenses. Management accrues costs forthese clinical studies based on the progress of the clinical trials, includingpatient enrollment, dosing levels of patients enrolled, estimated costs to dosepatients, invoices received and contracted costs when evaluating the adequacyof the accrued liabilities. Significant judgments and estimates are made andused in determining the accrued balance in any accounting period. Actualresults could differ from these estimates.

 

**4.****              Stock-BasedCompensation**

 

We account for grants of stock options according to AccountingPrinciples Board (“APB”) Opinion No. 25, *Accountingfor Stock Issued to Employees* (“APB 25”) and relatedInterpretations. Pro forma net loss information, as required by SFASNo. 123, *Accounting for Stock-BasedCompensation* (“SFAS 123”), is presented below in accordancewith SFAS No. 148, *Accounting forStock-Based Compensation—Transition and Disclosure*(“SFAS 148”).Any deferred stock-based compensation calculated according to APB 25 isamortized over the vesting period of the individual options, generallyfour years, in accordance with Financial Accounting Standards Board(“FASB”) Interpretation No. 28, *Accountingfor Stock Appreciation Rights and Other Variable Stock Option and Award Plans*(“FIN 28”).

 

We have elected to continue to follow the intrinsic value method ofaccounting as prescribed by APB 25 to account for employee stock options.

 

7

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The following table illustrates the effect on net loss and loss pershare if we had applied the fair value recognition provisions of SFAS 123to stock-based compensation for the three month periods ended March 31,2003 and 2004.

 
|                                                                                      |   | **Three  Months Ended March 31,** |       |
|-------------------------------------------------------------------------------------------|--------|----------------------------------------|------------|
|                                                                                      |   | **2003**                               |       | **2004** |   |
|                                                                                      |   |                                   |       |   |   |
| Net loss - as reported                                                                    |   | $                                      | (7,133,349 | ) | $ | (5,146,525 | ) |
|                                                                                      |   |                                   |       |   |   |
| Add: Stock-based compensation expense  included in reported net loss                      |   | 396,816                                |       | 90,802 |   |
|                                                                                      |   |                                   |       |   |   |
| Deduct: Recovery of stock-based  compensation expense included in reported net loss       |   | (762,195                               | )          | — |   |
|                                                                                      |   |                                   |       |   |   |
| Deduct: Stock-based compensation expense as  determined under the fair value based method |   | (697,638                               | )          | (544,088 | ) |
|                                                                                      |   |                                   |       |   |   |
| Pro forma net loss                                                                        |   | $                                      | (8,196,366 | ) | $ | (5,599,811 | ) |
| Loss per share:                                                                           |   |                                   |       |   |   |
| Basic and diluted - as reported                                                           |   | $                                      | (0.28      | ) | $ | (0.17 | ) |
|                                                                                      |   |                                   |       |   |   |
| Basic and diluted - pro forma                                                             |   | $                                      | (0.32      | ) | $ | (0.18 | ) |

 

Such pro forma disclosures may not be representative of the pro formaeffect in future years because options vest over several years and additionalgrants may be made each year.

 

**5.****              NetLoss Per Common Share**

 

Net loss per share is calculated in accordance with, SFAS No. 128, *Earnings Per Share*(“SFAS 128”).Under the provisions of SFAS 128, basic net loss per common share iscomputed by dividing the net loss for the period by the weighted average numberof vested common shares outstanding during the period. Diluted net loss percommon share is the same as basic net loss per share and is computed givingeffect to all dilutive potential common stock, including options, non-vestedcommon stock, convertible preferred stock and convertible preferred stockwarrants.

 

**6.****              Commitmentsand Contingencies**

 

*Lease Commitments*

 

We lease offices and research and development facilities, as well ascertain office and lab equipment under agreements that expire at various datesthrough 2008.

 

*Contingencies*

 

In December 2002, we obtained an exclusive worldwide license to PDXfrom Memorial Sloan - Kettering Cancer Center, SRI International and SouthernResearch Institute (collectively, the “Licensor”). Under this agreement, theCompany is obligated to pay the Licensor a milestone payment of $1,000,000 onthe earlier of: a) enrollment of the first patient in a multi-center, Company -sponsored Phase 2 trial; or June 23, 2004.

