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RAPT Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

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RAPT Therapeutics Inc. reports financial results for Q4 and year ended December 31, 2023, with a net loss of $30.9 million in Q4 and $116.8 million for the year. The company maintains a solid cash position of $158.9 million. RAPT is focused on lifting the clinical hold on Phase 2 trials of zelnecirnon in atopic dermatitis and asthma while continuing the Phase 2 study of tivumecirnon in cancer.
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Insights

The reported net loss of RAPT Therapeutics for both the fourth quarter and the full year of 2023 represents a significant increase compared to the previous year. This uptick in net loss is a critical factor for investors, as it suggests a higher cash burn rate. The company's solid cash position of $158.9 million, however, provides a buffer that may support ongoing research and development (R&D) activities. It is imperative to assess the sustainability of this cash reserve in relation to the increased R&D expenditure, particularly as it relates to the development of zelnecirnon.

Investors should also consider the implications of the clinical hold on zelnecirnon trials. While patient safety must be the priority, any delays in clinical trials can have a material impact on the company's timeline for potential revenue generation. The market typically reacts to such uncertainties and the ability of the company to resolve these issues swiftly could be a pivotal factor in maintaining investor confidence. The ongoing Phase 2 study of tivumecirnon in cancer and the upcoming update at AACR could provide positive catalysts if the results are promising.

The increased R&D expenses, particularly associated with zelnecirnon, reflect RAPT Therapeutics' commitment to advancing its pipeline. However, the clinical hold on Phase 2 trials for atopic dermatitis and asthma introduces a level of risk and uncertainty. From a medical research perspective, the resolution of such holds is not always straightforward and can involve extensive dialogue with regulatory bodies. The outcome of these discussions could significantly affect the drug's development timeline and, consequently, the company's market valuation.

Understanding the clinical profile of zelnecirnon and tivumecirnon is crucial. If the safety concerns are addressed and the drugs prove to be efficacious, they could meet significant unmet needs in their respective therapeutic areas. The impact on the stock market will largely depend on the perceived potential of these drugs to capture market share in the competitive fields of inflammatory diseases and oncology. The update at AACR will be closely watched for indications of tivumecirnon's clinical efficacy and safety, which could influence the company's R&D strategy moving forward.

When evaluating the business implications of RAPT Therapeutics' financial results, it is essential to consider the broader market context. The biotechnology sector is known for its high levels of investment in R&D in exchange for the potential of significant long-term payoffs. The company's strategic focus on oral small molecule therapies positions it within a niche that is gaining interest due to the convenience of oral administration compared to intravenous treatments.

The increase in general and administrative expenses, including stock-based compensation, is a common trend in growing biotech firms seeking to attract and retain talent. However, investors should monitor these expenses closely to ensure they align with the company's growth trajectory and value creation. The current cash position appears robust, but the burn rate will need to be carefully managed, especially if the clinical holds extend or additional funding rounds are necessitated.

Company maintains solid cash position of $158.9 million

SOUTH SAN FRANCISCO, Calif., March 07, 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 fourth quarter and year ended December 31, 2023.

“We are working diligently to lift the clinical hold on our Phase 2 trials of zelnecirnon in atopic dermatitis and asthma,” said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. “Patient safety is our top priority. We expect to provide an update once we have defined a plan to move ahead and appreciate your patience during this process. Separately, our Phase 2 study of tivumecirnon in cancer is ongoing and we will be presenting an update at AACR in April.”

Financial Results for the Fourth Quarter and the Year Ended December 31, 2023

Fourth Quarter Ended December 31, 2023

Net loss for the fourth quarter of 2023 was $30.9 million, compared to $23.0 million for the fourth quarter of 2022.

Research and development expenses for the fourth quarter of 2023 were $26.8 million, compared to $19.5 million for the same period in 2022. The increase in research and development expenses was primarily due to higher development costs related to zelnecirnon, as well as increased expenses for personnel, lab supplies, consultants, facilities and stock-based compensation, partially offset by lower development costs related to tivumecirnon and early-stage programs.

General and administrative expenses for the fourth quarter of 2023 were $6.5 million, compared to $5.0 million for the same period in 2022. The increase in general and administrative expenses was primarily due to increases in expenses for personnel, stock-based compensation and facilities.

Year Ended December 31, 2023

Net loss for the year ended December 31, 2023 was $116.8 million, compared to $83.8 million in 2022.

