Full Press Release Details
VIRIDIAN THERAPEUTICS REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS AND
PROVIDES CORPORATE UPDATES
Waltham, Mass., August 11, 2021 Viridian Therapeutics, Inc.
(Nasdaq: VRDN) ( the Company or Viridian ), a biopharmaceutical company advancing new treatments for patients suffering from serious diseases and underserved by current therapies, today announced financial results for the
second quarter ended June 30, 2021, and provided corporate updates.
We continue to make rapid progress with our lead TED program, VRDN-001, said Jonathan Violin, Ph.D., President and Chief Executive Officer of Viridian. Following a highly collaborative pre-IND dialogue with the FDA for VRDN-001, we remain on track to submit IND filings for both VRDN-001 and VRDN-002 to the FDA in the fourth quarter of 2021. This would
put us on track to report key Phase 1/ 2 proof of concept clinical data in TED patients in the second quarter of 2022 for VRDN-001, quickly followed by Phase 1 first-in-human data in mid-year 2022 for VRDN-002. We are also progressing our discovery programs as we expand our pipeline
beyond IGF-1R and TED, advancing our strategy to discover and develop novel and differentiated monoclonal antibodies.
Second 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 Thyroid Eye Disease (TED). This antibody has previously been studied in over
100 oncology patients as AVE1642, informing plans for rapid development in TED. The Company recently completed a successful pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) and gained alignment on initial
development plans and the proposed design for a randomized, placebo-controlled Phase 1/ 2 clinical proof of concept trial. This trial will evaluate safety, tolerability, and efficacy with the potential for clinically meaningful improvement in
proptosis, the defining characteristic of TED, previously shown to be improved by IGF-1R blockade. The protocol allows for flexibility to subsequently assess multiple doses and treatment regimens to inform
product profiles that may be superior to currently available therapies.
The Company remains on track to file an IND in the fourth quarter of 2021, with initial proof of concept clinical data in TED patients expected in the second quarter of 2022.
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. Data
from this trial are expected by mid-year 2022, and could demonstrate feasibility of a low-volume 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 discovery pipeline beyond IGF-1R and TED, with a focus on opportunities that will leverage validated mechanisms, technologies, and modalities 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. The Company continues to evaluate additional opportunities to expand its product pipeline
for rare disease indications and remains focused on opportunities to leverage validated mechanisms and technologies to bring new therapeutic options to patients underserved by current therapies.
Scientific Presentations: The Company announced that it will present preclinical data on VRDN-001 and VRDN-002 at the American Thyroid Association (ATA) Annual Meeting, which will be held virtually from September 30 to October 3, 2021. Details of the Company s presentations will be announced in the
Second Quarter 2021 Financial Results
Position: Cash, cash equivalents and short-term investments were $109.3 million as of June 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 $8.8 million to $12.6 million during the second quarter of 2021, compared to $3.8 million during the second 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 second quarter of 2021.
G&A Expenses: General and administrative expenses increased by $3.8 million to $6.5 million during the second quarter of 2021,
compared to $2.7 million during the second 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 $18.0 million for the second quarter of 2021, compared to $6.4 million for the second
Shares Outstanding: As of August 10, 2021, Viridian had approximately 31,294,508 shares of common stock outstanding on an as-converted basis, which included 9,542,087 shares of common stock and approximately 21,752,421 shares of common stock issuable upon the conversion of 326,270 shares of preferred stock.
About Viridian Therapeutics, Inc.
Viridian Therapeutics
is a biotechnology company advancing new treatments for patients suffering from serious diseases and 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), a debilitating auto-immune 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. Learn more about Viridian and its programs at www.viridiantherapeutics.com.
@ViridianThera and on LinkedIn.