 

In December 2003, we entered into an agreement with BaxterHealthcare Corporation (“Baxter”) for certain development and manufacturingservices for the clinical and commercialization production of RSR13. Wecurrently have no commitments to Baxter under this agreement. The minimumpurchase obligations are subject to United States Food and Drug Administration(“FDA”) approval of RSR13.

 

We enter into indemnification provisions under our agreements withother companies in our ordinary course of business, typically with businesspartners, contractors, clinical sites and suppliers. Under these provisions wegenerally indemnify and hold harmless the indemnified party for losses sufferedor incurred by the indemnified party as a result of our activities. Theseindemnification provisions generally survive termination of the underlyingagreement. The maximum potential amount of future payments we could be requiredto make under these indemnification provisions is unlimited. We have notincurred material costs to defend lawsuits or settle claims related to theseindemnification agreements. As a result, the estimated fair value of theseagreements is minimal. Accordingly, we have no liabilities recorded for theseagreements as of March 31, 2004.

 

8

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**7.****              Recently IssuedAccounting Pronouncement**

 

In March 2004, the Securities and Exchange Commission (“SEC”)issued Staff Accounting Bulletin (“SAB”) No. 105, *Loan Commitments Accounted For As DerivativeInstruments*(“SAB 105”)*.*SAB 105summarizes the views of the SEC regarding the application of generally acceptedaccounting principles to loan commitments accounted for as derivativeinstruments. The adoption of SAB 105 has not had, nor do we believe itwill have, a material impact on our current or prospective financialstatements.

 

**8.****              Subsequent Event**

 

In February 2004, the FDA accepted for Priority Review theCompany’s New Drug Application (“NDA”) to market RSR13 (efaproxiral) as anadjunct to whole brain radiation therapy (“WBRT”) for the treatment of brainmetastases from breast cancer. On May 3, 2004, the FDA’s Oncologic DrugsAdvisory Committee (“ODAC”) reviewed and voted not to recommend approval ofRSR13 for this indication. Although the FDA is not bound by ODAC’srecommendation, it generally takes such recommendations into consideration whendetermining whether or not to approve a new drug product for marketing in theUnited States. The FDA’s Division of Oncology Drug Products is expected to takefinal action on the Company’s NDA by June 4, 2004.

 

## **ITEM 2.**                           MANAGEMENT’SDISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

## ** **

*The following Management’s Discussion andAnalysis of Financial Condition and Results of Operations, as well asinformation contained elsewhere in this report, contains statements thatconstitute “forward-looking statements” within the meaning of Section 27Aof the Securities Act of 1933, as amended, and Section 21E of the SecuritiesExchange Act of 1934, as amended. You can identify these statements byforward-looking words such as “may,” “will,” “expect,” “intend,” “anticipate,”“believe,” “estimate,” “plan,” “could,” “should” and “continue” or similarwords. Actual results could differ materially from those anticipated in theseforward-looking statements. Factors that could cause or contribute to suchdifferences include, but are not limited to, those mentioned in the discussionbelow and those described in the “Risk Factors” discussion of our AnnualReport on Form 10-K, as amended, for the year ended December 31, 2003filed with the Securities and Exchange Commission. As a result, you should notplace undue reliance on these forward-looking statements. We do not intend toupdate or revise these forward-looking statements to reflect future events ordevelopments.*

 

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**Overview**

 

Allos Therapeutics, Inc. is a biopharmaceutical company that is focusedon developing and commercializing innovative small molecule drugs for improvingcancer treatments. Small molecule drugs, in general, are non-protein productsproduced by chemical synthesis rather than biological methods. We strive todevelop drugs that improve the treatment of cancer and enhance the power ofcurrent therapies. Our goal is to build a profitable company by generatingincome from products we develop and commercialize, either alone or togetherwith one or more potential strategic partners. Our focus is on productopportunities that leverage our internal clinical development and regulatoryexpertise and address important medical markets. We have two productcandidates that are currently under development, RSR13 (efaproxiral) and PDX(pralatrexate). In addition, we endeavor to grow our existing portfolio ofproduct candidates through ongoing product acquisition and in-licensingefforts.

