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Cyclacel Hosting Research & Development Day

On October 24, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it will host a research and development day, featuring key opinion leaders (KOL), with a focus on the Company’s CDK2/9 inhibitor, oral fadraciclib, and PLK1 inhibitor, oral CYC140, on Monday, October 31, 2022 at 10:00 am Eastern Time (Press release, Cyclacel, OCT 24, 2022, View Source [SID1234622311]).

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The R&D Day will feature renowned KOLs in oncology and program updates from senior management.

Jasmine Zain, MD, from City of Hope National Medical Center, will be providing an overview of the unmet medical needs in the treatment of T-cell lymphomas.
Do-Youn Oh, MD, PhD, from Seoul National University, will discuss unmet medical needs and current treatment options for hepatobiliary cancers.
The Cyclacel leadership team will then provide a program update on the company’s pipeline, highlighting patient data from the 065-101 oral fadraciclib Phase 1/2 study in solid tumors and lymphoma. In addition, an update will address progress with CYC140, Cyclacel’s oral PLK1 inhibitor, in a Phase 1/2 study as a potential treatment for solid tumors and lymphoma.

A live Q&A session will follow the formal presentations. To register for the event, please click here.

Dr. Zain is a professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of the T cell Lymphoma Program at the Toni Stephenson Lymphoma Center at City of Hope since 2014. She has led many clinical trials for T cell lymphomas and is a member of the NCCN Guidelines Committee for the treatment of T cell lymphomas.

Dr. Zain obtained her medical degree from Fatima Jinnah Medical College for Women in Lahore, Pakistan. She went on to complete an internship and residency at North Shore Hospital, Forest Hills, NY, followed by a hematology/oncology fellowship at New York University Medical Center. During her career she has worked at many institutions including Columbia University and NYU Medical Center. Her focus remains in developing novel therapies for T cell lymphomas.

Triple-board certified in hematology, oncology and internal medicine, Dr. Zain is an active member of several professional associations and has published more than 78 peer-reviewed publications, abstracts and book chapters. She has been invited to speak both nationally and internationally.

Dr. Oh is Professor, Division of Medical Oncology, Department of Internal Medicine at Seoul National University and Seoul National University College of Medicine.

Dr. Oh graduated from Seoul National University College of Medicine in 1997, and had residency training in Internal Medicine, and a fellowship in Hematology/Medical Oncology training at the Seoul National University Hospital. She received her PhD in the Department of Internal Medicine at the Seoul National University College of Medicine in 2005.

Her main research interests include gastric, pancreatic, and biliary tract cancer, with a particular interest in translational research and early new drug development. She has published over 250 peer-reviewed journal articles and has many committee memberships, including the Korean Cancer Association, Korean Association of Clinical Oncology, Korean Cancer Study Group, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and American Association for Cancer Research (AACR) (Free AACR Whitepaper).

Theriva Biologics Announces Presentation at the 14th International Oncolytic Virotherapy (IVOC) Conference Describing Phase 1 Investigator-sponsored Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

On October 24, 2022 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported a presentation of previously released data from a Phase 1 investigator-sponsored study evaluating VCN-01 in combination with durvalumab for patients with recurrent/ metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) (Press release, Theriva Biologics, OCT 24, 2022, View Source [SID1234622309]). Data will be featured in an oral presentation at the 14th International Oncolytic Virotherapy (IVOC) Conference, being held from in Karuizawa, Japan from October 23-26.

Details on the presentation can be found below.

Title: VCN-01 changes tumor stroma when administered systemically in combination with Durvalumab (MEDI4736) in subjects with recurrent/ metastatic squamous cell carcinoma of the head and neck (R/M HNSCC): Biological data of a Phase I Study
Abstract: 0136
Presenter: Frank Tufaro, Ph.D., Chief Operating Officer of Theriva Biologics
Presentation Date and Time: Tuesday, October 25, 2022 at 11:20 a.m. JST/Monday, October 24, 2022 at 10:00 p.m. ET
Location: Karuizawa Prince Hotel West
A copy of the presentation will be accessible under the ‘Events’ section of the Theriva Biologics website.

