WINTER 2021

THE LIFE SCIENCES REPORT

Life Sciences Venture Wilson Sonsini Clients on the Front Lines Financings for of the COVID-19 Pandemic Wilson Sonsini Clients

By Scott Murano, Partner (Palo Alto) We at the firm are extremely proud of which will lead the development our work with innovative life sciences efforts of emricasan, selected clinical The table on page 4 includes data companies, many of which are currently sites at two major medical centers in from life sciences transactions in working to address challenges associated the City metropolitan area which Wilson Sonsini Goodrich & with COVID-19. There are examples to conduct the study. Wilson Sonsini Rosati clients participated across the from numerous sectors—including represented Amerimmune in the second half of 2019 and the first half of biotech, digital health, medical devices, transaction. 2020. Specifically, the table compares— and pharmaceuticals—ranging from by industry segment—the number of companies developing and testing • AuraVax Therapeutics, a closings, the total amount raised, and treatments and prospective vaccines Houston-based biotech company the average amount raised per closing to those involved in developing novel vaccines and across the two six-month periods. personal protective equipment, medical therapies to help patients defeat supplies, or other key components debilitating respiratory diseases Continued on page 4... needed to care for those who are such as COVID-19, entered into an experiencing illness. exclusive license option agreement with the University of Houston Below is a sampling of COVID-19-related with respect to the intellectual In This Issue client activity in which our firm has property covering a novel intranasal recently been involved: vaccine technology. Under the Wilson Sonsini Clients on the terms of the agreement, AuraVax Front Lines of the COVID-19 • Amerimmune, a research center has the option to exclusively license Pandemic...... Pages 1-3 and immunology laboratory with patents covering this technology. Life Sciences Venture a strong focus on identifying In addition, AuraVax entered into Financings for Wilson Sonsini underlying mechanisms of immune an exclusive license agreement Clients ...... Pages 1, 4-5 disorders, and Histogen, a clinical- with Massachusetts General A Discussion with Cyrano stage therapeutics company focused Hospital (MGH) covering certain Therapeutics CEO Rick Geoffrion on developing therapeutics that IP and technology rights regarding About the Early Feasibility ignite the body’s natural process compositions and discoveries of Studies Program ...... Pages 6-8 to repair and maintain healthy liposomal STING agonists led by Five Mistakes Medical Device biological function, entered into Mei X. Wu, Ph.D., of the Wellman Start-Ups Make ...... Pages 9-10 a collaborative development and Center for Photomedicine at commercialization agreement MGH. The transaction bolsters USJMF and JSNC Host MedTech Emerging Growth to jointly develop emricasan, an the development of AuraVax’s Companies 2020 Virtual orally active caspase inhibitor, lead COVID-19 intranasal vaccine Roadshow ...... Pages 11-12 for the treatment of COVID-19. and strengthens its platform for An Interview with Additionally, Histogen has received therapeutic development targeting Dr. Wasim Malik of Investigational New Drug (IND) a range of viral infections. Wilson Iaso Ventures ...... Pages 13-16 approval from the FDA to initiate a Sonsini is advising AuraVax Select Life Sciences Client Phase 1 study of emricasan in mild Therapeutics on business advisory Highlights...... Pages 17-24 COVID-19 patients to assess safety and corporate legal matters, and tolerability. Amerimmune, and represented the company

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Wilson Sonsini Clients on the Front Lines of the COVID-19 Pandemic (Continued from page 1)

in connection with the above in the United States. In addition, active COVID-19 in individuals with agreements. CorVent announced an agreement or without symptoms, and in adults with Siemens Healthineers for U.S. and children two years of age or • The Canadian COVID Coalition, a distribution of the RESPOND-19 older. The test—the first of its kind to group of companies that have joined Ventilator to their network of be granted an EUA—will help reduce forces in the war on COVID-19, has hospital, healthcare system, and the spread of COVID-19 through volunteered its time and resources government customers. Wilson rapid self-detection, providing to identify the nanobodies that are Sonsini handles all of CorVent’s users with real-time results in the activated in the immune response corporate work and advised on the safety of their own homes, enabling against COVID-19. The Coalition company’s seed financing in May self-isolation and patient education is offering free, non-exclusive, and 2020. on escalation of medical care. As limited exclusive licenses to foster such, it provides an essential new rapid development of diagnostic and • Density, a start-up building AI- tool to help combat the COVID-19 therapeutic tools to help neutralize powered, people-counting infrared pandemic. Wilson Sonsini assisted COVID-19’s impact. The group has sensors, closed a $51 million Series Ellume in their discussion with the published 51 antibodies that show C financing round. Kleiner Perkins FDA and is working with Ellume to promising ability to bind to the led the round, with contributions help commercialize and distribute COVID-19 virus by attaching to from 01 Advisors, Upfront Ventures, their COVID-19 Home Test. its crown-like spikes, which could Founders Fund, Ludlow Ventures, result in neutralizing the virus by Launch, LPC Ventures, and • Everlywell, a leading digital health preventing it from invading human individual investors Alex Rodriguez, company that received the first cells. Other Coalition members Alex Davis, Kevin and Julia Hartz, FDA Emergency Use Authorization include Novobind, Cedarlane, and Cyan and Scott Banister. The of its kind for its COVID-19 Test SignalChem, and Natural Products infusion brings the start-up’s total Home Collection Kit in May 2020, Canada. Wilson Sonsini is advising raised to over $74 million, following announced an oversubscribed the Coalition on IP strategy to $23 million in previous funding. Series D financing of $175 million. ensure that the resulting products In many ways, Density’s products New investors participating in the are accessible to all countries around were tailor-made for a global health round include funds and accounts the world. crisis, as cities around the world managed by BlackRock, The have imposed limits on businesses Chernin Group (TCG), Foresite • CorVent Medical, a Coridea regarding the number of customers Capital, Greenspring Associates, portfolio company focused on they allow in. Density co-founder Lux Capital, Morningside Ventures, developing versatile, reusable, and CEO Andrew Farah says the and Portfolia, as well as existing lifesaving ventilators, announced $51 million will be put toward investors Goodwater Capital, that the FDA has issued an addressing “unprecedented demand” Highland Capital Partners, and Next Emergency Use Authorization (EUA) from offices, manufacturers, Coast Ventures. This for primary critical care use of the grocery stores, industrial plants, brings the total capital raised by company’s RESPOND-19 Ventilator, and governments trying to abide by the company to over $250 million. which is designed for rapid capacity limits during the pandemic. Everlywell plans to use the funds expansion of critical care ventilation Wilson Sonsini represented Density to expand its virtual care offerings, capacity to allow hospitals to treat in the transaction. scale its testing and infrastructure, more patients suffering from acute drive clinical research and disease respiratory distress syndrome • Ellume, a digital diagnostics management through testing, (ARDS) during times of greatest company, announced that its rapid, and grow its national leadership need. The surge support system is at-home COVID-19 antigen test position in the at-home testing optimized for long-term storage and has been granted Emergency Use market. Wilson Sonsini represented ensures cost-efficient healthcare Authorization (EUA) from the Everlywell in the transaction. preparedness. With EUA granted, FDA. The Ellume COVID-19 Home the RESPOND-19 Ventilator is Test will be available without a • Gauss Surgical, the leading now available for commercial use prescription for the detection of developer of computer vision

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2 WINTER 2021 THE LIFE SCIENCES REPORT

Wilson Sonsini Clients on the Front Lines of the COVID-19 Pandemic (Continued from page 2)

applications for healthcare, and program. The award will help scale diagnostics and biosurveillance Cellex, a leading biotechnology Mammoth Biosciences’ CRISPR- technologies for the Department company specializing in point-of- based DETECTR BOOST™ test of Defense. Under the program, care diagnostic testing, announced onto high-throughput automated Mammoth will leverage its an exclusive partnership to launch platforms in commercial labs DETECTR platform to detect a rapid, at-home and point-of-care for COVID-19 diagnostics at emerging biological threats. COVID-19 antigen test. Cellex, an accelerated rate, increasing which was the first company to access to accurate tests with faster Wilson Sonsini Goodrich & Rosati receive an FDA Emergency Use turnaround across the country. represented Mammoth Biosciences Authorization for rapid COVID-19 With a $1.5 billion investment from in the above transactions. antibody testing in April 2020, is federal stimulus funding, the RADx in advanced clinical trials with a initiative infuses funding into early • Pattern Bioscience, a privately rapid antigen test that demonstrated innovative technologies to speed held in vitro diagnostics company nearly 90 percent sensitivity and development of rapid and widely founded in 2016 to help combat 100 percent specificity in early accessible COVID-19 testing. The the problem of antibiotic trials. When paired with a newly Rapid Acceleration of Diagnostics resistance, announced a $9 developed, AI-powered application Tech (RADx Tech) program million Series B-1 financing. The from Gauss that enables users to specifically aims to support the round of funding will accelerate perform and interpret the test with a development and commercialization the development and clinical smartphone, its use can be expanded of innovative technologies to validation of its rapid bacterial to aid in the rapid diagnosis of significantly increase the U.S. identification and susceptibility SARS-CoV-2 infections. Users follow testing capacity for SARS-CoV-2. testing (ID/AST) technology. The video instructions to collect a nasal company’s phenotypic testing swab sample and perform the rapid Subsequently, Mammoth signed platform is well suited to address antigen test. Within 15 minutes, the agreements with MilliporeSigma all common bacterial infections, app prompts the user to scan their and Hamilton Company targeting including complex infections (like rapid test with their smartphone commercialization of the DETECTR pneumonia) that elude other rapid and then processes the image with BOOST™ high-throughput antibiotic susceptibility testing network architecture optimized for CRISPR-based SARS-CoV-2 test technologies—a characteristic that is the Cellex assay. The app informs after Emergency Use Authorization important during COVID-19, when the user if the test result is negative from the FDA. The test will leverage more patients are hospitalized and or positive for SARS-CoV-2 antigens Mammoth’s DETECTR BOOST™ in need of mechanical ventilation. within seconds. Cellex and Gauss platform and will provide a turnkey Ventilated patients carry higher risk aim to have the antigen test and solution for commercial laboratories of developing bacterial pneumonia companion app authorized by the to enable a multi-fold increase in and are commonly treated with FDA in early 2021. Wilson Sonsini testing capacity. According to the antibiotics before current antibiotic advised Gauss with respect to the company, the high-throughput susceptibility tests can be completed. arrangement. systems will be compatible with Pattern’s faster bacterial tests can both nasal swab and saliva samples reduce the risk of antibiotic misuse • Mammoth Biosciences, which is and are targeting 1,500 tests per and enable focused treatment, harnessing the diversity of nature eight-hour shift with minimal user improving patient outcomes and to power the next-generation interaction. reducing selective pressures that of CRISPR products, received a lead to drug resistance. Wilson contract from the National Institutes In addition, Mammoth recently Sonsini represented Pattern in the of Health (NIH) as part of its announced that it has secured a financing transaction. $1.5 billion Rapid Acceleration subcontract with MRIGlobal, the of Diagnostics (RADx) program, prime contractor with the Defense making it the first CRISPR-based Advanced Research Projects initiative to be funded by the Agency, to develop CRISPR-based

