fbpx

X

Biotech IPOs in 2023: Shaping the Future of Innovation

Biotech IPOs in 2023: Shaping the Future of Innovation

Biotech IPOs offer exciting opportunities for investors.

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 20 biotech IPOs have made it to Wall Street in 2023:

 

Cargo Therapeutics

Cargo Therapeutics

IPO date: November 9, 2023

IPO price: $15.00

Price on November 24, 2023: $14.72

Cargo Therapeutics, Inc., a forward-thinking clinical-stage biotech company dedicated to advancing next-generation, potentially curative cell therapies for cancer patients, has recently unveiled the pricing details for its IPO. The offering comprises 18,750,000 shares of common stock, priced at $15.00 per share, and Cargo’s common stock started trading on the Nasdaq Global Select Market on November 10, 2023, under the ticker symbol “CRGX.”

At the core of Cargo’s mission is addressing the inherent limitations of approved cell therapies, encompassing issues such as limited durability of effect, safety concerns and unreliable supply. The company’s strategic focus encompasses innovative programs, platform technologies and manufacturing strategies tailored to directly tackle these challenges.

Cargo is presently in the process of evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase II clinical trial. This trial is targeting patients with large B-cell lymphoma (LBCL) whose disease has either relapsed or proved refractory (R/R) to CD19 CAR T-cell therapy.

The Phase I results underscore the safety and antitumor activity of the CAR T-cell therapy specifically targeting CD22, in adult patients with LBCL that is R/R to CD19 CAR T-cell therapy. Cargo’s strategic roadmap also includes plans to investigate CRG-022 in pediatric B-cell acute lymphoblastic leukemia (B-ALL).

Additionally, Cargo is progressing its preclinical program, CRG-023, designed to target tumor cells with three B-cell antigen targets — CD19, CD20 and CD22. Cargo Therapeutics stands at the forefront of innovative cell therapies, aiming to revolutionize cancer treatment and enhance patient outcomes.

 

Lexeo Therapeutics

Lexeo Therapeutics

IPO date: November 2, 2023

IPO price: $11.00

Price on November 24, 2023: $11.03

Headquartered in New York City, Lexeo is a clinical-stage genetic medicines company with a mission to revolutionize healthcare through groundbreaking science that transforms the treatment of diseases. The company recently disclosed the pricing details for its IPO, involving 9,090,910 shares of common stock at a public offering price of $11.00 per share. The gross proceeds to Lexeo from the offering, anticipated to be around $100.0 million before deducting underwriting discounts, commissions and other associated expenses, underscore its commitment to advancing innovative medical solutions.

Lexeo is committed to reshaping healthcare by applying pioneering scientific approaches to redefine the treatment landscape for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease. Employing a systematic development strategy, Lexeo uses early proof-of-concept functional and biomarker data to propel a pipeline of programs.

The US Food and Drug Administration (FDA) has given Rare Pediatric Disease designation and Orphan Drug designation to LX2006 for the treatment of cardiac Friedreich’s ataxia (FA). LX2006, a gene therapy candidate designed to enhance the expression of the frataxin protein to restore normal mitochondrial function and energy production in myocardial cells, is currently undergoing a Phase I/II clinical trial.

LX1001, another gene therapy candidate delivering an APOE2 gene for treating APOE4 homozygous patients with Alzheimer’s disease, is undergoing evaluation in an ongoing open-label, dose-escalation Phase I/II clinical trial. Notably, LX1001 has earned Fast Track designation from the FDA for the treatment of patients with early Alzheimer’s disease who are APOE4 homozygous, with the goal of slowing disease progression. Lexeo’s groundbreaking work exemplifies its dedication to pushing the boundaries of genetic medicine for patients’ lives.

 

Abivax

Abivax

IPO date: October 20, 2023

IPO price: $11.60

Price on November 24, 2023: $10.16

Abivax SA, a clinical-stage biotechnology company dedicated to developing therapeutics that leverage the body’s innate regulatory mechanisms to modulate immune responses in patients with chronic inflammatory diseases, recently announced the pricing of its IPO on the Nasdaq Global Market. This involved a capital increase of 20,325,500 new ordinary shares, including a public offering of 18,699,460 ordinary shares in the form of American depositary shares (ADS). The anticipated aggregate gross proceeds from the IPO are approximately $235.8 million.

As a clinical-stage entity, Abivax is actively assessing its leading drug candidate, obefazimod, in Phase III clinical trials aimed at treating adults with moderately to severely active ulcerative colitis (UC).

The company is also in the planning stages for a Phase IIa clinical trial of obefazimod in patients with Crohn’s disease and exploring its potential applications in other inflammatory indications.

