“The second quarter was a very productive period for the company, highlighted by advancements in both of our mitochondrial disease programs,” said
Second Quarter and Recent Highlights
- Published REN001 Phase 1 leg-immobilization study in the
Journal of Clinical Trials (Link) - Reported positive results from REN001 Phase 1b long-chain fatty acid oxidation disorders (LC-FAOD) study
- Announced plans to initiate a third REN001 program in primary mitochondrial myopathies (PMM) patients with nuclear DNA (nDNA) defects
- Appointed
Roshawn Blunt to the Board of Directors
Anticipated Milestones
- Presentation of LC-FAOD studies at the
International Network for Fatty Acid Oxidation Research and Management (INFORM) Conference ,Aug 28-29 (Freiburg, Germany ) - Completion of enrollment in the pivotal STRIDE study, year-end 2022
- Meetings with regulatory agencies to discuss LC-FAOD and nDNA PMM programs, 4Q22/1Q23
Financial Results for the Three Months Ended
The Company reported a net loss of
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Corporate Access Events
Baird Global Healthcare Conference ,Sep 13-14 (New York )- Landenburg Thalmann Annual Healthcare Conference,
Sep 29 (New York ) - Piper Sandler Annual Healthcare Conference,
Nov 29 –Dec 1 (New York )
About
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, REN001, is a potent and selective agonist of the peroxisome proliferator-activated receptor delta (PPARδ). REN001 has been shown to increase transcription of genes involved in mitochondrial function and increase fatty acid oxidation, and may increase production of new mitochondria. For additional information, please see reneopharma.com.
About REN001
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 LC-FAOD. For additional information, please see clinicaltrials.gov.
About PMM
PMM are a group of disorders caused by genetic mutations within the mitochondrial DNA or nDNA that affect the activity of enzymes or other proteins in the mitochondria. In PMM 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 or 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 LC-FAOD
LC-FAOD are a group of rare genetic metabolic disorders caused by mutations or deletions in the nDNA. These genetic alterations prevent the body from breaking down long-chain fatty acids during metabolism. The most severe cases of LC-FAOD are diagnosed within the first few days or weeks of life. Young patients often present with a severe energy deficit that results in lethargy, liver dysfunction, hypoglycemia, encephalopathy, and high risk for sudden death. Older patients usually present with muscle weakness, exercise intolerance, muscle aches, or rhabdomyolysis which can damage the heart and kidneys and cause permanent disability or even death.
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 and commercialization of REN001, results, conduct, progress, plans and timing of Reneo’s clinical studies, including the planned registration plan in
Consolidated Balance Sheets
(In thousands, except share and par value data)
2022 | 2021 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 118,264 | $ | 124,660 | ||||
Short-term investments | 8,588 | 23,010 | ||||||
Prepaid expenses and other current assets | 5,159 | 6,064 | ||||||
Total current assets | 132,011 | 153,734 | ||||||
Property and equipment, net | 236 | 212 | ||||||
Right-of-use assets | 1,283 | — | ||||||
Other non-current assets | 78 | 78 | ||||||
Total assets | $ | 133,608 | $ | 154,024 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,560 | $ | 2,022 | ||||
Accrued expenses | 6,367 | 4,180 | ||||||
Operating lease liabilities, current portion | 408 | — | ||||||
Total current liabilities | 8,335 | 6,202 | ||||||
Operating lease liabilities, less current portion | 1,061 | — | ||||||
Other long-term liabilities | — | 167 | ||||||
Performance award | 55 | 444 | ||||||
Total liabilities | 9,451 | 6,813 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock, 24,457,838 and 24,455,390 shares issued and outstanding at | 3 | 3 | ||||||
Additional paid-in capital | 234,062 | 231,902 | ||||||
Accumulated deficit | (110,076 | ) | (84,728 | ) | ||||
Accumulated other comprehensive income | 168 | 34 | ||||||
Total stockholders’ equity | 124,157 | 147,211 | ||||||
Total liabilities and stockholders’ equity | $ | 133,608 | $ | 154,024 | ||||
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 8,132 | $ | 6,279 | $ | 17,410 | $ | 11,751 | ||||||||
General and administrative | 4,299 | 2,949 | 8,036 | 4,691 | ||||||||||||
Total operating expenses | 12,431 | 9,228 | 25,446 | 16,442 | ||||||||||||
Loss from operations | (12,431 | ) | (9,228 | ) | (25,446 | ) | (16,442 | ) | ||||||||
Other income | 119 | 12 | 98 | 14 | ||||||||||||
Net loss | (12,312 | ) | (9,216 | ) | (25,348 | ) | (16,428 | ) | ||||||||
Unrealized gain on short-term investments | 104 | 5 | 134 | 5 | ||||||||||||
Comprehensive loss | $ | (12,208 | ) | $ | (9,211 | ) | $ | (25,214 | ) | $ | (16,423 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.50 | ) | $ | (0.43 | ) | $ | (1.04 | ) | $ | (1.40 | ) | ||||
Weighted-average shares used in computing net loss per share, basic and diluted | 24,463,824 | 21,364,369 | 24,461,085 | 11,770,948 | ||||||||||||
Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Six Months Ended | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (25,348 | ) | $ | (16,428 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 2,113 | 1,325 | ||||||
Depreciation and amortization | 41 | 20 | ||||||
Amortization/accretion on short-term investments | (22 | ) | 33 | |||||
Changes in the fair value of performance award | (389 | ) | 363 | |||||
Non-cash lease expense | 241 | — | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | 905 | (2,457 | ) | |||||
Accounts payable and accrued expenses | 1,726 | (1,164 | ) | |||||
Operating lease liabilities | (222 | ) | — | |||||
Other current and long-term liabilities | — | 18 | ||||||
Net cash used in operating activities | (20,955 | ) | (18,290 | ) | ||||
Cash flows from investing activities | ||||||||
Purchases of property and equipment | (68 | ) | (31 | ) | ||||
Purchase of available-for-sale short-term investments | (15,922 | ) | (26,989 | ) | ||||
Proceeds from maturities of available-for-sale short-term investments | 30,500 | — | ||||||
Net cash provided by (used in) investing activities | 14,510 | (27,020 | ) | |||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of Series B convertible preferred stock, net of issuance costs | — | 47,239 | ||||||
Proceeds from initial public offering, net of offering costs | — | 84,639 | ||||||
Proceeds from issuance of common stock in connection with equity plans | 49 | 187 | ||||||
Net cash provided by financing activities | 49 | 132,065 | ||||||
Net (decrease) increase in cash and cash equivalents | (6,396 | ) | 86,755 | |||||
Cash and cash equivalents, beginning of period | 124,660 | 53,613 | ||||||
Cash and cash equivalents, end of period | $ | 118,264 | $ | 140,368 | ||||
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 | $ | — | $ | 10 | ||||
Accrued deferred initial public offering costs | $ | — | $ | 30 | ||||
Contacts:
Managing Director
jallaire@lifesciadvisors.com
Investor Relations
dspangler@reneopharma.com
Source:
2022 GlobeNewswire, Inc., source