AIM ImmunoTech reports IRB go ahead for AMP-511 clinical trial

AIM ImmunoTech Inc. (NYSEMKT:AIM) announced that Institutional Review Board has given its approval for the expansion of the AMP-511 Expanded Access Program clinical trial for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome using Ampligen. The new approval will allow the company to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms.

Under the new trial protocol amendment, out of the 100 active participants, up to 20 participants may be the ‘Long Haulers’. These are the patients who have persistent symptoms. The company is currently working to prepare the protocol for submission to the US FDA. A large number of survivors of the first SARS-CoV-1 epidemic in 2003 kept reporting typical chronic fatigue-like symptoms after recuperating from the acute illness. It is estimated that nearly 27 percent of survivors display chronic fatigue syndrome as per the CDC criteria.

The data has shown that COVID-19 patients may develop a similar illness as exhibited by SARS-CoV-1 patients. AIM CEO Thomas K. Equels states,

“In addition, unpublished data from AIM indicates that ME/CFS patients respond better to Ampligen the earlier they receive the drug, so enrolling ‘Long Haulers’ earlier in their diagnosis could potentially benefit these patients while also providing valuable information for all ME/CFS patients.”

AIM is working on its drug candidate for pancreatic cancer as well. The company reported that it received statistically significant positive survival benefits of using Ampligen for treating locally advanced/metastatic pancreatic cancer after systemic chemotherapy. The overall survival for the experimental group was compared to a large historical control cohort. Median survival was found to be nearly two-fold higher. The program was started in January 2017.

AIM plans to seek Fast Track or Breakthrough designation for the drug candidate from the FDA. It also anticipated getting ND authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial. The company may also file with the European Medicines Agency and the FDA an orphan drug status application for use of Ampligen in the treatment of late-stage pancreatic carcinoma.

AIM ImmunoTech is an immuno-pharma company and is mainly invested in treating different types of cancers, viral diseases, and immune disorders. The company has a robust development pipeline with various drug candidates at different stages. Its main drug candidates are Ampligen and Alferon N Injection. Ampligen sterile solution is already approved for treating severely debilitated patients with chronic fatigue syndrome who have been diagnosed for longer than one year. Alferon N Injection is approved for treating refractory or recurrent external condylomata acuminata. The injection will be launched after receiving the manufacturing approval from the FDA.

Analysis

AIM Ampligen is already approved for ME/CFS, a market of over $5 billion, of which AIM share is anticipated $500 million at 10% penetration. The company has a market capitalization of ~$85 million, with price at $2.08 near low in a 52-week range of $0.38 to $7.11. Over 92% shares are held by the public, over 6% by institutions, and 1.11% by insiders. Wall Street analysts are very bullish with a score of 4.66/5 and a price target of $6.25. Revenue guidance for 2020 and 2021 is $799,000 and $1.52 million, respectively. The company has a debt of $2.34 million and cash reserves of ~$35 million, a runway of about three fiscal years, considering cash burn of $10.9 million and $11.6 million in the last two fiscal years 2018 and 2019, respectively.

Investment Thesis

The company is in position to draw synergy by using Ampligen for a wide array of conditions. The stock has plenty of catalysts coming up to fuel its growth.

Vir Biotechnology reports positive data for VIR-2482 as influenza A treatment

Vir Biotechnology Inc. (NASDAQ:VIR) provided an update for its lead drug candidate VIR-2482 in the prevention of influenza A. The company also provided new health economics outcomes research showing that elderly adults with comorbidities endure more serious effects of influenza.

As per preliminary, blinded pharmacokinetic and safety data from the Phase 1 study, the intramuscular dosing of VIR-2482 was found to be well tolerated in healthy volunteers at doses up to 1,800mg. It also showed a prolonged half-life, which is conducive to once-per-season dosing. Preclinical data also showed that the drug candidate has broad binding and neutralizing potential against all major strains of influenza A. VIR-2482 also significantly decreased morbidity and averted mortality in mouse models when it was administered prophylactically 24 hours prior to lethal doses of influenza.

