Venture Kick, a private philanthropic initiative, provides as much 150,000 Swiss francs in pre-seed funding to Swiss startups and offers structured, entrepreneurial training to build robust, winning businesses. Entrepreneurs pitch for finance as many as three times, as they compete for increasing amounts of funding at each stage. Founders gain direct feedback from the expert juries and access to an international network of successful entrepreneurs and investors. Venture Kick has supported 600 Swiss startup projects with 24.9 million francs to date. Supported projects have incorporated as 454 active companies, creating 6,033 jobs, and attracting 2.49 billion francs worth of subsequent investment. Companies founded by Venture Kick alums represented 55 percent of the TOP 100 Swiss Startup Award 2018.  In 2019 Venture Kick will support idea-stage startup projects with 4.35 million francs, to bring Swiss science to global markets.

Venture Kick

Broadview Ventures, Inc. (Broadview) was established in 2008 as a new program conceived by the Leducq family. Through Broadview, the trust will work to accelerate the development of promising technology in cardiovascular and neurovascular disease through targeted investment in and support of early stage technology ventures.  The Foundation Leducq, based in Paris, France, is the beneficiary of a charitable trust. In order to further the Foundation Leducq's mission in cardiovascular and neurovascular disease, the trust has made funds available to Broadview to develop a program which will promote early state technology in these fields through investments, licensing agreements and consortium funding arrangements, as well as professional, management and consulting support.  With this initiative the trust joins other leaders in the venture philanthropy movement in seeking creative solutions to the problem of what is commonly referred to as the 'translational gap', a significant component of which is a lack of funding at a critical moment in the development of new technology and science.

Broadview Ventures

Apollo Health Ventures is an Early Stage Investment Firm interested in accelerating breakthrough scientific discoveries to the clinic by building life science companies around new therapeutic technologies. Apollo Ventures focuses on assets with the potential to treat, prevent, or even reverse age-related diseases such as Alzheimer's, Heart Disease, Sarcopenia, Frailty, and Cancer, with the ultimate goal of increasing healthy human lifespan. Apollo invests in early stage companies, works with scientists and entrepreneurs to create new ventures, and engages in hypothesis-driven company building.

Apollo Health Ventures

Schroder Adveq was founded in 1997 and is a leading asset manager investing globally in private equity. Pension funds, insurance companies, endowments, family offices and other financial institutions located in Europe, North America and the Asia-Pacific region entrust us with their funds because of our solution-focused approach to private equity.

Schroder Adveq

Viva BioInnovator (VBI) is the specialized investment and incubation arm of Viva Biotech Holdings. We focus on the initial creation and development of biotech startups across all indications and drug types. During the early stages of drug discovery, we can nurture and accelerate a startup's growth from idea to clinical program.  VBI's unique investment and incubation model started out of necessity in 2014. Our roots are in drug discovery services, where we operate world-leading and proprietary drug discovery platforms. While serving big pharma customers from around the globe, we came to realize the huge demand from many entrepreneurs who have great ideas but cannot receive funding to advance their plan due to lack of data. We saw the value in many of these innovative ideas and provided our CRO drug discovery services, operational support, and monetary backing to help these creative scientists embark on the ''0 to 1''​ transformation. This spark launched our ''equity for service (EFS)''​ investment and incubation model.  VBI is based in Shanghai, with an office in Boston and personnel in California. As of early 2019, VBI has invested in over 30 companies out of the hundreds of proposals submitted for review and we plan to invest at a rapid pace in the years to come. The majority of our current portfolio companies are US based, but we are open to proposals globally and are excited to see new ideas that fit our investment strategy.  If you would like to learn more about us, please visit: www.vivabioinnovator.com  Or send an email to innovation@vivabiotech.com  If you would like to learn more about our parent company, Viva Biotech, please visit: www.vivabiotech.com

Viva BioInnovator

Bernina BioInvest

4see ventures is a Swiss venture capital firm investing in exceptional entrepreneurs who are defining the future. We focus on real game-changers in their industries who are having a positive impact on society.

4See Ventures

Humboldt Fund is an investment firm that seeks to invests in bio revolution companies.

Humboldt Fund

HAYA Therapeutics

HAYA Therapeutics is a developer of RNA-based therapeutics created to treat heart failure. The company's therapeutics utilizes biopharmaceutical therapy to target a heart specific regulator of fibrosis, the long noncoding RNA, enabling physicians to to block myocardial fibrosis and treat heart failure.

