Q&A with Latane Conant, CMO at 6sense

Q&A with Latane Conant
Latane Conant, CMO at 6sense has always been keenly focused on leveraging data to ensure marketing programs result in deals, not just leads.

At 6sense, Latane helps sales and marketing leaders increase revenue by tapping into the power of predictive intelligence to uncover buyers who are ready to buy.

MEDIA 7: As a child, what did you want to be when you grew up?
LATANE CONANT:
The first thing I ever wanted to be was a lifeguard and swim coach. When I was 5 years old, I joined the swim team as one of the youngest swimmers. At 13, I was too young to be a lifeguard so I begged them to create a “JR lifeguard” position. This was essentially deck swabbing and towel service but I didn’t care. So they hired me and called me “young jedi”. The head lifeguard loved to play jokes on me. One time he gave me a ruler and said every deck chair needed to be 10 ¾ inches apart. There were 50+ deck chairs, but I went out and started measuring. Finally, after a few chairs, they called me over the loudspeaker to come back to the office and we all had a big laugh. Another time they took me down to the filter room, which was underground and pretty spooky.

BUT as a young jedi, I had to learn how the system worked. We descended under the deck and I climbed a rickety old ladder to look down into the pump. Another lifeguard in scuba gear was waiting underwater and jumped out of the filter tank and scared the bejesus out of me! Once I calmed down I thought it was pretty hysterical! My role could have been seen as pretty mundane - bathroom cleaning and towel folding - BUT I loved the people I worked with so much. I worshipped the lifeguards and swim coaches!

They kept me on my toes and in stitches all summer, so it’s still one of the best jobs I’ve ever had. I finally graduated to teaching swim lessons, with a focus on kids who did not swim at all and were afraid to go in the pool. Nothing was more rewarding than seeing someone do something they thought they could not, or actually loving something that used to scare them - like put their head underwater, dive off the blocks, or swim the butterfly stroke for a lap.

M7: Latane, you have always thrived on working with wicked smart people. How do you get the best out of them when there is a common notion that it’s difficult to make smart people work together?
LC: 
Talented people want to be able to do great work. Not the average, crank some blogs out or run an event, but truly cool and differentiated things. My job is to be a force field and ensure the team has the opportunity to try different things and do their best work. This means providing focus. A powerful focus tool we use is the V2MOM. V2MOM stands for Vision, Values, Methods, Obstacles, and Metrics. Vision is what you want to achieve. Ideally your vision makes everyone uncomfortably excited. Values are why it matters, what you believe, guiding principles for decision making. Methods are where the rubber meets the road and are the top things you will do to achieve the vision.

Under each method, it's key to detail out obstacles (so you can plan around them) and metrics so you know if the method is on track. What’s nice about the system is that it provides built-in planning and is time bound. So every quarter I get my team together and we revise our V2MOM. This builds consensus around the vision and how we are going to get there. Every method gets assigned an owner, which drives accountability. And we publically track the metrics weekly so everyone knows our progress. The interesting thing about the V2MOM is not what's on the V2mom but what is NOT on the V2MOM. Because the process requires hyper prioritization of what you are going to do in a given time period, it forces focus.

I’m pretty obsessed and love the V2MOM. I am happy to share more on how teams can adopt, implement, and use it.  In fact, maybe in my next life, I will be a V2mom consultant!


"Marketing is harder and harder these days because buyers want to remain anonymous."