To comprehensively assess obefazimod’s clinical impact, a pivotal Phase III program will involve 1,200 moderate to severe UC patients across 36 countries, covering North America, Europe, Latin America and the Asia Pacific. Abivax asserts that obefazimod stands out as a highly differentiated oral drug candidate, using a novel mechanism of action centered on the upregulation of a single microRNA (miR-124) known for its potent anti-inflammatory properties.

 

Adlai Nortye

Adlai Nortye

IPO date: September 29, 2023

IPO price: $23.00

Price on November 24, 2023: $10.26

Adlai Nortye is a leading global clinical-stage biotech company specializing in innovative oncology drugs. The company’s R&D, as well as its global clinical operations, are centrally located in the US and China.

The company recently disclosed the pricing details for its IPO, featuring 2,500,000 American depositary shares (ADS). Anticipated aggregate gross proceeds, including $57.5 million from the public offering, are set at $97.5 million. Trading of the ADS started on the Nasdaq Global Market on September 29, 2023, under the ticker symbol “ANL.”

Currently, three drug candidates are in the clinical stage: (i) buparlisib (AN2025), a pan-PI3K inhibitor undergoing a global Phase III clinical trial; (ii) palupiprant (AN0025), an oral EP4 antagonist undergoing a Phase Ib trial in combination with pembrolizumab for patients with multiple solid tumors; and (iii) AN4005, an oral small molecule PD-L1 drug currently in a Phase I trial. Additionally, a Phase I clinical trial has started for a combination therapy involving AN2025, AN0025 and atezolizumab, targeting various PIK3CA mutant solid tumors.

The company is also progressing three in-house preclinical programs: AN8025, a multifunctional antibody serving as a T-cell and antigen-presenting cell (APC) modulator fusion protein; AN1025, an oral small molecule degrader of β-catenin; and AN9025, an oral small molecule pan-KRAS inhibitor.

Adlai Nortye has established a distinguished management team and a scientific advisory board comprising industry leaders and influential scientists. These individuals provide international and strategic guidance to the company’s R&D, business development and operational teams. In addition to strengthening its internal R&D capabilities, Adlai Nortye actively pursues partnerships with prominent multinational pharmaceutical companies such as Eisai and Novartis to maximize the potential of its pipeline programs.

 

RayzeBio (RYZB)

IPO date: September 14, 2023

IPO price: $18.00

Price on November 24, 2023: $23.50

RayzeBio, Inc. (Nasdaq: RYZB), a focused radiopharmaceutical company dedicated to developing an innovative pipeline targeting well-validated solid tumor targets, has recently concluded its upsized IPO of $358 million, comprising 19,869,240 shares of common stock. The company’s trading symbol, “NMRA,” has been officially designated for this endeavor.

RayzeBio is actively establishing itself as a vertically integrated radiopharmaceutical therapeutics (RPT) firm aimed at combatting various forms of cancer. Its lead program is currently in Phase III clinical trials.

The company has strategically cultivated a pipeline of multiple drug candidates within therapeutic areas that boast substantial market potential, similar to the emergence of antibody-drug conjugates as a groundbreaking treatment modality for certain types of cancer.

At the forefront of RayzeBio’s pioneering portfolio stands RYZ101, a standout drug designed for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETS). In a Phase Ib trial involving a total of 17 patients who had previously received Lu177 treatment and subsequently experienced disease progression, RYZ101 demonstrated excellent tolerance. Notably, there were no observed dose-limiting toxicities (DLTs) during the requisite 8-week DLT evaluation period in the initial treatment cycle.

Currently, the company is actively enrolling patients in a Phase III global randomized clinical trial that will compare the efficacy of RYZ101 against the investigator’s choice of the standard of care within a similar patient population.

 

Neumora Therapeutics is among the new biotech IPOS 2023.

Neumora Therapeutics (NMRA)

IPO date: September 14, 2023

IPO price: $17.00

Price on November 24, 2023: $11.96

Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company at the forefront of redefining neuroscience drug development.. Their IPO offering comprised 14,710,000 shares of common stock at a public price of $17.00 per share. Trading of these shares commenced on the Nasdaq Global Select Market on September 15, 2023, under the ticker symbol “NMRA.” Neumora anticipates that the total value of shares offered will be approximately $250 million.

Neumora’s therapeutic portfolio currently encompasses seven clinical and preclinical neuroscience programs, each targeting novel mechanisms of action to address a wide spectrum of underserved neuropsychiatric disorders and neurodegenerative diseases.

The company’s research efforts are bolstered by an integrated suite of translational, clinical and computational tools that facilitate the generation of insights necessary for the advancement of precision medicine approaches.

