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Cidara Therapeutics Provides Corporate Update and Reports Second Quarter 2022 Financial Results

Cidara Therapeutics, Inc.

Cidara Therapeutics, Inc.

SAN DIEGO, Aug. 09, 2022 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics aimed at improving the standard of care for patients suffering from serious diseases, today announced Reported financial results for the second quarter ended June 30, 2022 and provided an update on its corporate activities and product pipeline.

“With the filing of an NDA for rezafungin for the treatment of candidemia and invasive candidiasis, we have reached a significant milestone in Cidara’s corporate development,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. “We are also pleased to announce a licensing agreement with Melinta Therapeutics for the US commercialization of rezafungin for up to $460 million. We expect a PDUFA target action date in Q1 2023.”

dr Stein continued, “In our Cloudbreak® program, we are advancing our Phase 1 trial of CD388, a highly potent, long-acting antiviral immunotherapy for universal prevention of seasonal and pandemic influenza, which we are conducting in partnership with Janssen. Furthermore, the compelling preclinical data generated by Cloudbreak so far and presented at our recent R&D Day underscored its significant potential in oncology.”

Current company highlights

  • Rezafungin NDA Submitted and License Agreement Announced with Melinta Therapeutics, Inc.: In July 2022, Cidara announced that it had submitted a New Drug Application (NDA) for rezafungin to the U.S. Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis. The Company also announced that it has entered into a licensing agreement with Melinta Therapeutics, Inc. (Melinta), under which Cidara has granted Melinta an exclusive license to commercialize rezafungin in the United States. Under the terms of the agreement, Cidara will receive an upfront payment of US$30 million within 30 days and is eligible for US$60 million in regulatory milestone payments and up to US$370 million in commercial milestone payments, for a potential total transaction value of Equivalent to $460 million, plus tiered royalties on US sales of low double-digit to mid-teen rezafungin, subject to offsetting for certain expenses incurred by Melinta. Cidara retains the rights to Rezafungin in Japan, while Mundipharma retains the commercial rights to Rezafungin outside of the US and Japan.

  • Hosted virtual research and development day: In July 2022, Cidara hosted a Virtual Research and Development Day with a panel discussion featuring key thought leaders in oncology, Ezra Cohen, MD, FRCPSC, FASCO, San Diego Center for Precision Immunotherapy, and Perry Nisen, MD, Ph.D. , Chief Executive Officer and Executive Chairman of Quanta Therapeutics, Inc. The panel focused on Cidara’s Cloudbreak platform, which couples potent inhibitors to a human antibody fragment to produce highly potent, long-acting drug-Fc conjugates (DFCs) that simultaneously inhibit several disease targets. The panel highlighted the principles behind the cloudbreak DFC approach, contrasted it with antibody-drug conjugates (ADCs), monoclonal antibodies (mAbs) and small molecule applications, and reviewed the potential benefits of DFCs in oncology. New data emerging from Cidara’s SARS-CoV-2 and oncology DFC programs in the immune checkpoint blockade pathway were presented.

Second quarter 2022 financial results

  • Revenues for the three and six months ended June 30, 2022 totaled $6.2 million and $13.3 million, respectively, compared to $32.9 million and $35.3 million for the same periods in 2021 Revenue for the three and six months ended June 30, 2021 included revenue of $27.0 million recognized upon transfer of an intellectual property license to Janssen. The remaining revenues for all periods relate to ongoing research and development and clinical care services for Mundipharma and Janssen.

  • Cash, cash equivalents and restricted cash totaled $25.0 million as of June 30, 2022 compared to $62.3 million as of December 31, 2021.

  • Research and development expenses for the three and six months ended June 30, 2022 were $15.3 million and $35.4 million, respectively, compared to $17.7 million and $33.6 million US Dollars for the same periods in 2021. Research and development expenses for all periods relate primarily to related clinical expenses involving the costs of rezafungin clinical trials and drug manufacturing, as well as clinical expenses related to the Janssen Collaboration Agreement.

  • General and administrative expenses for the three and six months ended June 30, 2022 were $4.1 million and $9.3 million, respectively, compared to $4.4 million and $9.2 million, respectively -dollars in the same period in 2021.

