Exhibit 10.1
| PATENT LICENSE AGREEMENT |
UTA#03-005 |
THIS
Agreement is between the Board of Regents ("Board") of The University of Texas System ("System"), an agency of the
State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, and EluSys Therapeutics, Inc., a Delaware corporation having
a principal place of business located at 10 Bloomfield Ave., Pine Brook, NJ 07058 ("Licensee").
TABLE
OF CONTENTS
RECITALS
| 3. | WARRANTY
AND SUPERIOR RIGHTS |
| 7. | INFRINGEMENT
BY THIRD PARTIES |
| 12. | CONFIDENTIAL
INFORMATION AND PUBLICATION |
| 13. | PATENTS
AND INVENTIONS |
| 14. | ALTERNATE
DISPUTE RESOLUTION |
| 15. | GENERAL
SIGNATURES APPENDIX A |
RECITALS
A.
Board owns certain Patent Rights related to Licensed
Subject Matter, which were developed at The University of Texas at Austin ("University"), a component institution of System.
B. Board
desires to have the Licensed Subject Matter developed and used for the benefit of Licensee,
Inventor, Board, and the public as outlined in Board's Intellectual Property Policy.
C. Licensee
wishes to obtain a license from Board to practice Licensed Subject Matter.
NOW,
THEREFORE, in consideration of the mutual covenants and premises herein contained, the parties agree as follows:
1. EFFECTIVE
DATE
This
Agreement is effective June 30, 2003 ("Effective Date").
2. DEFINITIONS
As
used in this Agreement, the following terms have the meanings indicated:
2.1
"Affiliate" means any business entity
50% or more owned by Licensee, any business entity which owns more than 50% of Licensee, or any business entity that is more than 50%
owned by a business entity that owns more than 50% of Licensee.
2.2
"Licensed Field" means antibodies that
bind immunologically to anthrax antigens.
2.3
"Licensed Product" means any antibodies
made or sold by Licensee consisting of Licensed Subject Matter.
2.4
"Licensed Subject Matter" means inventions
and discoveries covered by Patent Rights within the Licensed Field.
2.5 "Licensed
Territory" means the world.
2.6 "Patent
Rights" means Board's rights whether domestic or foreign in information or discoveries
in the antibodies disclosed and claimed in the patent application entitled: (1) Recombinant
Antibodies for the Detection and Neutralization of the Anthrax Toxin, serial number 10/288,269
filed on November 5, 2001, and (2) the U.S. patent application entitled "Antibodies
With Increased Affinities For Anthrax Antigens" inventors Barrett R. Harvey, George
Georgiou, and Brent L. Iverson, serial number 10/620,049 filed July 15, 2003. The Patent
Rights include all divisions, continuations, reissues, or reexaminations thereof, and any
letters patent that issue thereon, which name at least George Georgiou and Brent Iverson
as either sole or joint inventors ("Inventors") and which relate to the manufacture,
use or sale of anthrax antibodies.
The
Patent Rights do not include any subject matter other than the anthrax antibodies or improvements thereof with the exception of claims
47-59 (attached as Appendix A) of serial number 10/288,269, filed on November 5, 2001.
Licensee
acknowledges that the Patent Rights do not include technology that may be used for the identification of antibodies and other binding
proteins except as specifically recited in claims 47-59 of serial number 10/288,269. Licensee further acknowledges that the Patent Rights
specifically exclude any other technology for the identification of antibodies and other binding proteins including, without limitation,
Anchored Periplasmic Expression ("APEx") technology and anchor-less library display technology such as Periplasmic Expression
with Cytometric Screening ("PEGS").
Licensee
acknowledges that one or more of the patent applications referred to herein discloses subject matter that is beyond the scope of the
Patent Rights, and that nothing herein will be deemed to grant to Licensee any rights in such subject matter. Licensee specifically acknowledges
that this Agreement does not grant to Licensee the right to prosecute patent applications claiming subject matter that is outside the
scope of the Licensed Subject Matter.
Licensee
agrees that nothing herein will be deemed to grant to Licensee any rights under any other University or System patents or patent applications
other than those listed in this Agreement. Licensee further agrees that nothing herein will be deemed to grant any rights in any technology
disclosed in the foregoing patent applications other than Licensed Subject Matter.
3. WARRANTY
AND SUPERIOR-RIGHTS
3.1
Except for the rights, if any, of the Government of
the United States, as set forth below, Board represents and warrants its belief that (i) it is the owner of the entire right, title,
and interest in and to Licensed Subject Matter, (ii) it has the sole right to grant licenses thereunder, and (iii) it has not knowingly
granted licenses thereunder to any other entity that would restrict rights granted to Licensee except as stated herein.
3.2 Licensee
understands that the Licensed Subject Matter may have been developed under a funding agreement
with the Government of the United States of America and, if so, that the Government may have
certain rights relative thereto. This Agreement is explicitly made subject to the Government's
rights under any agreement and any applicable law or regulation. If there is a conflict between
an agreement, applicable law or regulation and this Agreement, the terms of the Government
agreement, applicable law or regulation will prevail.
