Partnology

Private #biotech funding rises as venture firms deploy cash! 26 companies closed private fundraising rounds worth more than $100 million in the first quarter, according to data from HSBC Innovation Banking shared with BioPharma Dive. While venture rounds have grown in size in recent years, $100 million is typically viewed as a significant threshold. 8 of those 26 biotechs were #cancer drugmakers, while 5 were startups developing programs for #neurological conditions, said Jon Norris, a managing director with HSBC. Overall, biotechs across the U.S. and Europe raised $6.8 billion in #venturecapital funding during the first three months of the year, nearly $1 billion more than the most active quarter in 2023. Venture firms are continuing to seek out surer bets, though. While some seed and Series A rounds are being built around more cutting-edge technology, many more are for tried-and-true management teams working to improve existing platforms, like #antibody-drug conjugates or #radiopharmaceuticals. Among the most active investors currently are OrbiMed, ARCH Venture Partners, GV (Google Ventures), RA Capital Management and Cormorant Asset Management, LP, according to William Blair. Several life sciences investment firms have closed new funds in the first quarter of 2024, including TCGX, Scion Life Sciences and Goldman Sachs — a sign of industry interest. Biotech #IPOs also rebounded last quarter to pre-pandemic levels! Initial public offerings by #biotechnology companies reached pre-pandemic levels during the first quarter, with nine #drugmakers collectively raising more than $1.3 billion, according to BioPharma Dive data. The sum is more than three times the $375 million in total proceeds from biotech IPOs in the first quarter last year, and roughly matches the first quarter total in 2020. Six of the nine biotechs to price IPOs between January and March raised $100 million or more. The largest two offerings, from CG Oncology and Kyverna Therapeutics, raised $380 million and $319 million respectively.

Recent Funding: Holoclara Inc (Los Angeles) raises $16 million Series A to develop therapeutics—with worms. Financing led by BOLD Capital Partners and will support clinical development of first-in-class, worm-derived medicines for allergies and autoimmune disorders and advancement of discovery engine. Frontier Medicines (San Francisco) announced the appointment of Gerardo Ubaghs Carrión as Chief Financial Officer and the additional close of $20 million extension to its Series C, bringing the total amount raised to $100 million, with the financing slated to accelerate multiple pipeline programs. M&A, Deals, Partnerships: Radionetics Oncology (San Diego) announced today the formation of a strategic relationship with Eli Lilly and Company to take forward Radionetics’ proprietary GPCR targeting small molecule #radiopharmaceuticals. Codexis, Inc. (Redwood City, CA) a leading enzyme engineering company, today announced it has entered into an asset purchase agreement with Crosswalk Therapeutics for the Company’s investigational Fabry and Pompe disease compounds. IPOs:  Alumis (San Francisco) announced the pricing of its IPO of 13,125,000 shares of common stock at an initial public offering price of $16.00 per share. FDA Approvals: Neurocrine Biosciences (San Diego) announced the U.S. FDA has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia (CAH). Longboard Pharmaceuticals (La Jolla) receives Breakthrough Therapy Designation for Bexicaserin (LP352) for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs). Circle Pharma, Inc. (San Francisco),a leader in macrocycle drug discovery and development, announced the submission of its first Investigational New Drug (IND) application to the U.S. FDA for CID-078, a first-and-only-in-class cyclin A/B RxL inhibitor. Soleno Therapeutics, Inc. (Redwood City) announced the submission of a NDA to the U.S. FDA for approval of DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia. ReCode Therapeutics (Menlo Park), a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, announced that the U.S. FDA has granted Orphan Drug Designation for RCT1100 for the treatment of primary ciliary dyskinesia (PCD). Abdera Therapeutics (Menlo Park) announced that the U.S. FDA has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy. Vir Biotechnology, Inc. (San Francisco) receives FDA IND clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection.

