As filed with the Securities and Exchange Commission on December
20, 2017
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
______________________________
FORM S-8
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
______________________________
MABVAX THERAPEUTICS HOLDINGS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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93-0987903
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(State
or Other
Jurisdiction
of Incorporation or Organization)
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(IRS
Employer
Identification
No.)
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11535 Sorrento Valley Road, Suite 400
San Diego, CA
(Address
of Principal Executive Offices)
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92121
(Zip
Code)
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FIFTH AMENDED AND RESTATED MABVAX THERAPEUTICS HOLDINGS,
INC.
2014 EMPLOYEE, DIRECTOR AND CONSULTANT EQUITY INCENTIVE
PLAN
(Full
Titles of the Plans)
J. David Hansen
Chief Executive Officer
MabVax Therapeutics Holdings, Inc.
11535 Sorrento Valley Road, Suite 400
San Diego, CA 92121
(Name
and Address of Agent for Service)
(858) 259-9405
(Telephone
Number, Including Area Code, of Agent for Service)
______________________________
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange
Act.
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Large
accelerated filer
☐
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Accelerated
filer
☐
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Non-accelerated
filer
(Do not
check if a smaller reporting company)
☐
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Smaller
reporting company
☒
Emerging
growth company
☒
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.
☐
Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes
☐
No
☒
______________________________
CALCULATION OF REGISTRATION FEE
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Title
of Securities
to
be Registered
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Amount to be Registered (1)
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Proposed
Maximum Aggregate
Offering Price (2)
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Amount of Registration
Fee (3)
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Common Stock, par
value $0.01 per share
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8,998,569
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$
0.835
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$
7,513,805
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$
935.47
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(1)
The number of
shares of common stock, par value $0.01 per share, of MabVax
Therapeutics Holdings, Inc., or the Registrant, stated above
consists of the number of additional shares which may be issued
under the Fifth Amended and Restated MabVax Therapeutics Holdings,
Inc. 2014 Employee, Director and Consultant Equity Incentive Plan,
or the 2014 Plan, that have not been previously registered. In
addition, pursuant to Rule 416(c) under the Securities Act of 1933,
as amended, or the Securities Act, this Registration Statement also
covers an indeterminate amount of interests to be offered or sold
pursuant to the employee benefit plan described
herein.
(2)
Estimated solely
for the purpose of calculating the amount of the registration fee
pursuant to Rules 457(c) and 457(h) promulgated under the
Securities Act. The offering price per share and the aggregate
offering price for shares reserved for future grant or issuance
under the 2014 Plan on the basis of the average of the high and low
sale prices of the Common Stock as reported on the NASDAQ Capital
Market as of a date (December 20, 2017) within five business days
prior to filing this Registration Statement.
(3)
Calculated pursuant
to Section 6(b) of the Securities Act.
EXPLANATORY NOTE
This registration statement on Form S-8 (the
“Registration Statement”) relates to an
additional
8,998,569
shares of
common stock, par value $0.01 per share (the “Common
Stock”) of MabVax Therapeutics Holdings, Inc. (the
“Registrant,” the “Company,”
“we,” “us” or “our”), which are
issuable pursuant to, or upon exercise of, awards that have been
granted or may be granted under our
MabVax Therapeutics
Holdings, Inc. 2014 Employee, Director and Consultant Equity
Incentive Plan
(as amended and
restated to date, the “Plan”).
Under the Plan, a total of
10,128,406 shares of Common Stock have been reserved for issuance
upon the grant of awards and exercise of options to officers,
directors, employees and consultants of the
Company.
The Registrant previously filed a Registration
Statement on Form S-8 to register
1,129,837
shares of Common Stock (File No.
333-
203200
), filed on April 2,
2015, authorized for issuance under the Plan. All applicable share
amounts reflect a 1-for-7.4 reverse split of the Registrant’s
Common Stock effected on August 16, 2016. Pursuant to General
Instruction E to Form S-8, Part I and Items 4-7 and 9 of Part II of
the Registrant's Registration Statement on Form S-8 (File No.
333-
203200
) are incorporated
herein by reference except to the extent supplemented, amended or
superseded by the information set forth herein. Only those items of
Form S-8 containing new information not contained in the earlier
registration statement are presented herein.
This
Registration Statement also includes a reoffer prospectus prepared
in accordance with General Instruction C of Form S-8 and in
accordance with the requirements of Part I of Form S-3, to be used
in connection with resales of securities registered hereunder by
selling stockholders (the “Selling Stockholders”), some
of whom may be considered affiliates of the Company, as defined in
Rule 405 under the Securities Act of 1933, as amended (the
“Securities Act”). The Selling Stockholders may be
selling up to an aggregate of 3,154,548 shares of common stock that
constitute “restricted securities” which have been
issued by the Registrant pursuant to the Plan, prior to the filing
of this Registration Statement.
REOFFER PROSPECTUS
3,154,548 Shares of Common Stock
This reoffer prospectus relates to 3,154,548
shares of common stock, $0.01 par value per share, of MabVax
Therapeutics Holdings, Inc. (“MabVax,” the
“Company,” “we”, “us” or
“our”) that may be offered and resold from time to time
by the selling stockholders identified in this prospectus (the
“Selling Stockholders”) for their own account. The
Selling Stockholders were issued restricted stock grants, options
to purchase shares of our common stock and other awards pursuant to
the Fifth Amended and Restated
MabVax Therapeutics Holdings,
Inc. 2014 Employee, Director and Consultant Equity Incentive Plan
(as amended, the “Plan”).
It is anticipated that the Selling Stockholders will offer the
common stock for sale at prevailing prices on the NASDAQ Capital
Market on the date of sale. We will receive no part of the proceeds
from sales made under this reoffer prospectus. The Selling
Stockholders will bear all sales commissions and similar expenses.
Any other expenses incurred by us in connection with the
registration and offering and not borne by the Selling Stockholders
will be borne by us.
The
Plan authorizes the issuance of up to 10,128,406 shares of our
common stock to officers, directors, employees and consultants of
the Company. This reoffer prospectus has been prepared for the
purposes of registering the common stock (including the common
stock issuable upon exercise of the options) under the Securities
Act to allow for future sales by the Selling Stockholders on a
continuous or delayed basis to the public without
restriction.
The
Selling Stockholders and any brokers executing selling orders on
their behalf may be deemed to be “underwriters” within
the meaning of the Securities Act, in which event commissions
received by such brokers may be deemed to be underwriting
commissions under the Securities Act.
Our
common stock is traded on the NASDAQ Capital Market under the
symbol “MBVX”. On December 20, 2017, the closing price
of our common stock on such market was $0.83 per
share.
Investing in our common stock involves risks. See “Risk
Factors” on page 6 of this reoffer prospectus. These are
speculative securities.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE
SECURITIES OR PASSED UPON THE ACCURACY OR ADEQUACY OF THIS
PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENCE.
The date of this prospectus is December 20, 2017.
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NO
PERSON HAS BEEN AUTHORIZED TO GIVE ANY INFORMATION OR TO MAKE ANY
REPRESENTATIONS, OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS, IN
CONNECTION WITH THE OFFERING MADE HEREBY, AND, IF GIVEN OR MADE,
SUCH INFORMATION OR REPRESENTATION MUST NOT BE RELIED UPON AS
HAVING BEEN AUTHORIZED BY THE COMPANY OR ANY OTHER PERSON. NEITHER
THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL
UNDER ANY CIRCUMSTANCES CREATE ANY IMPLICATION THAT THERE HAS BEEN
NO CHANGE IN THE AFFAIRS OF THE COMPANY SINCE THE DATE HEREOF. THIS
PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION
OF AN OFFER TO BUY ANY SECURITIES OFFERED HEREBY BY ANYONE IN ANY
JURISDICTION IN WHICH SUCH OFFER OR SOLICITATION IS NOT AUTHORIZED
OR IN WHICH THE PERSON MAKING SUCH OFFER OR SOLICITATION IS NOT
QUALIFIED TO DO SO OR TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE
SUCH OFFER OR SOLICITATION.
PROSPEC
T
US
SUMMARY
The
following summary highlights selected information contained in this
prospectus. This summary does not contain all the information you
should consider before investing in the securities. Before making
an investment decision, you should read the entire prospectus
carefully, including the section entitled “Risk
Factors” before deciding to invest in our common stock. In
this prospectus, unless otherwise noted, “MabVax,”
“Company,” “we,” “us,” and
“our” refer to MabVax Therapeutics Holdings,
Inc.
Company Background
We are a Delaware corporation, originally
incorporated in 1988 under the name Terrapin Diagnostics, Inc. in
the state of Delaware, and subsequently renamed “Telik,
Inc.” in 1998, and thereafter renamed MabVax Therapeutics
Holdings, Inc. in September 2014. Our principal corporate office is
located at 11535 Sorrento Valley Road, Suite 400, San Diego, CA
92121 and our telephone number is (858) 259-9405. On July 8, 2014,
we consummated a merger with MabVax Therapeutics, pursuant to which
our subsidiary Tacoma Acquisition Corp. merged with and into MabVax
Therapeutics, with MabVax Therapeutics surviving as our wholly
owned subsidiary. Our internet address is
www.mabvax.com
.
Information on our website is not incorporated into this
prospectus.
Business Overview
We
are a clinical-stage biotechnology company focused on the
development of antibody-based products to address unmet medical
needs in the treatment of cancer. MabVax has discovered a
pipeline of human monoclonal antibody products based on the
protective immune responses generated by patients who have been
vaccinated against targeted cancers with our proprietary
vaccines. MabVax's lead development program is centered
around our HuMab-5B1 antibody, which is fully human and discovered
from the immune response of cancer patients vaccinated with an
antigen-specific vaccine during a Phase I trial at Memorial Sloan
Kettering Cancer Center, or MSK. The antigen the
antibody targets is expressed on more than 90% of pancreatic
cancers, and expressed in significant percentages on small cell
lung cancer, stomach, colon and other cancers, making the antibody
potentially broadly applicable to many types of cancers. We
have other antibody candidates that are in preclinical
development.
Monoclonal
antibodies are produced from a single DNA sequence encoded into
multiple cells that all produce the same single antibody. We
generate our pipeline of antibody-based product candidates from
patients who have been vaccinated with proprietary vaccines
licensed from MSK. Our approach involves surveying the protective
immune response from many patients to identify a monoclonal
antibody candidate against a specific target on the surface of a
cancer cell. We believe this approach provides us with a novel
next-generation human antibody technology platform. We believe our
approach to antibody discovery allows us to identify antibody
candidates with superior performance characteristics while
minimizing many of the toxicity and off target binding drawbacks
(phenomenon occurring when antibodies bind to non-cancer cells) of
other discovery technologies.
Our
lead clinical development program is a Phase 1 clinical trial of
our HuMab-5B1 radioimmunotherapy (“RIT”) product that
we have designated as MVT-1075. The development of MVT-1075 is
based on experience we gained through clinical studies of over 50
patients with either our antibody we designate as MVT-5873, or our
imaging agent we designate as MVT-2163 that are discussed in more
detail in our descriptions and results to date of our clinical
development programs. We initiated the Phase 1 clinical trial of
MVT-1075 in June 2017 and completed enrollment and dosing of
the last patient in the initial cohort of patients in December
2017. The clinical program is intended to evaluate the product for
the treatment of pancreatic, colon and lung cancer. The primary
objective is to determine the maximum tolerated dose in patients
who have failed prior therapies. Secondary endpoints include
evaluating tumor response rate and duration of response by RECIST
1.1, and to determine dosimetry and pharmacokinetics. This
dose-escalation study utilizes a traditional 3+3 design. We
expect to receive and report on interim safety data and tumor
assessment using standard RECIST measurement criteria for cohort 1
in the first quarter 2018.
We
also intend to continue clinical development of the antibody
MVT-5873 in combination with gemcitabine and nab-paclitaxal in
first line therapy for the treatment of patients newly diagnosed
with pancreatic cancer. We have treated two cohorts of patients in
our combination therapy, for a total of six patients to date in
this study. In December 2017, we completed enrollment of an
additional cohort of three patients in the combination therapy with
the objective of confirming early observations. We expect to
receive and report on interim response data for the latest cohort
in the first quarter of 2018.
On
September 6, 2017, we announced that we have engaged Greenhill
& Co. (NYSE: GHL) to serve as a financial advisor to assist us
in exploring and evaluating strategic options with the goal of
maximizing stockholder value. We have received and are evaluating
several inbound inquiries and transaction options, as well as
identifying new opportunities which could include the acquisition
of MabVax by another company, the sale or divestiture of specific
assets coupled with a reverse merger, merging with another company,
or licensing of selected technologies. We do not have a defined
timeline for the exploration of strategic alternatives, as we are
still receiving inquiries, and are not confirming that the
evaluation will result in any strategic alternative being announced
or consummated. We do not intend to discuss or disclose
further developments during this process unless and until our Board
of Directors has approved a specific action or otherwise determined
that further disclosure is appropriate. While Greenhill & Co.
continues as our financial advisor, we will continue to advance our
Phase 1 clinical programs including our MVT-1075 radioimmunotherapy
clinical trial for the treatment of pancreatic, colon and lung
cancers, and our MVT-5873 clinical trial in combination with one or
more chemotherapy agents in first line therapy for patients newly
diagnosed with pancreatic cancer.
Our Growth and Core Business Strategy
Our
primary business strategy is to develop our early antibody product
candidates through proof of concept clinical trials, which may
represent either phase I or phase II clinical trials depending on
the program and extent of progress. Once through proof of concept
clinical trials, we will decide whether to license, partner or sell
those product candidates, or continue to develop the candidates
depending on several variables such as access to additional
capital, cost of later stage clinical trials, risk of such
development efforts, and the value derived from licensing,
partnering or selling those assets.
Our Clinical Development Programs
MVT-1075 – our lead development program as a
Radioimmunotherapy for Pancreatic Cancer
In
June 2017, we initiated a Phase 1 clinical trial of our HuMab-5B1
radioimmunotherapy product MVT-1075 based on experience we gained
through clinical studies of over 50 patients with either the
antibody MVT-5873, or our imaging agent we designate as
MVT-2163.
MVT-1075
combines the demonstrated targeting specificity of the HuMab-5B1
antibody with the proven clinical success of a low-energy radiation
emitter, 177Lutetium [177Lu]. We dosed MVT-1075 in our first
patient in June 2017 and completed enrollment of the initial cohort
in December 2017. This Phase 1 first-in-human clinical trial is an
open-label, multi-center study evaluating the safety and efficacy
of MVT-1075 in up to 22 patients with CA19-9 positive malignancies.
The primary objective is to determine the maximum tolerated dose
and safety profile in patients with recurring disease who have
failed prior therapies. Secondary endpoints are to evaluate tumor
response rate and duration of response by RECIST 1.1, and to
determine dosimetry and pharmacokinetics. This dose-escalation
study utilizes a traditional 3+3 design that is commonly used by
companies as a dose escalation strategy typical for phase I trials
for the treatment of cancer. The investigative sites are Honor
Health in Scottsdale, Arizona, and Memorial Sloan Kettering Cancer
Center in New York City.
In
April, the Company reported preclinical results for MVT-1075 at the
American Association of Clinical Research (AACR) Annual Meeting,
demonstrating suppression, and in some instances, regression, of
tumor growth in xenograft animal models of pancreatic cancer,
potentially making this product an important new therapeutic agent
in the treatment of pancreatic, colon and lung cancers. Supporting
the MVT-1075 RIT clinical investigation are the Company's
successful MVT-5873 and MVT-2163 Phase 1a safety and target
specificity data which were reported earlier this year at the
annual meetings of the American Society for Clinical Oncology
(ASCO) and the Society for Nuclear Medicine and Molecular Imaging
(SNMMI), respectively. The combined results from 50 patients in the
Phase 1 MVT-5873 and MVT-2163 studies established safety and
provided significant insight into drug biodistribution and an
optimal dosing strategy, which the Company has incorporated into
the MVT-1075 program.