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 the Company s expectations,
strategies, 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, its projected cash runway, the timing, progress and plans for the Company s ongoing and future research and clinical development programs, future regulatory interactions,
expectations regarding the timing for data, and the timing of the Company s IND filings for VRDN-001 and VRDN-002. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. 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. We may not
actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our 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; and those risks set forth under the caption Risk Factors in the Company s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on
March 26, 2021, the Company s other periodic reports 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 BALANCE SHEETS
(in thousands, except share and per share data)
| June 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 27,704 | $ | 45,897 | ||||
| Short-term investments | 81,597 | 81,742 | ||||||
| Prepaid expenses and other current assets | 4,110 | 1,972 | ||||||
| Unbilled revenue related party | 2,051 | |||||||
| Total current assets | 115,462 | 129,611 | ||||||
| Property and equipment, net | 298 | 309 | ||||||
| Operating lease right-of-use asset, net | 1,567 | 478 | ||||||
| Other assets related party | 778 | 856 | ||||||
| Other assets | 97 | 1 | ||||||
| Total assets | $ | 118,202 | $ | 131,255 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,392 | $ | 670 | ||||
| Accrued liabilities | 14,150 | 9,703 | ||||||
| Current portion of deferred revenue related party | 288 | 301 | ||||||
| Total current liabilities | 16,830 | 10,674 | ||||||
| Other liabilities related party | 1,293 | 501 | ||||||
| Other liabilities | 1,167 | 43 | ||||||
| Total liabilities | 19,290 | 11,218 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, series A non-voting convertible preferred stock, $0.01 par value; 435,000 shares authorized; 340,219 and 398,487 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 154,363 | 180,801 | ||||||
| Preferred stock, $0.01 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | ||||||||
| Common stock, $0.01 par value; 200,000,000 shares authorized; 8,608,886 and 4,231,135 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 86 | 42 | ||||||
| Additional paid-in capital | 259,786 | 218,089 | ||||||
| Accumulated other comprehensive loss | (12 | ) | (8 | ) | ||||
| Accumulated deficit | (315,311 | ) | (278,887 | ) | ||||
| Total stockholders equity | 98,912 | 120,037 | ||||||
| Total liabilities and stockholders equity | $ | 118,202 | $ | 131,255 |
VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue related party | $ | 1,090 | $ | $ | 2,541 | $ | ||||||||||
| Collaboration revenue | 681 | |||||||||||||||
| Grant revenue | 168 | 315 | ||||||||||||||
| Total revenue | 1,090 | 168 | 2,541 | 996 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 12,565 | 3,836 | 26,371 | 9,939 | ||||||||||||
| General and administrative | 6,523 | 2,706 | 12,683 | 5,429 | ||||||||||||
| Total operating expenses | 19,088 | 6,542 | 39,054 | 15,368 | ||||||||||||
| Loss from operations | (17,998 | ) | (6,374 | ) | (36,513 | ) | (14,372 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 34 | 33 | 89 | 128 | ||||||||||||
| Interest and other expense | (94 | ) | (235 | ) | ||||||||||||
| Net loss | (17,964 | ) | (6,435 | ) | (36,424 | ) | (14,479 | ) | ||||||||
| Change in unrealized gain (loss) on investments | 9 | (4 | ) | |||||||||||||
| Comprehensive loss | $ | (17,955 | ) | $ | (6,435 | ) | $ | (36,428 | ) | $ | (14,479 | ) | ||||
| Net loss | $ | (17,964 | ) | $ | (6,435 | ) | $ | (36,424 | ) | $ | (14,479 | ) | ||||
| Net loss per share, basic and diluted | $ | (2.21 | ) | $ | (1.82 | ) | $ | (5.04 | ) | $ | (4.41 | ) | ||||
| Weighted-average shares used to compute basic and diluted net loss per share | 8,106,765 | 3,538,490 | 7,226,447 | 3,285,123 |
VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS EQUITY
(in thousands, except share data)
| Series A Non-Voting Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders Equity | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | |||||||||||||||||||||||||
| Balance as of December 31, 2020 | 398,487 | $ | 180,801 | 4,231,135 | $ | 42 | $ | 218,089 | $ | (278,887 | ) | $ | 120,037 | |||||||||||||||
| Issuance of common stock upon the conversion of convertible preferred stock | (43,664 | ) | (19,811 | ) | 2,911,071 | 29 | 19,782 | |||||||||||||||||||||
| Issuance of common stock upon exercises of warrants | 56,935 | 1 | 939 | 940 | ||||||||||||||||||||||||
| Issuance of common stock for exercises of stock options and vesting of restricted stock units | 31,249 | 307 | 307 | |||||||||||||||||||||||||
| Issuance of common stock for cash under employee stock purchase plan | 980 | 12 | 12 | |||||||||||||||||||||||||
| Share-based compensation expense | 3,175 | 3,175 | ||||||||||||||||||||||||||
