UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 14, 2023, RAPT Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2022. A copy of the press release is furnished as Exhibit 99.1 to this report.
The information in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 8.01 Other Events.
The Company is filing the investor presentation slides (the “Corporate Presentation”) attached as Exhibit 99.2 to this Current Report on Form 8-K, which the Company may use from time to time in conversations with investors and analysts.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit |
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Exhibit Description |
99.1 |
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99.2 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 the undersigned thereunto duly authorized.
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RAPT Therapeutics, Inc. |
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Date: |
March 14, 2023 |
By: |
/s/ Rodney Young |
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Rodney Young |
Exhibit 99.1
RAPT Therapeutics Reports Fourth Quarter And Year End Financial Results
Company maintains strong cash position of $249.1 million
SOUTH SAN FRANCISCO, Calif. – March 14, 2023 – 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, 2022.
“2022 was an important year of progress, as we advanced both of our two lead programs, RPT193 and FLX475, in inflammatory disease and cancer, respectively,” said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. “This progress has positioned us for future milestones in 2023, including our anticipated initiation of a Phase 2a trial with RPT193 in asthma this quarter and a clinical data update from our ongoing Phase 2 trial of FLX475 in multiple cancer indications, which we are targeting for the second half of this year. For our Phase 2b trial of RPT193 in atopic dermatitis, we now expect topline results in mid-2024 due to recent slower than expected patient enrollment as we did not see the seasonal uptick that we anticipated. Our cash position is strong and we expect it to provide runway into mid-2025, well beyond the expecteddata readout.”
Financial Results for the Fourth Quarter and Year Ended December 31, 2022
Fourth Quarter Ended December 31, 2022
Net loss for the fourth quarter of 2022 was $23.0 million, compared to $17.9 million for the fourth quarter of 2021.
Research and development expenses for the fourth quarter of 2022 were $19.5 million, compared to $14.3 million for the same period in 2021. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and FLX475, personnel and stock-based compensation expense.
General and administrative expenses for the fourth quarter of 2022 were $5.0 million, compared to $4.5 million for the same period in 2021. The increase in general and administrative expenses was primarily due to increases in expenses for personnel, stock-based compensation and facilities, partially offset by a decrease in professional services.
Year Ended December 31, 2022
Net loss for the year ended December 31, 2022 was $83.8 million, compared to $69.2 million in 2021.
Research and development expenses for the year ended December 31, 2022 were $67.1 million, compared to $57.0 million in 2021. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and increases in expenses for early-stage programs, personnel and laboratory supplies, partially offset by decreases in development costs related to FLX475, facilities costs and stock-based compensation expense.
General and administrative expenses for the year ended December 31, 2022 were $20.2 million, compared to $16.0 million in 2021. The increase in general and administrative expenses was primarily due to increases in expenses for professional services, personnel, stock-based compensation and facilities.
As of December 31, 2022, the Company had cash, cash equivalents and marketable securities of $249.1 million. In December 2022, we completed an underwritten public offering of 4,338,104 shares of common stock and received approximately $75.0 million in net proceeds, after deducting underwriting discounts and other offering-related costs.
