Exhibit 2.1
CERTIFICATE OF OWNERSHIP AND MERGER
MERGING
REZOLUTE, INC.
(a Delaware corporation)
INTO
ANTRIABIO, INC.
(a Delaware corporation)
AntriaBio, Inc., a Delaware corporation
(the “Company”), in accordance with Section 253 of the Delaware General Corporation Law, does hereby certify as follows:
1. The
Company is incorporated pursuant to the laws of the Delaware General Corporation Law.
2. The
Company owns all of the outstanding shares of common stock of Rezolute, Inc., a Delaware corporation (the “Subsidiary”).
The Subsidiary has no shares of any other class or series of stock outstanding.
3. The
Company, by the following resolutions of its Board of Directors, duly adopted on December 2, 2017, determined to merge into itself
the Subsidiary on the conditions set forth in such resolutions:
WHEREAS
, this Board of Directors
desires to approve the merger of Rezolute, Inc., a wholly-owned Delaware subsidiary of the Company (the “Subsidiary”),
with and into the Company and establish the terms and conditions of such merger in accordance with the provisions of Section 253
of the Delaware General Corporation Law;
NOW BE IT, RESOLVED
, that the merger of the Subsidiary with and into the Company pursuant to the provisions of Section 253
of the Delaware General Corporation Law and the provisions set forth below is hereby approved.
RESOLVED
, that, on the date
that is ten (10) calendar days from the date a Certificate of Ownership and Merger is filed with the Delaware Secretary of State
(the “Effective Date”), the identity, existence, purposes, powers, objects, franchises, privileges, rights and immunities
of the Company shall continue in effect and unimpaired by the merger, and the corporate franchises, existence and rights of the
Subsidiary shall be merged into the Company and the Company shall, as the surviving corporation, be fully vested therewith; and,
further, that the separate existence and corporate organization of the subsidiary, except as they may continue by statute, shall
cease of the Effective Date.
RESOLVED
, that, as of the
Effective Date, all shares of the Subsidiary’s Common Stock held by the Company shall be cancelled.
RESOLVED
, that the Certificate
of Incorporation of the Company shall continue to be the Certificate of Incorporation of the Company as the surviving corporation
and shall remain in effect until it shall be amended or altered in accordance with the provisions thereof; provided, however, that
Article I of such Certificate of Incorporation shall be amended to read as follows:
“FIRST: The Name of the
Corporation is Rezolute, Inc.”
RESOLVED
, that the officers
of the Company are hereby authorized and directed to execute a Certificate of Ownership and Merger in accordance with the terms
set forth in these resolutions and to file, or tender for filing, and record and take such other action as may be necessary to
effectuate the merger and the actions contemplated hereby in any and all jurisdictions where such filing, recording or other action
shall be required.
4. The
Certificate of Ownership and Merger shall be effective on December 18, 2017.
IN WITNESS WHEREOF
, the undersigned
has signed his name and affirmed that this instrument is the act and deed of the Company and that the statements herein are true,
under penalties of perjury, this 6
th
day of December, 2017.
[The remainder of this page is intentionally
left blank.]
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ANTRIABIO, INC.,
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a Delaware corporation
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By:
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/s/ Nevan Elam
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Name: Nevan Elam
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Title: Chief Executive Officer
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Exhibit 99.1
AntriaBio Announces Exclusive License
Agreement for a Phase 2 Orphan Disease Therapy with XOMA Corporation and Name Change to Rezolute, Inc.
LOUISVILLE, Colorado, December 7, 2017 – (GLOBE NEWSWIRE)
–
Rezolute, Inc.
(“Rezolute” or the “Company”) (OTCQB: ANTB),
a
clinical
stage biopharmaceutical company specializing in the development of innovative drug therapies for metabolic and orphan diseases,
and
XOMA Corporation
(“XOMA”) (NASDAQ: XOMA)
, a pioneer in the discovery, development and licensing
of therapeutic antibodies,
announced today
that they have executed a license agreement
that provides Rezolute with the exclusive global rights to develop and commercialize
RZ358
(formerly
XOMA 358
) for
Congenital Hyperinsulinism (CHI), an ultra-orphan indication.
RZ358 is a first-in-class fully human monoclonal antibody that
counteracts the effects of elevated insulin via allosteric modulation of the insulin receptor, making it well-suited as a therapy
for severe, persistent hypoglycemia caused by hyperinsulinemic conditions such as CHI. XOMA demonstrated clinical proof-of-concept
through Phase 2a studies and Rezolute plans to advance clinical development in 2018. The compound has received designated orphan
status in the US and European Union.
