Full Press Release Details
VIRIDIAN THERAPEUTICS REPORTS THIRD QUARTER 2021 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATES
Waltham, Mass., November 4, 2021 Viridian Therapeutics, Inc. (NASDAQ: VRDN) (the Company or
Viridian ), a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by today s therapies, today announced financial results for the third quarter ended September 30, 2021, and
provided corporate updates.
In the third quarter, we made substantial progress strengthening the Company with key leadership hires, a
successful financing, and our recent submission of an IND for VRDN-001 for the treatment of Thyroid Eye Disease, stated Jonathan Violin, Ph.D., Viridian s President and CEO. Our pipeline is rapidly advancing, and we remain on track
to report clinical data from our VRDN-001 and VRDN-002 programs in the second quarter of 2022 and mid-year 2022, respectively. In addition, we continue to advance our discovery pipeline to broaden our portfolio of potential best in class
Third Quarter 2021 and Recent Highlights
VRDN-001: Viridian s most advanced product candidate is VRDN-001, a differentiated monoclonal antibody targeting insulin-like growth
factor-1 receptor (IGF-1R), a clinically and commercially validated target for the treatment of TED. This antibody has previously been studied in over 100 oncology patients as AVE1642, informing plans for rapid development in TED. The Company
recently submitted an IND application for VRDN-001 to the United States Food and Drug Administration (FDA). The Company is planning to initiate a randomized, placebo-controlled Phase 1/2 clinical trial of VRDN-001 evaluating safety, tolerability,
and efficacy. The proposed clinical trial protocol allows for flexibility to assess multiple doses and treatment regimens to inform product profiles that may be superior to currently available therapies. The Company believes this clinical trial
could provide key proof of concept data showing clinically meaningful improvements in signs and symptoms of TED, such as proptosis, the defining characteristic of TED, previously shown to be improved by IGF-1R blockade. The Company expects to
announce top line proof of concept clinical data in the second quarter of 2022 from the trial that includes TED patients in two randomized, placebo-controlled cohorts.
VRDN-002: Viridian s second product candidate, VRDN-002, is a distinct anti-IGF-1R antibody that incorporates half-life extension
technology and is designed to support administration as a convenient, low-volume, subcutaneous injection. IND-enabling activities remain on track with plans to file an IND by the end of 2021. The Company expects to initiate clinical development with
a Phase 1 single ascending dose trial to explore safety, tolerability, pharmacokinetics, and target engagement of intravenous VRDN-002 in healthy volunteers. Top line data from this trial are expected to be announced in mid-year 2022 and could
support feasibility of a low-volume injection and/or low-frequency dosing paradigm. In parallel, formulation development is on track to support initiation of a clinical trial evaluating low-volume subcutaneous injection of VRDN-002 in 2022. The
Company believes a low-volume subcutaneous injection could improve convenience for patients and physicians, mitigate treatment burdens, and expand the settings of care for TED therapies.
Discovery Pipeline: Viridian s corporate development strategy includes expanding its
pipeline beyond IGF-1R and TED with a focus on opportunities that will leverage validated mechanisms and technologies to bring new therapeutic options to patients underserved by today s available medicines. The most advanced of these programs
is VRDN-004, a therapeutic monoclonal antibody program currently in discovery stage for an undisclosed rare disease. The Company continues to evaluate additional opportunities to expand its product pipeline for rare disease indications.
Completed Financing: In September 2021, Viridian announced the closing of an underwritten public offering of 7,344,543 shares of its common stock,
which included the exercise in full by the underwriters of their option to purchase up to 1,159,089 additional shares of common stock, at a public offering price of $11.00 per share and 23,126 shares of Series B preferred stock at a public offering
price of $733.37 per share, which are convertible into approximately 1,541,810 shares of common stock, subject to beneficial ownership conversion limits. The net proceeds to Viridian from the offering were approximately $91.9 million after deducting
underwriting discounts, commissions, and other offering expenses.
Scientific Presentations: The Company presented two posters featuring
preclinical data on VRDN-001 and VRDN-002 at the 90th Annual Meeting of the American Thyroid Association (ATA):
Management and Board
of Directors Appointments:
Third Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents and short-term investments were $213.8 million as of September 30, 2021, compared
to $127.6 million as of December 31, 2020. The Company believes that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2024.
R&D Expenses: Research and development expenses increased by $5 million to $8.1 million during the third quarter of 2021, compared to
$3.1 million during the third quarter of 2020. The increase in research and development expenses was primarily driven by the advancement of the Company s lead programs, including expenses related to manufacturing and IND enabling studies.
This increase was partially offset by a decrease in clinical trial expenses in the third quarter of 2021.
G&A Expenses: General and
administrative expenses increased by $2.3 million to $6.2 million during the third quarter of 2021, compared to $3.9 million during the third quarter of 2020. The increase in general and administrative expenses was driven by increases
in personnel related costs, including severance, share-based compensation charges, and consulting expenses.
Net Loss: The Company s net loss was $14.03 million for the third quarter of 2021, compared
to $5.5 million for the third quarter of 2020.
Shares Outstanding: As of November 3, 2021, Viridian had approximately 42,365,036
shares of common stock outstanding on an as-converted basis, which included 21,722,349 shares of common stock and approximately 20,642,687 shares of common stock issuable upon the conversion of 286,499 and 23,126 shares of Series A and Series B
preferred stock respectively.