Sutro Biopharma Announces Departure of Chief Medical Officer

On October 24, 2022 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that Chief Medical Officer, Arturo Molina, M.D., M.S., F.A.C.P. will be leaving the company to pursue other opportunities, effective November 4, 2022 (Press release, Sutro Biopharma, OCT 24, 2022, View Source [SID1234622308]). Sutro will continue its executive search for a new CMO. In the interim, Bill Newell CEO, with support from Sutro’s senior clinical development team, will oversee all clinical activities and related functions.

"We thank Arturo for his many contributions to the Company and wish him well as he pursues his future endeavors," said Bill Newell, Sutro’s Chief Executive Officer. "We are at an exciting time in our company’s growth, with our platform yielding six next-generation, clinical-stage product candidates. I am confident in our team’s ability to execute on our clinical objectives for STRO-002, including the plans for a registrational directed trial in advanced ovarian cancer. Our experienced clinical and regulatory teams, together with our external clinical advisors—which I will directly oversee—remain fully engaged on our development of STRO-002."

Chugai Announces 2022 3rd Quarter Results

On October 24, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reportes its financial results for the third quarter of fiscal year 2022 (Press release, Chugai, OCT 24, 2022, View Source [SID1234622293]).

"Chugai achieved record-high revenues and profits for the first nine months of 2022 following the strong first half of the year. Domestic sales were driven by growing market penetration of new products including Vabysmo, the new ophthalmic drug launched in May 2022, while Hemlibra continued to increase overseas sales. Research and Development also progressed well in the third quarter, particularly for in-house projects which are expected to propel our medium- to long-term growth. The world’s first filing for regulatory approval of our anti-C5 recycling antibody, crovalimab, was accepted in China. In addition, clinical development was initiated for DONQ52, a new bispecific antibody. We will continue to focus all our efforts on innovation to address unmet medical needs so that we can contribute to patients waiting for new treatments," said Dr. Osamu Okuda, Chugai’s President and CEO.

Third Quarter Financial Results (Core results, January to September 2022)
Chugai reported record-high financial results for the first nine months in 2022, as revenues increased by 7.7% and operating profit increased by 2.9% over the same period last year.

An increase in domestic and overseas sales outweighed a decrease in royalties and other operating income, resulting in a 7.7% increase in total revenues. Domestic sales increased by 6.9%. Sales in the Oncology field decreased by 2.4% as the impact of the NHI drug price revision and biosimilars in mature products, including Avastin and Herceptin, exceeded the sales growth from a new product Polivy, which was approved for an additional indication in August this year, and a mainstay product Kadcyla as well as Foundation Medicine business. In the Specialty field, renamed from the Primary field following the organizational change in July, sales increased by 17.1% due to the contributions from the supply of Ronapreve to the government in the first quarter, as well as an approximately 20% increase in sales of the mainstay product Hemlibra. Steady market penetration of new products, including Vabysmo launched in May, also contributed. The increase in overseas sales was driven by a 2-times increase of Hemlibra owing to the full-scale export to Roche at regular shipping price and a more than 20% increase in Actemra, which obtained emergency use authorization and regulatory approval for severe COVID-19 in the U.S. and Europe, respectively, since last June. On the other hand, royalties and other operating income decreased by approximately 40%, mainly due to a significant decrease in royalty income related to the initial shipments of Hemlibra.

Cost to sales ratio improved by 1.2 percentage points year-on-year to 40.7%, mainly due to a change in the product mix. Operating expenses grew by 4.3% as both marketing and distribution and research and development expenses increased, while general and administration expenses decreased. Marketing and distribution expenses increased mainly due to foreign exchange effects. Research and development expenses increased mainly due to the progress of projects under development and foreign exchange effects. General and administration expenses decreased primarily due to decreases in various expenses, as well as recognizing gains on sales of property, plant and equipment. As a result, Core operating profit totaled ¥299.0 billion (+2.9%).

