OnKure Therapeutics Q3 loss widens to $17.8M
OnKure expects its cash position to provide runway into 2029 while two drug candidates advance toward planned IND submissions.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
OnKure Therapeutics, Inc. reported a third-quarter 2026 net loss of $17.846 million, compared with $14.699 million a year earlier; net loss per share was $0.36, compared with $1.09. Research and development expense was $15.064 million, up from $11.915 million, primarily due to outsourced preclinical work, manufacturing and consulting. General and administrative expense was $4.287 million, compared with $3.586 million, reflecting personnel-related and consulting costs.
As of September 30, 2026, cash, cash equivalents and marketable securities were $163.3 million, which the company expects to provide a cash runway into 2029. OnKure said OKI-355, for vascular anomalies, and OKI-345, for breast cancer, remain on track for planned IND submissions in the first half of 2027. It is initiating PANORAMA, a multiregional observational registry to characterize disease course and treatment patterns among people with vascular anomalies; genotyping will be offered to all participants.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- None.
Negative
- Moderate pointQuarterly net loss was $17.846 million, versus $14.699 million a year earlier.
8-K Event Classification
Key Figures
Key Terms
PI3Kα pan-mutant-selective inhibitor medical
Investigational New Drug (IND) application regulatory
therapeutic index medical
longitudinal observational registry medical
hotspot PI3Kα mutations medical
Earnings Snapshot
Cash, cash equivalents and marketable securities of $163.3 million as of September 30, 2026 are expected to provide cash runway into 2029; IND submissions for OKI-355 and OKI-345 are planned for the first half of 2027.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much cash does OKUR have and how long is its expected runway?
What was OKUR's third-quarter 2026 net loss?
What is the PANORAMA registry?
When does OKUR plan to submit IND applications for OKI-355 and OKI-345?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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.
Item 2.02 Results of Operations and Financial Condition.
On November 4, 2026, OnKure Therapeutics, Inc. issued a press release reporting financial results for the quarter ended September 30, 2026.
The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) of this report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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Press Release titled "OnKure Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Highlights" dated November 4, 2026. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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.
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ONKURE THERAPEUTICS, INC. |
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November 4, 2026 |
By: |
/s/ Jason Leverone |
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Name: Jason Leverone |
EXHIBIT 99.1
OnKure Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Highlights
-- Announces PANORAMA, an OnKure-sponsored, large-scale, multiregional registry designed to characterize the natural disease course and treatment patterns of people living with vascular anomalies
-- Executing IND-enabling activities for next-generation PI3Kα pan-mutant-selective candidates OKI-345 in breast cancer and OKI-355 in vascular anomalies, with IND submissions planned for 1H 2027
BOULDER, CO, November 4, 2026 -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the third quarter ended September 30, 2026, and provided recent business highlights.
“We continue to advance the development of next-generation PI3Kα pan-mutant-selective inhibitors through our pipeline, including OKI-355 in vascular anomalies and OKI-345 in breast cancer. Both of our lead programs remain on track for IND submissions in the first half of 2027,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure.
“People living with vascular anomalies remain underserved, and we believe OnKure has an opportunity to help shape the future of treatment for this community. Mutations in the PIK3CA gene drive a range of vascular malformations, providing a compelling rationale for our development of OKI-355, which is designed to provide broad coverage across these mutations. We are excited to build on that work with the introduction of PANORAMA, a large-scale observational registry designed to generate insights that may inform future research and treatment strategies. Together, these efforts reflect our commitment to addressing both the need for new therapies and the gaps in disease knowledge that can guide their development,” said Samuel Agresta, M.D., Chief Medical Officer of OnKure.
Vascular Anomalies
OnKure continues to advance its development of OKI-355, a next-generation PI3Kα pan-mutant-selective inhibitor candidate announced in March 2026 to lead its development pipeline in vascular anomalies. OKI-355 is designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in vascular anomalies. OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI-355 in the first half of 2027.
Expanding its commitment to the vascular anomalies community, the Company is also initiating PANORAMA, a large-scale, multiregional, longitudinal observational registry of people living with vascular anomalies. The registry will support retrospective and prospective analyses to characterize the natural disease course, treatment patterns, and associations between genetic variants and clinical characteristics. Genotyping will be offered to all participants and may support clinical diagnosis in regions where access to genetic testing is limited.
Breast Cancer
In breast cancer, OnKure continues to advance its development of OKI-345, a next-generation PI3Kα pan-mutant-selective inhibitor candidate selected in March 2026. OKI-345 is designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in breast cancer, both as monotherapy and in combination regimens. OnKure plans to submit an IND application to the FDA for OKI-345 in the first half of 2027.
Financial Results
Cash position: As of September 30, 2026, the Company reported cash, cash equivalents, and marketable securities of $163.3 million, which is expected to provide cash runway into 2029.
Research and development (R&D) expenses: R&D expenses were $15.1 million for the third quarter of 2026, compared to $11.9 million for the third quarter of 2025. The increase was primarily driven by an increase in outsourced preclinical R&D expenses, manufacturing costs and consulting expenses.
General and Administrative (G&A) expenses: G&A expenses were $4.3 million for the third quarter of 2026, compared to $3.6 million for the third quarter of 2025. The increase was primarily driven by increases in personnel-related and consulting costs.
Net loss and net loss per share were $17.8 million, or $0.36 per share, for the third quarter of 2026, compared to $14.7 million, or $1.09 per share, for the third quarter of 2025.
