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 November 7, 2024, PepGen Inc. announced its financial results for the quarter ended September 30, 2024 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:
Exhibit Number |
Description |
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: |
November 7, 2024 |
By: |
/s/ Noel Donnelly |
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Noel Donnelly, Chief Financial Officer |
PepGen Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights
– FREEDOM-DM1 data from 5 and 10 mg/kg cohorts in patients with DM1 expected
in the first quarter of 2025 –
– Study designs of CONNECT program optimized based on encouraging results from early cohort –
– Strengthened leadership team with addition of Paul Streck, MD, MBA, as head of R&D –
BOSTON— November 7, 2024-- 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 and recent corporate highlights for the quarter ended September 30, 2024.
“We are pleased with the progress we have made across our pipeline and organization during the third quarter, as we continued to advance our lead clinical programs and strengthened our leadership team with the addition of Paul Streck to head our research and clinical development efforts. Paul has already made a positive impact on our organization and our clinical development strategy in both myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD),” said James McArthur, PhD, President and CEO of PepGen. Said Paul Streck, MD, MBA, Head of R&D: “In our DM1 program, the 10 mg/kg cohort of our FREEDOM-DM1 study is fully enrolled and we are encouraged by the emerging data from both the 5 and 10 mg/kg cohorts. We look forward to presenting a fulsome update of both cohorts by the end of the first quarter of 2025, followed by additional data readouts expected from the DM1 and DMD programs during 2025.”
Continued Dr. McArthur: “We leveraged the encouraging 5 mg/kg results from our CONNECT1-EDO51 study in DMD reported in July to further optimize the study designs of both CONNECT1 and CONNECT2-EDO51. With these protocol enhancements in place, we expect to report data from the expanded CONNECT1 10 mg/kg cohort before year-end 2025. We remain deeply committed to advancing our programs with the goal of improving the lives of individuals suffering from severe neuromuscular and neurological diseases.”
Recent Program Updates
PGN-EDODM1: Myotonic Dystrophy Type 1
PGN-EDO51: Duchenne Muscular Dystrophy
Corporate Update
Financial Results for the Three Months Ended September 30, 2024
About PGN-EDODM1
PGN-EDODM1, PepGen's investigational candidate in development for the treatment of DM1, utilizes the Company's proprietary Enhanced Delivery Oligonucleotide (EDO) technology to deliver a therapeutic oligonucleotide that is designed to restore the normal splicing function of MBNL1, a key RNA splicing protein. DM1 is a progressively disabling, life-shortening genetic disorder. DM1 is estimated to affect 40,000 people in the United States, and over 74,000 people in Europe. The U.S. Food and Drug Administration has granted PGN-EDODM1 both Orphan Drug and Fast Track Designations for the treatment of patients with DM1.
About PGN-EDO51
PGN-EDO51, PepGen's clinical candidate for the treatment of DMD, utilizes the Company's proprietary EDO technology to deliver a therapeutic phosphorodiamidate morpholino oligomer (PMO) that is designed to target the root cause of this devastating disease. PGN-EDO51 is designed to skip exon 51 of the dystrophin transcript, an established therapeutic target for approximately 13% of DMD patients, thereby aiming to restore the open reading frame and enabling the production of a truncated, yet functional dystrophin protein. The U.S. Food and Drug Administration has granted PGN-EDO51 both Orphan Drug and Rare Pediatric Disease Designations for the treatment of patients with DMD amenable to an exon-51 skipping approach.
About PepGen
PepGen 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 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 designed to target the root cause of serious diseases.
For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.
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 therapeutic potential and safety profile of our product candidates, including, based on early data, PGN-EDO51 and PGN-EDODM1, the design, initiation and conduct of clinical trials, including expected timelines for our CONNECT1 and CONNECT2 Phase 2 trials, our FREEDOM Phase 1 trial and our FREEDOM2 Phase 2 trial, the expected timing for additional data reports from our CONNECT1 Phase 2 trial, and our FREEDOM Phase 1 trial, ongoing and planned regulatory interactions, and our financial resources and expected cash runway.
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 risks related to: delays or failure to successfully initiate or complete our ongoing and planned development activities for our product candidates, including PGN-EDO51 and PGN-EDODM1; our ability to enroll patients in our clinical trials, including CONNECT1, CONNECT2, FREEDOM and FREEDOM2; that our interpretation of clinical and preclinical study results may be incorrect, or that we may not observe the levels of therapeutic activity in clinical testing that we anticipate based on prior clinical or preclinical results, including for PGN-EDO51 and PGN-EDODM1; our product candidates, including PGN-EDO51 and PGN-EDODM1, may not be safe and effective or otherwise demonstrate safety and efficacy in our clinical trials; adverse outcomes from our regulatory interactions, including delays in regulatory review, clearance to proceed or approval by regulatory authorities with respect to our programs, including clearance to commence planned clinical studies of our product candidates, or other regulatory feedback requiring modifications to our development programs, including in each case with respect to our CONNECT1, CONNECT2, FREEDOM and FREEDOM2 clinical trials; changes in regulatory framework that are out of our control; unexpected increases in the expenses associated with our development activities or other events that adversely impact our financial resources and cash runway; and our dependence 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 our most recent annual report on Form 10-K and quarterly report on Form 10-Q that are filed with the SEC. PepGen explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
This release discusses PGN-EDO51 and PGN-EDODM1, investigational therapies that have not been approved for use in any country and is not intended to convey conclusions about their efficacy or safety. There is no guarantee that PGN-EDO51, PGN-EDODM1 or any other investigational therapy will successfully complete clinical development or gain regulatory authority approval.
Condensed Consolidated Statements of Operations
(unaudited, in thousands)
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Three Months Ended |
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2024 |
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2023 |
Operating expenses: |
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Research and development |
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$ 17,722 |
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$ 20,540 |
General and administrative |
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5,449 |
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4,240 |
Total operating expenses |
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$ 23,171 |
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$ 24,780 |
Operating loss |
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$ (23,171) |
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$ (24,780) |
Other income (expense) |
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Interest income |
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1,826 |
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1,578 |
Other (expense) income, net |
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(39) |
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(88) |
Total other income, net |
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1,787 |
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1,490 |
Net loss before income tax |
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$ (21,384) |
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$ (23,290) |
Income tax expense |
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— |
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— |
Net loss |
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$ (21,384) |
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$ (23,290) |
Net loss per share, basic and diluted |
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$ (0.66) |
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$ (0.98) |
Weighted-average common shares outstanding, basic and diluted |
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32,581,542 |
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23,790,430 |
Condensed Consolidated Balance Sheets
(unaudited, in thousands)
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September 30, |
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December 31, |
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2024 |
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2023 |
Assets |
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Cash, cash equivalents and marketable securities |
$ 138,857 |
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$ 110,407 |
Other assets |
31,377 |
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32,645 |
Total assets |
$ 170,234 |
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$ 143,052 |
Liabilities and stockholders’ equity |
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Liabilities |
$ 32,779 |
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$ 34,631 |
Stockholders’ equity |
137,455 |
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108,421 |
Total liabilities and stockholders’ equity |
$ 170,234 |
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$ 143,052 |
Investor Contact
Dave Borah, CFA
SVP, Investor Relations and Corporate Communications
dborah@pepgen.com
Media Contact
Julia Deutsch
Lyra Strategic Advisory
Jdeutsch@lyraadvisory.com