The pandemic hasn't kept biotechs from going public. In fact, through the first five or so months of the year, the industry has raised more than $3.3 billion through IPOs, more capital than biotechs have raised during the first five months of any of the previous 20 years. Although 10 of the 19 IPOs completed this year were in January and February, before stay-at-home orders went into effect in the U.S., quite a few companies have IPOed since then, raising money without executives ever leaving their homes, let alone their cities.

All eyes (virtually) focused on ASCO

In normal times, well over 40,000 delegates would be in Chicago right now attending the American Society of Clinical Oncology (ASCO) annual meeting. However, these are certainly not normal times, with all conference activities disrupted or canceled because of the COVID-19 pandemic. As a result, delegates “attended” from their own homes and tuned into to the presentations from leading cancer researchers at the ASCO20 virtual scientific program, which started on May 29. The meeting was closely watched by analysts and investors alike. A two-part feature will examine how the equities of public biopharmaceutical companies that are developing cancer therapies perform over the course of the event.

COVID-19 developments

The World Health Organization is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing. More than 35 countries and international bodies have signed up to support the COVID-19 Technology Access Pool (C-TAP), as a single repository for knowledge and IP, with the aim of accelerating discovery of treatments through open science research and fast tracking manufacturing by mobilizing capacity at a local level, around the world.

Aerpio Pharmaceuticals Inc. and Quantum Leap Healthcare Collaborative said an agreement was reached to evaluate Tie2-activating compound razuprotafib in a new, randomized treatment arm in the I-SPY COVID trial for the treatment of acute respiratory distress syndrome (ARDS) in adults with moderate to severe COVID-19. Ajinomoto Bio-Pharma Services said it entered a manufacturing agreement with Humanigen Inc. for the fill finish supply of lenzilumab, which is being studied in a phase III trial in adult, hospitalized patients with COVID-19. Heat Biologics Inc. is collaborating with Waisman Biomanufacturing to establish a partnership for the manufacture of Heat's COVID-19 vaccine. Waisman specializes in the manufacture of cellular therapeutics and other biologics for early stage trials and is part of the University of Wisconsin. Merck KGaA said its Milliporesigma arm and Baylor College of Medicine disclosed an extension of their ongoing collaboration to advance a manufacturing platform to fight COVID-19, accelerating the transition to phase I trials. Merck & Co. Inc. is placing two separate bets on recombinant viral vector technology in a broad effort to tackle COVID-19, in which it is also in-licensing a small-molecule antiviral drug. It is acquiring Austrian vaccine developer Themis Bioscience GmbH in a move that propels the latter firm’s COVID-19 vaccine program to the front ranks of the industry pipeline. It is entering a COVID-19 vaccine development collaboration with the not-for-profit vaccine research organization IAVI. And it is collaborating with Ridgeback Biotherapeutics Inc. on the development of an oral antiviral drug, EIDD-2801, now in phase I development. Nantkwest Inc. and Immunitybio Inc. said the latter was selected to participate in Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021. Efforts will focus on the development, testing and large-scale manufacturing of Immunitybio’s COVID-19 human adenovirus vaccine candidate. The National Institute for Innovation in Biopharmaceutical Manufacturing received $8.9 million from the U.S. Department of Commerce's National Institute of Standards and Technology to fund projects supporting the nation's response to the COVID-19 pandemic. Some of the institute's planned projects include providing virus proteins and improving blood testing capabilities and the development of automated contact tracing technology within pharmaceutical manufacturing facilities to limit the spread of coronavirus in essential workers. Novavax Inc. has acquired Praha Vaccines a.s., based in the Czech Republic, for about $167 million in cash. The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic. Novavax said the facility is expected to provide an annual capacity of more than 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, its COVID-19 vaccine candidate. Oxford Biomedica plc signed a one-year clinical and commercial supply agreement with Astrazeneca plc for the GMP manufacture of the adenovirus vector-based COVID-19 vaccine candidate AZD-1222, which is in clinical trials in the U.K. Oxford will provide Astrazeneca multiple batches of vaccine, the majority of which are expected to be produced throughout 2020.

Clinical trials

A phase III test of roluperidone, a drug developed by Minerva Neurosciences Inc. with a goal of treating negative symptoms in schizophrenia, found that the experimental medicine failed to deliver statistically significant differences vs. placebo in improving both the trial's primary endpoint, a common measure of symptom severity, and its secondary endpoint, a score measuring social function. Company shares (NASDAQ:NERV) fell 72.5% to $3.71 on the news following a day of heavy trading May 29.

