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-Merger would actualize publicly-traded immuno-oncology biotechnology aggregation developing atypical articles for alleviative early- and late-stage cancer-



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-Growing artefact action utilizing Versamune®, a novel, versatile, multi-functional platform-



-Phase 1/2 analytic abstracts on beforehand artefact applicant PDS0101 suggests immunotherapeutic anti-cancer action and favorable assurance contour in aboriginal date cervical cancer-

-Combined aggregation affairs to admit assorted Phase 2b/3 analytic trials of PDS0101 in HPV-associated cancers-



-PDS stockholders accepted to own ~70% of the accumulated aggregation and Edge stockholders ~30%-

-Conference alarm appointed for today, November 26, 2018, at 8:30 am ET-

BERKELEY HEIGHTS, N.J. and NORTH BRUNSWICK, N.J., Nov. 26, 2018 (GLOBE NEWSWIRE) — Edge Therapeutics, Inc. (Nasdaq: EDGE) and PDS Biotechnology Corporation, a privately-held, clinical-stage blight immunotherapy company, appear today that their corresponding boards of admiral accept accustomed a absolute alliance agreement. The alliance is accepted to actualize a accumulated aggregation with a growing action of abutting bearing blight immunotherapies based on the proprietary, multi-functional Versamune® technology platform, and acceptable banknote to armamentarium operations into 2020.

“We accept that the proposed alliance of PDS Biotechnology and Edge Therapeutics will actualize a accumulated aggregation that can achieve actor amount through our proprietary Versamune® belvedere and a able action of abutting bearing immunotherapies targeting several blight markets including the multi-billion-dollar HPV-induced blight market,” said Frank K. Bedu-Addo, Ph.D., Co-Founder, President and Chief Controlling Officer of PDS. “We apprehend that the accumulated aggregation will accept the banking assets and accomplished administration to achieve our key near-term objectives: first, to admit assorted late-stage analytic studies for our beforehand artefact applicant PDS0101; and second, to added beforehand our preclinical programs adjoin the clinic.”

“Since advertisement our affairs to seek cardinal alternatives for Edge Therapeutics, our antecedence has been to analyze a alliance applicant that we accept has the abeyant to abide our mission to advice patients and to accommodate allusive amount to our stockholders,” said Brian A. Leuthner, Edge’s President and Chief Controlling Officer. “Following a accurate appraisal and activity process, the Edge Lath of Admiral has assured that a alliance with PDS Biotechnology, with a clinical-stage artefact applicant that has accustomed the abeyant in patients to abode important limitations of accepted immuno-oncology approaches, a growing development pipeline, and a atypical abutting bearing technology, offers an accomplished befalling to actualize such value. We accept that PDS represents an adorable alliance accomplice for Edge as PDS prepares to beforehand assorted late-stage analytic programs through key milestones in 2019 and beyond.”

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Versamune® Platform

PDS Biotechnology’s Versamune® belvedere is based on atypical and proprietary constructed cationic lipids, which beforehand analytical intra-cellular commitment of tumor-related antigens and actuate important immunologic signaling pathways that abet able appointment and admeasurement of analytical populations of analgesic T-cells able accurately to beforehand and annihilate annihilative cells.  Versamune® induces the activation of blazon I interferons and associated chemokines consistent in a potentially able and targeted allowed acknowledgment adjoin blight cells. In addition, in preclinical studies, Versamune® has been apparent to affected important immuno-suppressive beef that abide aural the bump to assure the bump from T-cell attack.

Growing Artefact Pipeline

PDS Biotechnology is developing PDS0101 for the analysis of assorted animal papilloma virus (HPV)-induced cancers, including cervical, anal and arch and abutting cancers. PDS Biotechnology affairs to admit assorted Phase 2/3 analytic trials for PDS0101 in HPV-associated cancers.

In a Phase 1/2a dose-escalating abstraction of PDS0101, after-effects accepted preclinical projections of aerial levels of alive HPV-specific analgesic T-cells (CD8 ) and anamnesis T-cell induction. In addition, T-cell responses were absolute of accommodating genetic/HLA sub-types. In the study, no dose-limiting toxicities were observed.

In accession to PDS0101, PDS Biotechnology’s action includes assorted preclinical programs developing Versamune®-based blight immunotherapies in aggregate with checkpoint inhibitors for assorted late-stage cancers.

Management Team

Pursuant to the alliance agreement, the administration aggregation of the accumulated aggregation is accepted to be comprised of Frank Bedu-Addo, PhD, Co-Founder, President, CEO of PDS Biotechnology who will serve as CEO, Brian Leuthner, President, CEO of Edge Therapeutics, who will serve as President, and Lauren Wood, MD, aforetime of the National Blight Institute, confined as the company’s Chief Medical Officer. In addition, Gregory Conn, PhD, Co-Founder and Chief Scientific Officer of PDS Biotechnology is accepted to abide as CSO of the accumulated company, and Andrew Saik, Chief Banking Officer of Edge Therapeutics is accepted to abide as CFO of the accumulated company.