3.3
Licensee understands and acknowledges that Board, by
this Agreement, makes no representation as to the operability or fitness for any use, safety, efficacy, ability to obtain regulatory
approval, patentability, and/or breadth of the Licensed Subject Matter. Board, by this Agreement, also makes no representation as to
whether there are any patents now held, or which will be held, by others or by Board in the Licensed Field, nor does Board make any representation
that the inventions contained in Patent Rights do not infringe any other patents now held or that will be held by others or by Board
.
3.4
Licensee, by execution hereof, acknowledges, covenants
and agrees that it has not been induced in any way by Board, System, University or its employees to enter into this Agreement, and further
warrants and represents that (i) it has conducted sufficient due diligence with respect to all items and issues pertaining to this Article
3 and all other matters pertaining to this Agreement; and (ii) Licensee has adequate knowledge and expertise, or has utilized knowledgeable
and expert consultants, to adequately conduct the due diligence, and agrees to accept all risks inherent herein.
4. LICENSE
4.1
Board hereby grants to Licensee a royalty-bearing, exclusive
license under Licensed Subject Matter to manufacture, have manufactured, use ,sell and offer to sell Licensed Products within the Licensed
Territory in the Licensed Field. This grant is subject to the payment by Licensee to Board of all consideration as provided herein, and
is further subject to rights retained by Board to:
a.
Publish the general scientific findings from research
conducted in whole or in part at the University or otherwise within the System related to Licensed Subject Matter subject to the terms
of Section 14, Confidential Information; and
b.
Use Licensed Subject Matter for research, teaching and
other educationally-related purposes.
4.2 Licensee
may extend the license granted herein to any Affiliate if the Affiliate consents to be bound
by this Agreement to the same extent as Licensee.
5. PAYMENTS
AND REPORTS
a. In
consideration of rights granted by Board to Licensee under this Agreement, Licensee will
pay Board the following: A non-refundable, upfront license fee in the amount of $62,500,
due and payable by November 15, 2003;
| b. | | A fee of $150,000 due and payable on the following schedule:
i. $50,000 by August 1, 2004
ii. $50,000 by August 1, 2005
iii. $50,000 by August 1, 2006 |
5.1
All amounts payable here by Licensee must be paid in
United States funds without deductions for taxes, assessments, fees, or charges of any kind. Checks must be payable to The University
of Texas at Austin and sent to:
The
Office of Technology Licensing
The
University of Texas at Austin
3925
West Braker Lane, Suite 1.9A
Austin,
Texas 78759
ATTN:
Director
5.2
Due and payable upon execution of this agreement, Licensee
will reimburse Board $15,690.26 for all out-of-pocket expenses thus far incurred by Board. Licensee must pay all future reasonable expenses
for filing, prosecuting, enforcing and maintaining the Patent Rights (the "Patent Expenses") within forty five (45) days of
receipt of a bill from patent counsel and will copy University on all billing.
5.3
Upon the payment by Licensee of the sum set forth in
Paragraph 5.1 (b) (iii) above, Licensee shall obtain a paid-up, worldwide, license under the Patent Rights.
6. TERM
AND TERMINATION
6.1 The
term of this Agreement is from the Effective Date to the full end of the term or terms for
which Patent Rights have not expired.
6.2 This
Agreement will earlier terminate:
a.
automatically if Licensee becomes bankrupt or insolvent
and/or if the business of Licensee is placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of Licensee or
otherwise; or at any time by mutual written agreement between Licensee and Board subject to any terms herein which survive termination.
which include the balance of the total amount due under 5.1.
6.3 Board
may terminate this Agreement at any time if Licensee:
a.
is in default in payment offees
b. is
in breach of any provision hereof and Licensee fails to cure any such default. breach or
false report within thirty (30) days after confirmed delivery of written notice thereof given
by Board; or
c. fails to fulfill its obligations relating to Patent Expenses set forth
in Section 5.3.
6.4 If this Agreement is terminated for any cause:
a. nothing herein will be construed to release either party of any obligation
matured prior to the effective date of the termination;
b. after the effective date of the termination. Licensee may sell all Licensed
Products and parts therefor it has on hand at the effective date of termination, if it pays all amounts due as of the effective date of
the termination according to the terms of Article 5; and
c. Licensee will be bound by the provisions of Articles 12 (Indemnification).
13 (Use of Board and Component's Name) and 14 (Confidential Information) of this Agreement.
6.5 Upon termination of this Agreement. Licensee at Board's request will return
to University all Confidential Information fixed in any tangible medium of expression.
7. INFRINGEMENT BY THIRD PARTIES
7.1 Licensee. at its expense. has the right but not the obligation to enforce
any patent exclusively licensed hereunder against infringement by third parties and it is entitled to retain recovery from such enforcement.
Licensee must pay Board an amount on any monetary recovery which is a reasonable approximation of the royalties and other amounts that
Licensee would have paid to Board if Licensee had sold the infringing products rather than the infringer, after deducting reasonable legal
expenses incurred in connection with such enforcement . If Licensee does not file suit against a substantial infringer of a patent within
6 months of knowledge thereof. then Board may enforce any patent licensed hereunder on behalf of itself and Licensee. Board retaining
all recoveries from such enforcement and/or reducing the license granted hereunder to non-exclusive.