About Viridian Therapeutics, Inc.
Viridian Therapeutics is a biotechnology company advancing new treatments for patients suffering from serious diseases but underserved by today s
therapies. Viridian s most advanced program, VRDN-001, is a differentiated monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R), a clinically and commercially validated target for the treatment of thyroid eye disease
(TED). TED is a debilitating autoimmune disease that causes inflammation and fibrosis within the orbit of the eye which can cause double vision, pain, and potential blindness. Patients with severe disease often require multiple remedial surgeries to
the orbit, eye muscles and eyelids. Viridian is based in Waltham, Massachusetts.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be
identified by the use of words such as, but not limited to, anticipate, believe, continue, could, estimate, expect, intend, may, might,
plan, potential, predict, project, should, target, will, or would or other similar terms or expressions that concern our expectations, plans and
intentions. Forward-looking statements include, without limitation, statements regarding the Company s expectations and guidance regarding its business plans and objectives for its product candidates and pipeline, including the therapeutic
potential and clinical benefits thereof, the safety and efficacy profiles of VRDN-001 and VRDN-002, the sufficiency of the Company s financial position and its projected cash runway, the timing, progress and plans for the Company s ongoing
and future research and clinical development programs, planned trial designs, future regulatory interactions, the timing of the Company s IND filing for VRDN-002 and expectations regarding the timing for data. Forward-looking statements are
neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and
uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not
limited to: uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; manufacturing risks; competition from other therapies or products; other matters that could
affect the sufficiency of existing cash, cash equivalents and short-term investments to fund operations; the company s future operating results and financial performance; the timing of pre-clinical and clinical trial activities and reporting
results from same; the effects from the COVID-19 pandemic on the company s research, development and business activities and operating results, including those risks set forth under the caption Risk Factors in our Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2021 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor
our affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking
statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
Verge Scientific Communications
VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue (related party, $2,541 and $0 at September 30, 2021 and December 31, 2020, respectively) | $ | 208 | $ | $ | 2,749 | $ | 681 | |||||||||
| Grant revenue | 315 | |||||||||||||||
| Total revenue | 208 | 2,749 | 996 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 8,121 | 3,111 | 34,492 | 13,050 | ||||||||||||
| General and administrative | 6,221 | 2,299 | 18,904 | 7,728 | ||||||||||||
| Total operating expenses | 14,342 | 5,410 | 53,396 | 20,778 | ||||||||||||
| Loss from operations | (14,134 | ) | (5,410 | ) | (50,647 | ) | (19,782 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 91 | 9 | 180 | 137 | ||||||||||||
| Interest and other expense | (93 | ) | (328 | ) | ||||||||||||
| Net loss | (14,043 | ) | (5,494 | ) | (50,467 | ) | (19,973 | ) | ||||||||
| Change in unrealized gain (loss) on investments | 9 | 5 | ||||||||||||||
| Comprehensive loss | $ | (14,034 | ) | $ | (5,494 | ) | $ | (50,462 | ) | $ | (19,973 | ) | ||||
| Net loss | $ | (14,043 | ) | $ | (5,494 | ) | $ | (50,467 | ) | $ | (19,973 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.25 | ) | $ | (1.48 | ) | $ | (5.95 | ) | $ | (5.82 | ) | ||||
| Weighted-average shares used to compute basic and diluted net loss per share | 11,183,578 | 3,719,186 | 8,487,485 | 3,430,867 |
VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| September 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 138,875 | $ | 45,897 | ||||
| Short-term investments | 74,937 | 81,742 | ||||||
| Prepaid expenses and other current assets | 3,649 | 1,972 | ||||||
| Unbilled revenue | $ | 479 | ||||||
| Total current assets | 217,940 | 129,611 | ||||||
| Property and equipment, net | 347 | 309 | ||||||
| Operating lease right-of-use asset, net | 1,461 | 478 | ||||||
| Other assets related party | 856 | |||||||
| Other assets | 1,457 | 1 | ||||||
| Total assets | $ | 221,205 | $ | 131,255 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,731 | $ | 670 | ||||
| Accrued liabilities | 10,320 | 9,703 | ||||||
| Current portion of deferred revenue (related party, $301 at Dec. 2020) | 288 | 301 | ||||||
| Total current liabilities | 14,339 | 10,674 | ||||||
| Other liabilities related party | 501 | |||||||
| Other liabilities | 2,275 | 43 | ||||||
| Total liabilities | 16,614 | 11,218 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, series A non-voting convertible preferred stock, $0.01 par value; 435,000 shares authorized; 321,334 and 398,487 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 145,794 | 180,801 | ||||||
| Preferred stock, series B non-voting convertible preferred stock, $0.01 par value; 5,000,000 shares authorized; 23,126 and 0 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 15,669 | |||||||
| Common stock, $0.01 par value; 200,000,000 shares authorized; 19,376,634 and 4,231,135 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 194 | 42 | ||||||
| Additional paid-in capital | 372,291 | 218,089 | ||||||
| Accumulated other comprehensive loss | (3 | ) | (8 | ) | ||||
| Accumulated deficit | (329,354 | ) | (278,887 | ) | ||||
| Total stockholders equity | 204,591 | 120,037 | ||||||
| Total liabilities and stockholders equity | $ | 221,205 | $ | 131,255 |