Based in Switzerland, HAYA Therapeutics is a biopharmaceutical developer of RNA-based therapeutics created to treat heart failure. The company's precision medicines target tissue and cell-specific long noncoding ribonucleic acid (IncRNA) to treat fibrotic diseases and other health conditions associated with aging, including cancer. Its proprietary DiscoverHAYA drug discovery engine enables it to generate a pipeline of lncRNA targeting anti-fibrotics for many tissues, including lung, kidney, liver, and the tumor microenvironment.

Leveraging personal data for custom-fit diagnosis and treatment

Precision Medicine

HAYA Therapeutics is a precision therapeutics company dedicated to developing innovative tissue and cell-selective genomic medicines for fibrotic diseases and other serious age-related conditions, including cancer. The company's proprietary DiscoverHAYA drug discovery engine focuses on long non-coding RNAs (lncRNAs) within the "dark matter" of the human genome, which are key tissue and cell-specific drivers of fibrosis and other disease processes.

HAYA Therapeutics Announces Funding from Swiss Innovation Agency Supporting Research Collaborations for Long Non-Coding RNA Therapies

HaYa Therapeutics • Biopôle • Switzerland

HAYA Is Developing Therapeutics Targeting Long Non-Coding RNAs

HAYA Therapeutics Establishes U.S. Location

HAYA Therapeutics Establishes U.S. Location • Biopôle • Switzerland

HAYA Therapeutics Completes CHF 18 Million • Biopôle • Switzerland

HAYA Therapeutics Adds Douglas L. Mann, M.D. as Chairperson of Clinical Advisory Board

HAYA Therapeutics triumphs at the TOP 100 Swiss Startup Award

Targeting complex diseases with complex molecules

Large-molecule Therapeutics

HAYA Therapeutics secures USD 1 billion deal with Lilly to target obesity through RNA platform

Based in Switzerland, HAYA Therapeutics is a biopharmaceutical developer of RNA-based therapeutics created to treat heart failure. The company's precision medicines target tissue and cell-specific long noncoding ribonucleic acid (IncRNA) to treat fibrotic diseases and other health conditions associated with aging, including cancer. Its proprietary DiscoverHAYA drug discovery engine enables it to generate a pipeline of lncRNA targeting anti-fibrotics for many tissues, including lung, kidney, liver, and the tumor microenvironment.HAYA is preparing its lead and only drug candidate HTX-001 for Phase I clinical trials within the next two to three years to stop and potentially reverse fibrosis in the heart. The company launched from stealth in May 2021 and concluded a seed funding round amounting to CHF 18 million (USD 20 million) led by Broadview Venture. The new funds were to be used to advance its treatment pipeline.

<div>
 
 Praxis Precision Medicines is a clinical-stage biopharmaceutical company that develops precision medicine for central nervous system disorders based on neuronal imbalance caused by genetic mutations.
 
 
 The company has four clinical-stage product candidates in its pipeline for treating disorders such as depression, epilepsy, movement disorders, and pain syndromes. The company&rsquo;s drug candidates include 1) PRAX-944, which is an inhibitor for essential tremor disorder linked to Parkinson&rsquo;s disease and is set to begin Phase 3 in mid-2023, 2) PRAX-222 in Phase 2 of clinical trials targets the SCN2A gene most commonly associated with early-onset epilepsy, 3) PRAX-562 was designed to block persistent sodium for patients suffering from rare diseases such as headache disorders and severe seizures and completed Phase 1 of clinical trials, and 4) PRAX-628 in Phase 2 clinical trials for treating focal epilepsy that originates in one side or area of the brain and affects one side of the body. Additionally, the firm has six pre-clinical drug candidates.
 
 
 Funding and financials
 
 
 The company went public in October 2020, trading on the Nasdaq Global Select Market under the ticker symbol &ldquo;PRAX&rdquo;. 
 <a href="https://sp-edge.com/updates/19453">
 In June 2023 
 </a>
 , the company announced an underwritten public offering of its common shares and pre-funded warrants, to raise approximately USD 59.1 million. The capital raised was used to support the company&rsquo;s ongoing operations and strategic initiatives, furthering the development of its pipeline and potential future endeavors.
 
