PepGen Inc. - PEPG STOCK NEWS

PepGen Inc. (Nasdaq: PEPG) announced its participation in the 29th Annual Congress of the World Muscle Society (WMS) in Prague, Czech Republic, from October 8-12, 2024. The company will present a short oral presentation and five posters on their Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) programs.

CEO James McArthur highlighted the favorable emerging safety profile of PGN-EDO51 in the CONNECT1-EDO51 trial, with no serious adverse events reported. The presentations will cover clinical and preclinical data on PGN-EDO51 for DMD and PGN-EDODM1 for DM1. Chief Medical Officer Michelle Mellion and Director of Research & Preclinical Development Ashling Holland will be among the presenters.

The presentations will be available on PepGen's website after the conference.

PepGen Inc. (Nasdaq: PEPG) announced that Christopher Ashton, PhD, will retire from its Board of Directors effective September 30, 2024. Dr. Ashton has served on PepGen's Board since December 2019 and was a member of the audit and compensation committees. Laurie Keating, JD, Chair of PepGen's Board, expressed gratitude for Dr. Ashton's nearly five years of service and valuable contributions.

Dr. Ashton cited his desire to focus on guiding pre-IPO companies as the reason for his retirement. He expressed confidence in PepGen's future, noting the company's progress in developing potential best-in-class therapies for serious neuromuscular and neurological diseases. Following Dr. Ashton's resignation, the size of PepGen's Board will be reduced from seven to six directors.

PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company, has awarded an inducement grant to its newly appointed Executive Vice President of Research & Development, Paul D. Streck, M.D., MBA. The grant, made under PepGen's 2024 Inducement Plan, includes a non-qualified stock option to purchase 202,816 shares of PepGen's common stock at $9.83 per share. The option has a ten-year term and will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following three years. This grant was approved outside of PepGen's stockholder-approved equity incentive plans, in accordance with Nasdaq Listing Rule 5635(c)(4).

PepGen Inc. (Nasdaq: PEPG) has appointed Paul Streck, M.D., MBA, as Executive Vice President, Head of Research & Development, effective immediately. Dr. Streck brings over 20 years of experience in drug development, regulatory, and medical affairs leadership to the clinical-stage biotechnology company. His impressive track record includes five IND approvals, six global regulatory launches, and nine commercial product launches.

Dr. Streck's extensive experience spans both large and small publicly traded biopharmaceutical companies, including roles as Chief Medical Officer at Albireo Pharma, Arena Pharmaceuticals, Alder Biopharmaceuticals, and Insmed. He has also held positions at GSK, Shire, and Amgen. This appointment comes at a important time for PepGen as they advance four active clinical trials and expand their pipeline of preclinical candidates in the field of oligonucleotide therapies for severe neuromuscular and neurological diseases.

PepGen Inc. (Nasdaq: PEPG) reported Q2 2024 financial results and corporate highlights. Key points:

1. CONNECT1-EDO51 trial: PGN-EDO51 at 5 mg/kg was well-tolerated, achieving mean exon skipping of 2.15% and mean dystrophin production increase of 0.26% after three months.

2. FREEDOM2-DM1 trial cleared by Health Canada and U.K. regulators, with initial dosing expected in H2 2024.

3. FREEDOM-DM1 trial results update expected in Q4 2024.

4. Financial position: $161.3 million in cash and equivalents as of June 30, 2024, expected to fund operations into 2026.

5. Q2 2024 net loss: $28.3 million, or $(0.87) per share.

PepGen Inc. (Nasdaq: PEPG) announced positive clinical data from the first dose cohort (5 mg/kg) of PGN-EDO51, its lead candidate for Duchenne muscular dystrophy (DMD) patients amenable to exon 51-skipping. In the CONNECT1-EDO51 Phase 2 trial, PGN-EDO51 showed:

• Mean exon skipping levels of 2.15% after three months
• Mean muscle-adjusted dystrophin level of 1.49%, a 0.70% increase from baseline
• Mean absolute dystrophin level of 0.61%, a 0.26% increase from baseline

The 5 mg/kg dose was well-tolerated, with all patients continuing to the long-term extension. Dosing of the second cohort at 10 mg/kg is ongoing. PepGen plans to optimize the design of the CONNECT2 Phase 2 trial based on these results.

PepGen has expanded its executive team with the appointments of Afsaneh Mohebbi, Ph.D., as Senior Vice President of Portfolio and Program Management, and Dave Borah, CFA, as Senior Vice President of Investor Relations and Corporate Communications. These appointments aim to strengthen PepGen's expertise as it prepares for significant clinical milestones in the second half of the year. Dr. Mohebbi brings extensive experience from her previous roles in biotech firms, including Agios Pharmaceuticals and Shire Human Genetic Therapies. She has a proven track record in advancing clinical candidates and managing cross-functional teams. Dave Borah, CFA, comes with over 20 years of experience in investor relations and corporate communications, having served at Mural Oncology and Bicycle Therapeutics. His background includes successful equity raises and increased analyst coverage, making him a valuable addition to PepGen's strategic communications efforts.

PepGen, a clinical-stage biotechnology company, announced two executive promotions. Michelle Mellion, M.D., is now Chief Medical Officer, and Hayley Parker, Ph.D., is the new Senior Vice President of Global Regulatory Affairs. These promotions highlight their significant contributions to PepGen's clinical and regulatory strategies. Mellion has been pivotal in advancing the company's neuromuscular programs and has a rich background in clinical development and neurology. Parker has been essential in shaping PepGen's global regulatory strategy, bringing extensive experience in regulatory affairs and rare diseases. These leadership changes aim to bolster PepGen's efforts in developing innovative oligonucleotide therapies for severe neuromuscular and neurological diseases.

PepGen (Nasdaq: PEPG), a clinical-stage biotech company, reported its Q1 2024 financial results and recent corporate highlights. Key points include the expected mid-2024 preliminary data from the CONNECT1-EDO51 trial and second half 2024 data from the FREEDOM1-DM1 trial. PepGen raised $86.3 million from stock offerings, extending its cash runway into 2026. Research and Development expenses for Q1 2024 were $14.7 million, up from $14.4 million in Q1 2023, and General and Administrative expenses rose to $5.1 million from $3.7 million. The company reported a net loss of $18.0 million, compared to $16.3 million in Q1 2023. They had 32.4 million shares outstanding as of March 31, 2024.