On September 24, 2021 A group of long-time stockholders (the "Nominating Stockholders" or the "Group") of CytoDyn Inc. ("CYDY or the "Company") (OTC: CYDY) reported that has nominated five highly experienced director candidates to serve on the Company’s Board of Directors reported its comprehensive strategic plan to obtain cancer therapy approval for Leronlimab (Press release, CytoDyn, SEP 24, 2021, View Source [SID1234590261]). If implemented, the Group believes this plan would begin to generate much-needed revenue for CYDY and position the Company to earn FDA approval for the drug, while enhancing the value of all stockholders’ shares.

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The Group’s strategy is designed to overcome current CYDY management’s failures to implement a coherent, effective plan to generate revenue and obtain FDA approval for Leronlimab. While the Group has tried to discuss the enormous potential of its oncological strategy to reinvigorate CYDY with the Board and management team, they have refused to meaningfully engage every step of the way. Instead, incumbent Company leadership has decided to focus on entrenching themselves and clinging to their outsized compensation packages at the expense of shareholders.

The Group’s approach to cancer therapy will be scientifically valid and extremely efficient and will be critical to unleashing the potential value of Leronlimab and the investments of all stockholders. The full plan can be found here, and highlights are as follows:

Utilize real data based on precision medicine determination of Leronlimab binding cancers;
Apply both combination therapy with complementary immune-oncology blockbuster drugs and adjuvant monotherapy in CCR5+ tumors;
Prioritize cancer targets based on CCR5 expression; and
Partner with leading oncology companies that lack a CCR5 asset like Leronlimab.
Dr. Bruce Patterson, one of the Group’s five nominees and a renowned virologist, pathologist, and cancer technology pioneer, stated: "We are excited to present our plan on how to maximize the value of Leronlimab and save the lives of countless cancer patients. We believe we have put in place a strategy that is not only executable but also best positions CYDY for future success and will repair the Company’s standing among the medical, regulatory, and investment communities. In order to protect the value of your investment in CYDY, we strongly you recommend you for our highly qualified director nominees on the WHITE proxy card today."

Dr. Patterson added, "Immuno-oncology (IO) has revolutionized oncological therapy for many cancers and makes up one of the largest cancer drug market segments. However, CYDY’s Board and management have utterly failed to capitalize on this tremendous opportunity and have not publicly presented any strategic plan on how they might make Leronlimab a reality. On the other hand, our cancer program will combine the value that Leronlimab has as a potential adjuvant therapy following treatment with the urgent opportunities that exist in IO and in doing so, will create enormous value for CYDY and its stockholders. This carefully designed plan is critical to the Company’s success, and we are excited by the prospect of finally being able to implement it."

The full text of the Group’s cancer therapy approval plan can be accessed at: www.advancingll.com/cancerplan

All CYDY shareholders are reminded that your vote is essential to charting a course towards lasting value creation and holding the current Board and management team accountable for the immense value destruction they have overseen throughout their tenure. Help us enable CYDY to achieve its incredible potential by voting the WHITE proxy card to elect the Group’s five independent director nominees today.

Important Information

Paul Rosenbaum, Jeffrey Beaty, Arthur Wilmes, Thomas Errico, M.D., Bruce Patterson, M.D., Peter Staats, M.D., Melissa Yeager and CCTV Proxy Group, LLC (collectively the "Participants") have filed a definitive proxy statement and accompanying WHITE proxy card with the Securities and Exchange Commission (the "SEC") to be used in connection with the solicitation of proxies from the stockholders of CytoDyn Inc. (the "Company"). All stockholders are advised to read the definitive proxy statement and other documents related to the solicitation of proxies. The definitive proxy statement and an accompanying proxy card is available at no charge on the SEC’s website at View Source In addition, the Participants will provide copies of the proxy statement, without charge, upon request. Requests for copies should be directed to the Participants’ Proxy Solicitor, Okapi Partners LLC, by calling (844) 202-7428.

