UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operation and Financial Condition
On August 12, 2022, PepGen Inc. announced its financial results for the quarter ended June 30, 2022 and other business updates. A copy of the press release is furnished as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibit relating to Item 2.02 of this Form 8-K shall be deemed to be furnished and not filed:
99.1 Press release issued by PepGen Inc. on August 12, 2022
104 Cover Page Interactive Data File (embedded within Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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PEPGEN INC. |
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Date: |
August 12, 2022 |
By: |
/s/ Noel Donnelly |
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Noel Donnelly, Chief Financial Officer |
PepGen Reports Second Quarter 2022 Financial Results and Recent Corporate Developments
Boston, August 12, 2022 – 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 second quarter ended June 30, 2022.
“During the second quarter we completed a successful initial public offering expected to fund operations into the first half of 2025 and initiated our Phase 1 Healthy Normal Volunteer (HNV) clinical trial of PGN-EDO51, our lead program for the treatment of Duchenne muscular dystrophy (DMD) patients who are amenable to an exon 51 skipping therapeutic approach,” stated James McArthur, Ph.D., President and CEO of PepGen. “PepGen looks forward to reporting the initial clinical results from our EDO51 HNV trial, including safety and tolerability, tissue drug pharmacokinetics and exon 51 skipping data, by the end of this year. In parallel, we are rapidly progressing our portfolio of Enhanced Delivery Oligonucleotide (EDO) therapeutics, and continue to drive towards an Investigational New Drug (IND) filing for PGN-EDODM1, our program for the treatment of myotonic dystrophy type 1 (DM1), in the first half of 2023. We also anticipate reporting non-human primate (NHP) data for PGN-EDO53, our program for the treatment of DMD patients who are amenable to an exon 53 skipping approach, and nominating our lead investigational drug candidates for DMD patients amenable to an exon 45 or exon 44 skipping approach, before the end of 2022.”
Recent Corporate Highlights
Upcoming Milestones Anticipated in 2022
Financial Results for the Three Months Ended June 30, 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 preclinical programs, product candidates, expected cash runway, achievement of milestones, and corporate and clinical/preclinical 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 preclinical studies of other product candidates or to obtain regulatory approval before commercialization for marketing of such products; our product candidates may not be safe and effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; we may not be able to nominate new drug candidates within the estimated timeframes; our estimation of addressable markets of our product candidates may be inaccurate; we may need additional funding before the end of our expected cash runway and may fail to timely raise such 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
gschanker@lifescicomms.com
Condensed Consolidated Statements of Operations
(unaudited)
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Three Months Ended |
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2022 |
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2021 |
Operating expenses: |
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Research and development |
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$ 14,240 |
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$ 3,216 |
General and administrative |
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3,401 |
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1,976 |
Total operating expenses |
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$ 17,641 |
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$ 5,192 |
Operating loss |
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(17,641) |
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(5,192) |
Other income (expense) |
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Interest income |
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250 |
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— |
Other income (expense), net |
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76 |
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(197) |
Total other income (expense), net |
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326 |
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(197) |
Net loss before income tax |
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$ (17,315) |
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$ (5,389) |
Income tax expense |
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— |
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— |
Net loss |
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$ (17,315) |
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$ (5,389) |
Net loss per share, basic and diluted |
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$ (1.23) |
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$ (6.03) |
Weighted-average common shares outstanding, basic and diluted |
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14,090,455 |
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894,060 |
Condensed Consolidated Balance Sheets
(unaudited)
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June 30, |
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December 31, |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 218,817 |
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$ 132,895 |
Other receivables |
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4,230 |
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4,744 |
Prepaid expenses and other current assets |
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3,433 |
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2,347 |
Total current assets |
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$ 226,480 |
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$ 139,986 |
Property and equipment, net |
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2,843 |
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636 |
Other assets |
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1,473 |
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3,019 |
Total assets |
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$ 230,796 |
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$ 143,641 |
Liabilities, convertible preferred stock, and stockholders’ equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ 5,392 |
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$ 3,240 |
Accrued expenses |
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15,185 |
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7,081 |
Total current liabilities |
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20,577 |
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10,321 |
Preferred stock warrant liability |
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— |
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226 |
Total liabilities |
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20,577 |
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10,547 |
Commitments and contingencies |
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Convertible preferred stock |
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— |
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165,176 |
Stockholders’ equity (deficit) |
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Common Stock |
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2 |
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— |
Additional paid-in capital |
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279,629 |
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1,653 |
Accumulated other comprehensive (loss) income |
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(99) |
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17 |
Accumulated deficit |
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(69,313) |
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(33,752) |
Total stockholders’ equity (deficit) |
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210,219 |
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(32,082) |
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) |
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$ 230,796 |
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$ 143,641 |