Full Press Release Details
PASSAGE BIO REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES RECENT BUSINESS HIGHLIGHTS
PHILADELPHIA - May 11, 2023 - Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2023 and provided recent business highlights.
"Over the last quarter, we have maintained a steady focus on the successful execution of our two lead clinical programs, taking the necessary steps to ensure the achievement of our upcoming milestones," said William Chou, M.D., president and chief executive officer of Passage Bio. "In our Imagine-1 study for GM1 gangliosidosis, we expect to report safety and biomarker data for Cohort 4 by mid-year and begin dosing patients at a third, higher dose in the second half of this year. For FTD, we have expanded our recruitment sites to accelerate enrollment and look forward to reporting initial safety and biomarker data from Cohort 1 by year-end. Our disciplined approach and judicious cash management gives us confidence that we can deliver long-term value for patients and exemplifies our commitment to develop transformative therapies for people with devastating CNS disorders."
Anticipated Upcoming Milestones
First Quarter 2023 Financial Results
Passage Bio (Nasdaq: PASG) is a clinical-stage genetic medicines company on a mission to provide life-transforming therapies for patients with CNS diseases with limited or no approved treatment options. Our portfolio spans pediatric and adult CNS indications, and we are currently advancing clinical programs in GM1 gangliosidosis and frontotemporal dementia and our preclinical pipeline, including programs in amyotrophic lateral sclerosis and Huntington's disease. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvania's Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. Through this collaboration, we have enhanced access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. More information is available at www.passagebio.com.
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 progress of clinical trials and the availability of clinical data from such trials; our expectations about our collaborators' and partners' ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; and the ability of our lead product candidates to treat their respective target 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 and obtain regulatory approval for our product candidates; the timing and results of preclinical studies and 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; 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; failure to protect and enforce our intellectual property, and other proprietary rights; our dependence on collaborators and other third parties for the development and manufacture of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays or work stoppages; 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.
| (Unaudited) | ||||||
| (in thousands, except share data and per share data) | March 31, 2023 | December 31, 2022 | ||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 33,372 | $ | 34,601 | ||
| Marketable securities | 134,402 | 155,009 | ||||
| Prepaid expenses and other current assets | 1,685 | 926 | ||||
| Prepaid research and development | 2,162 | 6,508 | ||||
| Total current assets | 171,621 | 197,044 | ||||
| Property and equipment, net | 21,599 | 22,515 | ||||
| Right of use assets - operating leases | 19,590 | 19,723 | ||||
| Other assets | 433 | 4,267 | ||||
| Total assets | $ | 213,243 | $ | 243,549 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 3,033 | $ | 4,065 | ||
| Accrued expenses and other current liabilities | 10,907 | 11,011 | ||||
| Operating lease liabilities | 3,303 | 3,275 | ||||
| Total current liabilities | 17,243 | 18,351 | ||||
| Operating lease liabilities - noncurrent | 23,649 | 23,832 | ||||
| Other liabilities | 2,000 | - | ||||
| Total liabilities | 42,892 | 42,183 | ||||
| Commitments and Contingencies | ||||||
| Stockholders' equity: | ||||||
| Common stock, $0.0001 par value: 300,000,000 shares authorized; 54,626,690 shares issued and outstanding at March 31, 2023 and 54,614,690 shares issued and outstanding at December 31, 2022 | 5 | 5 | ||||
| Additional paid in capital | 697,517 | 694,733 | ||||
| Accumulated other comprehensive income (loss) | (427) | (966) | ||||
| Accumulated deficit | (526,744) | (492,406) | ||||
| Total stockholders' equity | 170,351 | 201,366 | ||||
| Total liabilities and stockholders' equity | $ | 213,243 | $ | 243,549 |
Statements of Operations and Comprehensive Loss
| Three Months Ended March 31, | ||||||
| (in thousands, except share and per share data) | 2023 | 2022 | ||||
| Operating expenses: | ||||||
| Research and development | $ | 16,836 | $ | 26,213 | ||
| Acquired in-process research and development | - | 1,500 | ||||
| General and administrative | 19,047 | 15,099 | ||||
| Loss from operations | (35,883) | (42,812) | ||||
| Other income (expense), net | 1,545 | 1 | ||||
| Net loss | $ | (34,338) | $ | (42,811) | ||
| Per share information: | ||||||
| Net loss per share of common stock, basic and diluted | $ | (0.63) | $ | (0.79) | ||
| Weighted average common shares outstanding, basic and diluted | 54,618,799 | 54,275,751 | ||||
| Comprehensive loss: | ||||||
| Net loss | $ | (34,338) | $ | (42,811) | ||
| Unrealized gain (loss) on marketable securities | 539 | (921) | ||||
| Comprehensive loss | $ | (33,799) | $ | (43,732) |
For further information, please contact:
Sam Brown Inc. Healthcare Communications