Full Press Release Details
Passage Bio Reports Fourth Quarter and Full-Year 2021 Financial Results and Provides Recent Business Highlights
Philadelphia, PA - March 3, 2022 - 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 fourth quarter and full year ended December 31, 2021 and provided recent business highlights.
"Our focus continues to be on executing across our three clinical programs, and we are pleased to report that we have already achieved one of our key goals with the dosing of the first patients in Cohorts 2 and 3 for the Imagine-1 clinical trial for GM1 gangliosidosis," said Bruce Goldsmith, Ph.D., president and chief executive officer, Passage Bio. "We advanced to the additional cohorts following positive interim safety, biomarker and efficacy data for Cohort 1. We look forward to enrolling additional patients across all our clinical studies and providing more data throughout 2022, including initial biomarker and safety data from Cohorts 2 and 3 in Imagine-1 in the second half of the year.
"We are also excited to advance our robust and differentiated CNS pipeline in partnership with Penn's Gene Therapy Program," Dr. Goldsmith added. "We are employing a diversified portfolio strategy spanning pediatric and adult CNS indications, both rare and large, to create sustained value. Toward the end of last year, we announced the exercising of options for Canavan and Huntington's Disease with the Gene Therapy Program, strengthening our pipeline to include nine programs in addition to our ongoing exploratory research programs in Alzheimer's Disease and temporal lobe epilepsy. We look forward to sharing more information and data on our pipeline programs throughout 2022."
Anticipated Upcoming Milestones:
Fourth Quarter and Full-Year 2021 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 4137048. A live audio webcast of the event will be available on the Investors & News 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.
At Passage Bio (Nasdaq: PASG), we are on a mission to provide life-transforming genetic medicines for patients with CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve. 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. This provides our team with 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 into clinical testing. 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 initiation 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 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 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, work stoppages, or supply chain disruptions caused by the coronavirus pandemic; 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.
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Passage Bio Investors:
| December 31, | ||||||
| (in thousands, except share data) | 2021 | 2020 | ||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 128,965 | $ | 135,002 | ||
| Marketable securities | 186,808 | 169,815 | ||||
| Prepaid expenses and other current assets | 1,726 | 1,405 | ||||
| Prepaid research and development | 7,567 | 10,961 | ||||
| Total current assets | 325,066 | 317,183 | ||||
| Property and equipment, net | 23,806 | 2,795 | ||||
| Other assets | 6,204 | 8,029 | ||||
| Total assets | $ | 355,076 | $ | 328,007 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 9,448 | $ | 5,265 | ||
| Accrued expenses and other current liabilities | 20,050 | 15,910 | ||||
| Total current liabilities | 29,498 | 21,175 | ||||
| Deferred rent | 6,921 | 2,077 | ||||
| Other liabilities | - | 41 | ||||
| Total liabilities | 36,419 | 23,293 | ||||
| Commitments and Contingencies | ||||||
| Stockholders' equity: | ||||||
| Common stock, $0.0001 par value: 300,000,000 shares authorized; 54,244,996 shares issued and 54,244,996 shares outstanding at December 31, 2021 and 45,917,084 shares issued and 45,614,807 shares outstanding at December 31, 2020 | 5 | 4 | ||||
| Additional paid-in capital | 675,346 | 475,617 | ||||
| Accumulated other comprehensive income (loss) | (413) | (12) | ||||
| Accumulated deficit | (356,281) | (170,895) | ||||
| Total stockholders' equity | 318,657 | 304,714 | ||||
| Total liabilities and stockholders' equity | $ | 355,076 | $ | 328,007 |
Statements of Operations and Comprehensive Loss
| Year Ended December 31, | ||||||
| (in thousands, except share and per share data) | 2021 | 2020 | ||||
| Operating expenses: | ||||||
| Research and development | $ | 117,673 | $ | 81,788 | ||
| Acquired in-process research and development | 8,000 | 1,000 | ||||
| General and administrative | 60,056 | 30,114 | ||||
| Loss from operations | (185,729) | (112,902) | ||||
| Interest income, net | 343 | 670 | ||||
| Net loss | $ | (185,386) | $ | (112,232) | ||
| Per share information: | ||||||
| Net loss per share of common stock, basic and diluted | $ | (3.48) | $ | (2.91) | ||
| Weighted average common shares outstanding, basic and diluted | 53,343,959 | 38,615,967 | ||||
| Comprehensive loss: | ||||||
| Net loss | $ | (185,386) | $ | (112,232) | ||
| Unrealized gain (loss) on marketable securities | (401) | (12) | ||||
| Comprehensive loss | $ | (185,787) | $ | (112,244) |