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Thursday, May 9, 2019

4 Biotech Companies List on the Nasdaq Today

Four biotech companies began trading on the Nasdaq this morning. Compared to last year’s big-money initial public offerings, it’s been a relatively slow year to date. March, however, markedseven life science IPOs, including Precision BioSciences, GenFit, Hookipa, Turning Point Therapeutics, Shockwave Medical, Silk Road Medical and Precision BioSciences. In April, Codiak BioSciences, Peloton Therapeutics, Bicycle Therapeutics, IDEAYA Biosciences, Karuna Pharmaceuticals, Brainsway, Applied Therapeutics, Guardion Health Sciences and NGM Biopharmaceuticals went public. Prior to today’s announcements, Trevi Therapeutics and TransMedics launched IPOs this month.
Here’s a look at today’s launches and one rumored IPO.
NextCureBased in Beltsville, Md., NextCure priced its IPO of 5 million common shares at $15 per share. Shares began trading today under the ticker symbol “NXTC.” The company is focused on immunomedicines to treat cancer and other immune-related diseases. On November 18, 2018, the company completed a Series B financing worth $93 million led by Hillhouse Capital Management and Quan Capital, and included Bay City Capital, Surveyor Capital (a Citadel company), Ping An Ventures, Taiho Ventures, ArrowMark Partners and NS Investment. All existing investors participated, including Canaan Partners, Lilly Asia Ventures, OrbiMed Advisors, Pfizer, Sofinnova Ventures and Alexandria Venture Investments. Eli Lilly and Company also invested $15 million in the financing in connection to an announced discovery and development deal announced November 5, 2018.
NextCure’s lead compound is NC318, a first-in-class therapeutic against a novel immunomodulatory target found on a restricted set of myeloid cells in the tumor microenvironment and on certain cancer types that includes lung, ovarian, and head and neck cancers.
CortexymeHeadquartered in South San Francisco, Cortexyme announced on April 16 that it had launched the GAIN Trial, an international Phase II/III study of its COR388 in mild to moderate Alzheimer’s patients. The trial will determine if the drug can slow or stop Alzheimer’s progression by inactivating the toxic proteins, or gingipains, released by P. gingivalis, a bacterium most commonly linked to chronic periodontal disease, but which has been shown to infect the brain and cause Alzheimer’s.
The company announced its IPO on May 8, with a public price of $17 per share for 4,412,000 shares of common stock. They began trading today under the ticker symbol “CRTX.”

Milestone PharmaceuticalsLocated in Montreal and Charlotte, NC, Milestone Pharmaceuticals is focused on developing etripamil for cardiovascular indications. The company announced the pricing of its upsized IPO yesterday at a price of $15 per share. It is offering 5,500,000 common shares and expects to raise about $82.5 million. They began trading today under the ticker symbol “MIST.”
On October 25, 2018, the company completed an $80 million private financing. New investors RTW Investments led the round and was joined by Venrock Healthcare Capital Partners and Boxer Capital of Tavistock Group. Existing investors included Novo Holdings, Forbion, funds managed by Tekla Capital Management, Domain Associates, BDC Capital, Pappas Capital, GO Capital, and Fonds de solidarite FTQ. This round builds on a previous July 2017 Series C financing led by Novo Holdings. The proceeds were used to support the company’s Phase III trial of etripamil for paroxysmal supraventricular tachycardia (PSVT) and to expand the company’s pipeline.
AxcellaHeadquartered in Cambridge, Mass., Axcella priced its IPO at $20 per share and is offering 3,571,428 shares of common stock. It began trading today under the ticker symbol “AXLA.” It plans to raise $71.4 million.
On April 11, Axcella presented new data at The International Liver Congress 2019 for its endogenous metabolic modulator (EMM) composition, AXA1665 in patients with mild and moderate hepatitis insufficiency or loss of liver function. The company’s lead candidate is designed to target several metabolic pathways that intersect key organ systems, including liver, muscle wasting, and gut health. The drug was well-tolerated and increased the basal (fasted) Fischer’s ratio by 40%, decreased plasma ammonia area, and showed a trend toward a leaner phenotype and muscle function.
BioNTechUnlike the four previously described companies that all began trading on the Nasdaq today, BioNTech is maneuvering for a possible future IPO, according to reports. Based in Mainz, Germany, BioNTech announced the acquisition of antibody assets and infrastructure yesterday from San Diego-based MabVax Therapeutics Holding, an oncology company. Under the terms of the deal, BioNTech acquired MabVax’s lead candidate, MVT-5873, in addition to other preclinical antibody assets to expand its existing antibody portfolio and RiboMABS development capabilities. MVT-5873 is currently in Phase I development in pancreatic cancer and has been tested in 35 patients with initial positive interim data announced in February 2018. In addition to the assets, it acquired MabVax’s infrastructure and lab equipment with plans to establish a research facility in San Diego.
Bloomberg reported in February that BioNTech was considering a U.S. IPO, possibly as early as this year. In addition to acquiring the new assets, BioNTech has development partnerships with Pfizer and Sanofi. At this time, however, it appears to be a rumor.

Immunomedics refiling timeline should bring some relief, says Piper Jaffray

Immunomedics indicated that it is now in broad alignment with the FDA around the issues raised in the Complete Response Letter and is projecting a biologics license application resubmission for sacituzumab to occur in early Q4, Piper Jaffray analyst Joseph Catanzaro tells investors in a post-earnings research note. The analyst believes this timeline is largely in-line with consensus and should provide a “bit of relief.” Investors may still have some questions around the Ascent trial timing, but given the FDA’s apparent comfort with the clinical data, a further approval delay is unlikely given the extreme unmet need in triple-negative breast cancer, adds the analyst. He maintains an Overweight rating on Immunomedics with a $20 price target.