1
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, RPT193 and 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,” “could,” “expect,” “look forward,” “plan,” “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 clinical development progress and the timing of initiation and completion of, and results from, clinical trials of RPT193 and FLX475 and our cash runaway. 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 may not be predictive of future data or results, may not demonstrate safety or efficacy or lead to regulatory approval, clinical trial site activation or enrollment rates that are lower than expected, including recent lower than expected enrollment in our Phase 2b clinical trial of RPT193 in AD, unanticipated or greater than anticipated impacts or delays due to macroeconomic conditions (including the long-term impacts of the COVID-19 pandemic, the conflict between Russia and Ukraine, inflation, rising 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 14, 2023 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
2
RAPT THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share per share data)
(Unaudited)
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Three Months Ended |
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Three Months Ended |
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Year Ended |
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Year Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue |
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$ |
— |
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$ |
756 |
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$ |
1,527 |
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$ |
3,813 |
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Operating expenses: |
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Research and development |
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19,454 |
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14,299 |
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67,082 |
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56,985 |
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General and administrative |
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4,977 |
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4,491 |
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20,240 |
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16,037 |
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Total operating expenses |
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24,431 |
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18,790 |
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87,322 |
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73,022 |
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Loss from operations |
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(24,431 |
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(18,034 |
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(85,795 |
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(69,209 |
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Other income, net |
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1,480 |
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105 |
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1,957 |
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5 |
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Net loss |
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$ |
(22,951 |
) |
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$ |
(17,929 |
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$ |
(83,838 |
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$ |
(69,204 |
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Other comprehensive income (loss): |
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Foreign currency translation gain (loss) |
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(88 |
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(23 |
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627 |
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258 |
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Unrealized gain (loss) on marketable securities |
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515 |
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(228 |
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(447 |
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(287 |
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Total comprehensive loss |
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$ |
(22,524 |
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$ |
(18,180 |
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$ |
(83,658 |
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$ |
(69,233 |
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Net loss per share, basic and diluted |
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$ |
(0.64 |
) |
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$ |
(0.61 |
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$ |
(2.58 |
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$ |
(2.53 |
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Weighted average number of shares used in computing |
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35,689,363 |
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29,539,031 |
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32,540,406 |
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27,390,326 |
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3
RAPT THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands)
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December 31, |
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December 31, |
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Assets |
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(Unaudited) |
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(1) |
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Current assets: |
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Cash and cash equivalents |
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$ |
38,946 |
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$ |
24,027 |
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Marketable securities |
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210,122 |
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165,627 |
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Prepaid expenses and other current assets |
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3,626 |
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3,319 |
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Total current assets |
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252,694 |
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192,973 |
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Property and equipment, net |
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2,539 |
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2,741 |
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Operating lease right-of-use assets |
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6,940 |
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— |
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Other assets |
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4,036 |
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2,922 |
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Total assets |
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$ |
266,209 |
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$ |
198,636 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
3,365 |
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$ |
1,999 |
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Accrued expenses |
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8,656 |
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6,326 |
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Deferred revenue, current |
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— |
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1,016 |
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Operating lease liabilities, current |
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2,171 |
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— |
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Other current liabilities |
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32 |
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254 |
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Total current liabilities |
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14,224 |
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9,595 |
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Deferred revenue, non-current |
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— |
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511 |
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Deferred rent, net of current portion |
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— |
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2,150 |
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Operating lease liabilities, non-current |
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6,819 |
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— |
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Total liabilities |
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21,043 |
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12,256 |
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Commitments |
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Stockholders’ equity: |
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Preferred stock |
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— |
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— |
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Common stock |
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3 |
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3 |
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Additional paid-in capital |
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613,073 |
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470,629 |
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Accumulated other comprehensive loss |
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(26 |
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(206 |
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Accumulated deficit |
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(367,884 |
) |
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(284,046 |
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Total stockholders’ equity |
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245,166 |
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186,380 |
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Total liabilities and stockholders’ equity |
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$ |
266,209 |
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$ |
198,636 |
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4
Transforming the Treatment of Inflammation and Cancer Corporate Presentation March 2023 Exhibit 99.2
Legal Disclaimers Statements in this Presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding RAPT Therapeutics, Inc.’s (the "Company," "we," or "us") research and clinical development plans; current and future drug candidates; business strategy and plans; regulatory pathways; and our ability to complete certain milestones. Words such as "believe," "anticipate," "plan," "expect," "will," "may," "upcoming," "milestone," "potential," "target" or the negative of these terms or similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the current beliefs of the Company's management with respect to future events and trends and are subject to known and unknown risks and uncertainties, including those described in the “Risk Factors” section of our most recent Form 10-K filed with the Securities and Exchange Commission, and any current and periodic reports filed thereafter, that may cause our actual performance or achievements to be materially different from any future performance or achievements expressed or implied by the forward-looking statements in this Presentation. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that any assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of such assumptions, fully stated in the Presentation. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this Presentation is given. Although we believe that the beliefs and assumptions reflected in the forward-looking statements are reasonable, we cannot guarantee future performance or achievements. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Presentation. This Presentation discusses drug candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of any drug candidates for any use for which such drug candidates are being studied.
