ABI-2280

Company Adds New Chief Medical Officer, Vice President of Project Management & Strategic Initiatives, and Vice President of Technical Operations REDWOOD CITY, Calif., Oct. 18, 2023 /PRNewswire/ -- Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of high-risk infections and pre-cancerous lesions caused by human papilloma virus (HPV), today announced several key new appointments designed to strengthen the company's leadership as it continues to advance its lead development candidate, ABI-2280. The company has added Elaine Chien, M.D., FACOG, as chief medical officer, Susan Wilson, Ph.D., as vice president of project management and strategic initiatives, and Rajashree Joshi-Hangal, Ph.D., as vice president of technical operations. Collectively, these individuals bring Antiva significant industry experience in areas directly related to the company's ongoing work in developing innovative treatments for diseases caused by HPV infection. "With the closing of our Series E financing earlier this year, Antiva entered an important new phase as we work to advance ABI-2280 into key efficacy studies across multiple indications. With this as a backdrop, we are thrilled to bring aboard Elaine, Susan, and Rajashree to fortify our growing team, while expanding the range of leaderships' expertise to align with our ambitious clinical development strategy," said Kristine Ball, chief executive officer of Antiva. "These individuals have each established themselves as highly regarded biopharmaceutical executives with impressive resumes of accomplishments and we look forward to them continuing to make an impact by contributing to Antiva's important work in the areas global and women's health." Antiva is currently working to advance ABI-2280 into key efficacy studies. Planned studies include Phase 2a clinical trials for the treatment of high-grade cervical intraepithelial neoplasia (CIN 2,3) and for the treatment for high-risk HPV infection, specifically in subtypes that can lead to cancer. ABI-2280 has potent antiviral activity across all genotypes of HPV and works by both directly blocking HPV replication and inducing apoptosis in HPV-infected lesions, while sparing normal cells. Antiva has leveraged its development expertise to formulate a vaginal tablet of ABI-2280 that will enable self-administration at diagnosis and facilitate worldwide distribution, increasing impact potential for patients. Dr. Chien is a board-certified, licensed OB/GYN physician with more than 25 years of clinical and biopharmaceutical industry experience, including leading multidisciplinary teams in support of the advancement of early to late-stage clinical programs. In her role as Antiva's CMO, Dr. Chien will be responsible for the creating and overseeing strategy, direction, and execution of the company's clinical development plans. Prior to joining Antiva, she served as vice president, clinical development and medical safety at Mirum Pharmaceuticals, where she was responsible for overall strategic and executional oversight of all development programs for the company's clinical-stage asset, as well as global medical safety and pharmacovigilance for all of Mirum's commercial and clinical assets. Prior to Mirum, Dr. Chien was the clinical development lead for the Myfembree® global Phase 3 endometriosis program at Myovant Sciences, and the medical safety lead at Clovis Oncology for the U.S. and EU approvals of Rubraca® for BRCA-positive ovarian cancer. Dr. Wilson is a seasoned biopharmaceutical industry executive with more than 25 years of experience leading and managing complex global research and development programs. As vice president of project management and strategic initiatives, she will be charged with establishing and leading Antiva's program management function, aligning and mobilizing cross-functional teams to drive execution of the company's development programs. Most recently, Dr. Wilson served as vice president, program, portfolio and alliance management (PPAM) at Revolution Medicines. During this time, she provided PPAM leadership for the company's portfolio of oncology-focused research and development assets from startup through rapid expansion of its clinical-stage portfolio. Dr. Wilson also provided key contributions to KAI Pharmaceuticals leading up to its July 2012 acquisition by Amgen, serving as the company's vice president, project management and project leader for KAI-4169, its lead development asset. Dr. Joshi-Hangal possesses more than 25 years of product development experience in the biopharmaceutical industry combining technical, operational, and regulatory aspects of chemistry, manufacturing, and controls (CMC). In her new role as vice president of technical operations with Antiva, she will be responsible for providing strategic direction, technical leadership, and operational execution of CMC development and manufacturing activities in support of the company's clinical development programs. Previously, Dr. Joshi-Hangal led CMC, regulatory affairs at Myovant Sciences, where she developed, implemented, and advised on global CMC regulatory strategies for new and late-stage programs including Myfembree® and Orgovyx®. She has also held positions of increasing managerial responsibilities in both technical and regulatory CMC areas at Astex Pharmaceuticals. During that time, Dr. Joshi-Hangal aided in the approval of hypomethylating agents, Dacogen® followed by Inqovi® by strategizing creative dose escalation formulations and shortening early phase of clinical development. About HPV-Related Diseases and Cervical Cancer Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. Many of these are transient infections the body is capable of clearing, but this typically takes months to years. When the infections persist, they are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers. The introduction of prophylactic vaccines for HPV was a major step forward in the fight against HPV-associated cancers by preventing infection by certain high-risk HPV subtypes. However, due to low adoption rates in the US, EU, and Japan, and limited access to the vaccines in developing countries, HPV infections and the disease states driven by such infections remain a major unmet clinical need. Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 604,000 women were diagnosed with cervical cancer worldwide and approximately 342,000 women died from the disease in 2020. About Antiva Biosciences Antiva Biosciences, Inc. is a clinical-stage biopharmaceutical company developing novel, topical therapeutics for the treatment of diseases caused by HPV infection. The company, based in the San Francisco Bay Area, was founded in 2012 by Dr. Karl Hostetler of The University of California San Diego. The company's lead drug candidate, ABI-2280 is being developed as a topical treatment for high-grade cervical intraepithelial neoplasia (HSIL, CIN 2,3) and for women with high-risk HPV infection. For more information, please visit: . Contact Information: Kristine Ball Antiva Biosciences, Inc. 650-822-1400 [email protected] Tim Brons Vida Strategic Partners (media) 646-319-8981 [email protected] SOURCE Antiva Biosciences, Inc.

