On November 16, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and ALX Oncology Holdings Inc. (NASDAQ: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported they have entered into a clinical collaboration to evaluate the combination of Zymeworks’ zanidatamab (formerly ZW25), a HER2-targeted bispecific antibody, and ALX148, a next-generation CD47 blocker, for the treatment of patients with advanced HER2-expressing breast cancer and other solid tumors (Press release, Zymeworks, NOV 16, 2020, View Source [SID1234571141]).

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Under the terms of the agreement, Zymeworks will conduct an open label, multi-center Phase 1b study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in a two-part study. The first part of the trial will evaluate the safety of the combination treatment. The second part of the trial will evaluate the safety, tolerability and anti-tumor activity of the combination in separate cohorts of subjects with HER2-positive breast cancer, HER2-low breast cancer, and non-breast HER2-expressing solid tumors.

"In addition to broad anti-tumor activity, zanidatamab’s safety profile supports combination approaches with other therapeutics," said Diana Hausman, M.D., Chief Medical Officer at Zymeworks. "Our collaboration with ALX Oncology and their CD47 blocker, ALX148, has the potential to further expand the opportunity for zanidatamab to provide benefit to a broader population of patients, including those with advanced HER2-expressing breast cancer."

Zanidatamab is designed to have multiple mechanisms of action, including immune clearance of HER2-expressing tumor cells by macrophages through antibody-dependent cellular phagocytosis (ADCP). CD47 is a "don’t eat me" signal that acts as a checkpoint inhibitor to macrophages. Cancer cells that express CD47 are resistant to immune clearance even when targeted with therapeutic antibodies. Treatment with zanidatamab plus ALX148 has the potential to increase the immune clearance of HER2-expressing cancer cells by combining a biparatopic antibody capable of binding at higher density than monospecific antibodies with a molecule that blocks CD47 on the same targeted cancer cells.

"We are excited about this collaboration with Zymeworks that combines two promising next-generation anti-cancer agents, a HER2-targeted bispecific antibody with a CD47 blocker, to enhance their potential activity in treating patients with advanced breast cancer," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "ALX148 was designed for safe use in combination to maximize clinical activity with a range of anti-cancer agents. This collaboration builds on the promising anti-tumor activity observed in clinical trials of ALX148 combined with a HER2-targeted therapy in patients with advanced HER2-positive gastric and gastroesophageal cancer."

Zanidatamab is in advanced clinical development, actively enrolling a pivotal study in patients with previously-treated HER2 gene-amplified biliary tract cancer. In addition, five active Phase 2 programs are underway, and Zymeworks plans to initiate a second pivotal study for zanidatamab as first-line treatment for advanced HER2-positive gastroesophageal adenocarcinomas.

Phase 1 studies of ALX148 have been conducted in combination with tumor antigen targeted antibodies, a checkpoint inhibitor and chemotherapy. Preliminary results from ASPEN-01, the ALX148 Phase 1b study, were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting [abstract 404]. ALX148 displayed promising initial clinical activity in patients with solid tumors, including advanced HER2-positive gastric and gastroesophageal cancer where ALX148 was well tolerated in combination with an anti-HER2 specific antibody and chemotherapy with no maximum tolerated dose reached. ALX Oncology plans to continue the advancement of ALX148 as a potential treatment for a range of solid tumor indications and is currently also in development in patients with higher risk myelodysplastic syndromes (ASPEN-02).

On November 16, 2020 ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that it has completed its previously announced private placement offering (the "Offering") of special warrants of the Company ("Special Warrants") (Press release, ProMIS Neurosciences, NOV 16, 2020, View Source [SID1234571140]). A total of 16,219,581 Special Warrants were issued in two closings at a price of $0.12 per Special Warrant, for gross proceeds of $1,946,349.72.

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The Company will be filing a short form prospectus to qualify the distribution of the Shares and Warrants issuable upon the deemed exercise of the Special Warrants (other than those Special Warrants issued to residents of Quebec). Each Special Warrant will convert, without payment of any additional consideration, into one common share of the Company and one transferable common share purchase warrant (a "Warrant"). Each Warrant will entitle the holder thereof to acquire one common share at an exercise price of $0.20 per share for a period of 60 months, subject to acceleration of the expiry date if the twenty-day volume-weighted average trading price of the common shares exceeds $0.60.