MVT-5873 – for the Treatment of Pancreatic
Cancer
MVT-5873 as a Monotherapy in
Late Stage Cancer Patients
– We reported results from our Phase
1a clinical trial of 32 patients being treated with our therapeutic
antibody MVT-5873 as a monotherapy, which was evaluated for
safety and tolerability in patients with advanced pancreatic cancer
and other CA19-9 positive cancers, in a poster presentation at the
American Society of Clinical Oncology (ASCO) Annual Meeting on June
3, 2017. The Company highlighted that the single agent MVT-5837
appears safe and well tolerated in patients at biologically active
doses. Furthermore, all patients were evaluated by RECIST 1.1 for
tumor response, and the Company reported 11 patients achieved
stable disease in this dose escalation safety trial of 32
patients.
The
results of the Phase 1a trial with MVT-5873 indicate that this
fully-human antibody targeting CA19-9 cancers can be administered
at doses with acceptable safety and with a potentially positive
impact on disease. CA19-9 is broadly expressed in various cancers
including pancreatic, colon, and small cell lung cancer making this
antibody potentially useful for a larger patient population.
Clinical signals from an identifiable subset of subjects enabled us
to understand those patients most likely to respond to a MVT-5873
based therapy. At the maximum tolerated dose (MTD) established in
this trial, we have demonstrated an acceptable safety margin for
the antibody.
MVT-5873 in Combination with a
Standard of Care Chemotherapy
– Based upon observations from the
first two cohorts of patients treated, the Company is continuing
clinical development of MVT-5873 in combination with gemcitabine
and nab-paclitaxal as a first line therapy for the treatment of
patients newly diagnosed with pancreatic cancer. MabVax had treated
six patients as of October 12, 2017 and in December 2017 completed
enrollment of an expanded cohort of an additional three patients
with the objective of obtaining additional safety and tumor
response (RECIST 1.1) data. Dr. Eileen O’Reilly,
Associate Director of the David M. Rubenstein Center for Pancreatic
Cancer Research, attending physician, member at Memorial Sloan
Kettering Cancer Center and Professor of Medicine at Weill Cornell
Medical College, is the lead investigator in the MVT-5873 Phase 1
clinical trial.
MVT-2163 – as an Imaging Agent for Pancreatic
Cancer
We
reported results from our Phase 1a clinical trial of ImmunoPET
imaging agent, MVT-2163, in 12 patients with locally advanced or
metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9
positive malignancies in a poster presentation and podium talk at
the Society of Nuclear Medicine and Molecular Imaging (SNMMI)
Annual Meeting held in Denver, CO on June 10-14, 2017.
The
Phase Ia clinical trial of MVT-2163 phase I trial was intended to
evaluate our next generation diagnostic PET imaging agent in
patients with locally advanced or metastatic adenocarcinoma of the
pancreas (PDAC) or other CA19-9 positive malignancies. MVT-2163
(89Zr-HuMab-5B1) combines the well-established PET imaging
radiolabel Zirconium-89 [89Zr] with the targeting specificity of
MVT-5873. We designed the trial to establish safety,
pharmacokinetics, biodistribution, optimal time to obtain the PET
image, and the amount of MVT-5873 to be administered as a blocking
dose prior to administration of MVT-2163 to obtain optimized PET
scan images.
As
of July 2017, 12 patients had been treated in this first-in-human
trial evaluating the safety and feasibility of MVT-2163 to image
pancreatic tumors and other CA19-9 positive malignancies. MVT-2163
was administered alone and in combination with MVT-5873 and was
well tolerated in all cohorts. The only toxicities were infusion
reactions that resolved on the day of the injection, with some
patients requiring standard supportive medication.
Uptake
of MVT-2163 was observed in primary tumors and metastases as early
as day two and continuously through day seven. Standard Uptake
Values (SUV), a measurement of activity in PET imaging, reached as
high as 101 in the study. The investors reported that the high SUVs
are amongst the highest lesion uptake values they have ever seen
for a radiolabeled antibody. Bone and soft tissue disease were
readily visualized and lesion uptake of the radiotracer was higher
than typically seen with PET imaging agents. The correlation with
Computerized Tomography (CT) scans was high.
We
reported that administering MVT-5873 prior to dosing MVT-2163
reduces liver uptake facilitating detection of liver metastases. In
addition, we determined that the MVT-5873 cold antibody pre-dose
does not interfere with the uptake of MVT-2163 on cancer
lesions.
In
summary, the MVT-2163 product produced acceptable safety
tolerability, pharmacokinetics and biodistribution. MVT-2163 also
produced high quality PET images identifying both primary tumor and
metastatic sites. There was a promising correlation with diagnostic
CT that warrants further studies correlating these findings with
histopathology to assess the accuracy of MVT-2163 in identifying
smaller metastatic nodes below the detection level of standard CT
scans. The continual increase in high SUV values on cancer lesions
in this study supports the use of the Company’s MVT-1075
radioimmunotherapy product which utilizes the same antibody to
deliver a radiation dose for the treatment of patients with
pancreatic, lung and colon cancers.
Plan for 2018
Based
on inquiries from third parties regarding their interest in MabVax
assets and clinical progress to date with MVT-5873, MVT-1075, and
MVT-2163, and with the assistance of investment advisor Greenhill
& Co., we expect to be able to decide on one or more strategic
alternatives for the Company in the first quarter of
2018.
We
currently plan to continue clinical development of MVT-1075 for the
treatment of locally advanced or metastatic pancreatic cancer
patients, by completing additional cohorts of patients in a dose
escalation safety trial to continue to assess the safety and
potential efficacy of this treatment, and expect to report results
in the first quarter of 2018.
We
also currently intend to continue clinical development of MVT-5873
in combination with gemcitabine and nab-paclitaxal in first line
therapy for the treatment of patients newly diagnosed with
pancreatic cancer. We have treated two cohorts of patients for a
total of six patients through September 22, 2017 in this study; and
have initiated enrollment for an additional cohort of patients with
the objective of confirming early observations in the first quarter
2018.
Our
plans beyond the first quarter 2018 will depend substantially on
which product portfolios are licensed and/or sold to potential
acquirers and/or licensees in the remainder of 2017 and early 2018,
and the availability of financial resources resulting from such
potential transactions that are under consideration when we enter
2018.
Listing Reverse Split
On
August 2, 2016, the Board approved a 1-for-7.4 reverse stock split,
or the “Listing Reverse Split.” The Listing Reverse
Split was intended to allow us to meet the minimum share price
requirement of the NASDAQ Capital Market. On August 11, 2016, we
received approval from the NASDAQ Capital Market for the listing of
our common stock under the symbol “MBVX”, subject to
implementation of the Listing Reverse Split and closing of our
August 2016 public offering (the “August 2016 Public
Offering”). On August 16, 2016, we implemented the
Listing Reverse Split, closed on the August 2016 Public Offering
and began trading on the NASDAQ Capital Market at the open of
business on August 17, 2016. Unless otherwise stated herein, all
per share amounts herein give effect to the Listing Reverse
Split.
Recent Events
July 2017 Private Placement
–
On July 27, 2017,
we entered into a subscription agreement with an accredited
investor pursuant to which we agreed to sell 152,143 restricted
shares of common stock for $125,000 (the “July 2017 Private
Placement”). As part of the transaction, the Company agreed
to reprice the investor’s warrant to purchase 225,225 shares
of common stock from $11.10 to $2.00 per warrant share and remove
the cashless exercise feature. The transaction closed on August 2,
2017. The impact of repricing the warrants to $2.00 a share,
which took effect on August 2, 2017, was immaterial, as the stock
price on the date of the closing of the transaction was $0.70 and
the warrants at $2.00 a share expired on October 10, 2017,
unexercised.
August 11, 2017 Registered
Direct Offering –
On
August 11, 2017, we entered into securities purchase agreements to
sell 2,386.36 shares of Series J Preferred Stock with a stated
value of $550 per share (the “August 2017
Offering”). The Series J Preferred Stock is convertible
into common stock at $0.55 per share, subject to adjustment for
stock splits, stock dividends, recapitalizations, combinations,
subdivisions or other similar events and was purchased by certain
existing investors of the Company (the “Prior
Investors”). The total amount of the securities purchase
agreements amounted to approximately $1,312,500, before estimated
expenses of $123,083. The Certificate of Designation for the
Series J Preferred Stock includes a 4.99% beneficial ownership
conversion blocker, a 19.99% blocker provision to comply with the
NASDAQ Capital Market rules until stockholders have approved any or
all shares of common stock issuable upon conversion of the Series J
Preferred Stock, which was approved in a special meeting of
stockholders on October 2, 2017 (the “October 2017 Special
Meeting”), and a 125% liquidation preference. All shares of
the Company’s capital stock will be junior in rank to the
Series J Preferred Stock at the time of creation, with respect to
the preferences as to dividends, distributions and payments upon
the liquidation, dissolution and winding-up of the Company, except
for the Company’s Series D Preferred Stock, Series E
Preferred Stock, Series F Preferred Stock, Series G Preferred
Stock, Series H Preferred Stock, and Series I Preferred
Stock.
In
connection with the August 2017 Offering, we agreed with the lead
investor (the “Lead Investor”) pursuant to a Letter
Agreement, dated August 9, 2017 (the “August 2017 Letter
Agreement”), to issue incentive shares (the “Incentive
Shares”) to Prior Investors as an incentive to invest in the
August 2017 Offering. Such Prior Investors received a portion of
65,000 shares in the form of a new Series K Preferred Stock,
allocated by the Lead Investor, and convertible into 6,500,000
shares of common stock, subject to stockholder approval, which was
also approved in the October 2017 Special Meeting. The stated value
of each share of Series K Preferred Stock is $0.01 and the
conversion rate is the stated value of $0.01 divided by .0001, or
one hundred (100) shares of common stock upon conversion of one (1)
share of Series K Preferred Stock, each subject to adjustment for
stock splits, stock dividends, recapitalizations, combinations,
subdivisions or other similar event, and have a 4.99% beneficial
ownership conversion blocker. In the event of a liquidation,
dissolution or winding up of the Company, each share of Series K
Preferred Stock will be entitled to a per share preferential
payment equal to the par value, or $0.01 per share. All shares of
the Company’s capital stock will be junior in rank to the
Series K Preferred Stock at the time of creation, with respect to
the preferences as to dividends, distributions and payments upon
the liquidation, dissolution and winding-up of the Company, except
for the Company’s Series D Preferred Stock, Series E
Preferred Stock, Series F Preferred Stock, Series G Preferred
Stock, Series H Preferred Stock, Series I Preferred Stock and
Series J Preferred Stock. The Company recorded a deemed dividend of
$3,120,000 in August 2017 in connection with issuing the Incentive
Shares.
The August 2017 Letter Agreement also specified the
following:
●
That the Company files
a proxy statement for a special meeting of stockholders within 10
days of closing the
August
2017 Offering. Proposals shall include (i) an amendment to the
Company’s Certificate of Incorporation to effect a reverse
stock split of its issued and outstanding common stock by a ratio
of not less than one-for-two and not more than one-for-twenty at
any time prior to one year from the date of the special meeting,
with the exact ratio to be set at a whole number within this range
as determined by the Board of Directors, (ii) the issuance of
securities in one or more non-public offerings where the maximum
discount at which securities will be offered will be equivalent to
a discount of 30% below the market price of the common stock, as
required by and in accordance with Nasdaq Marketplace Rule 5635(d),
(iii) the issuance of securities in one or more non-public
offerings where the maximum discount at which securities will be
offered will be equivalent to a discount of 20% below the market
price of the Common Stock, as required by and in accordance with
Nasdaq Marketplace Rule 5635(d), (iv) the issuance of the Series J
Conversion Shares and (v) the issuance of the Inducement
Shares.
●
Lead
Investor will commit to investing an additional $1,000,000 in a new
private or public offering of up to $8,000,000 (the
“$8,000,000 Financing”). The $8,000,000 Financing shall
sign and close following shareholder approval of each of the
proposals identified in the August 2017 Letter
Agreement.
●
That the
employment terms of all
management be reduced to two years from three years and that
management defer portions of their salary for the remainder of the
year, which shall be paid upon the earlier of completion of the
$8,000,000 Financing or a business transaction that represents, or
transactions in the aggregate that represent, in excess of
$10,000,000.
Effective
with the Company’s pay period ending August 10, 2017, and
without changing their employment agreements dated July 1, 2017,
several members of management volunteered to defer receiving
portions of their salaries for the remainder of 2017. The voluntary
deferral of cash payments is intended to help with the
Company’s cash flow for the remainder of the year, with
voluntary reductions by the management team committed to remain in
effect until the earlier of completing a successful financing of at
least $8.0 million, a business transaction that represents, or
business transactions in the aggregate that represent, an amount of
$10.0 million or greater, or the end of the year, whichever occurs
first. The employment agreements with the Company remain unchanged,
except that the executives have volunteered to reduce the terms of
their employment agreements to two years from three in connection
with the August 2017 Offering and August 2017 Letter Agreement
with the Lead Investor.
On
August 14, 2017, the Chairman of the Compensation Committee, acting
on behalf of the Board of Directors sent a letter to each executive
of the Company stating that the Board deems it in the best
interests of the Company to request that the executive voluntarily
defer a portion of his regular salary to help with cash flow of the
Company. On August 16 and August 21, 2017, Paul Resnick, M.D. and
Paul Maffuid, Ph.D., respectively gave notice of good reason (as
that term is defined in their employment agreements or “Good
Reason”) for termination of their employment. The Company had
30 days from the notification date under each of their employment
agreements to cure their concerns. In oral discussions with each
executive the President and Chief Executive Officer communicated on
behalf of the Compensation Committee the Company’s intention
to provide additional equity compensation in return for salary
deferrals. Given the perceived uncertainty about the
Company’s plans at the time for addressing the concerns of
Dr. Resnick and Dr. Maffuid, and that nothing in writing had been
provided as possible equity compensation, they each submitted their
notices to the Company of good reason for termination. Further,
they each expressed in oral conversations that they wanted to
remain employed by the Company. The Company cured each
executive’s concerns within the 30-day cure period, by
reinstating the deferred salary for Dr. Resnick in one instance,
and in granting restricted stock to all executives with vesting
over time, as disclosed in the filings of Form 4s following the
approvals. Both executives rescinded their notices of good reason
for termination on September 7, 2017, and all executives’
employment agreements remain unchanged as the salary deferrals
remain to be voluntary.
In
order to meet the NASDAQ Capital Market rules in the August 2017
Offering, we were not obligated to issue any shares of common stock
upon conversion of the Series J Preferred Stock which would cause
the Company to breach our obligations under the rules and
regulations of the NASDAQ Capital Market, which limit the aggregate
number of shares issued at a discount to market at 19.99% of the
number of shares outstanding on the closing date of the August 2017
Offering, except that such limitation shall not apply in the event
that we obtain the approval of our stockholders as required by the
applicable rules of the NASDAQ Capital Market for issuances of
common stock in excess of such amount. Similarly, none of the
Series K Preferred Stock may be converted into common stock until
we obtain the approval of our stockholders. At the October 2017
Special Meeting, we obtained approval to issue shares underlying
all of the Series J Preferred Stock and the Series K Preferred
Stock.
September 11, 2017 Registered
Direct Offering –
On
September 11, 2017,
we entered into an agreement to sell 4.0 million
shares of common stock at $0.50 a share for gross proceeds of
approximately $2.0 million, before estimated expenses of
$147,639. The shares were offered and sold to certain accredited
investors in a registered direct offering. Laidlaw &
Company (UK) Ltd. acted as placement agent for the
offering.
September 22, 2017 Registered
Direct Offering –
On
September 22, 2017, we entered into a subscription agreement with
select accredited investors relating to the Company’s
registered direct offering, issuance and sale of 2,016,129 shares
of the Company’s common stock, $0.01 par value per share. The
purchase price per share was $0.62. The total amount of the
subscription agreements amounted to $1,250,000, before estimated
expenses of $35,000.