Six companies went public in the last two quarters of 2022, a similar pace to what's currently underway in 2023. Biotech executive Raymond Stevens, Ph.D., recalls the public biotech market of 2013, when a lot of companies were “wondering and waiting,” biding their time and assessing their value as recovery from the 2008 housing crisis dragged on. The way he remembers it, “the market had been closed.”  And now, in 2023, he sees a lot of similarities: “It’s a little bit eerie, in a way,” he told Fierce Biotech.  Stevens was undeterred in 2013, however. The company he was running at the time, Receptos, closed a $73 million IPO anyway, adding warmth to a frigid IPO market that included 44 companies by the end of the year. Stevens now finds himself at the helm of a new biotech—Structure Therapeutics—and once again felt the company’s story was resonating enough to ditch the private cover. Structure announced a $166.7 million IPO in February, one of the highest public raises of the year so far.  Only six drug-developing biotechs have finalized or announced IPO plans so far this year, compared to 19 in 2022, the lowest annual total in a decade. Roderick Wong, M.D., chief investment officer at RTW Investments, was pretty blunt about the situation.  “It’s bad,” he said. “The first quarter of this year is kind of similar to last fall, basically.”  Six companies went public in the last two quarters of 2022, a similar pace to what's currently underway in 2023, according to a review from Evaluate Vantage (PDF). The sluggish pace stems in large part from an industrywide recalibration after COVID sent middling biotechs sprinting toward the public marketplace, many of which were without data. Evaluate’s 2021 review (PDF) reported a record 98 IPOs that year, totaling more than $14 billion in value.  Wong considers a normal range for the industry to be between 30 to 40 IPOs in a given year. What’s changed, he says, is a renewed sense of discipline among investors, and a recommitment of sorts to value hard data over hype. “Data” is surprisingly interpretable, with Wong classifying it as proof-of-concept data that varies depending on the investment risk of a particular asset.  “[N]ow we say it like it's so obvious, but you know, when it was over 100 IPOs … probably the majority didn't have any data,” he said. “So going back to data, it's kind of like a new thing or kind of back to normal.” Comparator comfort    The driver of Structure’s early interest is simple: The company is in phase 1 trials for a GLP-1 inhibitor, the target that’s single-handedly busting open the commercial market for new obesity and diabetes treatments. Big Pharmas Lilly and Novo Nordisk are at the forefront, but a growing line of competitors is entering the fold, Structure included. Even though the biotech has yet to produce sought-after clinical data, the target is so derisked that investors couldn’t help but jump aboard. Stevens credits Structure’s success partly to not overvaluing itself while private, a decision that made the public leap a bit easier. “Part of the calculation though, was if we did another private round that's gonna push us up into eventually when we go public, we would have to go public as a billion dollar company,” said Stevens, noting the company’s valuation post-IPO is somewhere in the $600 million range.  Acelyrin poses the same upside, developing small-molecule treatments against IL-17A, a validated target for treating immunology conditions that’s largely been tackled using monoclonal antibodies. The biotech’s upsized public offering announced this week could rake in more than $600 million, dwarfing the other IPOs this year.  Jon Congleton, CEO of Mineralys, was making a slightly different pitch as he worked with investors at the end of last year, summarizing his strategy as elevating evidence versus promise. The biotech's legitimacy was bolstered in 2022 thanks to proof-of-concept phase 2 data for lead asset lorundrostat. It didn't hurt that the company raised a nine-digit financing earlier in the year and was equipped with clear pivotal trial plans after an end-of-phase-2 meeting with the FDA. Congleton says that Mineralys’ momentum accrued throughout 2022 made him and investors relatively indifferent to the public market conditions, though they were aware it was precarious terrain.  “I don't want to say we were dismissive of what was going on around us but we had a clear sense of our plan,” he said. Mineralys' IPO netted $202 million in February.  Mineralys also has a market comparator giving investors confidence that it’s heading down the right trail. Lorundrostat is an aldosterone synthase inhibitor designed to treat hypertension, following in the footsteps of CinCor Pharma’s baxdrostat. That drug was the basis of AstraZeneca’s $1.8 billion acquisition of CinCor, which was completed in late February. Olivier Litzka, Ph.D., a partner at Andera Partners and a Mineralys board member, said competition is a good thing for investors. “Everybody wants to see comparators and especially in more difficult times,” he said. “People are happy to see that something similar was successful.” For the management team at Coya Therapeutics, convincing investors required being financially vested themselves. CEO Howard Berman, Ph.D., says all corners of the company’s leadership—from C-suite members to scientific advisers—have put their own money into the biotech. "[W]e all came to the table, and we put a lot of money personally into the deal,” he said. “You don’t see that very often. And that allowed the investors to say, ‘You know what, these guys have skin in the game.’”  