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.

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. 

Recent Funding: New #AI drug discovery powerhouse Xaira Therapeutics (San Francisco) rises with $1 billion in funding - the largest initial funding commitment in ARCH history. Incubated by ARCH Venture Partners and Foresite Labs with none other than Marc Tessier-Lavigne, Ph.D., former CSO at Genentech, at the helm. The company was co-founded by David Baker, Ph.D., professor of biochemistry and director of the Institute for Protein Design at the University of Washington. Xaira will combine machine learning, data generation and therapeutic product development to build a platform for #drugdiscovery. Endeavor BioMedicines (San Diego) pulls in $132M to back #cancer, lung disease drugs. The oversubscribed series C stretches the company's cash runway through 2026. Money will be channeled into lead asset ENV-101, which is designed to block a cellular wound-healing pathway known as Hedgehog. Phase 2a data set to be presented at the American Thoracic Society annual meeting show that no patients treated with ENV-101 had signs of disease progression, compared to two given placebo. Norwest Venture Partners (Menlo Park) announces $3 Billion global fund to partner with the next generation of enduring companies. Norwest expanded the focus of its healthcare practice over the last two years by adding #biotech. The most recent biotech company investments include Engrail Therapeutics and Ray Therapeutics, Inc. Recent Layoffs: Bristol Myers Squibb plans to cut costs by $1.5 billion by the end of 2025 in a massive restructure that includes laying off about 2,200 employees. The company is shuttering its Cancer Immunology & Cell Therapy Thematic Research Center in Redwood City, CA. M&A, Deals, Partnerships: Incyte announced that it is buying Escient Pharmaceuticals for $750 million to gain control of a pipeline led by clinical-phase treatments of atopic #dermatitis and other skin conditions. Escient’s lead asset is an antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2), a receptor that is expressed on mast cells. The small molecule, EP262, is in Phase Ib/II trials in those three conditions and clinical proof-of-concept data are due early in 2025. Cidara Therapeutics (San Diego) reacquires global development and commercial rights to CD388 and announces private placement financing of $240 Million. The financing was led by RA Capital Management to fund Phase 2b clinical trial of CD388, which is active against all strains of influenza A and B, and being developed for pre-exposure prophylactic treatment. Regeneron expands in gene editing with $100 million #CRISPR drug developer Mammoth Biosciences deal (Brisbane, CA). Through their collaboration, the companies plan to develop in vivo gene therapies that combine Regeneron’s viral vector technology with Mammoth’s #DNA editing platforms, which are designed to be more compact than the industry standard.

Recent Funding: Zura Bio Limited (Nasdaq: ZURA) (San Diego) announces oversubscribed $112.5 million private placement. Zura Bio is a clinical stage, multi-asset #immunology company developing novel dual-pathway #antibodies for #autoimmune and #inflammatory diseases. Proceeds are expected to support the accelerated development of tibulizumab (ZB-106), including the planned Phase 2 clinical trial in systemic sclerosis (SSc). The combination of anticipated net proceeds with existing cash and cash equivalents is expected to support operations through 2027. Asher Biotherapeutics (San Francisco) has closed a $55 million series C to support the mission of developing precisely-targeted therapies for #cancer, #autoimmune and #infectious diseases. More specifically, the new cash will go toward advancing the biotech's lead program, dubbed AB248, a CD8+ T cell selective IL-2 currently being assessed in a phase 1a/1b clinical trial. The asset is being tested out as a monotherapy and in combination with Keytruda among patients with recurrent locally advanced or metastatic solid tumors who have received prior PD1 or PD-L1 checkpoint inhibitor treatment. Benitec Biopharma Inc. (Hayward), a clinical-stage, gene therapy-focused, biotech developing novel #genetic medicines based on its proprietary “Silence and Replace” #DNA-directed #RNA interference (“ddRNAi”) platform, today announced a $40 million PIPE financing. Their proprietary platform combines RNAi with #genetherapy to create medicines that simultaneously facilitate sustained silencing of disease-causing genes and concomitant delivery of wildtype replacement genes following a single administration of the therapeutic construct. Rubedo Life Sciences (Sunnyvale), a biopharma developing therapies targeting senescent cells which drive age-related diseases, today announced the closing of a $40M Series A financing round. The funding will be used to advance the company’s lead candidate RLS-1496 in chronic atopic #dermatitis and chronic #psoriasis, which will be entering Phase 1 studies. Rubedo is also developing additional therapies that selectively target senescent cells in #pulmonary diseases with significant unmet medical need, such as #IPF, with a program recipient of a substantial CIRM grant last year. FDA Approvals: The FDA is set to release its verdict on Day One Biopharmaceuticals’ (Brisbane) NDA for tovorafenib as a monotherapy for relapsed or progressive pediatric low-grade glioma (#pLGG) on or before April 30.  Accounting for 30% to 50% of all CNS tumors, pLGG is the most common #braintumor in children, and there are currently no approved therapies for most patients with pLGG. The FDA is expected to release its verdict on ImmunityBio, Inc.’s (Culver City) BLA for its investigational IL-15 activator N-803, which is being proposed as a combination treatment with bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle-invasive #bladdercancer (NMIBC).