Recent Funding: Marea Therapeutics (SF) has emerged with $190 million and a mid-stage #cardiometabolic clinical program. Incubated by Third Rock Ventures, the #biotech will use the money to fund phase 2 activities for lead program MAR001, a monoclonal antibody (#mAb) designed to inhibit ANGPTL4, a protein highly expressed in body fat. Preclinical models found that MAR001 reduced triglycerides, remnant cholesterol and ectopic fat, while improving insulin sensitivity. The biotech plans to launch a phase 2b trial assessing MAR001 for #metabolic dysfunction in the beginning of next year. Iambic Therapeutics (San Diego) has now raised an oversubscribed $50 million extension round led by new investors Mubadala Capital and Exor Ventures. The new cash will be used to advance the biotech's #clinical and #preclinical pipeline. This includes IAM1363, a small molecule inhibitor designed to treat both wild-type and oncogenic HER2 mutants currently in phase 1/1b testing, as well as a preclinical dual CDK2/4 inhibitor designed to tackle treatment resistance in solid tumors. āshibio, Inc (Brisbane) exited stealth mode today with $40 million in seed and Series A financing to advance therapies for bone and connective tissue disorders. MPM BioImpact led the Series A round, with contributing funds from Agent Capital, YK Bioventures, and Mirae Asset Capital Life Science. Recent Layoffs:  eFFECTOR Therapeutics, Inc. (Solana Beach): The #oncology biotech has laid off staff as it plans to wind down. This includes eFFECTOR CEO Stephen Worland, Ph.D.; CFO Michael Byrnes; and CMO Douglas Warner, M.D., who all stopped serving in their positions at the end of last week. M&A, Deals, Partnerships: Belharra Therapeutics (San Mateo & San Diego), a next-generation #chemoproteomics company transforming small molecule drug discovery by illuminating binding pockets on elusive, high-value drug targets across the proteome, announced a strategic collaboration with Sanofi to advance the discovery of novel small molecule therapeutics for #immunological diseases. FDA Approvals: Halozyme, Inc. (San Diego) announced that argenx received U.S. FDA approval for VYVGART® Hytrulo co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (#CIDP). Adicet Bio, Inc (Redwood City) announced that the U.S. FDA has cleared the Company’s IND application to evaluate ADI-270, an armored allogeneic “off-the-shelf” gamma delta chimeric antigen receptor (CAR) T cell therapy candidate targeting CD70+ #cancers, for the treatment of relapsed/refractory renal cell #carcinoma (RCC). 4D Molecular Therapeutics (SF) announced U.S. FDA clearance of the IND for 4D-175, an R100 vector-based intravitreal #genetic medicine, for the treatment of patients with geographic atrophy.

Versant Ventures debuts Santa Ana Bio, Inc. (Alameda) with $168 million and a trio of programs that riff in new ways on existing ideas like targeting mast cells and stimulating the PD-1 pathway. One of Santa Ana’s drugs, dubbed SAB01, is a so-called bispecific #antibody. It is designed to mute the mast cells that drive allergic disease by blocking a protein called c-Kit. But the drug will only do so when it detects another target that’s found on those cells. Foresite Capital (Larkspur) an investment firm that backs life sciences and healthcare companies, has raised a $900 million fund. The fund, Foresite’s sixth, will invest in companies focused on precision medicine, healthcare delivery and life sciences infrastructure. In drug developers, specifically, the firm is looking for those using #genetics and #machinelearning to identify potential therapies. Actio Biosciences, Inc. (San Diego) announces $55 Million Series A financing to deploy a suite of proprietary tools and deep #genetics expertise to develop #therapeutics against targets shared between rare and more prevalent diseases. They have a lead small molecule program targeting TRPV4 mutations advancing toward clinic for treatment of Charcot-Marie-Tooth disease type 2C and other serious bone diseases. Actio also announced an innovative partnership with The Jackson Laboratory to develop and implement new transgenic models of rare disease pathways. M&A, Deals, Partnerships: Johnson & Johnson is handing back a bispecific T cell engager program designed to target both CD20 and CD3 to its partner Xencor, ending a significant piece of an agreement between the companies that started in 2021. Xencor completed enrollment for a Phase 1 trial of plamotamab last year. The biotech said the drug is now Phase 2-ready, adding it will review its potential to address unmet needs. The original collaboration and license deal saw Xencor get $100 million upfront for global development and commercialization rights to plamotamab. Other Interesting News: The failure of a Pfizer medicine for #Duchenne muscular dystrophy adds new uncertainty around the effectiveness of #genetherapy for the muscle-wasting condition. Pfizer said the treatment missed its mark in a definitive Phase 3 study of boys between 4 and 7 years of age with DMD. Pfizer said the therapy didn’t lead to a significant difference versus placebo on a measure of motor function, or on key secondary measures such as timed tests for how quickly study participants could stand or walk. Avidity Biosciences, Inc. (San Diego) drug for muscular dystrophy shows promise. Shares in Avidity rose by nearly one-third as the company revealed new clinical trial data for its drug del-brax in a form of #musculardystrophy.  Among eight patients treated with del-brax, Avidity reported greater than 50% average reduction in a panel of genes regulated by another gene called DUX4. Avidity also said participants showed signs of increased strength.