Drug approvals

Intravenous artesunate, the international standard of care to treat severe malaria, has finally won full FDA approval for the condition, which affects about 300 of the approximately 2,000 people diagnosed with malaria in the U.S. each year. Amivas LLC, a joint venture set up in 2016 solely to make the life-saving drug available in the U.S., won the approval following a priority review. The treatment is approved for use following a complete course of an oral antimalarial regimen.

Deals of the week

Arcus Biosciences Inc. has signed a 10-year cancer immunotherapy deal with Gilead Sciences Inc., which could be worth as much as $2 billion. Gilead is paying Arcus $175 million up front, a $200 million equity investment, and pledging potentially $1.6 billion or more in the form of R&D support, opt-in cash and milestone payments.

Daiichi Sankyo Inc. has entered a strategic agreement with Syneos Health Inc. to develop cancer therapies.

Genome editing startup Edigene Inc. and CAR T developer Immunochina Pharmaceuticals Co. Ltd. have unveiled joint efforts to develop an allogeneic CAR T therapy for cancer.

Hutchison China Meditech Ltd. and Beigene Ltd. will collaborate in the U.S., Europe, China and Australia on evaluating the safety, tolerability and efficacy of combining Chi-Med’s candidates, surufatinib and fruquintinib (Elunate), with Beigene’s anti-PD-1 antibody, tislelizumab, to treat solid tumors.

Regeneron Pharmaceuticals Inc. has initiated an underwritten public secondary offering of its common shares to effect the exit of investment by its partner Sanofi SA, which intends to sell approximately 12.8 million of its approximately 23.2 million Regeneron shares, or approximately 20.6% ownership in the company, and to grant underwriters a 30-day option to purchase an additional 10% of shares.

In a deal potentially worth $3 billion, Repare Therapeutics Inc. entered a research collaboration with Bristol Myers Squibb Co. to identify synthetic lethal precision oncology targets for drug candidates. The pharma receives exclusive worldwide rights for developing and commercializing selected oncology targets discovered in the collaboration.

Ritter Pharmaceuticals Inc. completed its merger with Qualigen Inc. to form Qualigen Therapeutics Inc., which will continue to focus on Qualigen’s business model of developing therapeutic products to treat cancer and infectious diseases.

Tavotek Biotherapeutics signed a research agreement with Genmab A/S to create and develop bispecific antibodies using Genmab's Duobody technology platform against disease-relevant target antigens. Tavotek will use its Tavoselect platform, with VHO phage and Fab phage libraries, to identify lead molecules for generating bispecific antibodies against validated target combinations with the objective of developing an immune-modulator bispecific antibody for autoimmune and inflammatory-related conditions.

Tetra Therapeutics said it inked a definitive merger agreement for its acquisition by Shionogi & Co. Ltd., including global rights to Tetra’s portfolio of compounds to treat brain disorders associated with cognitive and memory deficits.

Financial transactions

Public offerings: Arcus Biosciences Inc. priced an underwritten public offering for gross proceeds of $302.5 million. Arena Pharmaceuticals Inc. priced a public offering for gross proceeds of $275 million. Argenx NV priced a global offering of shares represented by American depository shares in the U.S. and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. The company anticipates total gross proceeds of about $750 million (about €682.4 million). Atara Biotherapeutics Inc. priced an underwritten public offering that will raise approximately $175.5 million. Avidity Biosciences Inc. has filed to raise up to $100 million in an IPO and applied to list its shares on Nasdaq under the symbol RNA. It is developing antibody-oligonucleotide conjugates, a new class of oligonucleotide-based therapies, to treat a wide range of diseases. Biocryst Pharmaceuticals Inc. priced a public offering with aggregate gross proceeds expected to be $100 million. Generation Bio Co. has filed to raise up to $125 million in an IPO and expects its shares will trade on Nasdaq under the symbol GBIO. Geron Corp. closed its public offering for estimated net proceeds of about $140 million. Iovance Biotherapeutics Inc. priced an underwritten public offering with gross proceeds expected to be approximately $525 million. Legend Biotech Corp. has filed to sell about 18.42 million American depositary shares in the price range of $18 to $20 each in its U.S. IPO. Marinus Pharmaceuticals Inc. priced an underwritten public offering with gross proceeds expected to be approximately $40 million. Mersana Therapeutics Inc. priced an underwritten public offering for gross proceeds of $152 million. Pliant Therapeutics Inc. has established terms for its IPO and plans to raise $90 million by offering 6 million shares at a price range of $14 to $16. Vaxcyte Inc. filed to raise up to $100 million in an IPO and expects that its shares will trade on Nasdaq under the symbol PCVX. Viela Bio Inc. priced its public offering for gross proceeds of about $169 million. Windtree Therapeutics Inc. closed its public offering for net proceeds of about $20.2 million.