3 WINTER 2021 THE LIFE SCIENCES REPORT

Life Sciences Venture Financings for Wilson Sonsini Clients (Continued from page 1)

2H 2019 2H 2019 2H 2019 1H 2020 1H 2020 1H 2020 Total Average Total Average Life Sciences Number of Amount Amount Number of Amount Amount Industry Segment Closings Raised ($) Raised ($M) Closings Raised ($M) Raised ($M) Biopharmaceuticals 42 $770.62 $18.35 56 $1,627.89 $29.07 Genomics 9 $81.96 $9.11 7 $103.32 $14.76 Diagnostics 13 $183.98 $14.15 16 $243.01 $15.19 Medical Devices & Equipment 39 $308.92 $7.92 53 $715.67 $13.50 Health IT 18 $180.02 $10.00 18 $280.77 $15.60 Healthcare Services 15 $465.01 $31.00 17 $359.54 $21.15 Total 136 $1,990.50 167 $3,330.20

The data demonstrates that venture amount raised increased 111.2 percent, half of 2020—healthcare services—was financing activity increased from the from $770.62 million to $1,627.89 million. unique in that it experienced an increase second half of 2019 to the first half in number of closings, but a decrease of 2020 with respect to total number Meanwhile, the industry segment with in total amount raised. Specifically, the of closings and total amount raised. the third-largest number of closings number of closings in the healthcare Specifically, the total number of closings during the first half of 2020—health services segment increased 13.3 percent, across all industry segments increased IT—experienced no change in number from 15 to 17, while the total amount 22.8 percent, from 136 to 167, while the of closings, but a significant increase raised decreased 22.7 percent, from total amount raised across all industry in total amount raised: the number of $465.01 million to $359.54 million. The segments increased 67.3 percent, from genomics segment experienced the $1,990.5 million to $3,330.2 million. opposite, a decrease in the number of closings and an increase in total amount Notably, the industry segment with From the second half raised: the number of closings decreased the second-largest number of closings 22.2 percent, from 9 to 7, while the total during the first half of 2020—medical of 2019 to the first amount raised increased 26.1 percent, devices and equipment—experienced half of 2020, the total from $81.96 million to $103.32 million. the largest increase in both number of The final remaining industry segment— closings and total amount raised from number of closings diagnostics—experienced an increase the second half of 2019 to the first half across all industry in both number of closings and total of 2020. Specifically, the number of amount raised. Specifically, the number closings in the medical devices and segments increased 22.8 of closings increased 23.1 percent, from equipment segment increased 35.9 percent, while the total 13 to 16, and the total amount raised percent, from 39 to 53, while the total increased 32.1 percent, from $183.98 amount raised increased 131.7 percent, amount raised across million to $243.01 million. from $308.92 million to $715.67 million. all industry segments Similarly, the industry segment with the In addition, our data suggests that largest number of closings during the increased 67.3 percent. Series B financing activity and bridge first half of 2020—biopharmaceuticals— financing activity, in each case as a experienced the second-largest increase percentage of all other financing activity, in both number of closings and total closings remained at 18, while the total increased from the second half of 2019 amount raised over the same period. amount raised increased 56 percent, from to the first half of 2020, while Series Specifically, the number of closings $180.02 million to $280.77 million. The A (including Series Seed) financing in biopharmaceuticals increased 33.3 industry segment with the fourth-largest activity and Series C and later financing percent, from 42 to 56, while the total number of closings during the first activity as a percentage of all other

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4 WINTER 2021 THE LIFE SCIENCES REPORT

Life Sciences Venture Financings for Wilson Sonsini Clients (Continued from page 4) financing activity decreased across the board for all stages of equity financings same period. Specifically, the number of from the second half of 2019 to the first Series A (including Series Seed) closings half of 2020. The average pre-money Overall, the data decreased from 30.8 percent to 27.5 valuation for Series A (including Series indicates that access to percent, the number of Series B closings Seed) financings increased 51.8 percent, increased from 15.4 percent to 17 percent, from $14.32 million to $21.74 million; the for the and the number of Series C and later average pre-money valuation for Series B life sciences industry closings decreased marginally from 15.4 financings increased 12.5 percent, from $71.81 million to $80.81 million; and the increased in the first half average pre-money valuation for Series of 2020 compared to C and later financings increased 53.1 Other data taken from percent, from $214.31 million to $328.1 the second half of 2019, transactions in which all million. with the most active firm clients participated Other data taken from transactions segments—medical in which all firm clients participated devices and equipment in the first half of 2020 in the first half of 2020 suggests that suggests that life sciences life sciences remains the most active and biopharmaceuticals— industry for investment among our driving the increased remains the most active clients. During that period, the life industry for investment sciences industry represented 33 percent activity. Moreover, those of total funds raised by our clients, while dollars were raised at among our clients. In that the software industry came in second, at period, the life sciences 30 percent of total funds raised. higher valuations across the board. industry represented 33 Overall, the data indicates that access percent of total funds to venture capital for the life sciences industry increased in the first half of which is consistent with the notion raised by clients. 2020 compared to the second half of that investors have been more focused 2019, with the most active segments— on reserving and deploying capital for medical devices and equipment and existing portfolio companies in this percent to 15.2 percent. Bridge financing biopharmaceuticals—driving the COVID financing world, rather than activity as a percentage of all other increased activity. Moreover, those making new in the form of financing activity experienced the most dollars were raised at higher valuations Series Seed or Series A investments. significant change, increasing from 21.7 across the board—for Series A (including percent during the second half of 2019 to Series Seed), Series B, and Series C 28.1 percent during the first half of 2020. and later financings. It is noteworthy Scott Murano that more of those investments were (650) 849-3316 Average pre-money valuations for life made in the form of Series B and bridge [email protected] sciences companies increased across the financings than in the prior period,

5 WINTER 2021 THE LIFE SCIENCES REPORT

A Discussion with Cyrano Therapeutics CEO Rick Geoffrion About the Early Feasibility Studies Program

Program, established by the U.S. Food So, before EFS, device clinical trials and Drug Administration (FDA) in 2013, and approvals would often occur in to be one of the hallmark advancements Europe years before the devices were in U.S. regulatory policy over the last 20 studied or cleared in the U.S.? years. For that reason, I am excited to be here today to discuss its merits. Yes. When the EFS Program was established by the FDA in 2013, virtually What is the Early Feasibility Studies all early-stage clinical research in (EFS) Program? medtech was being conducted outside the U.S., primarily in Europe. U.S. The FDA issued guidance in 2013 for an patients were getting access to new Early Feasibility Study Investigational medical innovations approximately four Device Exemption (IDE) pathway, years after patients in Europe would effectively devising an early-stage clinical access them. That was despite the fact trial process that could go through an that the majority of the world’s medtech FDA review with more appropriate pre- companies were housed in the U.S. clinical and engineering data suitable The majority of medtech innovation for an early-stage device. Before that, all was happening here in the U.S. and Wilson Sonsini attorney Charles Andres IDE approvals were based on the clinical the majority of funding available for recently sat down with Rick Geoffrion, requirements of a full-blown Premarket medtech innovation was here in the U.S. a medical device and life sciences Approval (PMA), disincentivizing most It was being created here, but only being entrepreneur who is currently the companies from considering clinical tested there. It made no sense. founder, president, and CEO of Cyrano research in the U.S. until well proven in Therapeutics, to discuss the importance outside-the-U.S. clinical studies. of the Early Feasibility Studies Program for medical device manufacturers. How did EFS come about? “When the EFS Program was

Charles: Rick, thanks for being here. To understand the background for the established by the FDA in Can you tell our readers a little bit creation of EFS, you have to go back 2013, virtually all early-stage about your background? to a watershed moment in the history of medical device innovation in the clinical research in medtech Rick: I have been in the medical United States—the approval of the was being conducted outside device and life sciences industry first percutaneous aortic valve in the for the last 35 years, founded or co- U.S., the Edwards Sapien valve. This the U.S., primarily in Europe. founded eight private venture-backed transformative, life-saving valve was companies, mostly in the cardiovascular approved in November 2011, more than U.S. patients were getting sector, and experienced a number of four years after CE Mark (Europe) and access to new medical transactions. My current company, nearly 10 years after the first-in-human Cyrano Therapeutics, is developing a clinical experience. At that time, many innovations approximately four treatment for chronic smell and flavor clinicians, industry, the FDA, and years after patients in Europe loss. I also serve as the vice chairman even Congress realized there was a of The Mullings Group Companies disconnect in getting novel, life-saving … despite the fact that the and sit on the executive committee and devices to U.S. patients. And the four- majority of medtech innovation board of directors of the Medical Device year gap in approval between U.S. and Innovation Consortium, where I co-chair Europe became a rallying cry for process was happening here in the U.S.” the Cardiovascular Early Feasibility improvement to improve access for Study (EFS) initiative. I consider the EFS highly innovative medical devices.

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6 WINTER 2021 THE LIFE SCIENCES REPORT

A Discussion with Cyrano Therapeutics CEO Rick Geoffrion . . . (Continued from page 6)

For example, if you were an early-stage pathway to approval in the U.S. by medtech company before 2013, not only initiating the pathway to approval or did you perform your first-in-man study “The most significant clearance in the U.S. at an earlier stage. outside of the U.S., but if you were a advantage [of an EFS] is that Let’s assume the first 10-15 cases in an Class III significant risk device, you EFS are successful, safety looks good, would perform your entire CE Mark a company is likely to have a and there appears to be an emerging study for approval in Europe, outside the faster pathway to approval signal on efficacy. The company can U.S., then use that data to finally start apply for an EFS extension to enroll in the U.S. by initiating the a study here in the U.S. Sometimes that more cases, until such time the company was only a feasibility study, not even a pathway to approval or is ready to start a pivotal trial. So, the pivotal study. As a consequence, patients EFS can dovetail nicely into a definitive clearance in the U.S. at an in the U.S. would wait four years longer path to approval in the U.S. It is also data to gain access to a medtech innovation earlier stage.” that can likely be leveraged toward a CE that was invented right here in the U.S. Mark application in Europe. And the EFS Program gives U.S. patients early Once U.S. patients did get access, they access to the newest and most innovative What are some key elements of an were often stuck with a first-generation therapy. EFS? device that was inherently inferior to second- and third-generation devices Are a reasonable number of EFS • Small number of subjects; usually being used at the same time in Europe typically run in the U.S. each year? 10-15 to start. and elsewhere in the world. So, from a patient standpoint, the most important • Can be a 510(k) (Class II) or a PMA More than 50 EFS are approved each standpoint, it was suboptimal, to say (Class III) device. year. the least. There were real human costs. • The study should be conducted early In addition, devices were starting to Can you provide more detail on in the device’s development. be developed specifically for non-U.S. how the Medical Device Innovation markets. The U.S. was falling behind, • Does not have to involve the first Consortium (MDIC) is working to the quality of healthcare delivery was clinical use of the device. make EFS better? impacted, and the FDA started to take • An EFS can be approved on less notice. non-clinical data. MDIC is working to make EFS better in several ways. First, we are creating The company is allowed to pause the What kinds of medical devices are • attention and awareness around the study and change design midstream eligible for EFS? EFS Program. Second, MDIC is working in an EFS. to engage the entire clinical research Per the FDA, the EFS Program is open to • The majority of EFS applications ecosystem to improve the time it takes devices subject to Premarket Approval, can be approved within a 30-day to initiate and complete an EFS. We Premarket Notification [510(k)], De period. have a wonderful steering committee, Novo classification, or Humanitarian chaired by Dr. David Holmes of Mayo • It is always important to have a pre- Device Exemption (HDE). EFS may be Clinic, with participation from the FDA, submission meeting with the FDA. applicable when clinical experience is senior clinicians, industry, and clinical They can tell you if you are ready to necessary because non-clinical testing is sites. MDIC has dedicated staff for submit for an EFS. unavailable or inadequate to provide the EFS, including a program director, and information needed to advance device together we’ve worked on a number of development. Therefore, EFS may be How does an EFS translate into projects and resources over the last few conducted on new devices without prior benefits for a medical device start-up years to create meaningful improvements clinical experience, and in some cases, company? in the EFS ecosystem. EFS may also be conducted on devices with limited prior clinical experience. The most significant advantage is that Next, after obtaining input from many a company is likely to have a faster stakeholders, we decided to start by