 
 For the year 
 <a href="https://sp-edge.com/updates/16211">
 2022
 </a>
 , net losses increased by 28% YoY to USD 214 million arising from a significant increase in R&amp;D expense (up by 29% YoY). For the six months ended June 2023, the company is yet to generate revenue from drugs, however received collaboration revenue of USD 1.5 million. Further, it reported a decline in net loss by 43.0% YoY to USD 34.3 million. Its cash and cash equivalent as of June 2023 was at USD 124.3 million, compared to USD 61.6 million in December 2022, which the company believes will be adequate to fund operations till Q1 2025. 
 
</div>

Praxis Precision Medicines

<div>
 
 Mirati Therapeutics is a commercial-stage biotechnology company developing oncology-targeted therapies to address KRAS mutations present in 25% of tumors, including lung, colorectal and pancreatic cancers. Mirati&rsquo;s lead product KRAZATI (adagrasib/ MRTX849) is an oral&nbsp; KRASG12C inhibitor approved in 2022 for certain non-small cell lung cancers.The company also has sitravatinib, a multi-kinase inhibitor, in Phase 3 trials for non-small cell lung cancer in combination with a Bristol-Myers Squibb checkpoint inhibitor.
 
 
 
 
 Additionally, Mirati is advancing multiple early-stage programs including KRAS G12D inhibitor MRTX1133 for pancreatic and colorectal cancers, which entered Phase 1 in 2023, as well as a synthetic lethal inhibitor MRTX1719. In December 2022, the company submitted an IND application for MRTX1133, a potent and selective KRAS G12D inhibitor, which was cleared by the FDA in January 2023. 
 
 
 Key partnerships and customers
 
 
 
 
 Mirati has multiple partnerships with leading biopharma companies to advance its pipeline, including discovery collaborations with Pfizer and clinical collaborations with Novartis, Boehringer Ingelheim, and 
 <a href="https://sp-edge.com/updates/14345">
 Incyte
 </a>
 . The company also has licensing agreements with BeiGene for sitravatinib and Zai Lab for MRTX849 in certain Asian markets.
 
 
 
 
 
 Funding and Financials
 
 
 
 
 The company went public in June 2013 to trade on Nasdaq under the ticker symbol &ldquo;MRTX&rdquo;. In August 2023, the company closed an 
 <a href="https://sp-edge.com/updates/20988">
 underwritten public offering
 </a>
 at USD 345 million. The new funds were used towards drug development and leadership expansion.&nbsp;
 
 
 
 
 <a href="https://sp-edge.com/updates/16725">
 For the year 2022 
 </a>
 , the firm's net losses increased to USD 740.9 million from USD 581.8 million. Net product revenue for the full year amounted to USD 0.7 million arising from the sale of KRAZATI, which received FDA approval for its commercial launch in December 2022. 
 
</div>

Mirati Therapeutics

<div>
 
 Tvardi Therapeutics is a clinical-stage biotechnology company developing precision medicine for different cancers, chronic inflammatory diseases, and fibrotic diseases. The company&rsquo;s pipeline focuses on the development of small-molecule inhibitors of STAT3, a regulatory protein that allows cancer cells to evade the immune system and survive.
 
 
 The company&rsquo;s orally administered monotherapy and lead product, TTI-101, is in Phase 1 clinical trials for patients with advanced solid tumors who have failed all other lines of therapy. Additionally, the drug is in preclinical trials for treating fibrosis and inflammation. The company is also developing TTI-102, a next-generation STAT3 inhibitor that is structurally similar but chemically different from TTI-101.&nbsp;
 
 
 Founded in 2017, the Texas-based company closed a Series B funding round in June 2021, which brought total funding to USD 81 million and the proceeds will be used to advance Tvardi&rsquo;s drug candidates through its clinical data readouts in mid-stage trials for cancer and fibrosis.
 
</div>

Tvardi Therapeutics

<div>
 
 Tango Therapeutics is a clinical-stage biotech company developing precision oncology therapies targeting synthetic lethality in cancer which leads to cell death. Its discovery platform identifies novel targets to develop drugs focused on: 1) countering tumor suppressor gene loss to help the immune system recognize and kill cancer cells, and 2) reversing cancer cell evasion of the immune system.
 
