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Bellicum Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Operational Update

On March 30, 2021 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the fourth quarter and full year 2020 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAR 30, 2021, View Source [SID1234577358]).

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"In 2020, we refined our focus on our next generation CAR-T cell therapies," said Rick Fair, President and Chief Executive Officer. "We are excited to have resumed our trial of BPX-601 with a focus on prostate cancer and initiated the BPX-603 trial in HER2+ solid tumors, and we look forward to providing updates on both programs as the year progresses."

Program Highlights and Current Updates

BPX-601 GoCAR-T
•In January, Bellicum announced the U.S. Food and Drug Administration (FDA) had lifted the clinical hold on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer. Bellicum has worked with clinical investigators to resume screening for patient enrollment without modification to the current study protocol.

•Bellicum plans to present a Phase 1 data update on BPX-601 and rimiducid in patients with metastatic castration-resistant prostate cancer in the first quarter of 2022.

BPX-603 GoCAR-T
•In December, Bellicum announced the enrollment and apheresis of the first patient in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. The company expects to provide initial Phase 1 data from this trial in the second half of 2021.

CaspaCIDe
•In February, Bellicum announced the first reported use of the CaspaCIDe safety switch to mitigate CAR-T cell toxicity. The report, published as an ahead-of-print publication in the digital edition of Blood, a journal published by The American Society of Hematology (ASH) (Free ASH Whitepaper), was a case from an investigator-sponsored trial (IST) at the University of North Carolina Lineberger Comprehensive Cancer Center of autologous CAR-T cells expressing CD19 and CaspaCIDe. In this patient, grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS) refractory to standard therapies was treated with rimiducid to activate CaspaCIDe. Within twelve hours of rimiducid administration, ICANS grade improved from 3 to 1 and was fully resolved after four days.

Exhibit 99.1

Corporate Updates

•In November, Bellicum completed an underwritten offering of 1,040,000 shares of common stock, pre-funded warrants to purchase 3,109,378 shares of common stock and accompanying warrants to purchase 4,149,378 shares of common stock. Gross proceeds to Bellicum were approximately $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Bellicum and excluding any proceeds that may be received upon exercise of the warrants.

•In October, Bellicum implemented a restructuring program to focus on the clinical development of BPX-601 and BPX-603, reduce headcount, pause the BCMA GoCAR-NK program, and discontinue discovery research and new product development.

•In October, Bellicum repaid in full all outstanding indebtedness and terminated all commitments and obligations under its loan agreement with Oxford Finance, for a payment of $27.4 million.

Fourth Quarter 2020 Financial Results

R&D Expenses: Research and development expenses were $8.7 million and $39.1 million for the fourth quarter and year ended December 31, 2020, respectively, compared to $13.3 million and $64.5 million during the comparable periods in 2019. The reduction in expenses in the fourth quarter resulted primarily from reduced expenses related to reduced rivo-cel related activities, reduced expenses resulting from Bellicum’s sale of its manufacturing facility and the corporate restructuring implemented during the fourth quarter of 2020, partially offset by an increase in expenses related to the GoCAR programs.

G&A Expenses: General and administrative expenses were $3.4 million and $15.5 million for the fourth quarter and year ended December 31, 2020, respectively, compared to $5.7 million and $30.0 million during the comparable periods in 2019. The reduction in expenses during the fourth quarter relative to the comparable period in 2019 was primarily due to the reduction in rivo-cel related commercialization activities as well as the effects of the corporate restructuring that reduced employee-related charges.

Loss from Operations: Bellicum reported a loss from operations of $13.0 million and $51.7 million for the fourth quarter and year ended December 31, 2020, respectively, compared to a loss from operations of $13.9 million and $87.4 million for the comparable periods in 2019.

Net Income/Loss: Bellicum reported net income of $18.8 million and a net loss $7.7 million for the fourth quarter and year ended December 31, 2020, respectively, compared to a net loss of $29.0 million and $112.5 million for the comparable periods in 2019. The results included a non-cash gain of $31.9 million and $46.1 million related to the change in fair value of the warrant and private placement option liability for the fourth quarter and year ended December 31, 2020, respectively.

