Cidara Therapeutics Announces Two Presentations on CD388 in Influenza at International Conference on Antiviral Research (ICAR) 2025
Presentation details:
Title: NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Study to Evaluate the Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for Prevention of Influenza in Subjects not at Risk for Influenza ComplicationsPresenter: James AlexanderAbstract number: 361 Date/Time: Poster Session 1: Tuesday, March 18, 2025, 5:15-6:15pm PT; Poster Session 2: Thursday, March 20, 2025, 9-10am PT Summary: The Phase 2b NAVIGATE trial to evaluate the safety and preventative efficacy of CD388 in a real-world environment completed enrollment of more than 5,000 participants in the United States and the UK. Prior Phase 1 and Phase 2a clinical data have shown that CD388, administered by subcutaneous injection, appeared to be well-tolerated and efficacious in healthy human volunteer studies. The results of the Phase 2b trial will inform dose selection and design for the planned Phase 3 development program.
Title: Real World Data-Based Modeling of Seasonal Influenza Variations to Support Clinical Dose Selection of CD388, A Novel Antiviral in Development for Prevention of Seasonal and Pandemic Influenza Presenter: Shawn FlanaganAbstract number: 352 Date/Time: Poster Session 1: Tuesday, March 18, 2025, 6:15-7:15pm PT; Poster Session 2: Thursday, March 20, 2025, 8-9am PT Summary: In trials involving community acquired infections, like influenza, variations in disease incidence over time may complicate interpretation of drug effect in Phase 2 and Phase 3 trials across multiple seasons, especially for long-acting drugs like CD388. Advanced model-based analysis was conducted to improve decision power based on simulated Phase 2 results over different flu seasons. While a standard proportions test was shown to be sensitive to influenza seasonal variations, the model-based analysis was not and increased decision power for clinical dose selection of CD388 for Phase 3.
About CD388CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/.
About Cidara TherapeuticsCidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara's lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company announced completion of enrollment of its Phase 2b NAVIGATE trial in December 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Forward-Looking StatementsThis release contains 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 'Forward-looking statements' describe future expectations, plans, results, or strategies and are generally preceded by words such as 'anticipates,' 'expect,' 'intends,' 'believes,' 'may,' 'plan' or 'will'. Forward-looking statements in this release include, but are not limited to, statements related to the potential of and future plans for CD388, and promising CD388 clinical data generated to date. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara's clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles on the enrollment of patients or other aspects of CD388 or other DFC development and other risks and uncertainties associated with Cidara's business in general. These and other risks are identified under the caption 'Risk Factors' in Cidara's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and other filings subsequently made with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
INVESTOR CONTACT:Brian RitchieLifeSci Advisors(212) 915-2578britchie@lifesciadvisors.com
MEDIA CONTACT:Michael FitzhughLifeSci Communications(628) 234-3889mfitzhugh@lifescicomms.comSign in to access your portfolio
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AND SUBSIDIARIES (Amounts in millions) (Unaudited) Six Months Ended June 29, June 30, 2025 2024 OPERATING ACTIVITIES Net income $ 174.9 $ 154.5 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation 17.9 16.9 Amortization of intangibles and other 10.3 9.8 Loss on disposal of long-lived assets and (gain) on sale of assets 0.2 (4.1 ) Stock-based compensation 9.5 10.0 Deferred income tax (6.2 ) (5.2 ) Changes in operating assets and liabilities, net of effects from business acquisitions: Accounts receivable (69.3 ) (50.0 ) Inventories (37.0 ) (16.8 ) Prepaid expenses and other assets (16.3 ) (0.8 ) Accounts payable, accrued expenses and other liabilities 40.9 16.6 Net cash provided by operating activities 124.9 130.9 INVESTING ACTIVITIES Additions to property, plant and equipment (19.8 ) (16.9 ) Proceeds from the sale of property, plant and equipment — 5.7 Business acquisitions, net of cash acquired (85.7 ) (96.3 ) Net cash used in investing activities (105.5 ) (107.5 ) FINANCING ACTIVITIES Payments of long-term debt — (40.0 ) Payments for withholding taxes on vested awards (11.1 ) (12.8 ) Payments for finance leases and other (1.3 ) (1.3 ) Payments to repurchase common stock (7.9 ) (8.1 ) Dividends (32.0 ) (26.7 ) Net cash used in financing activities (52.3 ) (88.9 ) Effect of exchange rate changes on cash and cash equivalents 15.3 (5.2 ) DECREASE IN CASH AND CASH EQUIVALENTS (17.6 ) (70.7 ) Cash and cash equivalents at beginning of year 386.9 350.1 CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 369.3 $ 279.4 Expand Segment Earnings and Non-GAAP Financial Measures In this press release, segment earnings is our GAAP performance measure used by our chief operating decision-maker ('CODM') to