An uptick in initial public offering (IPO) filings in recent weeks suggests that the market for first-time biotech stocks is finally recovering after three years of sparse activity capped by share prices that had fallen from the highs of coming to market and had yet to recover.

A spot check by GEN shows 22 biotechs having gone public so far this year as of October 7, up from 16 for the same period a year ago. The 22 IPOs have generated combined gross proceeds of $3.653 billion, up 37% year-over-year from the $2.669 billion garnered by the 16 companies that went public in 2023 through October 7.

“We believe that companies that have unique assets with derisked and understood biology should continue to find favor among public investors and succeed regardless of market conditions,” Nilesh Kumar, PhD, head, biotech private investments with Wellington Management, and William Craig, the firm’s investment director, concluded recently.

StockWatch spotlights two biotechs, one which has gone public and the other having filed a registration statement to do so in recent weeks:

BioAge Labs

Soon after BioAge Labs (BIOA) announced a $170 million Series D financing in January that extended its cash runway into at least late 2026, GEN Edge asked co-founder and CEO Kristen Fortney, PhD, when BioAge might consider going public: “When it makes sense, right? There are pros and cons, but biotech is expensive, especially when you’re in Phase II.”

Eight months later, Fortney and BioAge concluded that it made sense.

On September 26 the company raised $198 million in gross proceeds by selling its initial 11 million shares at $18 a share on the Nasdaq Global Select Market. Those proceeds grew to $227.7 million gross after underwriters exercised in full their option to purchase 1.65 million additional shares at the IPO price.

That action increased BioAge’s net proceeds from the IPO Prospectus by 15.5%, to an estimated $206.8 million from $179.1 million, according to the company’s IPO Prospectus.

Since the IPO launch, BioAge shares jumped 22%, to $21.89 on Friday, followed by another 5% increase Monday that sent shares up to an even $23 at 10:17 a.m. before settling for a 2.5% gain at $22.44 as of 1:41 p.m.

BioAge was one of four biotechs that went public last month alone. The other three were Bicara Therapeutics (BCAX; $362 million in gross proceeds, MBX Biosciences (MBX; $163.2 million), and Zenas BioPharma (ZBIO; $258.7 million).

“BioAge’s IPO could serve as a bellwether for the obesity sector, potentially catalyzing further investment and innovation,” Kazi Y. Helal, PhD, senior research analyst, biotech, with Pitchbook, posted on X.

Investors appear enthused by BioAge’s focus on the red-hot obesity drug space, where both Novo Nordisk and Eli Lilly have generated “blockbuster” annual sales exceeding $1 billion by marketing semaglutide and tirzepatide, respectively, in indications that include type 2 diabetes and obesity management. Lilly is a current collaboration partner of BioAge, while Novo Nordisk will be next year.

Lilly and BioAge plan to study BioAge’s lead pipeline candidate azelaprag (BGE-105) in two Phase II trials designed to assess the oral apelin receptor (APJ) agonist’s potential to drive significant improvements in weight loss when combined with Lilly’s tirzepatide, the glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) co-agonist. Tirzepatide is indicated to treat adults with type 2 diabetes as Mounjaro®, as well as adults with obesity or who are overweight under the name Zepbound®.

BioAge and Lilly are recruiting patients in the ongoing Phase II STRIDES trial (NCT06515418), designed to evaluate azelaprag in combination with tirzepatide. The companies anticipate topline results in the third quarter of 2025.

The second Phase II trial will assess azelaprag in combination with Novo Nordisk’s semaglutide, marketed as Wegovy® (in obesity) and Ozempic® (in diabetes). That trial is expected to launch in the first half of 2025 and topline results expected in the second half of 2026

Based in Richmond, CA, BioAge focuses on metabolic disease therapies that apply insights from human aging.

