ARAVIVE, INC. Item 1.01 Entry into a Material Definitive Agreement.
Investment Agreement
On
Pursuant to the Investment Agreement, the Investor agreed to purchase a
pre-funded warrant (the "Pre-Funded Warrant") to purchase up to 4,545,455 shares
(the "Warrant Shares", and collectively with the Pre-Funded Warrant, the
"
Pursuant to the Investment Agreement, the Company is obligated to hold an annual
or special meeting of stockholders (the "Stockholder Meeting") for the purpose
of obtaining the Requisite Stockholder Approval (as defined below). The
Stockholder Meeting shall be held no later than one-hundred and twenty (120)
days following the date of Investment Agreement (one hundred and fifty days
(150) if the
In addition, pursuant to the Investment Agreement, the Investor has agreed not
to transfer the
The Investment Agreement contains representations and warranties of the parties customary for transactions of this type.
The foregoing description of the Investment Agreement does not purport to be complete and is qualified in its entirety by reference to the Investment Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The representations and warranties contained in the Investment Agreement were made solely for the benefit of the parties to the Investment Agreement. In addition, such representations and warranties (i) are intended not as statements of fact, but rather as a way of allocating the risk between the parties to the Investment Agreement; (ii) have been qualified by reference to confidential disclosures made by the parties in connection with the Investment Agreement; and (iii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Investment Agreement is included with this filing only to provide investors with information regarding the terms of the Investment Agreement, and not to provide investors with any other factual information regarding the Company or its business. Stockholders should not rely on the representations and warranties or any descriptions thereof as characterizations . . .
Item 3.02 Unregistered Sales of
Pursuant to the Investment Agreement described in Item 1.01 of this Current
Report on Form 8-K, which description is incorporated herein by reference, on
The issuance and sale of the
4
--------------------------------------------------------------------------------Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On
Item 7.01 Regulation FD Disclosure
The Company will be making several presentations to investors over the next several weeks. In connection with the presentations, the Company intends to discuss the updated corporate presentation, which is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The presentation contains certain updated renal data, including the following:
? A total of 26 patients with 2L+ clear cell renal cell cancer have been dosed
with batiraxcept + cabozantinib. 16 patients have been dosed with 15mg/kg
batiraxcept and 10 patients have been dosed with 20mg/kg batiraxcept.
o The safety profile of batiraxcept + cabozantinib is consistent with the
established safety profile for cabozantinib. The one adverse effect that is
related to batiraxcept is infusion-related reactions. This adverse effect is
managed by a premedication regimen.
? 23 patients have had at least one CT scan: 15 patients who received 15mg/kg
batiraxcept + cabozantinib and 8 patients who received 20mg/kg batiraxcept +
cabozantinib.
o 9/23 (39%) had a partial response
o 14/23 (61%) had stable disease; 11 out of 14 (79%) patients with stable
disease demonstrated decrease from baseline tumor size
o No patient progressed at the first CT scan
? 13 patients have had at least 16 weeks of follow up and, thus, have been on
study long enough to have at least 2 CT scans.
o 6/13 (46%) had confirmed partial responses
o 6/13 (46%) had confirmed stable disease; 1/13 (8%) had stable disease on the
first CT scan and progressed at the second CT scan
5--------------------------------------------------------------------------------
New data from the study testing 15mg/kg batiraxcept + gemcitabine + nab-paclitaxel in patients with advanced or metastatic pancreatic adenocarcinoma eligible to receive gemcitabine + nab-paclitaxel as first-line treatment:
? 6 patients have had at least one CT scan on study: o 3/6 (50%) had a partial response o 2/6 (33%) had a stable disease o 1/6 (16.7%) progressed at the first scan
The information in this Item 7.01, and in the investor presentation furnished as
Exhibit 99.2 to this Current Report on Form 8-K shall not be deemed to be
"filed" for purposes of Section 18 of the Exchange Act or otherwise subject to
the liabilities of that section or Sections 11 and 12(a)(2) of the Securities
Act and shall not be incorporated by reference into any filing with the
Item 8.01 Other Matters.
On
The Company has updated its corporate presentation to include updated renal data and new data from the study testing 15mg/kg batiraxcept + gemcitabine + nab-paclitaxel in patients with advanced or metastatic pancreatic adenocarcinoma eligible to receive gemcitabine + nab-paclitaxel as first-line treatment set forth below.
The following is certain updated renal data:
? A total of 26 patients with 2L+ clear cell renal cell cancer have been dosed
with batiraxcept + cabozantinib. 16 patients have been dosed with 15mg/kg
batiraxcept and 10 patients have been dosed with 20mg/kg batiraxcept.
o The safety profile of batiraxcept + cabozantinib is consistent with the
established safety profile for cabozantinib. The one adverse effect that is
related to batiraxcept is infusion-related reactions. This adverse effect is
managed by a premedication regimen.
? 23 patients have had at least one CT scan: 15 patients who received 15mg/kg
batiraxcept + cabozantinib and 8 patients who received 20mg/kg batiraxcept +
cabozantinib.
o 9/23 (39%) had a partial response
o 14/23 (61%) had stable disease; 11 out of 14 (79%) patients with stable
disease demonstrated decrease from baseline tumor size
o No patient progressed at the first CT scan
? 13 patients have had at least 16 weeks of follow up and, thus, have been on
study long enough to have at least 2 CT scans.
o 6/13 (46%) had confirmed partial responses
o 6/13 (46%) had confirmed stable disease; 1/13 (8%) had stable disease on the
first CT scan and progressed at the second CT scan
New data from the study testing 15mg/kg batiraxcept + gemcitabine + nab-paclitaxel in patients with advanced or metastatic pancreatic adenocarcinoma eligible to receive gemcitabine + nab-paclitaxel as first-line treatment:
? 6 patients have had at least one CT scan on study: o 3/6 (50%) had a partial response o 2/6 (33%) had a stable disease o 1/6 (16.7%) progressed at the first scan
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number Description 4.1 Form of Pre-Funded Common Stock Purchase Warrant ofAravive, Inc. 10.1 Investment Agreement, dated as ofJanuary 3, 2022 , by and amongAravive, Inc. ,Eshelman Ventures, LLC , and solely for purposes of Article IV and V of the Investment Agreement,Fredric N. Eshelman , Pharm.D. 99.1 Press release issued byAravive, Inc. onJanuary 3, 2022 . 99.2 Corporate Presentation datedJanuary 2022 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). 6
--------------------------------------------------------------------------------
© Edgar Online, source