Cortexyme indicated to open at $17.90, IPO priced at $17.00

https://thefly.com/landingPageNews.php?id=2907071

Axonics touts results from pivotal FDA IDE r-SNM urinary dysfunction trial

Axonics Modulation Technologies (NSDQ:AXNX) Monday released the results from the FDA investigational device exemption pivotal study of its r-SNM Sacral Neuromodulation system exploring its use in treating urinary dysfunction.
The Irvine, Calif.-based company said it presented results from the study, dubbed the ARTISAN-SNM study, at the 2019 American Urological Association’s Annual Meeting in Chicago this week.
Axonics presented six-month results from the 129-patient, unblinded pivotal clinical study, and said that it hopes the results will support FDA approval of the system.
Data at six months indicated that 90% of the treated patients responded to the therapy, experiencing a 50% or greater reduction in urgency incontinence episodes compared to the baseline. Urgency incontinence episodes in all patients were reduced from an average of 5.6 per day at baseline to 1.3 per day, the company said.
Results indicated that 80% of therapy responders had a 75% or greater reduction in episodes, with 34% experiencing a complete 100% reduction. Patients reported clinically meaningful improvements in quality of life rated on their ICIQ-QABqol scores, Axonics said.
A total of 93% of patients said they were satisfied with therapy received from the r-SNM device, and 98% reported acceptable charging experiences. No serious device related adverse events were reported.
“The ARTISAN-SNM study has demonstrated that the Axonics r-SNM System is providing clinically significant symptom relief to patients. The high levels of patient success and satisfaction exceed historical clinical results for Sacral Neuromodulation. The Axonics r-SNM System, designed to last a minimum of 15-years in the body, is a game-changing solution for physicians and patients as it significantly reduces the need for device replacement surgeries associated with the legacy non-rechargeable implant which has historically been the only SNM system available,” chief medical officer Dr. Karen Noblett said in a press release.
In March, Axonics took a hit after it posted fourth-quarter and 2018 losses that exceeded the consensus forecast on Wall Street.

Baird names Sarepta a ‘Fresh Pick’ ahead of Pfizer data

Baird analyst Brian Skorney named as a “Fresh Pick” ahead of the report of competitive data due in late June from Pfizer’s (PFE) Duchenne muscular dystrophy program that he predicts will “fall flat.” If that turns out to be the case, it should remove the most significant overhang on Sarepta shares, contends Skorney, who keeps an Outperform rating on Sarepta.

Mylan takeover rumor circulated by Intereconomia

Intereconomia, which has previously been the source of a number of takeover rumors, has published a new report speculating on a possible buyout of Mylan.

Mustang Bio’s first-of-a-kind CAR-T starts trials

US biotech Mustang Bio says that an investigator-led trial of its CAR-T therapy for multiple myeloma – the first to target CS1 protein – has started recruiting patients.
The multiple myeloma pipeline is filled with CAR-T therapies but most are targeting BCMA, including Celgene’s bb2121 which is considered the pacesetter in the race for approval in the category with an FDA verdict due later this year.
Mustang reckons that by targeting CS1 – also known as CD319, CRACC and SLAMF7 – its MB-104 CAR-T will be differentiated from the BCMA pack and could carve out a lucrative niche in the large and growing multiple myeloma market.
CS1 is expressed by cancer cells in nearly all multiple myeloma patients, and also has low expression in normal tissues, preventing those cells from being severely damaged during treatment.
The trial will be carried out at City of Hope cancer treatment and research centre in Southern California, which is fast becoming one of the premier facilities in the US for cell therapies. It will enrol heavily pre-treated myeloma patients who have received at least three prior treatment options and test positive for the CS1 antigen.
“Multiple myeloma accounts for 10% of all blood and bone marrow cancers,” said Xiuli Wang, a City of Hope research professor who has been involved in testing MB-104 in preclinical and translational research.
“CS1 is a very promising target for multiple myeloma patients who currently have few viable treatment options,” she added.
There is a precedent for the therapy as CS1 is targeted by Bristol-Myers Squibb and AbbVie’s multiple myeloma antibody Empliciti (elotuzumab), which has been tipped to become a blockbuster product but has been sluggish in its sales growth since reaching the market in 2015. Last year BMS, which books sales for the product, said it made $247 million in Empliciti revenues.
Mustang also announced this week that it had raised $32 million in a public offering that will help it fund its CAR-Ts for blood cancer, solid tumours and rare genetic diseases.
Along with MB-104. Mustang’s cancer-targeted CAR-T’s include MB-102, a CD123-targeting therapy for acute myelogenous leukaemia that is also partnered with City of Hope and due to start trials shortly, and MB-106, a CD20-targeted therapy partnered with Fred Hutchinson Cancer Center and heading towards trials in non-Hodgkin lymphoma and chronic lymphocytic leukaemia.
Its most advanced project is MB-107, a gene therapy licensed from St Jude Children’s Research Hospital for X-linked severe combined immunodeficiency (X-SCID), also called ‘bubble boy’ syndrome, that is in a phase 1/2 trial. Data from the trial were published in the New England Journal of Medicine last month.