 
 
 
 Tango has five pipeline programs, including lead candidate TNG908, an inhibitor for multiple cancer indicators. The FDA approved TNG908's IND in January 2022 and granted it Orphan Drug Designation. TNG908 is in Phase I/II trials, with preliminary efficacy data expected in H1 2023. Tango also plans to file INDs for TNG260 (STK11 mutant cancers) and TNG348 (BRCA1/2-mutant cancers). In 
 <a href="https://www.globenewswire.com/news-release/2023/01/25/2595034/0/en/Tango-Therapeutics-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-TNG462-Provides-Additional-Business-Updates.html">
 January 2023
 </a>
 , the FDA cleared the IND for TNG462, a next-gen PRMT5 inhibitor for cancers with MTAP deletion.
 
 
 
 
 Key partnerships and customers
 
 
 
 
 
 Outside its pipeline, the company also entered into a collaborative partnership with big pharma Gilead Sciences Inc., in October 2018 which was later expanded for two years in August 2020 to identify new immune evasion targets.
 
 
 
 
 Funding and financials&nbsp;
 
 
 
 
 
 Tango went public in August 2021 via a SPAC deal, trading on Nasdaq under the ticker symbol &ldquo;TNGX&rdquo;, and the company received gross proceeds of USD 353 million. In August 2023, the company raised USD 80 million via a 
 <a href="https://sp-edge.com/updates/20955">
 private placement
 </a>
 , which was led by Nextech. The new funds were used toward expanding its TNG908 and TNG462 PRMT5 programs to various other indications.
 
 
 
 
 Tango has not yet generated any drug sales and does not expect to do so for several years. However, for the full-year the company reported collaboration revenue of USD 24.9 million (down 4.42% YoY) and a net loss of USD 108.2 million (up 85.9% YoY).
 
 
 
</div>

Tango Therapeutics

<div>
 
 IDEAYA Biosciences is a clinical-stage biotech developing precision cancer therapies based on synthetic lethality - when specific gene mutations pair to cause cell death. The company also studies combining synthetic lethality with immunotherapies and DNA damage to enhance treatment efficacy. While current drugs target limited mutations like BRCA1/2, IDEAYA aims to treat broader genetic subpopulations.&nbsp;
 
 
 
 
 Its pipeline includes synthetic lethality-driven precision medicines across four potential first-in-class clinical-stage product candidates. Of these, the company owns/controls commercial rights of the three most-advanced of these product candidates: darovasertib, IDE397, and IDE161. As of May 2024, the company was also advancing Werner Helicase program for which a development candidate has been selected in collaboration with GlaxoSmithKline, and, subject to investigational new drug-, or IND-, enabling studies, are targeting an IND in 2024. In addition. the company also works on multiple earlier-stage preclinical programs. 
 
 
 By targeting specific genetic drivers, IDEAYA advances precision oncology using synthetic lethality approaches. The company is focused on developing novel targeted therapies for patient populations with high unmet need and limited treatment options.&nbsp;&nbsp;
 
 
 In December 2023, IDEAYA Biosciences teamed up with Gilead Sciences to test the combination of IDE397 and Trodelvy in a Phase I clinical trial for MTAP-deletion bladder cancer.
 
 
 
 
 Key partnerships and customers
 
 
 
 
 The company collaborates with pharmaceutical partners to advance its pipeline, including a strategic partnership with GSK in June 2020. The collaboration with GSK covers co-development and commercialization of two synthetic lethality programs. IDEAYA received USD 100 million upfront and USD 20 million in a direct private placement through the GSK deal. In June 2022, IDEAYA announced it would co-develop its Pol Theta candidate with GSK, with a Phase 1 trial starting in the first half of 2023.&nbsp;
 
 
 
 
 IDEAYA also holds an exclusive license from Novartis for LXS196 (IDE196), a PKC inhibitor for metastatic uveal melanoma. Additionally, the company is exploring IDE196 combinations with Pfizer and its potential in other rare skin diseases. In July 2022, IDEAYA signed an agreement with Amgen to evaluate IDE397 with Amgen's AMG 193 in solid tumors. Strategic pharma partnerships help advance and expand IDEAYA's pipeline of synthetic lethality precision oncology programs.
 
 
 
 
 Funding and financials
 
 
 
 
 
 The company was listed on the Nasdaq Global Select Market under the ticker symbol &ldquo;IDYA&rdquo; in May 2019, raising USD 50 million via an initial public offering. In September 2022, the company raised USD 92 million.&nbsp;
 
 
 
 
 For 2022, the company reported a net loss of USD 58.7 million (up 17.9% YoY) while collaboration revenue was USD 50.9 million (up 82.3% YoY). 
 