On September 24, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $4.20 per share (Press release, Onconova, SEP 24, 2021, View Source [SID1234590260]). The gross proceeds of the offering to the Company are expected to be $21 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, Onconova granted the underwriters a thirty-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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The closing of the offering is expected to occur on or about September 28, 2021, subject to the satisfaction of customary closing conditions.

Guggenheim Securities is acting as sole book-running manager. Ladenburg Thalmann & Co. Inc. and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above are being offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission (the "SEC") on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on September 23, 2021 and is available on the SEC’s website at View Source The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 24, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or are resistant to, current treatment regimens reported that it has entered into securities purchase agreements with certain healthcare-focused institutional investors to raise approximately $15 million in gross proceeds, before placement agent fees and other offering expenses payable by Kintara, through the issuance of 12,000,000 shares of its common stock (or common stock equivalents) and investor warrants to purchase up to an aggregate of 12,000,000 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Kintara Therapeutics, SEP 24, 2021, View Source [SID1234590259]). Each share of common stock (or common stock equivalent) is being sold together with one investor warrant to purchase one share of common stock at a combined offering price of $1.25. The investor warrants have an exercise price of $1.25 per share and are exercisable for three and one half years from the date of issuance. The closing of the offering is expected to occur on or about September 28, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Company currently intends to use the net proceeds from the offering for funding its clinical studies, working capital and other general corporate purposes, including, but not limited to, funding acquisitions or investments in businesses, products or technologies that are complementary to the Company’s businesses, products and technologies.

The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254662) filed with the Securities and Exchange Commission (SEC) on March 24, 2021 and declared effective on April 1, 2021. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 24, 2021 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that senior management will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 1:20 p.m. ET (Press release, Celldex Therapeutics, SEP 24, 2021, View Source [SID1234590258]).

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A webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for 30 days following the event.

On September 24, 2021 Tiziana Life Sciences plc ("Tiziana", LSE: TILS, NASDAQ: TLSA), a biotechnology company a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases reported its interim results for the six months ended 30 June 2021 (Press release, Tiziana Life Sciences, SEP 24, 2021, View Source [SID1234590256]).

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Highlights during the period:

CLINICAL PROGRAMMES

Foralumab
TZLS-401

Announced an update on further analysis of lymphocyte subsets from blood samples from a Phase 1 study with nasally administered Foralumab in healthy volunteers. Results exhibiting statistically significant immunomodulatory effects on CD8 cytotoxic T-lymphocytes and other inflammatory biomarkers were observed. Systemic levels of Foralumab were below the lower quantitation limit of 8 ng/mL suggesting that nasally administered Foralumab appears to exert its effects via nasal epithelium utilizing local and lymphatic immune systems directly. These data support other clinical and pre-clinical studies showing that this route of administration is capable of inducing site-targeted immunomodulation and anti-inflammatory effects. Furthermore these pharmacodynamic data point to a clinical dose range that Tiziana intends to test in further clinical development among MS patients.

Announced positive data from the exploratory clinical study in Brazil investigating nasally administered Foralumab, its proprietary anti-CD3 human monoclonal antibody, either alone or in combination with orally administered dexamethasone ("Dexa") in COVID-19 patients. The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), and INTRIALS, a full-service Latin American CRO based in São Paulo, Brazil. The objectives of the trial were to assess safety of the treatment and to evaluate if progression of the diseases is delayed with nasally administered 100mcg/day Foralumab (50mcg/nostril). This study enrolled 39 patients randomized in three cohorts: cohort 1, control with no treatment (n=16); cohort 2; nasally administered Foralumab plus 3 days of priming with orally administered 6 mg Dexamethasone (n=11) and cohort 3; nasally administered Foralumab (n=12). The Foralumab treatment regimen was once a day dosing for 10 consecutive days There were no significant differences between cohort 2 and 3. All treatments were well-tolerated. There were no grade 3 or 4 severe adverse events ("SAEs") in any of the cohorts. The CT scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab as compared to those in the control group. The results of the study were published in the peer-reviewed journal, Frontiers in Immunology entitled "Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study" in August 2021.

