KLRS 8-K
Kalaris Therapeutics, Inc. (KLRS)
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): September 2, 2020
ALLOVIR, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39409 | 83-1971007 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
AlloVir, Inc.
139 Main Street, Suite 500
Cambridge, Massachusetts 02142
(Address of principal executive offices, including zip code)
(617) 433-2605
(Registrant’s telephone number, including area code)
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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | 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:
| Title of each class | Trade Symbol(s) |
Name of each exchange on which registered | ||
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| Common Stock, $0.0001 par value per share | ALVR | 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 September 2, 2020, AlloVir, Inc. announced its financial results for the quarter ended June 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 Current Report on Form 8-K, including Exhibit 99.1, attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 |
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SIGNATURE
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.
| AlloVir, Inc. | ||||||
| Date: September 2, 2020 | By: | /s/ David Hallal | ||||
| David Hallal | ||||||
| Chief Executive Officer | ||||||
Exhibit 99.1
AlloVir Reports Second Quarter 2020 Financial Results
Cambridge, Mass. – September 02, 2020 – AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, today reported financial results for the second quarter ended June 30, 2020.
“AlloVir has achieved important scientific and operational milestones that have us well positioned for growth,” said David Hallal, Chairman and Chief Executive Officer of AlloVir. “As we have advanced our portfolio of allogeneic, off -the-shelf, virus specific T cell therapies and are bolstered by a strong cash position stemming from our recent IPO, we look forward to executing our robust plans to progress the important pivotal and proof-of-concept studies across our pipeline.”
Second Quarter 2020 Financial Highlights
| • | Research and development expenses were $8.9 million for the quarter ended June 30, 2020 compared to $2.8 million for the quarter ended June 30, 2019. The increase year-over-year is attributable to costs related to the development of the company’s product candidates, increased activity in outsourcing of manufacturing, and an increase in headcount and external consultants in support of research activities. |
| • | General and administrative expense was $3.3 million for the quarter ended June 30, 2020 compared to $3.2 million for the quarter ended June 30, 2019. The increase year-over-year was primarily attributable to legal, accounting and professional fees related to costs associated with operating activities and the preparations for becoming a public company. |
| • | Stock-based compensation expense was $0.5 million and $1.4 million for the three months ended June 30, 2020 and 2019, respectively. |
| • | As of June 30, 2020, AlloVir had cash, cash equivalents, and marketable securities of $104.5 million, which compares to cash, cash equivalents, and marketable securities of $126.1 million as of December 31, 2019. |
| • | For the quarter ended June 30, 2020, net loss was $11.6 million or $4.43 per share compared to a net loss of $5.3 million or $5.05 per share for the quarter ended June 30, 2019. The total number of common shares and preferred shares outstanding as of June 30, 2020 was 2,801,059 and 59,398,350, respectively. For purposes of calculating the earnings per share, only the common shares were used in the denominator. |
Subsequent Events
| • | In August, the Company closed on an initial public offering raising $317.7mm in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. We believe that the net proceeds from our IPO, together with our existing cash, cash equivalents and short-term investments, will enable us to fund our operating expenses and capital expenditure requirements into 2023. |
About AlloVir
AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company’s innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir’s technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.
AlloVir uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company’s website in the ‘Investors & Media’ section. Accordingly, investors should monitor such portions of the AlloVir website, in addition to following press releases, SEC filings and public conference calls and webcasts.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir’s development and regulatory status of our product candidates and its strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir’s financial results, the timing for completion of AlloVir’s clinical trials of its product candidates, whether and when, if at all, AlloVir’s product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir’s SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
AlloVir, Inc. Statement of Operations (Unaudited)
Three and Six Months Ended June 30, 2019
| Three Months Ended | Six Months Ended | |||||||||||||||
| (in thousands, except share and per share data) | June 30, | June 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue |
$ | — | $ | — | $ | — | $ | 165 | ||||||||
| Operating expenses: |
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| Research and development |
8,885 | 2,755 | 15,724 | 3,906 | ||||||||||||
| General and administrative |
3,268 | 3,190 | 6,269 | 4,977 | ||||||||||||
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| Total operating expenses ** |
12,153 | 5,945 | 21,993 | 8,883 | ||||||||||||
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| Loss from operations |
(12,153 | ) | (5,945 | ) | (21,993 | ) | (8,718 | ) | ||||||||
| Total other income, net: |
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| Interest income |
166 | 503 | 623 | 619 | ||||||||||||
| Other income, net |
355 | 140 | 399 | 273 | ||||||||||||
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| Net loss |
$ | (11,632 | ) | $ | (5,302 | ) | $ | (20,971 | ) | $ | (7,826 | ) | ||||
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| Net loss per share —- basic and diluted |
$ | (4.43 | ) | $ | (5.05 | ) | $ | (8.66 | ) | $ | (8.49 | ) | ||||
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| Weighted-average common shares outstanding—-basic and diluted |
2,625,648 | 1,050,190 | 2,420,797 | 921,995 | ||||||||||||
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AlloVir, Inc. Balance Sheet
As of June 30, 2020 (Unaudited) and December 31, 2019
| (in thousands) | June 30, | December 31, | ||||||
| 2020 | 2019 | |||||||
| Assets |
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| Current assets: |
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| Cash, cash equivalents and short-term investments |
$ | 104,451 | $ | 126,077 | ||||
| Other current assets |
2,837 | 1,236 | ||||||
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| Total current assets |
107,288 | 127,313 | ||||||
| Other assets |
10,558 | 12,109 | ||||||
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| Total assets |
$ | 117,846 | $ | 139,422 | ||||
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| Liabilities and stockholders’ deficit |
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| Current liabilities |
$ | 8,915 | $ | 9,106 | ||||
| Long-term liabilities |
7,098 | 8,692 | ||||||
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| Total liabilities |
16,013 | 17,798 | ||||||
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| Preferred Stock |
173,127 | 173,127 | ||||||
| Total stockholders’ deficit |
(71,294 | ) | (51,503 | ) | ||||
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| Total liabilities, preferred stock, and stockholders’ deficit |
$ | 117,846 | $ | 139,422 | ||||
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Media contact:
Courtney Heath
ScientPR
617-872-2462