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): November 13, 2020
PMV Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-39539 |
46-3218129 |
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(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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Clarke Drive, Suite 3, Cranbury, NJ |
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08512 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (609) 642-6670
Not Applicable
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, $0.00001 par value per share |
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PMVP |
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The Nasdaq Global Select Market |
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 13, 2020, PMV Pharmaceuticals, Inc. announced its financial results for the third quarter ended September 30, 2020. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “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 expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
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Exhibit Number |
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Description |
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99.1 |
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PMV Pharmaceuticals Reports Third Quarter 2020 Financial Results and Corporate Highlights |
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1
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 thereunto duly authorized.
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PMV Pharmaceuticals, Inc. |
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Date: November 13, 2020 |
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By: |
/s/ Winston Kung |
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Winston Kung |
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Chief Operating Officer, and Chief Financial Officer (Principal Financial Officer) |
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Exhibit 99.1
PMV Pharmaceuticals Reports Third Quarter 2020 Financial Results and Corporate Highlights
November 13, 2020
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U.S. Food and Drug Administration (FDA) clearance of PMV Pharmaceutical’s investigational new drug application for its lead product candidate PC14586 |
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PMV Pharma lead product candidate PC14586 granted Fast Track designation by the FDA |
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Expanded Board of Directors with appointment of Rich Heyman, Ph.D., and Laurie Stelzer |
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Successful completion of initial public offering, raising approximately $243.5 million. |
CRANBURY, NJ, November 13, 2020 (GLOBE NEWSWIRE) – PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today reported financial results for the third quarter ended September 30, 2020, and provided corporate highlights.
“PMV Pharma has achieved important scientific, clinical, and operational milestones over the past quarter,” said David Mack, Ph.D., President and Chief Executive Officer. “The Investigational New Drug (IND) application for our lead product candidate PC14586 was cleared by the U.S. FDA in September. We believe the capital raised to date will enable us to execute on the clinical development of PC14586, while also continuing to invest in our discovery pipeline of small molecule, tumor-agnostic precision medicine products.”
Corporate Highlights
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Received IND clearance from the FDA to initiate a Phase 1/2 study of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. The Phase 1/2 study will enroll patients with a p53 Y220C mutation as determined by next generation sequencing. Phase 1 will evaluate escalating doses of PC14586 to determine the recommended Phase 2 dose and to assess safety, pharmacokinetics, and preliminary anti-tumor activity. Phase 2 will determine the overall response rate and duration of response. For more information, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750). |
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In October, the U.S. FDA granted PMV Pharma Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. |
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Advanced its R273H program, targeting a second p53 hot spot mutant, toward lead optimization, and progressed the Company’s pipeline derived from its proprietary discovery platform. |
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Raised $70.0 million in a Series D financing round in July 2020 with Avoro Capital, RA Capital Management, and Wellington Management Company joining existing investors OrbiMed Advisors, Nextech Invest, Viking Global Investors, and Boxer Capital of Tavistock Group. |
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Successfully completed an IPO at a public offering price of $18 per share, with gross proceeds totaling approximately $243.5 million. |
Third Quarter 2020 Financial Highlights
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PMV Pharma ended the third quarter with $373.1 million in cash, cash equivalents, and marketable securities compared to $101.5 million as of December 31, 2019. Net cash provided by financing activities for the nine months ended September 30, 2020 was $294.3 million compared to $0.1 million for the nine months ended September 30, 2019. Net cash used in operations was $22.4 million for the nine months ended September 30, 2020 compared to $17.0 million for the nine months ended September 30, 2019. |
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Net loss for the quarter ended September 30, 2020 was $8.8 million compared to $6.2 million for the quarter ended September 30, 2019. |
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Research and development (R&D) expenses were $6.0 million for the quarter ended September 30, 2020 compared to $4.9 million for the quarter ended September 30, 2019. The increase in R&D expenses was primarily related to increase in personnel, preclinical development, and IND filing of PC14586. |
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General and administrative (G&A) expenses were $2.7 million for the quarter ended September 30, 2020, compared to $1.5 million for the quarter ended September 30, 2019. The increase in G&A expenses was primarily due to an increase in personnel and other corporate costs related to building out infrastructure for growth. |
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants. p53 mutations are found in approximately half of all cancers. The field of p53 biology was established by our co-founder Dr. Arnold Levine when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma is headquartered in Cranbury, New Jersey. For more information, please visit www.pmvpharma.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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s future plans or expectations for PC14586, including expectations regarding the success of its current clinical trial for PC14586; the future plans or expectations for the Company’s discovery platform, including the advancement of our R273H program to lead optimization; and the period over which the Company estimates its existing cash and cash equivalents will be sufficient to fund its current operating plan. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company’s product candidate development activities and planned clinical trials, the Company’s ability to execute on its strategy, regulatory developments in the United States and operate as an early clinical stage company, the potential for clinical trials of PC14586 or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, the Company’s ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company’s clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 13, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
PMV Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
(Unaudited)
(in thousands)
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September 30, 2020 (unaudited) |
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December 31, 2019 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
373,150 |
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$ |
73,278 |
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Short-term marketable securities |
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— |
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28,208 |
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Prepaid expenses and other current assets |
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522 |
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607 |
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Total current assets |
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373,672 |
