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Arvinas Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update Recently Announced the Initiation of Patient Dosing in the First Phase 1 Clinical Trial with a Targeted PROTAC Protein Deg

Key Takeaway: Arvinas Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update Recently Announced the Initiation of Patient Dosing in the First Phase 1 Clinical Trial with a Targeted PROTAC Protein Degrader ARV-110 NEW HAVEN, Conn. March 26, 2019 Arvinas, In

Full Press Release Details

Arvinas Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
Recently Announced the Initiation of Patient Dosing in the First Phase 1 Clinical Trial with a Targeted
PROTAC Protein Degrader ARV-110
NEW HAVEN, Conn. March 26, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class
of therapies that degrade disease-causing proteins, today reported financial results for the fourth quarter and full year ended December 31, 2018 and provided a corporate update.
Since our founding in 2013, Arvinas has been focused on leading and advancing the field of targeted protein degradation and we are proud of our progress
to date. 2018 was a transition year for Arvinas with preparations for moving into the clinic with our two lead programs. The hard work and dedication of our team recently enabled us to initiate patient dosing in our first Phase 1 clinical trial of ARV-110, our oral androgen receptor (AR)-targeted PROTAC protein degrader for the treatment of men with metastatic castration-resistant prostate
cancer, said John Houston, Ph.D., President and CEO of Arvinas. We believe ARV-110 is the first in this new class of targeted protein degraders to enter human clinical trials, and we anticipate
bringing ARV-471, an estrogen receptor (ER)-targeted PROTAC protein degrader for the treatment of women with locally advanced or metastatic ER+ / HER2- breast cancer, into the clinic in the third quarter
While our initial clinical programs will be in oncology, this is just the beginning for Arvinas. There are many protein targets for
which our PROTAC technology may be advantageous, including undruggable targets. We are moving into new and exciting therapeutic areas, developing new PROTAC protein degraders against neurodegenerative targets such as tau,
which is implicated in Alzheimer s Disease. We have engineered targeted PROTAC protein degraders that, in preclinical studies, have achieved blood-brain barrier penetration, a key step in developing drugs with the potential to treat
neurodegenerative diseases, continued Dr. Houston.
Business Highlights and Recent Developments
Anticipated Milestones and Expectations
Based on its current operating plan,
Arvinas expects its cash, cash equivalents, and marketable securities as of December 31, 2018 will be sufficient to fund its operating expenses and capital expenditure requirements into the first half of 2021.
Full Year and Fourth Quarter Financial Highlights
Cash, Cash Equivalents and Marketable Securities Position: As of December 31, 2018, cash, cash equivalents, and marketable securities were
$187.8 million as compared to $39.2 million as of December 31, 2017. The increase related to net proceeds from our IPO of $114.6 million, proceeds from our Series C financing of $55.0 million, proceeds from our Pfizer
collaboration of $28.0 million, and proceeds from a partially forgivable loan of $2.0 million; offset by cash used to fund operations and professional fees paid related to our IPO of $51.0 million. Cash, cash equivalents, and
marketable securities increased by $98.0 million in the fourth quarter of 2018. This increase related to net proceeds from our IPO of $114.6 million, offset by cash used to fund operations, and professional fees paid related to our IPO of
Research and Development Expenses: Research and development expenses were $45.2 million and $14.6 million for the
year and quarter ended December 31, 2018, respectively as compared to $28.8 million and $6.7 million for the year and quarter ended December 31, 2017, respectively. The increase in research and development expenses for the year
and quarter primarily related to investigational new
drug application ( IND )-enabling costs associated with ARV-110 and ARV-471 in addition to increases in
costs associated with our discovery operations.
General and Administrative Expenses: General and administrative expenses were $12.9 million
and $5.8 million for the year and quarter ended December 31, 2018, respectively as compared to $3.5 million and $1.2 million for the year and quarter ended December 31, 2017, respectively. The increase in general and
administrative expenses for the year and quarter primarily relate to increases in our infrastructure in preparation of becoming a publicly traded company.
Revenues: Revenue was $14.3 million and $3.4 million for the year and quarter ended December 31, 2018, respectively as compared to
$7.6 million and $2.6 million for the year and quarter ended December 31, 2017, respectively. This increase in the year and quarter was due to an increase in license and rights to technology and research and development activities