Other public offerings: Poxel SA completed a private placement for gross proceeds of €17.68 million (US$19.4 million). Tricida Inc. closed an offering of $200 million aggregate principal amount of its 3.5% convertible senior notes due 2027 in a private offering to institutional buyers.

Venture funding: Abcellera Biologics Inc. closed a $105 million series B financing aimed at expanding its capacity and investing in new technologies that complement its antibody discovery engine. Arvelle Therapeutics GmbH closed the final tranche of its series A financing round of $42.7 million. The total capital raised in the round was $207.8 million. Exscientia Ltd. has closed a $60 million series C funding, attracting Novo Holdings as new investor to lead the round, which will enable the artificial intelligence specialist to progress its first in-house program to the clinic before the end of the year. Insitro Inc. raised $143 million in an oversubscribed series B financing. Monte Rosa Therapeutics Inc. emerged from stealth mode with $32.5 million in funding commitments from series A investors Versant Ventures and New Enterprise Associates to enable it to bring new science into the increasingly crowded field of targeted protein degradation. Palvella Therapeutics Inc. closed an oversubscribed $45 million series C financing.

Regulatory news

As the FDA continues to shift its limited resources to the development and review of COVID-19 therapies and vaccines, other drugs in the pipeline may be delayed. In a question-and-answer guidance released last week, the agency acknowledged that, going forward, it may not be able to sustain its current performance level in meeting all its goal dates for new drugs and biologics. Rather than extend PDUFA and BsUFA dates across the board, the FDA will notify sponsors directly about their pending applications, according to the guidance.

Unpredictable and unaffordable copays for insulin could be a thing of the past for millions of people enrolled in certain Medicare Part D prescription drug plans. With manufacturers picking up much of the tab, more than 1,750 plans have applied to lower insulin copays for the 2021 plan year – to a maximum of $35 for a month’s supply – through the Part D Senior Savings Model that was announced March 11, the U.S. Centers for Medicare & Medicaid Services said last week. Participating plans would offer the low copay across a range of insulin products from the beginning of the year through the Part D coverage gap. Outside the model, seniors pay 25% of a drug’s list price while they’re in the coverage gap.

The Institute for Clinical and Economic Review has released a draft evidence report assessing the comparative clinical effectiveness and value of treatments, including marketed biosimilars, for ulcerative colitis. The report assessed Abbvie Inc.’s Humira (adalimumab); Johnson & Johnson’s (J&J) Simponi (golimumab); J&J’s Remicade (infliximab); Pfizer Inc.’s Inflectra; and Merck & Co. Inc.’s Renflexis, biosimilars to Remicade; Pfizer’s Xeljanz (tofacitinib); J&J’s Stelara (ustekinumab); and Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab). Comments on the draft should be submitted by July 29, 2020. The report will be discussed Sept. 24 at a meeting of the California Technology Assessment Forum.

The FDA will hold its annual user fee meeting June 22, on the financial transparency and efficiency of PDUFA, BsUFA and GDUFA, according to a notice in the Federal Register. At the virtual meeting, the agency will discuss the five-year plans for the agreements; its progress in implementing resource-capacity planning and modernized time reporting; and its progress in addressing the findings from last year’s independent third-party evaluation of the resource management associated with the agreements. In addition to making comments at the meeting, the public may submit comments, through July 22. Registration for the webcast meeting is due by June 19.

Word on the Street: Industry responses to the issues of the week

"We all agreed that this was going to be the new norm at least for the foreseeable future. I don't think we're going to go back to the full two-week traditional travel across the globe in a jet to do investments in the future. I think we have fundamentally shifted the way we do IPOs. Period."
Anthony Sun, CEO, Zentalis Pharmaceuticals Inc., commenting on the firm’s four-day virtual IPO roadshow instead of the typical 10 to 14 days, talking with investors on the phone or via video chat

“The reason we chose mRNA technology, even though it has not been done before, is because we have a two-year collaboration with Biontech on a flu vaccine. We felt we had enough expertise, enough scale and could go at speed.”
Albert Bourla, CEO, Pfizer Inc. The company is investing $2 billion in COVID-19 research. Most of that expenditure will be within the next year for the two mRNA vaccines it is developing with German biotech Biontech SE.

“As we know, cancer usually consists of a mixture of mutated cells with uncontrollable growth. A portfolio of allogeneic CAR T products targeting a pool of cancer antigens could be really attractive to manage this devastating disease in the future.”
Dong Wei, CEO, Edigene Inc., which will be working with Immunochina Pharmaceuticals Co. Ltd. to develop an allogeneic CAR T therapy for cancer

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