PepGen Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights
PepGen Inc. (PEPG) reported Q3 2024 financial results with a net loss of $21.4 million ($0.66 per share), compared to $23.3 million ($0.98 per share) in Q3 2023. The company ended the quarter with $138.9 million in cash and equivalents, expected to fund operations into 2026. R&D expenses decreased to $17.7 million from $20.5 million year-over-year, while G&A expenses increased to $5.4 million from $4.2 million.
The company expects to report data from the FREEDOM-DM1 trial's 5 and 10 mg/kg cohorts in Q1 2025, and from the CONNECT1-EDO51 10 mg/kg cohort by end-2025. PepGen strengthened its leadership by appointing Paul Streck as Head of R&D.
PepGen Inc. (PEPG) ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando una perdita netta di 21,4 milioni di dollari (0,66 dollari per azione), rispetto a una perdita di 23,3 milioni di dollari (0,98 dollari per azione) nel terzo trimestre 2023. L'azienda ha chiuso il trimestre con 138,9 milioni di dollari in contante e equivalenti, che dovrebbero finanziare le operazioni fino al 2026. Le spese per ricerca e sviluppo sono diminuite a 17,7 milioni di dollari rispetto ai 20,5 milioni dell'anno precedente, mentre le spese generali e amministrative sono aumentate a 5,4 milioni di dollari rispetto ai 4,2 milioni.
L'azienda prevede di riportare i dati sui gruppi di 5 e 10 mg/kg del trial FREEDOM-DM1 nel primo trimestre del 2025, e sui gruppi da 10 mg/kg del trial CONNECT1-EDO51 entro la fine del 2025. PepGen ha rafforzato la sua dirigenza nominando Paul Streck come responsabile della ricerca e sviluppo.
PepGen Inc. (PEPG) informó los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 21.4 millones de dólares (0.66 dólares por acción), en comparación con una pérdida de 23.3 millones de dólares (0.98 dólares por acción) en el tercer trimestre de 2023. La compañía cerró el trimestre con 138.9 millones de dólares en efectivo y equivalentes, que se espera financien las operaciones hasta 2026. Los gastos en I+D disminuyeron a 17.7 millones de dólares desde 20.5 millones, mientras que los gastos generales y administrativos aumentaron a 5.4 millones de dólares desde 4.2 millones.
Se espera que la empresa reporte datos de los grupos de 5 y 10 mg/kg del ensayo FREEDOM-DM1 en el primer trimestre de 2025, y del grupo de 10 mg/kg del ensayo CONNECT1-EDO51 para finales de 2025. PepGen fortaleció su liderazgo nombrando a Paul Streck como jefe de I+D.
PepGen Inc. (PEPG)는 2024년 3분기 재무 결과를 발표하며 2,140만 달러(주당 0.66달러)의 순손실을 기록했다고 전했습니다. 2023년 3분기에는 2,330만 달러(주당 0.98달러)의 순손실이 있었습니다. 회사는 1억 3,890만 달러의 현금 및 현금성 자산을 보유하여 2026년까지 운영 자금을 지원할 예정입니다. 연구 개발 비용은 전년 대비 2050만 달러에서 1,770만 달러로 감소했으며, 관리 비용은 420만 달러에서 540만 달러로 증가했습니다.
회사는 2025년 1분기까지 FREEDOM-DM1 시험의 5mg/kg 및 10mg/kg 집단의 데이터를 보고할 예정이며, 2025년 말까지 CONNECT1-EDO51의 10mg/kg 집단의 데이터를 보고할 계획입니다. PepGen은 Paul Streck을 연구 개발 책임자로 임명하여 리더십을 강화했습니다.
PepGen Inc. (PEPG) a annoncé les résultats financiers du troisième trimestre 2024, montrant une perte nette de 21,4 millions de dollars (0,66 dollar par action), comparé à une perte de 23,3 millions de dollars (0,98 dollar par action) au troisième trimestre 2023. L'entreprise a terminé le trimestre avec 138,9 millions de dollars en liquidités et équivalents, prévu pour financer ses opérations jusqu'en 2026. Les dépenses en recherche et développement ont diminué à 17,7 millions de dollars contre 20,5 millions l'année précédente, tandis que les dépenses générales et administratives ont augmenté à 5,4 millions de dollars contre 4,2 millions.
