ExSight Ventures (“EV”) joined a $10 million Series B financing round in 2C Tech Corporation Inc. (the “Company” or “2C Tech”), an early-stage biotechnology company. 2C Tech is developing nanoparticle technology to treat a number of retinal degenerative conditions. EV joins select investors Hoya Corp., InFocus Capital Partners and others. This investment will enable the Company’s pursuit of an early feasibility study (“EFS”) for the treatment of Retinitis Pigmentosa (“RP”).
Since 2C Tech’s founding they have sought to bring quantum dot (“QD”) technology to patients. The Company has accomplished much to date with a relatively modest amount of capital. 2C Tech has already conducted an ex-US Phase I clinical trial to assess the safety of their QD technology in humans. The Mexico City based trial was completed in 2016. The results were promising: QDs were shown to be safe for use in humans and preliminary data suggests the technology’s efficacy in improving vision damaged by retinitis pigmentosa.
2C Tech moves toward a clinical study on the accelerated EFS pathway. The Center for Devices and Radiological Health (CDRH) “EFS Program facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation.” This device pathway promises a faster and less capital-intensive time to the clinic. The EFS pathway allows for the enrollment of a small number of subjects and is used to evaluate the device design concept with respect to initial clinical safety and device functionality.
The Company expects to submit an Investigational Device Exemption application (“IDE”) to the FDA in early 2020. Once approved 2C Tech will initiate the EFS clinical trials to demonstrate efficacy and product safety. The trial protocol will include the Ora-VNC™ mobility course as a primary endpoint, a functional vision metric specifically tailored for RP patients. The approach is similar in concept to that used in the successful Spark Therapeutics trials. The majority of clinical trial sites have already been identified and await the IDE approval to begin enrollment. The first patient should be treated by the middle of 2020 with results expected in the latter part of the year.
If successful with the EFS study 2C Tech has several options for rare and orphan disease pathways that could further accelerate and expedite time to market. The technology would represent a breakthrough in treating not only patients with retinitis pigmentosa but other blinding conditions as well. Other potential indications include AMD, glaucoma and diabetic retinopathy. Dr. Rahhal stated, "2C Tech is attempting this unique application of quantum dot technology, to quickly get treatment in the hands of clinicians, using routine, well-accepted, office-based intravitreal injection. 2C Tech could soon help large numbers of patients across the entire spectrum of RP and other retinal degenerations."
The combination of strong pre-clinical data, promising clinical data and a strong leadership team gives us confidence that 2C Tech will be able to bring their device to market and greatly impact the treatment of RP patients. We are excited to be part of the 2C Tech story.
The ExSight Ventures team is enthusiastically announcing the launch of the ExSight Ventures Syndicate on AngelList! AngelList is a platform site that enables accredited investors to invest in companies and funds. Syndicates “are single-deal VC funds created to invest in a specific startup.” AngelList Syndicates allow investors “to invest deal-by-deal in specific companies.” AngelList provides a digital platform that will enable both ExSight Ventures and these companies access to additional investors outside of our existing networks. The platform delivers an efficient solution for us to offer and administer co-investment opportunities.
Our investment strategy targets the most promising early-stage ophthalmology companies. These prospective investments include innovative companies that span sectors including therapeutics, diagnostics, and devices. The financings these companies are seeking to raise are frequently more than our current investment capabilities permit. We believe we have found a solution that will help us scale our investment capabilities and strengthen our investing abilities.
The ExSight Ventures Syndicate will provide our existing investors and other accredited investors access to the types of investments that comprise our current portfolio. Where and when possible, we will use AngelList Syndicates to amplify the firm’s capabilities. Not every opportunity will qualify for the Syndicate nor will it always be possible to obtain an allocation, particularly in deals where ExSight Ventures does not lead. Our AngelList Syndicate will allow our “backers” to help us fund the most innovate companies in vision-care. The AngelList platform will help us in our mission to preserve and restore vision. We have built a very robust pipeline of investment opportunities and are eager to maximize our participation in those opportunities through AngelList Syndicates.
ExSight’s second fund, 8th Line II held a first close May 27 with participation from many of our existing investors. We also welcomed several new investors. The focus remains the same: to invest in the most innovative companies working to preserve and restore vision. We are quite fortunate to count among our investors in each fund colleagues, family, and friends. The ExSight team is exceptionally proud of what we are building and consider our investors an integral part of our story. Were it not for the support and partnership of each of you this would not be possible. When we came together to form ExSight in 2014, we did so intending to partner with talented founders and committed investors to tackle vision loss. Five plus years into that journey, that dream is becoming a reality. The road to success for startups and the venture funds that invest in them is long. Though still early, we are encouraged by the progress of our portfolio companies and the continued support of our investors. Thank you to each one of you!
Now, back to work!