Shares Outstanding: As of March 22, 2021, Bellicum had 8,318,273 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock can be converted into 10 shares of common stock. In the November 2020 financing, the company issued 1,040,000 shares of common stock and pre-funded warrants to purchase 3,109,378 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $37.0 million as of December 31, 2020, compared to $93.8 million as of December 31, 2019. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2022.

Conference Call and Webcast
Bellicum’s management will host a webcast and conference call today at 5 p.m. ET / 2 p.m. PT, March 30, 2021, to discuss the financial results for the fourth quarter 2020 and provide a corporate update. The live call may be accessed by dialing (877) 407-3103 for domestic callers and (201) 493-6791 for international
2

Exhibit 99.1

callers. A live webcast of the call will be available from the Investors and Media section of the company’s website at www.bellicum.com and a replay will be available shortly after the live event.

CohBar Reports Fourth Quarter 2020
Financial Results and Provides Business Update

On March 30, 2021 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 fourth quarter ended December 31, 2020 (Press release, CohBar, MAR 30, 2021, View Source [SID1234577357]).

"We made significant progress with our Phase 1b clinical study and preclinical programs," stated Steven Engle, CohBar’s Chief Executive Officer. "We completed enrollment in the CB4211 Phase 1b study for the treatment of NASH and obesity and nominated a CB5138 Analog as our second clinical candidate based on positive preclinical studies during the last quarter. We also initiated a collaboration with NIAID to evaluate the potential of CB5064 Analogs for the treatment of COVID-19 associated ARDS, which followed confirmatory results in a preclinical model of ARDS. Overall, we are pleased with the advancement of our portfolio this past quarter and look forward to sharing our first clinical results on the CB4211 program."

Fourth Quarter 2020 and Recent Highlights

Completed enrollment in the Phase 1b stage of the clinical study of CB4211 under development 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. Nonalcoholic steatohepatitis (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. The company plans to announce last subject visit, which is anticipated in April. The company currently expects topline data at the end of the second quarter based on timing of the last subject visit and other factors.
Nominated CB5138-3 as lead clinical candidate for Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases: In March, the company announced the selection of CB5138-3 for advancement into IND-enabling activities. CohBar completed candidate screening and selected CB5138-3 based on its preclinical efficacy, preliminary safety data, and drug-like properties. CohBar has initiated IND-enabling activities for CB5138-3 with the goal of starting clinical studies in 2022. In addition, the company is continuing to evaluate the efficacy of CB5138 Analogs in models of other fibrotic diseases. IPF is a chronic, progressive, debilitating, and usually fatal interstitial lung disease that affects approximately 187,000 people worldwide.
Signed a Non-Clinical Evaluation Agreement (NCEA) with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the potential of CB5064 Analogs for the treatment of COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): In January, the company announced it will be utilizing the non-clinical and pre-clinical services program offered by the NIAID, a division of the National Institutes of Health (NIH). NIAID will be responsible for any study conducted under the NCEA, such as the golden Syrian hamster SARS-CoV-2 model which has been used in the assessment of other COVID-19 therapeutics.
Generated confirmatory results in preclinical study of CB5064 Analog apelin receptor agonists in COVID-19 Associated ARDS and ARDS: In December, the company announced confirmatory results in an evaluation of its CB5064 Analogs in an ARDS model. These positive results included reduced levels of fluid accumulation and cytokine secretion. These are key processes underlying the lethal consequences of severe ARDS and COVID-19 associated ARDS. Based on these results, the company believes that these apelin agonists could be a potential treatment for ARDS patients in general, of which there are approximately three million globally.
Hosted key opinion leader webinar on IPF and CohBar’s antifibrotic peptides: In November, 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. The keynote speaker was 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. Maher provided an authoritative and insightful overview of the IPF landscape, emphasizing the urgent need for new treatments. CohBar’s Chief Scientific Officer, Ken Cundy, Ph.D., presented recent results from CohBar’s antifibrotic program.
Gained additional bank research coverage: Recently, Wall Street banks Aegis Capital, Chardan Capital, and WBB Securities initiated coverage on CohBar and issued research reports on the company. Previously, ROTH Capital and Brookline Capital Markets initiated research coverage in 2020.
Featured in prominent biotechnology and business media: Recently, CohBar has been featured in publications such as BioSpace, Longevity Technology, and Chief Executive Magazine. For more information, please visit the Newsroom page on CohBar’s website at www.cohbar.com/news-media/newsroom.

