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Shares of Novavax (NVAX) hit a 52-week low on Wednesday, falling 6% to $33.04, then sinking even lower in Thursday pre-market trading, dipping another 1% to $32.82 (as of 9:04 a.m.). The bad stock news came as the FDA expanded its emergency use authorizations (EUA) of the Pfizer/BioNTech and Moderna COVID-19 vaccines to include bivalent formulations for use as single “updated” boosters at least two months following primary or booster vaccination.
Moderna’s booster or COVID-19 Vaccine, Bivalent, also known as mRNA-1273.222, targets Omicron subvariants BA.4 and BA.5, and is authorized for use in adults 18 years of age and older. The 50 µg booster dose of mRNA-1273.222 consists of 25 µg of mRNA encoding for the spike protein of BA.4/.5 and 25 µg encoding for the original strain of the SARS-CoV-2 virus.
Pfizer-BioNTech’s COVID-19 Vaccine, Bivalent, is authorized for people 12 years of age and older. The vaccine combines 15-µg of mRNA encoding the wild-type spike -protein of SARS-CoV-2 present in the original Pfizer-BioNTech COVID-19 vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants.
The expanded authorizations came two weeks after Novavax submitted to the FDA its application for an EUA for its own booster dose for adults ages 18 and older.
The expanded EUAs will likely expand the gap in doses administered between Novavax and three more established COVID-19 vaccine rivals—not only Pfizer/BioNTech and Moderna, but also Johnson & Johnson (J&J), whose single shot jab is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells.
As of August 31, according to the U.S. Centers for Disease Control and Prevention (CDC)’s COVID-19 Data Tracker, only 14,559 doses of Novavax’s vaccine had been administered nationwide, compared with 18,866,547 for J&J, 229,236,868 for Moderna, and 360,175,884 for Pfizer/BioNTech.
The CDC also recorded just 2,591 Americans as being fully vaccinated by Novavax’s vaccine, compared with 17,080,700 with J&J’s jab, 77,824,706 with Moderna’s, and 128,817,297 with the Pfizer/BioNTech vaccine. Doses of Novavax’s vaccine have been available for use in the U.S. since July, compared with February 2021 for J&J and December 2020 for the Pfizer/BioNTech and Moderna vaccines.
On Sunday, Jefferies analyst Roger Song, MD, CFA, shared figures from his firm’s own COVID-19 vaccine global supply/demand weekly tracker that portends better news for Novavax, both now and the rest of this year.
Jefferies’ tracker showed 1.21 million doses of Novavax’s vaccine having been administered year to date, and about 108 million doses of Novavax’s vaccine having been delivered.
“We see a path to achieve [Novavax’s] updated revenue guidance of $2-2.3B in 2022,” Song wrote. [That guidance was slashed in August from between $4 billion and $5 billion, which triggered a one-day 30% decline in Novavax’s share price August 9.]
How well Novavax follows that path to fulfilling its revenue guidance will depend on several factors cited by Song that could affect near term demand.
They include: Orders and advance purchase agreement updates, quarter-on-quarter sales, worldwide ancestral/Omicron-containing booster approvals expected in the second half of this year, full U.S. approval expected later this year, a possible Omicron bivalent booster approval, as well as new variants/cases, duration of immunity/severe disease protection and variant specific/multi-valent/combo vaccine.
As for Pfizer, BioNTech and Moderna, the FDA EUAs did not do much for the companies’ stock. Following the FDA EUAs on Wednesday, Pfizer shares dipped 1%, from $45.85 to $45.23. BioNTech shares slid about 2%, from $147.08 to $144.64, while Moderna sank nearly 3% $135.93 to $132.27.
“The continued development of Omicron-specific boosters alone highlights the mRNA vaccine platform’s speed and flexibility. However, the uptake of these new boosters, expected to be rolled out in fall/winter, is predicted to mirror the poor uptake patterns of other recent boosters,” said Emily Martyn, MPH, Pharma Analyst at GlobalData. “New ideas are urgently needed to encourage as many people as possible to accept the fall/winter boosters, or we risk reinfection and the possibility of yet more variants.”
Chimerix shares spiked 23% on Monday, from $2.16 to $2.6499, before ending trading with an 8% gain after announcing it had signed an up-to-$680 million, 10-year contract with the Biomedical Advanced Research and Development Authority (BARDA) for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of Tembexa® (brincidofovir) to the U.S. government.
The contract (5A50122C00047) includes an initial product procurement of 319,000 treatment courses for approximately $115 million. In addition to product procurement, the contract supports post-marketing activities of approximately $13 million.
In addition to the BARDA contract, Chimerix stands to make millions from selling its worldwide rights for Tembexa to Emergent BioSolutions (EBS). Back in May when that contract was announced, Chimerix was expected to receive $225 million upfront and up to $100 million in milestone payments.
But the EBS contract was subject to revision after the BARDA contract was finalized. Under the revised EBS agreement, Chimerix stands to gain $238 million upfront, up to $124 million in milestones, a 15% royalty on gross profit from sales of Tembexa outside the U.S.; a 20% royalty on gross profit from sales of Tembexa in the U.S. that exceed 1.7 million treatment courses; and up to an additional $12.5 million tied to achieving additional developmental milestones.
“Our collaboration with BARDA for the development of Tembexa has provided the United States government with a second therapeutic option to ensure the federal government’s readiness for a potential smallpox emergency,” Chimerix CEO Mike Sherman said in a statement.
[The first is Siga Technologies’ Tpoxx® (tecovirimat), which made headlines earlier this year when the federal government allowed the drug to be used as a monkeypox treatment under an expanded access program.]
