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Reata Pharmaceuticals, Inc. Announces Closing of Class A Common Stock Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On November 18, 2019 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata" or the "Company"), a clinical-stage biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 2,760,000 shares of its Class A common stock, which included 360,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares, at a price to the public of $183.00 per share (Press release, Reata Pharmaceuticals, NOV 18, 2019, View Source [SID1234551431]). The gross proceeds to Reata from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $505.1 million.

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Citigroup, Jefferies, SVB Leerink and Stifel acted as the joint book-running managers for the offering. Baird, Cantor and Ladenburg Thalmann acted as the co-managers for the offering.

Reata intends to use the net proceeds from the offering for working capital and general corporate purposes, which include, but are not limited to, advancing the development of bardoxolone methyl and omaveloxolone through clinical trials, preparing to file New Drug Applications for bardoxolone for the treatment of patients with Alport syndrome and omaveloxolone for the treatment of patients with Friedreich’s ataxia, planning for commercialization of its potential products, and making payments due under our agreement with AbbVie Inc.

The securities described above were offered pursuant to an automatically effective shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (the "SEC") on July 23, 2018. The offering was conducted only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by request at Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146); at Jefferies, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; at SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected]; or Stifel, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected].

This news release is for informational purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation, or sale of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

MATEON THERAPEUTICS TO PRESENT NEW AND UPDATED DATA FOR OT101 (TRABEDERSEN) ACTIVITY AGAINST BRAIN TUMORS AT THE 2019 SOCIETY FOR NEURO-ONCOLOGY (SNO) ANNUAL MEETING

On November 18, 2019 Oncotelic Inc. ("Oncotelic"), a wholly owned subsidiary of Mateon Therapeutics Inc. (OTCQB:MATN) dedicated to the development of innovative treatments for cancer, reported that it will present data updates regarding the anti-brain tumor activity of its 1st-in class RNA therapeutic OT101 during the upcoming 2019 Society for Neuro-Oncology (SNO) Annual Meeting on November 20-November 24 in Phoenix, Arizona (View Source (Press release, Mateon Therapeutics, NOV 18, 2019, View Source [SID1234551430]).

"We look forward to sharing the latest data on the clinical impact potential of OT101 that will add to the body of evidence supporting its potential as a future treatment option for high-grade glioma patients," said Fatih Uckun, M.D., Ph.D., Chief Medical Officer, Mateon Therapeutics. "These presentations underscore our continued efforts to advance the standard of care and improve treatment expectations for brain tumor patients," added Vuong Trieu, Ph.D, the Chief Executive Officer and President of Mateon Therapeutics.

On November 22, for the first time, the Mateon team will present a poster regarding the predictors of response and treatment outcome. Presentation details:
Abstract #: ATIM-10
Abstract Title: Clinical predictors of response for recurrent/refractory glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA, WHO grade III) patients treated with the anti-TGF ß 2 RNA therapeutic OT-101
Session: Poster Session
Date: Friday November 22, 2019
Presentation Time: 7:30 PM – 9:30 PM

On November 23, Dr. Uckun will give a talk as oral abstract speaker on the comparison between OT101 and the standard chemotherapy drug temozolomide in high-grade anaplastic astrocytoma patients. Presentation details:
Abstract #: ATIM-06
Presentation Title: Treatment of recurrent/refractory (R/R) anaplastic astrocytoma (AA, WHO grade 3) patients with anti-TGFß2 RNA therapeutic OT-101 versus temozolomide is associated with improved overall survival
Session: Concurrent Session 3B: Surgery/Radiation Therapy/CNS Metastasis (3B)
Date: Saturday November 23, 2019
Presentation Time: 1:40 PM – 1:50 PM

Later on November 23, the Mateon team will present a second poster with post-hoc analysis of the single agent efficacy of OT101 with prolonged follow-up results from the G004 Phase 2 clinical study. Presentation details:
Abstract #: ATIM-03
Abstract Title: Anti-TGFß2 RNA therapeutic OT-101 induces durable objective responses in patients with recurrent/refractory (R/R) glioblastoma multiforme (GBM, WHO grade 4) or anaplastic astrocytoma (AA, WHO grade 3)
Session: Poster Session
Date: Saturday November 23, 2019
Presentation Time: 5:00 PM – 7:00 PM

"The durable objective responses achieved in adult patients with recurrent/refractory high-grade gliomas after treatment with our lead anti-TGF beta2 compound OT-101 contribute to our optimism that new treatment strategies leveraging OT101 may favorably change the therapeutic landscape for difficult-to-treat brain tumors with a very poor prognosis," Dr. Uckun explained.

Last month, US Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for OT101/Trabedersen for the treatment of diffuse intrinsic pontine glioma (DIPG) as a drug for a "rare pediatric disease," as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act. "Our recently published in silico validation of the TGF beta2 gene product, which is the molecular target for OT101/Trabedersen, as a target for immunotherapy in pediatric high-grade gliomas, especially DIPG, indicates that OT101 may also have future potential for the treatment of pediatric DIPG, an orphan disease with a low survival rate and no established or effective standard of care," explained Dr. Uckun.

Dr. Trieu stated: "There is no standard treatment for progressive DIPG after the failure of radiation therapy and no salvage regimen has been shown to extend survival. Therefore, there is an urgent need for therapeutic innovations for treatment of DIPG. Further development of OT-101 may offer renewed hope for salvage therapy of pediatric DIPG patients who have this rare and fatal disease."

PharmaCyte Biotech Successfully Completes Final Manufacturing Run of Clinical Trial Product

On November 18, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its partner, Austrianova Singapore (Austrianova), has successfully completed the second and final GMP manufacturing run to produce PharmaCyte’s clinical trial product (Press release, PharmaCyte Biotech, NOV 18, 2019, View Source [SID1234551429]). The product is now ready for "release testing." The data from the "release testing" of both manufacturing runs will be included in an Investigational New Drug application (IND) and submitted to the U.S. Food and Drug Administration (FDA) to support PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC).