Founders’ Update

During the fourth 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 a paper on the mechanisms of action of the mitochondrial peptide, Humanin, titled "The IL-27 Component EBI-3 and its Receptor Subunit IL-27Rα Are Essential for the Cytoprotective Action of Humanin on Male Germ Cells" in the journal Biology of Reproduction; and a commentary in the PBS periodical Next Avenue, entitled "COVID-19 and the Future of Aging: Prospects for Geroscience."

Dr. Barzilai was a keynote speaker at the Quest for a COVID-19 Vaccine at the New York Academy of Science event in a presentation titled "Immunosenescence and COVID-19 Vaccines for the Elderly" and at AFAR’s The Future is Now: Innovations in AI and Big Data for Healthspan and Longevity event. 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.

Fourth Quarter 2020 Financial Highlights

Cash and Investments: CohBar had cash, cash equivalents and investments of $21.0 million as of December 31, 2020, compared to $12.6 million as of December 31, 2019. The cash burn for the quarter ended December 31, 2020, was approximately $2.4 million.

R&D Expenses: Research and development expenses were $2.7 million for the three months ended December 31, 2020, compared to $1.9 million in the prior year quarter. The increase in research and development expenses was primarily due to higher clinical trial costs related to the timing of those expenses offset by lower stock-based compensation costs.

G&A Expenses: General and administrative expenses were $1.7 million for both the three months ended December 31, 2020 and 2019.

Net Loss: For the three months ended December 31, 2020, net loss, which included $0.6 million of non-cash expenses, was $4.7 million, or $0.08 per basic and diluted share. For the three months ended December 31, 2019, net loss, which included $0.7 million of non-cash expenses, was $3.7 million, or $0.09 per basic and diluted share.

Fourth Quarter Investor Call and Slide Presentation:

Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 145 355 3814 and password CWBR, or
Go to www.cohbar.com and click on Q4 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 March 30, 2021, through 11:59 p.m. Eastern Time on April 20, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13717040. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

Surface Oncology’s SRF617 Receives Orphan Drug Designation from FDA for Treatment of Pancreatic Cancer

On March 30, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for one of the company’s lead therapeutic candidates, SRF617, for the treatment of patients with pancreatic cancer (Press release, Surface Oncology, MAR 30, 2021, View Source [SID1234577356]).

"We are pleased to receive this important designation from the FDA, which supports our conviction that new immunotherapies for pancreatic cancer are urgently needed," said Alison O’Neill, M.D., senior vice president, clinical development at Surface Oncology. "We are very encouraged by our clinical progress to date with SRF617, a highly innovative therapy with the potential to promote anti-tumor immunity in patients with cancer. SRF617 is in Phase 1/1b studies across a variety of solid tumors, including combination studies with gemcitabine and abraxane in patients with pancreatic cancer."

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user fees and eligibility for seven years of marketing exclusivity.

About SRF617:

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, pancreatic cancer stromal cells within the tumor micro-environment express high levels of CD39 which may inhibit anti-cancer immune responses. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents.

Labcorp to Announce First Quarter Financial Results on April 29, 2021

On March 30, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it will release its first quarter of 2021 financial results before the market opens on Thursday, April 29, 2021, and then will host a conference call and webcast beginning at 9:00 a.m. ET to discuss the results (Press release, LabCorp, MAR 30, 2021, View Source [SID1234577355]). The earnings release and accompanying financial information will be posted on the Labcorp Investor Relations website.

Interested parties can access the conference call by dialing 1-877-898-8036 within the U.S. and Canada, or 1-720-634-2811 internationally, using the conference ID 6566853. In addition, a real-time webcast of the conference call will be available on the Labcorp Investor Relations website.

An audio replay of the conference call will be available from 1:00 p.m. ET on April 29, 2021, until 11:30 p.m. ET on May 13, 2021, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the conference ID 6566853. The webcast of the conference call will be archived and accessible through April 15, 2022, on the Labcorp Investor Relations website.

IGM Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

On March 30, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent developments (Press release, IGM Biosciences, MAR 30, 2021, View Source [SID1234577354]).

