PHILADELPHIA, Aug. 05, 2021 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2021 and provided recent business highlights.

“As we advance our pipeline and invest in our capabilities, we are committed to becoming a leader in developing transformative genetic medicines for people with CNS disorders,” said Bruce Goldsmith, Ph.D., president and chief executive officer of Passage Bio. “I am extremely excited about the opportunity that the expanded partnership with Penn’s Gene Therapy Program creates for us to address the significant unmet needs of not only rare but also larger patient populations impacted by devastating CNS disorders. Our expanded research collaboration will include the identification of relevant biological targets for genetic modulation. We also have continued to build the talent of our company so that we can efficiently and effectively execute our clinical programs and new research opportunities. I’m also very pleased with our recent executive appointments.”

James M. Wilson, M.D., Ph.D., chief scientific advisor for Passage Bio; Rose H. Weiss professor and director, Orphan Disease Center; professor in Departments of Medicine and Pediatrics, Perelman School of Medicine; and director of University of Pennsylvania’s Gene Therapy Program (GTP), said: “We are delighted with the progress that has been made through our collaborative R&D relationship with Passage Bio. Extending the scope of our collaboration is a logical next step and will allow us to deploy our gene therapy technologies into potential treatments for even larger patient populations that suffer from severe disabling and lethal neurological diseases.”

Eliseo Salinas, M.D., MSc., chief R&D officer of Passage Bio, added: “As we broaden our CNS pipeline, we also continue to prioritize execution against our three lead clinical development programs. We are making steady progress opening our global network of clinical sites across nine countries and three continents and managing through lingering COVID-19 pandemic impacts. We continue to expect to dose the first patients in the third quarter for our clinical trials for frontotemporal dementia with granulin mutations, upliFT-D; and Krabbe disease, GALax-C. We also expect to report initial safety and 30-day biomarker data in the fourth quarter for our ongoing Imagine-1 global trial for GM1 gangliosidosis. We’re excited by the momentum we’re building in our journey to deliver life-transforming therapies for patients with rare CNS disorders.”

Recent Highlights

Anticipated Upcoming Milestones

Second Quarter 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 4037236. 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.

About Passage Bio

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.

Penn Financial Disclosure

Dr. Wilson is a chief scientific advisor, collaborator, consultant and co-founder of Passage Bio. As such, he holds an equity stake in the company, his laboratory at Penn receives sponsored research funding from Passage Bio, and as an inventor of certain Penn intellectual property that is licensed to Passage Bio, Dr. Wilson may receive additional financial benefits in the future. The University of Pennsylvania receives sponsored research funding from Passage Bio and has licensed intellectual property to the company that may result in future financial returns to Penn.

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 regarding our new research program with Penn’s Gene Therapy Program in large indications, including whether the expanded collaboration will result in any new product candidates in the selected targets or other indications; 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 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.

For further information, please contact:

Investors:
Stuart Henderson
Passage Bio
267.866.0114
shenderson@passagebio.com

Media:
Gwen Fisher
Passage Bio
215.407.1548
gfisher@passagebio.com


Passage Bio, Inc.
Balance Sheets
(Unaudited)

       
(in thousands, except share data)    June 30, 2021    December 31, 2020
Assets        
Current assets:        
Cash and cash equivalents $215,457  $135,002 
Marketable securities  192,343   169,815 
Prepaid expenses and other current assets  3,863   1,405 
Prepaid research and development  7,176   10,961 
Total current assets  418,839   317,183 
Property and equipment, net  13,480   2,795 
Other assets  7,206   8,029 
Total assets $439,525  $328,007 
Liabilities and stockholders’ equity       
Current liabilities:       
Accounts payable $16,402  $5,265 
Accrued expenses and other current liabilities  14,847   15,910 
Total current liabilities  31,249   21,175 
Deferred rent  6,007   2,077 
Other liabilities  -   41 
Total liabilities  37,256   23,293 
       
Commitments and Contingencies       
       
Stockholders’ equity:       
Common stock, $0.0001 par value: 300,000,000 shares authorized; 54,066,165 shares issued and 53,956,380 shares outstanding at June 30, 2021 and 45,917,084 shares issued and 45,614,807 shares outstanding at December 31, 2020  5   4 
Additional paid-in capital  660,457   475,617 
Accumulated other comprehensive income (loss)  19   (12)
Accumulated deficit  (258,212)  (170,895)
Total stockholders’ equity  402,269   304,714 
Total liabilities and stockholders’ equity $439,525  $328,007 


Passage Bio, Inc.
Statements of Operations and Comprehensive Loss
(Unaudited)

  Three Months Ended June 30,
 Six Months Ended June 30,
 
(in thousands, except share and per share data)    2021
 2020
 2021
 2020
Operating expenses:                
Research and development $33,112  $19,902  $58,082  $33,019 
Acquired in-process research and development  —   —   1,500   — 
General and administrative  15,422   7,402   27,886   12,197 
Loss from operations  (48,534)  (27,304)  (87,468)  (45,216)
Interest income, net  99   132   151   459 
Net loss $(48,435) $(27,172) $(87,317) $(44,757)
Per share information:                   
Net loss per share of common stock, basic and diluted $(0.90) $(0.60) $(1.66) $(1.42)
Weighted average common shares outstanding, basic and diluted  53,885,651   45,386,308   52,615,606   31,581,851 
Comprehensive loss:                
Net loss $(48,435) $(27,172) $(87,317) $(44,757)
Unrealized gain on marketable securities  26   —   31   — 
Comprehensive loss $(48,409) $(27,172) $(87,286) $(44,757)