M&A, Deals, Partnerships: Sanofi completes acquisition of Inhibrx Biosciences, Inc. (San Diego), enhancing its rare disease pipeline with SAR447537, a promising treatment for alpha-1 antitrypsin deficiency (AATD). Inhibrx shareholders approved the acquisition, valued at approximately $1.7 billion. Biotech M&A slumps as drugmakers take a break from public deals. After defying the biggest dealmaking downturn in a decade, Big Pharma is taking a little breather from chasing public companies in favor of smaller, private targets. Drugmakers including Bristol Myers Squibb and AbbVie spent heavily on targets during the later months of last year, often paying hefty premiums in a bid to refresh aging portfolios with new blockbuster medicines. - Sector transaction values cool off after hot streak in 2023 - Big Pharma switches to private deals, with activity up 198% - The value of biotech deals down by more than 40% year-on-year to about $40 billion. IPOs:  Rapport Therapeutics (Boston & SD) announces pricing of IPO. Rapport is a #clinical-stage #biotechnology company focused on discovery and development of transformational small molecule medicines for patients suffering from central nervous system disorders. Rapport announced the pricing of its initial public offering of 8,000,000 shares of its common stock at a public offering price of $17.00 per share. Alumis (South SF) readies IPO to fund rival drug to Bristol Myers Squibb's SOTYKTU™ (deucravacitinib) US HCP. Biotechnology startup Alumis outlined plans for an initial public offering that would fund clinical development of a pair of #autoimmune and #neurological disease drugs. Both medicines are TYK2 inhibitors, a group of oral medicines that drugmakers are positioning as alternatives to injectable #biologics for #inflammatory conditions. FDA Approvals: Eli Lilly and Company Alzheimer’s drug gets unanimous backing of FDA panel. An experimental and closely watched medicine for #Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration. The panel unanimously voted that the medicine, developed known as #donanemab, appears to be an effective treatment for certain Alzheimer’s patients. The experts also concluded, by an 11-0 vote, that the drug’s benefits outweigh its risks, despite some safety concerns. Should the agency grant approval, donanemab would be the third Alzheimer’s therapy of its kind cleared for the U.S. market. These medicines work by breaking up sticky, toxic collections of “amyloid beta,” a protein many researchers believe to be a root cause of the memory-robbing disease.

Recent Funding: AltruBio Inc. (San Francisco) has secured up to $225 million in Series B funding designed to take an immune checkpoint enhancer, dubbed ALTB-268, through a midphase ulcerative colitis program. According to AltruBio, the prospect has shown potency in down-regulating chronic pathogenic T cells in preclinical and early human tests. AltruBio put ALTB-268 through a phase 1 study in healthy volunteers in 2023, leading to the initiation of a midphase study in patients with #ulcerativecolitis who are refractory to #biologics. The biotech expects to report data on the primary clinical remission endpoint in the first half of 2025. M&A, Deals, Partnerships: Inhibrx, Inc. (La Jolla) announced that, at a special meeting, the Company's stockholders approved the sale to Sanofi of all the assets and liabilities primarily related to INBRX-101, an optimized, recombinant alpha-1 antitrypsin augmentation therapy currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency. Gamma Biosciences (Menlo Park), a life sciences platform established by KKR to address the advanced therapy bioprocessing market, announced that it has entered into an agreement whereby Merck KGaA, Darmstadt, Germany, will acquire Gamma operating company Mirus Bio for $600 million in cash. Mirus Bio is a leading provider of innovative transfection solutions used for the delivery of genetic material into cells. FDA Approvals: Abdera Therapeutics (San Francisco), a biopharma company leveraging its advanced antibody engineering ROVEr™ platform to design and develop tunable, precision #radiopharmaceuticals for #cancer, announced that the U.S. FDA has cleared the company’s Investigational New Drug (IND) application for ABD-147, the first delta-like ligand 3 (DLL3) targeting radiopharmaceutical for the treatment of small cell lung cancer (#SCLC) and large cell #neuroendocrine carcinoma (LCNEC). Abdera plans to initiate a Phase 1 clinical trial in the second half of 2024.