Unlike some of Coya’s 2023 peers, their public offering announced in the final days of 2022 was slim, just $15 million. The company fundraised on the back of six-month, proof-of-concept data from a phase 1 trial led by Houston Methodist hospital. Additional 48-week data presented in March found that the company’s lead combination amyotrophic lateral sclerosis biologic was safe and slowed disease progression. Chief Financial Officer and Chief Operating Officer David Snyder said Coya’s investors are largely high net-worth individuals and family offices that were interested in the liquidity that a public company offered. It wasn't the only option on the table, however. Snyder recalled considering the once-trendy special purpose acquisition corporation path to a reverse merger. The company ultimately felt a clean IPO was the best possible option.  “Right now for us, we want to be able to assure investors that, were they to come into our company, we’ll be able to take them to meaningful milestones with COYA302,” said Snyder. “And we’re optimistic that we’re one trial away.” The recent accelerated approval of Biogen’s treatment for SOD1 ALS and full approval of Amylyx’s Relyvrio add fuel to the company’s fire, with Berman arguing that the regulatory landscape is ripe for more therapies.  But the company is walking a financial tightrope, or, as Berman described, “there’s not a lot of overhang here.” The $15 million is enough to launch a potentially pivotal phase 2 trial, but more cash will be needed to reach 2025, when said trial is expected to read out. Berman hopes that this time next year, the company will have raised additional capital.  Late-stage dilemma   Other executives that find themselves at a similar crossroads are choosing to stay private. Such is the case for Antiva Biosciences, which recently closed only the third series E in biotech since the middle of July 2022. The company elected to once again take the private financing route—this time bringing in $53 million—in large part because the public market has been so tumultuous.  “No one has pursued high-risk HPV infection as a treatable disease, even though it's the number one sexually transmitted infection in the world,” said outgoing CEO and incoming Chairman Gail Maderis. “And the ability to be able to do this, without those pressures of the public market, particularly in a choppy market climate, is a luxury and I think that positions us and our drug for success.”  Antiva plans to use its new funds to test out lead asset ABI-2280 in a handful of upcoming trials. If the subsequent data are positive, Madeira thinks that may trigger an IPO.  “We’ll keep our fingers crossed and hope that the public market climate and economic climate are in our favor at that time, which they certainly are not right now,” she said.  Investors that do buy into private rounds are not going above and beyond at the rate they used to, according to data from venture financing law firm Cooley. The number of “up” financings in the life science industry in the first quarter of 2023—defined as a company increasing its value in a given financing—fell to less than 70% of new rounds. The share of financings that were “flat” almost doubled from 9% of rounds to 17%. A year ago, 92% of new financings were “up” rounds.  The size of later rounds has also shrunk. The median series C round in March 2023 was $3.5 million, the third-lowest month in the last four years, according to Cooley data. In May 2022, the median series C was more than $270 million.  “I think there's kind of a real problem in the mid-to-late stage,” said Wong. “It doesn't matter if the IPO window reopens, frankly, because it's not going to all of a sudden go to some high rate of deals.” He says that will likely result in more companies that have to get creative with their financing, either through reverse mergers or “any trick in the book.”  That naturally begs the question: when will the IPO window reopen? As is often the case among investors, sentiment differs. Andera’s Litzka is wary of optimism, saying there’s still concern and the markets lack a “positive momentum.” “I'm not sure whether this year will bring the massive turnaround; maybe a stepwise improvement,” he said.  Wong, on the other hand, thinks biotech will eventually benefit from retail investors trading in their tech stock for biopharma. And it’s only a matter of time, he believes, before the recent upswing in M&A activity translates to more dry powder.  “People should have made some money, and that money then finally frees up some room to support these small companies,” he said. “So I kind of feel like it should be happening, it just hasn't happened yet.”