Jounce Therapeutics (JNCE)
Jounce shares fell 16% on Tuesday, from $4.29 to $3.61, after acknowledging that the combination of its lead candidates—vopratelimab (vopra), an inducible costimulator (ICOS) agonist, plus the PD-1 inhibitor pimivalimab (pimi; formerly JTX-4014)—missed their primary endpoint in the Phase II SELECT trial (NCT04549025), designed to evaluate the combination vs. pimi alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients.
The trial tested two pulsatile and differentiated doses of vopra in the combination groups against pimi monotherapy, using as the primary endpoint the mean percent change from baseline in tumor size in all measurable lesions, averaged over nine and 18 weeks as assessed by central independent radiology review. While the study was powered to detect a 20% absolute difference of the pooled combo doses compared to pimi alone, the actual difference was just 7%, Jounce said.
However, the combination dose cohort with the lowest dose of vopra (0.03mg/kg) showed an absolute mean change of 15%. In prespecified secondary endpoints, that combo showed an overall response rate (ORR) of 40% compared to 25% in pimi alone—as well as landmark six-month progression free survival (PFS) of 80% vs. 33% for pimi alone.
“Although we are intrigued by the preliminary efficacy trends, particularly the landmark PFS and ORR in the lower vopra dose combination arm, the SELECT results do not support moving into registration studies as had been our previous goal,” Jounce CEO and president Richard Murray, PhD, said in a statement. “We will re-evaluate the vopra program in the context of our broader pipeline in the coming months.”
Liquidia shares spiked 43% on Wednesday, from $5.38 to $7.71 at 2:36 pm before finishing the day with a 7% gain, to $5.77, after a mixed set of rulings in U.S. District Court for the District of Delaware in a longstanding patent infringement case filed by United Therapeutics (UTHR).
United Therapeutics has alleged that Liquidia’s proposed treprostinil inhalation powder, YutrepiaTM would infringe on patents it holds that include No. 9,593,066 (Process to Prepare Treprostinil, the Active Ingredient in Remodulin®), and No. 10,716,793 (Treprostinil Administration by Inhalation).
U.S. District Court Judge Richard Andrews ruled that Yutrepia would infringe five of six claims of the ’066 patent, but found those claims to be invalid, adding that the only valid claim was not infringed by Liquidia. The ‘066 patent protects a method of making treprostinil, the active pharmaceutical ingredient in both Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI™ (treprostinil) Inhalation Powder.
However, Andrews also that Liquidia would induce infringement of the five asserted claims in the ‘793 patent—siding with United Therapeutics, which lost a recent Patent Trial and Appeal Board (PTAB) decision holding that all claims in the ‘793 patent were unpatentable.
United Therapeutics has requested rehearing regarding the PTAB decision, which came in an inter partes review of the ’793 patent initiated by Liquidia. If the PTAB does not reverse itself, United Therapeutics said Wednesday, it will appeal the board’s decision. The company noted that the ’793 patent remains valid during the pendency of all appeals—and predicted that any IPR appeal process will likely take at least a year.
“We’re pleased with the Court’s decision on the ’793 patent, and our legal team is evaluating options for the ’066 patent,” said Shaun Snader, Vice President and Associate General Counsel—IP and Litigation at United Therapeutics, said in a statement.
Added Liquidia CEO Roger Jeffs in his company’s statement: “While we are disappointed with the Court’s decision on the ‘793 patent, we are optimistic that the PTAB’s favorable decision will be affirmed on appeal, thereby unlocking the path to potential approval of Yutrepia by mid-2024, if not earlier.”
Shuttle Pharmaceuticals (SHPH)
Who said the IPO market is dead? Shuttle shares nearly quintupled on Wednesday, zooming 374% from the initial public offering (IPO) price of $8.125 per “unit” [consisting of a share of common stock and a warrant to purchase one share of common stock], with 1,225,888 units offered, for total gross proceeds of $9,960,340.
But in a sign that the market isn’t yet back from the decline that started last year, Shuttle Pharma’s proceeds are down from the $14.3 million projected when it first planned a larger IPO back in June. Boustead Securities acted as lead underwriter for the IPO, with Valuable Capital serving as co-underwriter.
Shuttle Pharma investors received better news on Thursday, when the company’s shares nearly tripled at the opening bell, spiking 176% to $106.20 before settling to $59.64 as of 1:20 p.m., a 55% gain. Investors appeared dazzled by the company’s claim in its IPO Prospectus that its novel therapies “are designed to cure cancer.”
Shuttle Pharma was founded in 2012 by faculty members of the Georgetown University Medical Center, with the aim of developing therapies that maximize the effectiveness of radiation therapy while limiting the side effects of radiation in cancer treatment.
The Rockville, MD, company’s pipeline includes lead candidate Ropidoxuridine, which has completed a Phase I trial and is designed to work by sensitizing rapidly growing cancer cells. Also in the pipeline are several selective histone deacetylase (HDAC) inhibitors, also designed to sensitize cancer cells as well as stimulate the immune system.
“Our platform of sensitizers are designed to address an urgent clinical need in patients with brain tumors, sarcomas and pancreatic cancers, all diseases that offer potential for orphan designations,” Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, MD, said in a statement.
In its IPO Prospectus, Shuttle Pharma acknowledged it will need to raise much more than it received through the IPO.
“We believe we will need approximately $22 million in additional funding to complete Phase III clinical trials for Ropidoxuridine and approximately $30 million in additional funding to complete Phase I through III clinical trials for our selective HDAC6 inhibitor,” Shuttle Pharma disclosed. “If such additional funds are required, we will have to secure additional funding from investors or through a joint development partner.”