M7: How does leveraging smart technologies like AI help marketers have an edge over others and achieve on-time targets?
LC:
We need every advantage we can get in order to be successful and AI provides that advantage. Marketing is harder and harder these days because buyers want to remain anonymous. In fact, 90 percent of B2B buying behavior is digital and anonymous. Buyers also buy in teams, so the buying journey and process is very fragmented across many people. According to Gartner, it’s typical for a buying team to have more than 10 people involved. Adding to that, buyers are resistant. Every member of the B2B buying team requires highly personalized multi-touch and multi-channel engagement to take a meeting.
But our current systems are built for known static data, which only 12% of marketers have confidence in.
Revenue-generating teams should look for platforms that allow them to uncover buyer behavior, particularly the anonymous behavior, so they can stop spending money, time, and energy on the accounts that aren’t even in-market. Instead, through AI and big data, that money, time and energy can be used to uncover their “dark funnel,” or the rich information that is being done on your company and/or solution in the dark. Next, they must prioritize. Look across behavior to determine and group buying teams. Look for changes in behavior over time to fully grasp which accounts are in-market, ready for an upsell, or have potential to churn. AI can deliver these insights with a high degree of accuracy so you can know when accounts are getting ready to open opportunities. Enabling you to focus your time, salespeople and BDRs on the BEST accounts. Once you have uncovered anonymous behavior and prioritized timing, it’s time to engage. Engaging is about orchestrating multi-touch, multi-channel, highly personalized messages at scale. This is where AI really shines. It tells us the best time to use display ads vs. email vs a direct mailer and even triggers actions across channels. It also ensures we are personalizing appropriately so if someone has consumed the demo it offers them another piece of content so they aren’t served the demo AGAIN.  Based on their behavior, buying stage, persona, and company we can dynamically deliver the best experience. Teams that use this approach see unbelievable results and are beating out their competition with 40 percent more opportunities, 5x larger deals, and 1.5x faster cycle times.


"Engaging is about orchestrating multi-touch, multi-channel, highly personalized messages at scale. This is where AI really shines."

M7: How does 6sense’s Account Based Orchestration Platform help revenue teams to compete and win in the age of account-based buying?
LC:
I had my team do some research on the typical results b2b sales and marketing teams see from their efforts. The picture is not pretty. In fact EVERY minute:
- DOZENS of interested buyers will visit your website but only ONE will identify themselves.
- Your most important prospect will receive 2 NEW EMAILS. They will likely delete them both without opening.
- Your sales reps will spend ONE-QUARTER of their time on leads who have no intention to buy.
- Your BDR team will make just over 6 calls. They will book ZERO meetings.

No wonder marketing and sales teams get misaligned. This is not competing or winning.

Account Based Marketing is all the rage - It requires selecting the best accounts to go after, detailed insights into accounts and personas, highly personalized multi-channel engagement, alignment with sales, and the ability to track “real stuff” like increased engagement, pipeline, and revenue. ABM makes a lot of sense vs. traditional tactics that result in millions of unopened emails that get sent each year, thousands of dollars spent on swag at events that don’t lead to an opportunity, etc. However, the dirty little secret is that it’s impossible to scale without GREAT customer insights and orchestration capabilities. This is why you hear a lot about ABM pilots and not about ABM at scale.
6sense brings sales, business development, customer success, and marketing together on one platform that provides an unprecedented level of insights and the ability to take action. 

6sense delivers ABM at scale by providing (at a click in an easy to use UI):
- an understanding of best accounts to go after based on your business objective, technographic, firmographic, and real-time behavioral information.
- insights into the key personas to engage, the topics they care about, and where they are in their buying stage.
- orchestrated engagement across tactics from email, to display ads, to direct mail.
- alerts for sales with relevant details like when to call, what to say, what accounts are doing anonymously/in the “dark funnel”, and what marketing activities are working.
- tracking and metrics around how campaigns perform, if new personas engage, if you influenced opportunities, and if you gained net new opportunities.

This means sales and marketing can get BACK to sales and marketing, aligning on a business objective, messaging, and the experience you want to deliver for prospects - one you can actually be proud of. One without useless forms, spam, and cold calls. And because our platform provides transparency, reduced mundane work, and competitive advantage, prospecting actually becomes fun!

