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Reneo Pharmaceuticals Reports Third Quarter 2023 Financial Results

Reneo Pharmaceuticals, Inc.
Reneo Pharmaceuticals, Inc.

Topline data results from the pivotal STRIDE study are expected in December 2023

IRVINE, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.

“We are looking forward to sharing topline results of our pivotal STRIDE study in December,” said Gregory J. Flesher, President and CEO of Reneo Pharmaceuticals. “In addition, we continue to be encouraged by the high participation rate in our STRIDE AHEAD open-label extension study, and are happy to announce enrollment of our first patient with PMM due to nuclear DNA defect in this ongoing trial. This is a very exciting time for the Reneo team and we want to thank our clinicians, patients, and stakeholders for supporting the mavodelpar development program.”

Third Quarter and Recent Highlights

  • Completed last patient last visit in the pivotal STRIDE study in adult patients with primary mitochondrial myopathies (PMM) due to mitochondrial DNA (mtDNA) defects; topline results expected in December 2023

  • Enrolled 88% of eligible STRIDE study patients in the STRIDE AHEAD open-label extension study; 65 patients treated beyond 52-weeks

  • Dosed the first patient with PMM due to a nuclear DNA (nDNA) defect in the STRIDE AHEAD open-label extension study

  • Presented multiple posters at scientific conferences highlighting additional mavodelpar data

  • Received Notice of Allowance from the U.S. Patent and Trademark Office for patent application No. 18/101,527 entitled “Use of PPAR-Delta Agonists in the Treatment of Disease,” with anticipated expiration in 2041

  • Repurchased 576,443 shares of our common stock for an aggregate purchase price of approximately $4.4 million directly from vTv Therapeutics, LLC in a private, non-underwritten transaction on October 30, 2023; all repurchased shares were retired

Financial Results for the Three Months Ended September 30, 2023

We reported a net loss of $19.2 million, or $0.57 per share, during the third quarter of 2023, compared to a net loss of $13.0 million, or $0.53 per share, for the same period in 2022. We had $125.6 million in cash, cash equivalents, and short-term investments as of September 30, 2023.

Research and development (R&D) expenses were $13.6 million during the third quarter of 2023, compared to $9.9 million for the same period in 2022. This increase in R&D expenses was primarily due to an increase of $2.2 million related to clinical development and contract manufacturing costs to support the marketing registration for mavodelpar, an increase of $1.0 million in medical affairs costs, and an increase of $0.9 million in personnel-related costs due to additional headcount, offset by a decrease of $0.5 million of other R&D activities.

General and administrative (G&A) expenses were $7.3 million during the third quarter of 2023, compared to $3.9 million for the same period in 2022. This increase in G&A expenses was primarily due to an increase of $2.1 million in commercial development activities and an increase of $1.2 million in facility and personnel-related costs due to additional headcount.

About STRIDE

The STRIDE study is a global, randomized, double-blind, placebo-controlled pivotal Phase 2b trial of mavodelpar in adult patients with PMM due to mtDNA defects. The study is designed to investigate the efficacy and safety of 100 mg mavodelpar administered once-daily over a 24-week period. The primary efficacy endpoint of the trial is the change from baseline in the distance walked during the 12-minute walk test (12MWT) at week 24. Secondary and exploratory endpoints include changes from baseline in PROMIS® Short Form Fatigue 13a, Modified Fatigue Impact Scale (MFIS), Patient Global Impression of Change (PGIC), Patient Global Impression of Severity (PGIS), 30 Second Sit-To-Stand (30STS) Test, Brief Pain Inventory (BPI), 36-Item Health Survey (SF-36), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Pedometer Step Count.

About STRIDE AHEAD

The STRIDE AHEAD study is an open-label extension (OLE) trial being conducted outside of the United States in patients with PMM due to mtDNA defects who participated in the STRIDE study or the mavodelpar Phase 1b study. The study is designed to evaluate the long-term safety and tolerability of 100 mg mavodelpar administered once-daily over a 24-month period. STRIDE AHEAD was amended to allow enrollment of treatment naïve patients with PMM due to nDNA defects.

About PMM

PMM are a group of rare, genetic metabolic disorders caused by mutations or deletions in the mtDNA or nDNA. These genetic alterations hamper the ability of mitochondria to generate energy from nutrient sources, resulting in energy deficits that are most pronounced in tissues with high energy demand such as muscle, brain, and heart. The symptoms of PMM include muscle weakness, exercise intolerance, movement disorder, deafness, blindness, and droopy eyelids among others. The prognosis for these disorders ranges in severity from progressive weakness to death.

About Mavodelpar

Mavodelpar (REN001) is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in clinical development for two rare genetic mitochondrial diseases that typically present with myopathy and have high unmet medical needs: PMM and long-chain fatty acid oxidation disorder. For additional information, please see clinicaltrials.gov.

About Reneo Pharmaceuticals

Reneo is a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, which are often associated with the inability of mitochondria to produce adenosine triphosphate (ATP). Our lead product candidate, mavodelpar (REN001), is a potent and selective agonist of the peroxisome proliferator-activated receptor delta (PPARδ). Mavodelpar has been shown to increase transcription of genes involved in mitochondrial function, increase fatty acid oxidation, and may increase production of new mitochondria. For additional information, please see reneopharma.com.