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Board of Directors

Pursuant to the alliance agreement, the Lath of Admiral of the accumulated aggregation is accepted to abide of four associates of the accepted PDS Biotechnology lath and three associates from the accepted Edge Therapeutics board.

Pursuant to the alliance agreement, Frank Bedu-Addo, PhD, Co-Founder, President, CEO of PDS Biotechnology and Brian Leuthner, President, CEO of Edge Therapeutics are accepted to serve on the Lath of Directors. Added lath associates are accepted to include: De Lyle W. Bloomquist, aforetime President, Global Chemicals Business for Tata Chemicals Ltd.; Gregory Freitag, J.D., CPA, AxoGen, Inc.’s General Counsel, SVP of Business Development; Sir Richard Sykes, ahead Chief Controlling and Chairman of GlaxoWellcome from 1995 to 2000 and again Chairman of GlaxoSmithkline until 2002; James J. Loughlin, aloft Accomplice at KPMG LLP and Robert Spiegel, M.D., FACP, ahead Chief Medical Officer of the Schering-Plough Research Institute.

In addition, Sol J. Barer, Ph.D., Chairman of the Lath of Admiral at Teva Pharmaceutical Industries Ltd. and who ahead spent 24 years at Celgene as, amid added positions, President, COO and CEO, as able-bodied as its Controlling Chairman and Chairman, is accepted to serve as an adviser to the Lath of Directors.

Proposed Transaction Details

The alliance is structured as a stock-for-stock transaction whereby all of PDS’s outstanding shares of accepted banal and balance convertible into or exercisable for PDS’s accepted banal will be adapted into Edge’s accepted banal and balance convertible into or exercisable for Edge accepted stock. Beneath the barter arrangement blueprint in the alliance agreement, anon afterward the merger, the aloft PDS aegis holders will own about 70% of the accumulated aggregation and absolute Edge aegis holders will own about 30% of the accumulated company, accountable to assertive abeyant adjustments as declared in the alliance agreement. The transaction has been accustomed by the boards of admiral of both companies. The alliance is accepted to abutting in the aboriginal division of 2019, accountable to the approval of the stockholders of anniversary aggregation as able-bodied as added accepted closing conditions.

Upon the closing of the transaction, the alloyed aggregation will accomplish beneath the PDS Biotechnology Corporation name, and the accumulated company’s accepted banal is accepted to abide to barter on NASDAQ beneath a new ticker attribute to be appear at a after date. Piper Jaffray acted as absolute banking adviser to Edge Therapeutics on the proposed transaction and Dechert LLP served as acknowledged admonition to Edge Therapeutics. DLA Piper LLP served as acknowledged admonition to PDS Biotechnology. 

A presentation summarizing the proposed alliance and accouterment added accomplishments advice will be filed on Form 8-K and be fabricated accessible at www.edgetherapeutics.com and at  www.pdsbiotech.com. Advice on the Edge website is not allotment of this columnist release.

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Conference Alarm Details

A appointment alarm and webcast will be captivated today, Monday, November 26, 2018 at 8:30 a.m. Eastern time to altercate the alliance amid Edge Therapeutics and PDS Biotechnology Corporation.

To admission by phone, amuse punch (877) 388-5691, or (562) 350-0788 for all-embracing callers, and advertence appointment ID 8488299 about 15 account above-mentioned to the call. A epitomize of the alarm may be accessed through December 3, 2018 by dialing (855) 859-2056, or (404) 537-3406 for all-embracing callers, and referencing appointment ID 8488299.

A alive webcast of the appointment alarm will be accessible at www.edgetherapeutics.com and at  www.pdsbiotech.com and will be archived for one year.

About Edge Therapeutics, Inc.

Edge Therapeutics, Inc. is a clinical-stage biotechnology aggregation that seeks to discover, beforehand and commercialize novel, hospital-based therapies able of transforming analysis paradigms for the administration of acute, life-threatening conditions. For added advice about Edge, amuse appointment www.edgetherapeutics.com.

About PDS Biotechnology

PDS Biotechnology is a clandestine aggregation with a growing action of clinical-stage immunotherapies to amusement assorted early-stage and late-stage cancers, including arch and abutting cancer, cervical cancer, anal cancer, prostate cancer, breast blight and added cancers. PDS Biotechnology’s beforehand artefact applicant PDS0101 accustomed able consecration of the accepted allowed responses (e.g. antigen-specific CD8 T-cell responses) after any empiric dose-limiting toxicities in a completed Phase 1/2a analytic trial. For added advice about PDS, amuse appointment www.pdsbiotech.com.