La société prévoit de communiquer les données des cohortes de 5 mg/kg et 10 mg/kg de l'essai FREEDOM-DM1 au premier trimestre 2025, et des cohortes de 10 mg/kg de l'essai CONNECT1-EDO51 d'ici la fin 2025. PepGen a renforcé sa direction en nommant Paul Streck comme responsable de la recherche et développement.
PepGen Inc. (PEPG) hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht, mit einem Nettverlust von 21,4 Millionen USD (0,66 USD pro Aktie), verglichen mit einem Verlust von 23,3 Millionen USD (0,98 USD pro Aktie) im dritten Quartal 2023. Das Unternehmen schloss das Quartal mit 138,9 Millionen USD in Bargeld und Äquivalenten, die voraussichtlich die Betriebe bis 2026 finanzieren werden. Die F&E-Ausgaben gingen im Jahresvergleich von 20,5 Millionen USD auf 17,7 Millionen USD zurück, während die allgemeinen und administrativen Ausgaben von 4,2 Millionen USD auf 5,4 Millionen USD anstiegen.
Das Unternehmen erwartet, im ersten Quartal 2025 Daten zu den 5 mg/kg und 10 mg/kg Kohorten der FREEDOM-DM1-Studie und bis Ende 2025 Daten zur 10 mg/kg Kohorte der CONNECT1-EDO51-Studie zu berichten. PepGen verstärkte seine Führungsriege, indem Paul Streck zum Leiter der F&E ernannt wurde.
- Cash position of $138.9 million sufficient to fund operations into 2026
- Reduced R&D expenses by $2.8 million year-over-year
- Decreased net loss per share from $0.98 to $0.66
- Net loss of $21.4 million in Q3 2024
- Increased G&A expenses by $1.2 million year-over-year
Insights
PEPG's Q3 results show a
The company's clinical pipeline progress in DM1 and DMD treatments represents significant potential value drivers. Key catalysts include data readouts from FREEDOM-DM1 in Q1 2025 and CONNECT1-EDO51 by end of 2025. Protocol optimizations for both CONNECT studies demonstrate strategic adaptation based on early results, potentially improving the probability of successful outcomes.
The optimization of CONNECT program protocols shows promising development strategy, particularly the extension of biopsy timing to Day 28 and adjustment of PUL test entry scores. The expansion of the 10 mg/kg cohort suggests confidence in safety profiles. The dual-track development of treatments for both DM1 and DMD provides multiple shots on goal in the neuromuscular disease space.
The FREEDOM-DM1 trial's progression with fully enrolled 10 mg/kg cohort and upcoming data from both 5 and 10 mg/kg cohorts represents a critical milestone. The initiation of FREEDOM2 Phase 2 trial by year-end adds another significant value-creating opportunity in the DM1 program.
– 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 –
“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
-
Phase 1 FREEDOM-DM1 Clinical Trial of PGN-EDODM1: The FREEDOM Phase 1 single ascending dose (SAD) study continues, and the Company expects to report safety, splicing correction and functional outcome measures from both the 5 mg/kg and 10 mg/kg dose cohorts by the end of the first quarter of 2025. The FREEDOM study is evaluating PGN-EDODM1 in approximately 32 adult patients with DM1 in
the United States ,Canada , and theUnited Kingdom . The Company expects to report results from the 15 mg/kg cohort in the second half of 2025.
-
Phase 2 FREEDOM2-DM1 Clinical Trial of PGN-EDODM1: FREEDOM2 is a Phase 2 randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) clinical trial evaluating PGN-EDODM1 in approximately 24 adult patients with DM1 in
Canada , theUnited Kingdom , and, subject to regulatory clearance,the United States . The Company expects to initiate dosing in FREEDOM2 by year-end.
