The Venture Codex

Participated · Series B · Sep 2021

Lexeo Therapeutics is a genetic medicine company focused on transforming treatment for cardiovascular diseases and Alzheimer's. The company is advancing genetic-medicine clinical programs and intends to use new capital to fund those programs. Lexeo closed a $95M private placement, selling shares at $15.13 per share, and entered into a registration rights agreement. Proceeds are earmarked for clinical programs and general corporate purposes and are expected to extend the company's runway into 2027. The financing brings Lexeo's total capital raised to $180M. Lexeo was founded in 2018, is based in New York, and has between 11 and 50 employees. LEXEO Therapeutics is a New York City–based, clinical-stage gene therapy company advancing AAV-based gene therapy candidates for genetically defined cardiovascular diseases and a genetically defined subgroup of Alzheimer’s disease. The company’s pipeline targets both larger-rare and more prevalent patient populations and claims potential to address up to one million patients in the United States across diverse cardiomyopathies. LEXEO’s foundational science stems from partnerships and exclusive licenses with Weill Cornell Medicine and the University of California, San Diego. The company is led by experienced genetic-medicine and rare-disease drug-development executives and is advancing a deep and diverse portfolio of candidates. LEXEO is positioning its programs for further development and collaboration to move candidates through clinical development and toward commercialization. LEXEO Therapeutics is a fully integrated clinical-stage company advancing adeno-associated virus (AAV)-mediated gene therapies for genetic cardiovascular conditions and central nervous system diseases. Its pipeline includes lead programs LX2006 (IV gene therapy for cardiomyopathy associated with Friedreich’s ataxia), LX1004 (CNS-administered therapy for CLN2 Batten disease), and LX1001 (CNS-administered therapy for APOE4-associated Alzheimer’s disease). The company also recently acquired cardiac gene therapy programs and is developing additional preclinical programs focused on the genetics of Alzheimer’s disease (LX1020 and LX1021). LEXEO reports having more than 15 AAV-mediated gene therapy programs in research and development. Proceeds from its recent financing will support continued preclinical pipeline expansion and advancement of its lead programs through clinical development toward meaningful data catalysts. The company was founded on a gene therapy research legacy at Weill Cornell Medicine’s Department of Genetic Medicine. LEXEO Therapeutics is a New York City–based, fully integrated clinical-stage gene therapy company focused on adeno-associated virus (AAV)-mediated treatments. The company's core pipeline includes three clinical-stage programs: LX2006 (IV AAV frataxin therapy for cardiomyopathy in Friedreich’s ataxia; Phase 1 start planned for 2021), LX1004 (CNS AAV CLN2 therapy; Phase 1/2 completed) and LX1001 (CNS AAV APOE2 therapy for APOE4 homozygotes; Phase 1 ongoing). Clinical data published for LX1004 in Science Translational Medicine showed a single administration slowed CLN2 disease progression and was well tolerated over an 18-month study period. LEXEO’s preclinical portfolio spans monogenic, hereditary and acquired diseases and includes up to 15 additional potential AAV programs primarily developed at Weill Cornell Medicine’s Department of Genetic Medicine. The company intends to advance clinical programs through to commercialization while maintaining an ongoing research collaboration with Weill Cornell. LEXEO launched with an $85 million Series A to advance its lead investigational programs and is headquartered at the Alexandria Center for Life Science in New York City.