 

We have never generated any revenue from product sales and haveexperienced significant net losses since our inception in 1992. We have incurredthese losses principally from costs incurred in our research and developmentprograms and from our general and administrative expenses. We expect tocontinue incurring net losses for the foreseeable future. The presence and sizeof these potential net losses will depend, in large part, on if and when wereceive regulatory approval in the United States or Europe to market RSR13 asan adjunct to radiation therapy for the treatment of brain metastases frombreast cancer. Our ability to generate revenue and achieve profitability isdependent on our ability, alone or with partners, to successfully complete thedevelopment of our product candidates, conduct clinical trials, obtain thenecessary regulatory approvals, and manufacture and market our product candidates.

 

In February 2004, the United States Food and Drug Administration(“FDA”) accepted for Priority Review the Company’s New Drug Application (“NDA”)to market RSR13 (efaproxiral) as an adjunct to whole brain radiation therapy(“WBRT”) for the treatment of brain metastases from breast cancer. On May 3,2004, the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) reviewed and votednot to recommend approval of RSR13 for this indication. The briefing documentssubmitted by the Company and the FDA in connection with the ODAC meeting, aswell as the slide presentations made by the Company and the FDA at the ODACmeeting, are posted on the FDA’s website; however, information found on the FDAwebsite is not incorporated by reference into this report. Although the FDA isnot bound by ODAC’s recommendation, it generally takes such recommendationsinto consideration when determining whether or not to approve a new drugproduct for marketing in the United States. The FDA’s Division of Oncology DrugProducts is expected to take final action on the NDA by June 4, 2004.

 

In February 2004, we initiated a randomized, open-label,multi-center Phase 3 trial of RSR13 as an adjunct to WBRT for thetreatment of brain metastases originating from breast cancer. Called ENRICH,the study will seek to enroll approximately 360 patients at up to 50cancer centers across North America and compare WBRT plus supplemental oxygenwith or without RSR13. The primary endpoint of the study will measure thedifference in survival between the two arms.

 

In March 2004, we filed a “shelf registration statement” on FormS-3 with the SEC to sell up to $75 million of any combination of commonstock, preferred stock, depositary shares, debt securities or warrants. The SECdeclared this registration statement effective as of April 21, 2004.Please see “Liquidity and Capital Resources” below for additional informationregarding the shelf registration statement.

 

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**Results of Operations**

 

*Research and Development.*  Research and development expenses includethe costs of basic research, nonclinical studies, clinical trials, regulatoryaffairs, biostatistical data analysis, patents, trademarks and licensing feesfor new products.

 

|                                  |   | **Three  Months Ended March 31,** |   |
|---------------------------------------|--------|----------------------------------------|--------|
|                                  |   | **2003**                               |   | **2004** |   |
|                                  |   | **(in  millions)**                     |   |
| Research and development, as reported |   | $                                      | 3.4    |   | $ | 2.0 |   |
|                                       |        |                                        |        |  |  |  |  |

 

The $1.4 million decrease for the three months endedMarch 31, 2004, was due primarily to lower clinical trial costs, reducedpersonnel costs resulting from our May 2003 expense reduction measures andlower non-clinical study costs necessary to support our clinical developmentprogram for our product candidates.

 

We expect research and development expenses to increase moderatelyduring the remainder of fiscal 2004, due primarily to costs associated with ourPhase 3 clinical trial of RSR13 for brain metastases from breast cancer,the Phase 1b/2 study of RSR13 in patients with non-small cell lung cancer(“NSCLC”), the commencement of a multi-site study of PDX for NSCLC, and amilestone payment of $1,000,000 for PDX due in June 2004. The amount andtiming of the increased costs related to our clinical trials is difficult topredict due to the uncertainty inherent in the timing of clinical trialinitiations, the rate of patient enrollment and the detailed design of futuretrials. In addition, if we receive regulatory approval in 2004 in theUnited States or Europe to market RSR13 as an adjunct to radiation therapy forthe treatment of brain metastases from breast cancer, we expect to incuradditional research and development expenses as we build clinicalinfrastructure to support our commercialization efforts. In order to fund ourresearch and development programs after the first half of fiscal 2005, we willrequire significant levels of additional capital. If we do not receiveregulatory approval to market RSR13 in the United States or Europe and areotherwise unable to raise sufficient additional funds, we may be forced tocurtail our development plans for one or more of our product candidates,including RSR13, in which case our research and development expenses maydecrease materially.