7.2 In any infringement suit or dispute, the parties agree to cooperate
fully with each other. At the request and expense of the party bringing suit, the other party will permit access to all relevant personnel,
records, papers, information, samples, specimens, etc., during regular business hours.
8. ASSIGNMENT
Except in connection with the sale of substantially all of Licensee's assets
to a third party, this Agreement may not be assigned by Licensee without the prior written consent of Board, which will not be unreasonably
withheld.
9. PATENT MARKING
Licensee will to the extent practical and subject to FDA rules and regulations
on labelling, mark all products and documentation manufactured or sold by Licensee under this Agreement with a patent notice as may be
permitted or required under Title 35, United States Code.
10. INDEMNIFICATION
Licensee agrees to hold harmless and indemnify Board, System, University,
its Regents, officers, employees and agents from and against any claims, demands, or causes of action whatsoever, including without limitation
those arising on account of any injury or death of persons or damage to property caused by, or arising out of, or resulting from, the
exercise or practice of the license granted hereunder by Licensee, its Affiliates or their officers, employees, agents or representatives
except where such causes of action are based on the gross negligence or willful malfeasance of Board, System, University, its Regents.
officers, employees or agents.
11. USE OF NAME
11.1 Licensee may not use the name of University, System or Board without express
written consent.
11.2 Board and University may use Licensee's name in brochures, webpages and
other publications in relation to University's intellectual property and commercialization achievements with the prior review and consent
of Licensee, which consent shall not be unreasonably or timely withheld.
12. CONFIDENTIAL INFORMATION AND PUBLICATION
12.1 Board and Licensee each agree that all information contained in documents
marked "confidential" and forwarded to one by the other (i) be received in strict confidence, (ii) be used only for the purposes
of this Agreement, and (iii) not be disclosed by the recipient party, its agents or employees without the prior written consent of the
other party, except to the extent that the recipient party can establish by competent written proof that such information:
a. was in the public domain at the time of disclosure;
b. later became part of the public domain through no act or omission of the
recipient party, it's employees, agents, successors or assigns;
c. was lawfully disclosed to the recipient party by a third party having the
right to disclose it;
d. was already known by the recipient party at the time of disclosure;
e. was independently developed by the recipient; or
f. is required by law or regulation to be disclosed.
12.2 Each party's obligation of confidentiality, nonuse and nondisclosure hereunder
will be fulfilled by using at least the same degree of care with the other party's confidential information as it uses to protect its
own confidential information. This obligation will exist while this Agreement is in force and for a period of 3 years thereafter.
12.3 University will submit its manuscript for any proposed publication of research
related to the Licensed Subject Matter conducted at University in whole or in part or in the System to Licensee at least 30 days before
publication, and Licensee will have the right to review and comment upon the publication in order to protect Licensee's confidential information.
Upon Licensee's request, publication will be delayed up to 60 additional days to enable Licensee to secure adequate intellectual property
protection of Licensee's property that would be affected by the publication.
13. PATENTS AND INVENTIONS
13.1 If University, Board and Licensee agree that any additional patent application
should be filed for Licensed Subject Matter, Licensee will prepare and file the appropriate additional patent applications, and Licensee
will reimburse patent counsel directly for all expenses incurred in searching, preparing, filing, prosecuting and maintaining same. Board
will approve all patent counsel chosen by Licensee, which approval will not be unreasonably withheld. Any transfer expenses will be paid
directly by Licensee. Licensee will copy University on all billing.
13.2 If Licensee notifies Board that it does not intend to pay the cost of an
application, or if Licensee does not respond or make an effort to agree with Board on the disposition of rights in the subject invention,
then Board may file an application at its own expense and Licensee will promptly provide Board a copy of any applications, amendments
responses, briefs and other documents in connection with the filing or prosecution of patent applications hereunder for Board's review
and approval prior to filing as time and other deadlines reasonably permit, as well as copies of any documents received from any patent
office or agent, associate, or attorney in connection with the prosecution of Patent Rights. Licensee will not change, drop or abandon
any claim of Patent Rights or file any patent application which may adversely affect University or Board's rights in the Patent Rights
or the Licensed Subject Matter or any fees due under this Agreement without first obtaining the written consent of Board, which will not
be unreasonably withheld.
13.3 Licensee further agrees that any rights under this section are specifically
limited to Licensed Subject Matter. Licensee specifically agrees that it will not seek to gain rights under this Agreement in any technology
other than Licensed Subject Matter. Licensed Subject Matter absolutely excludes, without limitation, technology that may be used for the
identification of anthrax antibodies including Anchored Periplasmic Expression ("APEx") technology and anchor-less library display
technology such as Periplasmic Expression with Cytometric Screening ("PECS").
14. ALTERNATE
DISPUTE RESOLUTION
14.1 Any
dispute or controversy arising out of or relating to this Agreement, its construction or
its actual or alleged breach will be decided by mediation. If the mediation does not result
in a resolution of such dispute or controversy, it will be finally decided by an appropriate
method of alternate dispute resolution, including without limitation, arbitration, conducted
in the city of Austin, Texas in accordance with the Commercial Dispute Resolution Procedures
[http://www.adr.org/rules/commercial_rules.html] of the American Arbitration Association.