October 10, 2017 Registered
Direct Offering
– On
October 10, 2017, we entered into a subscription agreement with
select accredited investors relating to the Company’s
registered direct offering, issuance and sale of 769,231 shares of
the Company’s common stock, $0.01 par value per share. The
purchase price per share was $0.65. The total amount of the
subscription agreements amounted to $500,000, before estimated
expenses of $15,000. The securities were offered by means of the
Company’s shelf registration statement on Form S-3 (File
#333-219291) which was declared effective on July 27, 2017 by the
Securities and Exchange Commission.
October 18, 2017 Preferred
Stock Exchange Agreement
– On October 18, 2017, we entered into
exchange agreements (each, an “Exchange Agreement” and
collectively, the “Exchange Agreements”) with the
holders of all of the Company’s outstanding shares of Series
F Preferred Stock, Series G Preferred Stock and Series H Preferred
Stock, pursuant to which an aggregate of 665,281 shares of Series F
Preferred Stock, 1,000,000 shares of Series G Preferred Stock and
850 shares of Series H Preferred Stock were exchanged for an
aggregate of 58,000 newly authorized shares of Series L Convertible
Preferred Stock (the “Series L Preferred Stock”)
convertible into 9,666,669 shares of common stock (the
“Conversion Shares”), subject to a conversion
restriction until shareholder approval is obtained. We obtained the
necessary shareholder approval on December 1,
2017.
The
terms of the Exchange Agreements and Series L Preferred Stock were
determined by arms-length negotiation between the parties. No
commission or other payment was received by the Company in
connection with the Exchange Agreements. Such exchange was
conducted and the Series L Preferred Stock issuable pursuant to the
Exchange Agreements, including the Conversion Shares, were issued
pursuant to the exemption provided by Section 3(a)(9) of the
Securities Act.
Pursuant
to a registration rights agreement entered into between the Company
and the holders on October 18, 2017, we agreed to use reasonable
best efforts to file a registration statement registering the
Conversion Shares for resale within ten days of closing and cause
the registration statement to be declared effective within 30 days
of filing.
THI
S
OFFERING
|
Shares
of common stock outstanding prior to this offering
|
|
20,588,765(1)
|
|
|
|
|
|
|
|
Shares
being offered by the Selling Stockholders
|
|
3,154,548
|
|
|
|
|
|
|
|
Shares
of common stock to be outstanding after the offering
|
|
23,743,313(1)(2)
|
|
|
|
|
|
|
|
Use of
Proceeds
|
|
We will not receive any proceeds from the sale of the shares of
common stock offered in this prospectus.
|
|
|
|
|
|
|
|
Risk
Factors
|
|
The
purchase of our common stock involves a high degree of risk. You
should carefully review and consider "Risk Factors” beginning
on page 6.
|
|
|
|
|
|
|
|
NASDAQ
Symbol
|
|
MBVX
|
|
(1)
As of December 20, 2017.
(2)
Assumes the exercise and sale of all options and restricted stock
grants being offered by the Selling Stockholders.
RISK F
A
CTORS
Investing
in our common stock involves a high degree of risk. Before making
an investment decision, you should consider carefully the risks,
uncertainties and other factors more fully described under
“Risk Factors” in our most recent Annual Report on Form
10-K for the year ended December 31, 2016, filed with the SEC on
March 1, 2017, as supplemented and updated by subsequent quarterly
reports on Form 10-Q and current reports on Form 8-K that we have
filed or will file with the SEC, which are incorporated by
reference into this prospectus.
Our
business, affairs, prospects, assets, financial condition, results
of operations and cash flows could be materially and adversely
affected by these risks. For more information about our SEC
filings, please see “Additional Information Available to
You”.
Risks Relating to Our Financial Condition
We will be required to raise additional funds to finance our
operations and remain a going concern; we may not be able to do so
when necessary, and/or the terms of any financings may not be
advantageous to us, requiring cutbacks in personnel.
Our
operations to date have consumed substantial amounts of cash.
Negative cash flows from our operations are expected to continue
over at least the next several years. Our cash utilization amount
is highly dependent on the progress of our product development
programs, particularly, the results of our preclinical and clinical
studies and those of our partners, the cost, timing and outcomes of
regulatory approval for our product candidates, and the rate of
recruitment of patients in our human clinical trials. In addition,
the further development of our ongoing clinical trials will depend
on upcoming analysis and results of those studies and our financial
resources at that time.
Although
we have raised approximately $4,900,000, net of offering costs,
since June 30, 2017, for various financings and offerings, we will
require future additional capital infusions including public or
private financing, strategic partnerships or other arrangements
with organizations that have capabilities and/or products that are
complementary to our own capabilities and/or products, in order to
continue the development of our product candidates. At present, we
have sufficient cash to fund operations until February 2018
assuming we do not complete any strategic or financing transactions
between now and February 2018. We are exploring and evaluating
strategic options with the goal of maximizing stockholder value,
and currently working with our financial advisor Greenhill &
Co., to assist us with our efforts.
Our
ongoing capital requirements will depend on numerous factors,
including: the progress and results of preclinical testing and
clinical trials of our product candidates under development; the
costs of complying with the FDA and other domestic and foreign
regulatory agency requirements, the progress of our research and
development programs and those of our partners; the time and costs
expended and required to obtain any necessary or desired regulatory
approvals; the resources that we devote to manufacturing
expenditures; our ability to enter into licensing arrangements,
including any unanticipated licensing arrangements that may be
necessary to enable us to continue our development and clinical
trial programs; the costs and expenses of filing, prosecuting and,
if necessary, enforcing our patent claims, or defending against
possible claims of infringement by third-party patent or other
technology rights; the cost of commercialization activities and
arrangements, if any, that we undertake; and, if and when approved,
the demand for our products, which demand depends in turn on
circumstances and uncertainties that cannot be fully known,
understood or quantified unless and until the time of approval,
including the range of indications for which any product is granted
approval. If we are unable to raise additional capital, then we may
have to substantially curtail our clinical trials which could slow
the progress in the development of our products.
We are required to obtain the consent of an existing investor, or
the Lead Investor, to certain future transactions, which may hinder
our ability to obtain future financing.
We granted to the Lead Investor the right to
approve future transactions that require stockholder approval under
the rules of the
NASDAQ Stock
Market LLC or any state laws (the “Consent”). These
transactions could include offerings of our securities, mergers,
acquisitions, or sales of some or substantially all of our
assets.
Should
the Consent be required in connection with future offerings, we may
be required again to provide additional consideration, including,
but not limited to, consideration in the form of cash and/or
additional shares of our capital stock and/or securities
convertible into or exercisable for shares of our capital stock, in
order to obtain the Consent. If we are unable to obtain the
Consent when necessary for future offerings, we may be unable to
raise additional funds. An inability to raise additional funds
could have a material adverse effect on our financial condition,
results of operations, ability to conduct our business and on the
price of our common stock.
The terms of our secured debt facility require us to meet certain
operating and financial covenants and place restrictions on our
operating and financial flexibility. If we raise additional capital
through debt financing, the terms of any new debt could further
restrict our ability to operate our business.
Effective
in January 2016, we entered into a $10 million loan and
security agreement with Oxford Finance LLC, or Oxford Finance, that
is secured by a lien covering substantially all of our assets,
excluding intellectual property. As of September 30, 2017, we had
an outstanding principal balance of approximately $3.9 million. The
option to draw the second $5 million expired on September 30, 2016.
The loan and security agreement contains customary affirmative and
negative covenants and events of default. The affirmative covenants
include, among others, covenants requiring us to maintain our legal
existence and governmental approvals, deliver certain financial
reports and maintain insurance coverage. The negative covenants
include, among others, restrictions on transferring collateral,
changing our business, incurring additional indebtedness, engaging
in mergers or acquisitions, paying dividends or making other
distributions, making investments and creating other liens on our
assets, in each case subject to customary exceptions. As of
December 20, 2017, we were in compliance with all the covenants. If
we default under the loan agreement, the lenders may accelerate all
of our repayment obligations and take control of our pledged
assets, potentially requiring us to renegotiate our agreement on
terms less favorable to us or to immediately cease operations.
Further, if we are liquidated, the lender’s right to
repayment would be senior to the rights of the holders of our
common stock and preferred stock to receive any proceeds from the
liquidation. The lenders could declare a default upon the
occurrence of any event that they interpret as a material adverse
change as defined under the loan agreement, thereby requiring us to
repay the loan immediately or to attempt to reverse the declaration
of default through negotiation or litigation. Any declaration by
the lenders of an event of default could significantly harm our
business and prospects and could cause the price of our common
stock to decline. If we raise any additional debt financing, the
terms of such additional debt could further restrict our operating
and financial flexibility.
We have a history of losses, and we anticipate that we will
continue to incur losses in the future; our auditors have included
in their audit report an explanatory paragraph as to substantial
doubt as to our ability to continue as a going
concern.
We have
experienced net losses every year since our inception and, as of
September 30, 2017, had an accumulated deficit of $101,046,557. Our
auditors have included in their audit report a “going
concern” explanatory paragraph as to substantial doubt as to
our ability to continue as a going concern that assumes the
realization of our assets and the satisfaction of our liabilities
and commitments in the normal course of business. Until such time
as we have completed more than one license agreement for our
technology, and assuming we have sufficient funding from such
licenses and financing transactions to continue to sustain
operations, we anticipate continuing to incur substantial
additional losses over at least the next several years due to,
among other factors, expenses related to the following: continuing
Phase I clinical trials with MVT-1075 as a radioimmunotherapy
agent, and MVT-5873 in combination with a chemotherapy agent, for
the treatment of various cancers, preclinical testing of follow-on
antibody candidates, investor and public relations, SEC compliance
efforts, anticipated research and development activities and the
general and administrative expenses associated with each of these
activities. We have not yet commercialized any product candidates.
Our ability to attain profitability will depend upon our ability to
enter into material revenue generating license arrangements,
develop and commercialize products that are effective and
commercially viable, to obtain regulatory approval for the
manufacture and sale of our products and to license or otherwise
market our products successfully. We may never achieve
profitability, and even if we do, we may not be able to sustain
being profitable. If we are unable to obtain additional capital we
may be forced to license, sell or terminate our activities with
respect to promising technologies which may require us to agree to
disadvantageous terms that will prevent us from realizing the
potential value from the results of our efforts and
expenditures.
Risks Related to our Business
If we are unable to obtain required regulatory approvals, we will
be unable to market and sell our product candidates.
Our
product candidates are subject to extensive governmental
regulations relating to development, clinical trials,
manufacturing, oversight of clinical investigators, recordkeeping
and commercialization. Rigorous preclinical testing and clinical
trials and an extensive regulatory review and approval process are
required to be successfully completed in the United States and in
each foreign jurisdiction in which we offer our products before a
new drug or other product can be sold in such jurisdictions.
Satisfaction of these and other regulatory requirements is costly,
time consuming, uncertain, and subject to unanticipated delays. The
time required to obtain approval by the FDA, or the regulatory
authority in such other jurisdictions is unpredictable and often
exceeds five years following the commencement of clinical trials,
depending upon the complexity of the product candidate and the
requirements of the applicable regulatory agency.
In
connection with the clinical development of our product candidates,
we face risks that:
●
the
product candidate may not prove to be safe and
efficacious;
●
patients
may die or suffer serious adverse effects for reasons that may or
may not be related to the product candidate being
tested;
●
we
may fail to maintain adequate records of observations and data from
our clinical trials, to establish and maintain sufficient
procedures to oversee, collect data from, and manage clinical
trials, or to monitor clinical trial sites and investigators to the
satisfaction of the FDA or other regulatory agencies;
●
the
results of later-phase clinical trials may not confirm the results
of earlier clinical trials; and
●
the
results from clinical trials may not meet the level of statistical
significance or clinical benefit-to-risk ratio required by the FDA
or other regulatory agencies for marketing approval.
Only
a small percentage of product candidates for which clinical trials
are initiated receive approval for commercialization. Furthermore,
even if we do receive regulatory approval to market a product
candidate, any such approval may be subject to limitations such as
those on the indicated uses for which we may market a particular
product candidate.
Our product candidates have not completed sufficient clinical
trials to obtain regulatory approval, and may never demonstrate
sufficient safety and efficacy in order to do so.
Our
product candidates are in the clinical and pre-clinical stages of
development. In order to achieve profitable operations, we alone,
or in collaboration with others, must successfully license,
develop, manufacture, introduce and market our products. The time
frame necessary to achieve market success for any individual
product, whether we or our potential strategic partners develop, is
long and uncertain. The products we are currently developing will
require significant additional research, development and
preclinical and clinical testing prior to application for
commercial use or sale. A number of companies in the biotechnology
and pharmaceutical industries have suffered significant setbacks in
clinical trials, even after showing promising results in early or
later-stage studies or clinical trials. Although we have obtained
some favorable results to-date in preclinical studies and clinical
trials of certain of our potential products, such results may not
be indicative of results that will ultimately be obtained in or
throughout such clinical trials, and clinical trials may not show
any of our products to be safe or capable of producing a desired
result. Additionally, we may encounter problems in our clinical
trials that may cause us to delay, suspend or terminate those
clinical trials.
Further,
our research or product development efforts may not be successfully
completed, any compounds we currently have under development may
not be successfully developed into drugs, may not receive
regulatory approval on a timely basis, if at all, and competitors
may develop and bring to market products or technologies that
render our potential products obsolete. If any of these events
occur, our business would be materially and adversely
affected.
If clinical trials or regulatory approval processes for our product
candidates are prolonged, delayed or suspended, we may be unable to
commercialize our product candidates on a timely basis, which would
require us to incur additional costs and delay our receipt of any
revenue from potential product sales.
We
cannot predict whether we, or our strategic partners if our product
candidates are licensed, will encounter problems with any of our
completed, ongoing or planned clinical trials that will cause us or
any regulatory authority to delay or suspend those clinical trials
or delay the analysis of data derived from them. A number of
events, including any of the following, could delay the completion
of our ongoing and planned clinical trials and negatively impact
our ability to obtain regulatory approval for, and to market and
sell, a particular product candidate:
●
conditions
imposed on us by the FDA or another foreign regulatory authority
regarding the scope or design of our clinical trials;
●
delays
in obtaining, or our inability to obtain, required approvals from
institutional review boards or other reviewing entities at clinical
sites selected for participation in our clinical
trials;
●
insufficient
supply of our product candidates or other materials necessary to
conduct and complete our clinical trials;
●
slow
enrollment and retention rate of subjects in our clinical
trials;
●
serious
and unexpected drug-related side effects related to the product
candidate being tested; and
●
delays
in meeting manufacturing and testing standards required for
production of clinical trial supplies.
Commercialization
of our product candidates may be delayed by the imposition of
additional conditions on our clinical trials by the FDA or any
other applicable foreign regulatory authority or the requirement of
additional supportive studies by the FDA or such foreign regulatory
authority. In addition, clinical trials require sufficient patient
enrollment, which is a function of many factors, including the size
of the patient population, the nature of the trial protocol, the
proximity of patients to clinical sites, the availability of
effective treatments for the relevant disease, the conduct of other
clinical trials that compete for the same patients as our clinical
trials, and the eligibility criteria for our clinical trials. Our
failure to enroll patients in our clinical trials could delay the
completion of the clinical trial beyond its expectations. In
addition, the FDA could require us to conduct clinical trials with
a larger number of subjects than we may have projected for any of
our product candidates. We may not be able to enroll a sufficient
number of patients in a timely or cost-effective manner.
Furthermore, enrolled patients may drop out of our clinical trials,
which could impair the validity or statistical significance of the
clinical trials.
