An initial public offering (IPO) is the process through which a privately held company offers its shares to the public for the first time, transforming into a publicly traded company. In the biotech industry, a biotech IPO refers to a specific case where a biotechnology company goes public and lists its shares on a stock exchange. This allows the company to raise funds from public investors. Successful biotech IPOs have the potential to generate substantial returns for early investors and provide the crucial capital required for biotech firms to sustain and advance their R&D endeavors.
Between 2021 and 2022, the biotech IPO market experienced a notable decline as investors grew increasingly cautious due to the uncertainties surrounding the pandemic and economic downturn. According to a research report by Refinitiv, a renowned American-British provider of financial market data and infrastructure, the global biotech sector experienced its most challenging year for IPOs since 2018. According to the Nasdaq Biotechnology Index (NBI), only 21 biotech IPOs were recorded in 2022, a significant decrease compared to the 104 biotech IPOs observed in 2021.
This decline can be attributed to various factors, including investor caution amidst the pandemic and economic uncertainties; however, with the Federal Reserve gradually slowing down its rate hikes, the biotech industry is optimistic about a resurgence in IPO activity throughout 2023.
According to a report from the Royal Bank of Canada (RBC), the biotech industry is expected to demonstrate positive performance in 2023. The report highlights the sustained momentum of large-cap biotech companies and the improved performance of small-cap firms. These positive trends are primarily driven by advancements in therapeutic areas and emerging technologies within the biotech sector. The RBC report expresses optimism regarding the potential growth and success of the industry in the coming year.
So far, the following seven biotech IPOs have made it to Wall Street in 2023:
Acelyrin (SLRN)
IPO date: May 4, 2023
IPO price: $18
Current price: $18.03
Headquartered in California, Acelyrin is a late-stage clinical biopharmaceutical company dedicated to expediting the development and delivery of groundbreaking medicines in the field of immunology. On May 4, 2023, Acelyrin announced its IPO of 30,000,000 shares of common stock at a price of $18.00 per share.
The success of Acelyrin can be attributed to its industry-leading immunology portfolio and a robust pipeline of clinical and preclinical programs. One of its notable candidates is izokibep, a small protein inhibitor of interleukin-17A (IL-17A). Izokibep has progressed to Phase II/III clinical trials for multiple indications, including hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and uveitis.
Recent announcements by Acelyrin have highlighted promising results from izokibep, demonstrating significant therapeutic improvements in patients across key measures such as joint pain, skin psoriasis and enthesitis resolution. The candidate has also shown high levels of response across different disease manifestations of psoriatic arthritis. Importantly, izokibep has demonstrated good tolerability, supporting its potential for long-term therapy.
Another noteworthy candidate from Acelyrin’s pipeline is lonigutamab, an anti-IGF-1R monoclonal antibody administered via subcutaneous delivery. Lonigutamab is currently undergoing evaluation for the treatment of thyroid eye disease in a Phase II trial.
With its compelling portfolio, clinical progress and potential market opportunities, Acelyrin is poised to make a significant impact in the field of immunology, as demonstrated by its successful IPO and investor interest in the company.
Kenvue (KVUE)
IPO date: May 3, 2023
IPO price: $22
Current price: $25.45
In 2022, Johnson & Johnson launched Kenvue as a dedicated entity for its consumer health business. Kenvue began trading on the New York Stock Exchange in May of this year, using the symbol “KVUE.” As the world’s largest pure-play consumer health company in terms of revenue, Kenvue is renowned for its portfolio of iconic brands, including Aveeno, BAND-AID Brand Adhesive Bandages, Johnson’s, Listerine, Neutrogena, Tylenol and Zyrtec.
“As a global leader at the intersection of healthcare and consumer goods, our carefully curated portfolio of science-backed, iconic brands has been trusted by consumers and recommended by healthcare professionals for generations. We are ready to bring a new view of care to the world,” said Thibaut Mongon, CEO of Kenvue, in the company’s press release.
Following the successful completion of the IPO, Johnson & Johnson became the majority shareholder of Kenvue, owning approximately 90.9 percent of the total outstanding shares of Kenvue’s common stock (or 89.6 percent if the underwriters exercise their over-allotment option in full). Johnson & Johnson also announced its intention to dispose of its majority stake in Kenvue common stock in 2023.
With an extensive product lineup, Kenvue achieved net sales of around $15 billion in 2022, serving a broad customer base of 1.2 billion people across more than 165 countries. The company’s long-term success can be attributed to its consistent investment in R&D and the commercialization of innovative new healthcare products.