The arbitration panel will include members knowledgeable in the evaluation of antibody technology.
Judgment upon the award rendered may be entered in the highest court or forum having jurisdiction,
state or federal. The provisions of this Article 16 will not apply to decisions on the validity
of patent claims or to any dispute or controversy as to which any treaty or law prohibits
such arbitration. The decision of the arbitration must be sanctioned by a court of law having
jurisdiction to be binding upon and enforceable by the parties.
15. GENERAL
15.1
This Agreement constitutes the entire and only agreement
between the parties for Licensed Subject Matter and all other prior negotiations, representations, agreements, and understandings are
superseded hereby. No agreements altering or supplementing the terms hereof may be made except by a written document signed by both parties.
Nothing contained in this agreement shall be construed as conferring any right by implication, estoppal, or otherwise except as expressly
granted herein.
15.2
Any notice required by this Agreement must be given
by prepaid, first class, certified mail, return receipt requested, addressed in the case of Board to:
Board
of Regents
The
University of Texas System 201 West 7th Street
Austin,
Texas 78701
ATTENTION:
Office of General Counsel
FAX:
(XXX) XXX-XXXX
PHONE:
(XXX) XXX-XXXX
with copies to:
The Office
of Technology Licensing The University of Texas at Austin
3925 West
Braker Lane, Suite 1.9A
Austin,
Texas 78759
ATTENTION:
Director
FAX: (XXX) XXX-XXXX
PHONE:
(XXX) XXX-XXXX
or
in the case of Licensee to:
EluSys
Therapeutics, Inc.
10 Bloomfield
Avenue
Pine
Brook, NJ 07058
Attention:
Vice President of Business Development
FAX:
(XXX) XXX-XXXX
PHONE:
(XXX) XXX-XXXX
or other addresses as may be given from time to time under the terms of
this notice provision.
15.3 Licensee must comply with all applicable federal, state and local laws
and regulations in connection with its activities pursuant to this Agreement.
15.4 This Agreement will be construed and enforced in accordance with the laws
of the United States of America and of the State of Texas.
15.5 Failure of Board to enforce a right under this Agreement will not act as
a waiver of that right or the ability to later assert that right relative to the particular situation involved.
15.6 Headings are included herein for convenience only and will not be used
to construe this Agreement.
15.7 If any part of this Agreement is for any reason found to be unenforceable,
all other parts nevertheless remain enforceable.
IN
WITNESS WHEREOF, parties hereto have caused their duly authorized representatives to execute this Agreement.
BOARD
OF REGENTS OF THE
UNIVERSITY OF TEXAS SYSTEM
By:
/s/ Juan Sanchez
Name:
Juan Sanchez, PhD
Title:
Vice President for Research
November
3, 2003
ELUSYS
THERAPEUTICS, INC.
By: /s/
Elizabeth G. Posillico
Name:
Elizabeth G. Posillico
Title: Vice President
of Business Development
Date: October
22, 2003
Appendix
A Claims of Serial Number 10/288.269. filed on November 5. 2001
Exhibit 99.1
Heat Biologics (“NightHawk Biosciences”)
Completes Acquisition of Elusys Therapeutics
Elusys becomes wholly-owned biodefense
subsidiary of NightHawk
Plans to expand ANTHIM® distribution
abroad
Durham, NC – April
20, 2022 – Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed “NightHawk Biosciences”), a fully-integrated
biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced it has completed
the acquisition of Elusys Therapeutics, Inc. a commercial-stage biodefense company and developer of ANTHIM® (obiltoxaximab), a treatment
for inhalation anthrax. ANTHIM® is approved for use in the U.S. and Canada, and under the brand name Obiltoxaximab SFL in Europe
and the United Kingdom.
Nighthawk acquired all outstanding
shares of Elusys, which will continue to operate as a wholly-owned subsidiary of NightHawk. No stock or warrants were issued in connection
with the acquisition, and Elusys had no outstanding term debt.
The strategic acquisition of
Elusys significantly expands the Company’s role in the biodefense space, complementing NightHawk’s RapidVax® platform,
which is designed to target emerging biological threats. Pursuant to this acquisition, NightHawk also announced it plans to migrate manufacturing
of ANTHIM® to its planned 500,000 square foot Scorpion biomanufacturing facility in Manhattan, Kansas, which is being constructed
to support development of commercial-scale biologics and large molecules.
To date, Elusys has been awarded
over $350 million in research and development grants, contracts and procurement orders from the Biomedical Advanced Research and Development
Authority (BARDA) and the U. S. Strategic National Stockpile (SNS). Through ongoing, multi-year partnerships with the U.S. government,
Elusys has been supplying ANTHIM® to the SNS - the government’s repository of critical medical supplies for biodefense preparedness.
Jeff Wolf, CEO of NightHawk, commented, “We
are excited to announce the closing of this transformative acquisition, which provides us with a solid foothold in the biodefense space.