We
do not know whether our clinical trials will begin as planned, will
need to be restructured, or will be completed on schedule, if at
all. Delays in our clinical trials will result in increased
development costs for our product candidates, and our financial
resources may be insufficient to fund any incremental costs. In
addition, if our clinical trials are delayed, our competitors may
be able to bring products to market before we do and the commercial
viability of our product candidates could be limited. In cases
where an outside party, such as the NCI conducts a clinical trial
on our behalf, we may not have direct involvement in discussions
with the FDA regarding the factors discussed above.
We are substantially dependent on the success of our product
candidates, MVT-1075, MVT-5873, and MVT-2163, and we cannot provide
any assurance that any of our product candidates will be
commercialized.
To
date, our main focus and the investment of a significant portion of
our efforts and financial resources has been in the development of
our product candidates, MVT-1075, MVT-5873, and MVT-2163, which are
in clinical development. Our future success depends heavily on our
ability to successfully license, manufacture, develop, obtain
regulatory approval, and commercialize these product candidates,
which may never occur. Before commercializing either
product candidate, we or any potential strategic partner will
require additional clinical trials and regulatory approvals for
which there can be no guarantee that we or our potential strategic
partners will be successful. We currently generate no revenues from
our product candidates, and we may never be able to develop,
license or commercialize a marketable drug.
Our product candidates will remain subject to ongoing regulatory
review even if they receive marketing approval, and if we or our
potential strategic partners fail to comply with continuing
regulations, we or our potential strategic partners could lose
these approvals and the sale of any of our approved commercial
products could be suspended.
Even
if we receive regulatory approval to market a particular product
candidate, the manufacturing, labeling, packaging, adverse event
reporting, storage, advertising, promotion, and record keeping
related to the product will remain subject to extensive regulatory
requirements. If we fail to comply with the regulatory requirements
of the FDA and other applicable domestic and foreign regulatory
authorities or discover any previously unknown problems with any
approved product, manufacturer, or manufacturing process, we could
be subject to administrative or judicially imposed sanctions,
including:
●
restrictions
on the products, manufacturers, or manufacturing
processes;
●
warning
letters;
●
civil
or criminal penalties;
●
fines;
●
injunctions;
●
product
seizures or detentions;
●
pressure
to initiate voluntary product recalls;
●
suspension
or withdrawal of regulatory approvals; and
●
refusal
to approve pending applications for marketing approval of new
products or supplements to approved applications.
Our industry is highly competitive and our product candidates may
become obsolete.
We
are engaged in a rapidly evolving field. Competition from other
pharmaceutical companies, biotechnology companies and research and
academic institutions is intense and likely to increase. Many of
those companies and institutions have substantially greater
financial, technical and human resources than we do. Those
companies and institutions also have substantially greater
experience in developing products, conducting clinical trials,
obtaining regulatory approval and in manufacturing and marketing
pharmaceutical products. Our competitors may succeed in obtaining
regulatory approval for their products more rapidly than we do.
Competitors have developed or are in the process of developing
technologies that are, or in the future may be, the basis for
competitive products. We are aware of potential competitors
developing products similar to our sarcoma vaccine, ovarian cancer
vaccine and pancreatic cancer antibodies product candidates. Our
competitors may succeed in developing products that are more
effective and/or cost competitive than those we are developing, or
that would render our product candidates less competitive or even
obsolete. In addition, one or more of our competitors may achieve
product commercialization or patent protection earlier than we do,
which could materially adversely affect our business.
If physicians and patients do not accept our future products, or
our potential strategic partner’s products, or if the market
for indications for which any product candidate is approved is
smaller than expected, we may be unable to generate significant
revenue, if any.
Even
if any of our product candidates obtain regulatory approval, they
may not gain market acceptance among physicians, patients, and
third-party payers. Physicians may decide not to recommend our
treatments for a variety of reasons including:
●
timing
of market introduction of competitive products;
●
demonstration
of clinical safety and efficacy compared to other
products;
●
cost-effectiveness;
●
limited
or no coverage by third-party payers;
●
convenience
and ease of administration;
●
prevalence
and severity of adverse side effects;
●
restrictions
in the label of the drug;
●
other
potential advantages of alternative treatment methods;
and
●
ineffective
marketing and distribution support of its products.
If
any of our product candidates are approved, but fail to achieve
market acceptance or such market is smaller than anticipated, we
may not be able to generate significant revenue and our business
would suffer.
As we evolve from a company that is primarily involved in clinical
development to a company that is also involved in licensing and
commercialization, we may encounter difficulties in expanding our
operations successfully.
As
we or our potential strategic partners advance our product
candidates through clinical trials, we may need to expand our
development, regulatory, manufacturing, marketing and sales
capabilities and may need to further contract with third parties to
provide these capabilities. As our operations expand, we likely
will need to manage additional relationships with such third
parties, as well as additional collaborators, distributors,
marketers and suppliers.
Maintaining
third party relationships for these purposes will impose
significant added responsibilities on members of our management and
other personnel. We must be able to: manage our development efforts
effectively; recruit and train sales and marketing personnel;
manage our participation in the clinical trials in which our
product candidates are involved effectively; and improve our
managerial, development, operational and finance systems, all of
which may impose a strain on our administrative and operational
infrastructure.
If
we enter into arrangements with third parties to perform sales,
marketing or distribution services, any product revenues that we
receive, or the profitability of these product revenues to us, our
revenues are likely to be lower than if we were to market and sell
any products that we develop without the involvement of these third
parties. In addition, we may not be successful in entering into
arrangements with third parties to license, sell and market our
products or in doing so on terms that are favorable to us. We
likely will have little control over such third parties, and any of
them may fail to devote the necessary resources and attention to
sell and market our products effectively. If we do not establish
sales and marketing capabilities successfully, either on our own or
in collaboration with third parties, we will not be successful in
commercializing our products.
The uncertainty associated with pharmaceutical reimbursement and
related matters may adversely affect our business.
Market
acceptance and sales of any one or more of our product candidates
will depend on reimbursement policies and may be affected by future
healthcare reform measures in the United States and in foreign
jurisdictions. Government authorities and third-party payers, such
as private health insurers and health maintenance organizations,
decide which drugs they will cover and establish payment levels. We
cannot be certain that reimbursement will be available for any of
our product candidates. Also, we cannot be certain that
reimbursement policies will not reduce the demand for, or the price
paid for, our products. If reimbursement is not available or is
available on a limited basis, we may not be able to successfully
commercialize any product candidates that we develop.
In
the United States, the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, also called the Medicare Modernization
Act, or MMA, changed the way Medicare covers and pays for
pharmaceutical products. The legislation established Medicare Part
D, which expanded Medicare coverage for outpatient prescription
drug purchases by the elderly but provided authority for limiting
the number of drugs that will be covered in any therapeutic class.
The MMA also introduced a new reimbursement methodology based on
average sales prices for physician-administered drugs.
The
United States and several foreign jurisdictions are considering, or
have already enacted, a number of legislative and regulatory
proposals to change the healthcare system in ways that could affect
our ability to sell our products profitably. Among policy makers
and payers in the United States and elsewhere, there is significant
interest in promoting changes in healthcare systems with the stated
goals of containing healthcare costs, improving quality and/or
expanding access to healthcare. In the United States, the
pharmaceutical industry has been a particular focus of these
efforts and has been significantly affected by major legislative
initiatives. We expect to experience pricing pressures in
connection with the sale of any products that it develops due to
the trend toward managed healthcare, the increasing influence of
health maintenance organizations and additional legislative
proposals.
Moreover,
the Patient Protection and Affordable Care Act, as amended by the
Health Care and Education Affordability Reconciliation Act, or
collectively, ACA, is intended to reduce the cost of health care
and substantially change the way health care is financed by both
government and private insurers. While we cannot predict what
impact on federal reimbursement policies this legislation will have
in general or on our business specifically, the ACA may result in
downward pressure on pharmaceutical reimbursement, which could
negatively affect market acceptance of, and the price we charge
for, any products we develop that receive regulatory
approval.
Our ability to generate product and/or licensing revenues will be
diminished if our therapies sell for inadequate prices or patients
are unable to obtain adequate levels of reimbursement.
Our
ability or our potential strategic partners’ abilities to
commercialize our therapies, alone or with collaborators, will
depend in part on the extent to which reimbursement will be
available from private health maintenance organizations and health
insurers and other healthcare payers. Significant uncertainty
exists as to the reimbursement status of newly approved healthcare
products. Healthcare payers are challenging the prices charged for
medical products and services. Cost control initiatives could
decrease the price that we would receive for any products in the
future, which would limit our revenue and profitability. Government
and other healthcare payers increasingly attempt to contain
healthcare costs by limiting both coverage and the level of
reimbursement for drugs and therapeutics. We might need to conduct
post-marketing studies in order to demonstrate the
cost-effectiveness of any future products to such payers’
satisfaction. Such studies might require us to commit a significant
amount of management time and financial and other resources. Our
future products might not ultimately be considered cost-effective.
Even if one of our product candidates is approved by the FDA,
insurance coverage may not be available, and reimbursement levels
may be inadequate, to cover such therapies. If government and other
healthcare payers do not provide adequate coverage and
reimbursement levels for one of our products, once approved, market
acceptance of such product could be reduced.
We only have a limited number of employees to manage and operate
our business.
As
of December 20, 2017, we have a total of 11 full-time employees and
one part-time employee. Our focus on limiting cash utilization
requires us to manage and operate our business in a highly
efficient manner. We cannot assure you that we will be able to
retain adequate staffing levels to run our operations and/or to
accomplish all of the objectives that we otherwise would seek to
accomplish.
We depend heavily on our executive officers, directors, and
principal consultants and the loss of their services would
materially harm our business.
We
believe that our success depends, and will likely continue to
depend, upon our ability to retain the services of our current
executive officers, directors, principal consultants and others. In
addition, we have established relationships with universities,
hospitals and research institutions, which have historically
provided, and continue to provide, us with access to research
laboratories, clinical trials, facilities and patients. The loss of
the services of any of these individuals or institutions would have
a material adverse effect on our business.
Our internal computer systems, or those of our third-party service
providers, licensees, licensors, collaborators or other contractors
or consultants, may fail or suffer security breaches, which could
result in a material disruption in our business and
operations.
Despite
the implementation of security measures, our internal computer
systems and those of our current and future service providers,
licensees, licensors, collaborators and other contractors and
consultants are vulnerable to damage from computer viruses,
unauthorized access, natural disasters, terrorism, war and
telecommunication and electrical failures. While we are not aware
of any such material system failure, accident or security breach to
date, if such an event were to occur and cause interruptions in our
operations, it could result in a material disruption of our
development programs and our business operations. For example, the
loss of clinical trial data from completed, on-going or future
clinical trials could result in delays in our regulatory approval
efforts and significant costs to recover or reproduce the data.
Likewise, we rely on third parties to manufacture our drug
candidates and conduct clinical trials, and similar events relating
to their computer systems could also have a material adverse effect
on our business. To the extent that any disruption or security
breach were to result in a loss of, or damage to, our data or
applications, or inappropriate disclosure of confidential or
proprietary information, we could incur liabilities and the further
development and commercialization of our product candidates could
be delayed.
Due in part to our limited financial resources, we may fail to
select or capitalize on the most scientifically, clinically or
commercially promising or profitable indications or therapeutic
areas for our product candidates or those that are in-licensed,
and/or we may be unable to pursue the clinical trials that we would
like to pursue.
We
have limited technical, managerial and financial resources to
determine the indications on which we should focus the development
efforts related to our product candidates. Due to our limited
available financial resources, we may have curtailed clinical
development programs and activities that might otherwise have led
to more rapid progress of our product candidates through the
regulatory and development processes.
We
may make incorrect determinations with regard to the indications
and clinical trials on which to focus the available resources that
we do have. Furthermore, we cannot assure you that we will be able
to retain adequate staffing levels to run our operations and/or to
accomplish all of the objectives that we otherwise would seek to
accomplish. Our decisions to allocate our research, management and
financial resources toward particular indications or therapeutic
areas for our product candidates may not lead to the development of
viable commercial products and may divert resources from better
opportunities. Similarly, our decisions to delay or terminate drug
development programs may also cause us to miss valuable
opportunities.
If the third parties on which we rely for the conduct of our
clinical trials and results do not perform our clinical trial
activities in accordance with good clinical practices and related
regulatory requirements, we may be unable to obtain regulatory
approval for or commercialize our product candidates.
We
use independent clinical investigators and other third-party
service providers to conduct and/or oversee the clinical trials of
our product candidates and expect to continue to do so for the
foreseeable future. We rely heavily on these parties for successful
execution of our clinical trials. Nonetheless, we are responsible
for confirming that each of our clinical trials is conducted in
accordance with the FDA’s requirements and our general
investigational plan and protocol.
The
FDA requires us and our clinical investigators to comply with
regulations and standards, commonly referred to as good clinical
practices, for conducting and recording and reporting the results
of clinical trials to assure that data and reported results are
credible and accurate and that the trial participants are
adequately protected. Our reliance on third parties that we do not
control does not relieve us of these responsibilities and
requirements. Third parties may not complete activities on schedule
or may not conduct our clinical trials in accordance with
regulatory requirements or the respective trial plans and
protocols. The failure of these third parties to carry out their
obligations could delay or prevent the development, approval and
commercialization of our product candidates or result in
enforcement action against us.
We have limited manufacturing capacity and have relied on, and
expect to continue to rely on, third-party manufacturers to produce
our product candidates.
We
do not own or operate manufacturing facilities for the production
of clinical or commercial quantities of our product candidates, and
we lack the resources and the capabilities to do so. As a result,
we currently rely, and expect to rely for the foreseeable future,
on third-party manufacturers to supply our product candidates.
Reliance on third-party manufacturers entails risks to which we
would not be subject if we manufactured our product candidates or
products ourselves, including:
●
reliance
on third-parties for manufacturing process development, regulatory
compliance and quality assurance;
●
limitations
on supply availability resulting from capacity and scheduling
constraints of third-parties;
●
the
possible breach of manufacturing agreements by third-parties
because of factors beyond our control; and
●
the
possible termination or non-renewal of the manufacturing agreements
by the third-party, at a time that is costly or inconvenient to
us.
If
we do not maintain our key manufacturing relationships, we may fail
to find replacement manufacturers or develop our own manufacturing
capabilities, which could delay or impair our ability to obtain
regulatory approval for our products and substantially increases
our costs or deplete profit margins, if any. If we do find
replacement manufacturers, we may not be able to enter into
agreements with them on terms and conditions favorable to us and
there could be a substantial delay before new facilities could be
qualified and registered with the FDA and other foreign regulatory
authorities.
The
FDA and other foreign regulatory authorities require manufacturers
to register manufacturing facilities. The FDA and corresponding
foreign regulators also inspect these facilities to confirm
compliance with current cGMPs. Contract manufacturers may face
manufacturing or quality control problems causing drug substance
production and shipment delays or a situation where the contractor
may not be able to maintain compliance with the applicable cGMP
requirements. Any failure to comply with cGMP requirements or other
FDA, EMA and comparable foreign regulatory requirements could
adversely affect our clinical research activities and our ability
to develop our product candidates and market our products following
approval.
Our
current and anticipated future dependence upon others for the
manufacture of our product candidates may adversely affect our
future profit margins and our ability to develop our product
candidates and commercialize any products that receive regulatory
approval on a timely basis.
If product liability lawsuits are successfully brought against us,
we may incur substantial liabilities and may be required to limit
commercialization of our product candidates and any products that
we may develop.
The
testing and marketing of medical products entail an inherent risk
of product liability. Although we are not aware of any historical
or anticipated product liability claims or specific causes for
concern, if we cannot successfully defend ourselves against product
liability claims, we may incur substantial liabilities or be
required to limit commercialization of our product candidates and
any products that we may develop. In addition, product liability
claims may also result in withdrawal of clinical trial volunteers,
injury to our reputation and decreased demand for any products that
we may commercialize. We currently carry product liability
insurance that covers our clinical trials up to a $5.0 million
annual aggregate limit. We will need to increase the amount of
coverage if and when we have a product that is commercially
available. If we are unable to obtain sufficient product liability
insurance at an acceptable cost, potential product liability claims
could prevent or inhibit the commercialization of any products that
we may develop, alone or with corporate partners.
