Full Press Release Details
Bio Reports First Quarter 2020 Financial Results and Recent Business Highlights
therapy collaboration with University of Pennsylvania's Gene Therapy Program extends collaboration by three additional years
and adds five new programs -
- Orphan Drug Designation recently
granted by FDA for lead development candidate PBGM01; program expected to enter the clinic for treatment of infantile GM1 in fourth
- Strong cash balance of $367M expected
to fund operations into 2023 -
PHILADELPHIA, May 11, 2020 (GLOBE NEWSWIRE) -- Passage
Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic
central nervous system disorders, today reported financial results for the first quarter ended March 31, 2020 and provided
recent business highlights.
"The first quarter was a significant time for Passage
Bio and the patients that we serve. Building upon the strong momentum since launching the company in 2018, we completed an upsized
IPO in March 2020 and are now working to bring our lead program, PBGM01, for the treatment of infantile GM1 gangliosidosis
into the clinic as soon as possible and advancing the balance of our deep pipeline," said Bruce Goldsmith, Ph.D., president
and chief executive officer of Passage Bio. "While the potential impacts of the COVID-19 pandemic are uncertain, with our
deeply experienced management team, supported by a strong cash position, we are confident in our ability to continue to execute
and remain on-track to meet our 2020 clinical development goals. As a company that aims, above all, to serve patients and families
suffering from rare, life-threatening CNS diseases with no alternative treatment options, we are committed to driving our programs
Recent Business Highlights
Anticipated Upcoming Milestones
First Quarter 2020 Financial Results
Conference Call Details
Passage Bio will host a conference call and webcast today at
8:30 a.m. ET. To access the live conference call, please dial 833-528-0605 (domestic) or 830-221-9711 (international) and
reference conference ID number 2588609. A live audio webcast of the event will be available on the Investors & Media
section of Passage Bio's website at investors.passagebio.com. The archived webcast will be available on Passage Bio's
website approximately two hours after the completion of the event and for 30 days following the call.
Passage Bio is a genetic medicines company focused on developing
transformative therapies for rare, monogenic central nervous system disorders with limited or no approved treatment options. The
company is based in Philadelphia, PA and has a research, collaboration and license agreement with the University of Pennsylvania
and its Gene Therapy Program (GTP). The GTP conducts discovery and IND-enabling preclinical work and Passage Bio conducts all
clinical development, regulatory strategy and commercialization activities under the agreement. The company has a development
portfolio of six product candidates, with the option to license eleven more, with lead programs in GM1 gangliosidosis, frontotemporal
dementia and Krabbe disease.
Forward-Looking Statements
This press release contains "forward-looking statements"
within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995,
including, but not limited to: our expectations about timing and execution of anticipated milestones, including our planned IND
submissions, initiation of clinical trials and the availability of clinical data from such trials; our cash forecasts, our expectations
about our collaborators' and partners' ability to execute key initiatives; and the ability of our lead product candidates
to treat the underlying causes of their respective target monogenic CNS disorders. These forward-looking statements may be accompanied
by such words as "aim," "anticipate," "believe," "could," "estimate,"
"expect," "forecast," "goal," "intend," "may," "might,"
"plan," "potential," "possible," "will," "would," and other words
and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially
from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our
product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical
study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive
of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical
activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities
may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the
occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure
to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology
failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other
aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages,
or supply chain disruptions caused by the COVID-19 pandemic; risks associated with current and potential future healthcare reforms;
risks relating to attracting and retaining key personnel; failure to comply with legal and regulatory requirements; risks relating
to access to capital and credit markets; and the other risks and uncertainties that are described in the Risk Factors section
in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed
with the SEC. Passage Bio undertakes no obligation to publicly update any forward-looking statement, whether written or oral,
that may be made from time to time, whether as a result of new information, future developments or otherwise.
| December | ||||||||
| March 31, | 31, | |||||||
| (in thousands, except share data) | 2020 | 2019 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 366,828 | $ | 158,874 | ||||
| Prepaid expenses | 2,921 | 156 | ||||||
| Prepaid research and development | 12,340 | 6,745 | ||||||
| Total current assets | 382,089 | 165,775 | ||||||
| Property and equipment, net | 1,137 | 1,087 | ||||||
| Other assets | 9,201 | 11,751 | ||||||
| Total assets | $ | 392,427 | $ | 178,613 | ||||
| Liabilities, convertible preferred stock and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,532 | $ | 629 | ||||
| Accrued expenses and other current liabilities | 2,696 | 3,052 | ||||||
| Total current liabilities | 5,228 | 3,681 | ||||||
| Deferred rent | 489 | 504 | ||||||
| Other liabilities | 44 | 76 | ||||||
| Total liabilities | 5,761 | 4,261 | ||||||
| Convertible preferred stock, $0.0001 par value: | ||||||||
| Series A-1 convertible preferred stock: No shares authorized, issued and outstanding at March | ||||||||
| 31, 2020; 63,023,258 shares authorized, issued and outstanding at December 31, 2019 | - | 74,397 | ||||||
| Series A-2 convertible preferred stock: No shares authorized, issued and outstanding at March | ||||||||
| 31, 2020; 22,209,301 shares authorized; issued and outstanding at December 31, 2019 | - | 46,311 | ||||||
| Series B convertible preferred stock: No shares authorized, issued and outstanding at March | ||||||||
| 31, 2020; 33,592,907 shares authorized, issued and outstanding at December 31, 2019 | - | 109,897 | ||||||
| Total convertible preferred stock | - | 230,605 | ||||||
| Stockholders' equity (deficit) : | ||||||||
| Common stock, $0.0001 par value: 100,000,000 shares authorized; 45,797,195 shares issued | ||||||||
| and 45,350,687 shares outstanding at March 31, 2020 and 5,194,518 shares issued and | ||||||||
| 4,293,039 shares outstanding at December 31, 2019 | 4 | - | ||||||
| Additional paid-in capital | 462,910 | 2,410 | ||||||
| Accumulated deficit | (76,248 | ) | (58,663 | ) | ||||
| Total stockholders' equity (deficit) | 386,666 | (56,253 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 392,427 | $ | 178,613 |
Statements of Operations (unaudited)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| (in thousands, except share and per share data) | 2020 | 2019 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 13,117 | $ | 3,033 | ||||
| General and administrative | 4,795 | 1,154 | ||||||
| Loss from operations | (17,912 | ) | (4,187 | ) | ||||
| Change in fair value of future tranche right liability | - | (3,482 | ) | |||||
| Interest income | 327 | - | ||||||
| Net loss | $ | (17,585 | ) | $ | (7,669 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (1.00 | ) | $ | (1.83 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 17,624,011 | 4,197,604 |
For further information, please contact:
Investor Relations, Inc.