Quarterly Financial Results (Core results, July to September 2022)
Revenues and operating profit for the third quarter (Jul-Sep) both decreased by approximately 20% against the same period last year. The leading cause of the decreases were that the supply of Ronapreve to the government, which was ¥42.8 billion yen in the same period last year, did not occur in the quarter under review, along with the significant decrease in royalty income related to the initial shipments of Hemlibra. Sales decreased by approximately 20%. While overseas sales increased by 3.7%, domestic sales decreased by less than 30% with the impact of Ronapreve, resulting in a decrease in overall sales. In domestic sales, the Oncology field reported a 5.1% decrease as mature products such as sales of Avastin and Herceptin decreased due to the NHI drug price revision and biosimilar impact, despite increases in a new product Polivy and a mainstay product Kadcyla. Sales of the Specialty field decreased by more than 40%, primarily for the supply of Ronapreve to the government last year. Excluding Ronapreve, sales of the Specialty field increased by 1.4%, driven by the contribution from new products including Vabysmo, which was launched in May this year. Overseas sales increased by 3.7% as the increase of Hemlibra owing to the full-scale export to Roche at regular shipping price outweighed a more than 30% decrease in sales of Actemra caused by a delay in production. In addition, we launched Edirol in China in July. Royalties and other operating income decreased by less than 40% chiefly due to the significant decrease in royalty income related to the initial shipments of Hemlibra. The cost to sales ratio improved by approximately eight percentage points against the same period last year, mainly due to a higher proportion of in-house products in total sales. Operating expenses were flat against the same period last year. No changes have been made in the full-year forecasts announced at the beginning of the fiscal year, while revenues and operating profit both decreased for the quarter under review.

R&D activities
The Company also made good progress in research and development. Among in-house projects, which will contribute to the Company’s medium-to long-term growth, Maruho launched the anti-IL-31 receptor antibody Mitchga in August as a treatment for itching associated with atopic dermatitis. Maruho is the licensee of the product in Japan. The world’s first filing of regulatory application for the anti-C5 recycling antibody, crovalimab, was accepted in China with a priority review designation for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Clinical development of an existing product Enspryng has started for new indications, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE). In addition, clinical development of a new bispecific antibody project, DONQ52, has been initiated for celiac disease, a disease with no approved drug treatments available. Furthermore, Chugai entered into an agreement with Roche to out-license NXT007, which is being developed as the next-generation project following Hemlibra.
As for in-licensed products from Roche, an additional indication for Polivy was approved as the first new treatment in 20 years for previously untreated diffuse large B-cell lymphoma. Chugai also filed an application for approval of RG6264, a fixed-dose subcutaneous combination of pertuzumab and trastuzumab, for the treatment of HER2-positive breast and colorectal cancer. Pertuzumab and trastuzumab are the same monoclonal antibodies as in Perjeta and Herceptin, respectively. Several new oncology projects have been added to our pipeline, including SHP2 inhibitor RG6433 and KRAS G12C inhibitor RG6330 for solid tumors.
In drug discovery research, Chugai entered into a license agreement with Noile-Immune Biotech in August for their PRIME CAR-T technology, making steady progress in its efforts toward multi-modality drug discovery through external collaboration.

Entry Into A Material Definitive Agreement

On October 24, 2022 Yumanity Therapeutics, Inc., a Delaware corporation ("Yumanity"), reported that entered into an Asset Purchase Agreement (the "Asset Purchase Agreement") with Janssen Pharmaceutica NV ("Janssen") (Filing, 8-K, Yumanity Therapeutics, OCT 24, 2022, View Source [SID1234622307]). Concurrently with the execution of the Asset Purchase Agreement, on June 5, 2022, Yumanity entered into an Agreement and Plan of Merger with Kineta, Inc., a Washington corporation ("Kineta"), and Yacht Merger Sub, Inc., a Washington corporation and wholly-owned subsidiary of Yumanity (the "Merger Agreement" and the transactions contemplated thereby, the "Merger").