Elusys has an established a successful track record collaborating with U.S. government agencies including BARDA, NIH, SNS and DOD. We
plan to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax®, our “plug
and play” platform designed for rapid development and delivery of new vaccines. In addition, we look forward to leveraging our new
Kansas facility, which will enable us to manufacture these therapies internally and therefore benefit from significant operating synergies,
as well as enhanced oversight, quality control, and speed to market. We are also exploring opportunities to expand ANTHIM® distribution
abroad. This transaction is perfectly aligned with our overall vision to establish a fully-integrated ecosystem to deliver medical innovations
faster, better, and more efficiently.”
David Lasseter, former Deputy
Assistant Secretary of Defense for Countering Weapons of Mass Destruction, and a member of NightHawk’s Biothreat Advisory Board,
commented, “This transaction is extremely timely, given the global uncertainty and unprecedented threats from foreign nations and
rogue actors. Anthrax is one of the most significant biological warfare threats facing our country, with real potential for mass casualties.
ANTHIM® represents a key medical countermeasure for the treatment of inhalation Anthrax.”
A special committee of Heat’s
Board of Directors negotiated and approved the transaction and Cassel Salpeter & Co. provided a fairness opinion in connection with
the transaction. Blank Rome LLP acted as legal counsel to Heat. Elusys was advised by RBC Capital Markets, LLC. Additional details
on the transaction are outlined in Company’s Form 8-K, which will be filed with the Securities and Exchange Commission and will
be available on the Company’s website.
About ANTHIM
Anthrax is a life-threatening infectious disease
caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis
spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which
is deadly in humans.
ANTHIM is a monoclonal antibody that binds to the
protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible
cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied
as single-dose vials for IV infusion.
Indications and Usage
ANTHIM is indicated in adult and pediatric patients
for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for
prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for
prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness
of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics
(PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have
direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross
the blood-brain barrier and does not prevent or treat meningitis.
IMPORTANT SAFETY
INFORMATION Including BOXED WARNING
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored
settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity
or anaphylaxis occurs.
WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylaxis have been reported during the
IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel
trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity
reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately
if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine
pre-medication does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.
ADVERSE REACTIONS
The safety of ANTHIM has been studied only in healthy volunteers.
It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus,
infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion
site pain, and pain in extremity.
USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK
of ANTHIM in the pediatric population.
To see the complete prescribing information for ANTHIM, click here.
About
Heat Biologics, Inc. / NightHawk Biosciences, Inc.
Heat
Biologics (to become “NightHawk Biosciences”) is a fully-integrated biopharmaceutical company focused on the development of
new drugs from discovery through biomanufacturing. The Company leverages its integrated ecosystem of subsidiaries to accelerate the creation
of novel therapies that arm the immune system, breaking through barriers that prolong traditional drug development. This empowers us to
bring our ideas to life with efficient control, superior quality, and uncharacteristic agility.
For more
information on the Company and is subsidiaries, please visit: www.nighthawkbio.com, and also follow us on Twitter.
Forward
Looking Statement
This release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified
by terminology such as "may," "should," "potential," "continue," "expects," "anticipates,"
"intends," "plans," "believes," "estimates," and similar expressions, and include statements
regarding plans to migrate manufacturing of ANTHIM® to the planned 500,000 square foot biomanufacturing facility in Manhattan, Kansas,
plans to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax, leveraging the new
Kansas facility to enable Heat to manufacture therapies internally, expected benefit to be derived from significant operating synergies,
as well as enhanced oversight, quality control, and speed to market, exploring opportunities to expand ANTHIM® distribution abroad
and establishing a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently. Important factors
that could cause actual results to differ materially from current expectations include, among others, the ability to migrate manufacturing
of ANTHIM® to the Manhattan, Kansas facility, the ability to expand ANTHIM® sales beyond the U.S., the ability to leverage Elusys’
existing relationships and distribution channels as a launching pad for RapidVax , the ability to expand ANTHIM® distribution abroad,
the ability to derive benefit from operating synergies, as well as enhanced oversight, quality control, and speed to market, the ability
to establish a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently, whether the combined business
of Heat and Elusys will be successful, Heat’s and Elusys’ ability to maintain license agreements, the continued maintenance
and growth of Heat’s and Elusys’ patent estate, Heat’s product candidates demonstrating safety and effectiveness, as
well as results that are consistent with prior results, the ability to initiate clinical trials and if initiated, the ability to complete
them on time and achieve the desired results and benefits continuing enrollment as expected, the ability to obtain regulatory approval
for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat’s
ability to promote or commercialize its product candidates for the specific indications, acceptance of product candidates in the marketplace
and the successful development, marketing or sale of Heat’s, developments by competitors that render such products obsolete or
non-competitive, and other factors described in Heat’s annual report on Form 10-K for the year ended December 31, 2021, subsequent
quarterly reports on Form 10-Qs and any other filings Heat makes with the SEC. Heat can give no assurance that the conditions to the
Merger will be satisfied. The information in this presentation is provided only as of the date presented, and Heat undertakes no obligation
to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except
as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
investorrelations@heatbio.com
N IGHT H AWK B IOSCIENCES CORPORATE PRESENTATION April 2022 PLEASE NOTE: Heat Biologics, Inc. anticipates transitioning to NightHawk Biosciences, Inc effective May 3, 2022.