Over the past four years, Kenvue has conducted over 500 clinical studies, showcasing its commitment to advancing medical knowledge and improving consumer health. Moreover, since 2020, Kenvue has introduced approximately 100 new product innovations each year, reinforcing its dedication to staying at the forefront of the industry.
CytoMed Therapeutics (GDTC)
IPO date: April 13, 2023
IPO price: $4
Current price: $2.75
CytoMed Therapeutics is a prominent R&D company based in Singapore, specializing in cell-based immunotherapy for the treatment of cancer. The company has garnered a strong reputation for its groundbreaking work in advancing chimeric antigen receptor-modified T (CAR-T) cells, particularly in the treatment of hematological malignancies. Additionally, CytoMed Therapeutics has extended the CAR-T principle to develop innovative therapies for solid tumors.
The company’s success can be attributed to its state-of-the-art platforms, namely CAR-γδ T Cells and iPSC-γδ NKT Cells. These cutting-edge technologies have enabled CytoMed Therapeutics to develop a robust pipeline of cell-based therapies targeting a wide range of cancers. The positive outcomes observed in preclinical studies and the validation of manufacturing processes have provided strong support for the efficacy and feasibility of these therapies.
Of particular significance is CytoMed Therapeutics’ leading CAR-γδ T cell technology known as CTM-N2D therapy, which is poised to enter Phase I clinical trials. This therapy holds promise in the field of cancer treatment.
The successful IPO of CytoMed Therapeutics will have a significant impact on the clinical development of their CTM-N2D product and further expansion of their technology in iPSC-γδ NKT and CTM-GDT products.
With strong investor interest in the company, CytoMed Therapeutics is well-positioned to make a notable contribution to the field of cell-based immunotherapy for cancer treatment. Their achievements in securing the IPO and generating investor enthusiasm highlight their potential for success.
Mineralys Therapeutics (MLYS)
IPO date: February 9, 2023
IPO price: $16
Current price: $13.93
Mineralys Therapeutics, a biopharmaceutical company headquartered in Pennsylvania, is dedicated to developing targeted medicines for diseases driven by abnormally elevated aldosterone levels. The year 2023 is proving to be significant for Mineralys Therapeutics as it expands its product portfolio to cover a wide range of medical conditions.
In March 2023, the company unveiled positive results from its Phase II Target-HTN trial, demonstrating the clinical significance of blood pressure reduction achieved by its candidate lorundrostat in the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN).
Building upon this success, Mineralys Therapeutics announced its plans for a Phase III trial to evaluate the safety and efficacy of lorundrostat for the treatment of uHTN and rHTN. The study, scheduled to being in late 2023, aims to recruit approximately 1,000 adults.
Additionally, Mineralys Therapeutics has announced a Phase II trial to assess the safety and efficacy of lorundrostat for treating uHTN and rHTN in a chronic kidney disease (CKD) population. The company eagerly anticipates the results of this trial, expected to be available in early 2024.
The company’s long-term success can be attributed to its commitment to investing in R&D. In 2022, the company allocated approximately $26.3 million to R&D efforts, representing a notable 60 percent increase compared to the previous year. A substantial portion of this investment, $7.4 million, was specifically dedicated to preclinical and clinical expenses associated with the development of lorundrostat. This demonstrates the company’s dedication to advancing the R&D of lorundrostat, a key component of its product portfolio.
Structure Therapeutics (GPCR)
IPO date: February 2, 2023
IPO price: $15
Current price: $32.03
Structure Therapeutics,a clinical-stage biopharmaceutical company headquartered in California, specializes in developing innovative oral therapeutics to address chronic diseases with unmet medical needs. In 2022, the company allocated $36.2 million to R&D, marking a substantial increase compared to the previous year’s expenditure of $29.1 million.
Notably, Structure Therapeutics announced positive outcomes from GSBR-1290, an orally available small molecule agonist of the GLP-1 receptor designed to target type 2 diabetes (T2D) and obesity. These outcomes were supported by positive safety, pharmacokinetic and tolerability data.
Leveraging their state-of-the-art platforms in structure-based drug discovery approaches, Structure Therapeutics continues to advance the development of molecules with optimal binding properties and conformational characteristics, enabling precise downstream signaling.
The company’s successful IPO in 2023 has further solidified its progress, particularly in advancing GSBR-1290. Structure Therapeutics eagerly anticipates the release of results from the ongoing Phase Ib/Phase IIa trials, expected in late 2023. This milestone signifies the company’s dedication to advancing its therapeutic candidates and addressing the medical needs of patients with T2D and obesity.
