Summary:
CVM reported its long-awaited Phase 3 results from its head & neck cancer trial for its immuno-therapy agent, Multikine, on June 29, 2021
The company press release had a "positive" tone, but the market reacted very negatively
Investors reacted negatively because the trial missed its primary endpoint
The company has taken a positive public view of the data based on analysis of certain subgroups and plans to present this data to investors on July 1, 2021
For more details on this positive subgroup analysis, why the market reacted negatively to it, and what we are looking for at tomorrow's investor conference, AND POST-CALL COMMENTS ADDED ON 7/1 AFTER THE INVESTOR CALL, read our full article HERE, after signing up (locks in our current introductory pricing). Learn more here. Plus, we disclose another immuno-oncology company with an upcoming readout that shares a lot of similarities to the recent CVM readout.
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CVM's long-awaited Phase 3 head and neck cancer readout for its immuno-oncology agent, Multikine, read out on June 29, 2021: "CEL-SCI’s Multikine® Immunotherapy Produces Significant 14.1% 5-Year Survival Benefit (62.7% Vs 48.6%) in the Group Receiving Surgery Plus Radiotherapy in a Landmark Head and Neck Cancer Phase 3 Study". Although the press release had a positive tone, the market reaction and primary readout were negative. Given the history of CVM, this trial, and the relationship between CVM and the biotech investment community and media, it should come as no surprise that this readout created a huge uproar (See e.g., FIG. 1). And CVM's CEO has engaged in some of the back and forth (See e.g., FIG. 2).
FIG.1 Adam Feuerstein tweet from 6/28/21
FIG. 2 Geert Kersten (CVM CEO) tweet from 6/28/21
As we pointed out in our subscriber post from May 17, 2021, with detailed facts, there are a lot yellow/red flags swirling around this CVM trial. And there are a lot of prior negative articles on the trial from STAT news/Adam Feuerstein (See this 5/17/21 article here and this 5/5/21 STAT article here) and others (e.g., see this previous Seeking Alpha article). Ahead of tomorrow's announced investor call to share the data that was announced last week, we provide further information to try to help investors to make decisions given this complex situation.
Now that we have the actual June 29, 2021 data readout in hand, we are challenged with the task of trying to understand it and use as the basis for investing decisions. In our subscriber post from May 17, 2021, we concluded the following with respect to this catalyst readout: "From an investment standpoint, we find way too many yellow/red flags on CVM and this trial to buy CVM stock or make any other bullish investment in this company." The press release and the resulting media backlash highlights the challenges faced by retail biotech investors, as we discussed in the above forum post and our prior free blog post on the CVM readout: "As investors we are often caught in the middle of CEOs, who by their job description are excellent salespeople for their company. And journalists, who make a living on hyping up issues." Thus, although CVM may be an extreme example, it is common to read a "positive" clinical trial readout press release, only to find that the key predefined endpoints were missed. Furthermore, the CVM readout highlights another huge challenge for biotech investors: We need to understand complex diseases and data readouts, or have consultants/friends/advisors we can trust to understand and explain these to us, which unfortunately, in many situations is incomplete.
Why did investors react negatively to the CVM data readout?
Despite the positive headline: "CEL-SCI’s Multikine® Immunotherapy Produces Significant 14.1% 5-Year Survival Benefit (62.7% Vs 48.6%) in the Group Receiving Surgery Plus Radiotherapy in a Landmark Head and Neck Cancer Phase 3 Study, the study did NOT meet its predefined primary endpoint.
This is evidenced by a a very important sentence that is pretty deep in the press release (probably should have been a headline bullet point in the PR):
"When the complete study population to which the Multikine treatment regimen was administered (i.e., the combined lower risk (no chemotherapy) and higher risk (with chemotherapy added)) was compared to control, the study did not achieve its primary endpoint of a 10% improvement in overall survival."
How could CVM put a positive spin on negative data?
The press release indicates that the trial is positive because of the following:
"Patients treated with the Multikine treatment regimen followed by surgery and radiotherapy (no chemotherapy) demonstrated statistically significant OS (ITT, p=0.0236, HR= 0.68) advantage vs. Standard of Care (SOC) alone; the 3-year survival advantage was 4.9% (72.4% vs 67.5%) and the 5-year survival advantage was 14.1% (62.7% vs 48.6%) for the pre-defined population receiving no chemotherapy."
Doesn't that positive subpopulation result warrant a positive reaction from investors?
To get our detailed answer to this, why the market reacted negatively to it, what we are looking for at tomorrow's investor conference, AND POST-INVESTOR CALL COMMENTS ADDED 7/1 AFTER THE CALL, read our full article HERE, after signing up (locks in our current introductory pricing). Learn more here. Plus, we disclose another immuno-oncology company with an upcoming readout that shares a lot of similarities to the recent CVM readout.
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Article history:
6/30 initial published at ~ 10PM Central
6/30 updated to provide info re: tomorrow's call ~11:35PM Central 7/1 added comment re: post call comments in forum post for subscribers - 10:25 AM
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