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Reneo Pharmaceuticals, Inc. (RPHM)

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12.00+1.29 (+12.04%)
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Previous Close10.71
Open10.63
Bid11.99 x 1300
Ask16.00 x 900
Day's Range10.63 - 12.14
52 Week Range7.63 - 17.18
Volume62,745
Avg. Volume125,543
Market Cap291.436M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
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  • Reneo Pharmaceuticals Reports First Quarter 2021 Financial Results
    GlobeNewswire

    Reneo Pharmaceuticals Reports First Quarter 2021 Financial Results

    SAN DIEGO, May 20, 2021 (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 quarter ended March 31, 2021 and provided an update on its clinical programs. Key Operational Highlights Initiated the STRIDE study, a global, randomized, double-blind, placebo-controlled Phase 2b clinical trial of REN001 in patients with primary mitochondrial myopathies (PMM)Completed an initial public offering (IPO) of the company’s common stock for total gross proceeds of approximately $94 million, before deducting underwriting discounts and commissions and offering expensesRe-initiated enrollment of two open-label Phase 1b clinical trials in patients with long-chain fatty acid oxidation disorder (LC-FAOD) and in patients with glycogen storage disease type V (McArdle disease)Initiated an observational clinical trial in patients with LC-FAOD to better understand changes in disease characteristics over time (“FORWARD” study)Appointed Eric Dube, Ph.D. to the Board of Directors and Vineet R. Jindal as Chief Financial Officer Anticipated Upcoming Milestones Enrollment of first patient in the STRIDE study (mid-year 2021)Complete enrollment of Phase 1b trials in LC-FAOD and McArdle disease (2H 2021)Report results from Phase 1b clinical trials in LC-FAOD and McArdle disease (1H 2022)Report results from the FORWARD study (2H 2022) “Our team’s recent efforts have led to the initiation of four clinical trials, key additions to the Board and management team, and the completion of our initial public offering,” said Gregory J. Flesher, President and Chief Executive Officer of Reneo. “With a strengthened capital position, we will continue to advance all of our REN001 clinical programs, as well as explore additional opportunities that will help establish Reneo Pharmaceuticals as a leading developer of drugs for rare diseases.” Financial Results for the Three Months Ended March 31, 2021 The company reported a net loss of $7.2 million, or $3.48 per share, for the three months ended March 31, 2021, compared to a net loss of $4.4 million, or $2.20 per share, for the same period in 2020. The company had $91.2 million in cash and cash equivalents as of March 31, 2021, exclusive of the net proceeds of approximately $84.8 million from the IPO. Research and development (R&D) expenses were $5.5 million for the three months ended March 31, 2021, compared to $3.6 million for the same period in 2020. The increase of $1.9 million was primarily due to an increase of $1.5 million related to clinical trial costs associated with the launch of our STRIDE and FORWARD studies and $0.4 million in employee and personnel related costs due to additional headcount required to support our clinical and CMC programs. General and administrative (G&A) expenses for the three months ended March 31, 2021 were $1.7 million, compared to $0.9 million for the same period in 2020. This increase of $0.8 million was primarily attributable to an increase of $0.8 million in employee and personnel related expenses. About Reneo PharmaceuticalsReneo 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). Reneo is developing REN001 to modulate genes critical to metabolism and generation of ATP, which is the primary source of energy for cellular processes. 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. About REN001REN001 is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in clinical development for three rare genetic mitochondrial diseases that typically present with myopathy and have high unmet medical needs: primary mitochondrial myopathies (PMM), long-chain fatty acid oxidation disorders (LC-FAOD), and glycogen storage disorder type V (McArdle disease). For more information on REN001 clinical trials, please see clinicaltrials.gov. About PMMPMM are a group of disorders that affect roughly 1 in 5,000 people worldwide. PMM are caused by genetic mutations in the mitochondrial or nuclear DNA that reduce the ability of mitochondria to produce energy from nutrient sources. This energy deficit particularly affects tissues and organs 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 STRIDESTRIDE is a global, randomized, double-blind, placebo-controlled Phase 2b clinical trial designed to assess the efficacy and safety of 100 mg REN001 administered orally once daily to patients with PMM. Approximately 200 adult PMM patients with alterations in mitochondrial DNA and a history of myopathy are expected to be enrolled into STRIDE. The primary efficacy endpoint of the trial is the change from baseline in the distance walked during a 12-minute walk test after 24 weeks of treatment. Secondary efficacy endpoints include changes from baseline in the Modified Fatigue Impact Scale (MFIS), Patient Global Impression of Change scale (PGIC), and other patient-reported outcomes. Forward-Looking StatementsStatements 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 results, conduct, progress and timing of Reneo’s clinical trials, and the regulatory approval path for REN001. 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.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)(in thousands, except share and par value data) MARCH 31, DECEMBER 31, 2021 2020 Assets Current assets: Cash and cash equivalents $91,221 $53,613 Prepaid expenses and other current assets 2,339 1,412 Total current assets 93,560 55,025 Property and equipment, net 81 69 Other non-current assets 1,680 127 Total assets $95,321 $55,221 Liabilities, convertible preferred stock and stockholders’ deficit Current liabilities: Accounts payable $556 $908 Accrued expenses 3,374 3,672 Total current liabilities 3,930 4,580 Deferred rent 32 36 Total liabilities 3,962 4,616 Commitments and contingencies (Note 10) Series A convertible preferred stock, $0.0001 par value; 24,302,472 shares authorized at March 31, 2021 and December 31, 2020; 24,302,472 shares issued and outstanding at March 31, 2021 and December 31, 2020, liquidation preference of $49,127 at March 31, 2021 and December 31, 2020 45,652 45,652 Series B convertible preferred stock, $0.0001 par value; 46,881,028 shares authorized at March 31, 2021 and December 31, 2020; 46,881,028 and 23,440,514 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively; liquidation preference of $94,770 and $47,385 as of March 31, 2021 and December 31, 2020, respectively 94,424 47,068 Stockholders’ deficit: Common stock, $0.0001 par value; 105,000,000 shares authorized at March 31, 2021 and December 31, 2020, 2,148,193 issued and 2,123,733 outstanding at March 31, 2021 and 2,053,070 shares issued and outstanding at December 31, 2020, respectively — — Additional paid-in capital 3,453 2,843 Accumulated deficit (52,170) (44,958) Total stockholders’ deficit (48,717) (42,115) Total liabilities, convertible preferred stock and stockholders’ deficit $95,321 $55,221 RENEO PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(in thousands, except share and per share data) THREE MONTHS ENDED MARCH 31, 2021 2020 Operating expenses: Research and development $5,472 $3,578 General and administrative 1,742 924 Total operating expenses 7,214 4,502 Loss from operations (7,214) (4,502) Other income 2 71 Net loss (7,212) (4,431) Unrealized gain on short-term investments — 6 Comprehensive loss $(7,212) $(4,425) Net loss per share attributable to common stockholders, basic and diluted $(3.48) $(2.20) Weighted-average shares used in computing net loss per share, basic and diluted 2,070,935 2,015,029 RENEO PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited)(in thousands) THREE MONTHS ENDED MARCH 31, 2021 2020 Cash flows from operating activities Net loss $(7,212) $(4,431) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 10 9 Amortization/accretion on short-term investments — (15) Stock-based compensation 471 92 Changes in operating assets and liabilities: Accounts payable, accrued expenses and other (927) 36 Prepaid expenses and other assets (929) (137) Deferred rent (2) (1) Net cash used in operating activities (8,589) (4,447) Cash flows from investing activities Purchase of property and equipment (25) (1) Proceeds from maturities of available-for-sale short-term investments — 5,200 Net cash (used in) provided by investing activities (25) 5,199 Cash flows from financing activities Proceeds from issuance of Series B convertible preferred stock, net of issuance costs 47,258 — Proceeds from exercise of stock options 187 26 Costs paid in connection with initial public offering (1,223) — Net cash provided by financing activities 46,222 26 Net increase in cash and cash equivalents 37,608 778 Cash and cash equivalents, beginning of period 53,613 17,501 Cash and cash equivalents, end of year of period $91,221 $18,279 Supplemental cash flow information: Property and equipment in accounts payable $2 $— Unpaid Series B convertible preferred stock issuance costs $19 $— Costs incurred in connection with initial public offering included in accrued expenses $361 $— Contacts: Joyce AllaireManaging DirectorLifeSci Advisors, LLCjallaire@lifesciadvisors.com Vinny JindalChief Financial OfficerReneo Pharmaceuticals, Inc.vjindal@reneopharma.com

