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): May 14, 2021
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 May 14, 2021, PMV Pharmaceuticals, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2021. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 of this Form 8-K, including the attached Exhibit 99.1, is intended to be furnished and 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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Press Release issued by PMV Pharmaceuticals, Inc., dated May 14, 2021. |
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1
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 thereunto duly authorized.
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PMV Pharmaceuticals, Inc. |
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Date: May 14, 2021 |
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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 First Quarter 2021 Financial Results and Corporate Highlights
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Presented late breaking preclinical data on PC14586, the Company’s first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator at the American Association for Cancer Research Annual Meeting 2021 |
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Expanded Board of Directors with the appointment of Charles M. Baum, M.D., Ph.D. |
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Appointed Guillermina (Gigi) Lozano, Ph.D. to the Scientific Advisory Board |
CRANBURY, NJ, May 14, 2021 (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 quarter ended March 31, 2021 and provided corporate highlights.
“PMV had a successful first quarter. We continued to advance our clinical and discovery programs, and our presentation at AACR provided compelling evidence that PC14586 selectively reactivates the p53 Y220C mutant protein, both in vitro and in vivo,” said David Mack, Ph.D., President and Chief Executive Officer. “Enrollment in our Phase 1/2 trial of PC14586, our first in class p53 Y220C reactivator, is progressing as planned. We are also thrilled to have welcomed Chuck Baum to our Board and Gigi Lozano to our SAB and look forward to leveraging their deep expertise in precision therapeutics and genetic drivers of cancer.”
Corporate Highlights:
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In March 2021, PMV Pharma presented late breaking preclinical data on PC14586, the Company’s first-in-class, tumor-agnostic, investigational small molecule p53 Y220C reactivator at the American Association for Cancer Research Annual Meeting 2021. The Oral presentation titled, “PC14586: The First Orally Bioavailable Small Molecule Reactivator of Y220C Mutant p53 in Clinical Development” was given by Melissa L. Dumble, Ph.D., Vice President Preclinical Development and Translational Science of PMV. |
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PMV Pharma continued to enroll patients in the Phase 1 portion of a Phase 1/2 clinical trial of PC14586 (NCT04585750). PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. |
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Appointment of Charles Baum, M.D., Ph.D., to the Board of Directors. Dr. Baum is the President and Chief Executive Officer and a Board Member of Mirati Therapeutics Inc. |
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Expanded Scientific Advisory Board with the appointment of p53 pioneer Dr. Guillermina (Gigi) Lozano, Professor and Chair, Department of Genetics, MD Anderson Cancer Center. |
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PMV Pharma is the process of relocating to a state-of-the-art laboratory and office building located in Princeton, NJ. |
First Quarter 2021 Financial Results
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PMV Pharma ended the fourth quarter with $348.4 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $12.9 million for the three months ended March 31, 2021 compared to $8.1 million for the three months ended March 31, 2020. |
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Net loss for the quarter ended March 31, 2021 was $11.6 million compared to $7.3 million for the quarter ended March 31, 2020. |
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Research and development (R&D) expenses were $7.5 million for the three months ended March 31, 2021 compared to $6.0 million for the three months ended March 31, 2020. The increase in R&D expenses was primarily related to increased headcount and clinical expenses for advancing development of PC14586, the Company’s lead drug candidate. |
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General and administrative (G&A) expenses were $4.2 million for the three months ended March 31, 2021, compared to $1.7 million for the three months ended March 31, 2020. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company. |
About p53
p53 plays a pivotal role in preventing abnormal cells from becoming a tumor by inducing programmed cell death. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. The p53 Y220C mutation is associated with many cancers, including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic, and ovarian cancers.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have the p53 Y220C mutation and has been granted Fast Track designation by the U.S. FDA.
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 timing for patient enrollment and success of its current clinical trial for PC14586; the future plans or expectations for the Company’s discovery platform; 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 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 3, 2021, the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 14, 2021 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.
Consolidated Balance Sheet Data
(unaudited, in thousands)
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March 31, 2021 (unaudited) |
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December 31, 2020 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
208,783 |
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$ |
361,422 |
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Marketable securities, current |
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122,706 |
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— |
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Prepaid expenses and other current assets |
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3,464 |
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3,339 |
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Total current assets |
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334,953 |
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364,761 |
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Property and equipment, net |
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697 |
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569 |
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Marketable securities, noncurrent |
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16,891 |
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— |
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Right-of-use assets, operating leases |
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828 |
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— |
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Other assets |
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1,024 |
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201 |
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Total assets |
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$ |
354,393 |
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$ |
365,531 |
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Liabilities, Convertible Preferred Stock, and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,252 |
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$ |
1,607 |
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Accrued expenses |
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3,878 |
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4,803 |
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Operating lease liability, current |
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666 |
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— |
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Total current liabilities |
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5,796 |
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6,410 |
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Operating lease liability, noncurrent |
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302 |
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— |
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Total liabilities |
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6,098 |
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6,410 |
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Stockholders’ equity: |
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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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469,790 |
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469,001 |
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Accumulated deficit |
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(121,482 |
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(109,880 |
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Accumulated other comprehensive loss |
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(13 |
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— |
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Total stockholders’ equity |
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348,295 |
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359,121 |
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Total liabilities and stockholders’ equity |
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$ |
354,393 |
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$ |
365,531 |
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PMV Pharmaceuticals, Inc.
Statements of Operations and Comprehensive Loss
(unaudited, in thousands, except share and per share amounts)
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Three Months Ended March 31, |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
7,500 |
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$ |
5,955 |
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General and administrative |
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4,174 |
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1,699 |
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Total operating expenses |
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11,674 |
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7,654 |
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Loss from operations |
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(11,674 |
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(7,654 |
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Other income (expense): |
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Interest income, net |
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128 |
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406 |
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Other expense |
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(52 |
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(5 |
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Total other income |
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76 |
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401 |
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Loss before provision for income taxes |
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(11,598 |
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(7,253 |
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Provision for income taxes |
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4 |
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2 |
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Net loss |
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(11,602 |
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(7,255 |
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Unrealized gains (losses) on marketable securities, net of tax |
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(13 |
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(80 |
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Comprehensive loss |
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$ |
(11,615 |
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$ |
(7,335 |
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Net loss per share -- basic and diluted |
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$ |
(0.26 |
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$ |
(2.38 |
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Weighted-average common shares outstanding |
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44,785,226 |
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3,046,200 |
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Contact
For Investors & Media:
Winston Kung
Chief Financial Officer
investors@pmvpharma.com