Signed an agreement with FHI CRO to conduct a follow-up, "proof of concept" Phase 2 study in hospitalized patients with severe COVID-19 and lung inflammation that is planned to begin in Q4 2021. Foralumab will be delivered intranasally using a metered dose delivery device.

Announced that the first patient with secondary progressive multiple sclerosis (SPMS) was dosed with nasally administered Foralumab at the Brigham and Women’s Hospital (BWH), Harvard Medical School, Boston, MA. Nasal Foralumab 50 mcg (25 mcg/nostril) was administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, will continue for six months to evaluate routine safety, tolerability, and neurological behaviors. The study will also examine microglial activation, by positron emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the treatment regimen.
Anti IL-6R mAb
TZLS-501, formerly NI-1201​

Working with Sciarra Laboratories to evaluate two hand-held nebulizer devices for use in the study and characterizing physical/performance characteristics. Once a device has been selected, a few candidate formulations of anti-IL6R mAb, from formulation development studies at STC Biologics, will be manufactured at small scale and evaluated using the devices.

Engaged ITR Laboratories in Canada to complete inhalation safety toxicology studies in Cynomolgous monkeys using the purified, characterized anti-IL6R mAb test item. Results from the study will be used to establish dosing for a Phase 1 study in healthy volunteers. Additional parenteral administration safety toxicology studies are in progress at ITR Laboratories to support clinical studies for treatment of autoimmune and inflammatory diseases.
Milciclib
TZLS-201

​Announced that it had executed an agreement with Takanawa Japan K.K, Pharma Team, (Takanawa) for a strategic business development plan to Identify a clinical partner in Japan and other Asian countries for further clinical development of Milciclib for treatment in advanced hepatocellular carcinoma (HCC) patients. HCC is the most common type of liver cancer and affects approximately 200,000 people per year.
Intellectual Property

As of September 2021, the Company has a total of 306 granted patents, 281 foreign and 25 US patents.
New appointments

Appointed Dr. Neil Graham MBBS, MD, MPH as Chief Medical Officer, Dr. Thomas Adams Ph.D. as Head of Drug Development and an executive director and Dr. Kevin Schutz, PharmD, as Vice-President of Regulatory Affairs.
Highlights post period end:

On September 2, 2021, Tiziana and Precision Biosciences announced an exclusive license agreement to explore Tiziana’s foralumab as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy. Precision’s approach to manufacturing produces CAR T cells that are virtually CD3-negative. Foralumab will be used as a lymphodepletion or tolerizing agent, either alone or in combination with other co-stimulatory molecules, to improve the long-term survival of CAR T cells in cancer treatment.

Tiziana has formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences Ltd, a Bermuda-incorporated company, as the ultimate parent company of the of the Tiziana Group. The reorganisation will be achieved by a scheme of arrangement under Part 26 of the Companies Act 2006.
FINANCIAL

For the six months to 30 June 2020 the consolidated Group made a loss of £12.59m (six months to 30 June 2020: £3.9m).

The Group ended the period with £38.6m cash as at 30 June 2021 (31 December 2020: £48.2m).
Research and development (R&D) expenses increased to £12.6m compared to £3.9m in the first half of 2020. The increase is primarily expenses related to the advancement of our proprietary programs, TZLS-401 and TZLS-501.

The Company cancelled the admission of its Ordinary Shares to trading on AIM and admitted its shares to trading on the main market for listed securities (of London Stock Exchange plc in January 2021.
The Company continues to carefully manage its working capital position and continues the process, as referred to below, to evaluate opportunities to raise further funds through the issue of additional equity capital.

To view the complete Interim Accounts click here: View Source