M7: What is the “dark funnel” and how can marketers embrace that?
LC:
So, the dark funnel is all of the data, information, people, and research that is happening right now for our product or solution that we have no insights into. You have to zoom out and think about the complexity of this cycle and how it’s changed. First of all, B2B buyers want to remain anonymous for as long as possible and our trick to making them not anonymous was to have some sort of gated content or to maybe try to run them down at a trade show or scan them but that doesn’t work anymore. All of our systems are set up for contact or a lead which is one person. What we find now is buyers buying in these teams, so you have to be able to understand how one person on the team is interacting with another person, how to put them together and how their collective research and desires come together. And again, all of that’s happening anonymously. So, the dark funnel research just went from one person to ten peoples’ research.

The other challenge is, in order to engage with buyers because they get so much noise and are so inundated, in fact in B2B we send about 300 billion emails a year, there’s only 7.7 billion people in the world and that’s not even B2C, so that doesn’t mean they’re on pottery barn’s list. So, our email motion in being able to break out of the noise is incredibly difficult. Hence, we have to have more touches and more capabilities and all of those emails and things that we’re sending are all in this dark funnel, we don’t truly understand how they’re getting consumed. So what ends up happening is we as marketers have to do a lot of guessing in how we design our programs and how we engage with customers and when you can start to really shine a light on the dark funnel and understand that rich research and the buying team and most importantly understand where they are in their journey, understand the timing. Rather than spamming you can start to really personalize in engagement and experience based on what they care about, who they are and most importantly, where they are in the buying journey.


"6sense brings sales, business development, customer success, and marketing together on one platform that provides an unprecedented level of insights and the ability to take action."

M7: To what extent does having a deep insight into a prospect’s buying journey help marketers in sales conversion and closing deals?
LC: 
Marketing is hard, selling is harder, and being a business development rep is the HARDEST. Business Development Reps and AE’s are expected to make hundreds of calls and send tons of email a week, but how do they know the contacts they are calling on aren’t random? Are they even in-market? How do they know when the best time to call is or what to even discuss without knowing the contacts needs? With outbound efforts, BDR’s and AE’s want opportunities, not just activity, but they don’t have a good way to make the right connections with the right content in order to be successful.

To reduce turnover and give outbound sales teams the best chance of success, we have to give them insights, with a robust group of digital signals to show if an account is actually in-market to buy or beginning the early stages of research. And with potential buyers leaving a digital footprint in the form of intent signals across the internet, both known and anonymous interactions with your website, as well as thousands of other 3rd party sites, we can take the guesswork out of identifying which accounts to target and what topics or competitors those accounts are searching.

Deep insights from 6sense help marketing, sales, and BDRs understand where each account is in their buyer journey and focus efforts on those who are actively in-market or in the early stages of research for our product or service. This lets the sales team know the ideal time to engage and what the account is interested in, taking the conversation from a cold call to a productive, meaningful one, driving higher conversions, win rates, and average deal size.

M7: 6sense recently launched Account-Based External Media Campaigns Analytics. How is it enabling media campaign effectiveness?
LC: 
The days of a four martini lunch and a deal are long gone since buyers don't want to talk to sales until they are 70% through the journey. Because of this shift, B2B digital ad spend is projected to hit $6.08 billion this year. It is an effective way to reach buyers in target accounts if done strategically with insights and proper measurement.

This feature focuses on digital agencies and the brands they work with. They use 6sense and all the rich insights on behavior and keywords in their campaign planning. It enables them to micro-segment and take an audience first approach vs designing a campaign and then finding an audience, flipping the campaign planning process on its head. 6sense also allows agencies to compare campaigns across different channels - tracking reach, engagement, and influence of these campaigns on accounts they are targeting for their customers.
Innovative agencies are partnering with us to deliver for their customers and they are seeing high returns on their investment.

M7: What is your favorite quote?
LC: 
“Anything worth doing is worth overdoing.” - Mick Jagger

ABOUT 6SENSE

6sense’s Account Based Orchestration Platform helps revenue teams compete and win in the age of Account Based Buying by putting the power of AI, big data and machine learning behind every member of the B2B revenue team, empowering them to uncover anonymous buying behavior, prioritize fragmented data to focus on accounts in market, and engage resistant buying teams with personalized, omni-channel, multi-touch campaigns. 6sense helps revenue teams know everything they need to know about their buyers so they can easily do anything they need to do to generate more opportunities, increase deal size, get into opportunities sooner, compete and win more often.