“We are excited about the addition of RZ358 to our growing
product pipeline and for the opportunity to take a Phase 2 program forward with the hope of being able to offer a significantly
better treatment option for a disease that is the most frequent cause of severe, persistent hypoglycemia in newborn babies and
children,” said Nevan Elam, Chairman and Chief Executive Officer of Rezolute. “XOMA has generated compelling safety
data and proof-of-concept for RZ358 and we look forward to advancing its development.”
Under the terms of the agreement, Rezolute will assume the
global development, regulatory filings, manufacturing and commercialization for RZ358. In turn, XOMA will receive a total of $18
million in the form of cash and shares of Rezolute common stock and will be eligible to receive up to an aggregate of $222 million
in clinical, regulatory and sales milestones. In addition, XOMA is entitled to receive royalties ranging from the high single
digits to the mid-teens based upon annual net sales of RZ358. Finally, under the terms of the agreement, Rezolute will pay XOMA
low single digit royalties on sales of the company’s other products.
“Having established proof-of-concept for XOMA 358 earlier
this year, we look forward to Rezolute continuing clinical development of the program,” stated Jim Neal, Chief Executive
Officer of XOMA. “Our license agreement with Rezolute places this important drug asset in the hands of a very capable endocrine-focused
team, provides XOMA with the potential to receive future milestones and royalties, and is an important milestone in the continued
transformation of our programs to fully-funded status. We welcome Rezolute to our broad portfolio of partners, including Novartis,
Five Prime and NanoTherapeutics, who continue the development of our product candidates.”
CHI is a rare genetic disorder that affects one in 50,000 newborns.
Ordinarily, beta cells in the pancreas secrete just enough insulin to keep blood sugar in the normal range. With CHI, the secretion
of insulin is not properly regulated as the beta cells secrete too much insulin resulting in excessive low blood sugar (severe
hypoglycemia). In infants and young children, these episodes are characterized by lethargy, irritability and difficulty feeding.
Repeated episodes of hypoglycemia increase the risk of serious complications such as breathing difficulties, seizures, developmental
delays and intellectual disability, vision loss, brain damage, coma and possibly death. CHI is the most common cause of persistent
hypoglycemia in children and about 60 percent of infants with CHI experience a hypoglycemic episode within the first month of life.
Other affected children develop hypoglycemia by early childhood. A significant number of patients cannot be adequately treated
with or do not tolerate existing medical therapies. Surgical removal of all or part of the pancreas is a cornerstone of management
for many patients, but is invasive and diabetes-inducing.
The Company’s new name reflects its transition as a developer
of potentially paradigm-shifting therapies for treating metabolic diseases and orphan indications with high unmet medical needs.
Under this strategy, the Company also exclusively licensed
ActiveSite Pharmaceuticals
’ oral plasma kallikrein inhibitor
(PKI) portfolio in August and is developing
RZ402
for Diabetic Macular Edema and
RZ602
for Hereditary Angioedema,
an orphan indication.
“The name change conveys our dedication to
identifying and developing therapies that are transformative and target well-known genetic pathways and mechanisms,”
stated Mr. Elam. With the recent licensing agreements executed with XOMA Corporation for a monoclonal antibody to treat CHI,
an orphan indication, and
ActiveSite Pharmaceuticals
for our oral Plasma Kallikrein Inhibitor (PKI) portfolio, we have
evolved into a company advancing a robust pipeline of innovative solutions for patients and providers.”
About Rezolute, Inc.
Rezolute is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve
the lives of patients with metabolic and orphan diseases. Rezolute is advancing a diversified pipeline including: RZ358 (Phase
2), an antibody for the ultra-orphan indication of Congenital HyperInsulinism (CHI), with an abbreviated path-to-market strategy; AB101
(Phase 1), a once-weekly injectable basal insulin with the potential to transform the treatment landscape in diabetes management
by reducing the therapeutic burden for patients and improving compliance; and a Plasma Kallikrein Inhibitor (PKI) portfolio with
two lead compounds, RZ402 (plan to file IND in H2 2018) targeting Diabetic Macular Edema (DME) and RZ602 (plan to file IND in
H1 2019) targeting Hereditary Angioedema (HAE), an orphan indication. For more information, visit:
www.rezolutebio.com
.
About XOMA Corporation
XOMA has an extensive portfolio of products, programs, and
technologies that are the subject of licenses the Company has in place with other biotech and pharmaceutical companies. Many of
these licenses are the result of the Company's pioneering efforts in the discovery and development of antibody therapeutics. There
are more than two dozen such programs that are fully funded by partners and could produce milestone payments and royalty payments
in the future. For more information, visit
www.xoma.com
.
