LMNL Joins COVID-19 Battle, PFE/BNTX Vaccine Data Promising, EVLO On Watch
Today’s Daily Dose brings you news about Pfizer/BioNTech’s COVID-19 vaccine trial results; Blueprint’s submission of Pralsetinib NDA; reverse merger of MedAvail with MYOS; Liminal BioSciences’ efforts to fight the ongoing pandemic and upsized public offering of AdaptHealth.
1. AdaptHealth Upsizes offering
AdaptHealth Corp. (AHCO), a provider of home medical equipment, has priced its upsized public offering of Class A Common Stock at $15.50 per share.
The size of the offering has now been increased to 8 million shares of common stock from the previously announced 6.5 million shares. The offering is expected to close on July 6, 2020.
The gross proceeds to AdaptHealth are expected to be approximately $124 million. On March 31, 2020, the Company had cash and cash equivalents of $48.2 million.
AHCO closed Wednesday’s trading at $18.78, up 16.65%.
2. Axogen Strengthens Balance Sheet
Axogen Inc. (AXGN) has strengthened its balance sheet by entering into a financing agreement with Oberland Capital, which provides up to $75.0 million in three tranches with interest-only payments over seven years.
The Company drew $35.0 million upon closing of the agreement on June 30, 2020, and the second tranche of $15.0 million can be drawn upon achieving two consecutive quarters with revenue of at least $20.0 million. The third tranche of $25.0 million will be drawn upon achieving two consecutive quarters with revenue of $28.0 million.
Axogen is slated to report financial results for the second quarter ended June 30, 2020, on August 5, 2020.
The Company expects second-quarter revenue to be at least $21 million, a decline of 21% compared to the year-ago quarter.
AXGN closed Wednesday’s trading at $11.73, up 26.95%.
3. Blueprint Submits Pralsetinib NDA
Blueprint Medicines Corp. (BPMC) has submitted a New Drug Application to the FDA for Pralsetinib for the treatment of patients with advanced or metastatic RET mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers.
Pralsetinib is an investigational, once-daily precision therapy designed to potently and selectively inhibit RET fusions and mutations, including predicted resistance mutations.
The Pralsetinib NDA was submitted under the Real-Time Oncology Review pilot program (RTOR program), an initiative that aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality by the FDA.
Pralsetinib is already under review by the FDA and European Medicines Agency in the proposed indication of locally advanced or metastatic RET fusion-positive non-small cell lung cancer. The FDA decision on Pralsetinib in non-small cell lung cancer is expected by November 23, 2020.
BPMC closed Wednesday’s trading at $79.02, up 1.31%.
4. Evelo Biosciences To Make Presentations At ESMO
Evelo Biosciences Inc. (EVLO) is all set to present clinical data from its phase I/II study of EDP1503, in combination with Merck’s KEYTRUDA, in patients with advanced metastatic microsatellite stable colorectal carcinoma (MSS CRC), triple-negative breast cancer (TNBC), and checkpoint inhibitor relapsed tumors at the ESMO World Congress on Gastrointestinal Cancer Virtual Meeting being held July 1 – 4, 2020.
The Company’s investigational drug EDP1815 will be studied in a phase II/III platform trial, dubbed TACTIC-E, which is evaluating certain experimental therapies in the prevention and treatment of life-threatening complications associated with COVID-19 in hospitalized patients at early stages of the disease.
The TACTIC-E study is sponsored by Cambridge University Hospitals NHS Foundation Trust. Interim data from the trial are anticipated during the fourth quarter of 2020.
EVLO closed Wednesday’s trading at $4.95, up 1.02%. In after-hours, the stock was up 4.24% at $5.16.
5. Liminal Joins COVID-19 Battle
Shares of Liminal BioSciences Inc. (LMNL) (LMNL.TO) soared more than 100 percent on Wednesday, following news that it has commenced the collection of convalescent plasma from donors who have recovered from COVID-19.
The convalescent plasma that contains antibodies to SARS-CoV-2, the virus that causes COVID-19, is being studied for administration to patients with COVID-19.
Liminal BioSciences, formerly known as Prometic Life Sciences Inc., is a clinical-stage biopharmaceutical company developing novel treatments for patients suffering from diseases related to fibrosis, including respiratory, liver, and kidney diseases that have a high unmet medical need.
The Company’s lead product candidate is Ryplazim for the treatment of congenital plasminogen deficiency. The biologics licensing application (BLA) for Ryplazim is expected to be resubmitted to the FDA this quarter (3Q, 2020). Ryplazim was denied FDA approval in 2018 due to issues related to Chemistry, Manufacturing, and Controls (“CMC”) portion of the BLA.
A multiple ascending dose phase I study of Fezagepras, an anti-inflammatory and anti-fibrotic agent, is expected to be initiated in the second half of 2020.
LMNL touched a new 52-week high of $31.45 in intraday trading on Wednesday, before closing the day at $22.79, up 117.05%. In after-hours, the stock fell 8.73% to $20.80.
6. MedAvail Reverse Merges With MYOS, To Be Listed On NASDAQ
MedAvail Inc., a private, in-clinic telemedicine-enabled pharmacy organization, is executing a reverse merger with MYOS RENS Technology Inc. (MYOS) to create a combined company that will focus on advancing MedAvail’s network of in-clinic pharmacies within Medicare sites across the U.S.
The combined company is expected to operate under the name MedAvail Holdings, Inc. and to continue to trade on the Nasdaq Capital Market. The muscle health business of MYOS will be spun off as a private unaffiliated company.
MYOS closed Wednesday’s trading at $2.44, up 177.27%.
7. Pfizer/BioNTech Report Promising Preliminary Results of COVID-19 Vaccine Candidate
Pfizer Inc. (PFE) and BioNTech SE (BNTX), on Tuesday, announced encouraging preliminary U.S. data from phase I/II trial of BNT162b1, the most advanced of their four investigational vaccine candidates, from their BNT162 mRNA-based vaccine program against SARS-CoV-2.
The reported preliminary data is from 24 healthy adults 18 to 55 years of age who received 2 vaccinations of BNT162b1 at 10 µg and 30 µg dose levels.
In the phase I/II trial, at day 28, all subjects who received 10 µg or 30 µg of BNT162b1 had significantly elevated receptor-binding domain (RBD)-binding IgG antibodies and neutralizing antibodies much higher than the sera of convalescent patients who had contracted SARS-CoV-2.
The level of antibodies relates to a vaccine’s efficacy.
From the four vaccine candidates, a lead vaccine candidate will be selected based on further data from the ongoing Phase 1/2 clinical trial. A phase IIb/III safety and efficacy study is expected to begin as early as July 2020.
If all goes well and if the BNT162 vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.
BNTX closed Wednesday’s trading at $64.14, down 3.90%. In after-hours, the stock was up 2.28% at $65.60.
PFE closed the day’s trading at $33.74, up 3.18%.
8. Stocks That Moved On No News
89bio Inc. (ETNB) closed Wednesday’s trading at $28.17, up 41.34%.
Aptinyx Inc. (APTX) closed Wednesday’s trading at $4.96, up 18.94%.
BELLUS Health Inc. (BLU) closed Wednesday’s trading at $11.83, up 14.97%.
Ekso Bionics Holdings Inc. (EKSO) closed Wednesday’s trading at $7.23, down 13.93%.
Vaxart Inc. (VXRT) closed Wednesday’s trading at $8.00, down 9.60%.
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