This presentation includes statements that are, or may be deemed, ‘‘forward - looking statements’’ within the meaning of the Priva te Securities Litigation Reform Act of 1995, as amended. In some cases, these forward - looking statements can be identified by the use of forward - looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “ app roximately” or, in each case, their negative or other variations thereon or comparable terminology, although not all forward - looking statements contain these words. They appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, an alyses or current expectations concerning, among other things, the timing of the opening of our facilities in San Antonino, Texas and Manhattan , K ansas, our ongoing and planned discovery and development of drugs targeting cancer, non - oncology, infectious disease medical countermeasures, our plann ed biosecurity/biodefense initiative, our planned bioanalytics , process development and manufacturing activities, our biologics drug discovery, the strength and breadth of our intellectual property, our ongoing and planned preclinical studies and clinical trials, the timing of and our ability to complete clinical trials and make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our ability to pa rtn er our product development, the degree of clinical utility of our products, particularly in specific patient populations, expectations regar din g clinical trial data, our results of operations, the industry in which we operate and the trends that may affect the industry or us. By their nature, forward - looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or ma y o ccur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward - looking statement conta ined in this presentation, we caution you that forward - looking statements are not guarantees of future performance and that our actual result s of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the for war d - looking statements contained in this presentation as a result of, among other factors, the factors referenced in the “Risk Factors” section of o ur Annual Report on Form 10 - K for the year ended December 31, 2021, our quarterly reports on Form 10 - Q for the subsequent quarters and our other subsequent fi lings with the Securities and Exchange Commission (collectively, our “SEC Filings”). In addition, even if our results of operations, financi al condition and liquidity, and the development of the industry in which we operate are consistent with the forward - looking statements contained in this present ation, they may not be predictive of results or developments in future periods. Any forward - looking statements that we make in this presentation speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of th is presentation, except as required by law. 2 Forward Looking Statements
3 Snapshot of N IGHT H AWK Fully integrated biopharmaceutical company developing novel therapies that arm the immune system • Key programs targeting oncology, inflammation, and medical countermeasures • Well - capitalized with strong balance sheet NightHawk Bio’s ecosystem enables agility to innovate and pivot • Ecosystem of integrated companies with efficient control of discovery, preclinical/clinical development, and biomanufacturing • End - to - end development from bench to commercial Major programs include: • Anthim® ( obiltoxaximab ) – FDA approved best - in - class antitoxin treatment for inhalational anthrax • HS - 110 – “off - the - shelf” cell - based immunotherapy with positive results in NSCLC (Phase 2) • PTX - 35 – potential first - in - class immunomodulatory antibody for treatment of solid tumors (Phase 1) • RapidVax ® – novel vaccine platform designed to a ccelerate time to clinic to combat emerging biological threats
4 Discovery N IGHT H AWK Ecosystem Streamlining Innovative Discoveries to Accelerate Clinical Development Preclinical/Clinical Development Biomanufacturing
Skunkworx Bio Discovery Sciences “Biology Drives Innovation” • Primary proprietary platform designed to enable rapid selection and validation of novel therapeutics for preclinical development • Additional novel therapeutic targeting and drug delivery platforms under development Unique Hotspot approach based on Pocket Biologics • Novel , highly diverse, proprietary compound libraries used to identify small proteins and human antibodies which bind to critical druggable targets • Advanced computational methods and bioinformatics inform target identification and improve development of candidate therapeutics Located in the New Jersey Bioscience Center - North Brunswick, NJ • Highly selective bioscience incubator in the heart of New Jersey’s “Research Corridor” 5
Oncology and Inflammation Development Heat Biologics – Realizing Immune Potential • Developing first - in - class immunomodulators that realize the potential of the immune system to treat and protect against a wide range of diseases • Proprietary gp96 - based vaccines to re - stimulate the immune system’s anti - tumor response • Phase 2 candidate HS - 110 ( vigenpumatucel - L) is an off - the - shelf allogenic cell therapy designed to stimulate immune responses against NSCLC Pelican Therapeutics – Next Generation T cell Immunotherapy for Cancer • Lead candidate, the monoclonal antibody PTX - 35, is an agonist of TNFRSF25 with the potential to shift the balance between inflammation and immunosuppression • In Phase I solid tumors as a potential first - in - class T cell co - stimulator • $15.2 million Cancer Prevention Institute of Texas (CPRIT) grant (the “CPRIT Grant”) to support development of PTX - 35 6