M&A, Deals, Partnerships: Xcell Biosciences Inc. (xcellbio), an innovative technology company focused on cell and gene therapy manufacturing applications, and AmplifyBio (San Francisco), a rapidly growing CDMO, announced the launch of a partnership designed to streamline and improve the manufacturing process for engineered T-cell receptor (#TCR) therapies targeting solid tumors. Recent Layoffs:  Takeda (San Diego): Amid a multi-year reorganization program, Takeda has told employees it will be shuttering a research site in San Diego, impacting 340 full-time employees. Tenaya Therapeutics (San Francisco) will lay off approximately 22% of its staff. The company said it has enough funds to last into the second half of 2025 as it continues development of therapies for several heart conditions. Bolt Biotherapeutics, Inc. (San Francisco) is discontinuing development of its lead #oncology asset and laying off approximately 50% of its workforce. The cuts will extend Bolt’s cash runway into the second half of 2026 as it prioritizes development of candidates that include an #antibody targeting tumor-associated #macrophages that is currently in Phase I trials. BioMarin Pharmaceutical Inc. is laying off approximately 170 employees globally. The move comes on the heels of BioMarin’s announcement last month that it will cut several of its pipeline programs. Erasca, Inc. (San Diego) will reduce its headcount by about 18% as it drops several pipeline programs, the #oncology company announced. Concurrently, it is licensing two candidates from Chinese companies for development in the U.S. and other markets. FDA Approvals: Atara Biotherapeutics (LA) a leader in T-cell #immunotherapy, has submitted a Biologics License Application (BLA) to the FDA for tabelecleucel (tab-cel®) indicated as monotherapy for treatment of adult and pediatric patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. Spinogenix, Inc.(San Diego) a clinical-stage biopharma pioneering first-in-class therapeutics that restore synapses, announced that the FDA has granted Orphan Drug Designation (ODD) to SPG601 for the treatment of Fragile X Syndrome (FXS). Other Interesting News: May 15 - The House Committee on Oversight and Accountability voted overwhelmingly to approve the #BiosecureAct, which now must get through the full House and Senate before President Joe Biden could sign it into law. The legislation would restrict business with China's WuXi AppTec as well as BGI Genomics, MGI, Complete Genomics and others, on national security grounds. Supporters say the legislation is needed to keep Americans' health and genetic information from foreign adversaries, who could weaponize the data. They also say it is dangerous for China to dominate the biotech supply chain. The targeted companies say the proposed legislation is based on false and misleading allegations and would limit competition.

Please join us in recognizing Chief Scientific Officer, Liliana Maruri Avidal in this weeks Biotech Leader Spotlight Series! Liliana is serving as the Chief Scientific Officer of ReIGNITE Therapeutics, Inc., a biotech company using Directed Evolution to develop high-capacity viral vectors to unlock the full potential of #genetic medicine. Previously, Liliana was the Senior Director of Preclinical Development at Mantra Bio, as well as a Scientific Advisor at Pfizer and 4D Molecular Therapeutics. She has over 15 years of experience in #virology, oncolytic #virotherapy, viral vector technologies, #cellbiology and #genetherapy, discovering functions of viral and cellular proteins and their mechanisms of action in preclinical studies and translational studies in academia and industry. She earned her Ph.D. in Biochemistry at the National Autonomous University of Mexico Biotechnology Institute. #womeninbio #femaleleaders #biotechleaders #biotechexecs #biotech #biotechnology #womeninscience #therapeutics #drugdevelopment