Raymond Stevens, PhD, CEO of Structure Therapeutics, stated in the company’s news release that the successful completion of their IPO in February 2023 has strengthened their financial position to advance GSBR-1290 and fulfill their mission of providing oral small molecule medicines to patients with high unmet medical needs. He further added that with the rapid global growth of T2D and obesity, they have completed dosing GSBR-1290 in healthy overweight volunteers in their Phase Ib clinical study. They are now looking forward to progressing into the Phase IIa study.
Genelux (GNLX)
IPO date: January 25, 2023
IPO price: $6
Current price: $25.45
Genelux, a clinical-stage biopharmaceutical company based in California, specializes in the development of oncolytic viral immunotherapies. In January, the company achieved a significant milestone by successfully launching its IPO. To celebrate this achievement, Genelux proudly rang the opening bell of the Nasdaq Stock Market on March 29, 2023.
“This is an exciting time for Genelux as we take important steps to realize our goal of building a leading immunotherapy company. We appreciate the continued support of all our stakeholders as we take strides designed to unleash the power of our platform,” said Thomas Zindrick, president and CEO of Genelux, in the company’s news release.
The IPO may generate around $15.0 million in total gross proceeds, which will bolster the company’s commitment and capability to advance its therapeutic candidates across various medical conditions.
Genelux harnesses its cutting-edge technology, the proprietary Choice discovery platform, to expedite the development of new products from initial concept to the commencement of clinical trials. With this strong foundation in place, Genelux remains dedicated to furthering the progress of its oncolytic immunotherapy, which targets individual patients with remarkable precision and offers significant advantages over conventional cancer treatments.
One of Genelux’s notable candidates is Olvi-Vec (olvimulogene nanivacirepvec), a proprietary, non-pathogenic oncolytic vaccinia virus specifically designed for the treatment of ovarian cancer. During multiple early- and mid-phase clinical trials involving around 150 patients, Olvi-Vec demonstrated encouraging efficacy and safety results, while also being generally well tolerated by patients. This significant outcome has paved the way for Genelux to advance Olvi-Vec into a Phase III clinical study in 2023, further validating the potential of Olvi-Vec as a promising treatment option for ovarian cancer.
Cadrenal Therapeutics (CVKD)
IPO date: January 20, 2023
IPO price: $5
Current price: $1.39
Cadrenal Therapeutics, a biopharmaceutical company headquartered in Florida, is focused on developing a cardiorenal therapy called tecarfarin. Tecarfarin aims to prevent systemic thromboembolism of cardiac origin in patients with end-stage renal disease and atrial fibrillation (ESRD + AFib).
The company recently achieved a significant milestone by completing an IPO for gross proceeds of $7.0 million. To commemorate this achievement, Cadrenal Therapeutics proudly rang the Nasdaq closing bell on February 8, 2023.
“We are excited to ring the Nasdaq closing bell to commemorate our recent IPO and announcement by the US Food and Drug Administration which granted a Fast Track designation to tecarfarin for the prevention of systemic thromboembolism, or more commonly referred to as blood clots, of cardiac origin in patients with end-stage renal disease and atrial fibrillation,” said Quang Pham, CEO of Cadrenal, in the company’s news release.
Tecarfarin, the company’s notable drug, is an oral anticoagulant and vitamin K antagonist. It shares a similar mechanism of action with warfarin which is indicated for the prevention of systemic thromboembolism.
In early 2023, the US Food and Drug Administration (FDA) granted Fast Track designation for tecarfarin for its potential in treating systemic thromboembolism of cardiac origin in patients with ESRD and AFib.
Tecarfarin has been assessed 11 clinical trials involving over 1,000 individuals. The trials, including Phase I, II and II/III, demonstrated encouraging efficacy and safety results for tecarfarin. The drug has shown good tolerability in both healthy adult patients and those with chronic kidney disease.
Building upon these promising results, Cadrenal Therapeutics announced plans for a pivotal Phase III trial evaluating tecarfarin versus placebo in subjects with ESRD and AFib who are not currently treated with chronic oral anticoagulation.
If tecarfarin receives FDA approval, the company anticipates annual revenues of approximately $1 billion in the US market.
The development of tecarfarin represents a significant advancement in cardiorenal therapy, addressing the unmet medical needs of patients with ESRD and AFib. Cadrenal Therapeutics’ IPO and ongoing clinical progress highlight the company’s commitment to bringing innovative treatments to market and improving the lives of patients at risk of systemic thromboembolism.
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