Forward-Looking Statements
This release, like many written and oral communications presented by Rezolute, Inc. and our authorized officers, may contain certain
forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements
to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform
Act of 1995, and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are
based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by
use of words such as "anticipate," "believe," "estimate," "expect," "intend,"
"plan," "project," "seek," "strive," "try," or future or conditional verbs such
as "could," "may," "should," "will," "would," or similar expressions. Our ability
to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ
materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation
to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements
were made.
Rezolute, Inc. Contact:
Noopur Liffick
VP of Corporate Development
(650) 549-4175
investor-relations@rezolutebio.com
Source: Rezolute, Inc.
Exhibit 99.2
A Letter From The Chairman & CEO
Dear Colleagues, Shareholders and Friends:
Today we issued a
press release
announcing our agreement with XOMA Corporation to in-license RZ358, a Phase 2 antibody to treat Congenital Hyperinsulinism (CHI),
an ultra-orphan metabolic disease. With the addition of this program to our product pipeline, we have achieved a significant milestone
in our corporate evolution, and the purpose of this letter is to update you on our go-forward plans as well as the status of the
business.
In my 2016 letter to shareholders, I highlighted
our belief in the importance of advancing our microsphere platform while opportunistically seeking to in-license or acquire external
programs and capabilities that could facilitate the creation of a robust, high-value biopharmaceutical company. Our corporate development
activities this year reflect the implementation of that strategy. We believe the best way to increase shareholder value and unlock
the possibility of up-listing onto a national stock exchange with the support of institutional investors is to advance multiple
pipeline programs at different stages across different platforms. I am happy to inform you that we now have four active programs
across three platforms including: (i) a Phase 2 antibody (RZ358), (ii) a Phase 1 microsphere (AB101), and (iii) two preclinical
oral plasma kallikrein inhibitors (RZ402 and RZ602).
In just a few months we have transformed
the company from a microsphere-based diabetes organization to a clinical stage metabolic and orphan disease company with a portfolio
of potentially paradigm-shifting therapies for patients and providers. “AntriaBio” is and will remain known as the
microsphere company developing a long-acting insulin. With the broadening of our capabilities, programs and mission, we are emphasizing
our new mandate. By changing the company’s name to “Rezolute,” we are resolved to apply different technologies
and modalities to develop transformative therapies for diseases with high unmet needs.
RZ358
CHI is a rare
genetic disorder that affects 1 in 50,000 newborns. Ordinarily, beta cells in the pancreas secrete just enough insulin to keep
blood sugar in the normal range. With CHI, the secretion of insulin is not properly regulated as the beta cells secrete too much
insulin resulting in excessive low blood sugar (severe hypoglycemia). In infants and young children, these episodes are characterized
by lethargy, irritability and difficulty feeding. Repeated episodes of hypoglycemia increase the risk of serious complications
such as breathing difficulties, seizures, developmental delays and intellectual disability, vision loss, brain damage, coma and
possibly death. CHI is the most common cause of persistent hypoglycemia in children and about 60 percent of infants with CHI experience
a hypoglycemic episode within the first month of life. Other affected children develop hypoglycemia by early childhood.
To avoid hypoglycemia, many children require
frequent glucose monitoring and feeding, including intravenous or intestinal administration of sugar solutions, particularly overnight.
This burdensome treatment regimen has a substantially negative effect on the quality of life for these children and their families.
In addition, a significant number of children cannot be adequately treated with, or do not tolerate, existing medical therapies.
Surgical removal of all or part of the pancreas is a cornerstone of management for many children, but is invasive and diabetes-inducing.
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1450 Infinite Drive, Louisville, CO 80027
P: 303.222.2128
www.rezolutebio.com
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RZ358 is a first-in-class fully human monoclonal
antibody that counteracts the effects of elevated insulin (hyperinsulinemia) by, in effect, turning down the insulin receptor when
too much insulin is present, making it well-suited as a treatment for severe, persistent hypoglycemia. XOMA demonstrated clinical
proof-of-concept for RZ358 in Phase 2a studies and the compound has designated orphan status in the US and EU. We are preparing
to launch Phase 2b studies in 2018 with the potential to accelerate late-stage pivotal trials for an abbreviated path-to-market
strategy.
AB101
As a prerequisite to engaging in our corporate
development/in-licensing activities, we first wanted to realize the objective that was the basis for the formation of AntriaBio.
