8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): May 2, 2019

CytoDyn Inc.

(Exact name of registrant as specified in its charter)

Delaware	000-49908	83-1887078
(State or other jurisdiction of incorporation)	(SEC File Number)	(I.R.S. Employer Identification No.)
1111 Main Street, Suite 660 Vancouver, Washington		98660
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (360) 980-8524

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Item 8.01. Other Events.

On May 2, 2019, the Company posted an updated version of the investor presentation deck titled “Leronlimab (PRO 140) HIV - Cancer” to its website at www.cytodyn.com. A copy of the investor presentation is filed as Exhibit 99.1 to this Form 8-K.

The Company does not intend to incorporate any contents from its website into this Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d)	Exhibit No.	Description.
	99.1	Investor Presentation.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CytoDyn Inc.
May 2, 2019	By:	/s/ Michael D. Mulholland
	Name:	Michael D. Mulholland
	Title:	Chief Financial Officer

EX-99.1

OTCQB: CYDY www.cytodyn.com HIV - Cancer BIOTECH SHOWCASE January 2019 Professor Richard G. Pestell M.D., Ph.D., MB., B.S., F.A.C.P., F.R.A.C.P., F.A.A.A.S., M.B.A. Vice Chairman and Chief Medical Officer Nader Pourhassan, Ph.D. Director, President & CEO ® Leronlimab (PRO 140) ® Trading Symbol CYDY Trading Symbol CYDY Exhibit 99.1

www.cytodyn.com Forward-Looking Statements 2 www.cytodyn.com Trading Symbol: CYDY

3 www.cytodyn.com CytoDyn Overview PHASE 2 – Initiated Unmet Medical Need PHASE 3 - Completed World’s first self-injectable for Unmet Medical Need Population PHASE 3 - Monotherapy Several patients on monotherapy for > 4.5 years HIV HIV GvHD PHASE 1b/2 – Initiated Unmet Medical Need TNBC PHASE 2 IND to be filed File for Orphan Drug Designation Colon Cancer 510(k) for medical device File with FDA for prostate cancer prognostic test Prognostic Ticker Symbol: CYDY 8 Pre-clinical studies to be initiated Melanoma, Pancreatic, Breast, Prostate, Colon, Lung, Liver and Stomach Cancer 8 Cancer indications

4 www.cytodyn.com Blocking HIV entry receptor (CCR5) Blocking CCR5/CCL5 interaction with leronlimab for use in CANCER Binds to CCR5 co-receptor on white blood cells Blocks HIV entry into white blood cells Leronlimab CCR5 CD4 T-Cell HIV Humanized monoclonal antibody Leronlimab (PRO 140) – A Humanized Monoclonal Antibody HAART Trading Symbol: CYDY

5 www.cytodyn.com Leronlimab (PRO 140) No serious side effects and no drug related serious adverse events (SAEs) in >740 patients in 8 clinical trials   Ranges from mild to severe (Diarrhea, nausea, lethargy, depression) Negligible toxicity in 740 patients   Problems with short- and long-term toxicity No drug resistance in patients on monotherapy for over 4.5 years 76% of HIV patients have at least one drug resistance Weekly, easy, subcutaneous self administration   Daily lifetime dosing with only 35% of patients with complete viral load suppression FDA: “fast track designation” – “accelerated approval possible” NIH: $28 million grants Side Effects Toxicity Resistance Compliance HAART Trading Symbol: CYDY

www.cytodyn.com CD02 Pivotal Combination Trial with Leronlimab (PRO 140) Trading Symbol: CYDY Pivotal Phase 3 Completed Primary Efficacy End Point Hit - p=0.0032 Safety of 24 weeks completed - With 81% of patients with suppressed viral load as compared to 43% last approved drug for this population No reported SAEs related to leronlimab BLA – submission green light from FDA Rolling Review Submission Granted by FDA 1/3 of BLA already submitted in March 2019 Potential label: One drug resistance in three classes or One drug resistance in two classes with limited treatment option to another class

7 www.cytodyn.com CD03 Leronlimab (PRO 140) Investigative Monotherapy Trial R5 patients w/suppressed viral load replacing HAART for leronlimab monotherapy Leronlimab monotherapy – One dose (2 consecutive injections), once a week High responder’s rate – non-responders return to their original regimen without any resistance or harm – No ADA (Anti-Drug Antibody) presence – No X4 grow out during the monotherapy Increasing response rate (Suppressed viral load without pills) Regulatory path Submit pivotal trial to the FDA 2Q2019 Trading Symbol: CYDY Dose Average duration post 10 weeks Responder’s rate post 10 weeks 525 mg 26 weeks 95% 700 mg 9 weeks 91%

P < .01 P < .01 www.cytodyn.com Effect of Leronlimab (PRO 140) on Xeno GvHD-Human BM Transplanted Into Immuno-Deficient Mice Results Published TRIAL TO RE-INITIATE WITH MODIFIED DOSE/PROTOCOL IN MAY 2019