We have been, and in the future may be, subject to securities class
action lawsuits and stockholder derivative actions. These, and
potential similar or related litigation, could result in
substantial damages and may divert management’s time and
attention from our business.
We
have been, and may in the future be, the target of securities class
actions or stockholder derivative claims. Any such actions or
claims could result in substantial damages and may divert
management’s time and attention from our
business.
Risks Related to our Intellectual Property
It is difficult and costly to protect our proprietary rights, and
we may not be able to ensure their protection.
We have
been issued patents, applied for other patents, and intend on
continuing to seek additional patent protection for our families of
antibodies from our antibody development program, our vaccines,
methods of use and other compounds that we
discover. However, any or all of such compounds, methods
or new uses of known compounds may not be subject to effective
patent protection. Further, the development of regimens for the
administration of our vaccines, which involve specifications for
the frequency, timing and amount of dosages, has been, and we
believe may continue to be, important to our efforts, although
those processes, as such, may not be patentable. In addition, our
issued patents may be declared invalid or our competitors may find
ways to avoid the claims in the patents.
Our
commercial success will depend, in part, on our ability to obtain
and maintain patent protection, protect our trade secrets and
operate without infringing on the proprietary rights of others. Our
commercial success will also depend, in part, on our ability to
market our product candidates during the term of our patent
protection. For example, certain patents including in
foreign countries within our portfolio expired in 2014 and can no
longer be relied on for protection in those countries. As of
December 20, 2017, we were the exclusive licensee or sole assignee
of 14 granted United States patents, 3 pending United States patent
applications, 7 international patents and 19 pending international
patent applications. The patent position of
pharmaceutical and biotechnology firms like us are generally highly
uncertain and involves complex legal and factual questions,
resulting in both an apparent inconsistency regarding the breadth
of claims allowed in United States patents and general uncertainty
as to their legal interpretation and enforceability. No
absolute policy regarding the breadth of claims allowed in
biopharmaceutical patents has emerged to date in the United States
or in many foreign jurisdictions. Changes in either the patent laws
or in interpretations of patent laws in the United States and
foreign jurisdictions may diminish the value of our intellectual
property. Accordingly, we cannot predict the breadth of claims that
may be enforced in the patents that we currently own or that may be
issued from the applications we have filed or may file in the
future or that we have licensed or may license from third parties,
including MSK for the vaccine antigen patents. Further, if any
patents we obtain or license are deemed invalid or unenforceable,
it could impact our ability to commercialize or license our
technology. Thus, patent applications assigned or
exclusively licensed to us may not result in patents being issued,
any issued patents assigned or exclusively licensed to us may not
provide us with competitive protection or may be challenged by
others, and the current or future granted patents of others may
have an adverse effect on our ability to do business and achieve
profitability.
One
of our issued US patents is directed to a candidate antibody
product that will expire in 2034. Other previously filed antibody
patent applications will, if issued, have patent expiration dates
depending on country and filing date between 2034 and
2038. It is possible that the term of the antibody
patent and certain patents issuing from the antibody patent
applications may be extended for a portion of the time the
candidate product was under regulatory review. Patents covering
components of the sarcoma vaccine will expire in
2022. Patents covering the polyvalent ovarian vaccine
will expire between 2018 and 2025. We believe that our
product candidates are eligible for Orphan Drug designation from
FDA depending on the indication for which it is approved by
FDA. Each product that receives an Orphan Drug
designation would be eligible for up to 7 additional years of
patent protection.
The
degree of future protection for our proprietary rights is uncertain
because legal means afford only limited protection and may not
adequately protect our rights or permit us to gain or keep our
competitive advantage. For example:
●
others
may be able to make compounds that are similar to our vaccines and
monoclonal antibody-based candidates and any future product
candidates we may seek to develop but that are not covered by the
claims of our patents;
●
if
we encounter delays in our clinical trials, the period of time
during which we could market our vaccines and monoclonal
antibody-based candidates under patent protection would be
reduced;
●
we
might not have been the first to conceive, make or disclose the
inventions covered by our patents or pending patent
applications;
●
we
might not have been the first to file patent applications for these
inventions;
●
any
patents that we obtain may be invalid or unenforceable or otherwise
may not provide us with any competitive advantages; or
●
the
patents of others may have a material adverse effect on our
business.
Due
to the patent laws of a country, or the decisions of a patent
examiner in a country, or our own filing strategies, we may not
obtain patent coverage for all the product candidates that may be
disclosed or methods involving these candidates that may be
disclosed in the parent patent application. We plan to pursue
divisional patent applications and/or continuation patent
applications in the United States and many other countries to
obtain claim coverage for inventions that were disclosed but not
claimed in the parent patent application, but may not succeed in
these efforts.
Composition
of matter patents on the active biological component are generally
considered to be the strongest form of intellectual property
protection for biopharmaceutical products, as such patents
generally provide protection without regard to any method of use.
We cannot be certain that the claims in our patent applications
covering composition-of-matter of our candidates will be considered
patentable by the U.S. Patent and Trademark Office, or USPTO,
courts in the United States or by the patent offices and courts in
foreign countries. Method of use patents protect the use of a
product for the method recited in the claims. This type of patent
does not prevent a competitor from making and marketing a product
that is identical to our product for an indication that is outside
the scope of the patented method. Moreover, even if competitors do
not actively promote their product for our targeted indications,
physicians may prescribe these products “off-label.”
Although off-label prescriptions may infringe or contribute to or
induce the infringement of method of use patents, the practice is
common and such infringement is difficult to prevent or prosecute.
Interference proceedings provoked by third parties or brought by
the USPTO may be necessary to determine the priority of inventions
with respect to our patents or patent applications or those of our
collaborators or licensors. An unfavorable outcome could require us
to cease using the related technology or to attempt to license
rights to it from the prevailing party. Our business could be
harmed if the prevailing party does not offer us a license on
commercially reasonable terms. Litigation or interference
proceedings may fail, resulting in harm to our business, and, even
if successful, may result in substantial costs and distract our
management and other employees.
There
have been numerous changes to the patent laws and proposed changes
to the rules of the USPTO, which may have a significant impact on
our ability to protect our technology and enforce our intellectual
property rights. For example, in September 2011, President Obama
signed the America Invents Act that codifies several significant
changes to the U.S. patent laws, including, among other things,
changing from a “first to invent” to a “first
inventor to file” system, limiting where a patent holder may
file a patent suit, replacing interference or “first to
invent” proceedings with derivation proceedings and creating
inter partes review and post-grant opposition proceedings to
challenge the validity of patents after they have been issued. The
effects of these changes are currently unclear as the USPTO only
recently has adopted regulations implementing the changes, the
courts have yet to address most of these provisions, and the
applicability of the act and new regulations on specific patents
and patent applications discussed herein have not been determined
and would need to be reviewed.
Periodic
maintenance fees on any issued patent are due to be paid to the
USPTO and foreign patent agencies in several stages over the
lifetime of the patent. The USPTO and various foreign governmental
patent agencies require compliance with many procedural,
documentary, fee payment and other similar provisions during the
patent application process. While an inadvertent lapse can in many
cases be cured by payment of a late fee or by other means in
accordance with the applicable rules, there are situations in which
noncompliance can result in abandonment or lapse of the patent or
patent application, resulting in partial or complete loss of patent
rights in the relevant jurisdiction. Noncompliance events that
could result in abandonment or lapse of a patent or patent
application include, but are not limited to, failure to respond to
official actions within prescribed time limits, non-payment of fees
and failure to properly legalize and submit formal documents. In
such an event, our competitors might be able to enter the market,
which would have a material adverse effect on our
business.
We
also rely on trade secrets to protect our technology, especially
where we do not believe patent protection is appropriate or
obtainable. However, trade secrets are difficult to protect.
Although we use reasonable efforts to protect our trade secrets,
our employees, consultants, contractors, licensees, licensors,
outside scientific collaborators and other advisors may
unintentionally or willfully disclose our information such that our
competitors may obtain it. Enforcing a claim that a third party
illegally obtained and is using any of our trade secrets is
expensive and time consuming, and the outcome is unpredictable.
Moreover, our competitors may independently develop equivalent
knowledge, methods and know-how, such as new therapies, including
therapies for the indications we are targeting. If others seek to
develop similar therapies, their research and development efforts
may inhibit our ability to conduct research in certain areas and to
expand our intellectual property portfolio, and also have a
material adverse effect on our business.
Moreover,
because some of the basic research relating to one or more of our
patent applications and/or patents were performed at various
universities and/or funded by grants, one or more universities,
employees of such universities and/or grantors could assert that
they have certain rights in such research and any resulting
products. Further, others may independently develop similar
products, may duplicate our products, or may design around our
patent rights. In addition, because of the assertion of rights by a
third-party or otherwise, we may be required to obtain licenses to
patents or other proprietary rights of others in or outside of the
United States. Any licenses required under any such patents or
proprietary rights may not be made available on terms acceptable to
us, if at all. If we do not obtain such licenses, we could
encounter delays in product market introductions during our
attempts to design around such patents or could find that the
development, manufacture or sale of products requiring such
licenses is foreclosed. In addition, we could incur substantial
costs in defending suits brought against us or about patents to
which we hold licenses or in suing to protect our own patents
against infringement.
We
require employees and the institutions that perform our preclinical
and clinical trials to enter confidentiality agreements with us.
Those agreements provide that all confidential information
developed or made known to a party to any such agreement during the
relationship with us be kept confidential and not be disclosed to
third-parties, except in specific circumstances. Any such agreement
may not provide meaningful protection for our trade secrets or
other confidential information in the event of unauthorized use or
disclosure of such information.
With
respect to our vaccine programs we have in-licensed rights from
third parties. If these license agreements terminate or expire, we
may lose the licensed rights to some or all our vaccine product
candidates. We may not be able to continue to develop them or, if
they are approved, market or commercialize them.
We
depend on license agreements with third-parties for certain
intellectual property rights relating to our product candidates,
including, but not limited to, the license of certain intellectual
property rights from MSK. In general, our license agreements
require us to make payments and satisfy performance obligations to
keep these agreements in effect and retain our rights under them.
These payment obligations can include upfront fees, maintenance
fees, milestones, royalties, patent prosecution expenses, and other
fees. These performance obligations typically include diligence
obligations. If we fail to pay, be diligent or otherwise perform as
required under our license agreements, we could lose the rights
under the patents and other intellectual property rights covered by
these agreements. If disputes arise under any of our license
agreements, including our license agreement with MSK, we could lose
our rights under these agreements. Any such dispute may not be
resolvable on favorable terms, or at all. Whether any disputes of
this kind are favorably resolved, our management’s time and
attention and our other resources could be consumed by the need to
attend to these disputes and our business could be harmed by the
emergence of such a dispute.
If
we lose our rights under these agreements, we might not be able to
develop any related product candidates further, or following
regulatory approval, if any, we might be prohibited from marketing
or commercializing these product candidates. In particular, patents
previously licensed to us might, after termination of an agreement,
be used to stop us from conducting these activities.
We are dependent on MSK for the establishment of our intellectual
property rights related to the vaccine program, and if MSK has not
established our intellectual property rights with sufficient scope
to protect our vaccine candidates, we may have limited or no
ability to assert intellectual property rights to our vaccine
candidates.
Under
our agreement with MSK, MSK was responsible for establishing the
intellectual property rights to the vaccine antigen conjugates,
mixtures of vaccine antigen conjugates that make up polyvalent
vaccine candidates and methods of use. As we were not responsible
for the establishment of our intellectual property rights to these
vaccine antigen conjugates, mixtures of vaccine antigen conjugates
and methods of use, we have less visibility into the strength of
our intellectual property rights to our vaccine candidates than if
we had been responsible for the establishment of these rights. If
MSK did not establish those rights so they are of sufficient scope
to protect the vaccine candidates, then we may not be able to
prevent others from using or commercializing some or all of our
vaccine candidates, and others may be able to assert intellectual
property rights in our vaccine candidates and prevent us from
further pursuing the development and commercialization of our
vaccine candidates.
We may not obtain exclusive rights to intellectual property created
because of our strategic collaborative agreements.
We
are party to collaborative research agreements, such as with
Rockefeller University and MSK, and expect to enter into agreements
with other parties in the future, each of which involve research
and development efforts. Under certain circumstances, we
may not have exclusive rights to jointly developed intellectual
property and would have to license the collaborative
partner’s interest in the jointly developed intellectual
property to obtain exclusive rights. We may not be able to
license our collaborative partner’s interest or license their
interest at reasonable terms. If we are unable to
license their interest we would not have exclusive rights to the
jointly developed intellectual property and, in some
collaborations, the collaborative partner may be free to license
their interest in the jointly developed intellectual property to a
competitor. In other collaborations, if we are unable to
license the collaborative partner’s interest we may not have
sufficient rights to practice the jointly developed intellectual
property. Such provisions to the jointly developed
intellectual property may limit our ability to gain commercial
benefit from some of or all the intellectual property we jointly
develop with our collaborative partners and may lead to costly or
time-consuming disputes with parties with whom we have
collaborative relationships over rights to certain innovations or
with other third parties that may result from the activities of the
collaborative arrangements.
We may incur substantial costs because of litigation or other
proceedings relating to patent and other intellectual property
rights and we may be unable to enforce or protect our rights to, or
use, our technology.
If
we choose to go to court to stop another party from using the
inventions claimed in any patents we obtain, that individual or
company has the right to ask the court to rule that such patents
are invalid or should not be enforced. These lawsuits are expensive
and would consume time and resources and divert the attention of
managerial and scientific personnel even if we were successful in
stopping the infringement of such patents or sustaining their
validity and enforceability. In addition, there is a risk that the
court will decide that such patents are not valid and that we do
not have the right to enforce them. There is also the risk that,
even if the validity of such patents is upheld, the court will
refuse to stop the other party on the grounds that such other
party’s activities do not infringe such patents. In addition,
the United States Court of Appeals for the Federal Circuit and the
Supreme Court of the United States continue to address issues under
the United States patent laws, and the decisions of those and other
courts could adversely affect our ability to sustain the validity
of our issued or licensed patents and obtain new
patents.
Furthermore,
a third party may claim that we or our manufacturing or
commercialization partners or customers are using inventions
covered by the third party’s patent rights and may go to
court to stop us or our partners and/or customers from engaging in
our operations and activities, including making or selling our
vaccine and monoclonal antibody-based candidates and any future
product candidates we may seek to develop. These lawsuits are
costly and could affect our results of operations and divert the
attention of managerial and scientific personnel. There is a risk
that a court would decide that we or our commercialization partners
or customers are infringing the third party’s patents and
would order us or our partners or customers to stop the activities
covered by the patents. In that event, we or our commercialization
partners or customers may not have a viable way around the patent
and may need to halt commercialization or use of the relevant
product. In addition, there is a risk that a court will order us or
our partners or customers to pay the other party damages for having
violated the other party’s patents or obtain one or more
licenses from third parties, which may be impossible or require
substantial time and expense. We cannot predict whether any license
would be available at all or whether it would be available on
commercially reasonable terms. Furthermore, even in the absence of
litigation, we may need to obtain licenses from third parties to
advance our research or allow commercialization of our candidates,
and we have done so from time to time. We may fail to obtain any of
these licenses at a reasonable cost or on reasonable terms, if at
all. In such events, we would be unable to further develop and
commercialize one or more of our drug candidates, which could harm
our business significantly. In the future, we may agree to
indemnify our commercial partners and/or customers against certain
intellectual property infringement claims brought by third parties
which could increase our financial expense, increase our
involvement in litigation and/or otherwise materially adversely
affect our business.
Because
of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our
confidential information could be compromised by disclosure during
this type of litigation, which could adversely affect our
intellectual property rights and our business. In addition, there
could be public announcements of the results of hearings, motions
or other interim proceedings or developments. If securities
analysts or investors perceive these results to be negative, it
could have a substantial adverse effect on the price of our common
stock.