The Company issued 13,819,581 Special Warrants in the first closing on November 4, 2020 and 2,400,000 Special Warrants in the second closing on November 16, 2020. In connection with the second closing, the Company paid cash finders’ fees in the amount of $11,760 and issued a total of 70,000 compensation warrants, each such compensation warrant having the same terms as the Warrants. The Company also wishes to correct the quantum of finders fees disclosed in its November 5, 2020 news release. In connection with the first closing, the Company paid cash finders’ fees in the amount of $58,464 and issued a total of 487,200 compensation warrants,

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

On November 16, 2020 Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported the closing of its previously announced registered direct offering for the issuance and sale of 2,522,784 shares of its common stock, at a purchase price of $1.78375 per share (Press release, Conatus Pharmaceuticals, NOV 16, 2020, View Source [SID1234571139]). Histogen has also issued to investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 1,892,088 shares of its common stock. The offering was priced at-the-market under Nasdaq rules.

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

The warrants have an exercise price of $ 1.70 per share, are exercisable immediately and will expire five and one-half years from the date of issuance.

The gross proceeds from this offering were approximately $4.5 million, before deducting placement agent’s fees and other offering expenses. Histogen intends to use the net proceeds from this offering for working capital and general corporate purposes, including expenses related to the clinical development of its products for its CCM, hECM and HSC programs, further research and development, capital expenditures and general and administrative expenses.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by Histogen pursuant to a "shelf" registration statement on Form S-3 (File No. 333-248074) previously filed with the Securities and Exchange Commission (the "SEC") on August 17, 2020 and declared effective by the SEC on August 26, 2020. The offering of the shares of common stock only was made 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 shares of common stock was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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 November 16, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the third quarter ended September 30, 2020 (Press release, CohBar, NOV 16, 2020, View Source [SID1234571138]).

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"We are pleased to announce that half of the planned subjects have completed dosing in our Phase 1b study evaluating CB4211 as potential treatments for NASH and obesity," said Steven Engle, CohBar’s Chief Executive Officer. "We currently expect top line data from the study in the second quarter of 2021, subject to the potential impact of COVID-19. Our preclinical programs are also progressing, with recent data for a CB5138 Analog in combination with the standard of care suggesting additional potential for improved treatments of Idiopathic Pulmonary Fibrosis. Our goal is to identify a clinical candidate for our IPF program early in the first quarter of 2021, subject to successful completion of the remaining required studies. In our CB5064 program for potential use in COVID-19/ARDS, we generated positive preliminary results in a preclinical model of Acute Respiratory Distress Syndrome."

"In order to finance these exciting programs, we raised $15 million during the quarter to advance our expanded R&D pipeline, added biotech focused institutional investors, and gained additional research analyst coverage," Mr. Engle continued. "We also expanded awareness and increased investor engagement by presenting at eight industry and healthcare bank conferences, and meeting with family offices and high net worth investors. Going forward, we are continuing to execute on our vision to treat multiple chronic diseases and extend healthy lifespan."

Third Quarter 2020 and Recent Highlights

Completed dosing in half of the planned subjects in the Phase 1b stage of the clinical study of CB4211 for NASH and Obesity: The ongoing study evaluates CB4211 in subjects with non-alcoholic fatty liver disease (NAFLD) and obesity with at least 10% liver fat. In August, the company announced the first subject had been dosed. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.
Showed that the combination of a CB5138 Analog antifibrotic peptide and nintedanib produced enhanced effects: In October, the company announced new preclinical data demonstrating that a CB5138 Analog has enhanced effects when combined with nintedanib, the leading treatment for Idiopathic Pulmonary Fibrosis (IPF), suggesting potential utility for combination therapy in IPF. The new data from the therapeutic mouse model of IPF showed that treatment with the combination of CB5138-2 and nintedanib produced greater reductions in fibrosis, inflammation, pro-inflammatory cytokine levels, and collagen deposition compared to either treatment alone. IPF is a chronic, progressive, debilitating, and usually fatal interstitial lung disease that affects approximately 187,000 people worldwide.
Presented antifibrotic results at the American Thoracic Society: In August, the company presented new pre-clinical efficacy results in a poster presentation at the American Thoracic Society 2020 International Conference. Antifibrotic and anti-inflammatory effects were demonstrated for MBT2 (CB5138-1) in vitro in human cells and in vivo in prophylactic and therapeutic preclinical models of IPF.