 

*Clinical Manufacturing.*  Clinical manufacturing expenses includethird party manufacturing costs for RSR13 for use in clinical trials, costs associatedwith pre-commercial scale-up of manufacturing to support anticipated commercialrequirements, and development activities for clinical trial material for PDX.

 

|                                |   | **Three  Months Ended March 31,** |   |
|-------------------------------------|--------|----------------------------------------|--------|
|                                |   | **2003**                               |   | **2004** |   |
|                                |   | **(in  millions)**                     |   |
| Clinical manufacturing, as reported |   | $                                      | 2.1    |   | $ | 0.8 |   |
|                                     |        |                                        |        |  |  |  |  |

 

The $1.3 million decrease for the three months endedMarch 31, 2004, resulted primarily from decreased third-partymanufacturing of RSR13 bulk drug substance as we currently have a sufficientsupply of RSR13 bulk drug substance and formulated drug product to support allof our currently pending and planned clinical trials involving RSR13.

 

We expect clinical manufacturing expenses to increase moderately duringthe second and third quarters of fiscal 2004, due primarily to costs associatedwith preparation for the potential commercialization of RSR13.

 

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*Marketing, General and Administrative.*  Marketing, general and administrativeexpenses include costs for pre-marketing activities, executive administration,corporate offices and related infrastructure and corporate development. 

 

|                                                |   | **Three  Months Ended March 31,** |   |
|-----------------------------------------------------|--------|----------------------------------------|--------|
|                                                |   | **2003**                               |   | **2004** |   |
|                                                |   | **(in  millions)**                     |   |
| Marketing, general and administrative, as  reported |   | $                                      | 2.0    |   | $ | 2.5 |   |
| Non-cash charges (recoveries)                       |   | (0.4                                   | )      | 0.1 |   |
|                                                |   | $                                      | 2.4    |   | $ | 2.4 |   |

 

Our marketing, general and administrative expenses, excluding thenon-cash stock-based compensation charges and recoveries, have remained stablerelative to the comparative period in the prior year. If we obtain regulatoryapproval for RSR13, we expect marketing, general and administrative expenses toincrease significantly as personnel are hired to develop a commercialorganization and expenses are incurred to support pre-launch marketingactivities. If we do not obtain regulatory approval for RSR13 or if we are notable to raise sufficient additional funds to support our operations, ourmarketing, general and administrative expenses will likely decrease as we maybe required to reduce our administrative infrastructure to conserve our capitalresources.

 

*Interest and Other Income, Net*.  Interest income, net of interest expense,for the three months ended March 31, 2003 and 2004, was $372,000 and$138,000, respectively. This $234,000 decrease primarily resulted from loweraverage investment balances and lower yields on United States governmentsecurities, high-grade commercial paper and corporate notes, and money marketfunds held by the Company.

 

*Non*-*cash Charges. *We have recorded stock-based compensation expense resultingprimarily from certain options granted prior to our initial public offeringwith exercise prices below the fair market value of our common stock on theirrespective grant dates. For the three months ended March 31, 2004, werecorded stock-based compensation expense of $72,000 in marketing, general andadministrative expenses, $13,000 in research and development expenses and$5,000 in clinical manufacturing expenses. For the three months endedMarch 31, 2003, we recorded a net recovery of $410,000 of stock-basedcompensation expense in marketing, general and administrative expenses, andstock-based compensation expense of $32,000 in research and developmentexpenses and $13,000 in clinical manufacturing expenses. The negative amountrecorded in marketing, general and administrative expenses is due to therecovery of $762,000 of stock-based compensation expense recorded in priorperiods, partially offset by $352,000 of stock-based compensation expense forthe three months ended March 31, 2003. The recovery of stock-basedcompensation expense resulted from the change in employment status of ourChairman from an employee to a consultant. As of March 31, 2004, we had$254,000 of unamortized deferred stock-based compensation remaining to be expensedin future periods.