The
pharmaceutical and biotechnology industries have produced a
proliferation of patents, and it is not always clear to industry
participants, including us, which patents cover various types of
products or methods of use. The coverage of patents is subject to
interpretation by the courts, and the interpretation is not always
uniform. If we are sued for patent infringement, we would need to
demonstrate that our products or methods either do not infringe the
patent claims of the relevant patent or that the patent claims are
invalid or unenforceable, and we may not be able to do this.
Proving invalidity or unenforceability is difficult. For example,
in the United States, proving invalidity requires a showing of
clear and convincing evidence to overcome the presumption of
validity enjoyed by issued patents.
Because
some patent applications in the United States may be maintained in
secrecy until the patents are issued, because patent applications
in the United States and many foreign jurisdictions are typically
not published until eighteen months after filing, because searches
and examinations of patent applications by the USPTO and other
patent offices may not be comprehensive, and because publications
in the scientific literature often lag behind actual discoveries,
we cannot be certain that others have not filed patent applications
for technology covered by our patents or pending applications. Our
competitors may have filed, and may in the future file, patent
applications and may have obtained patents covering technology
similar to ours. Any such patents or patent application may have
priority over our patent applications, which could further require
us to obtain or license rights to issued patents covering such
technologies. If another party has obtained a U.S. patent or filed
a U.S. patent application on inventions similar to ours, we may
have to participate in a proceeding before the USPTO or in the
courts to determine which patent or application has priority. The
costs of these proceedings could be substantial, and it is possible
that our application or patent could be determined not to have
priority, which could adversely affect our intellectual property
rights and business.
We
have received confidential and proprietary information from
collaborators, prospective licensees and other third parties. In
addition, we employ individuals who were previously employed at
other biotechnology or pharmaceutical companies. We may be subject
to claims that we or our employees, consultants or independent
contractors have improperly used or disclosed confidential
information of these third parties or our employees’ former
employers. Litigation may be necessary to defend against these
claims. Even if we are successful in defending against these
claims, litigation could result in substantial cost and be a
distraction to our management and employees. If we are not
successful, our ability to continue our operations and our business
could be materially, adversely affected.
Some
of our competitors may be able to sustain the costs of complex
intellectual property litigation more effectively than we can
because they have substantially greater resources. In addition, any
uncertainties resulting from the initiation and continuation of any
litigation could have a material adverse effect on our ability to
raise the funds necessary to continue our operations, on our
ability to hire or retain employees, or otherwise on our
business.
Risks Related to our Common Stock
Our restated certificate of incorporation, our amended and restated
by-laws and Delaware law could deter a change of our management
which could discourage or delay offers to acquire us; certain
restrictions in our agreements with existing stockholders could
also discourage or delay offers to acquire us.
Certain
provisions of Delaware law and of our restated certificate of
incorporation, as amended, and amended and restated by-laws, could
discourage or make it more difficult to accomplish a proxy contest
or other change in our management or the acquisition of control by
a holder of a substantial amount of our voting stock. It is
possible that these provisions could make it more difficult to
accomplish, or could deter, transactions that stockholders may
otherwise consider to be in their best interests or in our best
interests. These provisions include:
●
establishing
a classified board of directors requiring that members of the board
be elected in different years, which lengthens the time needed to
elect a new majority of the board;
●
authorizing
the issuance of “blank check” preferred stock that
could be issued by our board of directors to increase the number of
outstanding shares or change the balance of voting control and
thwart a takeover attempt;
●
prohibiting
cumulative voting in the election of directors, which would
otherwise allow for less than a majority of stockholders to elect
director candidates;
●
limiting
the ability of stockholders to call special meetings of the
stockholders;
●
prohibiting
stockholder action by written consent and requiring all stockholder
actions to be taken at a meeting of our stockholders;
and
●
establishing
90 to 120-day advance notice requirements for nominations for
election to the board of directors and for proposing matters that
can be acted upon by stockholders at stockholder
meetings.
The rights of our common stockholders are limited by and
subordinate to the rights of the holders of Series D Preferred
Stock, Series E Preferred Stock, Series I Preferred Stock, Series J
Preferred Stock, Series K Preferred Stock and Series L Preferred
Stock; these rights may have a negative effect on the value of
shares of our common stock.
The holders of our Series D Preferred Stock,
Series E Preferred Stock, Series I Preferred Stock, Series J
Preferred Stock, Series K Preferred Stock and Series L Preferred
Stock have rights and preferences generally superior to those of
the holders of common stock. The existence of these superior rights
and preferences may have a negative effect on the value of shares
of our common stock. These rights are more fully set forth in the
Series D Preferred Stock certificate of designations, Series E
Preferred Stock certificate of designations, Series I Preferred
Stock certificate of designations, Series J Preferred Stock
certificate of designations,
Series K Preferred Stock certificate of
designations, and Series L Preferred Stock certificate of
designations, respectively, and include, but are not limited to the
right to receive a liquidation preference, prior to any
distribution of our assets to the holders of our common stock, in
an amount equal to $0.01 per share, or $441 for the Series D
Preferred Stock; $0.01 per share, or $333, for the Series E
Preferred Stock; $0.01 per share, or $7,985, for the Series I
Preferred Stock; $687.50 per share, or $531,252, for the Series J
Preferred Stock;
$0.01 per
share, or $632, for the Series K Preferred Stock; and $100.00 per
share, or $5,800,000, for the Series L Preferred
Stock.
We may fail to regain compliance for continued listing on the
NASDAQ Capital Market and a delisting of our stock could make it
more difficult for investors to sell their shares
Our
common stock was approved for listing on the
NASDAQ
Capital Market in August 2016 where
it continues to be listed. The listing rules of the
NASDAQ
Capital Market require the Company
to meet certain requirements. These continued listing standards
include specifically enumerated criteria, such as:
●
a $1.00
minimum closing bid price;
●
stockholders’
equity of $2.5 million;
●
500,000
shares of publicly-held common stock with a market value of at
least $1 million;
●
300
round-lot stockholders; and
●
compliance with the
NASDAQ
Capital Market’s
corporate governance requirements, as well as additional or more
stringent criteria that may be applied in the exercise of the
NASDAQ
Capital Market’s
discretionary authority.
On
September 6, 2017, the
NASDAQ
Capital Market informed the Company that it had failed to maintain
a minimum bid price of $1.00 per share for more than 30 consecutive
business days. The Company can regain compliance if, at any time
during the 180-day period ending March 5, 2018, the closing bid
price of the common stock is at least $1.00 for a minimum of ten
consecutive business days. On October 2, 2017, at a special meeting
of stockholders, our
Board of
Directors received approval, if the Board deems to be necessary to
achieve a higher stock price to continue to meet the continued
listing qualifications for the
NASDAQ
Capital Market
, to amend our Amended and Restated Certificate of
Incorporation to effect a reverse stock split of our issued and
outstanding common stock by a ratio of not less than one-for-two
and not more than one-for-twenty at any time prior to September 28,
2018, with the exact ratio to be set at a whole number within this
range as determined by the Board of Directors
in its sole direction to continue to meet the
continued listing qualifications for
the
NASDAQ
Capital Market
.
No decision has been made yet by our
Board of Directors to implement a reverse split. However, if we
were to effect such a reverse stock split, our stockholders may
bring actions against us in connection with that reverse stock
split that could divert management resources, cause us to incur
significant expenses or cause our common stock to be further
diluted. Continued listing during this period is also contingent on
our continued compliance with all listing requirements other than
for the minimum bid price. On August 22, 2017, the NASDAQ Capital
Market notified us that we also no longer satisfied the minimum
$2.5 million stockholders’ equity requirement as of June 30,
2017. As of September 30, 2017, we regained compliance with the
stockholders’ equity requirement.
If we
fail to comply with the
NASDAQ
Capital Market’s continued listing standards, we may be
delisted and our common stock will trade, if at all, only on the
over-the-counter market, such as the OTC Bulletin Board or OTCQX
market, and then only if one or more registered broker-dealer
market makers comply with quotation requirements. In
addition, delisting of our common stock could depress our stock
price, substantially limit liquidity of our common stock and
materially adversely affect our ability to raise capital on terms
acceptable to us, or at all.
Finally, delisting
of our common stock would likely result in our common stock
becoming a “penny stock” under the Exchange
Act. The principal result or effect of being designated
a “penny stock” is that securities broker-dealers
cannot recommend the shares but must trade it on an unsolicited
basis. Penny stock rules require a broker-dealer, prior to a
transaction in a penny stock not otherwise exempt from those rules,
to deliver a standardized risk disclosure document prepared by the
SEC, which specifies information about penny stocks and the nature
and significance of risks of the penny stock market. A
broker-dealer must also provide the customer with bid and offer
quotations for the penny stock, the compensation of the
broker-dealer and sales person in the transaction, and monthly
account statements indicating the market value of each penny stock
held in the customer’s account. In addition, the penny stock
rules require that, prior to a transaction in a penny stock not
otherwise exempt from those rules; the broker-dealer must make a
special written determination that the penny stock is a suitable
investment for the purchaser and receive the purchaser’s
written agreement to the transaction. These disclosure requirements
may have the effect of reducing the trading activity in the
secondary market for shares that become subject to those penny
stock rules. Under such circumstances, shareholders may find it
more difficult to sell, or to obtain accurate quotations, for our
common stock, and our common stock would become substantially less
attractive to certain purchasers such as financial institutions,
hedge funds and other similar investors.
Future sales of our securities, or the perception in the markets
that these sales may occur, could depress our stock
price.
Additional equity financings or other share
issuances by us, including shares issued in connection with
strategic alliances and corporate partnering transactions, could
adversely affect the market price of our common stock. As of
December 20, 2017, we had 18,668,610 shares held by our existing
shareholders available for resale pursuant to Rule 144 or resale
registration statements, upon conversion of Series D Preferred
Stock, Series E Preferred Stock, Series I Preferred Stock, Series J
Preferred Stock, Series K Preferred Stock and Series L Preferred
Stock. Sales by existing stockholders of a large number of shares
of our common stock in the public market or the perception that
additional sales could occur could cause the market price of our
common stock to drop.
Moreover, to the extent that
additional shares of our outstanding stock are registered, or
otherwise become eligible for resale, and are sold, or the holders
of such shares are perceived as intended to sell them, this could
further depress the market price of our common
stock. These factors could also make it more difficult
for us to raise capital or make acquisitions through the issuance
of additional shares of our common stock or other equity
securities.
If we do not progress in our programs as anticipated, our stock
price could decrease.
For
planning purposes, we estimate the timing of a variety of clinical,
regulatory and other milestones, such as when a certain product
candidate will enter clinical development, when a clinical trial
will be completed or when an application for regulatory approval
will be filed. Our estimates are based on present facts and a
variety of assumptions. Many of the underlying assumptions are
outside of our control. If milestones are not achieved when we
estimated that they would be, investors could be disappointed, and
our stock price may decrease.
Our stock price may be volatile; you may not be able to resell your
shares at or above your purchase price.
Our
stock prices and the market prices for securities of biotechnology
companies in general have been highly volatile, with recent
significant price and volume fluctuations, and may continue to be
highly volatile in the future. For example, during the 12 months
ended December 20, 2017, our common stock traded between $0.427 per
share and $4.25 per share. The following factors, in addition to
other risk factors described in this section, may have a
significant impact on the market price of our common stock, some of
which are beyond our control:
●
developments
regarding, or the results of, our clinical trials;
●
announcements
of technological innovations or new commercial products by our
competitors or us;
●
our
issuance of equity or debt securities, or disclosure or
announcements relating thereto;
●
developments
concerning proprietary rights, including patents;
●
developments
concerning our collaborations;
●
publicity
regarding actual or potential medical results relating to products
under development by our competitors or us;
●
regulatory
developments in the United States and foreign
countries;
●
litigation;
●
economic
and other external factors or other disaster or crisis;
or
●
period-to-period
fluctuations in our financial results.
Our common stock may be affected by limited trading volume and
price fluctuations which could adversely impact the value of our
common stock.
While
there has been relatively active trading in our common stock over
the past twelve months, there can be no assurance that an active
trading market in our common stock will be maintained. Our common
stock has experienced, and is likely to experience in the future,
significant price and volume fluctuations which could adversely
affect the market price of our common stock without regard to our
operating performance. In addition, we believe that factors such as
quarterly fluctuations in our financial results and changes in the
overall economy or the condition of the financial markets could
cause the price of our common stock to fluctuate substantially.
These fluctuations may also cause short sellers to periodically
enter the market in the belief that we will have poor results in
the future. We cannot predict the actions of market participants
and, therefore, can offer no assurances that the market for our
common stock will be stable or appreciate over time.
The number of shares of issued and outstanding common stock as of
December 20, 2017, represents approximately 45% of our fully
diluted shares of common stock. Additional issuances of shares of
common stock upon conversion and/or exercise of preferred stock,
options to purchase common stock and warrants to purchase common
stock will cause substantial dilution to existing
stockholders.
At
December 20, 2017, we had 20,588,765 shares of common stock issued
and outstanding. Up to an additional 18,668,610 shares may be
issued upon conversion of our Series D Preferred Stock, Series E
Preferred Stock, Series I Preferred Stock, Series J Preferred
Stock, Series K Preferred Stock, and Series L Preferred Stock;
1,268,056 shares issuable upon exercise of warrants at a weighted
average price of $6.37; 2,856,092 shares upon exercise of all
outstanding options to purchase our common stock at a weighted
average price of $4.65; and 2,496,671 shares issuable upon vesting
of restricted stock units granted, resulting in a total of up to
45,878,494 shares that may be issued and outstanding. The issuance
of any and all of the 25,289,429 shares issuable upon exercise or
conversion of our outstanding convertible securities will cause
substantial dilution to existing stockholders and may depress the
market price of our common stock.
If our common stock is not listed on a national securities
exchange, compliance with applicable state securities laws may be
required for subsequent offers, transfers and sales of the shares
of common stock offered hereby.
The securities offered hereby are being offered
pursuant to one or more exemptions from registration and
qualification under applicable state securities laws. Because our
common stock is listed on the
NASDAQ Capital Market, we are not required to
register or qualify in any state the subsequent offer, transfer or
sale of the common stock. If our common stock is delisted from the
NASDAQ Capital Market and is not eligible to be listed on another
national securities exchange, subsequent transfers of the shares of
our common stock offered hereby by U.S. holders may not be exempt
from state securities laws. In such event, it will be the
responsibility of the holder of shares or warrants to register or
qualify the shares for any subsequent offer, transfer or sale in
the United States or to determine that any such offer, transfer or
sale is exempt under applicable state securities
laws.
The rights of our common stockholders are limited by and
subordinate to the rights of the holders of Series D Preferred
Stock, Series E Preferred Stock, Series I Preferred Stock, Series J
Preferred Stock, Series K Preferred Stock and Series L Preferred
Stock; these rights may have a negative effect on the value of
shares of our common stock.
The
holders of our Series D Preferred Stock, Series E Preferred Stock,
Series I Preferred Stock, Series J Preferred Stock, Series K
Preferred Stock and Series L Preferred Stock have rights and
preferences generally superior to those of the holders of common
stock. The existence of these superior rights and preferences may
have a negative effect on the value of shares of our common stock.
These rights are more fully set forth in the Series D Preferred
Stock certificate of designations, Series E Preferred Stock
certificate of designations, Series I Preferred Stock certificate
of designations, Series J Preferred Stock certificate of
designations, Series K Preferred Stock certificate of designations,
and Series L Preferred Stock certificate of designations,
respectively, and include, but are not limited to the right to
receive a liquidation preference, prior to any distribution of our
assets to the holders of our common stock, in an amount equal to
$0.01 per share or $441 for the Series D Preferred Stock, $0.01 per
share or $333 for the Series E Preferred Stock, $0.01 per share or
$7,985 for the Series I Preferred Stock, $687.50 per share or
approximately $531,252 for the Series J Preferred Stock, $0.01 per
share or $632 for the Series K Preferred Stock and $100.00 per
share or approximately $5.8 million for the Series L Preferred
Stock.