Expansion into Cancer Indications 9 www.cytodyn.com Named world-renowned oncologist Dr. Richard Pestell Chief Medical Officer and Vice Chairman (https://www.youtube.com/watch?v=98J1HgCm8wU) Leads leronlimab (PRO 140) non-HIV development programs Led 2 National Cancer Institute-designated cancer centers Lombardi Comprehensive Cancer Center at Georgetown University Sidney Kimmel Cancer Center at Thomas Jefferson University Executive Vice President Thomas Jefferson University (25,000 employees, $5.6B) Founded ProstaGene to develop CCR5 technology in cancer Issued patents for technology on metastasis (many types of cancer) Showed > 50% of 2,200 patients -increased CCR5 in breast cancer CCR5 inhibitors blocked breast, prostate and colon cancer metastasis in pre-clinical studies Trading Symbol: CYDY

CCR5 is Expressed in >50% of Breast Cancer Metastatic cancer. 50% of breast cancers CCR5+ Leronlimab (PRO 140) reduces breast cancer invasion in pre-clinical studies 0 200 400 600 800 1000 Control PRO140 Vicriviroc Distance of Invasion (mm) P<0.001 P<0.001 Control Leronlimab PRO140 (1/500) Vicriviroc CCL5 10 www.cytodyn.com Professor Richard Pestell, PhD, MD Trading Symbol: CYDY

Control PRO140 (1/100) 20 sec before adding CCL5 60 sec after adding CCL5 240 sec after adding CCL5 60 sec after adding FBS 0 200 400 600 800 1000 CCL5 FBS 0 200 400 600 800 1000 CCL5 FBS Control PRO140 A B C Time (Sec) Time (Sec) -1 0 1 2 3 -1 0 1 2 3 Relative FI of Fluo-4 Relative FI of Fluo-4 Leronlimab (PRO 140) Blocks Breast Cancer Ca+2 signaling 11 www.cytodyn.com Professor Richard Pestell, PhD, MD Trading Symbol: CYDY

CCR5 Antagonists Block Breast Cancer Metastasis Time (weeks) 1 2 3 4 Control Maraviroc 12 www.cytodyn.com Professor Richard Pestell, PhD, MD Trading Symbol: CYDY

advanced-stage metastatic colorectal cancer who are refractory to standard chemotherapy, including regorafenib Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients Cancer Cell. 2016 587-601 Objective Tumor Response, Phase 1 Trial 13 Trading Symbol: CYDY

CCR5 Antagonists Block Metastasis 14 www.cytodyn.com Professor Richard G. Pestell Professor Richard Pestell, PhD, MD Trading Symbol: CYDY 0 1 2 3 6 5 7 weeks 4 Control Leronlimab Maraviroc

Leronlimab (PRO 140) Breast Cancer Trial November 2018-December 2019 Phase II Breakthrough (unmet need) April 2019-July 2021 (Phase III) Pro-140 525 mg 1sc/week Carboplatin AUC 2q week x3 28 days cycle TNBC Rx Refractory CCR5+ CTC Endpoints OS PFS’ Decreased CTC 15

1. AACR presentation April 1 Atlanta Georgia. CCR5 associated with HER2 in circulating tumor cells (CTCs) is a novel biomarker for patients with metastatic breast cancer (MBC) . CTCs were found positive (≥5) in all seven MBC patients with a range of numbers between 124 and 442 Clinical studies updates 16 TNBC breast cancer

Trial open to accrual measuring CTC

1. Pacific Hematology Oncology Associates Dr. Milana Dolezal  mdolezal@phoamd.com 2100 Webster street suite 220, San Francisco, ca 9411 david@PHOAMD.COM 415-923-3012 Other sites to open: Northwestern University Medical School, Methodist Houston, Vanderbilt University, Sidney Kimmel Cancer Center.   Trial open to accrual * * * * *

19 www.cytodyn.com Milestones Target Dates BLA submission – HIV combination therapy – unmet medical need 3Q2019 Revenue potential of about $480 million 2020 Initiate first ever monotherapy Phase 3 pivotal trial 1H2019 Triple-Negative Breast Cancer study first patient injected 2Q2019 Triple-Negative Breast Cancer study interim results 2019 GvHD interim results 2H2019 Prognostic test licensed – 510(k) filing with the FDA 1H2019 IND-Protocol for colon cancer Phase 2 1H2019 Large Pharma discussion for potential licensing or partnering 1H2019 8 preclinical studies with leronlimab - Filing 8 INDs for 8 Phase 2 trials (if results of preclinical studies are positive) 2019 PRO 140 Important Milestones for HIV and Cancer 2019 Ticker Symbol: CYDY

OTCQB: CYDY www.cytodyn.com HIV - Cancer BIOTECH SHOWCASE January 2019 Professor Richard G. Pestell M.D., Ph.D., MB., B.S., F.A.C.P., F.R.A.C.P., F.A.A.A.S., M.B.A. Vice Chairman and Chief Medical Officer Nader Pourhassan, Ph.D. Director, President & CEO ® Leronlimab (PRO 140) ® Trading Symbol CYDY Trading Symbol CYDY