Participated · Series D · Sep 2024

ONL Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapeutics to protect and improve vision in patients with retinal disease, specifically geographic atrophy (GA) associated with dry AMD. The firm targets a mechanism of action that prevents Fas-mediated death of retinal cells and inflammatory signaling pathways, which it cites as root causes of vision loss. Its lead candidate, ONL1204 Ophthalmic Solution, showed reductions in the rate of growth of GA lesions in a Phase 1b trial after six months with either a single injection or two injections 90 days apart versus sham. A consistent treatment effect was observed when comparing treated eyes to fellow eyes. The company is led by CEO David Esposito and co-founder and chief scientific officer David Zacks, M.D., Ph.D. ONL plans to use the new financing to expand development efforts and further advance its differentiated clinical program in GA. ONL Therapeutics is a clinical-stage biopharmaceutical company based in Ann Arbor, Michigan, developing first-in-class therapeutics to protect retinal cells from Fas-mediated cell death. Its lead asset, ONL1204 Ophthalmic Solution, is a novel small-molecule Fas inhibitor intended to protect photoreceptors and other retinal cells across a range of retinal diseases. ONL1204 has an active IND and has been granted orphan drug designation by the FDA for macula-off rhegmatogenous retinal detachment (RRD). The company is preparing to initiate a U.S.-based Phase 2 study in macula-off RRD next quarter and is conducting two ongoing Phase 1b studies in geographic atrophy (GA) associated with AMD and in progressing open-angle glaucoma (OAG) at sites in Australia and New Zealand. Preclinical work is ongoing to enable trials in other indications, including inherited retinal degeneration. The recently announced financing will support advancement of ONL1204 into Phase 2 and regulatory preparations for additional Phase 2 programs in GA and OAG. ONL Therapeutics, based in Ann Arbor, Michigan, is developing novel therapies to protect vision in patients with retinal disease. Its lead compound, ONL1204, is a novel small-molecule Fas inhibitor designed to protect key retinal cells, including photoreceptors, from Fas-mediated cell death. The company is building a platform of products intended for a range of blinding diseases, including retinal detachment, glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD). ONL1204 has been granted orphan drug designation by the U.S. FDA for retinal detachment, and the company has focused initial clinical plans on the acute indication of retinal detachment while pursuing preclinical work for chronic indications. Planned clinical activity includes completing a Phase 1 study in retinal detachment and initiating Phase 1b studies in open-angle glaucoma and dry AMD, plus a repeat-dose toxicology study to support accelerated chronic dosing. The company is led by CEO David Esposito and co-founder/CSO David Zacks, M.D., Ph.D. ONL Therapeutics is developing a platform of Fas inhibitors intended to protect key retinal cells and preserve vision across a range of retinal diseases. Its lead compound, ONL1204, is a novel, first-in-class small-molecule Fas inhibitor designed to protect photoreceptors and other retinal cells from cell death. ONL1204 has been granted orphan drug designation by the U.S. FDA for the treatment of retinal detachment. The company is preparing ONL1204 for a Phase I study in retinal detachment to be conducted in Australia later in 2019. ONL is pursuing a Series B to continue funding clinical development and to expand its Fas inhibitor pipeline into indications including glaucoma, age-related macular degeneration, and inherited retinal degeneration. Financially, ONL recently raised $3 million in a convertible note from a mix of current investors, management, and new investors to advance its clinical program. ONL Therapeutics is developing ONL1204, a novel first‑in‑class small‑molecule Fas inhibitor designed to prevent retinal cell death via direct and inflammatory signaling. The company is initially advancing ONL1204 toward clinical trials for retinal detachment, where the compound has received U.S. FDA orphan drug designation. Preclinical data and literature cited by the company support potential application of ONL1204 in glaucoma, wet and dry age‑related macular degeneration (AMD), non‑infectious uveitis and other retinal neuropathies. ONL closed a $4.25 million Series A and combined those proceeds with a recently announced $1.0 million grant from the National Eye Institute to finalize preclinical development. The financing also included conversion of a previously announced $1.0 million bridge loan. Funds will be used to complete preclinical work, prepare for first‑in‑human trials, and broaden research into other ocular indications with significant unmet need.