Participated · Equity · Mar 2021

Aura Biosciences is a clinical-stage oncology company developing a novel VDC (virus-like drug conjugate) technology platform. Its lead candidate, AU-011 (belzupacap sarotalocan), is a first-in-class VDC in Phase 2 development for first-line treatment of choroidal melanoma and has received Orphan Drug and Fast Track designations from the FDA. AU-011 is activated with infrared light via an ophthalmic laser, is designed to preserve key eye structures and vision, and can be delivered in an ophthalmologist’s office without surgery. The company plans to advance AU-011 into a pivotal Phase 3 program and continue research across additional ocular oncology indications. Aura also intends to expand the VDC platform into non-ophthalmic solid tumors, beginning with bladder cancer. The company is headquartered in Cambridge, MA. Aura Biosciences is developing a new class of targeted therapies for ocular oncology, with its lead program AU-011 aimed at primary choroidal melanoma. AU-011 is a first-in-class light-activated therapy made of proprietary viral-like particle bioconjugates that bind selectively to tumor cells and are activated with an ophthalmic laser to disrupt tumor cell membranes while sparing key eye structures. The therapy can be delivered in an ophthalmologist’s office without a surgical procedure and has received orphan drug and fast track designations from the U.S. FDA. AU-011 is being developed under a CRADA with the National Cancer Institute. Aura plans to use proceeds from its recent financing to support late-stage clinical development of AU-011. The company positions AU-011 as a potentially vision-sparing alternative to plaque radiotherapy and enucleation, addressing a high unmet need for a disease with no approved targeted therapies. Aura Biosciences is developing a new class of light-activated viral nanoparticle therapies that selectively target and destroy cancer cells, with its lead program AU-011 focused on primary treatment of ocular melanoma. AU-011 is being developed under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. The company is led by founder and CEO Elisabet de los Pinos, Ph.D. Aura closed a $30M Series C to support its clinical programs. Proceeds will be used to expand infrastructure supporting ongoing clinical development and to continue enrolling patients in its Phase 1b/2 study of AU-011. Aura also plans to expand its Cambridge footprint in 2018 with additional employees, space and equipment. Aura Biosciences is a Cambridge, Mass.–based biotechnology company developing a new class of therapies that use viral nanoparticle conjugates to target and selectively destroy tumor cells. Its lead program, AU-011, is being developed for the primary treatment of ocular melanoma, has been granted orphan drug designation by the U.S. FDA, and was developed under a CRADA with the National Cancer Institute. The company secured an additional $8 million round of financing from expanded commitments by existing investors, including Advent Partners, Chiesi Ventures, Ysios Capital, Alexandria Venture Investments and several individual investors. Proceeds from the financing will be used to advance AU-011 into clinical testing, which the company expects to begin early next year. Aura says it has made significant strides since the closing of its Series B over a year ago while also advancing preclinical programs in other indications. The company has strengthened its governance and clinical guidance by adding Henri Termeer to its Board of Directors and expanding its Clinical Advisory Board with leading ocular oncologists. Aura Biosciences develops a platform of viral nanoparticles designed to selectively target solid tumors and metastases while sparing normal epithelium. Its lead product conjugates a viral nanoparticle with a potent, laser-activated cell‑killing molecule (IRDye 700DX) supplied by LI-COR Biosciences. The technology was discovered and developed in partnership with Dr. John Schiller’s lab at the National Cancer Institute and has shown selective tumor uptake in multiple in vitro and in vivo models. Aura positions the therapy to both eliminate tumors and preserve vision for patients with rare ocular cancers that lack targeted or FDA‑approved treatments. The company plans to use its recent financing to advance its candidates into clinical trials for eye cancers and to further develop additional cancer indications. Aura emphasizes a first‑in‑class approach aimed at high tumor specificity and reduced off‑target toxicity.

Participated · Series B · Dec 2020

Reneo Pharmaceuticals is a San Diego, CA–based clinical-stage pharmaceutical company focused on therapies for patients with genetic mitochondrial diseases. Its lead investigational candidate, REN001, is an oral, once-daily drug known to control several genes involved in mitochondrial activity. Reneo is developing REN001 as a potential first-in-class treatment to improve cellular energy metabolism by enhancing mitochondrial function and potentially increasing the number of mitochondria. The company announced a $95M Series B financing to advance its clinical development programs. The financing involved both existing and new investors to support continued development of REN001. Reneo also announced the appointment of Gregory J. Flesher as President and CEO, with founding CEO Dr. Niall O’Donnell remaining on the board. Reneo Pharmaceuticals is a San Diego-based clinical stage pharmaceutical company developing therapies for diseases associated with deficits in cellular metabolism and energy production. Its lead program is REN001, a PPAR delta agonist being developed to treat genetically defined rare mitochondrial diseases such as fatty acid oxidation disorders (FAOD) and primary mitochondrial myopathies (PMM). The company is led by president and CEO Niall O'Donnell, Ph.D. Reneo completed a $50m Series A financing to support its programs. Proceeds will fund ongoing Phase 1b clinical trials as well as other clinical and preclinical studies. Its board includes Mike Grey, Niall O'Donnell, Ed Mathers, Johan Kordel, Arthur Pappas and Lon Cardon.