Phil Pang, M.D., Ph.D., chief medical officer of Vir Biotechnology said,

“The data also suggest that VIR-2482, because of its broad influenza A strain coverage, potency and prolonged half-life, has the potential to be the first neutralizing monoclonal antibody to address this large unmet need.”

VIR-2482 is an intramuscularly administered influenza A-neutralizing monoclonal antibody. Previous data has shown that its in vitro application may cover all major strains of influenza A that have arisen since the 1918 Spanish influenza pandemic. The drug candidate also does not depend upon an individual to develop their own antibody response. It has been half-life engineered.

Analysis

Vir is targeting a global influenza market that was $3.96 billion in 2018 and is estimated to reach $6.20 billion by 2026 at a CAGR of 5.9%. Vir has a market capitalization of $4.39 billion, with stock priced at $37.27, midway of the 52-week range between $11.65 and $75. About 32% of shares are held by institutions, over 40% by PE/VC firms, over 20% by the public & public corporate and 7.58% by insiders. Wall Street analysts are bullish with an average score of 3.75/5 and a price target of $55. While the company's cash burn in 2019 was $37.6 million, it was $136.2 million in the TTM. Debt of ~$17 million and cash reserves of ~$552 million suggest a cash runway of at least three years. Vir's revenue guidance for 2020 and 2021 is ~$114 million and ~$142 million, respectively.

Investment Thesis

While the company has a strong development pipeline, the stock is likely to benefit from its COVID-19 project. However, there may be a temporary negative impact of study halt for AAT Study.

CRISPR Therapeutics reports positive CARBON trial for CD19+ B-cell Malignancies

CRISPR Therapeutics (NASDAQ:CRSP) reported positive topline data from its CARBON trial. The study is designed to assess the safety and efficacy of CTX110 for treating relapsed or refractory CD19+ B-cell malignancies.

The CARBON trial is an open-label, multicenter study. It recruited patients with relapsed or refractory non-Hodgkin lymphoma who have received at least two prior lines of therapy. Patients were given CTX110 following three days of lymphodepletion using fludarabine and cyclophosphamide. The primary endpoints of the study included safety and overall response rate, whereas key secondary endpoints included progression-free survival, overall survival, and duration of response.

At dose levels 1 to 3, no DLTs were reported. However, three patients reported Cytokine Release Syndrome, which was Grade 2 or below and was resolved with the aid of tocilizumab. For dose level 4, the patient achieved a complete response as demonstrated by the PET/CT assessment. However, the patient died 52 days after CTX110 infusion.

For dose levels 2, 3 and 4, complete response was achieved. The four patients with CR showed deep responses such as the complete resolution of extranodal disease, a Deauville score of 2 or lower and normalization of all nodal disease to 1.5 cm or smaller.

CRISPR Therapeutics is the sponsor of the CARBON trial. The company has a robust portfolio of development programs spanning hemoglobinopathies, oncology, regenerative medicine, and rare diseases.

Analysis

CRISPR's candidate is targeting a global non-Hodgkin lymphoma market of ~$6.1 billion in 2019, estimated to reach ~$9.2 billion by 2025 at a CAGR of 6.87%. The company has a market capitalization of $6.47 billion at a price of $90.16 per share, near a 52-week high of $111.9. Wall Street analysts are bullish at an average score of 3.94/5 and a price target of $102.93. While the company earned revenue of ~$290 million in 2019, there is less than $10 million revenue guidance for 2020 and 2021, respectively. The company's debt is $50.22 million, and cash reserves are $945.07 million. The cash burn in fiscal 2019 was $63.5 million, while the TTM burn is $73.7 million.

Investment Thesis

The company has hit a roadblock with the death of one study participant. Any dip in the stock may be used for building long-term position.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.



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