You will experience future dilution as a result of future equity
offerings
We
may in the future offer additional shares of our common stock or
other securities convertible into or exchangeable for our common
stock. Although no assurances can be given that we will
consummate a financing, in the event we do, or in the event we sell
shares of common stock or other securities convertible into shares
of our common stock in the future, additional and substantial
dilution will occur. In addition, investors purchasing
shares or other securities in the future could have rights superior
to investors in this offering.
CAUTIONAR
Y
NOTE REGARDING
FORWARD-LOOKING STATEMENTS
This
prospectus contains “forward-looking statements”, which
represent the Company’s current expectations or beliefs
including, but not limited to, statements concerning the
Company’s operations, performance, financial condition and
growth. For this purpose, any statements contained in this
prospectus that are not statements of historical fact are
forward-looking statements. Without limiting the generality of the
foregoing, words such as “may”,
“anticipation”, “intend”,
“could”, “estimate”, or
“continue” or the negative or other comparable
terminology are intended to identify forward-looking statements.
These statements by their nature involve substantial risks and
uncertainties, such as credit losses, dependence on management and
key personnel, variability of quarterly results, and the ability of
the Company to continue its growth strategy and competition,
certain of which are beyond the Company’s control. Should one
or more of these risks or uncertainties materialize or should the
underlying assumptions prove incorrect, actual outcomes and results
could differ materially from those indicated in the forward-looking
statements.
Any
forward-looking statement speaks only as of the date on which such
statement is made, and the Company undertakes no obligation to
update any forward-looking statement or statements to reflect
events or circumstances after the date on which such statement is
made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time and it is not possible for
management to predict all of such factors, nor can it assess the
impact of each such factor on the business or the extent to which
any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements.
USE
O
F
PROCEEDS
The
shares of common stock offered hereby are being registered for the
account of the Selling Stockholders named in this prospectus. As a
result, all proceeds from the sales of the common stock will go to
the Selling Stockholders and we will not receive any proceeds from
the resale of the common stock by the Selling
Stockholders.
The
Selling Stockholders may sell the common shares issued to them from
time-to-time at prices and at terms then prevailing or at prices
related to the then current market price, or in negotiated
transactions.
SELLING ST
O
CKHOLDERS
The
table below based upon information currently known by us, sets
forth as of December 20, 2017, (i) the number of shares held of
record or beneficially by the Selling Stockholders as of such date
(as determined below) and (ii) the number of shares that may be
sold or otherwise disposed of under this prospectus by each Selling
Stockholder. We will not receive any proceeds from the resale
of the common stock by the Selling Stockholders. Assuming all the
shares registered below are sold by the Selling Stockholders, none
of the Selling Stockholders will continue to own any shares of our
common stock issued to them pursuant to the Plan, including shares
of common stock issuable upon exercise of options issued pursuant
to the Plan. Beneficial ownership includes shares of common
stock plus any securities held by the holder exercisable for or
convertible into shares of common stock within 60 days
after December 20, 2017, in accordance with Rule 13d-3(d)(1)
under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”). The inclusion of any shares in this
table does not constitute an admission of beneficial ownership for
the Selling Stockholder named below. We do not know when or in what
amounts a Selling Stockholder may sell or otherwise dispose of the
shares of common stock covered hereby. The Selling Stockholders may
not sell or otherwise dispose of any or all of the shares offered
by this prospectus and may sell or otherwise dispose of shares
covered hereby in transactions exempt from the registration
requirements of the Securities Act. Because the Selling
Stockholders may sell or otherwise dispose of some, all or none of
the shares covered hereby, and because there are currently no
agreements, arrangements or understandings with respect to the sale
of any of the shares, we cannot estimate the number of the shares
that will be held by the Selling Stockholders after completion of
the offering. However, for purposes of the following table, we have
assumed that all of the shares covered hereby are sold by the
Selling Stockholders pursuant to this prospectus.
All
Selling Stockholders named are current or former officers or
directors of us. Unless otherwise indicated below, to our
knowledge, all persons named in the table have sole voting and
investment power with respect to their shares of common stock,
except to the extent authority is shared by their spouses under
applicable law. Unless otherwise indicated below, to our
knowledge, no persons named in the table are a broker-dealer or
affiliate of a broker-dealer. Unless otherwise indicated, all
addresses are c/o MabVax Therapeutics Holdings, Inc., 11535
Sorrento Valley Road, Suite 400, San Diego, CA 92121.
We
will, from time to time, supplement this prospectus in order to
reflect grants under the Plan and/or to name grantees who are
officers and/or directors as Selling Stockholders.
|
Name of Director and Officer
|
Shares Beneficially Owned
Prior to Offering
(1)
|
|
Percent
Beneficially Owned
Prior to Offering
|
Number of
Shares Offered
(2)
|
|
Number of Shares
Beneficially Owned
After Offering
|
|
Percent
Beneficially Owned
After Offering
(1)
|
|
|
J. David
Hansen
|
1,427,911
|
(3
)
|
6.51
%
|
1,357,310
|
(4)
|
70,601
|
|
*
|
%
|
|
Philip O.
Livingston
|
346,519
|
(5
)
|
1.67
%
|
153,238
|
(6)
|
193,281
|
(7
)
|
*
|
%
|
|
Gregory P.
Hanson
|
541,457
|
(8
)
|
2.57
%
|
503,123
|
(9)
|
38,334
|
|
*
|
%
|
|
Kenneth M.
Cohen
|
174,480
|
(10
)
|
*
|
160,685
|
(11)
|
13,795
|
(12
)
|
*
|
%
|
|
Paul W.
Maffuid
|
474,478
|
(13
)
|
2.26
%
|
447,167
|
(14)
|
27,311
|
|
*
|
%
|
|
Paul V.
Maier
|
164,447
|
(15
)
|
*
|
160,685
|
(16)
|
3,762
|
|
*
|
%
|
|
Thomas C.
Varvaro
|
162,169
|
(17
)
|
*
|
159,083
|
(18)
|
3,086
|
|
*
|
%
|
|
Jeffrey F.
Eisenberg
|
153,020
|
(19
)
|
*
|
153,020
|
(19)
|
0
|
|
*
|
%
|
|
Paul
Resnick
|
60,237
|
(20
)
|
*
|
60,237
|
(20)
|
0
|
|
*
|
%
|
|
TOTAL
|
|
|
|
3,154,548
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*Less
than 1%
(1)
Based upon
20,588,765 shares of our common stock issued and outstanding on
December 20, 2017.
(2)
Assumes the
exercise and sale of all options, awards and restricted stock
grants being offered by the Selling Stockholders.
(3)
Includes (i) 727,210 restricted stock units vesting within 60 days
of December 20, 2017 and (ii) 630,100 shares subject to options
exercisable within 60 days of December 20, 2017.
(4)
Represents (i) 727,210 restricted stock units vesting within
60 days of December 20, 2017 and (ii) 630,100 shares subject to
options exercisable within 60 days of December 20,
2017.
(5)
Includes (i) 176,675 shares held by RTP Venture Fund, (ii) 14,885
shares held by Philip O. Livingston, (iii) 1,721 shares held by the
Joan L. Tweedy 2011 Revocable Trust, or the Tweedy Trust, (iv)
100,000 restricted stock units vesting within 60 days of December
20, 2017, and (v) 53,238 shares subject to options exercisable
within 60 days of December 20, 2017 held by Philip O. Livingston.
Voting and dispositive decisions of RTP Venture Fund, LLC are made
by Philip Livingston, and Philip O. Livingston is a trustee of the
Tweedy Trust. The address for RTP Venture Fund, LLC is 156 E. 79th
Street, Apt. 6C, New York, NY 10075.
(6)
Represents (i)
100,000 restricted stock units
vesting within 60 days of December 20, 2017, and (ii) 53,238 shares
subject to options exercisable within 60 days of December 20,
2017.
(7)
Represents
(i) 176,675 shares held by RTP Venture Fund, (ii) 14,885 shares
held by Philip O. Livingston, and (iii) 1,721 shares held by the
Joan L. Tweedy 2011 Revocable Trust, or the Tweedy Trust. Voting
and dispositive decisions of RTP Venture Fund, LLC are made by
Philip Livingston, and Philip O. Livingston is a trustee of the
Tweedy Trust. The address for RTP Venture Fund, LLC is 156 E. 79th
Street, Apt. 6C, New York, NY 10075.
(8)
Includes (i) 449,159 restricted stock units vesting within 60 days
of December 20, 2017 and (ii) 53,964 shares subject to options
exercisable within 60 days of December 20, 2017.
(9)
Represents (i) 449,159 restricted stock units vesting within 60
days of December 20, 2017 and (ii) 53,964 shares subject to options
exercisable within 60 days of December 20, 2017.
(10)
Includes (i) 100,000 restricted stock units vesting within 60 days
of December 20, 2017, (ii) 60,685 shares subject to options
exercisable within 60 days of December 20, 2017, and (iii) 6,238
shares of common stock issuable upon exercise of outstanding
warrants.
(11)
Represents (i) 100,000 restricted stock units vesting within 60
days of December 20, 2017 and (ii) 60,685 shares subject to options
exercisable within 60 days of December 20, 2017.
(12)
Includes 6,238 shares of common stock issuable upon
exercise of outstanding warrants.
(13)
Includes (i) 406,382 restricted stock units vesting within 60 days
of December 20, 2017 and (ii) 40,785 shares subject to options
exercisable within 60 days of December 20, 2017.
(14)
Represents (i) 406,382 restricted stock units vesting within 60
days of December 20, 2017 and (ii) 40,785 shares subject to options
exercisable within 60 days of December 20, 2017.
(15)
Includes (i) 100,000 restricted stock units vesting within 60 days
of December 20, 2017 and (ii) 60,685 shares subject to options
exercisable within 60 days of December 20, 2017.
(16)
Represents (i) 100,000 restricted stock units vesting within 60
days of December 20, 2017 and (ii) 60,685 shares subject to options
exercisable within 60 days of December 20, 2017.
(17)
Includes (i) 100,000 restricted stock units vesting within 60 days
of December 20, 2017 and (ii) 59,083 shares subject to options
exercisable within 60 days of December 20, 2017.
(18)
Includes (i) 100,000 restricted stock units vesting within 60 days
of December 20, 2017 and (ii) 53,020 shares subject to options
exercisable within 60 days of December 20, 2017.
(19)
Represents (i) 100,000 restricted stock units vesting within 60
days of December 20, 2017 and (ii) 53,020 shares subject to options
exercisable within 60 days of December 20, 2017.
(20)
Represents (i) 29,944 restricted stock units vesting within
60 days of December 20, 2017 and (ii) 30,293 shares subject to
options exercisable within 60 days of December 20,
2017.
PLAN O
F
DISTRIBUTION
Timing of Sales
The
Selling Stockholders may offer and sell the shares covered by this
prospectus at various times. The Selling Stockholders will act
independently of our Company in making decisions with respect to
the timing, manner and size of each sale.
No Known Agreements to Resell the Shares
To
our knowledge, no Selling Stockholder has any agreement or
understanding, directly or indirectly, with any person to resell
the common stock covered by this prospectus.
Offering Price
The
sales price offered by the Selling Stockholders to the public may
be:
●
the
market price prevailing at the time of sale;
●
a
price related to such prevailing market price; or
●
such
other price as the Selling Stockholders determine from time to
time.
Manner of Sale
The
common stock may be sold by means of one or more of the following
methods:
●
a
block trade in which the broker-dealer so engaged will attempt to
sell the common shares as agent, but may position and resell a
portion of the block as principal to facilitate the
transaction;
●
purchases
by a broker-dealer as principal and resale by that broker-dealer
for its account pursuant to this prospectus;
●
ordinary
brokerage transactions in which the broker solicits
purchasers;
●
through
options, swaps or derivatives;
●
in
transactions to cover short sales;
●
privately
negotiated transactions; or
●
in
a combination of any of the above methods.
The
Selling Stockholders may sell their common stock directly to
purchasers or may use brokers, dealers, underwriters or agents to
sell their common stock. Brokers or dealers engaged by the Selling
Stockholders may arrange for other brokers or dealers to
participate. Brokers or dealers may receive commissions, discounts
or concessions from the Selling Stockholders, or, if any such
broker-dealer acts as agent for the purchaser of common stock, from
the purchaser in amounts to be negotiated immediately prior to the
sale. The compensation received by brokers or dealers may, but is
not expected to, exceed that which is customary for the types of
transactions involved.
Broker-dealers
may agree with a Selling Stockholder to sell a specified number of
common stock at a stipulated price per common stock, and, to the
extent the broker-dealer is unable to do so acting as agent for a
Selling Stockholder, to purchase as principal any unsold common
stock at the price required to fulfill the broker-dealer commitment
to the Selling Stockholder.
Broker-dealers
who acquire stock as principal may thereafter resell the common
stock from time to time in transactions, which may involve block
transactions and sales to and through other broker-dealers,
including transactions of the nature described above, on the NASDAQ
Capital Market or otherwise at prices and on terms then prevailing
at the time of sale, at prices then related to the then-current
market price or in negotiated transactions. In connection with
resales of the common stock, broker-dealers may pay to or receive
from the purchasers of shares commissions as described
above.
If
our Selling Stockholders enter into arrangements with brokers or
dealers, as described above, we are obligated to file a
post-effective amendment to this registration statement disclosing
such arrangements, including the names of any broker-dealers acting
as underwriters.
The
Selling Stockholders and any broker-dealers or agents that
participate with the Selling Stockholders in the sale of the common
stock may be deemed to be “underwriters” within the
meaning of the Securities Act. In that event, any commissions
received by broker-dealers or agents and any profit on the resale
of the common stock purchased by them may be deemed to be
underwriting commissions or discounts under the Securities
Act.
We
will make copies of this prospectus available to the Selling
Stockholders for the purpose of satisfying the prospectus delivery
requirements of the Securities Act.
Sales Pursuant to Rule 144
Any
common stock covered by this prospectus which qualifies for sale
pursuant to Rule 144 under the Securities Act may be sold
under Rule 144 rather than pursuant to this
prospectus.
Regulation M
Each
Selling Stockholder will be subject to the applicable provisions of
the Exchange Act, and the associated rules and regulations under
the Exchange Act, including Regulation M, which provisions may
limit the timing of purchases and sales of shares of our Common
Stock by the Selling Stockholders.
Accordingly,
during such times as a Selling Stockholder may be deemed to be
engaged in a distribution of the common stock, and therefore be
considered to be an underwriter, the Selling Stockholder must
comply with applicable law and, among other things:
●
may
not engage in any stabilization activities in connection with our
common stock;
●
may
not cover short sales by purchasing shares while the distribution
is taking place; and
●
may
not bid for or purchase any of our securities or attempt to induce
any person to purchase any of our securities other than as
permitted under the Exchange Act.
Penny Stock Rules
The
SEC has adopted regulations which generally define “penny
stock” to be any equity security that has a market price (as
defined) of less than $4.00 per share or an exercise price of less
than $4.00 per share, subject to certain exceptions. Our securities
are covered by the penny stock rules, which impose additional sales
practice requirements on broker-dealers who sell to persons other
than established customers and “institutional accredited
investors.” The term “institutional accredited
investor” refers generally to those accredited investors who
are not natural persons and fall into one of the categories of
accredited investor specified in subparagraphs (1), (2), (3),
(7) or (8) of Rule 501 of Regulation D
promulgated under the Securities Act, including institutions with
assets in excess of $5,000,000.