BioAge has developed a platform consisting of more than 50 million data points collected from longitudinal samples, data, and health records of more than 10,000 patients over 50+ years. The platform uses multi-omics to measure 10,000-plus molecules per sample, as well as artificial intelligence (AI) to map longevity pathways and identify potential drug targets.

Orum Therapeutics

Orum Therapeutics divides its operations between Daejeon, South Korea, and the Boston suburb of Lexington, MA. But when it comes to going public, the developer of cell-specific, targeted protein degraders (TPD²®) and stabilizers (TPS²™) is singly focused on South Korea and its KOSDAQ market, where it has disclosed to South Korea’s Financial Supervisory Service its intent to launch an IPO.

Asked why Orum seeks to list its shares on KOSDAQ, Sung Joo Lee, PhD, Orum Therapeutics CEO and founder, told GEN Edge: “With a strong track record of supporting innovation-driven enterprises, KOSDAQ is an attractive market for biotech companies. The exchange has implemented special listing provisions that cater to technology-focused firms, making it an ideal platform for companies like ours.”

KOSDAQ enables companies who do not meet all the exchange’s capital requirements to list their shares if they show high technology and growth potential, through its Special Technology Assessment Track. Through that mechanism, Orum received evaluations of its technology from an unnamed company that graded it an “A” (will not be significantly affected by future environmental changes), and two evaluation agencies, the Korea Health Industry Development Institute and I-Credible, which graded it a “BBB” (may be somewhat affected by future environmental changes).”

“Additionally, KOSDAQ provides excellent access to Korean investors who are familiar with our company and the local biotech landscape,” Lee explained. “Our decision to list on KOSDAQ aligns closely with the feedback and preferences expressed by our current investors. Their insights and support have been invaluable in guiding our IPO strategy.”

In its Registration Statement, filed October 2, Orum disclosed plans to offer three million shares at a price ranging from KRW 30,000 ($22.33) to KRW 36,000 ($26.79). Gross proceeds from the IPO would thus range from KRW 90 billion (about $67 million) to KRW 108 billion ($80.4 million).

Orum has estimated net proceeds from the IPO at KRW 85.899 billion ($63.925 million). Most of Orum’s proceeds from its IPO, KRW 57.153 billion ($42.5 million), will go toward research and development expenses, which include personnel expenses for researchers at the headquarters and overseas subsidiaries. Orum is among companies seeking less toxic alternatives to busulfan as a bone conditioning regimen, a crucial component of cell and gene therapy protocols.

Another KRW 28.745 billion (about $21.4 million) will be used as operating funds, which include the personnel expenses of the CEO and executives of the management headquarters, executives of the management headquarters of overseas subsidiaries, and general management expenses.

Orum finished last year with a net profit of KRW 68.2 billion ($50.75 million) on revenue of KRW 135.4 billion (about $100.8 million). Virtually all of that revenue came from the $100 million upfront Orum received when it sold its early clinical phase program to develop ORM-6151 to Bristol Myers Squibb (BMS) in September 2023, with the pharma giant also agreeing to pay an additional up to $80 million in milestone payments.

The companies have declined to disclose additional details of their partnership to develop ORM-6151, a first-in-class, anti-CD33 antibody-enabled G1 to S phase transition 1 protein (GSPT1) degrader initially developed by Orum to treat acute myeloid leukemia (AML) and other CD33-expressing malignancies.

BMS is one of two top-tier biopharmas with which Orum has established partnerships. In July, Vertex Pharmaceuticals agreed to use Orum’s TPD² platform to discover targeted conditioning agents for use with gene editing therapies, through a collaboration that could generate up to $945 million-plus for Orum. Vertex has agreed to pay Orum $15 million upfront, plus option payments and milestones potentially totaling up to $310 million per target for up to three targets, as well as tiered royalties on potential future global annual net sales.

Orum has granted Vertex rights to conduct research using its TPD² approach to developing degrader antibody conjugate (DACs), next-generation versions of antibody-drug conjugates (ADCs) that use antibodies to precisely deliver small molecule targeted protein degrader payloads to cancer cells and other targeted biological therapies.