Elusys Therapeutics Medical Countermeasures Definitive agreement for acquisition executed in December 2021 • Sophisticated knowledge and hands - on experience in biodefense biologics • Program Management expertise with government agencies including the NIH, DoD, and BARDA Developer and marketer of Anthim ® , best - in - class monoclonal antibody antitoxin for anthrax • For treatment of inhalation anthrax in combination with antibiotics or, and as a prophylaxis when alternative therapies are not available or are not appropriate. Prescribing information: https://anthim.com/ • FDA approval in 2016, orphan drug designation • Approved in 2020 as only licensed anthrax treatment in EU, UK, and CA • Orphan drug designation in EU at time of approval Established government partnerships and funding • Received over $250M of non - dilutive development contracts from the NIH, DoD, and BARDA • Completed $70M in procurement contracts to supply Anthim to the U.S. Strategic National Stockpile (2016, 2018) • Completed first phase of contract for $50 million; HHS options to procure up to $31 million of Anthim by the first half of 20 23 7
Scorpion Biological Services Biomanufacturing and Analytical Labs Designed to provide scale - up GMP process development and biomanufacturing, cell and immuno - assay development, and bioanalytical lab services • Dedicated capacity to accelerate NightHawk preclinical and clinical development efforts • Contract manufacturing and bioanalytical services for external biopharmaceutical companies • Focus on American supply chain for materials and equipment Clinical Scale Facility, San Antonio, Texas – grand opening Q3 2022* • Designed to provide a scalable process development • Production of GMP material to large - scale clinical manufacturing and cold storage facilities Commercial Scale Facility, Manhattan, Kansas – breaking ground Q3 2022* • 500,000 sq. ft. state - of - the - art cGMP commercial biomanufacturing facility • 48+ bioreactors, ~144,000 liters for biomanufacturing of large - scale biologics 8 * per scheduled timeline
P roduct Pipeline 9 CTA = cancer testis antigen NSCLC = Non - small cell lung cancer CATEGORY PROGRAM MOA (MODALITY) INDICATION IND - ENABLING PHASE 1 PHASE 2 PHASE 3 APPROVED STATUS Oncology HS - 110 gp96 + CTAs (Cell Therapy) NSCLC End - of - Ph 2 Planning HS - 130 OX40L (Cell Therapy) Solid Tumors Ph 1 Enrollment Complete PTX - 35 TNFRSF25 (mAb) Solid Tumors Ph 1 Enrollment Ongoing Medical Countermeasures RapidVax gp96 + OX40L (Vaccine) Multiple Indications Platform Development Antitoxin ( mAb ) Anthrax Marketed Product
gp96 Platform Overview Activating the Immune System Key gp96 platform features • Leverages gp96’s role as a natural molecular warning system • Can be engineered to secrete target antigens bound to gp96 - Ig • Off - the - shelf allogeneic cell vaccine • Scalable manufacturing • Amenable to stockpiling • Broad applications in infectious diseases and cancer Lead product: HS - 110 • Completed Phase 2 trial for NSCLC 10
HS - 110 ( viagenpumatucel - L) gp96 - Based Cancer Vaccine Targeting Solid Tumors HS - 110 is a first - in - class, “off - the - shelf”, allogeneic cell - based immunotherapy • Engineered to secrete a wide range of cancer - associated antigens bound to the immunostimulatory chaperone gp96 • Designed to stimulate and facilitate uptake of cancer antigens by antigen presenting cells (APCs), which in turn activate a broad, T - cell medicated immune response against a patient’s cancer • Worldwide rights available Enrollment complete for Phase 2 NSCLC evaluating HS - 110 in combination with PD - 1 therapy • Positive interim survival data in previously treated PD - (L)1 naïve and PD - (L)1 progressor NSCLC patients • Plan to discuss registrational pathways with potential partners Combination of HS - 110 and PD - (L)1 therapies may confer additional survival benefit in multiple cancers • Line extension strategy to include additional indications that have been approved for PD - (L)1 therapies 11
12 HS - 110 Clinical Proof - of - Concept Achieved HS - 110 in Combination with Nivolumab HS - 110 + Nivolumab 1 94% non - squamous and 6% squamous All (N=47) ISR+ (N=28) ISR - (N=19) mOS (months) 24.6 33.6 4.5 Nivolumab 2 Non - squamous BMS Checkmate 057 Study 2 (N=292) mOS (months) 12.2 HS - 110 + Nivolumab 1 at ≥2 nd line after CPI failure All (N=68) ISR+ (N=52) ISR - (N=16) mOS (months) 11.9 12.1 6.8 Treatment Options 3 at ≥3rd line after CPI failure Gemcitabine 4 (N=27) Docetaxel 4 (N=25) Chemotherapy 5 (N=28) mOS (months) 7.5 6.8 9.0 Cohort A: Previously treated checkpoint inhibitor (CPI) naïve NSCLC patients Cohort B: NSCLC patients whose disease progressed on or following CPI treatment 1 Results as of November 2021 data cut . Subgroup analyses were retrospective ; 2 Trial did not contain a comparative nivolumab - only arm . Nivolumab - only data is historical published data ( Borghaei et al . 2021 . J Clin Oncol) ; 3 Trial did not contain a comparative chemotherapy - only arm . Treatment data is historical published data and not from HS - 110 trial ; 4 C onstatini et al . 2018 . ERJ Open Research ; 5 Schvartsman et al . 2017 . Lung Cancer HS - 110 in combination with nivolumab compares favorably with published data • Well - tolerated in combination with checkpoint inhibitor Two NSCLC settings are under evaluation: • Checkpoint Inhibitor (CPI) naïve patients • Patients that progressed after CPI treatment Potential to measure responsiveness • Improved OS in subsets of patients that experienced a dermal injection site reaction (ISR)