The
penny stock rules require a broker-dealer, prior to a
transaction in a penny stock not otherwise exempt from the rules,
to deliver a standardized risk disclosure document in a form
required by the Securities and Exchange Commission, obtain from the
customer a signed and dated acknowledgement of receipt of the
disclosure document and to wait two business days before effecting
the transaction. The risk disclosure document provides information
about penny stocks and the nature and level of risks in the penny
stock market. The broker-dealer also must provide the customer with
current bid and offer quotations for the penny stock, the
compensation of the broker-dealer and its salesperson in the
transaction and monthly account statements showing the market value
of each penny stock held in the customer’s
account.
The
bid and offer quotations, and the broker-dealer and salesperson
compensation information, must be given to the customer orally or
in writing prior to effecting the transaction and must be given to
the customer in writing before or with the customer’s
confirmation. In addition, the penny stock rules require that
prior to a transaction in a penny stock not otherwise exempt from
these rules, the broker-dealer must make a special written
determination that the penny stock is a suitable investment for the
purchaser and receive the purchaser’s written agreement to
the transaction.
These
disclosure requirements may have the effect of reducing the level
of trading activity in the secondary market for the stock that is
subject to these penny stock rules. Consequently, these penny stock
rules may affect the ability of broker-dealers to trade our
securities. We believe that the penny stock rules discourage
investor interest in and limit the marketability of our common
stock.
State Securities Laws
Under
the securities laws of some states, the common stock may be sold in
such states only through registered or licensed brokers or dealers.
In addition, in some states the common stock may not be sold unless
the shares have been registered or qualified for sale in the state
or an exemption from registration or qualification is available and
is complied with.
Expenses of Registration
We
are bearing all costs relating to the registration of the common
stock. These expenses are estimated to be $10,000, including, but
not limited to, legal, accounting, printing and mailing fees. The
Selling Stockholders, however, will pay any commissions or other
fees payable to brokers or dealers in connection with any sale of
the common stock.
LE
G
AL
MATTERS
The
validity of the issuance of the securities offered hereby will be
passed upon for us by Sichenzia Ross Ference Kesner LLP. Additional
legal matters may be passed upon for us or any underwriters,
dealers or agents, by counsel that we will name in the applicable
prospectus supplement.
EX
P
ERTS
The
consolidated financial statements of MabVax Therapeutics Holdings,
Inc. as of December 31, 2016 and 2015, and for the years then ended
incorporate by reference in this registration statement have been
so incorporated in reliance on the report of CohnReznick LLP, an
independent registered public accounting firm, which included an
explanatory paragraph about MabVax Therapeutics Holdings,
Inc.’s ability to continue as a going concern, given on the
authority of the said firm as experts in auditing and
accounting.
INTERESTS OF NAM
E
D EXPERTS AND COUNSEL
No
expert or counsel named in this prospectus as having prepared or
certified any part of this prospectus or having given an opinion
upon the validity of the securities being registered or upon other
legal matters in connection with the registration or offering of
the common stock was employed on a contingency basis or had, or is
to receive, in connection with the offering, a substantial
interest, directly or indirectly, in the registrant or any of its
parents or subsidiaries.
INCORPORATION OF CERT
A
IN DOCUMENTS BY REFERENCE
We
have filed a registration statement on Form S-8 with the
Securities and Exchange Commission under the Securities Act. This
prospectus is part of the registration statement but the
registration statement includes and incorporates by reference
additional information and exhibits.
The
Securities and Exchange Commission permits us to "incorporate by
reference" the information contained in documents we file with the
Securities and Exchange Commission, which means that we can
disclose important information to you by referring you to those
documents rather than by including them in this prospectus.
Information that is incorporated by reference is considered to be
part of this prospectus and you should read it with the same care
that you read this prospectus. Information that we file later with
the Securities and Exchange Commission will automatically update
and supersede the information that is either contained, or
incorporated by reference, in this prospectus, and will be
considered to be a part of this prospectus from the date those
documents are filed. We have filed with the Securities and Exchange
Commission, and incorporate by reference in this
prospectus:
●
Annual
Report on Form 10-K for the year ended December 31, 2016 filed with
the SEC on March 1, 2017;
●
Quarterly Reports
on Form 10-Q for the quarters ended March 31, 2017, June 30, 2017
and September 30, 2017 filed with the SEC on May 22, 2017, August
14, 2017 and November 7, 2017, respectively;
Current Reports on
Form 8-K or Form 8-K/A (excluding any reports or portions
thereof that are deemed to be furnished and not filed) filed on May
3, 2017, May 10, 2017, May 16, 2016, May 22, 2017, May 26, 2017,
June 15, 2017, July 3, 2017, August 8, 2017, August 14, 2017,
August 14, 2017, August 22, 2017, August 29, 2017, September 8,
2017, September 8, 2017, September 12, 2017, September 13, 2017,
September 22, 2017, September 28, 2017, October 3, 2017, October 6,
2017, October 11, 2017, October 11, 2017, October 19, 2017,
November 16, 2017, November 22, 2017, and December 1, 2017
;
and
●
The
description of the Common Stock contained in our Form 8-A filed on
August 16, 2016.
We
also incorporate by reference all additional documents that we file
with the Securities and Exchange Commission under the terms of
Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act that
are made after the date of the initial registration statement but
prior to effectiveness of the registration statement and after the
date of this prospectus but prior to the termination of the
offering of the securities covered by this prospectus. We are not,
however, incorporating, in each case, any documents or information
that we are deemed to furnish and not file in accordance with
Securities and Exchange Commission rules.
You
may request, and we will provide you with, a copy of these filings,
at no cost, by calling us at (303) 794-2000 or by writing to us at
the following address: MabVax Therapeutics Holdings, Inc., 11535
Sorrento Valley Road, Suite 400, San Diego, CA 92121.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Subsection
(a) of Section 145 of the General Corporation Law of
Delaware, or the DGCL, empowers a corporation to indemnify any
person who was or is a party or is threatened to be made a party to
any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative (other
than an action by or in the right of the corporation) by reason of
the fact that he is or was a director, employee or agent of the
corporation or is or was serving at the request of the corporation
as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise, against
expenses (including attorneys’ fees), judgments, fines and
amounts paid in settlement actually and reasonably incurred by him
in connection with such action, suit or proceeding if he acted in
good faith and in a manner he reasonably believed to be in or not
opposed to the best interests of the corporation and, with respect
to any criminal action or proceeding, had no reasonable cause to
believe his conduct was unlawful.
Subsection
(b) of Section 145 of the DGCL empowers a corporation to
indemnify any person who was or is a party or is threatened to be
made a party to any threatened, pending or completed action or suit
by or in the right of the corporation to procure a judgment in its
favor by reason of the fact that such person acted in any of the
capacities set forth above, against expenses (including
attorneys’ fees) actually and reasonably incurred by him in
connection with the defense or settlement of such action or suit if
he acted in good faith and in a manner he reasonably believed to be
in or not opposed to the best interests of the corporation and
except that no indemnification may be made with respect to any
claim, issue or matter as to which such person shall have been
adjudged to be liable to the corporation unless and only to the
extent that the Court of Chancery or the court in which such action
or suit was brought shall determine upon application that, despite
the adjudication of liability but in view of all of the
circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the Court of Chancery
or such other court shall deem proper.
Section 145
of the DGCL further provides that to the extent a director,
officer, employee or agent of a corporation has been successful on
the merits or otherwise in the defense of any action, suit or
proceeding referred to in subsections (a) and (b) or in
the defense of any claim, issue or matter therein, he shall be
indemnified against expenses (including attorneys’ fees)
actually and reasonably incurred by him in connection therewith;
that indemnification or advancement of expenses provided for by
Section 145 shall not be deemed exclusive of any other rights
to which the indemnified party may be entitled; and empowers the
corporation to purchase and maintain insurance on behalf of a
director, officer, employee or agent of the corporation against any
liability asserted against him or incurred by him in any such
capacity or arising out of his status as such whether or not the
corporation would have the power to indemnify him against such
liabilities under Section 145.
Reference
is also made to Section 102(b)(7) of the DGCL, which enables a
corporation in its certificate of incorporation to eliminate or
limit the personal liability of a director for monetary damages for
violations of a director’s fiduciary duty, except for
liability (i) for any breach of the director’s duty of
loyalty to the corporation or its stockholders, (ii) for acts
or omissions not in good faith or which involve intentional
misconduct or a knowing violation of law, (iii) under
Section 174 of the DGCL (providing for liability of directors
for unlawful payment of dividends or unlawful stock purchases or
redemptions) or (iv) for any transaction from which the
director derived an improper personal benefit. Our amended and
restated certificate of incorporation provides that we must
indemnify our directors to the fullest extent under applicable law.
Pursuant to Delaware law, this includes elimination of liability
for monetary damages for breach of the directors’ fiduciary
duty of care to MabVax Holdings and its stockholders. However, our
directors may be personally liable for liability:
●
for
any breach of duty of loyalty to us or to our
stockholders;
●
for
acts or omissions not in good faith or that involve intentional
misconduct or a knowing violation of law;
●
for
unlawful payment of dividends or unlawful stock repurchases or
redemptions; or
●
for
any transaction from which the director derived an improper
personal benefit.
In
addition, our amended and restated bylaws provide
that:
●
we
are required to indemnify our directors and executive officers to
the fullest extent not prohibited by Delaware law or any other
applicable law, subject to limited exceptions;
●
we
may indemnify our other officers, employees and other agents as set
forth in Delaware law or any other applicable law;
●
we
are required to advance expenses to our directors and executive
officers as incurred in connection with legal proceedings against
them for which they may be indemnified; and
●
the
rights conferred in the amended and restated bylaws are not
exclusive.
This
prospectus is part of a Registration Statement on Form S-8
that we filed with the SEC. As permitted by the SEC's rules, this
prospectus and any prospectus supplement, which form a part of the
registration statement, do not contain all the information that is
included in the registration statement. You will find
additional information about us in the registration
statement. Any statements made in this prospectus or any
prospectus supplement concerning legal documents are not
necessarily complete and you should read the documents that are
filed as exhibits to the registration statement or otherwise filed
with the SEC for a more complete understanding of the document or
matter.
We
file annual, quarterly and current reports, proxy statements and
other information with the SEC. You may read, without charge,
and copy the documents we file at the SEC's public reference rooms
in Washington, D.C. at 100 F Street, NE, Room 1580, Washington, DC
20549, or in New York, New York and Chicago, Illinois. You
can request copies of these documents by writing to the SEC and
paying a fee for the copying cost. Please call the SEC at
1-800-SEC-0330 for further information on the public reference
rooms. Our SEC filings are also available to the public at no
cost from the SEC's website at http://www.sec.gov. In
addition, we make available on or through our Internet site copies
of these reports as soon as reasonably practicable after we
electronically file or furnish them to the SEC. Our Internet site
can be found at www.mabvax.com.
3,154,548 SHARES OF COMMON STOCK
REOFFER PROSPECTUS
December 20, 2017
P
A
RT II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
ITEM 3. INCORPORATION OF DOCUMENTS BY REFERENCE
The
Company hereby incorporates by reference into this Registration
Statement the documents listed below. In addition, all documents
subsequently filed pursuant to Sections 13(a), 13(c), 14 and 15(d)
of the Exchange Act that are made after the date of the initial
registration statement but prior to effectiveness of the
registration statement and after the date of this prospectus but
prior to the termination of the offering of the securities covered
by this prospectus, shall be deemed to be incorporated by reference
into this Registration Statement and to be a part hereof from the
date of filing of such documents.
●
Annual
Report on Form 10-K for the year ended December 31, 2016 filed with
the SEC on March 1, 2017;
●
Quarterly Reports
on Form 10-Q for the quarters ended March 31, 2017, June 30, 2017
and September 30, 2017 filed with the SEC on May 22, 2017, August
14, 2017 and November 7, 2017, respectively;
Current Reports on
Form 8-K or Form 8-K/A (excluding any reports or portions
thereof that are deemed to be furnished and not filed) filed on May
3, 2017, May 10, 2017, May 16, 2016, May 22, 2017, May 26, 2017,
June 15, 2017, July 3, 2017, August 8, 2017, August 14, 2017,
August 14, 2017, August 22, 2017, August 29, 2017, September 8,
2017, September 8, 2017, September 12, 2017, September 13, 2017,
September 22, 2017, September 28, 2017, October 3, 2017, October 6,
2017, October 11, 2017, October 11, 2017, October 19, 2017,
November 16, 2017, November 22, 2017, and December 1, 2017
;
and
●
The
description of the Common Stock that is contained in our Form 8-A
filed on August 16, 2016.
Item 8. Exhibits.
A list
of exhibits included as part of this Registration Statement is set
forth in the Exhibit Index to this Registration Statement and is
incorporated herein by reference.
SIG
N
ATURES
Pursuant to the
requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets
all of the requirements for filing on Form S-8 and has duly caused
this Registration Statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of San Diego,
State of California, on December 20, 2017.
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MABVAX THERAPEUTICS
HOLDINGS, INC.
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By:
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/s/
J.
David Hansen
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J. David
Hansen
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President and
Chief Executive Officer
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By:
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/s/
Gregory
P. Hanson
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Gregory
P. Hanson
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Chief
Financial Officer
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SIGNATURES A
N
D POWER OF
ATTORNEY
Each
person whose signature appears below constitutes and appoints J.
David Hansen and Gregory P. Hanson, and each of them singly, his
true and lawful attorneys-in-fact and agents, with full power of
substitution and resubstitution in each of them singly, for him and
in his name, place and stead, and in any and all capacities, to
sign any and all amendments (including post-effective amendments)
to this Registration Statement on Form S-8 of MabVax Therapeutics
Holdings, Inc., and to file the same, with all exhibits thereto and
other documents in connection therewith, with the Securities and
Exchange Commission, granting to the attorneys-in-fact and agents,
and each of them, full power and authority to do and perform each
and every act and thing requisite or necessary to be done in or
about the premises, as full to all intents and purposes as he might
or could do in person, hereby ratifying and confirming all that the
attorneys-in-fact and agents or any of each of them or their
substitute may lawfully do or cause to be done by virtue
hereof.
Pursuant to the
requirements of the Securities Act of 1933, this Registration
Statement has been signed by the following persons in the
capacities and on the dates indicated.
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Signature
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Title
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Date
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/s/ J. David
Hansen
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Chairman
of the Board, President and
Chief
Executive Officer
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December
20, 2017
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J.
David Hansen
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(Principal
executive officer)
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/s/ Gregory P.
Hanson
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Chief
Financial Officer
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December
20, 2017
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Gregory P.
Hanson
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(Principal
financial and accounting officer)
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/s/ Kenneth M.
Cohen
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Director
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December
20, 2017
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Kenneth M.
Cohen
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/s/ Philip O.
Livingston
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Director
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December
20, 2017
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Philip
O. Livingston, M.D.
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/s/ Paul V.
Maier
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Director
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December
20, 2017
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Paul
V. Maier
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/s/ Thomas C.
Varvaro
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Director
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December
20, 2017
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Thomas
Varvaro
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/s/ Jeffrey F.
Eisenberg
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Director
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December
20, 2017
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Jeffrey
Eisenberg
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INDEX TO EXHIBITS
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Exhibit
No.
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Description
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Form
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Filing
Date/Period
End
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Exhibit
Number
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Form
of Common Stock Certificate
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S-1
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09/29/2014
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4.1
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5.1
*
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Opinion of Sichenzia Ross Ference Kesner LLP, as to the legality of
the securities being registered
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23.1
*
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Consent of Independent Registered Public Accounting
Firm
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23.2
*
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Consent of Sichenzia Ross Ference Kesner LLP (included as part of
Exhibit 5.1)
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24.1
*
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Power of Attorney (included on the signature page to this
Registration Statement)
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99.1
*
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Fifth
Amended and Restated MabVax Therapeutics Holdings, Inc. 2014
Employee, Director and Consultant Equity Incentive
Plan
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*
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Filed herewith
|
Unless
otherwise indicated, the above referenced exhibits are all
incorporated by referenced herein from the original form on which
such exhibit was originally filed.
II-3