DISCOVERY Oral Drugs Targeting Critical Immune Drivers of Disease RPT193 (Inflammation): Oral agent targeting inflammatory Th2 cells Phase 1b in AD: efficacy on all key exploratory endpoints with excellent safety and tolerability Phase 2b in AD ongoing, data expected mid 2024 Plan to initiate Phase 2a in Asthma Q1 2023 FLX475 (Oncology): Selectively targets immunosuppressive tumor Treg PoC in Phase 2 with mono and combo activity Phase 2 data update expected 2H 2023 HPK1 (Oncology) Other inflammation and oncology targets CLINICAL Proprietary discovery engine Diversified pipeline Large market opportunities Clinically de-risked assets Strategic collaborations
Proprietary Drug Discovery and Development Engine R Drug discovery Clinical development Rapid Interrogating clinically-relevant big datasets to identify targets and biomarkers Driven by data to improve chances of clinical success Critical immune drivers of cancer and inflammation A Analytics P Patient selection T Targeting
RPT193: CCR4 Antagonist for Inflammatory Diseases
RPT193: Oral Th2 Inhibitor for Inflammatory Diseases Highly potent and selective once-daily oral CCR4 antagonist designed to safely reduce Th2-inflammation in a broad range of allergic disorders Clear benefit on signs and symptoms in Phase 1b in moderate-to-severe atopic dermatitis Favorable safety and tolerability: no laboratory safety monitoring or black box warning expected Potential positioning as drug of first choice after inadequate response to TCS and prior to injectables US patent coverage through at least 2039 Phase 2b AD data expected mid 2024 and pivotal studies anticipated to start in 2025 Plan to initiate Phase 2a asthma trial Q1 2023 AD Lesional Skin
RPT193 Targets Th2 Cells: Key Drivers of Inflammation in Atopic Dermatitis, Asthma and Other Diseases Epithelial Barrier Surface CCR4 Th2 IL-5 IL-4 IL-13 Inflammation Thickening Itch Signaling via CCR4 regulates Th2 cell migration into inflamed tissues and enhances cytokine secretion Cytokines Allergen, Microbes RPT193 is a potent and selective oral CCR4 antagonist that specifically inhibits Th2 cell migration and activation CCL17 CCL22 anti-IL4Rα Ab anti-IL5/R Ab anti-IL13 Ab
Enrolled 31 patients into a double-blind, randomized trial with 2:1 allocation of RPT193 to placebo Monotherapy study: steroid and immunosuppressant washout period; rescue steroids not permitted through Day 43 Not powered for any specific endpoint Exploratory endpoints include: EASI, Pruritus Numerical Rating Scale (NRS), SCORAD and vIGA Data presented are from the Intent to Treat dataset Phase 1b Trial Explored RPT193 Activity in Patients with Moderate-to-Severe Atopic Dermatitis Obtain Informed Consent ≥12-month history of AD 18-65 years of age (inclusive) BMI ≥18 and <40 kg/m2 BSA ≥10% EASI ≥12 vIGA ≥3 Screening (Up to 35 days) Day -35 -1 RPT193 400 mg once daily Placebo Randomization (2:1) Treatment (28 days) Follow-up (14 days) 1 29 8 15 43 Study Assessments (Day 1 to 43)
Phase 1b Baseline Demographics and Disease Characteristics Placebo RPT193 N 10 21 Age, Mean (Range) 35.8 (22-64) 41.0 (19-63) Female, n (%) 4 (40.0%) 12 (57.1%) Baseline Characteristics EASI, Mean (Range) 21.07 (13.6-45.5) 18.49 (12-30) BSA, Mean (Range) 24.5 (10-61) 23.3 (11-55) vIGA 3, n (%) 8 (80.0%) 18 (85.7%) Peak NRS, Mean (Range) 7.3 (3-10) 6.9 (3-10) Peak NRS ≥4, n (%) 9 (90.0%) 20 (95.2%)
RPT193 Differentiated from Placebo for EASI and EASI-50 at Day 29 with Further Improvement at Day 43 % Improvement in EASI Proportion of EASI-50 19.3% 43.6% 32.9% 41.9% Follow-up Treatment Follow-up Treatment *p < 0.05 * *