Participated · Seed · Sep 2021

Opus Genetics develops AAV-based gene therapies targeting inherited retinal diseases and describes itself as patient-first and clinical-stage. Its portfolio includes a derisked LCA5 lead program currently in a Phase 1/2 clinical trial. The company is advancing multiple preclinical candidates, including programs targeting rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP) and MERTK-related retinitis pigmentosa. Opus plans IND-enabling studies for a newly designed AAV vector to replace mutated MERTK in retinal pigmented epithelial cells and anticipates the RHO vector safety study will be the last preclinical study before entering clinical trials. Opus is based in Research Triangle Park, N.C., and is backed by the Foundation Fighting Blindness’ venture arm, the RD Fund. The company’s current financing update reflects project-based, non-dilutive support to advance preclinical and IND-enabling work. Opus Genetics is a patient-focused gene therapy company developing AAV-based therapies for orphan inherited retinal diseases. The company was formed to advance preclinical work from scientific cofounders Jean Bennett, Junwei Sun and Eric Pierce, with lead programs licensed from the University of Pennsylvania. Its lead programs, OPGx-001 (LCA5) and OPGx-002 (RDH12/LCA13), target severe forms of Leber congenital amaurosis and recent preclinical data have demonstrated potential to restore retinal structure and function. Opus expects to file an IND for OPGx-001 in early 2022 and to enter the clinic in mid-2022. The company says it is building novel orphan manufacturing scale and efficiencies and plans to expand its pipeline with additional programs. Opus is based in Raleigh, N.C., and launched with seed funding to advance its preclinical programs.

Participated · Equity · Oct 2020

Azitra combines the skin microbiome with genetic engineering to develop live biotherapeutic products (LBPs) and consumer programs using engineered and wild-type bacteria. Its platform leverages proteomics and a proprietary panel of Staphylococcus epidermidis strains to identify candidates for treating skin conditions. Clinical and development programs target cancer therapy–associated skin rashes, orphan indications such as Netherton syndrome, and atopic dermatitis, with additional consumer and OTC product efforts planned. The company was founded in 2014 by scientists from Yale and works with dermatology, microbiology, and genetic engineering experts. Azitra has an existing collaboration and joint development agreement with Bayer announced in January 2020 to advance candidate strains for adverse skin conditions. The company is clinical-stage and recently advanced its financing position through a Series B led by Leaps by Bayer. Azitra develops live biotherapeutic medical dermatology products by combining microbiome science with molecular genetics. Its pipeline includes candidates targeting cancer therapy–associated skin rashes (ATR-04) and Netherton syndrome (ATR-02), and programs for atopic dermatitis and ichthyosis vulgaris. The company has initiated plans to run a series of clinical studies and move its lead candidates into the clinic in 2020. Proceeds from recent financing will be used to expand the management team and advance clinical programs. Azitra was founded in 2014 by scientists from Yale and is based in Farmington, Connecticut. To date the company has raised $17 million. Azitra combines microbiome science and genetic engineering to develop therapies for skin disease. Its lead program, AZT-02, is a topical ointment composed of a proprietary strain of Staphylococcus epidermidis engineered to secrete LEKTI for treating Netherton syndrome. The product is designed to establish residence on the patient’s skin and continuously and stably deliver therapeutic protein in situ, with potential immunomodulatory and anti-pathogen benefits. Azitra advances both consumer health and pharmaceutical programs targeting atopic dermatitis, dry skin, cancer therapy–associated rashes and targeted orphan indications. The company received a Phase II SBIR grant of $719,700 from the National Science Foundation to support advanced development of AZT-02, building on prior Phase I NSF STTR and a Phase I SBIR award from NIAMS (NIH). Principal investigators on the current program are founder and Chief Scientific Officer Travis Whitfill and Julia Oh, Ph.D., of The Jackson Laboratory, which is collaborating on the work. Azitra was founded in 2014 by scientists from Yale University and is based in Farmington, Conn. Azitra is a preclinical-stage biotech focused on treating skin disease by combining the microbiome with molecular genetic engineering. Its pipeline includes pharmaceutical programs for atopic dermatitis (eczema), ichthyosis vulgaris, and Netherton Syndrome, plus a consumer health product to restore microbiome balance for rough, dry, or sensitive skin. The company is preparing for first-in-human testing this year and is advancing CMC, formulation development, and commercialization activities. Specific programs named in the release are AZT-04 (consumer health human studies), AZT-01 (IND-enabling studies for eczema and ichthyosis vulgaris), and a Netherton’s program moving toward proof-of-concept. Azitra was founded in 2014 by scientists from Yale and operates within the UConn Technology Innovation Program ecosystem. The company has raised $5.4 million in total to date. Azitra is a preclinical company that aims to treat skin conditions by harnessing the skin’s own microbiome. Its lead candidate, AZT-01, is a recombinant strain of a safe skin bacterium engineered to secrete therapeutic proteins locally when applied topically in a cream. The bacteria are designed to colonize the skin, restore the microbiome, and deliver missing or therapeutic proteins for conditions such as eczema, staph infections, rare genetic skin diseases and cosmetic applications. The company has been working with scientists in dermatology, microbiology, and microbiomics since 2014 to develop and test its platform. Prior funding included seed support from Peter Thiel’s Breakout Labs program and other non-dilutive grants. The recent financing will fund continued preclinical testing of the platform across a variety of skin conditions. Azitra is based in Farmington, Conn.