The primary reason most of us invested our time, energy and money was to advance AB101, a once-weekly injectable basal insulin
for patients with diabetes, into the clinic as a potential disruptive therapy in the $11 billion basal insulin market that is still
dominated by insulin analogs administered by daily injections.
A year ago, we set a corporate goal to
complete a successful manufacturing campaign, file an investigational new drug application (IND) with the US Food & Drug Application
(FDA) and start our Phase 1 first-in-human clinical study of AB101, all by the middle of 2017. In fact, we achieved each of these
objectives: we produced sterile AB101 material in the first half of 2017; we filed our IND in June; and we recently completed the
first of up to five potential cohorts in the AB101 clinical study being conducted at ProSciento, a contract research organization
in Southern California. We look forward to dosing the next cohort in the new year, with the goal of demonstrating that the pharmacological
profile of AB101 lasts for more than a week while meaningfully lowering glucose levels.
PKI Portfolio
In August of this year, soon after initiating
our first-in-human study of AB101, we took the first step in realizing our corporate development objectives by in-licensing ActiveSite
Pharmaceuticals’ oral plasma kallikrein inhibitor (PKI) portfolio. In our evaluation of the PKI portfolio, we became increasingly
convinced of its potential to address serious diseases. Further, we believe the PKI portfolio may be the most advanced oral program
in the space, given the extensive preclinical work previously conducted, including not only
in vitro
modeling, but also
in vivo
studies in the rodent, dog and monkey.
Plasma kallikrein is an enzyme that is
part of the kinin system, which is a complex metabolic cascade that can play a prominent role in inflammation. Specifically, plasma
kallikrein ultimately contributes to the production of a peptide called bradykinin, which causes blood vessels to enlarge or dilate,
resulting in problematic inflammation and vascular leakage. By inhibiting the formation of plasma kallikrein and the subsequent
production of bradykinin, we believe we may be able to treat metabolic and orphan diseases associated with vascular leakage. For
example, diabetic macular edema (DME) and hereditary angioedema (HAE) are two diseases that are impacted by the kinin system that
could potentially benefit from an oral PKI.
RZ402
DME is a metabolic disease that results
from an increase in retinal vascular permeability (RVP) in the setting of diabetic retinopathy (abnormal retinal blood vessel growth
caused by poorly controlled blood sugar levels). Vascular leakage from retinal blood vessels leads to swelling of the retina, including
the macula, an area of the retina that is very important for vision. The kinin system and the production of bradykinin have been
implicated in the vascular leakage associated with DME. It is estimated that approximately 50 million individuals worldwide suffer
from vision-threatening complications of diabetes, including DME, which is one of the main causes of vision loss in working-age
adults globally. With the growth of diabetes, DME is expected to increase in prevalence beyond its current estimate of 750,000
individuals in the US and 21 million worldwide.
Current treatment approaches are onerous,
involving injections into the eye by retinal specialists on a monthly or bimonthly basis. In addition to a segment of the DME population
that does not respond to these treatments, the extent of therapeutic benefit directly correlates with adherence to this route of
administration and regimen, which is a significant burden for both patients and their healthcare providers, leading to high rates
of non-adherence and ultimately, suboptimal therapeutic outcomes.
RZ402 is a potential new therapy for DME
from the PKI portfolio. RZ402 has been shown to normalize RVP in clinically-relevant animal models of macular edema as effectively
as the current injectable treatments, thereby supporting its potential as a stand-alone therapy for macular edema resulting from
diabetes and other causes. We are planning to file an IND for RZ402 in the second half of 2018.
RZ602
HAE is
an
orphan disease
characterized by recurring attacks of sudden and extreme swelling that can affect the face and mucous membranes,
abdomen and genitalia. Attacks can be painful, debilitating, varied in frequency and even life-threatening, due to
swelling
around the airway. The disease is caused by a problem with a gene that controls the management of a specific protein, the C1 inhibitor.
When there is an imbalance in the C1 inhibitor, there may be excessive bradykinin production causing tiny blood vessels to “leak”
or push fluid into parts of the patient’s body, resulting in an HAE attack. The trigger for an attack is variable from person
to person and even time to time.
Currently available therapies target the
prevention or termination of attacks, but are highly invasive and inconvenient due to the subcutaneous/intravenous routes of administration
or have an undesirable side effect profile. Approximately one in 50,000 patients worldwide have HAE.
RZ602 is a potential new therapy for HAE
from the PKI portfolio. Similar to our efforts with RZ402 for DME, the objective of RZ602 is to stop the inflammatory cascade by
inhibiting the production of kallikrein and thereby halting the downstream release of bradykinin and eventual swelling. We plan
to file an IND for RZ602 in the first half of 2019.