Amendment to PIPE Securities Purchase Agreement

As previously reported in the Current Report on Form 8-K filed by Yumanity with the U.S. Securities and Exchange Commission (the "SEC") on June 6, 2022 (the "Original Report"), Yumanity previously entered into a securities purchase agreement (the "Securities Purchase Agreement"), dated June 5, 2022, with certain investors (the "PIPE Investors"), pursuant to which, and on the terms and subject to the conditions of which, the PIPE Investors agreed to purchase an aggregate of 14,354,067 shares (subject to proportional adjustment for any reverse stock split) of common stock of Yumanity, par value $0.001 per share ("Common Stock"), for $2.09 per share, for an aggregate purchase price of $30 million, in a private placement expected to close immediately following, and conditioned upon, the closing of the Merger (the "Private Placement").

On October 24, 2022, the PIPE Investors and Yumanity agreed to change the purchase price per share to $1.65 per share of Common Stock such that the PIPE Investors will purchase an aggregate of 18,181,818 shares of Common Stock in the Private Placement. October 24, 2022, Yumanity, Kineta and each of the PIPE Investors entered into an amendment to the Securities Purchase Agreement (the "Securities Purchase Agreement Amendment"), to (i) amend the per share purchase price and aggregate number of shares to be purchased, each as reflected therein, and (ii) provide for the issuance of an aggregate of 6,031,668 warrants to purchase shares of Kineta (the "Warrants"). The Warrants were issued by Kineta and will be treated in the same manner as all other outstanding warrants of Kineta at the effective time of the Merger, as described in the Registration Statement (as defined below), and will receive a portion of the consideration allocated to other Kineta securityholders under the terms of the Merger Agreement. For the avoidance of doubt, the Warrants are not issued by Yumanity. Any Warrants issued to a PIPE Investor will only be exercisable following the closing of the Private Placement and will expire in the event any PIPE Investor fails to consummate the Private Placement pursuant to the terms of the Securities Purchase Agreement, as amended by the Securities Purchase Agreement Amendment.

Amendment to Registration Rights Agreement

As previously reported in the Original Report, Yumanity previously entered into a Registration Rights Agreement (the "Registration Rights Agreement"), dated June 5, 2022, with the PIPE Investors concurrently with the execution of the Securities Purchase Agreement. Pursuant to the Registration Rights Agreement, Yumanity will prepare and file a resale registration statement with the SEC within 60 calendar days following the closing of the Private Placement covering the shares of Yumanity’s common stock issued in the Private Placement. Yumanity has also agreed, among other things, to indemnify the PIPE Investors and their respective directors, officers, stockholders, members, partners, employees and agents, and each person who controls such PIPE Investor, from certain liabilities and to pay certain expenses incurred by Yumanity in connection with the registration of the shares issued in the Private Placement.

On October 24, 2022, the PIPE Investors and Yumanity entered into an amendment to the Registration Rights Agreement (the "Registration Rights Agreement Amendment"). The Registration Rights Agreement Amendment amended the Schedule of Purchasers attached to the Registration Rights Agreement to reflect the number of shares purchased by each PIPE Investor pursuant to the Securities Purchase Agreement Amendment.

The foregoing descriptions of the Securities Purchase Agreement Amendment, the Warrants, the Registration Rights Agreement Amendment and the transactions contemplated thereby are not complete and are subject to, and qualified in their entirety by reference to, the text of the Securities Purchase Agreement Amendment, the Warrants and the Registration Rights Agreement Amendment, forms of which are included as Exhibit 10.1, Exhibit 10.2 and Exhibit 10.3, respectively, to this Current Report on Form 8-K (this "Current Report"), and incorporated herein by this reference.