 

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**Liquidity and Capital Resources**

 

Since inception, we have financed our operations primarily throughpublic and private placements of common and preferred stock, resulting in netproceeds to us of $149.2 million through March 31, 2004, andapproximately $14.3 million of interest income generated through theinvestment of such proceeds. We have used $104.9 million of cash foroperating activities through March 31, 2004. Cash, cash equivalents,short-term investments and long-term marketable securities were approximately$53.0 million and $41.5 million at March 31, 2003 and 2004,respectively. Net cash used in operating activities for the three months endedMarch 31, 2003 and 2004 was $7.6 million and $4.1 million,respectively, and was used primarily to fund net losses, excluding non-cashcharges. We expect the net cash used in operating activities to increaseon a quarterly basis during the remainder of 2004 as we enroll patients per ourclinical development plan and prepare for the potential commercialization ofRSR13.

 

Net cash provided by investing activities for the three months endedMarch 31, 2003 and 2004 was $13.4 million and $3.1 million,respectively, and consisted primarily of proceeds from maturities ofinvestments, net of purchases and capital expenditures.

 

Net cash provided by financing activities during the three months endedMarch 31, 2003 and 2004 was $48,000 and $87,000, respectively, andresulted from the exercise of common stock options.

 

On March 5, 2004, we filed a “shelf registration statement” onForm S-3 with the SEC to sell up to $75 million of any combination ofcommon stock, preferred stock, depository shares, debt securities and warrants.This registration statement, which the SEC declared effective on April 21,2004, is intended to give us the flexibility to take advantage of financingopportunities from time to time when market conditions are favorable. Underthis registration statement, we may sell our securities:

 

•                  directly topurchasers;

•                  to or throughunderwriters or dealers;

•                  through agents;or

•                  through acombination of such methods.

 

In the event that we offer our securities directly to purchasers or topurchasers through agents, the shares may be sold at a single closing and asingle price, or at multiple closings and at multiple prices. We expect thatthe price or prices for any such securities sold in such circumstances willreflect our negotiations with prospective investors, the market price of ourcommon stock, recent trends in the market price of our common stock, otherfactors considered material by the prospective investors and, if applicable,consultation with any agent involved with the sale or sales. As ofMarch 31, 2004, we have paid and recorded accruals for legal, accountingand other fees in the amount of $39,000 related to this registration statement.To date we have not sold any securities under this shelf registrationstatement.

 

Based upon the current status of our product development andcommercialization plans, we believe that our existing cash, cash equivalentsand investments will be adequate to satisfy our capital needs through at leastthe first half of fiscal 2005, regardless of whether RSR13 receives regulatoryapproval in June 2004 or if approval is delayed. If RSR13 receivesregulatory approval for marketing in the United States in June 2004, wewould expect to generate revenue from product sales beginning in the thirdquarter of 2004. We would also expect to increase our operating expenses by atleast $15 to $20 million during the first 12 months after launch inorder to develop a commercial organization and to engage in marketingactivities.

 

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We anticipate continuing our current development programs andbeginning other long-term development projects on new products or technologies.These projects will require many years and substantial expenditures to completeand may ultimately be unsuccessful. We will require significant amounts ofadditional capital beyond the first half of fiscal 2005 from outside sources tocontinue research and development activities, fund operating expenses, pursueregulatory approvals and build sales and marketing capabilities, as necessary.Our actual capital requirements will depend on many factors, including thestatus of product development; the time and cost involved in conductingclinical trials and seeking regulatory approvals; the time and cost involved infiling, prosecuting and enforcing patent claims; competing technological andmarket developments; and our ability to market and distribute our futureproducts and establish new collaborative and licensing arrangements. Ourforecast of the period of time through which our financial resources will beadequate to support our operations is a forward-looking statement that involvesrisks and uncertainties, and actual results could vary materially. The factorsdescribed above will impact our future capital requirements and the adequacy ofour available funds.