Research and development expenses for the year ended December 31, 2023 were $101.0 million, compared to $67.1 million in 2022. The increase in research and development expenses was primarily due to higher development costs related to zelnecirnon, as well as increased expenses for personnel, lab supplies, consultants, facilities and stock-based compensation, partially offset by lower development costs related to tivumecirnon and early-stage programs.

General and administrative expenses for the year ended December 31, 2023 were $26.1 million, compared to $20.2 million in 2022. The increase in general and administrative expenses was primarily due to increases in expenses for personnel, stock-based compensation, facilities and professional services.

As of December 31, 2023, the Company had cash and cash equivalents and marketable securities of $158.9 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,” “expect,” “plan,” “target” 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 therapeutic potential of RAPT’s product candidates, clinical development progress and the timing of initiation, enrollment and completion of, and availability of results from, clinical trials of zelnecirnon (RPT193) and tivumecirnon (FLX475), RAPT’s expectations concerning the clinical hold of its Phase 2 trials of zelnecirnon, including its investigation of the incident, 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 hold 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, including lower than expected enrollment in our Phase 2b clinical trial of zelnecirnon in AD, 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 7, 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
December 31,
  Three Months Ended
December 31,
  Year Ended
December 31,
  Year Ended
December 31,
 
  2023  2022  2023  2022 
Revenue $  $  $  $1,527 
Operating expenses:            
Research and development  26,764   19,454   101,002   67,082 
General and administrative  6,453   4,977   26,060   20,240 
Total operating expenses  33,217   24,431   127,062   87,322 
Loss from operations  (33,217)  (24,431)  (127,062)  (85,795)
Other income, net  2,341   1,480   10,264   1,957 
Net loss $(30,876) $(22,951) $(116,798) $(83,838)
Other comprehensive income (loss):            
Foreign currency translation gain (loss)     (88)  (655)  627 
Unrealized gain (loss) on marketable securities  224   515   784   (447)
Total comprehensive loss $(30,652) $(22,524) $(116,669) $(83,658)
Net loss per share, basic and diluted $(0.80) $(0.64) $(3.05) $(2.58)
Weighted average number of shares used in computing
   net loss per share, basic and diluted
  38,383,867   35,689,363   38,338,161   32,540,406 



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

  December 31,
2023
  December 31,
2022
 
Assets (Unaudited)  (1) 
Current assets:      
Cash and cash equivalents $47,478  $38,946 
Marketable securities  111,384   210,122 
Prepaid expenses and other current assets  2,920   3,626 
Total current assets  161,782   252,694 
Property and equipment, net  2,448   2,539 
Operating lease right-of-use assets  5,228   6,940 
Other assets  3,871   4,036 
Total assets $173,329  $266,209 
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $5,176  $3,365 
Accrued expenses  14,103   8,656 
Operating lease liabilities, current  2,448   2,171 
Other current liabilities  109   32 
Total current liabilities  21,836   14,224 
Operating lease liabilities, non-current  4,458   6,819 
Total liabilities  26,294   21,043 
Commitments      
Stockholders’ equity:      
Preferred stock      
Common stock  3   3 
Additional paid-in capital  631,611   613,073 
Accumulated other comprehensive gain (loss)  103   (26)
Accumulated deficit  (484,682)  (367,884)
Total stockholders’ equity  147,035   245,166 
Total liabilities and stockholders’ equity $173,329  $266,209 


(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.

FAQ

What was RAPT Therapeutics' net loss for the fourth quarter of 2023?

RAPT Therapeutics reported a net loss of $30.9 million for the fourth quarter of 2023.

What were the research and development expenses for the fourth quarter of 2023?

Research and development expenses for the fourth quarter of 2023 were $26.8 million.

How much cash and cash equivalents did RAPT Therapeutics have as of December 31, 2023?

As of December 31, 2023, RAPT Therapeutics had cash and cash equivalents and marketable securities of $158.9 million.

What is RAPT Therapeutics focused on in terms of clinical trials?

RAPT Therapeutics is focused on lifting the clinical hold on Phase 2 trials of zelnecirnon in atopic dermatitis and asthma and continuing the Phase 2 study of tivumecirnon in cancer.

RAPT Therapeutics, Inc.

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Biotechnology
Pharmaceutical Preparations
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United States of America
SOUTH SAN FRANCISCO