"IGM reached a number of important milestones in 2020, including the presentation of encouraging initial results from our Phase 1 trial of IGM-2323 at the 2020 ASH (Free ASH Whitepaper) Annual Meeting and the initiation of our Phase 1 clinical trial evaluating IGM-8444 in patients with solid cancers and non-Hodgkin’s lymphoma," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "While 2020 was filled with significant accomplishments, we expect that 2021 will be even more productive. We expect to complete dose escalation in the Phase 1 study of IGM-2323 and establish a recommended Phase 2 dose, as well as complete initial dose escalation studies with IGM-8444 and initiate combination clinical studies of IGM-8444 with a standard chemotherapy regimen and with birinapant, our newly licensed Inhibitor of Apoptosis Proteins antagonist. We also expect to file an IND for our IL-15 x PD-L1 antibody, IGM-7354, in 2021."

Pipeline Updates

IGM-2323

Recommended Phase 2 dose expected in 2021. IGM has now cleared the titration dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs and is currently open to enrollment to what is planned to be its top titration dose cohort, 50/1000 mgs. IGM is also currently enrolling to the expansion dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs. IGM expects to complete enrollment in the Phase 1 dose escalation study and establish a recommended Phase 2 dose in 2021.
IGM-8444

Additional dose cohorts cleared. IGM has now cleared the first two dose cohorts of the single-agent portion of its Phase 1 clinical study and is currently open to enrollment to the third (3 mg/kg) of four single-agent biweekly dose escalation cohorts. IGM is also currently open to enrollment to its first chemotherapy combination dose cohort and its first single-agent weekly dose cohort. IGM expects to report initial data in solid tumors from the dose escalation portion of this Phase 1 trial in the second half of 2021.
Entered into exclusive licensing agreement with Medivir for birinapant. In January 2021, IGM entered into an exclusive license agreement with Medivir AB, by which IGM received global, exclusive development and commercialization rights for birinapant, a clinical-stage SMAC mimetic that binds to and degrades Inhibitors of Apoptosis Proteins (IAPs), leading to cell death (apoptosis) in tumor cells. IGM plans to begin clinical testing of birinapant in combination with IGM-8444 this year.
IGM-7354

File Investigational New Drug (IND) application. IGM expects to file an IND application with the U.S. Food and Drug Administration (FDA) in 2021 for IGM-7354 in order to begin clinical testing. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology. In this case, the immune stimulating IL-15 is attached to the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells.
Corporate Updates

Completed manufacturing facility. Construction of IGM’s new cGMP manufacturing facility in Mountain View, California has been completed. IGM expects that cGMP manufacturing at this facility will begin in 2021.
Completed upsized underwritten public offering of common stock.In December 2020, IGM closed a public offering of its common stock and prefunded warrants, with gross proceeds of $230.0 million, before deducting the underwriting discounts and commissions and other offering expenses payable by IGM.
Fourth Quarter and Full Year 2020 Financial Results

Cash and Investments: Cash and investments as of December 31, 2020 were $366.3 million, compared to $236.6 million as of December 31, 2019.
Research and Development (R&D) Expenses: For the fourth quarter and year ended 2020, R&D expenses were $19.6 million and $65.0 million, respectively, compared to $12.8 million and $35.3 million for the fourth quarter and year ended 2019, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2020, G&A expenses were $5.1 million and $18.3 million, respectively, compared to $3.2 million and $9.2 million for the fourth quarter and year ended 2019, respectively.
Net Loss: For the fourth quarter of 2020, net loss was $24.6 million, or a loss of $0.79 per share, compared to a net loss of $14.8 million, or a loss of $0.49 per share, for the fourth quarter of 2019. For the year ended 2020, net loss was $81.4 million, or a loss of $2.65 per share, compared to a net loss of $43.1 million, or a loss of $4.80 per share, for the year ended 2019.
2021 Financial Guidance
IGM expects full year GAAP operating expenses to be between $175 million and $185 million including estimated non-cash stock-based compensation expense of approximately $25 million. IGM expects to end 2021 with a balance of over $200 million in cash and investments.

Conference Call and Webcast
IGM will host a conference call and webcast to discuss this announcement today, March 30, at 4:30 p.m. ET. To access the live call by phone please dial (866) 649-1996 (domestic) or (409) 217-8769 (international); the conference ID is 2447309. A live audio webcast of the event may also be accessed through the "Investors" section of IGM’s website at www.igmbio.com. A replay of the webcast will be available for 30 days following the event.