Stay at the forefront of the week’s champions and runners-up among publicly traded biotech companies and the reasons behind the ups or downs of their stock price fluctuations.
Pfizer (PFE) is flush with cash after bringing to market not one but two COVID-19 products over the past 18 months. The pharma giant finished the first quarter with a 77% year-over-year jump in revenues, to $25.661 billion—of which more than half (51.5%) consisted of the $13.227 billion in revenues from direct sales and alliance revenue from COVID-19 vaccine Comirnaty®, co-developed and co-marketed with BioNTech. Pfizer alone racked up another $1.47 billion in revenues from Paxlovid® (nirmatrelvir and ritonavir), the COVID-19 pill that won FDA emergency use authorization in December 2021.
Pfizer at deadline had yet to file its Form 10-Q quarterly report for Q1, and did not include updated cash and investment numbers in its press release and presentation to analysts of its January-March 2022 results. However, the company finished 2021 with $1.944 billion in cash and cash equivalents, and $29.125 billion in short-term investments.
So what’s Pfizer to do with all that money? Why, put it to work by acquiring companies whose therapeutics fit within its therapeutic areas of interest. Last month, Pfizer said it will acquire ReViral for up to $525 million, adding an infectious disease pipeline the buyer hopes will help it meet the unmet need for RSV treatments. In March, Pfizer completed its $6.7 billion acquisition of Arena Pharmaceuticals announced in December 2021, adding an immuno-inflammatory disease pipeline, led by Arena’s Phase II/II lead candidate etrasimod.
The latest example of Pfizer’s buying spree came on Tuesday, when Pfizer said it agreed to acquire BioHaven Pharmaceuticals for $11.6 billion, all of it in cash.
Biohaven investors roared their approval of the deal by sending the company’s shares rocketing 68%, to $140.00 from $83.14 at Monday’s close. Pfizer investors also liked what they heard, judging from the pharma giant’s shares climbing nearly 2%, to $49.49 from $48.64 a day earlier.
One possible reason: Pfizer is likely to be the only buyer for Biohaven, and not have to shell out more for the company in order to fend off another suitor.
“We don’t believe that it’s likely that another player will come in at a higher price, especially given that Pfizer already owned the OUS right for Nurtec ODT,” Marc Goodman, a Senior Research Analyst at SVB Securities covering neuroscience and ophthalmology, and two colleagues wrote Tuesday in a research note.
OUS stands for “outside the United States,” where Pfizer gained the right to commercialize Nurtec ODT and another migraine drug in development, zavegepant, through an up-to-$1.24 billion global agreement the companies signed in November 2021.
Goodman and colleagues downgraded Biohaven from Outperform to Market Perform while maintaining its price target of $150 a share, “as we expect the stock to trade based on deal dynamics and no longer on fundamentals.”
Pfizer agreed to acquire all outstanding shares of Biohaven it does not already own for $148.50 per share cash. For each Biohaven share they own, Pfizer and other Biohaven common shareholders will also receive a half share of New Biohaven, a new publicly traded company that will retain Biohaven’s non-CGRP development stage pipeline compounds. The new Biohaven company to be spun out will be capitalized with $275 million cash—and will also have the right to receive tiered royalties from Pfizer on any annual net sales of rimegepant and zavegepant in the U.S. that exceed $5.25 billion.
Caribou Biosciences (CRBU)
Caribou shares rose 22% on Thursday after the company announced it had positive initial data showing a 100% overall response rate and 80% complete response rate for its five evaluable patients from the Phase I ANTLER trial (NCT04637763) assessing its lead candidate CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). The initial data are set to be shared at the European Hematology Association (EHA) 2022 Hybrid Congress, to be held June 9-17 in Vienna, Austria.
“These excellent initial outcomes represent important steps toward validating our chRDNA genome-editing platform as well as our plans for future development of CB-010 and our broader pipeline,” Rachel Haurwitz, PhD, Caribou’s president and CEO, said in a statement.
CB-010 is an allogeneic, anti-CD19 CAR-T cell therapy derived from healthy donor T cells. CRISPR-Cas9 chRDNAs designed to significantly reduce off-target editing were used to generate three genome edits in the manufacture of CB-010, according to an abstract of the presentation: Knockout of the TRAC gene to eliminate TCR expression to reduce the risk of Graft vs Host Disease; site-specific insertion of an anti-CD19 CAR into the TRAC locus; and knockout of the gene encoding PD-1, designed to limit CAR-T cell exhaustion.
At EHA, Caribou is scheduled to share longer follow-up data from patients in Cohort 1 of the ANTLER trial who received a single administration of CB-010 at the first dose level of 40 x106 CAR-T cells.
One analyst shared Haurwitz’s enthusiasm for the early results.
“While early and certainly not flawless, we see these data as an ‘inside-the-park homerun’ supporting the selectivity and precision of the chRDNA platform, and positioning CB-010’s PD-1 knockout approach as de facto best in class until proven otherwise,” Mani Foroohar, MD, a Senior Research Analyst with SVB Securities focusing on Genetic Medicines, wrote in a research note.