 

We intend to raise additional capital in the future through eitherequity or debt financings, collaborative arrangements with corporate partners,or from other sources, including product sales, if any. Such arrangements maybe dilutive to our existing stockholders. In addition, if additional funds areobtained through arrangements with collaborative partners or other sources,such arrangements may require us to relinquish rights to some of ourtechnologies, product candidates or products under development that we wouldotherwise seek to develop or commercialize ourselves. There is no assurancethat we will be successful in consummating any such arrangements. In the eventwe are not able to raise sufficient additional funds, we may be required to delay,scale back, or eliminate one or more of our product development programs andour business and future prospects for revenue and profitability may be harmed.

 

**CriticalAccounting Policies**

 

Our discussion and analysis of our financial condition and results ofoperations are based upon our financial statements, which have been prepared inaccordance with accounting principles generally accepted in the United Statesof America. The preparation of these financial statements requires us to makeestimates and assumptions that affect the reported amounts of assets,liabilities, and expenses. We base our estimates on historical experience,available information and assumptions that we believe to be reasonable underthe circumstances. We apply estimation methodologies consistently from periodto period. The actual results may differ from these estimates under differentassumptions or conditions. The critical accounting policies are discussed inItem 7 Management’s Discussion and Analysis of Financial Condition andResults of Operations included in our Annual Report on Form 10-K, as amended,for the fiscal year ended December 31, 2003. These critical accountingpolicies are subject to judgments and uncertainties, which affect theapplication of these policies. We have not made any changes in any of thesecritical accounting polices during the three months ended March 31, 2004.

 

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**Risk Factors**

 

In addition to the other informationcontained in this report, we caution stockholders and potential investors thatthe following important risk factors, among others, in some cases haveaffected, and in the future could affect, our actual results of operations andcould cause our actual results to differ materially from those expressed in anyforward-looking statements made by or on behalf of us. The followinginformation is not intended to limit in any way the characterization of otherstatements or information under other captions as cautionary statements forsuch purpose. These factors include:

 

•                  Delay, difficulty, or failure to obtain adequatefinancing on acceptable terms to fund future operations, including research,development and commercialization of product candidates.

 

•                  Delay,difficulty, or failure to obtain regulatory approval or clearance to market ourproduct candidates, including delays or difficulties in development because ofinsufficient proof of safety or efficacy.

 

•                  Failureto complete clinical trials on schedule, in compliance with applicableregulations and at an acceptable cost; failure to demonstrate the safety andefficacy of our product candidates in their target indications.

 

•                  The ability to obtain, maintain and enforceintellectual property rights; the cost of acquiring in-process technology andother intellectual property rights, either by license, collaboration orpurchase of another entity; the cost of enforcing or defending our intellectualproperty rights.

 

•                  Failureof third-party collaborators to effectively conduct research and development activities,including drug discovery and clinical testing; conflicts of interest orpriorities or disputes that may arise between us and such third-partycollaborators.

 

•                  Dependence upon third parties to manufacture ourproduct candidates; failure of third parties to manufacture our productcandidates in compliance with regulatory requirements and at an acceptablecost; failure of third parties to supply sufficient quantities of our productcandidates for preclinical, clinical or commercial purposes; failure toestablish alternative sources of supply of our product candidates.

 

•                  The ability to create sales, marketing anddistribution capabilities for our product candidates, or enter into agreementswith third parties to perform these functions.

 

•                  The ability to obtain acceptable prices oradequate levels of reimbursement for our products from third-party payors,including government and health administration authorities and private healthinsurers.

 

•                  Competitiveor market factors that may limit the use or broad acceptance of our productcandidates.

 

•                  Theability to attract and retain highly qualified management and scientificpersonnel.

 

•                  Changesin accounting rules and regulations, such as accounting for guarantees,restructuring charges and stock options, that could have a significant adverseimpact on our results of operations, causing our stock price to decline andnegatively impacting our efforts to obtain adequate financing.