Notably, in October of this year, one of
our competitors, KalVista, announced a transaction with Merck whereby Merck agreed to pay KalVista $37 million up front and up
to $715 million in milestone payments for an intravitreal (injection into the eye) PKI currently in Phase 2, as well as other potential
preclinical oral PKIs for DME. Merck also agreed to take a 10% equity stake in KalVista with a $9 million investment. We believe
this transaction validates the potential utility of the kallikrein pathway in treating certain diseases.
Other Pipeline Activities
Our research scientists are actively leveraging
our multiple platform technologies to formulate new compounds, conduct studies and screen potential new product candidates as we
seek to evolve our product pipeline.
Expansion of our Board of Directors
and Scientific Advisory Board
In preparation for a potential up-listing
to a national exchange in 2018, this year we added several new members to our Board of Directors (Board) and implemented certain
governance requirements, including the creation of various Board committees. In October, we announced our newest Board member,
Gil Labrucherie, who is Chief Financial Officer of Nektar Therapeutics, a biopharmaceutical company. In March, two other pharmaceutical
executives joined the Board, including Tae Hoon Kim and Samir R. Patel, M.D. Mr. Kim is currently Chief Executive Officer of Aju
Pharm, a pharmaceutical company in the Republic of Korea and Dr. Patel is co-founder, principal and former CEO of SPEC Pharma,
LLC. Finally, in October Dr. Robert Bhisitkul joined our Scientific Advisory Board and he is a retinal specialist and Professor
of Clinical Ophthalmology at the University of California, San Francisco School of Medicine. His expertise in DME drug development
will be invaluable as we advance RZ402 into the clinic.
Capital Requirements and Effect of Name
Change
Given our current financial needs as well
as our desired strategy to advance our product pipeline candidates, we are planning to raise capital in the first half of 2018,
primarily from institutional investors. We anticipate our capital-raising activities may include the issuance of equity or debt
securities, obtaining credit facilities or other financing mechanisms. Clearly, if we are unable to raise capital, our prospects
will be materially and adversely impacted.
The Company’s name change does not
affect our corporate structure. The rights of stockholders holding certificated shares under currently outstanding stock certificates
and the number of shares represented by those certificates will remain unchanged. The name change does not affect the validity
or transferability of any currently outstanding stock certificates nor will it be necessary for stockholders with certificated
shares to surrender any stock certificates they currently hold as a result.
Closing
We hope you share in our excitement about
today’s announcement regarding RZ358 and our evolution as a company. With the addition of RZ358 as well as RZ402 and RZ602,
we have “more shots on goal” with a diversification strategy centered around metabolic and orphan diseases. We are
not dependent upon any single pipeline candidate for success. Through our corporate development activities, we have significantly
increased the value and attractiveness of the company. I am particularly pleased we have been able to accomplish the in-licensing
of RZ358 and the PKI portfolio with only $750,000 in upfront cash and minimal dilution. This is a phenomenal achievement and virtually
unprecedented in our industry.
In 2018, we have the following five primary
goals:
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(1)
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raise capital and up-list onto a national exchange;
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(2)
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prepare for and initiate a Phase 2b study of RZ358;
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(3)
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complete our ongoing Phase 1 study of AB101;
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(4)
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complete the requisite preclinical work and file an IND for RZ402; and
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(5)
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name one project currently in discovery as a pipeline candidate based upon
in vivo
studies.
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I encourage you to visit our revised website
and review our new
corporate presentation
with more information about our programs.
In closing, I would like to thank all of
our stakeholders, particularly our investors, for their patience and taking a long-term view of our potential as a high-value biopharmaceutical
company. We believe the steps we have taken this year to evolve the company have significantly contributed to shareholder value.
We are resolved to push forward in 2018 – we are
Rezolute
!
With warm regards,
Nevan C. Elam
Chairman and Chief Executive Officer
Forward-Looking Statements
This shareholder letter, like many written and oral communications
presented by AntriaBio, Inc. and Rezolute, Inc. (the “Company”), and our authorized officers, may contain certain forward-looking
statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be
covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act
of 1995, and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based
on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use
of words "anticipate," "believe," "estimate," "expect," "intend," "plan,"
"project," "seek," "strive," "try," or future or conditional verbs such as "could,"
"may," "should," "will," "would," or similar expressions. Our ability to predict results
or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from
anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as
of the date of this letter. Except as required by applicable law or regulation, the Company undertakes no obligation to update
these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.