ExSight Ventures partner, Dr. Firas Rahhal is not a stranger to the stage at the various Ophthalmology Innovation Summit meetings (AAO, ASCRS) and has even appeared on OIS TV as an interviewee (here). Though based in Los Angeles Firas made his debut as OIS TV host at this year's OIS@ASRS in Chicago. Dr. Rahhal sat down with many leaders from the world of ophthalmology interviewing executives from Bausch + Lomb, Aerie Pharmaceuticals, Genentech, and more in Chicago. Firas also interviewed the CEO of one of the early-stage companies we are most excited about, Michael O'Rourke from Re-Vana Therapeutics. Re-Vana is developing a sustained drug delivery technology.
Dr. Rahhal had this to say about the experience, "OIS at ASRS was an incredible meeting. The diverse array of talent from the scientific, clinical, investment, and commercial communities was particularly impressive this year. I was gratified and appreciated the opportunity to serve on the Retinal Innovations Financing Panel with key investment professionals in our space, as well as formally interview, for “OIS TV”, many industry leaders with new developments in the Ophthalmology space, including Dry AMD therapeutics, long-acting drug delivery to the retina, as well as surgical devices and Artificial Intelligence applications."
When asked if he had a future in television, Firas remarked, "I really enjoyed the interviews tremendously, and had fun with the lively discussions with some extremely brilliant, innovative, and nice people. I was glad that my “chatty” and informal professional communication style turned out to be handy, for a change!”
The ExSight Ventures team will be in attendance at the next OIS event when it convenes ahead of the American Academy of Ophthalmology in San Francisco this October. If you're attending, please reach out to say hello!
LensGen, an ExSight Ventures portfolio company, was the buzz of this year's American Society of Cataract and Refractive Surgery meeting (“ASCRS”) in San Diego. Members of the ExSight team were in the audience to hear Drs. Eric Donnenfeld, Uday Devgan, and Sumit (Sam) Garg present benefits of the company’s novel Juvene™, (the Complete Premium) IOL, and early results from the “Grail” Study. In addition to the reception LensGen had three high profile presentations during the ASCRS meetings. The first presentation by Uday Devgan, M.D. was given at Cataract/Refractive Subspecialty day. Dr. Devgan, who was also a presenter at the LensGen reception was interviewed after his talk by Healio. Dr. Devgan was the first to introduce ExSight to LensGen several years ago.
The next presentation by Sam Garg, M.D. was made to a full audience at OIS. Dr. Garg’s talk was front-page news in Eye World ASCRS. The final presentation in this series was given by Eric Donnenfeld, M.D., to a packed house in the main ballroom at the Innovators Lecture session. Each year, ASCRS honors individuals whose innovative ideas have benefited ophthalmologist and their patients at the prestigious Innovators Lecture. Dr. Donnenfeld presented on the Juvene IOL technology and shared the early “Grail” study results. You can watch that presentation in Healio.
It was a very exciting ASCRS for LensGen! We are honored to be a small part of the LensGen story and are very optimistic about their future prospects. Ram and the rest of the LensGen team deserve praise for their dedication and execution.
The OIS meetings always keep us busy with a full slate of meetings. These one-day conferences occur around various ophthalmology academy and society meetings throughout the year. OIS unites key constituents in ophthalmic innovation, including industry, entrepreneurial, and clinical leaders all working to develop and commercialize products to preserve and restore vision. The meetings present an opportunity for ExSight to meet with our portfolio companies, learn about new potential investments, and network with other investors and key industry partners. Dr. Rahhal joined investors from KKR, InFocus Capital Partners, and others in a panel discussion led by OIS co-chair, William “Bill” Link of Versant Ventures and Flying L Partners.
Trefoil Therapeutics, Inc., an early-stage biopharmaceutical company and ExSight Ventures portfolio company, announced their $28 million Series A financing. Trefoil is developing a regenerative approach to treating corneal dystrophies and other diseases. We initially invested in Trefoil's 2016 Series 1 financing and enthusiastically participated in the Series A financing. This financing is a significant milestone in bringing their treatment closer to an approved therapy.
When we first invested we wrote in a note to our investors, "Trefoil's innovations promise to improve patients' lives with a more efficacious treatment and significantly lower risk minimally invasive procedure." Since then, the company has made significant progress in bringing this treatment closer to reality for patients suffering from these disorders. Trefoil has generated preclinical data that has shown "TTHX1114's ability to accelerate corneal clearing in animal models of corneal endothelial dystrophy and enhance healing in corneal chemical injury and herpetic keratopathy." The company has also demonstrated "TTHX1114 stimulates the proliferation and migration of endothelial tissue" in human cornea organ culture models of both healthy and diseased corneas.
Bios Partners led the round and was joined by Access Biotechnology with participation from all existing investors. The proceeds will provide for the completion of a Phase 2a proof-of-concept study in corneal endothelial dystrophy. Trefoil plans to file an Investigational New Drug (IND) application with the FDA in early 2020 and subsequently begin the clinical trial. This financing will also fund the continued development of a topical formulation of TTHX1114 for the treatment of ulcerative conditions of the cornea. The company plans a second IND submission for corneal epithelial conditions in 2021.
The Trefoil team's ability to plan carefully, execute effectively, and communicate clearly have advanced the company's development to this crucial stage. An exceptional and seasoned leadership team, robust preclinical data, and compelling science bode well for getting these breakthrough therapies to patients. We consider ourselves fortunate to be a small part of the Trefoil story. Press Release.
