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 Operations and Financial Condition.
On March 23, 2023, PepGen Inc. announced its financial results for the year ended December 31, 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 |
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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 hereunto duly authorized.
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PEPGEN INC. |
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Date: |
March 23, 2023 |
By: |
/s/ Noel Donnelly |
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Noel Donnelly, Chief Financial Officer |
Exhibit 99.1
PepGen Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Developments
BOSTON, March 23, 2023 – PepGen Inc. (Nasdaq: PEPG), 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 fourth quarter and full year ended December 31, 2022 and highlighted recent corporate developments.
“2022 was a truly transformative year for PepGen, as we generated first-in-human data for PGN-EDO51, our lead product candidate for the treatment of Duchenne muscular dystrophy (DMD), in a Phase 1 Healthy Volunteer (HV) trial, completed a successful initial public offering and made meaningful progress across our pipeline of Enhanced Delivery Oligonucleotide (EDO) investigational therapeutics,” commented James McArthur, Ph.D., President and CEO of PepGen. “As we look ahead in 2023, we anticipate initiating two parallel Phase 2 studies of PGN-EDO51 in patients whose disease is amenable to an exon 51 skipping approach. Building on the safety profile and high levels of exon skipping and tissue concentration observed in our Phase 1 trial, and the accumulation of exon skipped transcript in preclinical repeat dose non-human primate (NHP) studies, we believe that repeat dosing of PGN-EDO51 may lead to the accumulation of exon 51 skipped transcript and dystrophin protein in patients, which may in turn drive meaningful clinical benefit for those who live with this devastating disease.”
Dr. McArthur continued, “PepGen also expects to initiate our Phase 1, randomized, placebo controlled, single ascending dose (SAD) clinical trial of PGN-EDODM1 for the treatment of myotonic dystrophy type 1 (DM1), in the first half of this year. Based on data obtained in our Phase 1 HV study of PGN-EDO51, we believe that PGN-EDODM1 has the potential to achieve tissue concentrations that could lead to clinically meaningful outcomes. We are committed to developing transformative therapeutics to address areas of great unmet need, and in 2023 we look forward to further strengthening our relationships across the rare disease community, from patients to their families, caregivers, physicians and beyond.”
Recent Corporate Highlights
Upcoming Anticipated Milestones
Financial Results for the three months and twelve months ended December 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 potential therapeutic benefits and safety profile of our candidates, initiation of the Phase 2 studies in PGN-EDO51 and the Phase 1 study in PGN-EDODM1, our interpretation of clinical and preclinical study results and how they may impact our programs, the filing of an IND application for PGN-EDODM1, scheduled participation and presentation of information in conferences 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 initiate or complete our planned clinical trials for PGN-EDO51 and and PGN-EDODM1 and preclinical studies of other product candidates or to obtain regulatory approval before commercialization for marketing of such products; our interpretation of clinical and preclinical study results may be incorrect; 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 take advantage of certain accelerated regulatory pathways; 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; we may encounter liquidity distress due to failure of financial institutions with which we maintain relationship; 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 annual report on Form 10-K 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, in thousands except share and per share amounts)
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Twelve Months Ended |
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Three Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
$ |
54,077 |
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$ |
18,999 |
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$ |
13,166 |
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$ |
4,541 |
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General and administrative |
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14,224 |
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8,110 |
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4,047 |
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2,670 |
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Total operating expenses |
$ |
68,301 |
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$ |
27,109 |
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$ |
17,213 |
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$ |
7,211 |
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Operating loss |
$ |
(68,301 |
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$ |
(27,109 |
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$ |
(17,213 |
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$ |
(7,211 |
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Other income (expense) |
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Interest income |
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2,793 |
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— |
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1,591 |
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— |
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Other income (expense), net |
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110 |
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(172 |
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(28 |
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67 |
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Total other income (expense), net |
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2,903 |
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(172 |
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1,563 |
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67 |
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Net loss before income tax |
$ |
(65,398 |
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$ |
(27,281 |
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$ |
(15,650 |
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$ |
(7,144 |
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Income tax expense |
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(3,706 |
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— |
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714 |
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— |
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Net loss |
$ |
(69,104 |
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$ |
(27,281 |
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$ |
(14,936 |
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$ |
(7,144 |
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Condensed Consolidated Balance Sheets
(unaudited, in thousands)
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December 31, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
181,752 |
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$ |
132,895 |
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Other receivables |
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58 |
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4,744 |
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Prepaid expenses and other current assets |
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4,273 |
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2,347 |
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Total current assets |
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$ |
186,083 |
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$ |
139,986 |
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Property and equipment, net |
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3,335 |
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636 |
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Operating lease right-of-use assets |
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26,549 |
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— |
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Other assets |
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1,473 |
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3,019 |
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Total assets |
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$ |
217,440 |
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$ |
143,641 |
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Liabilities, convertible preferred stock, and stockholders’ equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
1,362 |
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$ |
3,240 |
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Accrued expenses |
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11,913 |
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7,081 |
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Operating lease liabilities |
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5,553 |
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— |
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Total current liabilities |
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18,828 |
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10,321 |
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Preferred stock warrant liability |
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— |
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226 |
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Operating lease liabilities, net of current portion |
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18,981 |
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— |
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Total liabilities |
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37,809 |
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10,547 |
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Commitments and contingencies |
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Convertible preferred stock |
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— |
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165,176 |
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Stockholders’ equity (deficit) |
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Common stock |
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2 |
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— |
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Additional paid-in capital |
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282,566 |
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1,653 |
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Accumulated other comprehensive (loss) income |
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(81 |
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17 |
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Accumulated deficit |
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(102,856 |
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(33,752 |
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Total stockholders’ equity (deficit) |
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179,631 |
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(32,082 |
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Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) |
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$ |
217,440 |
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$ |
143,641 |
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