Neumora Therapeutics’ notable success can be attributed to its industry-leading portfolio and a robust pipeline of clinical and preclinical initiatives.

Among these, the flagship program, navacaprant, stands out as a highly selective, innovative kappa opioid receptor (KOR) antagonist currently in Phase III development. Navacaprant holds promise as a potential standalone therapy for major depressive disorder (MDD). This investigational oral medication, administered once daily, is specifically designed to modulate the dopamine and reward processing pathways, which play pivotal roles in regulating mood, cognition, reward and behavior. The KOR system, a well-characterized pathway with a known role in mediating depressive-like states, serves as the foundation for this novel approach to treating MDD and other major neuropsychiatric disorders.

 

Mira Pharmaceuticals (MIRA)

IPO date: August 2, 2023

IPO price: $7.00

Price on November 24, 2023: $3.08

Headquartered in Maryland, Mira Pharmaceuticals emerges as a pre-clinical-stage pharmaceutical pioneer, distinguished by its unwavering dedication to the development and eventual commercialization of a groundbreaking molecular synthetic cannabinoid analog (THC).

This innovation holds profound potential as a therapeutic solution for adult patients grappling with anxiety and cognitive decline commonly associated with early-stage dementia. Notably, Mira Pharmaceuticals recently marked a significant milestone with the announcement of the pricing for its inaugural public offering. This offering comprises 1,275,000 shares of common stock, and was priced at an IPO rate of $7.00 per share, culminating in an aggregate gross sum of $8.9 million.

Standing at the forefront of Mira’s groundbreaking portfolio is its standout drug, MIRA1a — a pioneering prescription medication. Setting a new precedent, MIRA1a uniquely targets cannabinoid receptors CB1 and CB2, offering potential therapeutic avenues for chronic pain management, anxiety relief and cognitive enhancement.

MIRA1a’s distinctive attribute is noteworthy: it achieves these benefits without the impurities and side effects often associated with marijuana usage, such as increased appetite and paranoia. Pre-clinical investigations have showcased the prowess of MIRA1a in elevating memory and augmenting cognitive performance within pre-clinical fear conditioning models. Moreover, MIRA1a has exhibited a notable capability to diminish pain and provide relief, as evidenced by its impact in pre-clinical heat tolerance models.

Mira Pharmaceuticals stands on the precipice of transformative medical advancements, with MIRA1a poised to revolutionize the landscape of therapeutic interventions. As the company ushers in a new era of pharmaceutical innovation, its IPO serves as a testament to its unwavering commitment to progress and the potential to reshape the lives of those burdened by anxiety, cognitive decline and chronic pain.

 

Turnstone Biologics

Turnstone Biologics (TSBX)

IPO date: July 20, 2023

IPO price: $12.00

Price on November 24, 2023: $2.57

Situated in the dynamic biotechnology landscape of California, Turnstone Biologics emerges as a trailblazing clinical-stage company dedicated to the transformation of cancer treatment. With a sharp focus on solid tumors, Turnstone spearheads an innovative approach to tumor-infiltrating lymphocytes (TIL) therapy, redefining the trajectory of medical progress. A momentous accomplishment was realized in July 2023 as Turnstone achieved a milestone of monumental significance — the launch of its IPO. This moment was commemorated as Turnstone proudly rang the opening bell of the market on July 20th, 2023.

Central to Turnstone’s innovative narrative is its pioneering TIL therapy, a groundbreaking paradigm predicated upon the meticulous identification, selection and amplification of the most potent tumor-reactive T cells, aptly termed Selected TILs.

This revolutionary approach represents a resolute departure from the confines of first-generation bulk TILs, which have exhibited objective responses within a delimited spectrum of tumor types.

Taking the lead in Turnstone’s portfolio is the TIDAL-01 program, a flagship initiative currently under evaluation in dual Phase I studies encompassing patients with melanoma, breast cancer and colorectal cancer. Alongside this flagship endeavor, Turnstone diligently advances an array of preclinical pipeline programs, including the eagerly anticipated TIDAL-02 — its next iteration of selected TILs — and a synergistic viral immunotherapy combination program in conjunction with TIDAL-01.

 

Sagimet Biosciences is among the new biotech IPOs in 2023.

Sagimet Biosciences (SGMT)

IPO date: July 13, 2023

IPO price: $16.00

Price on November 24, 2023: $3.97

Sagimet Biosciences stands at the forefront of clinical-stage biopharmaceutical innovation, steadfastly dedicated to the creation of groundbreaking therapeutics designed to combat significant medical challenges. Among its core focuses are nonalcoholic steatohepatitis (NASH), a liver disease of critical concern, as well as specific cancer types. Central to Sagimet’s approach is an unwavering commitment to targeting dysfunctional metabolic pathways, thereby paving the way for transformative treatments.