Participated · Series B · Jul 2020

VarmX is a spin-off from Leiden University Medical Center (founded in 2016) developing VMX-C001, a modified recombinant human blood clotting factor X designed to restore normal clotting in the presence of factor Xa inhibitors. The lead program targets treatment of severe spontaneous bleeding in patients on DOACs and prevention of bleeding during urgent surgery. VarmX has completed enrollment of VMX-C001’s first-in-human study to demonstrate safety and provide clinical proof of concept; initial data were scheduled for presentation at the ISTH conference (June 24–28, 2023) with full study results to follow later in the year. The company says VMX-C001 may offer universal, single-dose reversal with ease-of-use and a safety profile suitable for emergency care, and it shows promise for additional indications. Proceeds from the recent financing will be used to obtain IND approval and complete preparations for a pivotal clinical trial, including large-scale manufacturing. VarmX is a pharmaceutical spin-off from Leiden University Medical Center, founded in 2016, developing VMX-C001, a modified recombinant blood factor X based on the venom of the Australian brown snake Pseudonaja textilis. VMX-C001 is being developed to treat severe spontaneous bleeding in patients taking FXa DOACs and to prevent bleeding in patients on FXa DOACs who require emergency surgery. The compound is insensitive to FXa DOACs and is intended to restore the coagulation cascade, with expected clinical advantages including universal dosing regardless of the FXa DOAC used, ease of administration, and absence of pro-thrombotic risk. VarmX plans to use newly awarded funding to upscale and accelerate cost‑effective manufacturing and to progress VMX-C001 into the next phase of its development. The company was awarded up to €17.5 million from the European Innovation Council (EIC) Accelerator, subject to negotiation, and previously raised €32 million in a July 2020 Series B backed by Ysios Capital, INKEF Capital, Lundbeckfonden Ventures, LSP, BioGeneration Ventures and InnovationQuarter. The target patient population includes over 10 million people in the US and Europe treated with FXa DOACs, of whom 2–3% experience spontaneous severe life-threatening bleeding annually, highlighting the clinical need. VarmX is a pharmaceutical spin-off from Leiden University Medical Center (LUMC) founded in 2016 that is developing VMX-C001, a modified recombinant factor X derived from Pseudonaja textilis venom to treat severe bleeding in patients on FXa DOACs. VMX-C001 is designed to be insensitive to FXa DOACs, restore the coagulation cascade, offer universal dosing regardless of the FXa DOAC used, and minimize pro-thrombotic risk. The company is also advancing discovery programs aimed at reversal agents for future anticoagulant classes, particularly those targeting factor XI(a). VarmX holds an exclusive license to the founder Pieter Reitsma’s inventions and has built a management team including CEO Alexander Vos and recently hired Dr. Bo Persson as SVP, CMC Development & Project Management. Planned near-term activities include a first-in-human (FIH) study of VMX-C001, progress toward registrational studies in severe bleeding and emergency surgery indications, and acceleration of manufacturing toward commercial scale. The company is preparing further senior clinical hires, including an experienced Chief Medical Officer, to support clinical development and regulatory strategy. VarmX, based in Leiden, The Netherlands, is developing lead compound PseudoXa to stop or prevent bleeding in patients taking synthetic factor Xa inhibitors. The product is derived from research into the properties of a snake venom and human factor X performed at the Leiden University Medical Center. The company is led by CEO Paul Bilars and CSO Professor Pieter Reitsma. The new financing will enable VarmX to advance PseudoXa into human clinical studies, expand its team and develop the production process. Development work will focus on purification and formulation as well as the pharmacodynamics and pharmacokinetics of the active compound. Financially, the company closed a €7.5m Series A and secured an additional €5.0m Innovation Credit, bringing support to €12.5m to fund these activities. VarmX is a Leiden University Medical Center spin-off focused on therapies in hemostasis and thrombosis. Its lead product, PseudoXa, is a modified factor X therapeutic protein being developed as a reversal agent to stop acute bleeding in patients taking factor Xa inhibitors such as apixaban, edoxaban, and rivaroxaban. The scientific basis for PseudoXa derives from research into properties of a snake venom, per the company’s CSO Pieter Reitsma. The company completed a seed financing round whose proceeds will be used to advance PseudoXa and to set up the manufacturing process. VarmX previously received pre-seed investment from Leiden University and UNIIQ. The company was founded in 2016 by Professor Pieter Reitsma, who serves as CSO.

