Avidity Biosciences, Inc. Stock Price, News & Analysis

Avidity Biosciences (Nasdaq: RNA), a biopharmaceutical company developing Antibody Oligonucleotide Conjugates (AOCs™), has announced plans for a $250 million public offering of common stock. The company also intends to grant underwriters a 30-day option to purchase up to an additional $37.5 million of shares. Leerink Partners and TD Cowen are acting as joint bookrunning managers for the offering.

Avidity plans to use the net proceeds to fund clinical programs, advance AOC platform research and development, and for working capital and general corporate purposes. The offering is subject to market conditions, and there is no assurance regarding its completion or terms.

Avidity Biosciences (Nasdaq: RNA) reported positive Q2 2024 results and significant progress in its clinical trials. Key highlights include:

1. Positive del-zota data showing a 25% increase in dystrophin production for DMD44 patients.

2. Initiation of the global Phase 3 HARBOR™ trial for del-desiran in DM1 patients.

3. Breakthrough Therapy designation for del-desiran from the FDA.

4. Positive del-brax data with >50% reduction in DUX4 regulated genes for FSHD patients.

5. Plans to accelerate registrational cohorts for del-brax.

6. Announcement of lead precision cardiology program target planned for Q4 2024.

7. Strong financial position with $1.3 billion cash on hand.

Financials: Q2 2024 collaboration revenue was $2.0 million, R&D expenses increased to $63.9 million, and G&A expenses rose to $20.7 million.

Avidity Biosciences (Nasdaq: RNA) announced positive results for delpacibart zotadirsen (AOC 1044) in the Phase 1/2 EXPLORE44™ trial for Duchenne muscular dystrophy (DMD44). The drug demonstrated:

• Unsurpassed muscle concentrations of PMO at 200 nM after three 5 mg/kg doses
• 37% increase in exon 44 skipping, up to 66% with 5 mg/kg dose
• 25% increase in dystrophin production, restoring up to 54% of normal levels
• Over 80% reduction in creatine kinase levels
• Favorable safety and tolerability profile

These results suggest potential for changing the treatment paradigm for DMD44 patients. The company plans to expedite the regulatory path for delpacibart zotadirsen and advance additional exon-skipping DMD candidates.

Avidity Biosciences (Nasdaq: RNA) has announced inducement grants for its new Chief Legal Officer and Corporate Secretary, John B. Moriarty, Jr. The grants, approved on August 1, 2024, include:

• A non-qualified stock option to purchase 160,000 shares of common stock
• 25,000 restricted stock units (RSUs)

These awards were granted under the company's 2022 Employment Inducement Incentive Award Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). The stock option has an exercise price of $44.57 per share, equal to the closing price of Avidity's stock on August 1, 2024. The stock option will vest over four years, while the RSUs will vest in four equal annual installments, both subject to Mr. Moriarty's continued employment.

Avidity Biosciences (Nasdaq: RNA) has appointed John B. Moriarty, Jr., J.D. as Chief Legal Officer and Corporate Secretary, effective immediately. With nearly 30 years of industry experience, Moriarty brings extensive legal expertise to guide the company through transformational growth. He succeeds John W. Wallen III, Ph.D., J.D., who will remain with the company through year-end and transition as a consultant.

Moriarty's previous roles include Executive VP and Chief Legal Officer at Mirati Therapeutics, Chief Legal Officer at Olema Oncology, and General Counsel positions at Portola Pharmaceuticals, Alexion, and Elan His appointment comes as Avidity advances three clinical development programs for rare muscle diseases and expands its AOC platform pipeline.

Avidity Biosciences (Nasdaq: RNA) has announced inducement grants under Nasdaq Listing Rule 5635(c)(4). The company's Human Capital Management Committee granted non-qualified stock options to purchase 128,200 shares of common stock and 22,100 restricted stock units (RSUs) to six new non-executive employees. These awards were granted under the 2022 Employment Inducement Incentive Award Plan as inducements for new employees joining Avidity.

The stock options have an exercise price of $45.12 per share, equal to the closing price of Avidity's common stock on July 19, 2024. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months. The RSUs will vest in four equal annual installments. Both are subject to continued employment with Avidity.

Avidity Biosciences (Nasdaq: RNA) announced the granting of non-qualified stock options and restricted stock units (RSUs) on June 20, 2024. The Human Capital Management Committee awarded options to purchase 173,300 shares and 86,650 RSUs to 14 new non-executive employees under the 2022 Employment Inducement Incentive Award Plan. The exercise price for the options is $37.61 per share, matching the closing price on June 20, 2024. The options and RSUs will vest over four years, contingent on continued employment. These inducements comply with Nasdaq Listing Rule 5635(c)(4).

Avidity Biosciences (Nasdaq: RNA) has partnered with the FSHD Society to raise awareness of facioscapulohumeral muscular dystrophy (FSHD) on World FSHD Day. In a webinar today at 1:00 p.m. ET, they will present promising initial data from their Phase 1/2 FORTITUDE trial. The trial investigates del-brax, the first therapy targeting the root cause of FSHD, showing over 50% reduction in DUX4 regulated genes and functional improvements for participants. Avidity emphasizes their commitment to advancing treatments for FSHD, a debilitating genetic disorder. The FSHD Society, a leading patient organization, supports this initiative, hopeful for a potential treatment from the FORTITUDE study.

Avidity Biosciences has concluded an upsized public offering of 12,132,500 shares of common stock, priced at $38.00 per share, including 1,582,500 shares sold under the underwriters' option. The gross proceeds from the offering amount to $461 million before deductions. The funds will support the development of Avidity's clinical programs, research and development of its AOC platform, and general corporate purposes. Joint bookrunning managers for the offering included TD Cowen, Leerink Partners, Cantor, Barclays, and Wells Fargo Securities. The offering was made under an automatically effective shelf registration filed with the SEC.