Form 8-K - Current report

false 0001505512 0001505512 2024-08-08 2024-08-08

 

 

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): August 8, 2024

 

 

Regulus Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		001-35670		26-4738379
(State of incorporation)		(Commission File No.)		(IRS Employer Identification No.)

 

4224 Campus Point Court, Suite 210 San Diego, CA		92121
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: [phone]

(Former name or former address, if changed since last report.)

 

 

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 (see General Instruction A.2. below):

 

☐	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 Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		RGLS		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. ☐

 

 

 

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Item 2.02

Results of Operations and Financial Condition.

On August 8, 2024, we issued a press release announcing our financial results for the second quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1. The information in this Item 2.02 and the attached Exhibit 99.1 are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 2.02 and the attached exhibit shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press release issued by Regulus Therapeutics Inc. on August 8, 2024 relating to financial results
104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

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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.

 

				Regulus Therapeutics Inc.
Date: August 8, 2024				By:		/s/ Joseph Hagan
						Joseph Hagan
						Chief Executive Officer

Exhibit 99.1

 

Regulus Therapeutics Reports Second Quarter 2024 Financial Results and Recent Updates

Announced positive topline data from the third cohort of patients in the Phase 1b MAD study of RGLS8429 in autosomal dominant polycystic kidney disease (ADPKD)

On track for an End-Of-Phase 1 meeting by year-end

Appointed Rekha Garg, M.D., M.S., to Chief Medical Officer

Ended second quarter 2024 with cash, cash equivalents, and investments of $95.9 million;

Cash runway into H1 2026

SAN DIEGO, August 8, 2024 – Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the “Company” or “Regulus”), today reported financial results for the second quarter ended June 30, 2024, and provided a corporate update.

“We were very pleased with the data we shared in the second quarter from our ongoing Phase 1b MAD study. Data from cohort three showed continued improvement on both polycystin and height adjusted total kidney volume (htTKV) after just three months of treatment, consistent with what was observed in cohort 2 but with greater mechanistic activity in polycystin changes and more patients showing reductions in kidney volume,” said Jay Hagan, CEO of Regulus. “This growing data set leaves us excited about the potential of RGLS8429 as a treatment for those living with ADPKD, a disease with high unmet need and limited treatment options. We remain on track to meet with FDA near the end of this year.”

Program Updates

RGLS8429 for ADPKD: In May 2024, the Company announced that it has advanced to the fourth cohort of patients in the Phase 1b MAD study of RGLS8429 in ADPKD. Patients in the fourth cohort are currently being enrolled and treated with an open label fixed dose of 300 mg of RGLS8429 every other week for three months. Enrollment in the fourth cohort is going well and we plan to provide topline data in early 2025 on a substantial number of subjects who will have completed the study.

In June 2024, the Company announced positive topline data from the third cohort of patients in Phase 1b MAD study of RGLS8429 in ADPKD. In the third cohort, 16 subjects were randomized 3:1 to receive either 3 mg/kg of RGLS8429 or placebo every other week for three months. RGLS8429 was well tolerated with no safety concerns. Results showed continued evidence of a mechanistic dose response based on urinary PC1 and PC2, with an increased dose response across patients compared to earlier cohorts. Further, a statistically significant percent change from baseline in PC1 and PC2 at 3 mg/kg compared to placebo was observed. The Company also conducted exploratory MRI imaging analysis which showed that 70% of patients showed reductions in height adjusted total kidney volume following completion of the 3 mg/kg dose level. Additionally, exploratory analyses showed correlations between increases in PC1, PC2 and reductions in htTKV. In July 2024, the Company presented additional analyses from the three completed cohorts, showing that RGLS8429 does not adversely impact kidney function as measured by blood urea nitrogen, kidney injury molecule and estimated glomerular filtration rate. Regulus plans to request an end of Phase 1 meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2024 and discuss the potential for a pivotal Phase 2/3 study of RGLS8429 under an Accelerated Approval regulatory pathway.

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Corporate Highlights

Strengthened executive leadership team through the promotion of Rekha Garg, M.D., M.S., to Chief Medical Officer. Dr. Garg has had extensive experience across multiple therapeutic areas including kidney disease at several companies including Sanifit Therapeutics, Infinity Pharmaceuticals, Amgen, and Eli Lilly.

Announced the addition of Regulus to the Russell 3000^® and Russell 2000^® Indexes. Membership in the US all-cap Russell 3000^® Index remains in place for one year and means automatic inclusion in the large-cap Russell 1000^® Index or small-cap Russell 2000^® Index, as well as the appropriate Growth and Value Style indexes.

Financial Results

Cash Position: As of June 30, 2024, the Company had $95.9 million in cash, cash equivalents, and investments. The Company expects its cash runway to extend into H1 2026.

Research and Development (R&D) Expenses: Research and development expenses were $8.3 million and $14.3 million for the three and six months ended June 30, 2024, respectively, compared to $5.0 million and $9.9 million for the same period in 2023, respectively. These amounts reflect internal and external costs associated with advancing our clinical and preclinical pipeline.