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Forward-Looking Statements

This columnist absolution contains advanced statements about Edge Therapeutics, Inc. and PDS Biotechnology Corporation, and their corresponding businesses, business prospects, action and plans, including but not bound to statements apropos advancing preclinical and analytic biologic development activities, timelines and bazaar opportunities; PDS Biotechnology actuality well-funded to beforehand its programs; the accumulated aggregation actuality assertive to accommodate allusive value-creating abstracts readouts; PDS Biotechnology’s artefact applicant actuality the optimal access to abode the unmet medical need; the accumulated company’s adeptness to advance development of PDS Biotechnology’s artefact candidates and achieve amount for stockholders; and the advancing closing date of the merger. All statements added than statements of absolute facts included in this columnist absolution are advanced attractive statements.  The words “anticipates,” “may,” “can,” “plans,” “believes,” “estimates,” “expects,” “projects,” “intends,” “likely,” “potential,” “will,” “should,” “to be,” and any agnate expressions or added words of agnate acceptation are advised to analyze those assertions as advanced statements. These advanced statements absorb abundant risks and uncertainties that could account absolute after-effects to alter materially from those anticipated, including, after limitation: the accident that the altitude to the closing of the alliance are not satisfied, the abortion to appropriate or at all access stockholder approval for the merger; uncertainties as to the timing of the cleanup of the alliance and the adeptness of anniversary of Edge and PDS Biotechnology to able the merger; risks accompanying to Edge’s adeptness to accurately appraisal its operating costs and its costs associated with the merger; risks accompanying to the bazaar amount of Edge’s accepted banal about to the barter ratio; the adeptness of Edge or PDS Biotechnology to assure their corresponding bookish acreage rights; aggressive responses to the merger; abrupt costs, accuse or costs consistent from the merger; and abeyant adverse reactions or changes to business relationships consistent from the advertisement or achievement of the merger. The artefact candidates that PDS Biotechnology develops may not advance through analytic development or accept appropriate authoritative approvals aural accepted timelines or at all. In addition, approaching analytic trials may not affirm any safety, authority or added artefact characteristics declared or affected in this columnist absolution and such artefact candidates may not be auspiciously commercialized.  Added factors that may account absolute after-effects to alter materially from such advanced statements accommodate those articular beneath the explanation “Risk Factors” in the abstracts filed by Edge with the Balance and Barter Commission from time to time, including its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Accepted Reports on Form 8-K.  Investors are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date of this columnist release. Except to the admeasurement appropriate by applicative law or regulation, neither Edge nor PDS Biotechnology undertakes any obligation to amend the advanced statements included in this columnist absolution to reflect consecutive contest or circumstances.

Additional Advice about the Alliance and Where to Find It

In affiliation with the proposed cardinal merger, Edge intends to book accordant abstracts with the Balance and Barter Commission (SEC), including a allotment account on Form S-4 that will accommodate a proxy account and prospectus. Investors may access the proxy statement/prospectus (when available), as able-bodied as added filings absolute advice about Edge, chargeless of charge, from the SEC’s Web armpit (www.sec.gov).  In addition, investors and securityholders may access chargeless copies of the abstracts filed with the SEC by Edge by administering a accounting appeal to: Edge Therapeutics, Inc. 300 Connell Dr #4000, Berkeley Heights, NJ 07922, Attention: Corporate Secretary or delivered via e-mail to [email protected] Investors and securityholders are apprenticed to apprehend the proxy statement, announcement and the added accordant abstracts back they become accessible afore authoritative any voting or advance accommodation with account to the merger.

This advice shall not aggregate an action to advertise or the address of an action to advertise or the address of an action to buy any securities, nor shall there be any auction of balance in any administration in which such offer, address or auction would be actionable above-mentioned to allotment or accomplishment beneath the balance laws of any such jurisdiction. No alms of balance shall be fabricated except by agency of a announcement affair the requirements of Section 10 of the Balance Act of 1933, as amended.

Participants in the Solicitation

Edge and PDS Biotechnology and their corresponding admiral and controlling admiral and assertive of their added associates of administration and advisers may be accounted to be participants in the address of proxies from the stockholders of Edge in affiliation with the proposed transaction. Advice apropos the appropriate interests of these admiral and controlling admiral in the alliance will be included in the proxy statement/prospectus referred to above. Added advice apropos the admiral and controlling admiral of Edge is additionally included in Edge Annual Report on Form 10-K for the year concluded December 31, 2017, filed with the SEC on March 1, 2018. These abstracts are accessible chargeless of allegation from the sources adumbrated above.

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