BOSTON, June 16, 2022 (GLOBE NEWSWIRE) — PepGen Inc. (“PepGen”), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the first quarter ended March 31, 2022.
“This has been a year of tremendous growth for PepGen, culminating in our recent transition to a clinical stage company and execution of a successful initial public offering,” stated James McArthur, Ph.D., President and CEO of PepGen. “We are continuing to drive our programs forward, and in April of this year we entered the clinic with PGN-EDO51, our lead program for the treatment of individuals with Duchenne muscular dystrophy (DMD) who are amenable to an exon 51 skipping approach. We look forward to reporting safety, pharmacokinetic and exon skipping data from our Phase 1 healthy normal volunteer study of PGN-EDO51 by the end of 2022 – this will be an important milestone in our efforts to advance this therapy for patients in desperate need of more effective treatment options.”
Recent Corporate Highlights
Anticipated Upcoming Milestones
Financial Results for the Three Months Ended March 31, 2022
About PepGen
PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the presentation of data from the ongoing Phase 1 study of PGN-EDO51, the filing of an IND application for PGN-EDODM1, the reporting of non-human primate data for PGN-EDO53 and the nomination of development candidates; and statements about our clinical and pre-clinical programs, product candidates, expected cash runway, achievement of milestones, and corporate and clinical/pre-clinical strategies.
Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may fail to successfully complete our Phase 1 trial for EDO51 and pre-clinical studies of other product candidates and obtain required approval before commercialization; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning PepGen’s programs and operations are described in its registration statement on Form S-1, which is on file with the SEC, and in its most recent quarterly report on Form 10-Q to be filed with the SEC. PepGen explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Investor Contact
Laurence Watts
Gilmartin Group
Laurence@gilmartinir.com
Media Contact
Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
gschanker@lifescicomms.com
Condensed Consolidated Statements of Operations (unaudited) |
|||||||
Three Months Ended March 31, |
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2022 | 2021 | ||||||
Operating expenses: | |||||||
Research and development | $ | 10,707 | $ | 5,530 | |||
General and administrative | 3,186 | 1,098 | |||||
Total operating expenses | $ | 13,893 | $ | 6,628 | |||
Operating loss | $ | (13,893 | ) | $ | (6,628 | ) | |
Other income (expense) | |||||||
Interest income | 9 | — | |||||
Other income (expense), net | 58 | (8 | ) | ||||
Total other income (expense), net | 67 | (8 | ) | ||||
Net loss before income tax | $ | (13,826 | ) | $ | (6,636 | ) | |
Income tax expense | (4,420 | ) | — | ||||
Net loss | $ | (18,246 | ) | $ | (6,636 | ) | |
Net loss per share, basic and diluted | $ | (18.94 | ) | $ | (7.42 | ) | |
Weighted-average common shares outstanding, basic and diluted | 963,588 | 894,060 | |||||
Condensed Consolidated Balance Sheets (unaudited) |
|||||||
March 31, 2022 |
December 31, 2021 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 118,854 | $ | 132,895 | |||
Other receivables | 4,574 | 4,744 | |||||
Prepaid expenses and other current assets | 2,240 | 2,347 | |||||
Total current assets | $ | 125,668 | $ | 139,986 | |||
Property and equipment, net | 2,569 | 636 | |||||
Other assets | 3,642 | 3,019 | |||||
Total assets | $ | 131,879 | $ | 143,641 | |||
Liabilities, convertible preferred stock, and stockholders’ deficit | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,888 | $ | 3,240 | |||
Accrued expenses | 14,234 | 7,081 | |||||
Total current liabilities | 16,122 | 10,321 | |||||
Preferred stock warrant liability | 168 | 226 | |||||
Total liabilities | 16,290 | 10,547 | |||||
Commitments and contingencies | |||||||
Convertible preferred stock | 165,176 | 165,176 | |||||
Stockholders’ deficit: | |||||||
Common Stock | — | — | |||||
Additional paid-in capital | 2,468 | 1,653 | |||||
Accumulated other comprehensive (loss) income | (57 | ) | 17 | ||||
Accumulated deficit | (51,998 | ) | (33,752 | ) | |||
Total stockholders’ deficit | (49,587 | ) | (32,082 | ) | |||
Total liabilities, convertible preferred stock, and stockholders’ deficit | $ | 131,879 | $ | 143,641 | |||
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