General and Administrative (G&A) Expenses: General and administrative expenses were $4.0 million and $6.7 million for the three and six months ended June 30, 2024, respectively, compared to $2.3 million and $4.8 million for the same periods in 2023, respectively. These amounts reflect personnel-related and ongoing general business operating costs.

Net Loss: Net loss was $11.0 million, or $0.17 per share (basic and diluted), and $19.5 million, or $0.41 per share (basic and diluted), for the three and six months ended June 30, 2024, compared to $7.0 million, or $0.37 per share (basic and diluted), and $14.2 million, or $0.79 per share (basic and diluted), for the same period in 2023.

About ADPKD

Autosomal dominant polycystic kidney disease (ADPKD), caused by mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60. Approximately 160,000 individuals are diagnosed with the disease in the United States alone, with an estimated global prevalence of 4 to 7 million.

About RGLS8429

RGLS8429 is a novel, next generation oligonucleotide for the treatment of ADPKD designed to inhibit miR-17 and to preferentially target the kidney. Administration of RGLS8429 has shown clear improvements in kidney function, size, and other measures of disease severity in preclinical models. Regulus announced completion of the Phase 1 SAD study in September 2022. The Phase 1 SAD study demonstrated that RGLS8429 has a favorable safety and PK profile. RGLS8429 was well-tolerated with no serious adverse events reported and plasma exposure was approximately linear across the four doses tested.

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In the Phase 1b MAD study Regulus announced topline data from the first cohort of patients in September 2023, from the second cohort of patients in March 2024 and from the third cohort of patients in June 2024. Regulus initiated enrollment in the fourth cohort of patients in May 2024. Patients in the fourth cohort will receive an open label, 300 mg fixed dose of RGLS8429 administered every other week for three months. Initial topline data from the fourth cohort are expected in early 2025.

About Regulus

Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field. Regulus maintains its corporate headquarters in San Diego, CA.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the Company’s RGLS8429 program and preclinical pipeline, the potential that RGLS8429 may be eligible for an Accelerated Approval pathway, potentially achieving therapeutic efficacy and clinical translation for patients, the expected timing for reporting interim or topline data, and the timing and future occurrence of other preclinical and clinical activities. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that the approach we are taking to discover and develop drugs is novel and may never lead to marketable products, that preliminary or topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and may not be indicative of future results, the FDA has not designated RGLS8429 for an Accelerated Approval pathway and such designation may not lead to a faster development, regulatory review or approval process and does not increase the likelihood that RGLS8429 will receive marketing approval, the risk that preclinical and clinical studies may not be successful, risks related to regulatory review and approval, risks related to our reliance on third-party collaborators and other third parties, risks related to intellectual property, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, the risk that additional toxicology data may be negative, and risks related to our ability to successfully secure and deploy capital. These and other risks are described in additional detail in Regulus’ filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of Regulus’ quarterly report on Form 10-Q available on the Company’s website or at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations Contact:

Cris Calsada

Chief Financial Officer

858-202-6376

[e-mail]

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Media Contact:

Sarah Sutton

Argot Partners

212-600-1902

[e-mail]

 

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Regulus Therapeutics Inc.

Selected Financial Information

Condensed Statement of Operations

(In thousands, except share and per share data)

 

		Three months ended June 30,								Six months ended June 30,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	8,309			$	4,976			$	14,349			$	9,901
General and administrative			3,951				2,339				6,736				4,783
Total operating expenses			12,260				7,315				21,085				14,684
Loss from operations			(12,260	)			(7,315	)			(21,085	)			(14,684	)
Other income, net			1,225				303				1,581				533
Loss before income taxes			(11,035	)			(7,012	)			(19,504	)			(14,151	)
Income tax expense			(1	)			(1	)			(1	)			(1	)
Net loss		$	(11,036	)		$	(7,013	)		$	(19,505	)		$	(14,152	)
Other comprehensive loss:
Unrealized loss on investments, net			(42	)			—				(87	)			—
Comprehensive loss		$	(11,078	)		$	(7,013	)		$	(19,592	)		$	(14,152	)
Net loss per share, basic and diluted		$	(0.17	)		$	(0.37	)		$	(0.41	)		$	(0.79	)
Weighted average shares used to compute basic and diluted net loss per share:			64,465,185				19,101,969				47,105,993				17,979,343

 

		June 30, 2024				December 31, 2023
Cash, cash equivalents and investments		$	95,929			$	23,767
Total assets			104,119				30,750
Term loan, less debt issuance costs			—				1,334
Stockholders’ equity			98,181				21,187

Document and Entity Information	Aug. 08, 2024
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001505512
Document Type	8-K
Document Period End Date	Aug. 08, 2024
Entity Registrant Name	Regulus Therapeutics Inc.
Entity Incorporation State Country Code	DE
Entity File Number	001-35670
Entity Tax Identification Number	26-4738379
Entity Address, Address Line One	4224 Campus Point Court
Entity Address, Address Line Two	Suite 210
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92121
City Area Code	(858)
Local Phone Number	202-6300
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, par value $0.001 per share
Trading Symbol	RGLS
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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