 
 On October 24, 2023, IDEAYA Biosciences priced an underwritten public offering of 5 million shares of common stock and pre-funded warrants to purchase 319,150 shares of common stock. The common stock offered was priced at USD 23.50 per share, while the exercise price of a pre-funded warrant was USD 0.0001. The offering was expected to bring in approximately USD 125 million in gross proceeds.
 
 
 
</div>

IDEAYA Biosciences

Companies providing genetic tests to identify individuals with high risk or at-risk of having hereditary disease, aid physicians with a diagnosis, and support clinical decision making.

Secure cloud-based platforms and data sharing networks that collect, index, store, and analyze large amounts of health data and patient population data sets from sources including genomic, clinical, wearables, imaging, and population data.

Biopharma and biotechnology companies that develop precision medicine drugs based on novel disease biomarkers present in multi-omic patient population data and genetic insights.

Companies that study intergenomic variations in genes associated with drug response and metabolism to match patients with the appropriate drug and dosage.

Companies that develop an in-vitro medical device or imaging tools and tests that identify genetic mutations for both diagnostic (nature of the disease) and prognostic (likely course of the disease) purposes, allowing providers to match a patient to a specific drug or therapy.

Software analytics platforms that integrate multiple omics datasets (genomics, transcriptomics, proteomics, and metabolomics) to gain insights and support target discovery, drug development, clinical trials, and diagnostics.

Some companies leverage AI/ML to develop tailored medication

Considers individual variability in genes, environment, and lifestyle for each person

Genomics is used across all the segments of precision medicine from diagnostic solutions to treatments

AI/ML analyzes genomic data to find drug targets, predict disease progression, and treatment response

HAYA Therapeutics is a precision therapeutics company dedicated to developing innovative tissue and cell-selective genomic medicines for fibrotic diseases and other serious age-related conditions, including cancer. The company's proprietary DiscoverHAYA drug discovery engine focuses on long non-coding RNAs (lncRNAs) within the "dark matter" of the human genome, which are key tissue and cell-specific drivers of fibrosis and other disease processes.
HAYA's lead therapeutic candidate is an antisense oligonucleotide targeting Wisper, a cardiac-enriched lncRNA that acts as a master driver of fibrosis in the heart. preclinical studies have demonstrated the ability of this candidate to halt and potentially reverse the fibrotic processes underlying heart failure. The company is developing this therapy for the treatment of non-obstructive hypertrophic cardiomyopathy, an orphan indication with limited treatment options. In April 2022, HAYA secured funding from Innosuisse, the Swiss Innovation Agency, to advance this lead program.
Beyond its lead candidate, HAYA is also developing a pipeline of lncRNA-targeting candidates for the tissue-specific treatment of fibrotic diseases in other organs, such as the lungs, kidney, liver, and the tumor microenvironment of solid cancers. In May 2022, the company received additional Innosuisse funding to leverage its DiscoverHAYA engine and identify oncology-associated fibroblast-specific lncRNAs for developing a precision RNA-targeted therapy against squamous cell carcinoma.

Innovent Biologics is a leading biopharmaceutical company founded in 2011 with the mission to develop and commercialize innovative and affordable medicines. The company focuses on oncology, cardiovascular and metabolic diseases, autoimmune disorders, and ophthalmology. As of March 2024, Innovent has ten approved products in the Chinese market, including TYVYT (sintilimab injection), BYVASDA (bevacizumab injection), SULINNO (adalimumab injection), and others. The company's core product, TYVYT, is an anti-PD-1 monoclonal antibody approved across seven indications, making it the most widely approved PD-1 inhibitor in China.
Innovent has a robust pipeline with three new drug applications under review, four assets in Phase III or pivotal trials, and 19 molecules in early clinical development. The company's innovative pipeline spans various modalities, including bispecific antibodies, antibody-drug conjugates (ADCs), and RNA therapeutics. In oncology, Innovent is advancing the next-generation immunotherapy combinations with ADCs, such as the CLDN18.2 ADC (IBI343) and the EGFR/B7H3 bispecific ADC (IBI3001). The company's metabolic pipeline includes mazdutide, a first-in-class GLP-1R/GCGR dual agonist in late-stage development for weight management.
Innovent has a strong emphasis on global innovation, with its Innovent Academy delivering eight novel molecules into IND-enabling stage in 2023. The company has established large-scale manufacturing facilities in Suzhou and Hangzhou to support global supply. Innovent collaborates with over 30 global healthcare leaders, reinforcing its commitment to advancing biopharmaceutical innovation worldwide.