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7 WINTER 2021 THE LIFE SCIENCES REPORT

A Discussion with Cyrano Therapeutics CEO Rick Geoffrion . . . (Continued from page 7) collecting the facts, the analytics on - Now some of these processes how well the ecosystem was working. are done in parallel, like IRB We reached out to industry sponsors and contracting, but it does “With the help of stakeholders and asked them to provide to MDIC on a objectively show that in the and the use of tools developed confidential basis the start-up statistics 2015-17 timeframe, it took nearly for their Early Feasibility Studies. MDIC a year to get an EFS clinical site by MDIC, by 2019 the average was uniquely equipped to bring these up and running in the United IDE approval time was reduced groups together and get them to share States—a very long time that had this data. This was a first for industry to little to do with the actual study from 68 days to only 53 days, share this kind of data, but we had good enrollment. IRB approvals were shaved cooperation from many companies and to 51 days, and the time to were able to gather a snapshot of the With the data in hand showing the issues performance of the clinical ecosystem. and the current state of affairs, we set first subject enrollment was We measured the FDA review cycles, out to bring the stakeholders together significantly reduced, from 187 the Institutional Review Board (IRB) to work on the common problems. Our review cycles, the contracting and first effort was a Best Practices Workshop days to only 88 days.” budgeting timing, and the time to first held in Washington at the MDIC offices patient enrollment. The results were eye- with 65 participants from leading opening to all the stakeholders and really industry players—both big companies quantified what to many had previously and small companies, clinical site agreed language on the thorniest issues. been anecdotal information. coordinators, principal investigators, the We believe that the use of the MCTA will FDA, CMS, and MDIC. Over a day and significantly improve the time to contract Here are the results of that first analysis a half, we discussed the key issues and approval once we have transitioned out conducted on 2015-17 EFS in the U.S.: openly shared best practices to achieve of the current pandemic. efficient processes. We published the • We found that FDA approval of the findings and made the information Impressive! Any last thoughts on EFS IDE was taking on average 68 days, available for everyone. and the Medical Device Innovation well within expectations for a timely Consortium? approval cycle. Then, with the help of all stakeholders If you go to the MDIC website at www. • IRB review times were slightly and the use of tools developed by MDIC, longer at 72 days—not that bad. by 2019 the average IDE approval time MDIC.org and look under the Initiatives was reduced from 68 days to only 53 tab, you will find a list of wonderful • Contract approval, however, was days, IRB approvals were shaved to free tools developed by MDIC to assist taking a surprisingly long 133 days— 51 days, and the time to first subject companies with the efficient execution nearly four months on average for a enrollment was significantly reduced, of an EFS. The program director for EFS sponsor and site to work through a from 187 days to only 88 days. at MDIC is Liliana Rincon Gonzalez and contract and budget. she can be reached at lrincon-gonzalez@ - The time to first patient One metric that had not yet improved mdic.org. The team at MDIC has done enrollment once all the was the time to contract approval. a great job creating these tools and we administrative activities were Therefore, a further key step was would like to invite all companies to take complete was then a surprisingly to develop a Master Clinical Trial advantage of it. Thank you. long 187 days—nearly six Agreement (MCTA) that streamlined the months. contract negotiating process between industry sponsors and sites with pre-

8 WINTER 2021 THE LIFE SCIENCES REPORT

Five Design Mistakes Medical Device Start-Ups Make

By Walt Maclay, President, Voler Systems

Start-ups are the lifeblood of the medical device industry. Large medtech companies depend on start-ups to eliminate some of the risk of new technologies. In addition, start-ups are very efficient in their use of funding, and they much faster than large companies.

That being said, start-ups are often inexperienced. Here are five common design mistakes they need to avoid:

1. Feature Creep

The biggest mistake start-ups make is trying to cram too much into that first device. When you start adding bells and whistles, it increases your timeline, it increases your budget, and it opens you up to more scrutiny by the Food and Drug Administration (FDA). We advise them to take a little time and think about the core things that are needed. Those core features are going to drive your minimum viable product (MVP). Get those done, get those right. Keeping the feature list limited keeps your budget the death of your product. On the other hasn’t been done before, you may run needs limited. Requirement creep will be hand, make sure you know what is really into unanticipated problems. The more needed, and put that in. unprecedented your project is, the longer it’s going to take, and the more The biggest mistake start- The best way to get this right is to it’s going to cost. As Murphy’s Law says, thoroughly understand your customer “If anything can go wrong, it will.” You ups make is trying to cram and the problem you are solving. This have to plan for that. It’s important requires interviewing many customers to understand what is risky and what too much into that first and watching them do their work. You isn’t. If the technology is unproven, do device. When you start can’t just ask them if they want your a feasibility study, or at least investigate product and what features they want. enough to be sure your risk is low. adding bells and whistles, You need to experience their pain, then figure out a solution no one else has If you are not thoroughly familiar with it increases your timeline, thought of. When you are tempted to add the technology, a consulting company it increases your budget, features, just focus on solving the urgent that is focused in the space will know problem the customer has. what technology is risky and what and it opens you up to technology isn’t. They can propose 2. Not Doing a Feasibility Study feasibility tests that will reduce the risk, more scrutiny by the FDA. or they may show that the risk is very Another big problem is that if you’re high, and you may not want to proceed. bringing to market something that

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9 WINTER 2021 THE LIFE SCIENCES REPORT

Five Design Mistakes Medical Device Start-Ups Make (Continued from page 9)

3. Underestimating the Amount develop the product, but to get FDA Walt Maclay, president and founder of Work Needed to Meet FDA approval, a proven design control process of Voler Systems, is recognized as a Requirements needs to be used. Product specs must domain expert in Silicon Valley technical clearly and unambiguously articulate consulting associations. He has spoken The FDA cares that the device is safe. A the product’s features, functionality, on sensors, wearable devices, wireless non-medical commercial device can be and behavior. Careful writing of the communication, and low power design. just good enough. A medical device has product requirements is the important From 2008 to 2010, he was president of the to be safe and effective, and that takes starting point in a more rapid approval Professional and Technical Consultants time and money. The FDA requires a lot process, and they are essential for the Association (PATCA). He is a senior life of documentation to prove it. A good verification process. Here is a white member of the Institute of Electrical and rule of thumb is to plan on a medical paper titled “Developing Product Electronic Engineers (IEEE) and a member device costing about three times as much Requirements for Medical Devices”: of the Consultants Network of Silicon as a consumer product to develop and https://volersystems.com/design-tips/ Valley. Walt has been an instructor at prepare to sell. This includes the extra voler-whitepaper-developing-product- Foothill College in the Product Realization design work, testing work, regulatory requirements-medical-devices/. Certificate Program, teaching successful work, and quality system work. new product introduction skills. He has If you have not done this before, an applied his outstanding leadership to many experienced design consulting firm can multidisciplinary teams that have delivered make sure your product requirements quality electronic devices. Walt holds a A good rule of thumb is to are done well. The requirements will be B.S.E.E. degree in electrical engineering adjusted by the risk analysis. You will plan on a medical device from Syracuse University. probably need to mitigate some risks costing about three times with design changes. The requirements Voler Systems, one of the top electronic should support the verification testing design firms in Silicon Valley, is committed as much as a consumer that will be done at the end of the design to delivering quality electronic products process. All of this should be prepared product to develop and on time and on budget. It provides design, before starting the design. It will save development, risk assessment, and prepare to sell. This time and money in the end. verification of new devices for medical, consumer, and industrial applications. 5. Not Getting the Right Expertise includes the extra design Voler is particularly experienced in work, testing work, Find people who know how to build the designing wearable and IoT devices, kind of device you want to build—people using its skill with sensors and wireless regulatory work, and who can help you not only develop the technology. The company has developed hundreds of products, including medical quality system work. product, but get it through the FDA. We work in partnership with start- devices, wearable devices, home health, ups to ensure that the right product is products for the aging, and other medical, being developed, that it will rapidly consumer, and industrial devices. 4. Ad Hoc Processes get FDA approval, and that it can be manufactured easily to get into the Start-ups often use ad hoc processes marketplace quickly and at minimum to explore the application needs and cost.

10 WINTER 2021 THE LIFE SCIENCES REPORT

USJMF and JSNC Host MedTech Emerging Growth Companies 2020 Virtual Roadshow

The 2020 MedTech Emerging Growth Companies Virtual Roadshow featured presentations from the following:

• Agile Devices • AiM Medical Robotics • Centerline Biomedical • Centese, Inc. • Eyedaptic • InformAI, Inc. • Invenio Imaging • Ischemia Care • Mitre Medical • MITRx, Inc. • Oracle Health, Inc. • osteolabs GmbH • PercAssist, Inc. • Prescient Surgical On October 12-14, 2020, US-Japan Akiyama, president of JSNC, and • Qidni Labs Medtech Frontiers (USJMF) and the Keith Kirkham, Minister Counselor • Quantason, LLC Japan Society of Northern California for Commercial Affairs from the U.S. • Radux Devices LLC ( JSNC), with the support of founding Embassy Tokyo. USJMF Chairman Jack • Regentys sponsor Wilson Sonsini Goodrich & Moorman then introduced Mr. Cleeland, • Shape Memory Medical Inc. Rosati, held the MedTech Emerging who delivered his keynote address. • Slate Therapeutics Growth Companies 2020 Virtual Seven cardiovascular-focused emerging • Smartlens, Inc. Roadshow. Featuring keynotes from companies gave brief presentations to • Sway Medical, Inc. Andrew Cleeland, CEO of the Fogarty the virtual audience, after which remarks Institute for Innovation, and David were provided by Dr. Fumiaki Ikeno of Cassak, founder and co-editor-in-chief ’s Byers Center for of iconic industry publication Medtech Biodesign. Each day concluded with interactive Strategist, and pitch presentations breakout sessions at which attendees from 22 innovative emerging growth Day Two kicked off with the keynote had the opportunity to participate in live medtech companies, the event attracted address from Mr. Cassak, which was Q&A sessions around virtual “tables” more than 500 attendees worldwide, followed by presentations from six with representatives from the presenting including a large contingent from companies in the neuro or orthopedic Japan. The keynote addresses and sectors and remarks from Mr. Akiyama. companies and bilingual medtech company presentations were all given The third and final day of the event experts facilitating the discussions. simultaneously in both English and highlighted presentations from nine Japanese. companies in the gastrointestinal, “This would have been our Seventh surgical, opthamology, ENT, or women’s Annual Medtech Week in Japan, with The first day of the event featured health sectors. perhaps 1,000 attendees,” said USJMF welcome addresses from Takahide Chairman Jack Moorman. “Though