Recent Funding: Lycia Therapeutics has secured an oversubscribed series C, reeling in $106.6 million to support the company's next-gen degradation approach leveraging #lysosomal targeting chimeras. The #biotech, which launched in 2019 in collaboration with academic founder and Nobel Laureate Carolyn Bertozzi, will use the series C cash to move its lead programs into the clinic for #autoimmune and #inflammatory diseases. Venrock Healthcare Capital Partners led the round, with participation from new investors Janus Henderson Investors, Marshall Wace and Franklin Templeton. Bluejay Therapeutics (San Mateo), a leader in the development of novel therapeutics, today announced the successful closure of a $182 million Series C financing round. This capital infusion will accelerate the clinical development of BJT-778, as the treatment for chronic #hepatitis D (HDV). The funds will also support the progression of additional promising candidates in Bluejay's robust pipeline for the treatment for chronic hepatitis B. As previously announced, BJT-778 has received PRIME designation from EMA based on early results from the Phase 1/2 study in HDV. This financing round was co-led by Frazier Life Sciences and a life science focused institutional investment firm. Attovia Therapeutics (Fremont) announced the closing of a $105 million oversubscribed Series B financing, bringing the total capital raised by the Company since its launch in June 2023 to $165 million. Proceeds from the financing will be used to advance the Company’s lead programs ATTO-1310 and ATTO-002 through initial clinical data readouts, expand the Company’s #immunology and #inflammation pipeline, and to further develop the ATTOBODY™ platform. Aardvark Therapeutics (La Jolla) has cashed in on #metabolic mania with an $85 million series C round, ahead of an anticipated IPO. It was previously reported that Aardvark was planning one last private financing between $75-100 million before an IPO in the late July timeframe. Aardvark is reportedly being advised by Cantor Fitzgerald, who participated in this latest round. It also has backing from Decheng Capital, which helped lead CG Oncology's successful IPO listing back in January. Other Interesting News: Replicate Bioscience, Inc., a clinical-stage company pioneering novel #srRNA technology for use across a range of #infectious, #oncology, and #autoimmune disease indications and beyond, presented new preclinical data and shared interim clinical trial results from an ongoing Phase 1 study at the American Society of Gene & Cell Therapy (ASGCT) annual meeting: - Positive data from Phase 1 trial of RBI-4000 vaccine achieve WHO-established surrogate of protection across all dose cohorts. - Vector improvements demonstrate broad potential of Replicate's srRNA for expanded indications in complex infectious disease and in situ expression of therapeutic proteins.

Recent Funding: BridgeBio (Palo Alto) has secured $200 million to equip its cancer-focused offshoot BridgeBio Oncology Therapeutics, formerly known as TheRas.  The company currently has one asset in the clinic—a KRAS G12C inhibitor dubbed BBO-8520 that is being evaluated in non-small cell lung #cancer —and two approaching human testing. The newly launched phase 1 study, which will test BBO-8520 as a single agent and in combination with Keytruda, puts the program years behind approved KRAS drugs sold by Amgen and Bristol Myers Squibb. But BBOT and its backers believe BBO-8520 could lead to better efficacy. Enlaza Therapeutics (San Diego), the first covalent #biologic platform company, raises $100M through its Series A financing led by the Life Sciences group of J.P. Morgan Asset Management’s Private Capital. The new biotech is working on protein drugs via the covalent biologic platform War-LockTM. Proceeds will be used to advance the platform and pipeline to the clinic with novel protein drugs that are designed to provide enhanced efficacy and reduced toxicity. The company already has preclinical data for a handful of #oncology candidates. Recent Layoffs: Gilead Sciences (Foster City, CA) is cutting 58 roles at a SF site, according to a WARN report. The layoffs are slated to be complete by June 28, according to the report. M&A, Deals, Partnerships: Akari Therapeutics, Plc and Peak Bio Inc. (Palo Alto) announced completion of a joint portfolio prioritization review pursuant to which the combined entity, following completion of the previously announced merger of Akari and Peak, will focus on Peak’s #ADC platform technology and Akari’s PAS-nomacopan Geographic Atrophy program. Astellas Pharma and Poseida Therapeutics, Inc. (San Diego) have entered into a second CAR-T contract to develop novel and flexible allogeneic cell therapies in #oncology. Astellas will conduct the transaction through its subsidiary Xyphos Biosciences. Poseida will contribute its proprietary allogeneic CAR-T platform, while Xyphos will lend both its ACCEL and convertibleCAR technologies. The partnership’s goal is to produce one CAR-T construct, which in turn will yield two convertibleCAR product candidates for solid tumors. Other Interesting News: Moderna walks away from potential $3B gene editing deal with Metagenomi (Emeryville). Metagenomi is capable of advancing programs on its own, CEO Brian Thomas said, adding that the biotech has over the years built up its footprint and talent base, as well as “leveraged significant private and public funding to greatly expand our gene editing toolbox, and established in-house manufacturing.” For Moderna, the discontinuation of the Metagenomi partnership comes after it suffered more than $1 billion in losses and write-downs linked to low demand for its vaccine and cancelled orders for Africa.