Compass Therapeutics (CMPX)
Shares of Compass soared 25% on Thursday after the company filed regulatory filings disclosing the purses of additional stock by Co-Founder and CEO Thomas J. Schuetz, MD, PhD; and board member Carl Gordon, PhD, a Founding Member, Managing Partner, and Co-Head of Global Private Equity for OrbiMed Advisors.
Schuetz acquired 27,836 shares at a weighted average share price of $1.80 a share on May 10. The $50,104.80 purchase brought to 5,153,303 the number of shares he now owns.
Gordon made three purchases totaling nearly $200,000 in recent days—10,200 shares at $1.63 a share on May 6 ($16,626), another 90,712 shares at $1.56 a share on May 9 ($141,510.72), and an additional 24,447 shares at $1.60 a share on May 10 ($39,115.20). Gordon now owns 14,625,478 shares of Compass common stock, which are held by OrbiMed Advisors, raising its stake in Compass to 3,571,428 shares.
Compass finished the first quarter with a $7.2 million net loss, relatively flat from the $7.3 million net loss reported in Q1 2021. The company reported cash and cash equivalents of $136.4 million, more than triple the $39.7 million it had as of March 31, 2021—and good enough to fund company operations into the second half of 2024.
Cullinan Oncology (CGEM)
Cullinan Oncology shares jumped 27% on Thursday, the day it announced an up to $405 million collaboration with Taiho Pharmaceutical through which Taiho will co-develop and co-commercialize in the U.S. Cullinan’s lead program CLN-081/TAS6417, an oral irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild-type EGFR.
Taiho has agreed to acquire Cullinan Oncology’s subsidiary Cullinan Pearl which holds worldwide rights outside of Japan to CLN-081/TAS6417. In return, Taiho agreed to pay Cullinan Oncology $275 million upfront and up to an additional $130 million in payments tied to achieving regulatory milestones related to EGFR exon20 non-small cell lung cancer (NSCLC).
Cullinan Pearl gained the worldwide-except-Japan rights to CLN-081/TAS6417 after the company was formed by Taiho, its subsidiaries, and Cullinan Oncology. Cullinan Pearl opened an Investigational New Drug (IND) application with the FDA and launched a global Phase I/IIa trial (NCT04036682) in NSCLC patients harboring EGFR exon 20 mutations; the study is now ongoing. Earlier this year, the FDA granted Breakthrough Therapy Designation for CLN-081/TAS6417. A pivotal study is expected to begin in the second half of this year.
Cullinan Pearl also licensed the rights to CLN-081/TAS6417 to Zai Lab in Greater China (Greater China, which includes mainland China, Hong Kong, Macau and Taiwan) in December 202. In return, Cullinan Pearl received from Zai $20 million upfront with the possibility of up to $211 million in development, regulatory, and sales-based milestone payments.
The deal is expected to close in the second quarter, subject to customary closing conditions that include expiration or termination of the waiting period under U.S. antitrust laws.
Inovio shares tumbled 27% Wednesday, the day after the company reported first-quarter earnings that missed analyst expectations, ended a Phase III trial for COVID-19 DNA vaccine candidate INO-4800, shifted INO-4800’s development focus to a heterologous booster strategy—and disclosed the abrupt departure of co-founder and CEO J. Joseph Kim, PhD, as President and CEO.
Kim was succeeded immediately by Jacqueline Shea, PhD, who was promoted from Chief Operating Officer, the position she has held since joining Inovio in 2019. Kim resigned from Inovio’s board, but agreed to serve in an advisory role to Shea, who will also join that board following its annual stockholders meeting on Monday.
“While we have many challenges to face, I believe strongly in the potential of our DNA medicines technology and continue to be inspired by Inovio’s talented and dedicated team,” Shea stated.
One challenge will be improving Inovio’s results going forward.
The company finished the first quarter with a $79.1 million net loss, compared with a $54.4 million net loss during the first three months of 2021. Total revenue was $199,000, down 46% year-over-year from $371,000, and 57% less than the $464,000 average of three revenue forecasts from as many analysts, as reported by Zacks Investment Research. Zacks downgraded Inovio shares from “Buy” to “Sell” in March after the company reported a larger negative price per share than forecast at the time by analysts, ($0.50) vs ($0.33).
Another challenge for Inovio is advancing the development of INO-4800
Along with its Q1 results, INOVIO announced it will end its Phase III INNOVATE trial of INO-4800, citing a lower global incidence of severe COVID-19 cases—as well as the desire to avoid increasing the trial’s size, and costs. The company also reasons that the heterologous booster market offers it greater opportunities as COVID-19 moves toward an endemic phase.
That’s a contrast to the very early days of the pandemic, when Inovio was considered enough of a COVID-19 vaccine leader to be highlighted on CBS’ “60 Minutes,” where the company showcased its early development work for INO-4800. Also featured in that segment was Moderna and its mRNA vaccine, which went on to receive emergency authorization and eventually, full approval from the FDA.
Inovio paused enrollment in the trial in March, saying at the time it would seek FDA approval to change INNOVATE’s primary endpoint from prevention of virologically confirmed COVID-19 disease to prevention of severe disease due to COVID-19.