In a recent landmark announcement, Sagimet Biosciences revealed the pricing of an expanded IPO. This offering, featuring a total of 5,312,500 shares of its Series A common stock, was made available to the public at a price of $16.00 per share. The resounding success of this IPO is poised to yield far-reaching impacts, propelling the company’s clinical advancements and the growth of its cutting-edge technology.

A prominent jewel in Sagimet’s crown is denifanstat, a leading drug candidate characterized by its unique attributes. This oral, once-daily pill marks a pioneering entry as a first-in-class inhibitor of FASN — an enzyme pivotal in the de novo lipogenesis (DNL) pathway. This pathway converts dietary sugar metabolites, such as fructose, into palmitate — a saturated fatty acid. denifanstat’s journey has been marked by significant recognition, with the FDA granting it Fast-Track designation in March 2021 for the treatment of NASH. This dynamic candidate has undergone comprehensive study, encompassing over 600 subjects ranging from healthy volunteers to patients grappling with NASH, acne and solid tumors.

As denifanstat forges ahead, it is currently under investigation within the realms of the FASCINATE-2 Phase IIb clinical trial. This trial, which centers on NASH and employs liver biopsy as its primary endpoint, underscores Sagimet Biosciences’ resolute commitment to advancing cutting-edge therapies and contributing significantly to the realm of biopharmaceutical innovation.

 

Apogee Therapeutics (APGE)

IPO date: July 13, 2023

IPO price: $17.00

Price on November 24, 2023: $17.20

Apogee Therapeutics is a Massachusetts-based biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology indications.

The success of Apogee Therapeutics can be attributed to its industry-leading portfolio and a robust pipeline of clinical and preclinical programs. Apogee’s antibody programs are designed to overcome the limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.

The company’s two most advanced programs are APG777 and APG808, which are being initially developed for the treatment of AD and COPD, respectively. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefits to patients underserved by today’s standard of care.

The positive outcomes observed in pre-clinical studies have provided strong support for the efficacy and feasibility of these therapies. Apogee is planning to initiate a Phase II trial in asthma next year and expects to further evaluate opportunities to develop APG777 for other inflammatory and immune indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis and prurigo nodularis.

 

60 Degree Pharmaceuticals (SXTP)

IPO date: July 12, 2023

IPO price: $5.30

Price on November 24, 2023: $0.59

Based in the heart of Washington, DC, 60 Degrees Pharmaceuticals, Inc. specializes in the research, development and distribution of innovative medicines aimed at combatting infectious diseases that profoundly impact the lives of millions worldwide.

The year 2023 marks a pivotal milestone for the company as its triumphant IPO underscores its steadfast commitment to advancing therapeutic solutions for preventing and treating infectious diseases.

This dedication is notably highlighted through the progression of Arakoda (tafenoquine), an FDA-approved drug since 2018, designed to address malaria prevention. The company has strategically forged exclusive research and licensing agreements with the US Army, thus fostering promising collaborations that are supported by compelling non-clinical and clinical data.

Adding to its repertoire of accomplishments, 60 Degrees Pharmaceuticals has garnered noteworthy strides in combating the ongoing challenges posed by infectious diseases. Particularly remarkable is the positive Phase II study data showcasing the efficacy of the tafenoquine regimen in mild-moderate COVID cases, thereby underscoring the versatility and potential impact of the company’s therapeutic innovations.

Underpinning its enduring success is 60 Degrees Pharma’s unwavering commitment to investing in robust R&D initiatives. A prominent illustration of this commitment lies in the forthcoming clinical development campaign for the repositioning of celgosivir — an innovative host-targeted glucosidase inhibitor. Although initially developed by separate entities for HIV and hepatitis C4, celgosivir presents a unique opportunity for the treatment of dengue infection. While exhibiting promising potential, it’s worth noting that, similar to other dengue antivirals, celgosivir’s efficacy has shown to diminish when administered after the onset of symptoms in animal models.

 

Intensity Therapeutics is a new Biotech IPO in 2023

Intensity Therapeutics (INTS)

IPO date: June 29, 2023

IPO price: $5.00

Price on November 24, 2023: $2.30

Intensity Therapeutics, a progressive clinical-stage biotechnology enterprise committed to pioneering novel immune-based intratumoral cancer therapies, has taken a significant stride in its journey.