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Andelyn Biosciences and Armatus Bio Partner to Manufacture Suspension-Based AAV Gene Therapy for Rare Neurological Disease

Andelyn Biosciences, Inc. | January 16, 2024

Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has partnered with Armatus Bio to accelerate manufacturing of their gene therapy treatment for Charcot-Marie-Tooth Type 1A (CMT1A), a rare genetic neurological disease associated with independence-limiting disability and risk of fatal complications that has no approved therapies today. The partnership will seek to maximize program efficiency and speed to clinical studies of this novel, precision approach. As part of the agreement, Armatus will leverage Andelyn's extensive experience in adeno-associated virus (AAV) production and its proprietary suspension platform for development activities, plasmid manufacturing, and viral vector toxicology and GMP clinical manufacturing. The partnership strengthens the working relationship and offers great hope for patients suffering from neuromuscular disease. Both organizations, located in the well-established and growing biotech hub of Columbus, Ohio, are aligned in their belief that the rise of gene therapies will continue to advance human health. Matt Niloff, Chief Commercial Officer at Andelyn Biosciences said, "We are extremely moved by Armatus Bio's commitment to address the urgent unmet needs in CMT1A and are impressed by its innovative therapeutic technology for the disease. We look forward to scaling up the process in our program-specific, configurable suspension platform, and accelerating the therapy into the clinic with the highest degree of quality." "Andelyn has demonstrated its strong capabilities in manufacturing complex genetic medicines with high quality and consistency, which will be critical to accelerating our development efforts," said Brian Price, PhD, Chief Technical Officer of Armatus. "We look forward to collaborating with Andelyn on this program as we work toward supporting this population that urgently awaits innovative solutions." From its time-tested experience, Andelyn is proud to offer its clients exceptional development, plasmid production, and quality manufacturing at its three Columbus, Ohio facilities. Andelyn is advancing client discoveries and manufacturing life-altering cell and gene therapies for rare and prevalent diseases. About Andelyn Biosciences, Inc. Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of three Columbus, Ohio facilities, Andelyn supports its clients in developing curative cell and gene therapies from concept through plasmid development and manufacturing, process development, and cGMP clinical and commercial manufacturing. Andelyn's versatile capabilities include cGMP manufacturing capacity for both adherent and suspension processes up to a 2,000-liter capacity. An advanced digital model, quality system, full regulatory support and supply chain vertical integration help Andelyn accelerate the development and manufacturing of its clients' innovative cell and gene therapies. About Armatus Bio Armatus Bio is a privately held late preclinical stage biotechnology innovator leveraging vectorized RNAi to address urgent unmet medical needs in genetically-driven neurological diseases. Based in Columbus, Ohio, the company is led by a seasoned team with expertise in drug development and delivery, and partnered with world renowned experts in vector biology, genomics, and neurology. The company's lead candidate for Charcot Marie Tooth Type 1A (CMT1A) has received Orphan Drug Designation and Rare Pediatric Drug Designation, and is advancing toward IND-enabling studies. The company is also developing a preclinical vectorized RNAi asset for the rare neuromuscular disease Facioscapulohumeral Muscular Dystrophy (FSHD).

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Medical

Heron Therapeutics Announces FDA Approval of ZYNRELEF® Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures

Heron Therapeutics, Inc. | January 29, 2024

Heron Therapeutics, Inc. a commercial-stage biotechnology company announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following ZYNRELEF administration. "The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures. The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle ("VAN") later this year, are expected to have a significant positive impact for ZYNRELEF and the Company," said Craig Collard, Chief Executive Officer of Heron. "We're excited for the opportunity to give even more healthcare providers and patients a new, safe and effective option for achieving long-lasting non-opioid pain control after painful surgical procedures," said Bill Forbes, Executive Vice President, Chief Development Officer at Heron. "This new approval further reinforces our commitment to providing meaningful solutions to address unmet medical needs in the acute care and oncology settings." ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. ZYNRELEF demonstrated superiority compared to bupivacaine with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. ZYNRELEF was initially approved by the FDA in May 2021 and received approval of the first supplemental NDA for an expanded label in December 2021. "Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like ZYNRELEF now available for additional orthopedic procedures is a great benefit to have in my practice," said Alexander Sah, M.D., orthopedic surgeon at Sah Orthopaedic Associates. "ZYNRELEF helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use." Important Safety Information for Patients ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which Can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID. Cannot be used during heart bypass surgery. Can increase the risk of gastrointestinal bleeding, ulcers, and tears. ZYNRELEF should also not be used if you are allergic to any component of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines. as a paracervical block, during childbirth. The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache. The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you. Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning. About ZYNRELEF ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU. About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.

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MedTech

Stevanato Group Launches EZ-fill® Kit and Laboratory Fill and Finish Service to Support Small Batch Drug Development and Commercialization

Stevanato Group | January 25, 2024

Stevanato Group S.p.A. a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, unveiled today two new offerings for efficient small batch pharmaceutical manufacturing: the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers (TEC). In a context where reducing time-to-market is key, Stevanato Group’s new EZ-fill® Kit offers fast access to a customizable and versatile solution to pharma and biotech companies needing to efficiently fill small batches with high-quality injectable formulations during clinical trials or commercial phases. The surge the industry has seen in biopharmaceuticals treating various diseases in several therapeutical areas may signal a significant growth potential for pharmaceutical companies. Injectables, comprising more than 60% of the over 21,000 drugs currently in development, of which 44% are biopharmaceuticals, require high-performance primary packaging and delivery technologies for proper storage and administration. Stevanato Group’s EZ-fill® Kit builds on its existing ready-to-use platform of pre-sterilized containment solutions – vials, cartridges, and syringes – allowing customers to effectively screen different primary packaging in combination with drug products. The kit will be available as a modular box made up of glass ready-to-use drug containers and add-on components on request, shipped by courier. As a result, the platform can bring enhanced levels of quality and safety to patients across the entire drug life cycle and improve the rate at which new drugs enter the market. EZ-fill® Kit will be presented at Pharmapack and is expected to be available commercially beginning in the second quarter of 2024. Additionally, to better support customers, Stevanato Group has introduced a non-GMP laboratory filling and finishing service at its Technology Excellence Centers (TEC) in Boston, USA, and Piombino Dese, Italy. This new service allows customers to assess and identify the possible effects of the fill-and-finish process on their product performance as early as the container selection stage, thus de-risking processes and enhancing development and commercialization strategy. “In the race to bring new advanced biopharmaceutical products to market and to patients, Stevanato Group is tackling the challenge of supporting customers with flexible drug containment and filling solutions in a timely manner," says Fabio Bertacchini, Senior Director EZ-fill® Vials & Cartridges at Stevanato Group. "Stevanato Group remains focused on developing new offerings that can help raise pharmaceutical manufacturing standards. By leveraging the expertise provided by our global TEC Centers, we aim to support customers' innovation, helping them face tests and de-risking processes and making right-the-first-time choices throughout their drug development journey.” About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.

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Medical

Andelyn Biosciences and Armatus Bio Partner to Manufacture Suspension-Based AAV Gene Therapy for Rare Neurological Disease

