David Mccullough Email & Phone Number

Cary, North Carolina, United States

An experienced and successful biotech executive providing strategic advisory services to C-suite executives and board of directors from start-up to established companies in both the public and private sector. From drug discovery through commercialization.

Philadelphia, Pa, Us

Enterin, Inc. is a clinical stage biopharmaceutical company developing hormones for the treatment of neurodegenerative and metabolic disorders. ENT-01 for Parkinson’s Disease related non-motor symptoms. ENT-03 for obesity and T2D. As CEO, Mr. McCullough’s primary focus was to set the overall strategy, build an infrastructure, a BOD’s and external SAB’s to support clinical success and ultimately increase shareholder value. Since joining Enterin Mr. McCullough has:*Led completion of a randomized, placebo-controlled Phase 2b trial meeting its primary and secondary endpoints *Enhanced probability of shareholder success by securing funding for a second compound in discovery and successfully leading the pre-IND development activities to the IND filing in approximately 12 months before successfully completing the phase 1a*Successfully outlined plan to the BOD’s and major shareholders to spin out the early-stage asset into a wholly owned subsidiary to support a broader financing and exit strategy for ENT-03*Led creation of equity story development and pitch to all institutional investors, bankers and research analysts*Created a large network of institutional investors who can lead/co-lead early and late stage programs *Led IPO process through completion of and acceptance of S1, completed TTW during Q2/22 just before IPO market crash *Raised over $35M in support of the development activities, some of which closed during the height of the pandemic when private funding was sidelined*Significantly transformed the Board of Directors including a change to the Chairmanship role as well as adding two exceptional, well known industry experts in finance and drug development*Built world-class Scientific Advisory Board’s in the field of neurology, obesity and T2D including the recruitment of the former Chief Medical Officer of Novo-Nordisk who developed Wegovy and Ozempic*Rebuilt vital areas of the company including CFO, CMO, Clinical Operations, CMC, and Regulatory Affairs

As part of building Merck’s US Allergy business, a strategic decision was made to create a stand-alone US entity in preparation for commercial launch. Allergopharma USA, Inc. was created under my leadership with the responsibility to operationalize NewCo and create the necessary capabilities for NDA filing and commercialization for the US territory.Led a cross functional team to spin out the EMDS US Allergy business into a new US entity and streamlined operations into the Merck organization. Created and executed the overall US business strategy for this new entity. Worked closely with Regulatory colleagues on submission of dossier to FDA with Allergopharma USA, Inc as the NDA holder. Led in the creation and execution of US IP strategy. Led organizational planning, resources, and structure of operations. Drove all facets of commercial launch strategy. P&L responsibility.

Boston, Massachusetts, Us

Parent company Merck and their European subsidiary Allergopharma GmbH were developing a novel Epinephrine auto-injector for treatment of anaphylaxis. Through Merck’s US subsidiary EMD Serono my responsibility was to build the US Allergy Franchise for commercialization. At the time of joining EMDS their estimated net present value of the asset was approximately $20M, however leveraging my key core strengths the asset value grew to over $500M.Responsible for building new Allergy Business in the US in prepartion for launch of novel epinephrine auto-injector including P&L accountability. Full responsibility for assessing, organizing and shaping strategy for this new US Allergy Franchise. Drove all commercial launch planning preparations for the franchise with a focus on lead product in >$1B market space. Built relationships with key opinion leaders and formed needed Advisory Boards. Lead role in evaluating US partnerships.

Led a small start-up focused on bringing HCV treatments to Egypt and Latin America where prevalence of disease is per capita the highest in the world. Shaped and implemented overall company strategy in HCV and led raise of seed capital. Led discussions with the Egyptian Health Authority, investigators, contract research organization and consultants. Led discussions with potential partners and new investors including a joint venture with a focus on raising over $30 million in new capital. Established three new corporations necessary to execute the strategy; US, Cayman Islands, Egypt. Constructed organizational design and operating agreements. Led development of the Commercial, Clinical and Manufacturing team’s respective plans and associated budgets.

Durham, Nc, Us

Joined BioCryst as a Corporate Officer and member of the Leadership Team reporting to the CEO. Upon joining, supported CEO/Board in the restructuring of the Management Team. The company was in need of a well thought out growth strategy that would renew confidence in the company. Shortly after joining co-developed a new strategy pitched to investors and closed a $65M PIPE. Co-led with CEO successful negotiation of a pre-approval commercial purchase agreement with United States Government for $22.5 M for an experimental drug. Accountable for all aspects of the commercial pre-launch and launch strategy for products in hereditary angio edema/anaphylaxis; inflammatory diseases, oncology and anti-virals. Led organization toward the approval and commercial launch of Peramivir in major markets. Led the Management and Board in implementing a comprehensive portfolio management process that identified and prioritized high value assets. Extensive experience in managing all aspects of the M&A and licensing process, both externally with partners and internally with key stakeholders including BOD’s. Renegotiated several unfavorable partnership agreements that saved BioCryst millions of dollars in potential payments. Built relationships and contacts with every large and mid-size pharma company in the US, EU, Japan, MENA region, India and China.

Darmstadt, De

A few years prior to joining the company Merck had formed a US business EMD with a focus on in-licensing of commercial stage assets or an acquisition of an established entity. In 2002, joined EMD and began using my deep commercial and industry knowledge to contribute to those efforts making significant contributions that led to Merck achieving its goal. M&A: Lead role in the valuation and purchase of Serono Biotech for $13.5B. Honored by Merck Board as a top contributor to closing this deal.For all M&A deals affecting the Pharma Division played lead role in the valuation of commercial and pipeline products across all therapeutic areas using cross functional teams of 10-15 people. This includes assessment of all commercial, clinical, regulatory, patent and CMC issues affecting the asset/business. Commercial evaluations for over 40 companies ranging in value from $200M-$18B including attempted acquisition of Schering AG. Commercial lead on evaluation of five additional companies with full due diligence leading to three tender offers and two non-binding offers.Oncology Licensing: Lead in the commercial assessment of strategic and financial attractiveness of all oncology opportunities and several assets in other therapeutic areas. Project lead for cross functional team assessment of over 700 different targets leading to 40 due diligences and two signed term sheets.