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11 WINTER 2021 THE LIFE SCIENCES REPORT

USJMF and JSNC Host MedTech Emerging Growth Companies . . . (Continued from page 11) we had to reschedule to 2021, we still conference. Overall, the feedback was best practices for wanted to provide an environment where very positive, and I think we have a medical device Japanese companies could get to know recipe for success we can use for future innovation and these exciting early-stage companies virtual conferences.” promote networking despite their inability to travel in person and collaboration to Japan. The keynotes and presentations “The Japan Society of Northern between U.S. were not only given in English, but they California, with its 115-year history, and Japanese had a real-time Japanese interpreter was delighted to partner with USJMF medical device on a parallel Zoom channel. The to deliver this incredibly informative organizations. Q&A was virtual, but felt up close and and productive event on medical device Wilson Sonsini is a co-founder and personal, as interested attendees could innovation. We look forward to jointly sponsor of USJMF, and partners Casey hosting similar events with USJMF in the McGlynn and Elton Satusky serve on future and bringing this type of industry- the organization’s board of directors, specific collaboration to our audience, along with Chairman Jack Moorman, “We still wanted to provide an sponsors, and partners,” said Takahide Dr. Fumiaki Ikeno of the Stanford Akiyama, president of the Japan Society Byers Center for Biodesign, Kirk Zeller environment where Japanese of Northern California. of Silicon Prairie Center and Nichibei companies could get to know MedTech Advisors, LLC, and Masa Ishii The 2020 MedTech Emerging Growth of AZCA Venture Partners. these exciting early-stage Companies Virtual Roadshow was held companies despite their in lieu of the USJMF/Wilson Sonsini trade mission and roadshow, which inability to travel in person to was originally scheduled to take place Japan … Overall, the feedback in Kyoto and Tokyo from November 7-13, 2020, but has been postponed was very positive, and I think until November 2021 due to the global Founded in 1905, the Japan Society we have a recipe for success pandemic. Early and growth-stage of Northern California works to medical device, diagnostic, and digital advance U.S.-Japan collaboration and we can use for future virtual health companies will be encouraged understanding in a global context. The conferences.” to apply to the 2021 trade mission and Society offers an array of programs and roadshow. Representatives from 22 such networking opportunities for people – USJMF Chairman Jack Moorman companies attended the Sixth Annual and organizations in the Bay Area with a Japan Medical Device Innovation Week strong interest in Japan. These programs via the USJMF/Wilson Sonsini trade draw on the diversity of the region, its be at a table with company presenters mission and roadshow in November importance as an exemplar of innovation and a knowledgeable medical device 2019. and economic growth, and its historic expert fluent in both Japanese and ties to Japan across fields including Founded in 2013, US-Japan Medtech English. Each table was limited to six business, technology, and the arts. Frontiers is a Silicon Valley-based attendees at a time, so it felt like a small nonprofit whose mission is to share meeting you might have after a typical

12 WINTER 2021 THE LIFE SCIENCES REPORT

An Interview with Dr. Wasim Malik of Iaso Ventures

in whatever age we happen to be born obvious, because the returns are far in. For me, the brain represents the higher than when achieved only with a next major frontier for exploration “lazy-money” approach. and discovery. In my journey through academic training and working At Iaso, we have adopted the studio in various industry sectors, from model to work with early-stage telecommunications and software companies in a hands-on way to help to healthcare, I concluded that the them grow and reach the next value brain and mind have defied human inflection point at an accelerated pace. understanding through the eons. We also identify market gaps through Demystifying the brain was something our extensive landscape analysis, that would motivate me to get out of bed opportunistically ideating and creating in the morning, so it seemed appropriate new ventures from the ground up. My to turn this interest into a career. belief is that this model brings the real value-add the market requires, The human genome project really particularly in specialty markets such as was when we turned the corner in our neuroscience, where domain expertise understanding of genetics. We have not makes all the difference. Wilson Sonsini partner Mark Solakian hit a similar milestone in neuroscience recently interviewed Dr. Wasim Malik, yet; therefore, our understanding of What are you looking for in your the managing partner at Boston-based the brain remains rudimentary at best. portfolio companies? And what Iaso Ventures, the nation’s first sector- Even the most basic innovations in are some of the qualities that you focused neuroscience and mental health brain science can greatly impact human have seen in successful portfolio venture capital firm. Wasim oversees Iaso society. This important knowledge companies? Ventures’ overall strategy, investments, gap and the opportunity for social and partnerships. Below is a selection of and business impact made it an easy Like most investors, we follow a highlights from their conversation. decision for me to jump headfirst into structured and disciplined deal analysis neuroscience innovation and investing. and due diligence process. Some of Mark: Could you provide us with a bit the key factors are the differentiated of background on Iaso Ventures? Iaso Ventures is a new fund and you technology that a company has have a unique model. You call it the developed, the robustness of the Wasim: We launched the firm last year Iaso Ventures Studio. Tell us about intellectual property, and the approach in response to the market gap we noticed the studio model, how it works, how to the regulatory and reimbursement related to innovation and early-stage it differs from other models, and any environment. investments in the neuroscience and other unique attributes. mental health space. In contrast with But perhaps most importantly, we generalist investment firms, our strategy The venture studio model is not a new like to look at the team. As early-stage revolves around an investor-operator invention—it goes back 25 years and has investors, we really invest in teams that team with deep sector expertise and been performing well in building high- are capable of executing, have a track an innovation ecosystem comprising value start-ups, especially in the tech record of innovation and achievement, value-add strategic partners. I am also industry. Rather than providing only and are able to perform nimbly under delighted about the strategic partnership investment dollars or hands-off advisory, ever-changing market conditions. We Iaso Ventures has with Wilson Sonsini. the studio model pairs up entrepreneurs even have an in-house organizational with experienced operators to roll up psychologist and leadership coach to What was your personal interest in their sleeves and co-create new ventures. assess the start-up team dynamics, build neuroscience, and what drew you to it The success of the studio model can be upon strengths, and fill any gaps. in your career? seen in the recent IPO of Snowflake—the largest software IPO to date. Snowflake We also pay serious attention to the Many of us are intrigued and inspired was started at Sutter Hill Ventures’ question “Who cares?” Often, we see by the mysteries that remain unsolved studio. The attraction for investors is exciting new technologies, but the

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13 WINTER 2021 THE LIFE SCIENCES REPORT

An Interview with Dr. Wasim Malik of Iaso Ventures (Continued from page 13) market may not be ready, the pathway especially in digital diagnostics and to commercialization may not be clear, therapeutics. We can also see the switch or the journey of identifying customers “Overall, the pandemic from sick care to preventive care, and creating initial traction may not have hasn’t increased the although these are still early days. started. In those cases, we really like to sit down with our entrepreneurs and venture market risk profile. Do you have any concerns about the figure out who should care and how to market and risk factors related to the make them care. In fact, historical data pandemic? suggests that during How does Iaso Ventures fit into the The most significant risk during the overall life sciences ecosystem in recessions, public equities pandemic has been the ability to raise Boston, and more broadly, throughout capital and maintain sufficient runway. the U.S. or internationally? can be up to 13 times riskier We’ve seen some degree of correction than .” and consolidation in the private markets. We are fortunate to be headquartered in In the early days of the pandemic, Boston, the global headquarters for life investors mostly directed their dry sciences innovation, with the highest powder toward existing investments concentration of biopharma companies of innovation through the lens of rather than making new bets. I read and some of the world’s top research restructuring traditional business models about predictions that 70 percent of powerhouses. This ecosystem provides with extensive horizontal and vertical start-ups would collapse, but that did the best opportunities and resources integration. not happen. Many overestimated the to build great companies by sourcing effects that the pandemic would have technology from top-tier schools, When applied to the future outlook on capital markets, as it is typical for working with well-regarded KOLs, and for venture, we expect that these capital markets to overreact, but because leveraging a dense cluster of strategics moving tectonic plates will give rise to of various factors, private markets have and investors. The Iaso Ventures team unforeseen cross-industry partnerships more or less remained stable. spans the major innovation hubs across and exit pathways. As a recent example, the U.S. and has cultivated robust we saw that Boston-based Control Labs, In the healthcare and life sciences international connections. a start-up with roots in medtech, was industry, some of the risk factors remain acquired by for potential use the same as before—primarily due to big As you look ahead, do you envision in future human-computer interaction bets being made on new, game-changing any expansion to your industry scope technology. technology platforms or disease- for additional or different vectors that modifying therapeutics. Overall, the could be of interest? Are you seeing any sectors that might pandemic hasn’t increased the venture be more attractive due to the current market risk profile. In fact, historical Iaso Ventures is charting out a state of the market or other drivers? data suggests that during recessions, bold agenda to imagine the future public equities can be up to 13 times of neuroscience and lay out the It is no surprise that the healthcare riskier than private equity, which can infrastructure to enable that future. We market has experienced massive growth partly be attributed to the long time are philosophically inspired by what the during the pandemic. Certain healthtech horizon and consequent stability of refers to as the applications have seen a significant VC/PE investments. “Fourth Industrial Revolution,” where uptick, prominent among them digital the boundaries between the biological, technologies for telehealth, now being Do you see behavioral health issues physical, and digital realms are blurred. used both for care delivery at home and developing as an impending crisis? for virtual clinical trials. We expect these What’s your take on why it’s a growing By embracing this transformative vision, industry trends will only grow in the concern? we are expanding our mission to push coming years. the envelope at the intersection of Currently, one in every five individuals healthcare and technology as it applies In the medium term, we foresee great globally suffers from a mental health to neuroscience and mental health. As potential for expansion across the tech- issue. Several factors suggest that part of this exercise, we see the world enabled healthcare services spectrum, there will be an increase in the mental

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14 WINTER 2021 THE LIFE SCIENCES REPORT

