Item
1.01 Entry into a Material Definitive Agreement.
On January 29, 2021, AIkido
Pharma, Inc. (the “Company”) purchased an 8% convertible promissory note (“Convertible Note”) issued by
Convergent Therapeutics, Inc. (“Convergent”) with a principal amount of $2 million pursuant to a Note Purchase Agreement
with Convergent. The Company paid a purchase price for the Convertible Note of $2 million. The Company will receive interest on
the Convertible Note at the rate of 8% per annum payable upon conversion or maturity of the Convertible Note.
The Convertible Note matures
after January 28, 2023 upon demand of a majority of the holders of the Convertible Notes. Prior to maturity, in the event that
Convergent undertakes a Qualified Financing (as defined in the Convertible Note), the Promissory Note will automatically convert
into the securities offered in the Qualified Offering (anticipated to be preferred equity) but at a conversion rate equal to the
lesser of 80% of the price paid by other investors for such securities in the Qualified Offering and the conversion rate determined
by dividing the outstanding principal of the Promissory Note by the number of shares of Convergent outstanding on a fully diluted
basis immediately prior to such Dilutive Issuance (the latter, the “Capped Conversion Ratio”). Additionally, in the
event of a change of control of Convergent the Company will have the right to accelerate the payment obligations under the Promissory
Note or convert into equity of Convergent at the Capped Conversion Ratio.
Additionally, the Convertible
Note contains standard and customary events of default that allows a majority of the holders of a outstanding Promissory
Notes to accelerate the payment obligations of Convergent under the Promissory Note.
The foregoing description
of the Agreement and Convertible Note is a summary and is qualified in its entirety by reference to the full Agreement and Convertible
Note, which are attached as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K.
About
Convergent
Convergent
has exclusive rights to technology related to next
generation radiopharmaceutical therapy for prostate cancer that is covered by multiple issued
U.S. and foreign patents. Convergent is currently conducting advanced human trials relating to prostate cancer treatments
involving peptide receptor radionuclide therapy (“PRRT”) that targets the prostate-specific membrane antigen (“PSMA”)
present on prostate cancer cells. The technology was developed under the direction of Dr. Neil Bander, Professor of Urologic Oncology
at Weill Cornell Medicine.
The
key component of Convergent’s PRRT prostate cancer therapy is its proprietary drug, CONV 01-α, a monoclonal antibody
conjugated with 225Ac, a radioactive alpha particle emitter. The function of CONV 01-α is unique in that it not
only binds specifically to the PSMA receptor on prostate cancer cells, but also stimulates the internalization of the receptor
along with itself and its powerful radioactive payload directly into tumor cells. Convergent is presently conducting two sets
of human clinical trials using CONV 01-α as a single agent treatment for prostate cancer. The first is a Phase 1a/2a Single
Ascending Dose Trial of CONV 01-α and the results are expected to be released in Q2 2021. In August of 2020, Convergent
began a second Phase 1b/2a trial to test the efficacy of multiple ascending doses of CONV 01-α. If FDA approved, CONV 01-α
would be the first antibody drug approved to direct a radioisotope into prostate cancer cells, and the first drug approved for
the use of 225Ac in cancer treatment.
Leveraging
the ability of CONV 01-α to internalize the PSMA receptor along with molecules bound to it, Convergent has also developed
a proprietary dual therapy by adding a second molecule that specifically binds to PSMA and also contains a radioactive isotope.
Convergent has identified certain small molecules that bind to PSMA, but at a different epitope than does CONV 01-α, and
therefore do not interfere with the binding of CONV 01-α or its ability to internalize PSMA. The result is that two different
radioactive drugs are internalized directly into prostate cancer cells. Importantly, Convergent identified small molecules, with
a current focus on the molecule PSMA I&T, that have different biodistributions in the body than does CONV 01-α, so as
to reduce additive damage from using two radioactive agents. PSMA I&T is a molecule routinely used clinically to perform imaging
to show the presence and distribution of PSMA in a prostate cancer patient. Preliminary animal data using this proprietary dual
action PRRT indicate that the two molecules administered together act in a truly synergistic fashion, i.e., the effect
of using both drugs together is significantly higher than the expected additive effects of using each separately.
Convergent
now has approval to begin human trials using CONV 01-α and PSMA I&T in a dual therapy, which are anticipated to begin
in February of 2021. In these trials, Convergent will test PSMA I&T containing either 177Lu, a beta particle emitter,
or 225Ac, the same alpha emitter in CONV 01-α. Convergent has approval to perform the three human trials listed
below for this dual therapy, anticipated to begin in February of 2021:
(1)
a Phase 1b/2a with the combination of CONV 01-α and PSMA I&T-β;
(2)
a Phase 2b with the combination of PSMA I&T-β ± CONV 01-α, and
(3)
a Phase 1b/2a with PSMA I&T-α ± CONV 01-α (i.e., both drugs with 225Ac, the α-particle
emitter).
Another
company is currently studying PSMA I&T-β, containing 177Lu, and has just completed a phase 3 trial in prostate
cancer. Separately, Novartis is pursuing FDA approval for another 177Lu-small molecule drug for prostate cancer treatment,
designated 177Lu-PSMA-617, which also binds PSMA. Novartis has recently completed a phase 3 registration trial for
treatment of metastatic castration-resistant prostate cancer (mCRPC), a form of advanced prostate cancer. Like PSMA I&T-β,
Novartis’s 177Lu-PSMA-617 may also be a promising candidate for use with CONV 01-α in the proprietary dual
PRRT therapy.