Annexon, Inc. (NASDAQ:ANNX) is one of the 12 hot penny stocks to invest in right now. Analyst Confidence Strong in Annexon (ANNX) Amid Vonaprument Advancement On November 19, 2025, The Fly reported that Wells Fargo increased its price target on Annexon, Inc. (NASDAQ:ANNX) from $14 to $27, while reiterating an “Overweight” rating. The investment firm’s price revision reflects its increased probability of success in the second half of 2026 for vonaprument’s Phase 3 trial in GA to 55% from 10%. The firm bel ...

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Summary of Annexon Conference Call Company Overview - **Company**: Annexon - **Industry**: Biotechnology, specifically focusing on neuroinflammatory diseases and autoimmune conditions Key Points Annexon's Unique Approach - Annexon is developing a next-generation complement platform targeting the neuroinflammatory cascade at the source of disease, differentiating it from downstream approaches targeting C3 and C5 [3][4] - The company is currently focused on two late-stage programs: - **Guillain-Barré Syndrome (GBS)**: Landmark WIN phase III program seeking global regulatory approval - **Geographic Atrophy (GA)**: Affects approximately 8 million patients, with significant vision preservation outcomes [3][4] Regulatory Milestones - Anticipated regulatory submissions for GBS in Europe by January 2026 and later in the year for the U.S. [4][12] - Phase III data for GA expected to read out in the second half of 2026 [4][5] Market Opportunity for GBS - GBS is considered a "sleeper blockbuster" with an annual patient population of 22,000-25,000 in the U.S. and Europe, with over 90% of patients receiving treatment [7][8] - Projected pricing for therapy ranges from $100,000 to $150,000, with a cost of goods sold under 3% [7][8] - The treatment is expected to significantly reduce hospital stays and associated costs, with GBS treatment costing nearly $5 billion annually in the U.S. [11] Efficacy and Safety Profile - The safety profile of Annexon's drug is comparable to placebo, with no significant adverse effects reported, unlike the standard of care (IVIG) which has a black box warning [9][10] - Approximately 90% of patients show improvement in muscle strength within the first week, with significant functional improvements noted by six months [10][11] Challenges in U.S. Regulatory Pathway - The U.S. regulatory process has been more complex, requiring additional data from U.S. patients due to ethical concerns regarding placebo-controlled studies [15][16] - Ongoing discussions with the FDA are focused on addressing the "America-first" policy approach, which may require additional U.S. patient data [22][23] Geographic Atrophy Program - The GA program is differentiated by its focus on stopping the inflammatory process at the source, aiming to protect neurons rather than just RPE cells [42][43] - The study has been over-enrolled to ensure robust statistical power for sub-analyses, with a focus on clinically meaningful endpoints [46][47] Future Directions - Annexon is exploring an oral program targeting classical complement pathways, with ongoing studies in cold agglutinin disease [52][53] - Potential future indications include myasthenia gravis and chronic forms of Guillain-Barré syndrome, with data expected in 2026 [57][58] Commercial Strategy - The company is not planning to market outside the U.S. directly but is in discussions for commercial partnerships in ex-U.S. regions [35] Additional Insights - The company emphasizes transparency in its clinical studies, aiming to provide consistent data across different patient populations [30][31] - The focus on neurodegenerative diseases and innovative treatment approaches positions Annexon as a key player in the biotechnology sector [42][43]

Core Viewpoint - Annexon, Inc. has successfully closed a public offering of 29,423,075 shares of common stock, raising approximately $86.25 million to advance its clinical platform targeting neuroinflammation in complement-mediated diseases [1][2]. Company Overview - Annexon, Inc. is focused on developing next-generation complement inhibitors aimed at stopping neuroinflammation, with a particular emphasis on C1q, which is crucial in the inflammatory pathway [5]. - The company’s pipeline addresses three therapeutic areas: autoimmunity, neurodegeneration, and ophthalmology, targeting unmet needs for nearly 10 million people globally [5]. Offering Details - The public offering included the full exercise of underwriters' options, resulting in the issuance of an additional 4,326,922 shares at a public price of $2.60 per share, along with pre-funded warrants for 3,750,000 shares at a price of $2.599 per share [1]. - The offering was conducted under a shelf registration statement filed with the SEC, which was declared effective in April 2024 [3].

Core Viewpoint - Annexon, Inc. has announced a public offering of common stock and pre-funded warrants to raise approximately $75 million to advance its clinical platform targeting neuroinflammation in complement-mediated diseases [1][2]. Group 1: Offering Details - The public offering consists of 25,096,153 shares of common stock priced at $2.60 per share and pre-funded warrants for 3,750,000 shares at a purchase price of $2.599 per share [1]. - The gross proceeds from the offering are expected to be $75 million before deducting underwriting discounts and commissions [2]. - The offering is set to close on November 14, 2025, subject to customary closing conditions [2]. Group 2: Underwriters - Goldman Sachs & Co. LLC, TD Cowen, and Wells Fargo Securities are acting as joint book-running managers for the offering [3]. Group 3: Company Overview - Annexon, Inc. is focused on developing complement inhibitors to address neuroinflammation, targeting diseases affecting the body, brain, and eye [6]. - The company's approach centers on C1q, aiming to prevent tissue damage caused by misdirected inflammatory pathways [6]. - Annexon's pipeline includes investigational drug candidates across autoimmunity, neurodegeneration, and ophthalmology, addressing the needs of nearly 10 million people globally [6].