An Interview with Dr. Wasim Malik of Iaso Ventures (Continued from page 14) health crisis. One reason is that workflow and ultimately increase the will be announcing several international we’ve succeeded in prolonging life, productivity of the overall healthcare partnerships in the coming months. so we have an aging population, and system and, in the end, improve patient corresponding age-related diseases care and quality of life. In addition to an all-star core team that and quality-of-life issues. An aging I am most proud of, we are building a population means higher prevalence Do you see signals that deal flow is stellar advisory group to establish Iaso of dementia, for example, and higher trending upward? Ventures at the forefront of thought cost of elder care. There has been a leadership both in neuroscience R&D significant rise in behavioral health In neuroscience and mental health, and in emerging business models that issues such as addiction, depression, deal flow has continued to increase can support fast-paced innovation. and anxiety, especially among teens and significantly in the last few years. millennials, which can be attributed to When we first started Iaso Ventures, we As managing director of a fund, an increased isolation and the lack of social were concerned about both the quality investor, and with regard to your connectedness. The pandemic has only and quantity of deal flow. However, portfolio companies, how do you plan exacerbated these challenges. our timing coincided perfectly with to apply a diversity and inclusion the upswing in the market interest in initiative? While this sounds ominous, there are neuroscience as a sector, resulting in rich also reasons to rejoice. Policy changes, deal activity. Alongside, we see robust I am proud to restate our commitment such as the Mental Health Parity interest from investors in this specific to promoting equal opportunity and Act, have enabled greater access to sector, both for its societal impact and ensuring that the core values of diversity mental health services. There is a shift the potential of outsized returns. and inclusivity are reflected in our team toward new pricing models, such as and portfolio composition. By bringing for therapeutic development for rare Thinking globally, what geographic these issues to the forefront, the Black diseases, which makes it possible to markets are you and your portfolio Lives Matter movement [in 2020] has develop new cures in an economically companies most interested in? provided tailwind to our efforts. We plan viable way. Value-based reimbursement to continue our mission of boosting models are shifting focus toward Brain health is of course a global issue. minority and women’s representation in healthcare outcomes and prevention- It’s fair to say it affects emerging markets the venture industry. As an immigrant based approaches, promoting population as much as it affects us here in the U.S., and minority founder myself, I am health initiatives. opening up global scaling opportunities. acutely aware of the many hurdles faced We’re also seeing great innovation in by women and people of color in the What industries do you see advancing neuroscience and mental health in many venture industry. Through specific firm- in 2021, or in the next five to 10 years? geographies around the world, such as wide initiatives, we are taking steps to Where do you think the next big Israel, Canada, Japan, and certain other correct these societal imbalances and disruption will occur? countries. In recent weeks, there have promote underrepresented communities been announcements about launching as founders, investors, and executives. In 2021 and beyond, we expect to see a multibillion-dollar global initiative to I want to point out that this focus advances in more game-changing promote mental health. on equitable representation does not platforms for therapeutic development. come at a price to our investors. On Increased interest in gene editing and Are there any new developments with the contrary, diversity of backgrounds stem cell technologies, for example, Iaso Ventures you’d like to share? and experiences is known to boost the has spawned vigorous R&D activity. potential for much higher returns. New approaches are being developed In our quest to build bridges with global for the medical use of naturally existing and especially emerging markets, we’re What is it like being an investor substances or their synthetic equivalents, actively expanding our geographical during the pandemic? such as psychedelic medicines for footprint by leveraging our international treating depression and PTSD. And networks. This will help us cast a bigger Somewhat counterintuitively, the finally, we notice a focus on connected net for deal sourcing, allow our start- pandemic is the best time for investing health platforms for patients, caregivers, ups to access global markets, and open in start-ups aiming to solve real business and providers, which can improve up opportunities for global scaling. We problems with an eye on generating

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15 WINTER 2021 THE LIFE SCIENCES REPORT

An Interview with Dr. Wasim Malik of Iaso Ventures (Continued from page 15) traction and profitability. Historically, The most naïve questions are the best It is advisable to look at the track funds with vintage in down-market ones, as new directions of inquiry can record of any legal or other partner an years have consistently outperformed. promote outside-the-box thinking and entrepreneur chooses to work with, and The reason is that market corrections generate paradigm-shifting insights. develop a comfort level that the partner bring valuations down to realistic Candid feedback—and tough love where has relevant subject-specific expertise levels, promote a survival-of-the-fittest needed—coupled with the ability to pivot and a broad market footprint. That often environment, and make available larger quickly and pivot often, can spell the translates into working with firms that talent pools. difference between roaring success and are highly reputed within the specific crash-and-burn situations. industry, have a global presence, and The timing could not be better for a offer full-service capabilities that can neuroscience-focused fund. There are I usually advise early-stage entrepreneurs address any sphere of legal needs as now multiple large studies linking to not be fixated on the uniqueness they arise. Outstanding law firms such COVID-19 to increased incidence of of their idea or the coolness of their as Wilson Sonsini, which are known for neurological disorders as well as mental technology, but instead to focus on their entrepreneurial DNA and for going health issues. Iaso Ventures is therefore the business model and the path to to bat for their start-up clients, are the uniquely positioned to invest in market profitability. To turn your question ideal partners for entrepreneurs. segments at the cusp of rapid expansion around, the question I most often ask of due to the pandemic. entrepreneurs is, “So what?” Prior to becoming the managing partner at Iaso Ventures, Dr. Wasim Malik served What is your view on the utility of Do you have any additional advice for as chief digital strategist at Roivant the scientific advisory board from the new entrepreneurs? Sciences, a global biopharma company. perspective of the CEO or CFO, board, He also served on the faculty at Harvard and investors? A core tenet of entrepreneurship is that Medical School and Massachusetts it takes a village. My advice for new General Hospital, where he built a research The team is one of the foremost things entrepreneurs is to build a team around program on tech-enabled clinical research we evaluate in our investment decisions. themselves that falls in place like pieces in neuroscience, anesthesia, and critical The scientific advisory board is a of a puzzle. Once you surround yourself care. In addition, Dr. Malik taught critically important segment of the team, with people smarter than yourself, entrepreneurship, neuroscience, and especially in life sciences and healthtech “constructive collisions” start to take machine learning at MIT, and served on start-ups. We talked earlier about the role place, which generate bold ideas and the visiting faculty at Brown University. He our firm’s location plays in our business launch great companies. It’s important received a Ph.D. in electrical engineering strategy. In the East Coast healthcare and to surround yourself with differing from Oxford, postdoctoral training in life sciences investment market, we tend opinions and encourage disagreement. neuroscience from MIT, and finance to be evidence-based and data-driven. education in venture capital and private We pay attention to the composition What are the qualities you look equity from . of the scientific advisory board, the for with respect to your outside Learn more about Iaso Ventures and Dr. complementarities of the individuals attorneys, and what do you encourage Malik at https://iasoventures.com/. involved, the ability of those individuals entrepreneurs to look for when to identify and capture opportunities selecting counsel? ______nimbly, and the ability to adapt in light of new discoveries or challenges along It goes without saying that having * This interview was originally published the way. specific expertise within one’s industry in the Q3 2020 edition of The Entrepreneurs Report published by Wilson Sonsini. is a core requirement, but perhaps even What kinds of questions are you asked more importantly, personal chemistry most often by entrepreneurs? and trust are critical. Selecting counsel is part of the journey of building a People that aren’t shy about asking business that lasts for years and years, so questions and are capable of active the selection of legal partners should be listening make good entrepreneurs. thoughtful.

16 WINTER 2021 THE LIFE SCIENCES REPORT

Select Life Sciences Client Highlights

Hurdle Raises $5 Million Series in Series A funding. The financing was clinical programs and further expand Seed Financing led by Khosla Ventures, along with its preclinical pipeline consisting of On January 25, 2021, Hurdle, an Perceptive Advisors, Casdin Capital, multiple programs in discovery to IND- innovative digital mental health Andreessen Horowitz, Sands Capital, enabling stages. Abbisko is dedicated platform company, announced that and top individuals, including Midas to the discovery and development of it has successfully closed a $5 million List investors /Breyer Capital innovative medicines for unmet medical Series Seed financing co-led by 406 and Rahul Mehta; Goldman Sachs’s needs in China and around the world. Ventures and Seae Ventures with former CFO and CIO R. Martin Chavez; Wilson Sonsini acted as counsel to participation from F-Prime. Hurdle will and biomedical device entrepreneur Warburg Pincus, a lead investor in the use the new capital to strategically scale Shlomo Ben-Haim. Wilson Sonsini financing.http://www.abbisko.com/ its evidence-based and tech-enabled advised Earli on IP matters related to the page96?_l=en&article_id=157. platform, designed to support culturally transaction. https://www.businesswire. diverse populations’ behavioral com/news/home/20210112005302/en/ Blacksmith Medicines Launches health needs. Wilson Sonsini advised Earli-Raises-40-Million-Series-A-. with Seed Funding and Research Hurdle in the transaction. https:// Funding-Led-by-Khosla-Ventures-With- Collaboration with Lilly www.prnewswire.com/news-releases/ Perceptive-Advisors-Casdin-Capital- On January 8, 2021, Blacksmith hurdle-raises-5-million-series-seed-to- Andreessen-Horowitz-Sands-Capital. Medicines, Inc., a biotechnology accelerate-expansion-of-its-mental- company focused on creating novel health-platform-with-special-focus-on- Gracell Biotechnologies Announces medicines for immuno-oncology and the-black-community-301213620.html. Pricing of IPO inflammatory diseases by targeting On January 8, 2021, Gracell human metalloenzymes, announced Pacific Biosciences Announces Biotechnologies Inc., a global clinical- that it has secured seed funding and has Multi-Year Collaboration with Invitae stage biopharmaceutical company entered into a research collaboration Corporation dedicated to discovering and developing with Eli Lilly and Company (Lilly). Lilly On January 13, 2021, Pacific Biosciences breakthrough cell therapies to address joins existing Blacksmith investors of California, Inc., a leading provider major industry challenges and fulfill Evotec A.G., MP Healthcare Partners, of high-quality, long-read sequencing unmet medical needs in the treatment MagnaSci Ventures, and Alexandria platforms, announced a multi-year of cancer, announced the pricing of Venture Investments. Wilson Sonsini collaboration with Invitae Corporation, its of 11,000,000 advised Blacksmith Medicines on IP a leading medical genetics company, to American Depositary Shares, each matters related to the transactions. begin development of a production-scale representing five ordinary shares, at https://www.prnewswire.com/news- high-throughput sequencing platform a public offering price of US$19 per releases/blacksmith-medicines-launches- leveraging the power of PacBio’s ADS. The gross proceeds to Gracell with-seed-funding-and-a-research- highly accurate HiFi sequencing to from the offering are expected to be collaboration-with-lilly-301203230.html. expand Invitae’s whole genome testing US$209 million. Wilson Sonsini advised capabilities. Wilson Sonsini represented Gracell on IP matters related to the DiCE Molecules Announces $80 PacBio in the transaction. https:// transaction. https://ir.gracellbio.com/ Million Series C Financing www.pacb.com/press_releases/pacific- news-releases/news-release-details/ On January 8, 2021, DiCE Molecules, a biosciences-and-invitae-to-develop- gracell-biotechnologies-announces- biopharmaceutical company leveraging ultra-high-throughput-clinical-whole- pricing-initial-public. its proprietary DNA-encoded library genome-sequencing-platform/. platform to discover and develop next- Abbisko Therapeutics Announces $123 generation therapeutics in immunology, Earli Raises $40 Million in Series A Million Series D Financing announced the completion of an $80 Funding On January 8, 2021, Abbisko million Series C financing. The financing On January 12, 2021, bioengineering Therapeutics Co., Ltd., an oncology- was led by RA Capital Management firm Earli, which developed in stealth focused biopharmaceutical company, with participation from new investors a new platform technology that will announced the completion of its including Eventide Asset Management, allow clinicians to exactly locate Series D financing of $123 million. The New Leaf Venture Partners, Soleus early cancers so they can be treated, proceeds from this round will be used Capital, Driehaus Capital Management, announced that it has raised $40 million to accelerate the progress of Abbisko’s Osage University Partners, and Continued on page 18...