Other press: Fierce, Healio, PE Hub, Pro Rata, Term Sheet, and InVision.
ExSight is pleased to announce Qura, Inc. (“Qura”) as the fifth and final portfolio company for 8th Line Investments, LLC. Qura is developing a miniaturized pressure sensor for the measurement of intraocular pressure (“IOP”) in patients with glaucoma. Glaucoma is a common disease that typically occurs when excess fluid builds up in the eye causing increased IOP damaging the optic nerve and leading to vision loss and blindness. ExSight joins InFocus Capital Partners and Santen Ventures, Inc., a corporate venture capital fund wholly owned by Santen Holdings U.S, Inc. in Qura’s Series A financing. The funding will be used for product development, testing, design, preclinical studies, and database development.
Qura’s QSmart™ wireless implantable pressure sensor (“WIPS”) technology and monitoring system promises to enable smarter treatment decisions based on better information. The miniature WIPS promises continuous monitoring and real-time IOP readings and updates. The data will then be transmitted to a tablet or other handheld device allowing physicians to evaluate glaucoma patients’ treatment in real-time. This technology will lead to better compliance within existing treatment paradigms and a better understanding of the disease. Additional insights gleaned from this data will drive drug and device developments for better treatments.
Qura’s CEO Doug Adams has previously remarked, “What makes this minimally invasive micro implant unique is that it will operate autonomously regardless of patient activity. The programmable device collects data based on the physician’s requirement and that data is transmitted to a handheld device or tablet. The physician will now have actionable data on which to base their treatment plans for the patient.”
We are excited to be part of the Qura story and their promise to improve treatments available to glaucoma patients!
ExSight is happy to announce an investment in ONL Therapeutics, Inc., an early stage biopharmaceutical company developing novel therapies for preserving sight in a range of retinal diseases. ExSight participated in a convertible note financing round with participation from existing investors. The funding will be used for IND enabling activities, clinical trial preparation and other activities.
ONL Therapeutics’ lead molecule, ONL 1204, is a novel, first-in class small molecule fatty acid synthase (“Fas”) inhibitor designed to protect the retina from cell death via both direct and inflammatory signaling in a range of retinal diseases. Fas is a known inducer of apoptosis, or cell death. The death of key retinal cells is the root cause of vision loss and is implicated in a wide range of retinal diseases, including retinal detachment and both the wet and dry forms of age-related macular degeneration (AMD).
ExSight partner and vitreo-retinal surgeon, Dr. Firas M. Rahhal stated, "No significant advances have occurred in visual results from the management of rhegmatogenous retinal detachment for the last 20 to 30 years. ONL has developed a therapeutic agent that, along with successful surgical repair, could significantly improve the visual outcomes of this potentially devastating condition. Additionally, the same agent could be similarly useful in the visual outcomes following acute angle closure glaucoma attacks. This too is an anatomic condition, repaired surgically, for which there have been no significant advances in treatment in recent decades." ONL’s therapeutic approach would be a transformative therapy having significant impact in an area of high unmet medical need. In other words, ONL perfectly fits ExSight’s investment thesis.
ExSight has been in contact with John Freshley, ONL President and CEO, and David Zacks, M.D., Ph.D., Co-Founder and CSO, for over 3 years. In that time the company has further de-risked their lead candidate, partnered with Novartis, developed a safe and ethical clinical trial protocol and identified additional potential indications. The ONL team has demonstrated tenacity, ability and significant scientific and clinical insights. The ExSight team is happy to be part of the ONL journey and look forward to contributing domain expertise to the company. “We are thrilled to invite ExSight into the family of ONL investors. ExSight is uniquely well-qualified to understand and actively contribute to ONL’s mission of protecting the vision of patients with retinal disease,” said Mr. Freshley.
For all those reasons and more we are excited to make ONL Therapeutics to the ExSight portfolio.
Alan is on the Board of Advisors of Odylia Therapeutics. Odylia has created a novel paradigm to catalyze the development of gene therapies for rare blinding inherited retinal diseases (IRDs). Its strategy is to provide a non-profit platform that can achieve significant discounts, efficiencies and economies of scale, so as to lower the costs and accelerate the development of treatments for IRDs from the lab through clinical trials.
Scientists, Advocates Team Up to Launch Odylia Therapeutics to Accelerate Gene Therapy Trials for Rare Conditions Causing Blindness
New nonprofit organization will bring treatments to clinical trial for people at risk for blindness due to ultra-rare inherited retinal diseases.
Boston, Mass. — Scientists and advocates today announced the formation of Odylia Therapeutics, a nonprofit corporation dedicated to creating gene therapies for ultra-rare genetic conditions causing blindness. The company’s efforts will concentrate on developing laboratory findings into human clinical trials for select diseases, addressing an unmet need for drug development in an area where there is currently little commercial interest. Odylia Therapeutics is being launched with support from Massachusetts Eye and Ear and the Usher 2020 Foundation, a charitable organization focused on finding cures for rare eye diseases. Read the full release here.