Led · Series B · Nov 2019

Actuate Therapeutics is a clinical-stage pharmaceutical company focused on developing and commercializing novel therapeutic agents for cancer and inflammatory diseases. Its lead program centers on 9-ING-41, which is being evaluated in the 1801 histology-agnostic clinical trial designed to move from single-agent testing to six different combinations with standard-of-care chemotherapies. The company plans to expand the 1801 trial to include an arm combining 9-ING-41 with irinotecan. With the additional $6.5M Series B-3 financing (bringing total Series B funding to over $28.2M), Actuate intends to initiate a Phase 2 clinical trial in myelofibrosis. Leadership includes President & CEO Daniel Schmitt, CMO Dr. Frank Giles, and Lead, Medical Affairs Dr. Ludimila Cavalcante. Initial combination regimens were prioritized based on preclinical evidence showing reversal of resistance to key cytotoxic agents in diverse models. Actuate Therapeutics is a Fort Worth, TX-based clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutic agents for cancer and inflammatory diseases. Its lead program is 9-ING-41, a glycogen synthase kinase-3 beta (GSK-3β) inhibitor being evaluated as a single agent and in combination with chemotherapy. The company is quickly advancing the 1801 Phase 1/2 clinical trial in adult cancer patients in the U.S. and has treated the first patient at Brown University/Rhode Island Hospital. The financing will support expansion of the 1801 trial into its U.S. and European oncology research network, initiation of investigator-initiated trials with physician/scientist collaborators, and advancement of a pediatric neuroblastoma program. Actuate is led by President & CEO Daniel Schmitt and Chief Medical Officer Dr. Frank Giles. The company raised capital in a Series B to fund these development activities.

Led · Series A · Jul 2019

Trefoil Therapeutics is developing novel engineered fibroblast growth factor-1 proteins (eFGF-1) as regenerative pharmacologic therapies to treat serious corneal endothelial diseases and epithelial disorders. Its lead product candidate, TTHX1114, is an engineered form of FGF‑1 designed to reverse vision loss by stimulating cell proliferation and migration. The underlying technology was developed by co‑founder Michael Blaber, Ph.D., and is licensed from Florida State University. The company is led by co‑founder and CEO David Eveleth, Ph.D., and is advancing both intravitreal/clinical and topical programs. Trefoil plans to complete a Phase 2a proof‑of‑concept study in corneal endothelial dystrophy (including Fuchs dystrophy) and to file an IND with the FDA in early 2020 to initiate that clinical trial. The company is also conducting IND‑enabling studies for a topical formulation of TTHX1114 with a planned second IND submission for corneal epithelial conditions in 2021.