17 WINTER 2021 THE LIFE SCIENCES REPORT

Select Life Sciences Client Highlights (Continued from page 17)

Asymmetry Capital Management. $21 million based on future performance. with Merck to discover, develop, Existing investors Northpond Ventures, The transaction combines Distributed and commercialize innovative, Sands Capital, Sanofi Ventures, Bio’s antibody libraries and immuno- next-generation T cell engager Alexandria Venture Investments, engineering platform with Charles immunotherapies for the treatment Altitude Life Science Ventures, and River’s extensive drug discovery and of cancer. Under the terms of the Agent Capital also participated. Wilson non-clinical development expertise agreement, Merck has received an Sonsini advised DiCE Molecules on to create an integrated, end-to-end exclusive worldwide license to products IP matters related to the transaction. platform for therapeutic antibody and intellectual property developed https://www.businesswire.com/news/ and cell and gene therapy discovery from this collaboration. In exchange, home/20210108005060/en/DiCE- and development. Wilson Sonsini Janux will be eligible to earn up to Molecules-Announces-80-Million- represented Distributed Bio in the $500.5 million per target in upfront and Series-C-Financing. transaction. https://www.businesswire. milestone payments, plus royalties on com/news/home/20210104005198/en/ sales of any product derived from the Harpoon Therapeutics Announces Charles-River-Laboratories-Acquires- collaboration. Merck will fund R&D Pricing of Public Offering of Common Distributed-Bio. performed under the collaboration. Stock Wilson Sonsini advised Janux on patent On January 6, 2021, Harpoon ONL Therapeutics Closes on $46.9 matters related to the transaction. https:// Therapeutics, Inc. announced the pricing Million in Series B Financing www.januxrx.com/janux-therapeutics- of an underwritten public offering On December 22, 2020, ONL announces-collaboration-with-merck- of 5,882,352 shares of its common Therapeutics, Inc., a biopharmaceutical to-develop-novel-drug-candidates-for- stock at a price to the public of $17 company developing novel therapies for immuno-oncology-using-t-cell-engager- per share. Harpoon expects the gross protecting the vision of patients with tractr-technology/. proceeds from the sale of the shares to retinal disease, announced it closed on be approximately $100 million, before $46.9 million in a Series B preferred Vivace Therapeutics Announces Close deducting underwriting discounts and stock financing. The financing included of $30 Million Series C Funding commissions and offering expenses new investors Bios Partners (which On December 16, 2020, Vivace payable by the company. In addition, led the round), Johnson & Johnson Therapeutics, Inc., a small-molecule drug Harpoon has granted the underwriters Innovation–JJDC, Inc., Kaitai Capital, discovery and development company in the offering a 30-day option to PSQ Capital, and Michigan Capital focused on targeting the Hippo pathway, purchase up to 882,352 additional shares Network Venture Fund III, as well as announced the closing of a $30 million of common stock at the public offering existing investors ONL Therapeutics Series C financing. The financing was led price. Wilson Sonsini advised Harpoon management, InFocus Capital Partners, by Boxer Capital with participation from Therapeutics on IP matters related to the ExSight Ventures, the University of new investor RA Capital Management transaction. https://www.globenewswire. Michigan’s Michigan Investment in New and existing investor Canaan Partners. com/news-release/2021/01/07/2154613/0/ Technology Startups program, Western Vivace anticipates advancing its en/Harpoon-Therapeutics-Announces- Michigan University’s Biosciences clinical candidate into first-in-human Pricing-of-Public-Offering-of-Common- Research & Commercialization Center, studies in early 2021, targeting tumors Stock.html. and the Capital Community Angels. dependent on activated YAP. Wilson Wilson Sonsini represented ONL Sonsini advised Vivace on patent Distributed Bio Acquired by Charles Therapeutics in the transaction. https:// matters related to the financing.https:// River Laboratories for $83 Million www.onltherapeutics.com/2020/12/22/ vivacetherapeutics.com/wp-content/ On January 4, 2021, Charles River onl-therapeutics-closes-46-9-million-in- uploads/Vivace-press-release-20201211- Laboratories International, Inc. series-b-financing-to-advance-onl1204- FINAL.pdf. announced that it acquired Distributed into-three-retinal-disease-indications/. Bio, a next-generation antibody Atsena Therapeutics Closes $55 discovery company, on December 31, Janux Therapeutics Announces Million Series A Financing 2020. The purchase price was $83 million Strategic Collaboration and License On December 16, 2020, Atsena in cash, subject to customary closing Agreement with Merck Therapeutics, a clinical-stage gene adjustments. In addition to the initial On December 18, 2020, Janux therapy company developing novel purchase price, the transaction includes Therapeutics announced a strategic treatments for inherited forms of contingent additional payments of up to collaboration and license agreement blindness, announced it has closed an

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Select Life Sciences Client Highlights (Continued from page 18) oversubscribed $55 million Series A 357,000 additional shares of its common share and the public offering price of financing. The proceeds will be used stock, at a price to the public of $76 per each pre-funded warrant was $89.99, to advance Atsena’s ongoing Phase share. The aggregate gross proceeds to with each pre-funded warrant having I/II clinical trial evaluating a gene ALX Oncology from the offering were an exercise price of $0.01. The aggregate therapy for patients with GUCY2D- approximately $208 million. Wilson gross proceeds to IGM from the offering associated Leber congenital amaurosis, Sonsini advised ALX Oncology on the were approximately $230 million. as well as complete manufacturing offering.https://ir.alxoncology.com/ . Wilson Sonsini represented IGM in the development for Phase III. Wilson news-releases/news-release-details/ transaction. https://investor.igmbio.com/ Sonsini advised Atsena Therapeutics alx-oncology-announces-closing-public- news-releases/news-release-details/igm- on IP matters related to the financing. offering-and-full-exercise. announces-closing-230-million-public- https://atsenatx.com/press-release/ offering-and-full. atsena-therapeutics-raises-55-million- Locanabio Announces $100 Million series-a-financing-to-advance-lca1- Series B Financing Opiant Pharmaceuticals Secures $50 gene-therapy-clinical-program-two- On December 14, 2020, Locanabio, Inc., Million in Convertible Debt Financing preclinical-assets-and-novel-capsid- an RNA-targeting gene therapy company On December 10, 2020, Opiant development-for-ocular-diseases/. focused on developing life-changing Pharmaceuticals, Inc., a specialty therapies for patients with severe pharmaceutical company developing Ripple Therapeutics Announces neurodegenerative, neuromuscular, medicines to treat addictions and drug Licensing Agreement, Series A and retinal diseases, announced a overdose, announced that it has entered Financing $100 million Series B financing. The into a $50 million convertible note On December 15, 2020, Ripple financing was led by Vida Ventures purchase and security agreement with a Therapeutics Corporation, a clinical- with participation from new investors syndicate of Pontifax Medison Finance, stage, ophthalmology-focused developer including RA Capital Management, a healthcare-dedicated venture and of novel therapeutics, announced Invus, Acuta Capital Partners, and an debt fund, and Kreos Capital, Europe’s the signing of an exclusive licensing investment fund associated with SVB leading growth debt firm. Opiant plans agreement for the rights to their Leerink, and prior Locanabio investors to use the proceeds to fund the potential lead product, IBE-814, for North ARCH Venture Partners, Temasek, future commercialization of OPNT003, America and Europe with Théa Open Lightstone Ventures, UCB Ventures, and nasal nalmefene, an investigational Innovation (TOI), a wholly owned GV. Wilson Sonsini represented Vida treatment for opioid overdose, which the subsidiary of Laboratoires Théa, the Ventures and Temasek in the transaction. company aims to file for approval by the leading independent ophthalmology https://locanabio.com/press-releases/ FDA at the end of 2021. Wilson Sonsini pharmaceutical company in Europe. In locanabio-announces-100-million- represented Opiant Pharmaceuticals in addition, Ripple announced that TOI series-b-financing-to-advance-portfolio- the transaction. https://ir.opiant.com/ is leading its Series A financing, which of-novel-rnatargeted-gene-therapies-for- news-releases/news-release-details/ raised $14.8 million. Wilson Sonsini is neurodegenerative-neuromuscular-and- opiant-pharmaceuticals-secures-50- advising Ripple on both transactions. retinal-diseases/. million-convertible-debt. https://www.accesswire.com/viewarticle. aspx?id=620401. IGM Biosciences Announces Closing Reneo Pharmaceuticals Raises $95 of $230 Million Public Offering Million in Series B Financing ALX Oncology Announces Close of On December 11, 2020, IGM Biosciences, On December 9, 2020, Reneo $208 Million Public Offering Inc. announced the closing of its Pharmaceuticals, a clinical-stage On December 14, 2020, ALX Oncology upsized underwritten public offering company focused on the development Holdings Inc., a clinical-stage immuno- of 1,221,224 shares of its common of therapies for patients with genetic oncology company, announced the stock, which includes the exercise of mitochondrial diseases, announced closing of its previously announced the underwriters’ option to purchase it has raised $95 million in a Series B underwritten public offering of additional shares in full, and pre-funded financing. The financing was co-led by 2,737,000 shares of its common stock, warrants to purchase 1,334,332 shares of Novo Ventures and Abingworth, and which includes the exercise in full of its common stock. The public offering was supported by existing investors the underwriters’ option to purchase price of common stock was $90 per New Enterprise Associates, RiverVest