Andelyn Biosciences, Inc. | January 16, 2024

Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has partnered with Armatus Bio to accelerate manufacturing of their gene therapy treatment for Charcot-Marie-Tooth Type 1A (CMT1A), a rare genetic neurological disease associated with independence-limiting disability and risk of fatal complications that has no approved therapies today. The partnership will seek to maximize program efficiency and speed to clinical studies of this novel, precision approach. As part of the agreement, Armatus will leverage Andelyn's extensive experience in adeno-associated virus (AAV) production and its proprietary suspension platform for development activities, plasmid manufacturing, and viral vector toxicology and GMP clinical manufacturing. The partnership strengthens the working relationship and offers great hope for patients suffering from neuromuscular disease. Both organizations, located in the well-established and growing biotech hub of Columbus, Ohio, are aligned in their belief that the rise of gene therapies will continue to advance human health. Matt Niloff, Chief Commercial Officer at Andelyn Biosciences said, "We are extremely moved by Armatus Bio's commitment to address the urgent unmet needs in CMT1A and are impressed by its innovative therapeutic technology for the disease. We look forward to scaling up the process in our program-specific, configurable suspension platform, and accelerating the therapy into the clinic with the highest degree of quality." "Andelyn has demonstrated its strong capabilities in manufacturing complex genetic medicines with high quality and consistency, which will be critical to accelerating our development efforts," said Brian Price, PhD, Chief Technical Officer of Armatus. "We look forward to collaborating with Andelyn on this program as we work toward supporting this population that urgently awaits innovative solutions." From its time-tested experience, Andelyn is proud to offer its clients exceptional development, plasmid production, and quality manufacturing at its three Columbus, Ohio facilities. Andelyn is advancing client discoveries and manufacturing life-altering cell and gene therapies for rare and prevalent diseases. About Andelyn Biosciences, Inc. Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of three Columbus, Ohio facilities, Andelyn supports its clients in developing curative cell and gene therapies from concept through plasmid development and manufacturing, process development, and cGMP clinical and commercial manufacturing. Andelyn's versatile capabilities include cGMP manufacturing capacity for both adherent and suspension processes up to a 2,000-liter capacity. An advanced digital model, quality system, full regulatory support and supply chain vertical integration help Andelyn accelerate the development and manufacturing of its clients' innovative cell and gene therapies. About Armatus Bio Armatus Bio is a privately held late preclinical stage biotechnology innovator leveraging vectorized RNAi to address urgent unmet medical needs in genetically-driven neurological diseases. Based in Columbus, Ohio, the company is led by a seasoned team with expertise in drug development and delivery, and partnered with world renowned experts in vector biology, genomics, and neurology. The company's lead candidate for Charcot Marie Tooth Type 1A (CMT1A) has received Orphan Drug Designation and Rare Pediatric Drug Designation, and is advancing toward IND-enabling studies. The company is also developing a preclinical vectorized RNAi asset for the rare neuromuscular disease Facioscapulohumeral Muscular Dystrophy (FSHD).

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Medical

Heron Therapeutics Announces FDA Approval of ZYNRELEF® Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures

Heron Therapeutics, Inc. | January 29, 2024

Heron Therapeutics, Inc. a commercial-stage biotechnology company announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following ZYNRELEF administration. "The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures. The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle ("VAN") later this year, are expected to have a significant positive impact for ZYNRELEF and the Company," said Craig Collard, Chief Executive Officer of Heron. "We're excited for the opportunity to give even more healthcare providers and patients a new, safe and effective option for achieving long-lasting non-opioid pain control after painful surgical procedures," said Bill Forbes, Executive Vice President, Chief Development Officer at Heron. "This new approval further reinforces our commitment to providing meaningful solutions to address unmet medical needs in the acute care and oncology settings." ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. ZYNRELEF demonstrated superiority compared to bupivacaine with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. ZYNRELEF was initially approved by the FDA in May 2021 and received approval of the first supplemental NDA for an expanded label in December 2021. "Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like ZYNRELEF now available for additional orthopedic procedures is a great benefit to have in my practice," said Alexander Sah, M.D., orthopedic surgeon at Sah Orthopaedic Associates. "ZYNRELEF helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use." Important Safety Information for Patients ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which Can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID. Cannot be used during heart bypass surgery. Can increase the risk of gastrointestinal bleeding, ulcers, and tears. ZYNRELEF should also not be used if you are allergic to any component of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines. as a paracervical block, during childbirth. The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache. The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you. Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning. About ZYNRELEF ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU. About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.

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