assess and evaluate segment results. Segment earnings exclude the impact of non-recurring and unusual items, such as restructuring costs, acquisition-related costs and gain or loss on sale of assets. The CODM uses segment earnings for insight into underlying trends comparing past financial performance with current performance by reporting segment on a consistent basis. Segment margin is defined as segment earnings divided by segment revenue. We refer to non-GAAP financial measures (including adjusted operating income, adjusted operating margin, adjusted net income, adjusted diluted earnings per share, organic sales, organic sales growth, free cash flow, cash conversion rate of free cash flow to net income and net debt to capitalization ratio) and provide a reconciliation of those non-GAAP financial measures to the corresponding financial measures contained in our consolidated financial statements prepared in accordance with GAAP. We believe these financial measures enhance the overall understanding of our historical financial performance and give insight into our future prospects. Adjusted operating income, adjusted operating margin, adjusted net income and adjusted diluted earnings per share eliminate certain expenses incurred and benefits recognized in the periods presented that relate primarily to our global restructuring programs, acquisition-related costs, gain or loss on sale of assets and the related income tax impacts on these items and tax adjustment items. Management then utilizes these adjusted financial measures to assess the run rate of the Company's operations against those of comparable periods. Organic sales and organic sales growth are non-GAAP measures of sales and sales growth excluding the impacts of foreign exchange, acquisitions and divestitures from period-over-period comparisons. Management believes reporting organic sales and organic sales growth provides useful information to investors, potential investors and others, and allows for a more complete understanding of underlying sales trends by providing sales and sales growth on a consistent basis. Free cash flow, cash conversion rate of free cash flow to net income, and the net debt to capitalization ratio, which are adjusted to exclude certain cash inflows and outlays, and include only certain balance sheet accounts from the comparable GAAP measures, are an indication of our performance in cash flow generation and also provide an indication of the Company's relative balance sheet leverage to other industrial manufacturing companies. These non-GAAP financial measures are among the primary indicators management uses as a basis for evaluating our cash flow generation and our capitalization structure. In addition, free cash flow is used as a criterion to measure and pay certain compensation-based incentives. For these reasons, management believes these non-GAAP financial measures can be useful to investors, potential investors and others. The Company's non-GAAP financial measures may not be comparable to similarly titled measures reported by other companies. The presentation of this additional information is not meant to be considered in isolation or as a substitute for financial measures prepared in accordance with GAAP. TABLE 3 (Amounts in millions) (Unaudited) Second Quarter Ended Americas Europe APMEA Total Net sales June 29, 2025 $ 498.5 $ 111.0 $ 34.2 $ 643.7 Net sales June 30, 2024 448.1 114.1 35.1 597.3 Dollar change $ 50.4 $ (3.1) $ (0.9) $ 46.4 Net sales % increase (decrease) 11.2 % (2.7) % (2.6) % 7.8 % Foreign exchange impact 0.1 % (4.9) % 1.5 % (0.8) % Acquisition impact (1.5) % — % — % (1.2) % Organic sales increase (decrease) 9.8 % (7.6) % (1.1) % 5.8 % Expand Six Months Ended Net sales June 29, 2025 $ 916.6 $ 219.4 $ 65.7 $ 1,201.7 Net sales June 30, 2024 866.9 237.4 63.9 1,168.2 Dollar change $ 49.7 $ (18.0) $ 1.8 $ 33.5 Net sales % increase (decrease) 5.7 % (7.6) % 2.8 % 2.9 % Foreign exchange impact 0.2 % (0.8) % 2.5 % 0.1 % Acquisition impact (1.4) % — % — % (1.0) % Organic sales increase (decrease) 4.5 % (8.4) % 5.3 % 2.0 % Expand TABLE 4 (Amounts in millions) (Unaudited) Six Months Ended June 29, June 30, 2025 2024 Net cash provided by operating activities $ 124.9 $ 130.9 Less: additions to property, plant, and equipment (19.8) (16.9) Plus: proceeds from the sale of property, plant, and equipment — 5.7 Free cash flow $ 105.1 $ 119.7 Net income $ 174.9 $ 154.5 Cash conversion rate of free cash flow to net income 60.1 % 77.5 % Expand TABLE 5 (Amounts in millions) (Unaudited) June 29, December 31, 2025 2024 Current portion of long-term debt $ — $ — Plus: long-term debt, net of current portion 197.3 197.0 Less: cash and cash equivalents (369.3) (386.9) Net debt $ (172.0) $ (189.9) Net debt $ (172.0) $ (189.9) Total stockholders' equity 1,892.4 1,707.9 Capitalization $ 1,720.4 $ 1,518.0 Net debt to capitalization ratio (10.0) % (12.5) % Expand TABLE 6 2025 FULL YEAR OUTLOOK – RECONCILIATION OF NET SALES GROWTH TO ORGANIC SALES GROWTH AND OPERATING MARGIN TO ADJUSTED OPERATING MARGIN (Unaudited) Total Watts Full Year 2025 Outlook Approximately Net Sales Net sales growth 2% to 5% Forecasted impact of acquisition / FX (2)% Organic sales growth Flat to 3% Operating Margin Operating margin 17.2% to 17.8% Forecasted restructuring / other costs 1.0% Adjusted operating margin 18.2% to 18.8% Expand