RPT193 Differentiated from Placebo on EASI-75, 90 and vIGA 0/1 at Day 43 *p < 0.05 * 28.6% 9.5% 14.3% 61.9% 20% 0% 0% 0% ** 36.4% 9.1% 27.3% 63.6% 0% 0% 0% 0% (N=8) (N=11) **p < 0.01 EASI ≥ 12 ITT EASI ≥ 16 Subgroup Similar efficacy between ITT and EASI ≥ 16 Subgroup
RPT193 Demonstrated Significant Improvement in AD-Associated Gene Signatures in the Skin MADAD: Meta-Analysis Derived Atopic Dermatitis score ***(p<0.001) Changes in the Lesional AD Transcriptome Mean % Improvement in MADAD Transcriptome *** -4% 52% % Improvement 40 20 0 PbO RPT193 NL Day1 Day29 NL Day1 Day29 RPT193 PbO Log2(Fold Change) 2 0 -2 PbO-Day1 PbO-Day29 RPT193-Day1 RPT193-Day29 Direction of Dysregulation in AD: Down-Regulated Up-Regulated
RPT193 Demonstrated Improvement in Itch and Sleep Proportion of NRS-4† 22.2% 45.0% †At least a 4-point improvement among patients with a baseline pruritus NRS ≥4 * % Change in Patient Oriented SCORAD (Sleep Loss + Pruritus) *p < 0.05
RPT193 6-Week Efficacy vs. Other Drugs at 12-16 Weeks* RPT193 RPT193 400 mg Biologics Orals Dupilumab Ph3 (300 mg q2wk) Lebrikizumab Ph2 (250 mg q2wk) Tralokinumab Ph3 (300 mg q2wk) Abrocitinib Ph3 (200 mg) Baricitinib Ph3 (2 mg) Etrasimod Ph2 (2 mg) Upadicitinib Ph2,3 (15 mg) % EASI improvement EASI-50 vIGA 0 or 1 100 RPT193 RPT193 0 40 20 60 All data shown are placebo-adjusted * Comparisons are based on published data and relative properties of other agents and do not reflect a head-to-head comparative study or clinical trial EASI-75 RPT193
RPT193 Phase 1b Safety No SAEs reported All AEs reported were mild or moderate in intensity No clinically significant safety laboratory abnormalities observed Overall safety profile suggests a well-tolerated oral drug that should not require laboratory safety monitoring
Ongoing Dose-Finding Phase 2b Monotherapy Trial in Patients with Moderate-to-Severe Atopic Dermatitis 169 Obtain Informed Consent ≥12-month history of AD 18-75 years of age BMI ≥18 BSA ≥10% EASI ≥16 vIGA ≥3 Screening (Up to 5 weeks) Day -35 -1 RPT193 400 mg once daily RPT193 200 mg once daily RPT193 50 mg once daily Placebo once daily Randomization (1:1:1:1) Treatment (16 weeks) Follow-up (up to 8 weeks) 1 113 29 57 85 127 Study Assessments (Day 1 to 169) 14 141 Goal enrollment: 268 patients, ~67 per arm Monotherapy study: standard protocol to washout steroids/immunosuppressants and restrict rescue medications Primary endpoint: EASI Secondary endpoints: EASI-50/75/90, vIGA, Pruritus NRS
Proposed Phase 2a Asthma Trial Design CONFIDENTIAL Goal enrollment: ~100 patients, ~50 per arm Primary Endpoint: “Loss of Asthma Control” Secondary Endpoint: ACQ-5, FEV1, etc. Obtain Informed Consent Moderate-to-severe Type 2 asthmatics Screening (Up to 6 weeks) Day -42 -1 RPT193 400 mg once daily Placebo Treatment (14 weeks) Follow-up (6 weeks) 1 141 Study Assessments (Day 1 to 141) Evaluation as Add-on Tapering of Inhaled Medications Monotherapy 43 78 99 Randomization (1:1) Run-in with standardized inhaled therapy (ICS+LABA and SABA) -28
RPT193 Commercial Vision: Building a Global Blockbuster Value Statement Positioning As the first-choice systemic therapy Sources: GlobalData: Atopic Dermatitis Global Drug Forecast and Market Analysis to 2030 | March 2022 * Decision Resources Guide; EU, US, and Japan market Simple, once-daily oral providing symptom relief and lesion reduction Favorable tolerability and safety from exquisite selectivity RPT193 Injectable Biologics Oral JAKs Topical JAKs/PDE4 TCS/TCI Massive Opportunity in the $24B projected global AD market* In Adults and Adolescents ≥ 12 yrs. with Mod-Severe AD Into the $21B Asthma Market* Additional Th2 Indications LAUNCH GROW and EXPAND In Children <12 yrs. with Mod-Severe AD In Adults with Mild AD