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. Such forward-looking statements include statements regarding, among other things, the potential development, registration and commercialization of mavodelpar, the timing of topline results from the STRIDE study and the anticipated expiration for patent applications. 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 “plans,” “will,” “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Reneo’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Reneo’s business in general, and the other risks described in Reneo’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Reneo undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

RENEO PHARMACEUTICALS, INC.
Consolidated Balance Sheets
(In thousands, except share and par value data)

 

 

 

September 30,
2023

 

 

December 31,
2022

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

11,737

 

 

$

19,927

 

Short-term investments

 

 

113,877

 

 

 

81,246

 

Prepaid expenses and other current assets

 

 

3,158

 

 

 

5,180

 

Total current assets

 

 

128,772

 

 

 

106,353

 

Property and equipment, net

 

 

529

 

 

 

453

 

Right-of-use assets

 

 

1,006

 

 

 

1,292

 

Other non-current assets

 

 

81

 

 

 

84

 

Total assets

 

$

130,388

 

 

$

108,182

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,473

 

 

$

1,893

 

Accrued expenses

 

 

10,765

 

 

 

4,827

 

Operating lease liabilities, current portion

 

 

325

 

 

 

404

 

Total current liabilities

 

 

13,563

 

 

 

7,124

 

Operating lease liabilities, less current portion

 

 

812

 

 

 

1,059

 

Performance award

 

 

1,069

 

 

 

29

 

Total liabilities

 

 

15,444

 

 

 

8,212

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 33,872,166 and 24,699,553 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

305,479

 

 

 

236,693

 

Accumulated deficit

 

 

(190,517

)

 

 

(136,683

)

Accumulated other comprehensive loss

 

 

(21

)

 

 

(43

)

Total stockholders’ equity

 

 

114,944

 

 

 

99,970

 

Total liabilities and stockholders’ equity

 

$

130,388

 

 

$

108,182

 


RENEO PHARMACEUTICALS, INC.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,622

 

 

$

9,938

 

 

$

39,009

 

 

$

27,348

 

General and administrative

 

 

7,266

 

 

 

3,902

 

 

 

19,038

 

 

 

11,938

 

Total operating expenses

 

 

20,888

 

 

 

13,840

 

 

 

58,047

 

 

 

39,286

 

Loss from operations

 

 

(20,888

)

 

 

(13,840

)

 

 

(58,047

)

 

 

(39,286

)

Other income

 

 

1,692

 

 

 

833

 

 

 

4,213

 

 

 

931

 

Net loss

 

 

(19,196

)

 

 

(13,007

)

 

 

(53,834

)

 

 

(38,355

)

Unrealized gain (loss) on short-term investments

 

 

10

 

 

 

(194

)

 

 

22

 

 

 

(60

)

Comprehensive loss

 

$

(19,186

)

 

$

(13,201

)

 

$

(53,812

)

 

$

(38,415

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.57

)

 

$

(0.53

)

 

$

(1.81

)

 

$

(1.57

)

Weighted-average shares used in computing net loss per share, basic and diluted

 

 

33,807,945

 

 

 

24,496,313

 

 

 

29,718,689

 

 

 

24,472,974

 


RENEO PHARMACEUTICALS, INC.
Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)

 

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(53,834

)

 

$

(38,355

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation

 

 

3,793

 

 

 

3,103

 

Depreciation and amortization

 

 

126

 

 

 

63

 

Amortization/accretion on short-term investments

 

 

(3,551

)

 

 

(169

)

Changes in the fair value of performance award

 

 

1,040

 

 

 

(378

)

Non-cash lease expense

 

 

354

 

 

 

338

 

Loss on disposal of fixed asset

 

 

5

 

 

 

3

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

2,025

 

 

 

1,146

 

Accounts payable and accrued expenses

 

 

6,507

 

 

 

2,838

 

Operating lease liabilities

 

 

(394

)

 

 

(338

)

Net cash used in operating activities

 

 

(43,929

)

 

 

(31,749

)

Cash flows from investing activities

 

 

 

 

 

 

Purchases of property and equipment

 

 

(196

)

 

 

(96

)

Purchase of available-for-sale short-term investments

 

 

(190,058

)

 

 

(67,329

)

Proceeds from maturities of available-for-sale short-term investments

 

 

161,000

 

 

 

36,500

 

Net cash used in by investing activities

 

 

(29,254

)

 

 

(30,925

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from public offering of common stock, net of offering costs

 

 

58,862

 

 

 

 

Proceeds from private placement of common stock, net of offering costs

 

 

4,667

 

 

 

 

Proceeds from issuance of common stock under the at-the-market facility, net of offering costs

 

 

1,009

 

 

 

 

Proceeds from issuance of common stock in connection with equity plans

 

 

455

 

 

 

146

 

Net cash provided by financing activities

 

 

64,993

 

 

 

146

 

Net decrease in cash and cash equivalents

 

 

(8,190

)

 

 

(62,528

)

Cash and cash equivalents, beginning of period

 

 

19,927

 

 

 

124,660

 

Cash and cash equivalents, end of period

 

$

11,737

 

 

$

62,132

 

Noncash operating activities:

 

 

 

 

 

 

Right-of-use assets obtained in exchange for lease obligations

 

$

 

 

$

1,524

 

Noncash investing and financing activities:

 

 

 

 

 

 

Property and equipment in accounts payable

 

$

11

 

 

$

 

 

 

 

 

 

 

 

 

 

Contacts:

Danielle Spangler
Investor Relations
Reneo Pharmaceuticals, Inc.
dspangler@reneopharma.com

Matthew Purcell
Media Inquiries
Russo Partners, LLC
matthew.purcell@russopartnersllc.com


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