Participated · Series C · May 2020

Amplyx Pharmaceuticals is a San Diego, CA–based biotech developing therapies for patients with compromised immune systems, including cancer and transplant patients and the critically ill. Its two lead programs are fosmanogepix (APX001), an antifungal agent targeting life‑threatening infections from Candida, Aspergillus and rare molds, and MAU868, a monoclonal antibody that potently neutralizes BK virus in transplant patients. The company is led by president and CEO Ciara Kennedy, Ph.D. Amplyx closed a $53M Series C extension, bringing the Series C to over $90M. The financing was led by Sofinnova Investments with participation from New Enterprise Associates, Lundbeckfonden Ventures, Arix Bioscience, Pappas Capital, RiverVest Venture Partners, 3x5 Partners and BioMed Ventures, and included new equity from Pfizer Inc. and Adage Capital Management. The company will use the proceeds to advance the clinical development of fosmanogepix and MAU868. Amplyx is developing novel, broad-spectrum antifungal agents to treat life-threatening fungal infections. Its lead candidate, APX001, has intravenous and oral formulations that completed a Phase 1 clinical program. The company plans to initiate Phase 2 trials in invasive aspergillosis and invasive candidiasis later this year. Amplyx will use the Series C proceeds to advance clinical development of APX001. To date the company has raised $118.5m in venture capital and secured more than $10m in grants from the National Institutes of Health. Ciara Kennedy, Ph.D., serves as chief executive officer. Amplyx Pharmaceuticals is a San Diego-based developer advancing APX001, a broad-spectrum antifungal agent for life-threatening fungal infections. APX001 has shown broad-spectrum activity in animal models against common Candida and Aspergillus species and potency versus rare, difficult-to-treat molds. The company intends to use the new funds to initiate clinical development of APX001, which was expected to enter clinical development in 2016. Amplyx recently expanded its management team with appointments including a chief medical officer, VP of biology, and VP of regulatory affairs. Financially, the company has raised $51.5M in venture capital and received more than $10M in grants from the National Institutes of Health. The latest $8.7M investment from 3x5 Partners brought the Series B round total to $49.2M. Amplyx Pharmaceuticals is developing novel, broad-spectrum antifungal agents, with lead compound APX001 advancing toward clinical testing. The company intends to use the Series B proceeds to advance clinical development of APX001. APX001 is slated to enter clinical development in 2016 and has shown broad-spectrum activity in animal models of invasive infection by common Candida and Aspergillus species, as well as potency against rare, difficult-to-treat molds. Amplyx has raised $42.5M in venture capital and received more than $10M in grants from the National Institutes of Health. The company is led by President and CEO Mike Grey, with Mitchell Mutz, Ph.D. as founder and chief scientific officer, Ciara Kennedy, Ph.D. as COO, and Susan Dube as VP of business development and administration. Amplyx Pharma was one of three companies that Tech Coast Angels invested in as part of a $2.9M deployment across Amplyx Pharma, Vokle, and MicroPower. The investment was reported alongside the group's broader Q1 activity, in which it put $11.5M into five follow-on deals. Two of the three deals that included Amplyx Pharma closed within the last two weeks. The article does not disclose the specific amount allocated to Amplyx Pharma within the $2.9M total. All disclosed activity was characterized as investments by Tech Coast Angels; no other investors or instruments were named. No product, revenue, user, location, or founding-year information for Amplyx Pharma was provided in the article.