 

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## **ITEM 3.**                             QUANTITATIVEAND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

## ** **

The primary objective of our investment activities is to preserveprincipal while at the same time maximizing the income we receive from ourinvestments without significantly increasing risk. Some of the securities thatwe invest in may have market risk and all are classified as held-to-maturity.We do not own derivative financial instruments in our investment portfolio.This means that a change in prevailing interest rates may cause the fair valueof the principal amount of the investment to fluctuate. For example, if we holda security that was issued with a fixed interest rate at the then-prevailingrate and the prevailing interest rate later rises, the fair value of theprincipal amount of our investment will probably decline. To minimize this riskin the future, we maintain a non-trading investment portfolio of investmentgrade, liquid debt securities that limits the amount of credit exposure to anyone issue, issuer, or type of instrument. The average duration of all of ourinvestments is less than one year. Due to the short-term nature of theseinvestments, we believe we have no material exposure to interest rate riskarising from our investments. Therefore, no quantitative tabular disclosure isprovided.

 

## **ITEM 4.**                             CONTROLSAND PROCEDURES

## ** **

As of the end of the period covering this report, an evaluation wascarried out under the supervision and with the participation of our management,including our principal executive and financial officer (the “Evaluating Officer”),of the effectiveness of our disclosure controls and procedures, as defined inRule 13a-15(e) of the Securities Exchange Act of 1934, as amended (“ExchangeAct”). Based on that evaluation, our management, including the EvaluatingOfficer, concluded that our disclosure controls and procedures were effectiveto ensure that information required to be disclosed by us in reports that wefile or submit under the Exchange Act is recorded, processed, summarized andreported within the time periods specified in Securities and ExchangeCommission’s rules and forms, and that such information is accumulated andcommunicated to our management, including the Evaluating Officer, asappropriate, to allow timely decisions regarding required disclosure.

 

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# **PART II.  OTHERINFORMATION**

# ** **

| **ITEM  1.** |   | **LEGAL  PROCEEDINGS**                         |   | **None** |
|--------------|--------|------------------------------------------------|--------|----------|
|         |   |                                           |   |     |
| **ITEM  2.** |   | **CHANGES IN  SECURITIES AND USE OF PROCEEDS** |   | **None** |
|         |   |                                           |   |     |
| **ITEM  3.** |   | **DEFAULTS UPON  SENIOR SECURITIES**           |   | **None** |
|         |   |                                           |   |     |
| **ITEM  4.** |   | **SUBMISSION OF  MATTERS TO A**                |   |     |
|         |   | **VOTE OF SECURITY  HOLDERS**                  |   | **None** |
|         |   |                                           |   |     |
| **ITEM  5.** |   | **OTHER  INFORMATION**                         |   | **None** |
|         |   |                                           |   |     |
| **ITEM  6.** |   | **EXHIBITS AND  REPORTS ON FORM 8-K**          |   | **None** |

## ** **

(a)                                  Exhibits:

 

31.01                     Rule 13a-14(a) Certification

 

32.01                     Section 1350Certification

 

(b)                                 Reportson Form 8-K

 

On February 4, 2004, we filed a report on Form 8-K reporting underItems 5 and 7 that the Division of Oncology Drug Products at the FDA hadaccepted for priority review our NDA seeking approval to market RSR13.

 

On February 12, 2004, we furnished a report on Form 8-K reportingunder Items 7 and 12 that we had issued an announcement of our FourthQuarter and Year-end 2003 financial results.

 

On March 15, 2004, we filed a report on Form 8-K reporting underItems 5 and 7 that the Oncologic Drugs Advisory Committee of the FDA plans toreview RSR13 (efaproxiral) on May 3, 2004.

 

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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 theundersigned, thereunto duly authorized.

 

 
| Date:  May 10, 2004 |   | **ALLOS THERAPEUTICS,  INC.**                                                                                                   |
|--------------------------|--------|---------------------------------------------------------------------------------------------------------------------------------|
|                     |   |                                                                                                                            |
|                     |   |                                                                                                                            |
|                     |   | /s/ Michael E. Hart                                                                                                             |
|                     |   | Michael E. Hart                                                                                                                 |
|                     |   | President, Chief Executive Officer and  Chief Financial Officer  (Principal Executive Officer and  Principal Financial Officer) |

 

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