Innovent Biologics

<div>
 
 ADC Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing next-generation antibody-drug conjugates (ADCs) for treating cancer. The company's ADCs leverage highly potent and targeted pyrrolobenzodiazepine (PBD) dimer technology, which causes the ADCs' antibodies to bind to specific tumor cell surface antigens. Once internalized, the potent PBD dimer is released inside the cell, creating covalent cross-links between the DNA strands, disrupting cell division without triggering DNA repair mechanisms.
 
 
 
 
 ADC Therapeutics' lead product candidate, Zynlonta, received FDA approval in April 2021 for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The company is also advancing a deep pipeline of other PBD-based ADCs targeting hematologic malignancies and solid tumors. As of May 2021, ADC Therapeutics reported revenues of USD 38.2 million, reflecting initial sales of Zynlonta.
 
 
 
 
 In March 2022, ADC Therapeutics acquired US commercial rights to Overrkey Biological's anti-HER2 ADC Overena, broadening its cancer treatment portfolio. The acquisition aligned with the company's strategic focus on expanding globally with its PBD-based ADC technology.
 
</div>

ADC Therapeutics

Sirnaomics is a biopharmaceutical company engaged in the discovery and development of RNA therapeutics. The company focuses on innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics utilizes two proprietary delivery platforms: the Polypeptide Nanoparticle Formulation (PNP) and the second generation of GalNAc conjugates called GalAhead.
Sirnaomics has established a robust pipeline of drug candidates, with several products in clinical and preclinical stages. The company's lead clinical product, STP705, has demonstrated positive results in Phase II clinical trials for the treatment of squamous cell carcinoma in situ (isSCC) and basal cell carcinoma (BCC). Additionally, STP705 is being explored for focal fat reduction in the medical aesthetics field. Another promising candidate, STP707, is a PNP formulation consisting of two siRNAs targeting TGF-β1 and COX-2 for intravenous treatment of solid tumors. STP707 has shown promising results in a Phase I basket clinical study, exhibiting stable disease response in 74% of evaluable patients.
Sirnaomics achieved a significant milestone by advancing STP122G, the first candidate utilizing the GalAhead technology, into clinical development. STP122G targets Factor XI for anticoagulation therapeutics and is currently undergoing Phase I clinical trials.
In March 2023, Sirnaomics' subsidiary, RNAimmune, received IND clearance from the FDA to initiate a Phase I clinical trial for RV-1770, an mRNA vaccine targeting respiratory syncytial virus (RSV). Additionally, RNAimmune obtained FDA clearance for a SARS-CoV-2 vaccine booster candidate, RV-1730.
Sirnaomics has established its manufacturing facility in China, enabling the transition from a biotech company to a biopharmaceutical corporation. The facility has successfully produced a full GMP batch of STP707 for human injection and is expected to support the company's clinical pipeline.
In July 2024, Sirnaomics announced the completion of IND-enabling studies for STP125G, an siRNA therapeutic targeting Apolipoprotein C3 (ApoC3) for the treatment of cardiovascular diseases. The positive results from non-human primate studies support the filing of an IND with the FDA.

Sirnaomics

Sesen Bio is a late-stage clinical company that previously focused on developing targeted fusion protein therapeutics for cancer treatment. Its lead product candidate, Vicineum, is a locally administered targeted fusion protein composed of an anti-epithelial cell adhesion molecule (EpCAM) antibody fragment tethered to a truncated form of Pseudomonas exotoxin A for the treatment of non-muscle invasive bladder cancer (NMIBC).
In February 2021, the FDA accepted Sesen Bio's Biologics License Application (BLA) for Vicineum to treat BCG-unresponsive NMIBC, granting Priority Review. However, in August 2021, the company received a Complete Response Letter from the FDA, requiring an additional Phase 3 clinical trial for potential resubmission. Following discussions with the FDA in March 2022, Sesen Bio aligned on most elements for the trial design and planned to meet again in mid-2022 to finalize outstanding items.
On July 15, 2022, Sesen Bio made the strategic decision to voluntarily pause further development of Vicineum in the US due to the incremental timeline and costs associated with the additional Phase 3 trial. The company shifted its primary focus to consummating a strategic transaction to maximize shareholder value while seeking a partner for Vicineum's further development.
In September 2022, Sesen Bio announced a pending merger with Carisma Therapeutics, a clinical-stage biopharmaceutical company developing immunotherapies based on engineered macrophages. This merger was approved by Sesen Bio's stockholders in March 2023, with the combined company operating under the name Carisma Therapeutics Inc. and trading on the Nasdaq under the ticker "CARM".
Upon closing the merger in March 2023, Sesen Bio declared a special cash dividend of USD 75 million (around USD 0.36 per share) to its stockholders and issued them Contingent Value Rights (CVRs) entitling them to potential proceeds from the sale of Vicineum and other assets, as well as a USD 30 million milestone payment under the Roche Asset Purchase Agreement.