Recent Funding: TORL BioTherapeutics, LLC (Los Angeles) announces $158 Million oversubscribed Series B-2 financing to advance the clinical development of its novel antibody-drug conjugate (#ADC) #oncology pipeline. Proceeds advance TORL-1-23, a first and potentially best-in-class, clinical-stage ADC for the treatment of Claudin 6 positive solid-tumors, TORL-2-307, and a clinical-stage ADC for the treatment of Claudin 18.2 positive solid tumors, as well as newly disclosed programs TORL-3-600, a first-in-class clinical-stage ADC for the treatment of Cadherin 17 positive advanced colorectal cancer, and TORL-4-500, a clinical-stage ADC for the treatment of DLK1 positive solid tumors. IPOs: Nurix Therapeutics (San Francisco) announces pricing of upsized $175 Million public offering. The protein degrader #biotech upsized its stock sale, which it will use primarily to fund studies of its three early-stage clinical drug candidates, including two protein degraders for B-cell malignancies. Nurix’s shares $NRIX jumped by around 11% in the past month after the company announced research deal extensions with both Gilead and Sanofi, though the stock fell about 6% Friday morning. FDA Approvals: Tr1X (San Diego), an #autoimmune and #inflammatory disease #celltherapy company, announced the FDA accepted the company's IND application for TRX103 for the prevention of Graft versus Host Disease (GvHD) in patients undergoing HLA-mismatched hematopoietic stem cell transplantation (HSCT). The company plans to initiate a Phase 1 study of TRX103, an investigational allogeneic off-the-shelf Tr1 Treg therapy, for this indication in the second quarter of 2024. Spinogenix, Inc. (San Diego) announced that the FDA has cleared the IND application for SPG601 for the treatment of people with Fragile X Syndrome (FXS). SPG601 works by restoring synaptic function to address core symptoms of FXS. The Phase 2a trial will evaluate the #neurophysiological and #clinical effects of single-dose SPG601 and placebo in adult men with FXS. Other Interesting News: Ultragenyx (Novato, CA) is inching closer to a Phase 3 study for its Angelman syndrome program, known as GTX-102. In a Phase 1/2 update Monday morning, Ultragenyx was light on data specifics but said a pivotal trial is expected to launch sometime this year. Its stock price $RARE fell by as much as 14% premarket but was down about 9% in early Monday trading. Boundless Bio (San Diego) announces first patient dosed in first-in-human Phase 1/2 clinical trial of BBI-825 in #cancer patients with resistance gene amplifications. BBI-825 is a novel, oral, selective ribonucleotide reductase (RNR) inhibitor and Boundless Bio’s second extrachromosomal #DNA (ecDNA)-directed therapy (ecDTx) to enter clinical development. Preclinically, BBI-825 has demonstrated tumor growth inhibition, including regressions, in both prevention and treatment of amplification-mediated resistance in MAPK pathway-activated tumors.