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102,093 |
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Property and equipment, net |
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573 |
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739 |
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Other assets |
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201 |
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201 |
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Total assets |
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$ |
374,446 |
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$ |
103,033 |
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Liabilities, Convertible Preferred Stock, and Stockholders’ Equity (Deficit) |
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Current liabilities |
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Accounts payable |
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$ |
548 |
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$ |
2,837 |
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Accrued expenses |
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4,928 |
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1,686 |
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Total current liabilities |
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5,476 |
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4,523 |
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Other liabilities |
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— |
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51 |
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Total liabilities |
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5,476 |
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4,574 |
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Convertible preferred stock |
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— |
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168,933 |
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Stockholders’ equity (deficit): |
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Preferred stock |
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— |
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— |
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Common stock |
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— |
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— |
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Additional paid-in capital |
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468,396 |
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4,969 |
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Accumulated deficit |
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(99,426 |
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(75,440 |
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Accumulated other comprehensive loss |
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— |
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(3 |
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Total stockholders’ equity (deficit) |
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368,970 |
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(70,474 |
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Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) |
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$ |
374,446 |
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$ |
103,033 |
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PMV Pharmaceuticals, Inc.
Condensed Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2020 |
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2019 |
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2020 |
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2019 |
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Operating Expenses: |
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Research and development |
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$ |
5,992 |
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$ |
4,895 |
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$ |
17,752 |
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$ |
15,060 |
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General and administrative |
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2,709 |
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1,545 |
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6,689 |
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4,222 |
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Total operating expenses |
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8,701 |
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6,440 |
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24,441 |
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19,282 |
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Loss from operations |
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(8,701 |
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(6,440 |
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(24,441 |
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(19,282 |
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Other (expense) income |
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Interest income, net |
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40 |
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272 |
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603 |
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985 |
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Other expense: |
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(100 |
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— |
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(143 |
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— |
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Total other (expense) income |
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(60 |
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272 |
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460 |
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985 |
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Loss before provision for income taxes |
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(8,761 |
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(6,168 |
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(23,981 |
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(18,297 |
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Provision for income taxes |
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3 |
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7 |
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5 |
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8 |
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Net loss |
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(8,764 |
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(6,175 |
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(23,986 |
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(18,305 |
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Unrealized (loss) gains on marketable securities, net of tax |
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(5 |
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(2 |
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3 |
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14 |
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Comprehensive loss |
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$ |
(8,769 |
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$ |
(6,177 |
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$ |
(23,983 |
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$ |
(18,291 |
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Net loss per share -- basic and diluted |
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$ |
(1.46 |
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$ |
(2.03 |
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$ |
(5.93 |
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$ |
(6.04 |
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Weighted-average common shares outstanding |
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6,022,457 |
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3,046,200 |
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4,045,527 |
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3,031,416 |
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Contact
For Investors:
Winston Kung
Chief Financial Officer
investors@pmvpharma.com
For Media:
Mariann Caprino
mcaprino@pmvpharma.com
(917) 242-1087 mobile