About OnKure Therapeutics
OnKure Therapeutics (Nasdaq: OKUR) is a clinical-stage biopharmaceutical company focused on the discovery and development of best-in-class precision medicines that target biologically validated drivers of vascular anomalies and cancers that are underserved by available therapies. Using a structure and computational chemistry-driven drug design platform, OnKure is committed to improving clinical outcomes for patients by building a pipeline of small molecule drugs designed to selectively target specific mutations thought to be key drivers of vascular anomalies and cancer. OnKure aims to become a leader in targeting PI3Kα and has multiple programs designed to enable best-in-class targeting of this important molecular target.
For more information about OnKure, visit us at www.onkure.com and follow us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, the PANORAMA registry, as well as OnKure’s product candidates and programs, including OKI-355 and OKI-345; OnKure’s ability to discover, develop and advance additional programs; expected milestones and the timing of such milestones, including the
submission of IND applications for OKI-355 and OKI-345; OnKure’s expected cash runway; and statements by OnKure’s President and Chief Executive Officer and Chief Medical Officer. In some cases, you can identify forward-looking statements by terminology such as “believe,” “expect,” “estimate,” “intend,” “may,” “plan,” “potentially,” “will” or the negative of these terms or other similar expressions.
These forward-looking statements are based largely on OnKure’s current expectations and projections about future events and trends that OnKure believes may affect its financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: OnKure’s limited operating history; the significant net losses incurred since inception; the ability to raise additional capital to finance operations; the risk that actual uses of cash and cash equivalents differ from the assumptions underlying OnKure’s expected cash runway; the ability to initiate, enroll and conduct the PANORAMA registry as planned and the risk that data generated by the registry may not yield useful insights or inform OnKure’s development programs; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, OnKure’s product candidates; the outcome of preclinical testing and early clinical trials for OnKure’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; OnKure’s limited resources; the risk of adverse events, toxicities or other undesirable side effects; potential delays or difficulties in the enrollment or maintenance of patients in clinical trials; the decision to develop or seek strategic collaborations to develop OnKure’s current or future product candidates in combination with other therapies and the cost of combination therapies; OnKure’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the substantial competition OnKure faces in discovering, developing, or commercializing products; OnKure’s ability to protect its intellectual property and proprietary technologies; developments relating to OnKure’s competitors and its industry, including competing product candidates and therapies; reliance on third parties, contract manufacturers, and contract research organizations; legislative, regulatory, political and economic developments and general market conditions; and those risks described in the section entitled “Risk Factors” in documents that OnKure files from time to time with the SEC, including its Annual Report on Form 10-K filed with the SEC on March 12, 2026, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 filed with the SEC on November 4, 2026, and any subsequent filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for OnKure’s management to predict all risk factors, nor can OnKure assess the impact of all factors on OnKure’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although OnKure believes that the expectations reflected in the forward-looking statements are reasonable, OnKure cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, OnKure undertakes no obligation to update publicly any forward-looking statements for any reason after the date of this press release.
Contact:
Dan Ferry
LifeSci Advisors
daniel@lifesciadvisors.com
ONKURE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands, unaudited)
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September 30, |
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December 31, |
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Assets |
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Current assets: |
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Cash, cash equivalents and marketable securities |
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$ |
163,305 |
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$ |
59,050 |
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Prepaid expenses and other current assets |
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2,288 |
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1,789 |
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Total current assets |
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165,593 |
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60,839 |
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Property and equipment, net |
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414 |
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618 |
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Operating lease, right-of-use asset |
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661 |
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387 |
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Other assets |
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409 |
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273 |
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Total assets |
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$ |
167,077 |
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$ |
62,117 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable, accrued expenses, and other current liabilities |
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$ |
8,538 |
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$ |
5,372 |
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Operating lease liabilities, current portion |
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251 |
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549 |
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Total current liabilities |
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8,789 |
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5,921 |
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Long-term liabilities |
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551 |
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12 |
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Total liabilities |
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9,340 |
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5,933 |
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Stockholders’ equity |
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157,737 |
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56,184 |
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Total liabilities and stockholders’ equity |
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$ |
167,077 |
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$ |
62,117 |
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ONKURE THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data, unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
$ |
15,064 |
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$ |
11,915 |
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$ |
39,382 |
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$ |
37,540 |
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General and administrative |
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4,287 |
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3,586 |
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12,483 |
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11,285 |
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Total operating expenses |
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19,351 |
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15,501 |
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51,865 |
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48,825 |
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Loss from operations |
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(19,351 |
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(15,501 |
) |
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(51,865 |
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(48,825 |
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Other income: |
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Interest income |
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1,505 |
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804 |
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3,516 |
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2,813 |
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Interest and other expense |
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— |
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(2 |
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— |
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(2 |
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Total other income |
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1,505 |
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802 |
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3,516 |
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2,811 |
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Net loss |
$ |
(17,846 |
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$ |
(14,699 |
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$ |
(48,349 |
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$ |
(46,014 |
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Net loss per share attributable to common stockholders: |
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Basic and diluted |
$ |
(0.36 |
) |
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$ |
(1.09 |
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$ |
(1.27 |
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$ |
(3.41 |
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Weighted average shares outstanding: |
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Basic and diluted |
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49,928,151 |
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13,530,892 |
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37,956,765 |
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13,488,493 |
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