Sesen Bio

ACELYRIN, INC. is a late-stage clinical biopharmaceutical company focused on developing transformative medicines for immunology and inflammatory diseases. The company's lead product candidate is izokibep, a next-generation inhibitor of interleukin-17A (IL-17A) designed to overcome limitations of monoclonal antibodies. Izokibep is being evaluated in multiple late-stage trials for moderate-to-severe hidradenitis suppurativa (HS), psoriatic arthritis (PsA), and noninfectious uveitis.
In March 2024, ACELYRIN reported positive top line data from a global Phase 2 billion/3 clinical trial of izokibep in PsA, meeting the primary endpoint of ACR50 at 16 weeks with high statistical significance. The trial also demonstrated robust clinical responses for higher hurdle endpoints like ACR70, PASI100, and composite measures, indicating izokibep's potential to provide clinically meaningful benefits. Additionally, ACELYRIN announced differentiated long-term 32-week data from a global Phase 2 billion trial of izokibep in HS, showing rapid, dose-ordered improvement across multiple disease manifestations, including HiSCR100 achieved earlier than reported by other IL-17 inhibitors.
ACELYRIN's other late-stage asset is lonigutamab, a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease (TED). In March 2024, ACELYRIN announced positive proof-of-concept data from a Phase 1/2 trial, demonstrating rapid improvements in proptosis and clinical activity score within three weeks after the first dose.
As of December 31, 2023, ACELYRIN had cash, cash equivalents, and short-term marketable securities totaling USD 721.3 million, providing a runway to support key late-stage data milestones and registrational studies across multiple indications. In January 2023, ACELYRIN acquired ValenzaBio, adding lonigutamab and other immunology assets to its pipeline.

ACELYRIN

Companies that develop engineered proteins that can target specific proteins or cells in the body

Companies that develop large molecules that can be used to target specific RNA molecules in the body, either to silence or replace them

Companies that develop large molecules that combine the targeting ability of monoclonal antibodies with the cytotoxic effects of chemotherapy drugs

Companies that develop large molecules that can be used to replace or supplement deficient or malfunctioning proteins in the body

Companies specializing in peptide-based treatments leverage short amino acid chains, known as peptides, to target and modulate various biological processes for therapeutic applications

AL/ML used to identify potential drug targets, and support protein engineering and optimization

ANALYST_QUICK_TAKE

PROMINENT_CATEGORY

<div>
 
 HAYA Therapeutics has entered into a multi-year contract with Eli Lilly to progress in the discovery of drugs aimed at obesity and related metabolic illnesses. In the arrangement, HAYA will get an upfront payment, along with equity investment, and may earn up to USD 1 billion in preclinical, clinical, and commercial milestone payments, in addition to royalties from product sales.
 The contract consists of using HAYA's RNA-directed regulatory genome platform to aid preclinical drug discovery, which might result in more efficient and less damaging treatments.&nbsp;
 
</div> Analyst QuickTake: 
 The agreement between HAYA and Eli Lilly is a part of the latter’s recent plans to expand its scope and product pipeline. In June 2024, Eli Lilly entered an agreement with <a href="https: 
//sp-edge.com/updates/31187"> Radionetics Oncology </a> to establish a path to potentially acquire the company and gain access to its pipeline of cancer radiotherapeutics. Additionally, in the same month, Eli Lilly acquired biopharmaceutical company <a href="https: 
//sp-edge.com/updates/31273"> Morphic Holding </a> to expand its immunology portfolio and develop new therapies in gastroenterology.

HAYA Therapeutics

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