primarily related to the Pfizer collaboration agreement initiated in January 2018 and the expanded Genentech agreement that was initiated in November 2017.
Net Loss: Net loss was $41.5 million and $16.1 million for the year and quarter ended December 31, 2018, respectively as compared
to $24.0 million and $4.7 million for the year and quarter ended December 31, 2017, respectively. The increase in net loss for the year and quarter ended December 31, 2018 was primarily due to the progression of ARV-110 through IND-enabling activities, clinical trial start-up costs for ARV-110, the
initiation of IND-enabling activities for ARV-471, investments in our discovery programs and investments in our infrastructure in preparation for becoming a publicly
traded company offset by an increase in revenue primarily related to the expanded Genentech collaboration agreement initiated in November 2017 and the Pfizer collaboration agreement initiated in January 2018.
ARV-110 is an orally-bioavailable PROTAC protein degrader designed to selectively target and degrade androgen receptor (AR).
ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). ARV-110 has demonstrated activity in
preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies. Arvinas believes the differentiated pharmacology of ARV-110, including its iterative activity, has the potential to translate into improved clinical outcomes for patients.
ARV-471 is targeting the estrogen receptor (ER) for the treatment of women with locally advanced or metastatic ER+ / HER2- breast cancer. A Phase 1 clinical trial for ARV-471
in women with locally advanced or metastatic ER+ positive / HER2- negative breast cancer, is expected to begin in the third quarter of 2019 and preliminary clinical data is expected in 2020.
Arvinas is a biopharmaceutical
company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies to 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. For more information, see 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, including the timing of our clinical trial for ARV-471 and of preliminary data from our clinical trial for ARV-110 and ARV-471, and 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 a Phase 1 clinical trial for ARV-110, successfully initiate and conduct a Phase 1 clinical trial for ARV-471,
complete other clinical trials for our 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, 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
Randy Teel, VP Corporate Development
Cory Tromblee, ScientPR
Consolidated Statement of Operations (Unaudited)
Quarter Ended December 31, Year Ended December 31,
2018 2017 2018 2017
Revenue $ 3,440,165 $ 2,572,293 $ 14,323,920 $ 7,578,876
Operating expenses:
Research and development 14,562,299 6,690,189 45,193,830 28,792,902
General and administrative 5,821,445 1,189,122 12,932,168 3,546,241
Total operating expenses 20,383,744 7,879,311 58,125,998 32,339,143
Loss from operations (16,943,579 ) (5,307,018 ) (43,802,078 ) (24,760,267 )
Interest and other income 855,713 578,992 2,321,612 711,061
Net loss (16,087,866 ) (4,728,026 ) (41,480,466 ) (24,049,206 )
Change in redemption value of redeemable preferred units (4,570,431 ) (198,366,756 ) (4,570,431 )
Net loss attributable to common units/shares $ (16,087,866 ) $ (9,298,457 ) $ (239,847,222 ) $ (28,619,637 )
Net loss per common unit/share, basic and diluted $ (0.52 ) $ (4.90 ) $ (25.45 ) $ (15.08 )
Weighted average common units/shares outstanding, basic and diluted 31,098,634 1,897,544 9,422,799 1,897,544
Consolidated Balance Sheet (Unaudited)
December 31,
2018 2017
Assets
Current assets:
Cash and cash equivalents $ 3,190,056 $ 30,912,391
Marketable securities 184,637,640 8,258,982
Account receivable 2,775,831 25,000,000
Other receivables 2,255,966 1,040,452
Prepaid expenses and other current assets 2,818,286 316,903
Total current assets 195,677,779 65,528,728
Property, equipment and leasehold improvements, net 3,583,036 1,298,881
Other assets:
Deposits 20,760 20,760
Total assets $ 199,281,575 $ 66,848,369
Liabilities and members /stockholders' equity
Current liabilities:
Accounts payable $ 2,758,184 $ 596,527
Accrued expenses 4,001,276 3,545,936
Deferred revenue 16,065,957 13,553,136
Current portion of long-term debt 154,461 159,265
Total current liabilities 22,979,878 17,854,864
Deferred revenue 37,484,714 48,545,625
Long term debt, net of current portion 2,000,000 151,122
Other non-current liability 150,000
Preferred unit warrant liability 50,888
Total liabilities 62,614,592 66,602,499
Commitments and contingencies
Redeemable convertible preferred units 61,480,432
Members'/Stockholders' equity:
Common units, no par value, 1,897,544 units issued and outstanding as of December 31, 2017 6,167
Incentive units, no par value, 3,669,963 units issued as of December 31, 2017 1,186,419
Common stock, $0.001 par value, 31,235,458 shares issued and outstanding as of December 31, 2018 31,236
Accumulated deficit (302,264,619 ) (62,417,397 )
Additional paid-in capital 439,118,089
Accumulated other comprehensive loss (217,723 ) (9,751 )
Total members /stockholders' equity 136,666,983 (61,234,562 )
Total liabilities and members /stockholders' equity $ 199,281,575 $ 66,848,369
Last updated: Mar 26, 2019