PGN-EDO51: Duchenne Muscular Dystrophy
- Phase 2 CONNECT1-EDO51 Clinical Trial of PGN-EDO51: Following encouraging data from the 5 mg/kg cohort reported in July, the Company continues to advance the CONNECT1 study. Based on learnings from the 5 mg/kg cohort, PepGen has amended the CONNECT1 study protocol. The changes include adjusting the timing for the final biopsy from Day 7 to Day 28 following the last dose of PGN-EDO51, adjusting the Performance of Upper Limb (PUL) test entry score from 3 to 4 for inclusion, and adjusting the eligible age group from 8 years of age and older to 6-16 years of age, all subject to regulatory clearance. The Company has also expanded the 10 mg/kg cohort from 3 to 4 participants. With these adjustments, the Company now expects to report results from the 10 mg/kg cohort by year-end 2025.
-
Phase 2 CONNECT2-EDO51 Clinical Trial of PGN-EDO51: Based on the data from CONNECT1, including the favorable emerging safety profile of PGN-EDO51, the Company is also working to optimize the design of the multinational CONNECT2 Phase 2 double-blind, placebo-controlled, MAD, 25-week trial. The CONNECT2 clinical trial is open in the
United Kingdom . The Company continues to engage with regulators in the European Union and expects to open the clinical trial inthe United States by year-end, subject to regulatory clearance.
Corporate Update
- In August, PepGen appointed Paul Streck, MD, MBA, as Executive Vice President and Head of the Company’s R&D organization. He brings more than 20 years of leadership experience in drug development, regulatory, and medical affairs.
- In September and October, the Company presented scientific and clinical data at numerous medical conferences, including at the 29th Annual Congress of the World Muscle Society. All of the presentations are available on the Investors page of PepGen’s website under Scientific Publications.
Financial Results for the Three Months Ended September 30, 2024
-
Cash, Cash Equivalents and Marketable Securities were
$138.9 million -
Research and Development Expenses were
$17.7 million $20.5 million -
General and Administrative Expenses were
$5.4 million $4.2 million -
Net Loss was
$21.4 million $(0.66) $23.3 million $(0.98)
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
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
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) |
||||||||
|
|
Three Months Ended
|
||||||
|
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
|
||||
Research and development |
|
$ |
17,722 |
|
|
$ |
20,540 |
|
General and administrative |
|
|
5,449 |
|
|
|
4,240 |
|
Total operating expenses |
|
$ |
23,171 |
|
|
$ |
24,780 |
|
Operating loss |
|
$ |
(23,171 |
) |
|
$ |
(24,780 |
) |
Other income (expense) |
|
|
|
|
||||
Interest income |
|
|
1,826 |
|
|
|
1,578 |
|
Other (expense) income, net |
|
|
(39 |
) |
|
|
(88 |
) |
Total other income, net |
|
|
1,787 |
|
|
|
1,490 |
|
Net loss before income tax |
|
$ |
(21,384 |
) |
|
$ |
(23,290 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(21,384 |
) |
|
$ |
(23,290 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.66 |
) |
|
$ |
(0.98 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
32,581,542 |
|
|
|
23,790,430 |
|
Condensed Consolidated Balance Sheets (unaudited, in thousands) |
|||||
|
September 30, |
|
December 31, |
||
|
|
2024 |
|
|
2023 |
Assets |
|
|
|
||
Cash, cash equivalents and marketable securities |
$ |
138,857 |
|
$ |
110,407 |
Other assets |
|
31,377 |
|
|
32,645 |
Total assets |
$ |
170,234 |
|
$ |
143,052 |
Liabilities and stockholders’ equity |
|
|
|
||
Liabilities |
$ |
32,779 |
|
$ |
34,631 |
Stockholders’ equity |
|
137,455 |
|
|
108,421 |
Total liabilities and stockholders’ equity |
$ |
170,234 |
|
$ |
143,052 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107757419/en/
Investor Contact
Dave Borah, CFA
SVP, Investor Relations and Corporate Communications
dborah@pepgen.com
Media Contact
Julia Deutsch
Lyra Strategic Advisory
Jdeutsch@lyraadvisory.com
Source: PepGen Inc.
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