  • GlobeNewswire

    Reneo Pharmaceuticals to Present at the Jefferies Virtual Healthcare Conference

    SAN DIEGO, May 19, 2021 (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 announced that it will present and participate in one-on-one investor meetings at the upcoming Jefferies Virtual Healthcare Conference taking place June 1-4, 2021. Presentation details can be found below. Date:Tuesday, June 1, 2021Time:1:00 PM ETPresentation Format:Fireside chat 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). Reneo is developing REN001 to modulate genes critical to metabolism and generation of ATP, which is the primary source of energy for cellular processes. 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. Contacts: Joyce AllaireManaging DirectorLifeSci Advisors, LLCjallaire@lifesciadvisors.com Vinny JindalChief Financial OfficerReneo Pharmaceuticals, Inc.investors@reneopharma.com

  • Reneo Pharmaceuticals Announces Pricing of Initial Public Offering
    GlobeNewswire

    Reneo Pharmaceuticals Announces Pricing of Initial Public Offering

    SAN DIEGO, April 08, 2021 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare, genetic, mitochondrial diseases, today announced the pricing of its initial public offering of 6,250,000 shares of its common stock at a public offering price of $15.00 per share, for total gross proceeds of approximately $93.8 million, before deducting underwriting discounts and commissions and offering expenses. All of the shares are being offered by Reneo. The shares are expected to begin trading on the Nasdaq Global Market on April 9, 2021 under the symbol “RPHM.” In addition, Reneo has granted the underwriters a 30-day option to purchase up to an additional 937,500 shares of common stock at the public offering price less underwriting discounts and commissions. The offering is expected to close on April 13, 2021, subject to satisfaction of customary closing conditions. Jefferies, SVB Leerink and Piper Sandler are acting as joint book-running managers for the offering. A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on April 8, 2021. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at prospectus_department@jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6105 or by e-mail at syndicate@svbleerink.com; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by e-mail at prospectus@psc.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Reneo PharmaceuticalsReneo 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). Reneo is developing REN001 to modulate genes critical to metabolism and generation of ATP, which is the primary source of energy for cellular processes. 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. Contacts: Joyce AllaireManaging DirectorLifeSci Advisors, LLCjallaire@lifesciadvisors.com Vinny JindalChief Financial OfficerReneo Pharmaceuticals, Inc.investors@reneopharma.com