Potential “Pipeline in a Product” Dermatology Respiratory Chronic Rhinosinusitis Allergy Eosinophilic Esophagitis Prurigo Nodularis Bullous Pemphigoid Alopecia Areata Asthma COPD (Th2 high) IPF Atopic Dermatitis Allergic Rhinitis Th2-Driven Inflammatory Diseases Chronic Urticaria
RPT193 Program Summary Oral selective Th2 inhibitor with clear benefit on signs and symptoms in AD Well tolerated with favorable safety Profile supports competitive positioning ahead of injectables and oral JAKs Massive commercial opportunity in AD, asthma and other Th2 indications 16-week Phase 2b study in AD ongoing, topline data expected mid 2024 Biologic-like efficacy not required for commercial success Plan to initiate Phase 2a study in asthma Q1 2023
FLX475: CCR4 Antagonist for Oncology
Treg Are Key Targets in the Tumor Microenvironment (TME) Correlate with poor prognosis across most cancers Mechanism for immune evasion by viruses and tumors Barrier to checkpoint inhibitor efficacy Challenge: selective inhibition of Treg in the TME Depleting antibodies targeting CD25, CCR4, etc. do not appear to have adequate selectivity Treg CD8 Cancer Types Bruni D et al. Nat Rev Cancer 2020
FLX475: Tumor Specific Treg Inhibitor in Phase 2 Chemically distinct potent and selective CCR4 small molecule antagonist Selectively blocks tumor Treg while sparing normal tissues and beneficial cells Potential for superior safety and efficacy compared to depleting antibodies US patent coverage through 2037 Monotherapy and combination antitumor activity in charged cancers Treg-Excluded Tumor Microenvironment Treg-Suppressed Tumor Microenvironment FLX475
Identification and Characterization of Charged Tumors “Charged” tumors: high CCR4 ligands, Treg and CD8 T cells Potential for both monotherapy and combination activity Include cancers with high unmet need and large markets Phase 2 trial expansions focused on charged cancers Data from in-house analysis of TCGA database combined with other data sets; Confirmed in > 400 tumor microarrays The graph above reflects a logarithmic scale on each axis NPC Nasopharyngeal; HNSCC Head & Neck Squamous Cell Carcinoma; NHL Non-Hodgkin Lymphoma; NSCLC Non-Small Cell Lung Cancer; TNBC Triple Negative Breast Cancer Treg CCR4 Ligands CD8 Signature Gastric EBV+ NPC EBV+ NSCLC Sq. TNBC Cervical HPV+ HNSCC NSCLC Ad. Virally-Associated Non-Virally-Associated NHL
Encouraging Monotherapy and Combination Efficacy Pembro Mono Pembro+TIGIT Pembro+FLX475 18%† 31% (4/13)^ 38% (3/8) ORR Comparison in PD-L1+* NSCLC *TPS ≥ 1%; †Keynote-010; ^Niu et al. ESMO 2020 CPI-Naïve NSCLC (Combo) EBV+ NK/T Lymphoma (Monotherapy) 4 of 6 responses to FLX475 monotherapy including 2 confirmed durable CMR Design: Open-label Phase 2, Simon 2-Stage Design Indications: Charged tumors with ≥1 line of therapy Dose: FLX475 100 mg QD; pembro 200 mg Q3wk Time Since Start of Treatment, Days cPR cPR cPR cPR uPR
FLX475 Program Summary Highly selective tumor Treg inhibitor differentiated from biologics Encouraging early efficacy as monotherapy and in combination with pembrolizumab Favorable safety and convenient oral dosing support broad combinability Enrolling Stage 2 expansions in 3 indications including CPI-naïve NSCLC Partner Hanmi Pharmaceuticals reported encouraging data for FLX475 + pembro in EBV+ gastric cancer Data update expected in 2H 2023
Key Takeaways and Upcoming Milestones RPT193: safe oral agent designed for a broad range of inflammatory diseases, in a definitive Phase 2b study in AD FLX475: highly selective tumor Treg inhibitor in multiple Phase 2 expansions as monotherapy and in combination with pembrolizumab Planned Key Milestones Q1 2023: RPT193 Phase 2a asthma trial start 2H 2023: FLX475 Phase 2 data update mid 2024: RPT193 Phase 2b AD topline data
Thank You