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Core Viewpoint - Annexon, Inc. has initiated a public offering of $75 million in common stock or pre-funded warrants, with an additional option for underwriters to purchase up to $11.25 million more, aimed at advancing its clinical platform targeting neuroinflammation in complement-mediated diseases [1][2]. Company Overview - Annexon, Inc. is focused on developing next-generation complement inhibitors to address neuroinflammation, targeting diseases affecting the body, brain, and eye [5]. - The company’s approach centers on C1q, a key molecule in the inflammatory pathway, with the goal of preventing tissue damage in various diseases [5]. - Annexon’s pipeline includes investigational drug candidates across three therapeutic areas: autoimmunity, neurodegeneration, and ophthalmology, addressing the needs of nearly 10 million people globally [5]. Offering Details - The public offering is being conducted under a shelf registration statement filed with the SEC, with a preliminary prospectus supplement to be made available [3]. - Goldman Sachs & Co. LLC, TD Cowen, and Wells Fargo Securities are serving as joint book-running managers for the offering [2].

OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 Commission File Number 001-39402 ANNEXON, INC. (Exact name of Registrant as specified in its Charter) Delaware 27-5414423 (State or other jurisdiction ...

Financial Performance - The company reported a net loss of $54.9 million, or $0.37 per share, for Q3 2025, compared to a net loss of $34.8 million, or $0.25 per share, for Q3 2024[6][12]. - General and administrative (G&A) expenses decreased to $7.3 million for Q3 2025 from $9.3 million in Q3 2024, reflecting corporate efficiencies[6][12]. Research and Development - Research and development (R&D) expenses increased to $49.7 million for Q3 2025, up from $30.1 million in Q3 2024, primarily due to advancements in the Phase 3 ARCHER II trial and global filings for GBS[6][12]. - The Tanruprubart GBS dossier is on track for MAA filing in January 2026, aiming to be the first approved targeted therapy for GBS, which affects approximately 150,000 people annually worldwide[1][2]. - The registrational Phase 3 ARCHER II trial for vonaprument in GA completed enrollment with 659 patients, with topline data expected in the second half of 2026[6][7]. - Vonaprument demonstrated a 73% reduction in the risk of vision loss in the Phase 2 trial, targeting the preservation of vision for over eight million GA patients globally[6][7]. - The ANX1502 proof of concept study for Cold Agglutinin Disease is ongoing, with completion anticipated in 2026, potentially making it the only oral C1s inhibitor for multiple neuroinflammatory autoimmune diseases[1][3][6]. - The company anticipates initial pharmacokinetic and biomarker data from the FORWARD study of Tanruprubart in 2026, which aims to broaden Western experience with the therapy[3][7]. Financial Position - Total current assets decreased from $316,461 million in December 2024 to $192,822 million in September 2025, a decline of approximately 39%[14]. - Total liabilities increased from $56,966 million in December 2024 to $67,700 million in September 2025, an increase of about 19%[14]. - Stockholders' equity dropped significantly from $293,105 million in December 2024 to $161,442 million in September 2025, a decrease of approximately 45%[14]. - Cash and cash equivalents rose to $139,419 million in September 2025, compared to $49,498 million in December 2024, representing a growth of over 180%[14]. - Accounts payable increased from $10,426 million in December 2024 to $18,219 million in September 2025, an increase of about 74%[14]. - Accumulated deficit worsened from $(710,699) million in December 2024 to $(869,133) million in September 2025, reflecting a deterioration of approximately 22%[14]. - Total assets decreased from $350,071 million in December 2024 to $229,142 million in September 2025, a decline of about 35%[14]. - Operating lease liabilities, current rose from $2,518 million in December 2024 to $2,818 million in September 2025, an increase of approximately 12%[14]. - Additional paid-in capital increased from $1,003,685 million in December 2024 to $1,030,536 million in September 2025, a growth of about 3%[14]. - Other non-current assets increased from $3,235 million in December 2024 to $8,549 million in September 2025, a significant increase of approximately 164%[14]. Collaboration and Commercialization - The company is engaged in discussions with pharmaceutical companies for collaboration opportunities to commercialize Tanruprubart for GBS in various geographies[6][7].

Core Insights - Annexon, Inc. is advancing its late-stage neuroinflammation platform with significant milestones expected in 2026, including the potential approval of targeted therapies for Guillain-Barré Syndrome (GBS) and Geographic Atrophy (GA) [1][2][3] GBS Program - The company is on track to submit a Marketing Authorisation Application (MAA) for Tanruprubart in GBS by January 2026, aiming to be the first approved targeted therapy for this condition, which affects approximately 150,000 people annually worldwide [2][3] - Ongoing discussions with the FDA are focused on the generalizability package to support the Biologics License Application (BLA) submission [2][3] GA Program - The Phase 3 trial for Vonaprument in GA is expected to deliver topline data in the second half of 2026, with the potential to be the first approved vision-sparing therapy for the eight million patients affected by GA globally [1][2][4] - The ARCHER II trial has completed enrollment with 659 GA patients, exceeding targets, and is designed to evaluate visual function as the primary endpoint [7] ANX1502 Program - ANX1502 is an oral C1s inhibitor currently in a proof-of-concept study for Cold Agglutinin Disease (CAD), with completion expected in 2026 [1][5][7] - The program aims to provide a convenient oral treatment option for multiple neuroinflammatory autoimmune diseases [5] Financial Position - As of September 30, 2025, the company reported cash and cash equivalents of $188.7 million, extending its operational runway into late Q1 2027 [7][8] - Research and development expenses increased to $49.7 million for Q3 2025, primarily due to advancements in the Phase 3 ARCHER II trial and global filings for Tanruprubart [8][13]