# EDGAR Filing Document

**Accession Number:** 0001610618
**File Stem:** 0001193125-23-055140
**Filing Date:** 2023-3
**Character Count:** 5794
**Document Hash:** 2bc3ca7612a6292b76c48b32d5c26aca
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-055140.hdr.sgml**: 20230301

**ACCESSION NUMBER**: 0001193125-23-055140

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20230301

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20230301

**DATE AS OF CHANGE**: 20230301

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Cidara Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001610618
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 461537286
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36912
- **FILM NUMBER:** 23689768

**BUSINESS ADDRESS:**
- **STREET 1:** 6310 NANCY RIDGE DRIVE
- **STREET 2:** SUITE 101
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** 858-752-6170

**MAIL ADDRESS:**
- **STREET 1:** 6310 NANCY RIDGE DRIVE
- **STREET 2:** SUITE 101
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** K2 THERAPEUTICS, INC.
- **DATE OF NAME CHANGE:** 20140611

?xml version="1.0" encoding="utf-8" ? 8-K

------

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

------

### FORM 8-K

------

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): March 1, 2023

------

## Cidara Therapeutics, Inc.

#### (Exact name of registrant as specified in its charter)

------

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-36912** | **46-1537286** |
| **(State or Other Jurisdiction**<br> **of Incorporation or Organization)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **Identification Number)** |

---

#### 6310 Nancy Ridge Drive, Suite 101

#### San Diego, California 92121
(858) 752-6170

#### (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices)

------

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:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **Symbol(s)** | **Name of each exchange**<br> **on which registered** |
| Common Stock, Par Value $0.0001 Per Share | CDTX | The Nasdaq Stock Market LLC |

---

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 8.01 Other Events.
On March 1, 2023, Cidara Therapeutics, Inc. (the "Company"), announced efficacy and safety data from a planned interim analysis of the Company's ongoing Phase 2a trial evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain, as of a February 13, 2023 data cut-off. The Phase 2a trial is a single-center, randomized, double-blind influenza challenge study in healthy volunteers designed to assess the prophylactic antiviral activity, safety, tolerability and pharmacokinetics of CD388 in healthy volunteers. The interim analysis is based on 56 subjects enrolled in the trial, with 28 subjects receiving a single dose of CD388 (150 mg) and 28 subjects receiving a placebo. The interim data for the primary efficacy endpoint of Area Under the Viral Load-Time Curve (VL-AUC) and for the secondary efficacy endpoint of influenza infection incidence for 150 mg CD388 versus placebo are shown below in Table 1.

#### Table 1.

---

| | | |
|:---|:---|:---|
|  | **&nbsp;&nbsp;&nbsp;&nbsp;Placebo (n=28)&nbsp;&nbsp;&nbsp;&nbsp;** | **CD388 150 mg (n=28)** |
|  **Area Under the Viral Load-time Curve (VL-AUC)- Mean (SD)** | 16.1 (11.9) | 10.7 (8.0) |
|  **PCR confirmed influenza infection- n (%)** | 14 (50%) | 6 (21.4%) |

---

As shown in Table 1, despite the small sample size in this planned interim analysis, a decrease in viral replication in the upper respiratory tract and influenza infection was observed in participants receiving a single dose of CD388 when compared to placebo. No treatment emergent adverse events leading to study discontinuation or serious adverse events were reported in the interim analysis. All participants included in the interim analysis received either CD388 or placebo and were then challenged with influenza five days later.

------

#### 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 hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **Cidara Therapeutics, Inc.** |  |
| Date: March 1, 2023 |  | /s/ Jeffrey Stein, Ph.D. |
|  |  | Jeffrey Stein, Ph.D. |
|  |  | President and Chief Executive Officer <br>(Principal Executive Officer) |

---