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): August 4, 2020
Arvinas, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38672 | 47-2566120 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
| 5 Science Park New Haven, Connecticut |
06511 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (203) 535-1456
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 (see General Instruction A.2. below):
| ☐ | 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 |
Trading |
Name of each exchange | ||
| Common stock, par value $0.001 per share | ARVN | The Nasdaq Stock Market LLC |
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 August 4, 2020, Arvinas, 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 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.
The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
| 99.1 | Press Release issued by the Registrant on August 4, 2020. |
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.
| ARVINAS, INC. | ||||||
| Date: August 4, 2020 | By: | /s/ Sean Cassidy | ||||
| Sean Cassidy | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
Arvinas Reports Second Quarter 2020 Financial Results and Provides Corporate Update
NEW HAVEN, Conn., August 4, 2020 — Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the second quarter ended June 30, 2020 and provided a corporate update.
“We were pleased to report updated dose escalation data from our Phase 1/2 trial of ARV-110 in men with metastatic castration-resistant prostate cancer. These data demonstrated safety and showed an early efficacy signal in a heavily pretreated patient population, highlighting the potential benefit of our PROTAC® platform. These data are a first for a targeted PROTAC® protein degrader, and we are excited to report more mature data from our ARV-110 program, and to announce interim data from our ARV-471 Phase 1/2 trial, in the fourth quarter of 2020,” said John Houston, Ph.D., President and Chief Executive Officer at Arvinas.
“As we look to the balance of 2020, we are in a stronger position than ever to lead the creation of an entirely new class of therapies that targets and degrades disease-causing proteins,” added Dr. Houston.
Business Highlights and Recent Developments
| • | The company presented early efficacy and updated safety data for ARV-110 at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. The data demonstrated that Arvinas’ PROTAC protein degrader ARV-110 had an acceptable safety profile (as of the data cut-off) and are the first to show early signs of clinical efficacy for ARV-110 in a heavily pretreated patient population. |
| • | The company enhanced its Board of Directors with the appointments of Linda Bain and Wendy Dixon, Ph.D. |
Anticipated Milestones and Expectations
| • | For the ARV-110 program, Arvinas expects to provide an update from its Phase 1/2 trial in the fourth quarter of 2020. |
| • | For the ARV-471 program, Arvinas expects to share Phase 1 dose escalation clinical data in the fourth quarter of 2020. |
| • | Arvinas expects to provide information about the advancement of additional programs in its robust preclinical pipeline in the second half of 2020. |
Financial Guidance
Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2022.
Financial Highlights
Cash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2020, cash, cash equivalents, and marketable securities were $242.7 million as compared with $280.9 million as of December 31, 2019. The decrease in cash, cash equivalents and marketable securities of $38.2 million for the first six months of 2020 was primarily related to cash used for operations of $43.2 million and the purchase of lab equipment and lease hold improvements of $3.2 million, partially offset by $4.0 million received from two collaborators, cash provided from the exercise of stock options of $2.6 million and changes in unrealized gain on marketable securities of $1.6 million.
Research and Development Expenses: Research and development expenses were $23.4 million for the quarter ended June 30, 2020, as compared with $16.0 million for the quarter ended June 30, 2019. The increase in research and development expenses of $7.4 million for the quarter was primarily related to increases in clinical
trial and CMC expenses associated with our AR program of $2.3 million and our ER program of $1.0 million, in addition to increases in preclinical expenses of $4.1 million associated with exploratory programs and investments in platform research.
General and Administrative Expenses: General and administrative expenses were $8.8 million for the quarter ended June 30, 2020, as compared to $6.4 million for the quarter ended June 30, 2019. The increase of $2.4 million was primarily related to an increase in personnel and facility related costs of $2.2 million.
Revenues: Revenue was $5.7 million for the quarter ended June 30, 2020, as compared with $4.0 million for the quarter ended June 30, 2019. The increase of $1.7 million was primarily related to the collaboration and license agreement with Bayer that was initiated in July 2019. Revenues are generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017.
Net Loss: Net loss was $25.2 million for the quarter ended June 30, 2020, as compared with $17.2 million for the quarter ended June 30, 2019. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses.
About ARV-110
ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.
ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.
About ARV-471
ARV-471 is an orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.
In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.