At the heart of Intensity’s innovative approach lies its cutting-edge DfuseRx technology platform. This platform empowers the creation of exclusive drug formulations that, upon direct injection, promptly infiltrate and disperse throughout tumors. By facilitating the diffusion of therapeutic agents into cancer cells, Intensity’s groundbreaking method aims not only to annihilate the injected tumor but also to stimulate the immune system’s recognition of non-injected tumors.

A standout contender within Intensity’s portfolio is its lead product candidate, INT230-6, currently under development to address patients grappling with solid tumors, including sarcoma and breast cancer.

Further bolstering its pursuit of transformative cancer therapeutics, Intensity has entered into strategic clinical collaboration agreements with industry giants. One such partnership with Merck Sharpe & Dohme (Merck) centers on the evaluation of INT230-6 in conjunction with pembrolizumab.

Additionally, an alliance with Bristol-Myers Squibb focuses on the combination of INT230-6 (currently undergoing Phase II trials) with Bristol-Myers Squibb’s anti-CTLA-4 antibody, ipilimumab. To expand its impact, Intensity has also inked agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) for a randomized controlled neoadjuvant Phase II study — dubbed the INVINCIBLE study — targeting women with early-stage breast cancer.

Amidst this compelling backdrop of scientific innovation, clinical advancements and burgeoning market prospects, Intensity stands poised to forge a noteworthy imprint on the realm of immunology. The culmination of these efforts is evidenced not only by the successful IPO but also by the profound interest exhibited by investors in the company’s visionary endeavors.

 

Azitra is a new biotech IPO in 2023

Azitra (AZTR)

IPO date: June 15, 2023

IPO price: $5.00

Price on November 24, 2023: $1.33

Azitra stands as an advanced clinical-stage precision dermatology firm harnessing its profound expertise in genetic engineering, proteomics and the intricate realm of the skin microbiome. This proficiency drives the creation and advancement of innovative therapeutic solutions targeting a spectrum of skin disorders.

A significant milestone was marked on June 15th, 2023, when Azitra proudly unveiled its IPO of common stock, valuing each share at $5.00, leading to a noteworthy gross sum of $7,500,000. The trading symbol “AZTR” has been designated for this venture.

Azitra’s pursuit of resolving the complexities of skin diseases is channeled through three core strategies: a unique microbial library, precision-engineered microbes for targeted drug delivery and cutting-edge genetic engineering techniques.

The company’s impressive track record owes much to its state-of-the-art platforms. Central to these platforms is Azitra’s proprietary microbial library, a collection encompassing around 1,500 distinct bacterial strains, meticulously screened for their distinctive therapeutic attributes. Augmenting this resource is an artificial intelligence and machine learning framework, which adeptly analyzes and predicts characteristics, thereby aiding in the screening of bacterial strains for promising drug candidates. Furthermore, the platform integrates a licensed genetic engineering technology, surmounting previous limitations in genetic manipulation.

Forefront among Azitra’s accomplishments is the development of ATR-12, an exclusive drug candidate harboring a novel strain of S. epidermidis that has been genetically enhanced to secrete a functional fragment of the LEKTI protein. Engineered with precision, ATR-12 is tailored to address Netherton syndrome, an ailment meriting Pediatric Rare Disease designation. The significance of this effort was underscored in May 2020, as Azitra was granted Rare Pediatric Disease designation by the FDA for ATR-12. This progress culminated in January 2023, with the FDA’s clearance for a first-in-human trial of ATR-12, a noteworthy stride in Azitra’s journey towards groundbreaking dermatological therapeutics.

 

Acelyrin

Acelyrin (SLRN)

IPO date: May 4, 2023

IPO price: $18.00

Price on November 24, 2023: $8.49

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

Kenvue (KVUE)

IPO date: May 3, 2023

IPO price: $22.00

Price on November 24, 2023: $20.26

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 logo

CytoMed Therapeutics (GDTC)

IPO date: April 13, 2023

IPO price: $4.00

Price on November 24, 2023: $3.70

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 logoMineralys Therapeutics (MLYS)

IPO date: February 9, 2023

IPO price: $16.00

Price on November 24, 2023: $6.21

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 logo

 

Structure Therapeutics (GPCR)

IPO date: February 2, 2023

IPO price: $15.00

Price on November 24, 2023: NA

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

Genelux (GNLX)

IPO date: January 25, 2023

IPO price: $6.00

Price on November 24, 2023: $11.07

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

Cadrenal Therapeutics (CVKD)

IPO date: January 20, 2023

IPO price: $5.00

Price on November 24, 2023: $0.47

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.


This article was first published on May 31, 2023, and updated to reflect new biotech IPOs in 2023.

To have your company featured on Xtalks, please email Vera Kovacevic, PhD, at: [email protected]