Generated preliminary efficacy in preclinical study of apelin agonists in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) and ARDS: In August, the company announced preliminary results in an evaluation of its CB5064 Analogs in an ARDS model. These positive results included reduced levels of fluid accumulation, neutrophil infiltration, and cytokine secretion. These are key processes underlying the lethal consequences of severe ARDS and COVID-19 associated ARDS. The company expects the apelin agonists to have potential to treat ARDS patients in general, of which there are approximately three million globally. CohBar previously presented data at the 2019 ADA Conference showing the activity of its CB5064 Analogs on glucose tolerance, insulin sensitivity, and weight loss in an obese mouse model of type 2 diabetes.
Raised $15M in new capital and added biotech focused institutional investors: In August, the company completed a public offering to support its clinical and preclinical programs. The company received aggregate gross proceeds of approximately $15 million before commissions and other estimated offering expenses. The company issued 12.3M units at a price of $1.22 per unit. Each unit consists of one share of the company’s common stock and one warrant to purchase 0.75 of a share of common stock at a per share exercise price of $1.44.
Gained additional bank research coverage: Recently, Wall Street banks ROTH Capital Partners and WBB Securities initiated coverage on CohBar. Brookline Capital Markets initiated coverage in May.
Hosted key opinion leader webinar on IPF and CohBar’s antifibrotic peptides: The company hosted a key opinion leader webinar on the current treatment landscape in IPF, the unmet medical need, and positive findings from preclinical studies of its CB5138 Analogs. This event was led by world-class medical expert Dr. Toby Maher, Director of Interstitial Lung Disease and Professor of Medicine at the Keck School of Medicine, University of Southern California. Dr. Toby Maher provided an authoritative and insightful overview of the IPF situation, emphasizing the urgent need for new treatments. CohBar’s Chief Scientific Officer, Ken Cundy, presented recent results from CohBar’s antifibrotic program.
Continued investment community outreach and continued partnering efforts: In the third quarter, the company presented and hosted meetings at several healthcare banking conferences: H.C. Wainwright NASH, H.C. Wainwright, and Oppenheimer. CohBar spoke at two COVID-19 conferences: ROTH COVID-19 Therapeutics in Development and Sachs Novel Coronavirus Investment Forum. The company also spoke at Targeting Metabesity, and at the BIO Investor Forum where the company met with prospective investors. Recently, the company presented at the BIO-Europe conference and continues to proactively engage in business development discussions.
Founders’ Update

During the third quarter and subsequent period, CohBar’s founders, Dr. Pinchas Cohen, Dean of the USC Leonard Davis School of Gerontology, and Dr. Nir Barzilai, Director of the Institute for Aging Research at Albert Einstein College of Medicine, continued to present and publish on the study of mitochondrial science, aging, and age-related diseases.

Dr. Cohen published two papers on how the genomics of mitochondrial DNA are related to diseases of aging, "A Mitochondrial Genome-Wide Association Study of Cataract in a Latino Population" in the Translational Vision Science & Technology Journal and "Mito-Omics and immune function: Applying novel mitochondrial omic techniques to the context of the aging immune system" in the Translation Medicine of Aging Journal.

Dr. Barzilai was a key speaker at the Aging Research & Drug Discovery (ARDD) Meeting. He also was interviewed by the Wall Street Journal, Bloomberg, and The Sun among other publications, and was featured in the Peter Attia Drive and Demystifying Science podcasts.

Third Quarter 2020 Financial Highlights

Cash and Investments: CohBar had cash, cash equivalents and investments of $23.4 million as of September 30, 2020, compared to $12.6 million as of December 31, 2019. The cash burn for the quarter ended September 30, 2020, was approximately $2.9 million.

R&D Expenses: Research and development expenses were $1.2 million for the three months ended September 30, 2020, compared to $1.9 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower clinical trial and stock-based compensation costs related to the timing of those expenses.

G&A Expenses: General and administrative expenses were $1.4 million for the three months ended September 30, 2020, compared to $1.3 million in the prior year quarter. The increase in general and administrative expenses was primarily due increased legal costs related to protecting our intellectual property.

Net Loss: For the three months ended September 30, 2020, net loss, which included $0.9 million of non-cash expenses, was $3.2 million, or $0.06 per basic and diluted share. For the three months ended September 30, 2019, net loss, which included $0.7 million of non-cash expenses, was $3.3 million, or $0.08 per basic and diluted share.
Third Quarter Investor Call and Slide Presentation:

Date: November 16, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13711606
Slide Presentation

Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 145 312 1885 and password CWBR, or
Go to www.cohbar.com and click on Q3 2020 Shareholder Presentation at the top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 16, 2020, through 11:59 p.m. Eastern Time on December 7, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13711606. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

On November 16, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the company will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference (Press release, Alpine Immune Sciences, NOV 16, 2020, View Source [SID1234571135]).

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The fireside chat will be available online during the week of November 23 in the investor relations section of the company’s website at View Source The virtual conference will be held from December 1-3, 2020.