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Venture Partners, Pappas Capital, venBio Partners, Versant Ventures, and MedAvail Completes Business and Lundbeckfonden Ventures, as Samsara BioCapital. Wilson Sonsini Combination with MYOS RENS well as new investors Rock Springs advised RayzeBio on intellectual Technology Capital, Aisling Capital, Amzak Health, property matters related to the On November 18, 2020, MedAvail, and other investors. Wilson Sonsini financing. https://www.businesswire. Inc., a healthcare technology company represented lead investors Novo Ventures com/news/home/20201208005030/en/ that embeds pharmacy services and Abingworth in the transaction. RayzeBio-Completes-105M-Series- directly into clinics and other points https://reneopharma.com/reneo- B-Financing-to-Advance-Targeted- of care, announced the completion pharmaceuticals-raises-95-million- Radiopharmaceuticals-for-Cancer. of its previously announced business in-series-b-financing-co-led-by-novo- combination with MYOS RENS ventures-and-abingworth/. Kinnate Biopharma Raises $276 Technology, Inc., an advanced nutrition Million in IPO company focused on improving muscle Pear Therapeutics Completes $80 On December 7, 2020, Kinnate health. Under the terms of the merger Million Series D Financing Biopharma Inc., a biopharmaceutical agreement, a wholly owned subsidiary of On December 8, 2020, Pear Therapeutics, company focused on the discovery MYOS merged with and into MedAvail, a developer of prescription apps to treat and development of small-molecule with MedAvail becoming the surviving addiction and insomnia, announced kinase inhibitors for difficult-to-treat, corporation and a wholly owned that it has successfully closed an genomically defined cancers, announced subsidiary of MYOS. Wilson Sonsini $80 million Series D financing led the close of its initial public offering, advised MedAvail in the transaction. by SoftBank Vision Fund 2 with raising $276 million. The shares began https://www.businesswire.com/news/ participation from existing investors, trading on the Nasdaq Global Select home/20201118005309/en/MedAvail-and- including Temasek, 5AM Ventures, Market on December 3 under the symbol MYOS-RENS-Technology-Announce- Arboretum Ventures, JAZZ Venture “KNTE.” Wilson Sonsini represented Closing-of-Business-Combination. Partners, Novartis, CrimsoNox, Kinnate Biopharma in the transaction. and EDBI, and new investors Forth https://investors.kinnate.com/news- ORIC Pharmaceuticals Announces Management, Pilot House, Sarissa releases/news-release-details/kinnate- Closing of Public Offering Capital, Shanda Group, and QUAD biopharma-announces-closing-initial- On November 17, 2020, ORIC Investment Management. Wilson public-offering-and. Pharmaceuticals, Inc., a clinical- Sonsini represented Temasek in the stage oncology company focused on transaction. https://www.businesswire. Court Dismisses Federal Securities developing treatments that address com/news/home/20201208005352/en/ Class Action Against Invuity mechanisms of therapeutic resistance, Pear-Therapeutics-Completes-80M- On November 24, 2020, the U.S. District announced the closing of its previously Series-D-Financing-Led-by-SoftBank- Court for the Northern District of announced underwritten public offering Vision-Fund-2. California issued an order dismissing of 5,796,000 shares of its common with prejudice a federal securities class stock, at a price to the public of $23 RayzeBio Announces $105 Million action lawsuit filed against Wilson per share. The gross proceeds to ORIC Series B Financing Sonsini clients Invuity Inc., its former from the offering were approximately On December 8, 2020, RayzeBio, a CEO, and its CFO. The complaint was $133.3 million. Wilson Sonsini biotechnology company developing filed following Invuity’s announcement represented ORIC in the transaction. a broad pipeline of targeted of its Q3 2016 earnings, which fell https://investors.oricpharma.com/ radiopharmaceuticals against validated of guidance issued in Q1 2016. The news-releases/news-release-details/oric- solid tumor targets, announced a $105 complaint alleged that Invuity was aware pharmaceuticals-announces-closing- million Series B financing. The round of, but failed to disclose, a negative sales public-offering-and-full. was led by Venrock Healthcare Capital pattern affecting revenue from existing Partners alongside new investors customers. Judge Jeffrey S. White held D3 Bio Launches with $200 Million OrbiMed, Redmile Group, Viking that the complaint failed to allege any Investment Global Investors, Logos Capital, false or misleading statements and failed On November 17, 2020, D3 Bio, Inc., a Cormorant Asset Management, to allege scienter. https://www.wsgr.com/ global biotechnology company focused LifeSci Venture Partners, Alexandria images/content/2/9/29225/invuity-order. on developing and commercializing Venture Investments, and others. Also pdf. precision medicines to improve or participating were existing investors replace existing standard-of-care

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Select Life Sciences Client Highlights (Continued from page 20) treatments that do not fully meet lead program through IND filing and in the financing.https://www.prweb. patient needs, announced that it has into clinical trials. 5AM Ventures and com/releases/stargazer_pharmaceuticals_ entered into definitive agreements with Wu Capital joined existing investors inc_announces_57_million_series_a_ respect to its US$200 million Series A Frazier Healthcare Partners and financing_and_initiation_of_a_phase_2a_ financing led by Boyu Capital, Matrix Jubilant Biosys Limited in the round. clinical_study_of_stg_001_in_stargardt_ Partners China, Sequoia Capital China, Wilson Sonsini advised Inipharm on disease_patients/prweb17524315.htm. the corporate venture fund of WuXi IP matters related to the transaction. AppTec, and certain other investors. https://www.businesswire.com/news/ Zimmer Biomet Acquires Relign Corp. Wilson Sonsini acted as legal counsel home/20201111005234/en/. On November 6, 2020, Zimmer Biomet, to Boyu Capital, Matrix Partners China, a leading medical device manufacturer, Sequoia Capital China, and the corporate Carbon Health Secures $100 Million in announced in its earnings report that it venture fund of WuXi AppTec in the Series C Funding has acquired Relign Corp., a privately transaction. https://www.businesswire. On November 10, 2020, Carbon Health held start-up in the growing $1.6 billion com/news/home/20201117005519/en/ Technologies, a technology-enabled arthroscopy market and overall $5 D3-Bio-Launches-with-US200-Million- healthcare provider, announced billion sports medicine market. Relign’s Investment-to-Develop-Precision- that it has secured $100 million in offerings include the consolidation of Medicines-Addressing-Unmet-Patient- Series C funding led by Dragoneer three differentiated arthroscopy tower Needs-in-Oncology-Immunology. Investment Group, with participation components into a single system, a from existing investors Brookfield first in the industry, and address a key Metagenomi Completes $65 Million Technology Partners (BTP), DCVC, and portfolio gap for Zimmer Biomet in the Series A Financing Builders VC. This investment will allow sports medicine and broader ambulatory On November 12, 2020, Metagenomi, a Carbon Health to further advance its surgery center markets. Wilson Sonsini next-generation gene editing company omnichannel care strategy and scale represented Relign in the transaction. launched by UC Berkeley scientists in nationally as a primary care provider in https://investor.zimmerbiomet.com/~/ 2018, emerged from stealth mode and a continued mission to bring world-class media/Files/Z/ZimmerBiomet-IR/press- successfully completed a $65 million healthcare to everyone. Wilson Sonsini release/q3-2020-earnings-release.pdf. Series A financing round. The Series represented Carbon Health in the A round was led by Leaps by Bayer transaction. https://www.businesswire. Forte Biosciences Announces Pricing and Humboldt Fund. Other investors com/news/home/20201110005767/en/ of $40 Million Public Offering included Sozo Ventures, Agent Capital, Carbon-Health-Secures-100M-in- On October 29, 2020, Forte Biosciences, InCube Ventures, and HOF Capital. Series-C-Funding-to-Become-Leading- a clinical-stage biopharmaceutical Wilson Sonsini advised Metagenomi on National-Healthcare-Provider. company, announced the pricing of patent matters related to the transaction an underwritten public offering of and launch of the company. https:// Stargazer Pharmaceuticals Announces 1,403,509 shares of its common stock metagenomi.co/press/metagenomi- $57 Million Series A Financing at a price to the public of $28.50 per closes-usd-65-million-series-a-financing- On November 9, 2020, Stargazer share. In addition, Forte has granted the led-by-leaps-by-bayer-and-humboldt- Pharmaceuticals, Inc., a underwriters a 30-day option to purchase fund/. biopharmaceutical company focused up to an additional 210,256 shares of on the development of novel treatment common stock at the public offering Inipharm Announces Close of $35 options for rare eye diseases, announced price, less underwriting discounts Million Series A Financing it has completed a Series A financing and commissions. Wilson Sonsini On November 11, 2020, Inipharm totaling $57 million from leading provided corporate and intellectual announced the close of a $35 million investors Novo Holdings, venBio property counsel to Forte Biosciences Series A financing round. Founded Partners, Canaan Partners, and Pontifax in the transaction. https://www. in 2018, the company is focused on to develop its proprietary compound fortebiorx.com/investor-relations/news/ discovering and developing therapies for STG-001 for treating Stargardt Disease. news-details/2020/Forte-Biosciences- liver and related diseases, with its initial Stargazer also announced the initiation Announces-Pricing-of-40.0-Million- program focused on those associated of a Phase 2a study of STG-001 in Public-Offering-of-Common-Stock/ with the genetically defined target Stargardt Disease patients. Wilson default.aspx. HSD17B13. The Series A funding will Sonsini has advised Stargazer since its support the advancement of Inipharm’s formation and represented the company

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Azura Ophthalmics Announces $20 first-of-their-kind inhaled therapies for Pharma of Switzerland for exploitation Million Financing cardiovascular diseases, announced that in greater China. Tenalisib is a next- On October 22, 2020, Azura Ophthalmics it has raised $30 million through the generation dual PI3K δ/γ inhibitor, which Ltd., a clinical-stage company first close of a Series C equity financing. is in Phase 2 clinical development for developing innovative therapies for The financing was led by an affiliate hematological malignancies. Rhizen Meibomian gland dysfunction (MGD) of Innoviva and also included existing Pharma will be eligible to receive upfront and related eye diseases, announced a investors Deerfield Management, and milestone payments worth up to $20 million financing. The round was HealthCap, and Morningside Venture. $149.5 million, as well as tiered royalties led by a syndicate of existing investors, The proceeds will be used primarily to on annual net sales of Tenalisib. Wilson including OrbiMed, TPG Biotech, fund the ongoing clinical development of Sonsini advised Curon Biopharma Brandon Capital’s Medical Research InRhythm, the company’s lead program, on licensing matters related to the Commercialization Fund, and Ganot for the treatment of a recent-onset transaction. https://www.globenewswire. Capital. On the back of encouraging episode of paroxysmal atrial fibrillation com/news-release/2020/10/12/2106806/0/ Phase 2 data to date, proceeds from the (PAF). Wilson Sonsini advised en/Rhizen-Pharmaceuticals-S-A- funding round will be used to advance InCarda on IP matters related to the and-Curon-Biopharmaceutical- Azura’s lead product candidate, AZR- financing. https://incardatherapeutics. Limited-Announce-an-Exclusive- MD-001, through a registration study for com/2020/10/21/incarda-therapeutics- Licensing-Agreement-to-Develop-and- the treatment of MGD. Wilson Sonsini raises-30-million-through-first-close-of- Commercialize-Tenalisib-a-Dual-PI3K- advised Azura on intellectual property series-c-equity-financing/. Delta-and-Gamma-Inhibito.html. matters, including patents, related to the transaction. https://www.businesswire. Spruce Biosciences Announces Closing Avail Medsystems Raises $100 Million com/news/home/20201022005332/en/ of Initial Public Offering in Series B Funding Azura-Ophthalmics-Raises-US20- On October 14, 2020, Spruce Biosciences On October 7, 2020, Avail Medsystems, Million-Registration-Studies. Inc., a late-stage biopharmaceutical the medical technology company company focused on developing and pioneering telemedicine for the SparingVision Announces €44.5 commercializing novel therapies procedure room, announced that it Million Fundraise for rare endocrine disorders with has raised $100 million in Series B On October 21, 2020, SparingVision, significant unmet need, announced the funding led by D1 Capital Partners, with a genomic medicine company focused closing of its initial public offering of participation from 8VC and existing on ocular diseases, announced a €44.5 6,900,000 shares of its common stock investors. Avail has developed Procedural million financing round. The round at a public offering price of $15.00 per Telemedicine™ technology that digitizes was led by 4BIO Capital and UPMC share. The gross proceeds to Spruce physical presence and enables HIPAA- Enterprises, and included Jeito Capital from the offering were $103.5 million. compliant collaboration among a and Ysios Capital. In addition, current Spruce’s common stock began trading network of healthcare professionals investors Bpifrance and Foundation on the Nasdaq Global Select Market and industry experts. Wilson Sonsini Fighting Blindness participated in on October 9 under the ticker symbol represented Avail Medsystems in the the round. Proceeds will be primarily “SPRB.” Wilson Sonsini advised Spruce transaction. https://www.businesswire. used to advance the development of Biosciences on patents and patent com/news/home/20201007005707/en/ SparingVision’s breakthrough treatment strategy related to the IPO. https:// Avail-Medsystems-Raises-100-Million- SPVN06 for the mutation-agnostic investors.sprucebiosciences.com/news- in-Series-B-Funding-Led-by-D1-Capital- treatment of retinitis pigmentosa. Wilson releases/news-release-details/spruce- to-Meet-Demand-for-Procedural- Sonsini advised SparingVision on the biosciences-announces-closing-upsized- Telemedicine%E2%84%A2-Technology- transaction. https://sparingvision.com/ initial-public. for-the-Operating-Room. images/PDF/press_releases/2020/201021_ SparingVision_financing.pdf. ​Curon Biopharmaceutical and Rhizen Ligand Completes Acquisition of Pharmaceuticals Announce Licensing Pfenex InCarda Therapeutics Raises $30 Agreement On October 1, 2020, Ligand Million in Series C On October 12, 2020, Curon Biopharma, Pharmaceuticals announced that it On October 21, 2020, InCarda a Shanghai-based clinical-stage has completed its tender offer for all Therapeutics, Inc., a privately held biopharmaceutical company, acquired outstanding shares of Pfenex Inc. biopharmaceutical company developing exclusive rights to Tenalisib from Rhizen for $437.5 million in cash, plus one