The capsules, which are fully filled with genetically modified live cells, were immediately put into PharmaCyte’s clinical trial syringes and then frozen. Austrianova has shipped a representative sample of the frozen syringes to third-party laboratories in Europe to undergo "release testing" related to the "safety" of the product. Austrianova will conduct "release testing" in-house related to the "functionality" of the encapsulated cells.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "Today is a great day at PharmaCyte. We have cleared what was a major hurdle for us and have completed our most impactful milestone to date. Successfully completing two manufacturing runs is a milestone that has now been met as we progress toward our submission of an IND to the FDA so we can begin our clinical trial in LAPC.

"Our GMP consultant, cGMP Validation, has informed us that while two successful manufacturing runs are not required by the FDA to request a Phase 2b clinical trial, it could go a long way in demonstrating to the FDA that our manufacturing process is robust and reproducible – manufacturing qualities that are highly embraced by the FDA."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

Savara Appoints Badrul Chowdhury, M.D., Ph.D as Chief Medical Officer

On November 18, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported the appointment of Badrul Chowdhury, M.D., Ph.D., to the newly created position of Chief Medical Officer (CMO), effective immediately (Press release, Savara, NOV 18, 2019, View Source [SID1234551428]). Dr. Chowdhury will be Savara’s senior physician overseeing the medical and regulatory strategy of the Company’s investigational programs from late-stage development through to approval. He will also provide oversight of medical affairs and patient safety across the portfolio.

Dr. Chowdhury joins Savara from AstraZeneca, where he was Senior Vice President, Chief Physician-Scientist for Respiratory, Inflammation, and Autoimmunity Late Stage Development, in Biopharmaceuticals R&D. For 16 years prior to that, Dr. Chowdhury served as Director, Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) where he provided scientific and regulatory oversight of both common and rare diseases such as asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, rheumatoid arthritis, systemic lupus erythromatosis, and various autoimmune and inflammatory diseases. Dr. Chowdhury is a medical doctor, and also holds a Ph.D. in Immunology. He completed Internal Medicine residency training from the Wayne State University School of Medicine, Detroit, Michigan, and Fellowship training in Allergy and Immunology from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, Maryland. He is double board certified in Internal Medicine and Allergy and Immunology.

Over the course of his career, Dr. Chowdhury has been a member of many committees within the FDA, NIH, World Health Organization (WHO), United Nations Environmental Programme (UNEP), and the American Academy of Allergy, Asthma, and Immunology (AAAAI). Additionally, he has published scientific articles in more than 60 peer-reviewed scientific and medical journals and has been bestowed numerous research, academic, and service awards/honors.

"It is with great enthusiasm that we welcome an accomplished regulatory strategist, Dr. Chowdhury, to the role of CMO," said Rob Neville, Chief Executive Officer, Savara. "His appointment comes at a critical time as we continue discussions with the FDA and EMA on the best path forward for the Molgradex aPAP program. With two decades of regulatory leadership experience at the FDA’s Pulmonary Division, where he presided over numerous approvals of medicines for pulmonary and orphan diseases, Dr. Chowdhury brings a unique perspective to the Company and we believe he will be instrumental in helping us achieve our goals."

"As a physician and researcher with a passion for addressing significant unmet needs in pulmonary diseases, I am excited to join the Savara team," said Dr. Chowdhury. "I am inspired by the Company’s dedication to becoming THE orphan lung disease company, spearheaded by the Molgradex aPAP program. After reviewing the clinical data from the Phase 3 IMPALA study, I believe that Molgradex can provide a meaningful therapy for these patients. I look forward to working with the executive team to navigate the regulatory pathway for Molgradex in aPAP and the Company’s other pipeline programs."

Zymeworks Announces Selection of ZW25 Abstract for Mini Oral Presentation at the
European Society for Medical Oncology Asia (ESMO Asia) Congress

On November 18, 2019 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the selection of an abstract highlighting updated single agent data from the Phase 1 clinical trial evaluating the HER2-targeted bispecific antibody, ZW25, in patients with HER2-expressing solid tumors for a mini oral presentation at the ESMO (Free ESMO Whitepaper) Asia 2019 Congress, taking place November 22 – 24 in Singapore (Press release, Zymeworks, NOV 18, 2019, View Source [SID1234551427]).

The presentation, entitled "Safety, Anti-Tumor Activity, and Biomarker Results of the HER2-Targeted Bispecific Antibody ZW25 in HER2-Expressing Solid Tumors," is scheduled for Friday November 22 at 3:30 pm SGT (local Singapore Time) during the mini oral session Developmental and Precision Medicine in room 311. The presentation number is 61O.

About the Phase 1 Clinical Trial

Zymeworks’ Phase 1 study has three parts. From part one of the study (the dose-escalation phase), the recommended single-agent dose was determined to be 20 mg/kg once every two weeks or 10 mg/kg weekly. In the second part of the study (the cohort expansion phase), additional patients are being enrolled to further assess ZW25’s single-agent tolerability and anti-tumor activity against a variety of cancer types in different settings. The third part of the study (the combination phase) is underway and evaluating ZW25 in combination with selected chemotherapy agents in gastroesophageal and breast cancer patients with HER2 high or lower HER2 expression levels. More information about ZW25 clinical trials can be found at clinicaltrials.gov.

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2. The FDA has granted Fast Track designation to ZW25 for first-line gastroesophageal adenocarcinoma in combination with standard of care chemotherapy and Orphan Drug designation to ZW25 for the treatment of both gastric and ovarian cancers.