About Arvinas
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, the conduct of and plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, the plans for presentation of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product
candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the “Risk Factors” sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.
Contacts for Arvinas
Investors
Will O’Connor, Stern Investor Relations
ir@arvinas.com
Media
Kirsten Owens, Arvinas Communications
kirsten.owens@arvinas.com
Arvinas, Inc.
Consolidated Statement of Operations (Unaudited)
| For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
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| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue |
$ | 5,747,681 | $ | 4,016,489 | $ | 11,987,309 | $ | 8,032,979 | ||||||||
| Operating expenses: |
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| Research and development |
23,416,090 | 16,000,638 | 45,142,776 | 30,190,996 | ||||||||||||
| General and administrative |
8,815,474 | 6,440,779 | 16,740,479 | 12,081,409 | ||||||||||||
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| Total operating expenses |
32,231,564 | 22,441,417 | 61,883,255 | 42,272,405 | ||||||||||||
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| Income (loss) from operations |
(26,483,883 | ) | (18,424,928 | ) | (49,895,946 | ) | (34,239,426 | ) | ||||||||
| Other income (expenses) |
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| Other income, net |
307,743 | 191,729 | 697,752 | 434,850 | ||||||||||||
| Interest income |
965,851 | 1,091,331 | 2,264,984 | 2,281,853 | ||||||||||||
| Interest expense |
(16,250 | ) | (22,778 | ) | (32,500 | ) | (46,416 | ) | ||||||||
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| Total other income |
1,257,344 | 1,260,282 | 2,930,236 | 2,670,287 | ||||||||||||
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| Net loss |
$ | (25,226,539 | ) | $ | (17,164,646 | ) | $ | (46,965,710 | ) | $ | (31,569,139 | ) | ||||
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| Net loss per common share, basic and diluted |
$ | (0.65 | ) | $ | (0.55 | ) | $ | (1.22 | ) | $ | (1.01 | ) | ||||
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| Weighted average common shares outstanding, basic and diluted |
38,739,922 | 31,440,051 | 38,644,209 | 31,408,658 | ||||||||||||
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Arvinas, Inc.
Consolidated Balance Sheet (Unaudited)
| June 30, 2020 |
December 31, 2019 |
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| Assets |
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| Current assets: |
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| Cash and cash equivalents |
$ | 21,593,656 | $ | 9,211,057 | ||||
| Marketable securities |
221,103,306 | 271,661,456 | ||||||
| Other receivables |
3,564,317 | 6,280,828 | ||||||
| Prepaid expenses and other current assets |
3,320,609 | 3,727,294 | ||||||
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| Total current assets |
249,581,888 | 290,880,635 | ||||||
| Property, equipment and leasehold improvements, net |
10,541,408 | 8,455,411 | ||||||
| Operating lease right of use assets |
2,429,500 | 2,278,623 | ||||||
| Other assets |
28,777 | 26,757 | ||||||
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| Total assets |
$ | 262,581,573 | $ | 301,641,426 | ||||
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| Liabilities and stockholders’ equity |
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| Current liabilities: |
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| Accounts payable |
$ | 2,429,757 | $ | 4,556,827 | ||||
| Accrued expenses |
7,404,460 | 7,602,904 | ||||||
| Deferred revenue |
22,964,819 | 19,979,525 | ||||||
| Current portion of operating lease liability |
920,765 | 673,896 | ||||||
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| Total current liabilities |
33,719,801 | 32,813,152 | ||||||
| Deferred revenue |
27,489,590 | 38,427,882 | ||||||
| Long term debt |
2,000,000 | 2,000,000 | ||||||
| Operating lease liability |
1,590,758 | 1,714,111 | ||||||
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| Total liabilities |
64,800,149 | 74,955,145 | ||||||
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| Commitments and Contingencies |
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| Stockholders’ equity: |
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| Common stock, $0.001 par value; 38,825,190 and 38,461,353 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively |
38,825 | 38,461 | ||||||
| Accumulated deficit |
(419,522,556 | ) | (372,556,846 | ) | ||||
| Additional paid-in capital |
615,601,031 | 599,097,090 | ||||||
| Accumulated other comprehensive income |
1,664,124 | 107,576 | ||||||
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| Total stockholders’ equity |
197,781,424 | 226,686,281 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 262,581,573 | $ | 301,641,426 | ||||
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