PTX - 35 Overview Potential First - in - Class TNF Receptor Superfamily Member 25 (TNFRSF25) Agonist Antibody PTX - 35 targets TNFRSF25 to shift the balance between inflammation and immunosuppression • Context driven T cell responses depending on activation signals and disease setting • Dynamic immunomodulatory properties of TNFRSF25 make it a compelling therapeutic target for context - dependent regulation of T cell responses and immune stability • Favorable safety profile demonstrated in non - human primates Phase 1 trial evaluating safety of PTX - 35 treatment for solid tumors • Anti - tumor activity demonstrated in preclinical colon, lung and breast cancer models • Preclinical data demonstrate anti - tumor activity, expansion of antigen - specific CD8 + T cells and decreased Treg suppression in the presence of tumor antigen (AACR 2021) • Awarded a $15.2M CPRIT grant to fund Phase 1 clinical development Worldwide rights licensed by NightHawk Biosciences 13
PTX - 35 Mechanism of Action Immunomodulatory Activity Dependent on Presence or Absence of Danger Signal 14 TNFRSF25 • Recognizes TNF - like ligand 1A secreted by several immune cell types • Highly and constitutively expressed on CD4 + FoxP3 + regulatory T cells Absence of an activating signal, co - stimulation of TNFRSF25 promotes • Expansion of immunosuppressive Treg cells • Treg expression of immunosuppressive markers CTLA4, TIGIT, and PD - 1 • Minimal impact on resting CD4 + and CD8 + T cells Presence of an activating signal, co - stimulation of TNFRSF25 promotes • Enhanced expansion of activated CD8 + effector T cells • Increased percent of inflammatory IFN g + Th1 & IL - 17 + Th17 CD4 + T cells • Decreased Treg function characterized by reduced CTLA4 expression
Anthim® Overview Best - in - Class Antitoxin for the Treatment of Anthrax Anthim treats & protects against inhalational anthrax disease • Monoclonal antibody that binds protective antigen (PA83) released by bacillus anthracis • Neutralizes anthrax toxin • In combination with antibiotics or prophylaxis when alternative therapies are not available • For complete prescribing information including limitations of use and box safety warning associated with HYPERSENSITIVITY and ANAPHYLAXIS, see https://anthim.com/ US FDA approval in 2016; CA, EU and UK approval as of 2020 • Only anthrax antitoxin to have received international licensure Anthim is supplied to the US Strategic National Stockpile • As part of ASPR’s objective to diversify supply and acquire products with a longer shelf - life, completed and shipped 2 orders totaling $70M in 2016 and 2018 • Completed first phase of contract for $50 million; HHS options to procure up to $31 million of Anthim by the first half of 2023 15
16 Anthim® Mechanism of Action Anthim Binds Protective Antigen to Prevent Anthrax Toxin Receptor Interaction
RapidVax ® Platform Overview A Customizable Approach to Countering Emerging Biological Threats Novel “plug - and - play” vaccine platform • Premanufactured gp96 - Ig/OX40L - Ig stockpile - amenable cells - potential to reduce time from identification to immunization • Target antigen sequences transfected into premanufactured RapidVax to rapidly create a pathogen - specific vaccine • Engineered for potential long - term protection via the stimulation of antibody production and immunological memory • Leverages favorable clinical trial safety profile previously observed for the gp96 platform 17
RapidVax ® Mechanism of Action Potential to Stimulate Pathogen - Specific Cellular and Humoral Immunity 18
Biothreat Advisory Board Bipartisan Board Providing Counsel on N IGHT H AWK’s Medical Countermeasure Initiatives 19 Andrew Weber Jack Kingston Dr. Gregory Koblentz Mark Pryor Former Deputy Asst. Sec. of Defense for Countering Weapons of Mass Destruction Former Asst. Sec. of Defense for Nuclear, Chemical & Biological Defense Programs Former US Representative, Secretariat of the Alliance for Biosecurity (current) Professor of Biodefense at George Mason University, Expert on Chemical and Biological Weapons Former US Senator, AR David Lasseter Greg Burel Gen. Richard Myers (Chairman) Former Director of the Strategic National Stockpile Former Chairman of the Joint Chiefs of Staff
N IGHT H AWK Highlights Marketed product and robust pipeline of immunomodulators spanning oncology, inflammation, and infectious disease • FDA approved Anthim ® ( obiltoxaximab ), best - in - class antitoxin for inhalation anthrax • Multiple biologics advanced from bench to clinic: HS - 110 and HS - 130 (allogenic cell therapies), PTX - 35 (antibody - based therapy) • RapidVax ® in development as a novel vaccine platform designed to a ccelerate time to clinic to combat emerging biological threats • Biothreat Advisory Board provides guidance on medical countermeasure initiatives End - to - end ecosystem designed to accelerate the development of discoveries to the delivery of novel therapeutics • Skunkworx Bio unique p roprietary biologics discovery platform and computational approach to drive intelligen t target identification • Heat Biologics and Pelican Therapeutics preclinical and clinical expertise support efficient trial design and execution • Elusys Therapeutics sophisticated knowledge and hands - on experience in medical countermeasures biologics and government funding • Scorpion Biological Services cGMP biomanufacturing and analytical services – 500,000+ sq ft commercial facility expansion in pro gress
21 N IGHT H AWK B IOSCIENCES PLEASE NOTE: Heat Biologics, Inc anticipates transitioning to NightHawk Biosciences, Inc effective May 3, 2022.