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RAPT Therapeutics Reports First Quarter 2024 Financial Results

RAPT Therapeutics, Inc.
RAPT Therapeutics, Inc.

Company maintains solid cash position of $141.6 million

SOUTH SAN FRANCISCO, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today reported financial results for the first quarter ended March 31, 2024.

The Company also announced today that it has decided to close and unblind both its Phase 2b clinical trial of zelnecirnon (RPT193) in atopic dermatitis (“AD”) and its Phase 2a trial of zelnecirnon in asthma. Both clinical trials were placed on clinical hold by the FDA in February 2024 based on a serious adverse event of liver failure requiring transplant in one patient in the AD trial. Prior to the imposition of the clinical hold, a total of 229 patients had been enrolled in the Phase 2b AD trial, of which approximately 110 had completed the 16-week dosing period.

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“Although there were a significant number of patients who were unable to complete the AD trial due to the hold, we believe we will have sufficient data, even if not statistically significant, to inform our path forward and support our discussions with the FDA,” said Brian Wong, President and CEO. “We are working with the clinical trial sites to clean the data and we anticipate that our analysis of the data will be completed in the third quarter of this year. Concurrently, we are continuing our investigation and analysis of the serious adverse event that triggered the clinical hold.”

Financial Results for the First Quarter March 31, 2024

First Quarter Ended March 31, 2024

Net loss for the first quarter of 2024 was $30.5 million, compared to $29.3 million for the first quarter of 2023.

Research and development expenses for the first quarter of 2024 were $24.8 million, compared to $25.6 million for the same period in 2023. The decrease in research and development expenses was primarily due to lower development costs related to zelnecirnon, tivumecirnon and early-stage programs as well as decreased expenses for lab supplies partially offset by increased expenses for personnel, consultants, facilities and non-cash stock-based compensation.

General and administrative expenses for the first quarter of 2024 were $7.7 million, compared to $6.0 million for the same period in 2023. The increase in general and administrative expenses was primarily due to increased expenses for personnel, non-cash stock-based compensation, consulting and facilities.

As of March 31, 2024, the Company had cash and cash equivalents and marketable securities of $141.6 million.

About RAPT Therapeutics, Inc.

RAPT Therapeutics is a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, zelnecirnon (RPT193) and tivumecirnon (FLX475), each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of inflammation and cancer, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “target,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the Company’s expectations concerning the clinical holds of its Phase 2 trials of zelnecirnon, including its investigation of the incident, its analysis of the data from the unblinded trials and the timing thereof, its ability to resolve issues to the FDA’s satisfaction and the availability of updates concerning such process and other statements that are not historical fact. Many factors may cause differences between current expectations and actual results, including unexpected or unfavorable safety or efficacy data observed during clinical studies, preliminary data and trends that may not be predictive of future data or results or that may not demonstrate safety or efficacy or lead to regulatory approval, the inability to resolve issues related to the clinical holds on the Phase 2 trials of zelnecirnon to the FDA’s satisfaction and to ultimately resume such trials, clinical trial site activation or enrollment rates that are lower than expected, unanticipated or greater than anticipated impacts or delays due to macroeconomic conditions (including the long-term impacts of ongoing overseas conflicts, inflation, higher interest rates and other economic uncertainty), changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process and the sufficiency of RAPT’s cash resources. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2024 and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements, except as required by law.

RAPT Media Contact:
Aljanae Reynolds
areynolds@wheelhouselsa.com

RAPT Investor Contact:
Sylvia Wheeler
swheeler@wheelhouselsa.com


RAPT THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share per share data)
(Unaudited)

 

 

 

Three Months Ended
March 31,

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

24,781

 

 

 

25,574

 

General and administrative

 

 

7,737

 

 

 

5,988

 

Total operating expenses

 

 

32,518

 

 

 

31,562

 

Loss from operations

 

 

(32,518

)

 

 

(31,562

)

Other income, net

 

 

1,997

 

 

 

2,291

 

Net loss

 

$

(30,521

)

 

$

(29,271

)

Other comprehensive income (loss):

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

(113

)

 

 

365

 

Total comprehensive loss

 

$

(30,634

)

 

$

(28,906

)

Net loss per share, basic and diluted

 

$

(0.79

)

 

$

(0.76

)

Weighted average number of shares used in computing
net loss per share, basic and diluted

 

 

38,625,365

 

 

 

38,280,539

 


RAPT THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands)

 

 

 

March 31,
2024

 

 

December 31,
2023

Assets

 

(Unaudited)

 

 

(1)

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

45,317

 

 

$

47,478

 

Marketable securities

 

 

96,262

 

 

 

111,384

 

Prepaid expenses and other current assets

 

 

6,781

 

 

 

2,920

 

Total current assets

 

 

148,360

 

 

 

161,782

 

Property and equipment, net

 

 

2,239

 

 

 

2,448

 

Operating lease right-of-use assets

 

 

4,772

 

 

 

5,228

 

Other assets

 

 

447

 

 

 

3,871

 

Total assets

 

$

155,818

 

 

$

173,329

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

6,771

 

 

$

5,176

 

Accrued expenses

 

 

11,807

 

 

 

14,103

 

Operating lease liabilities, current

 

 

2,508

 

 

 

2,448

 

Other current liabilities

 

 

82

 

 

 

109

 

Total current liabilities

 

 

21,168

 

 

 

21,836

 

Operating lease liabilities, non-current

 

 

3,815

 

 

 

4,458

 

Total liabilities

 

 

24,983

 

 

 

26,294

 

Commitments

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

646,045

 

 

 

631,611

 

Accumulated other comprehensive gain (loss)

 

 

(10

)

 

 

103

 

Accumulated deficit

 

 

(515,203

)

 

 

(484,682

)

Total stockholders’ equity

 

 

130,835

 

 

 

147,035

 

Total liabilities and stockholders’ equity

 

$

155,818

 

 

$

173,329

 

(1) The consolidated balance sheet for December 31, 2022 has been derived from audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.