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Select Life Sciences Client Highlights (Continued from page 22) non-transferable contingent value was led by Aisling Capital with million, before deducting underwriting right (CVR) per share representing participation from founding investor discounts and commissions and the right to receive a contingent Versant Ventures and existing investor estimated offering expenses. The shares payment of $78 million in cash New Enterprise Associates (NEA). began trading on September 18 on the if a certain specified milestone is Additional new investors included HBM Nasdaq Global Select Market under the achieved. Pfenex is a development Healthcare Investments, Cormorant ticker symbol “ATHA.” Wilson Sonsini and licensing biotechnology company Asset Management, GV, Amzak Health, represented Athira in the offering. with commercial products focused Casdin Capital, Sixty Degree Capital, https://www.athira.com/athira-pharma- on leveraging its proprietary protein and Cambridge Asset Management. announces-pricing-of-initial-public- production platform, Pfenex Expression Wilson Sonsini advised NEA in the offering/. Technology®, to develop next-generation transaction. https://www.businesswire. and novel protein therapeutics. Wilson com/news/home/20200924005403/en/ Metacrine Announces Pricing of Sonsini represented Pfenex in the Monte-Rosa-Therapeutics-Announces- Initial Public Offering transaction. https://investor.ligand. 96-Million-Series-B-Financing-to- On September 15, 2020, Metacrine, com/press-releases/detail/428/ligand- Advance-Small-Molecule-based-Protein- Inc., a clinical-stage biopharmaceutical completes-acquisition-of-pfenex-inc. Degradation-Platform. company focused on discovering and developing differentiated therapies for Flame Biosciences Completes $100 Libra Therapeutics Launches with $29 patients with liver and gastrointestinal Million Common Stock Financing Million Series A Financing diseases, announced the pricing of On September 30, 2020, Flame On September 23, 2020, Libra its initial public offering of 6,540,000 Biosciences, a clinical-stage Therapeutics launched to develop shares of its common stock at a public biopharmaceutical company developing novel drug candidates focused on offering price of $13 per share. The shares antibodies to treat cancer and restoring the cellular balance lost began trading on the Nasdaq Global inflammatory diseases, announced the in neurodegenerative diseases. In Market on September 16 under the ticker completion of a $100 million common conjunction with its launch, Libra symbol “MTCR.” Wilson Sonsini advised stock financing. The financing was Therapeutics has secured $29 million Metacrine in patent matters related to led by Rock Springs Capital, with in Series A financing, co-led by the IPO. https://investors.metacrine. participation from funds and accounts Boehringer Ingelheim Venture Fund com/news-releases/news-release-details/ advised by T. Rowe Price Associates, (BIVF), Epidarex Capital, and Santé. metacrine-announces-pricing-initial- Inc., Cormorant Asset Management LP, The round was joined by Yonjin public-offering. Janus Henderson Investors, Surveyor Venture, Dolby Family Ventures, and Capital, Samsara BioCapital, Adage Sixty Degree Capital. Wilson Sonsini NiKang Therapeutics Completes $50 Capital Management LP, Terra Magnum has advised Libra Therapeutics since Million Series B Financing Capital Partners, Logos Capital, and its formation and represented the On September 14, 2020, NiKang Acuta Capital Partners. Wilson Sonsini company in the Series A transaction. Therapeutics, a biotech company focused advised Terra Magnum Capital Partners https://www.libratherapeutics.com/ on developing novel small-molecule in the financing.https://flame.bio/ post/libra-launches-with-29m-series- oncology drug discovery, announced news/flame-biosciences-announces- a-to-develop-novel-therapeutics-for- the completion of a $50 million Series $100million-common-stock-financing- neurodegenerative-diseas. B financing. The financing was led by to-further-advance-drugs-targeting- RTW Investments, with additional inflammasome.php. Athira Pharma Prices Initial Public support from existing investor CBC Offering Group and new investors Lilly Asia Monte Rosa Therapeutics Raises $96 On September 17, 2020, Athira Pharma, Ventures, Casdin Capital, HBM Million in Series B Financing Inc., a clinical-stage biopharmaceutical Healthcare Investments, Matrix Partners On September 24, 2020, Monte Rosa company focused on developing small China, and Octagon Capital. NiKang Therapeutics, a biotechnology company molecules to restore neuronal health and will use the proceeds to support the developing precision medicines to stop neurodegeneration, priced its initial preclinical and clinical development of degrade disease-causing proteins, public offering of 12 million shares of its several promising oncology programs announced the closing of a $96 million common stock at $17.00 per share. The and further enhance the company’s Series B financing. The financing gross proceeds are expected to be $204 drug discovery pipeline. Wilson Sonsini

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Select Life Sciences Client Highlights (Continued from page 23) advised NiKang Therapeutics in the GI Windows Medical Corp. Announces Tango Therapeutics and Gilead An- transaction. https://www.einnews.com/ Series A-1 Financing nounce Expanded Strategic Oncology pr_news/526165507/nikang-therapeutics- On August 19, 2020, GI Windows Medi- Collaboration completes-50-million-series-b-financing. cal Corp, a clinical-stage medical device On August 17, 2020, Gilead Sciences company, announced a $16.4 million and Tango Therapeutics announced an Korro Bio Announces $91.5 Million Series A-1 financing. The financing expanded strategic collaboration focused Series A Financing attracted Johnson & Johnson Innovation on the discovery, development, and On September 10, 2020, Korro Bio, Inc., – JJDC, Inc., along with Sonder Capital, commercialization of innovative targeted a biotech start-up founded in 2018, GT Healthcare, JC Investco, and anoth- immune evasion therapies for patients announced a $91.5 million Series A er strategic investor. In addition to the with cancer. Gilead will make a $125 mil- financing to advance its novel platform institutional financing, GI Windows lion upfront payment to Tango and a $20 for precise, single-base, RNA editing received investments from existing million equity investment in the compa- to modulate protein function for shareholders as well as new investors ny. In addition, Gilead will have the right therapeutic applications. The financing the Kennedy Trust and Coleman Trust. to option up to 15 programs over the was led by Wu Capital with participation Wilson Sonsini represented GI Win- seven-year collaboration for up to $410 from current investors Atlas Venture dows in the financing.https://257e80b3- million per program in opt-in, extension, and New Enterprise Associates. Wilson 17d1-4e77-b00b-5db7f134ecb0. and milestone payments. Wilson Sonsini Sonsini advised Wu Capital in the filesusr.com/gd/3c37ac_620d570415e- represented Tango Therapeutics in the financing. https://www.korrobio.com/ 14391b5ac536ff9027b0f.pdf. agreement. https://www.tangotx.com/ press-releases/korro-bio-closes-91-5- press_releases/gilead-sciences-and-tan- million-series-a-financing-to-advance- iRhythm Technologies Announces go-therapeutics-to-expand-strategic-on- the-next-frontier-in-rna-therapeutics. Pricing of Upsized Public Offering of cology-collaboration/. Common Stock Recursion Announces $239 Million On August 18, 2020, iRhythm Tech- Mission Bio Raises $70 Million in Series D Financing and Collaboration nologies, Inc., a leading digital health Series C Financing with Bayer care solutions company focused on the On August 13, 2020, Mission Bio, Inc., a On September 9, 2020, Bayer, a advancement of cardiac care, announced pioneer in high-throughput single-cell global life sciences, healthcare, and the pricing of its underwritten public DNA and multi-omics analysis, announced nutrition company, and Recursion offering of 1,093,167 shares of its com- a $70 million Series C financing led by Pharmaceuticals, Inc., a digital biology mon stock at a public offering price of Novo Growth, the growth equity arm company industrializing drug discovery, $175 per share before deducting under- of Novo Holdings. Soleus Capital also entered into a strategic collaboration. writing discounts and commissions. All joined the round, along with earlier Under the collaboration, Recursion’s of the shares are being offered for sale investors Mayfield, Cota, and Agilent, purpose-built, AI-guided drug discovery by iRhythm Technologies. The gross bringing the company’s total funding to platform and Bayer’s small-molecule proceeds from the offering were expected more than $120 million. Wilson Sonsini compound library and deep scientific to be $191.3 million. Wilson Sonsini rep- advised Mission Bio in the transaction. expertise will be leveraged to discover resented iRhythm Technologies in the https://missionbio.com/press/series-c-no- and develop new treatments for fibrotic transaction. https://www.globenewswire. vo-backed/. diseases. In addition, Leaps by Bayer, the com/news-release/2020/08/19/2080396/0/ impact investment arm of Bayer AG, is en/iRhythm-Technologies-Announc- leading Recursion’s $239 million Series es-Pricing-of-Upsized-Public-Offer- D financing with an investment of $50 ing-of-Common-Stock.html. million. Wilson Sonsini represented

Recursion in both transactions. https:// www.recursion.com/news-and-views.

24 WINTER 2021 THE LIFE SCIENCES REPORT

Casey McGlynn, a leader of the firm’s life sciences practice, has editorial oversight ofThe Life Sciences Report and was assisted by Philip Oettinger, Elton Satusky, Scott Murano, and James Huie. They would like to take this opportunity to thank all of the contributors to the report, which is published on a semi-annual basis.

Casey McGlynn Philip Oettinger Elton Satusky Scott Murano James Huie (650) 354-4115 (650) 565-3564 (650) 565-3588 (650) 849-3316 (650) 565-3981 [email protected] [email protected] [email protected] [email protected] [email protected]

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