| Change in unrealized loss on investments | (13 | ) | ||||||||||||||||||||||||||
| Net loss | (18,460 | ) | (18,460 | ) | ||||||||||||||||||||||||
| Balance as of March 31, 2021 | 354,823 | 160,990 | 7,231,370 | 72 | 242,304 | (297,347 | ) | 105,998 | ||||||||||||||||||||
| Issuance of common stock upon the conversion of convertible preferred stock | (14,604 | ) | (6,627 | ) | 973,648 | 10 | 6,617 | |||||||||||||||||||||
| Issuance of common stock under 2021 ATM, net of issuance costs | 403,868 | 4 | 7,048 | 7,052 | ||||||||||||||||||||||||
| Share-based compensation expense | 3,817 | 3,817 | ||||||||||||||||||||||||||
| Change in unrealized gain on investments | 9 | |||||||||||||||||||||||||||
| Net loss | (17,964 | ) | (17,964 | ) | ||||||||||||||||||||||||
| Balance as of June 30, 2021 | 340,219 | $ | 154,363 | 8,608,886 | $ | 86 | $ | 259,786 | $ | (315,311 | ) | $ | 98,912 |
| Series A Non-Voting Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders Equity | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | |||||||||||||||||||||||||
| Balance at December 31, 2019 | $ | 2,324,126 | $ | 23 | $ | 183,900 | $ | (168,169 | ) | $ | 15,754 | |||||||||||||||||
| Prior period adjustment from adoption of ASC 842 | (3 | ) | (3 | ) | ||||||||||||||||||||||||
| Issuance of common stock and warrants in a public offering, net of issuance costs | 1,000,000 | 10 | 13,871 | 13,881 | ||||||||||||||||||||||||
| Issuance of common stock pursuant to a 2019 stock purchase agreement, net of issuance costs | 146,667 | 2 | 4,047 | 4,049 | ||||||||||||||||||||||||
| Issuance of common stock under the 2017 ATM, net of issuance costs | 65,004 | 1 | 669 | 670 | ||||||||||||||||||||||||
| Shares issued for cash upon the exercise of stock options under an equity incentive plan | 1,149 | 13 | 13 | |||||||||||||||||||||||||
| Issuance of common stock for cash under employee stock purchase plan | 1,545 | 16 | 16 | |||||||||||||||||||||||||
| Share-based compensation expense | 664 | 664 | ||||||||||||||||||||||||||
| Net loss | (8,044 | ) | (8,044 | ) | ||||||||||||||||||||||||
| Balance at March 31, 2020 | 3,538,491 | 36 | 203,180 | (176,216 | ) | 27,000 | ||||||||||||||||||||||
| Issuance of common stock and warrants in a public offering, net of issuance costs | (17 | ) | (17 | ) | ||||||||||||||||||||||||
| Share-based compensation expense | 623 | 623 | ||||||||||||||||||||||||||
| Net loss | (6,435 | ) | (6,435 | ) | ||||||||||||||||||||||||
| Balance at June 30, 2020 | $ | 3,538,491 | $ | 36 | $ | 203,786 | $ | (182,651 | ) | $ | 21,171 |
VIRIDIAN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Six Months Ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (36,424 | ) | $ | (14,479 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Share-based compensation expense | 6,992 | 1,287 | ||||||
| Implementation of ASC 842 and other non-cash lease expenses | (1,200 | ) | 131 | |||||
| Depreciation and amortization | 58 | 132 | ||||||
| Loss on sale of equipment | 67 | |||||||
| Amortization of premiums and discounts on available-for-sale securities | 481 | 281 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other assets | (2,156 | ) | 622 | |||||
| Unbilled revenue related party | (2,051 | ) | ||||||
| Deferred revenue related party | 779 | |||||||
| Accounts payable | 1,601 | (810 | ) | |||||
| Accrued and other liabilities | 5,683 | (2,412 | ) | |||||
| Net cash used in operating activities | (26,170 | ) | (15,248 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of short-term investments | (67,381 | ) | ||||||
| Maturities of short-term investments | 67,042 | 2,000 | ||||||
| Purchases of property and equipment | (69 | ) | ||||||
| Proceeds from sale of property and equipment | 75 | 1 | ||||||
| Net cash provided by (used in) investing activities | (333 | ) | 2,001 | |||||
| Cash flows from financing activities: | ||||||||
| Proceeds from the issuance of common stock | 8,529 | 19,783 | ||||||
| Payment of issuance costs associated with the sale of common stock | (218 | ) | (1,193 | ) | ||||
| Payments of principal of notes payable | (1,333 | ) | ||||||
| Proceeds from the issuance of notes payable | 1,726 | |||||||
| Net cash provided by financing activities | 8,311 | 18,983 | ||||||
| Net increase (decrease) in cash and cash equivalents | (18,192 | ) | 5,736 | |||||
| Cash and cash equivalents at beginning of period | 45,897 | 24,846 | ||||||
| Cash and cash equivalents at end of period | $ | 27,704 | $ | 30,582 | ||||
| Supplemental disclosure of cash flow information | ||||||||
| Cash paid for interest | $ | $ | 145 | |||||
| Supplemental disclosure of non-cash investing and financing activities | ||||||||
| Purchase of property and equipment in accounts payable | $ | 120 | $ | |||||
| Unpaid common stock issuance costs included in current liabilities | $ | $ | 19 | |||||
| Change in unrealized loss on investments | $ | (4 | ) | $ | ||||
| Amortization of public offering costs | $ | $ | 30 |