  • Net loss for the three months ended June 30, 2022 was $13.1 million compared to net income of $10.7 million for the same period in 2021. For the six months ended June 30, 2022 and In 2021, the net loss was $31.4 million and $7.6 million, respectively.

  • As of June 30, 2022, Cidara had 69,238,508 common shares outstanding and 1,818,472 Series X convertible preferred shares outstanding, convertible into 18,184,720 common shares.

About Cidara Therapeutics

Cidara is developing long-acting therapeutics that aim to improve the standard of care for patients with serious illnesses. The Company’s portfolio includes new approaches aimed at transforming existing prevention and treatment paradigms, initially with its lead Phase 3 antifungal candidate rezafungin, in addition to DFCs targeting viral and oncological diseases from Cidara’s proprietary Cloudbreak platform. Cidara is headquartered in San Diego, California. Visit www.cidara.com for more information.

Forward-Looking Statements

This press 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 Private Securities Litigation Reform Act of 1995. Words such as “expect,” “will” and similar expressions (and any other words or expressions referring to future events, conditions or circumstances) convey uncertainty as to future events or results and are intended to identify these forward-looking statements. Forward-looking statements describe, among other things, future expectations, plans, results or strategies and in this press release include, among other things, statements regarding whether the FDA will accept the NDA for rezafungin for filing and assign a Prescription Drug User Fees Act (PDUFA) date; whether the NDA for rezafungin will be approved in the expected timeframe or at all; and the likelihood that Melinta will successfully commercialize rezafungin in the United States and achieve milestones that trigger payments under the license agreement. Such statements are subject to a variety of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements. B. unexpected delays or adverse results from Cidara’s pre-clinical or clinical trials, delays in action by regulatory authorities due to restrictions on inspections and other impacts related to COVID-19, impact of the COVID-19 pandemic or other barriers to patient enrollment, or other aspects of CD388 development. These and other risks are discussed under the heading “Risk Factors” in Cidara’s most recent quarterly report on Form 10-Q and other subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date made and are based on assumptions and estimates made by management as of that date. Cidara undertakes no obligation to publicly update any forward-looking statement, whether as a result of receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Richie
LifeSci Advisor
(212) 915-2578
[email protected]

MEDIA CONTACT:
Patrick Bursey
LifeSci Communication
(203) 430-9545
[email protected]

CIDARA THERAPEUTICS, INC.

Condensed Consolidated Income Statement (unaudited)

Three months ended
June 30th

Six months ended
June 30th

(In thousands, except share and per share data)

2022

2021

2022

2021

Revenues:

Income from the collaboration

$

6.216

$

32,863

$

13,325

$

35,271

total revenue

6.216

32,863

13,325

35,271

Operating expenses:

Research and Development

15,255

17,720

35,421

33,569

General and administrative

4,074

4,370

9,278

9.151

business expenses

19,329

22,090

44,699

42,720

Profit (loss) from operations

(13.113

)

10,773

(31.374

)

(7,449

)

Other output:

Interest expense, net

(6

)

(62

)

(26

)

(132

)

Total other expenses, net

(6

)

(62

)

(26

)

(132

)

Net profit (loss) and total result (loss)

(13.119

)

10,711

(31,400

)

(7,581

)

Allocation of Income to Participating Securities

(1,892

)

Net Income (Loss) Attributable to Common Shareholders.

$

(13.119

)

$

8,819

$

(31,400

)

$

(7,581

)

Basic net income (loss) per common share

$

(0.19

)

$

0.18

$

(0.46

)

$

(0.16

)

Diluted net income (loss) per common share

$

(0.19

)

$

0.18

$

(0.46

)

$

(0.16

)

Shares used to calculate basic net income (loss) per common share

69,133,700

48.677.008

68,638,651

47,826,812

Shares used to calculate diluted net income (loss) per common share

69,133,700

59.323.220

68,638,651

47,826,812

Condensed Consolidated Balance Sheet Data

June 30, 2022

December 31, 2021

(in thousands)

(unaudited)

Cash, cash equivalents and restricted cash

$

25.007

$

62,273

total assets

39,524

75,325

Term Loan

370

2,591

Total Liabilities

47,485

53,752

total equity

(7,961

)

21,573

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