The IPO price will be finalized after Orum completes a demand forecast it plans to conduct for domestic and foreign institutional investors from October 24–30, to be followed by a public subscription effort for two days from November 5–6, to be overseen by underwriter Korea Investment & Securities.

Leaders and laggards

  • Capricor Therapeutics (CAPR) shares jumped 27% from $17.07 to $21.65 Friday after the company announced plans to present positive three-year safety and efficacy results from its HOPE-2 open-label extension study (HOPE-2-OLE; NCT04428476) assessing its lead asset deramiocel as a treatment for Duchenne muscular dystrophy (DMD): “The data will highlight the long-term, multi-modal benefits of deramiocel. Data is being presented at the 29thAnnual Congress of the World Muscle Society (WMS 2024), being held October 8–12 in Prague, Czechia. Capricor CEO Linda Marbán, PhD, stated that data from HOPE-2 OLE was foundational to the company’s recent decision to commence filing a Biologics License Application (BLA) seeking full approval of deramiocel in DMD cardiomyopathy, which triggered a two-day, 73% stock surge late last month.
  • Gritstone Bio (GRTS) shares plunged 62% from $0.58 to $0.22 on October 1 after the company disclosed that it had hired Raymond James as its financial advisor to help review “potential value-maximizing strategies,” after reporting “encouraging” interim data from its ongoing Phase II trial assessing its individualized neoantigen-based vaccine GRANITE (GRT-C901/GRT-R902) in frontline microsatellite stable colorectal cancer (MSS-CRC). Gritstone reported a 21% relative risk reduction of progression or death with GRANITE vs. control in all treated patients, and a 38% relative risk reduction of progression or death with GRANITE vs. control in a subgroup of patients with low circulating tumor DNA (ctDNA). “With this new dataset in hand, we continue to actively explore several strategic and funding alternatives to rapidly advance our innovative immunotherapy for the benefit of patients,” stated Andrew Allen, MD, PhD, Gritstone’s co-founder, president, and CEO. Overall survival data is expected in the second half of 2025.
  • Shattuck Labs (STTK) shares nosedived 64% between September 30 and Wednesday after the company said it was eliminating 40% of its workforce and ending development of its bi-functional fusion protein candidate SL-172154, designed to target CD47 on malignant cells and CD40 on immune cells. The company will instead pivot its pipeline to prioritize development of SL-325, its DR3 antagonist antibody. Shattuck plans to start clinical development in patients with inflammatory bowel disease (IBD), reasoning that TL1A/DR3 blocking antibodies have shown compelling efficacy as monotherapy. The company expects to file an investigational new drug (IND) application in the third quarter of 2025. Shattuck employed 75 full-time employees in Austin, TX, and Durham, NC, at the end of 2023. Shares tumbled 45% from $3.49 to $1.92 October 1, then skidded another 35% to $1.25 on Wednesday.
  • Theriva™ Biologics (TOVX) shares soared 44% from $1.24 to $1.79 Thursday after the company announced a positive Data and Safety Monitoring Committee (DSMC) review of results from the second cohort of its Phase Ib/IIa trial (NCT04692181) assessing its acute graft-versus-host-disease prevention candidate SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant recipients. The DSMC recommended the study proceed with enrolling patients into Cohort 3, where SYN-004 or placebo will be administered in combination with cefepime. A total of 15 serious adverse events (SAEs) were reported among 10 patients, with the most common SAE being infections and infestations, including sepsis. No patients died within the 30-day follow-up period after the last dose of study drug. One patient died 95 days after dosing and a second patient, 211 days after due to cancer relapse and pneumonia respectively—deaths deemed unrelated to SYN-004.

The post StockWatch: BioAge, Orum Reflect Renewed Interest in IPOs appeared first on GEN – Genetic Engineering and Biotechnology News.

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