On March 17, 2021 NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported business highlights and financial results for the fiscal year ending December 31, 2020 (Press release, Nanobiotix, MAR 17, 2021, View Source [SID1234576805]).

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"2020 was a banner year for Nanobiotix, despite challenges posed by COVID-19. Our company achieved several milestones to advance our priority development pathways in head and neck cancer and immuno-oncology; and our successful Nasdaq IPO positioned us to keep our pace in 2021. We look forward to building on our progress to ensure that we deliver the potential benefits of NBTXR3 to patients with deliberate speed," commented Laurent Levy, founder and chairman of the executive board of Nanobiotix.

2020 Financial Highlights

In 2020 total revenue remained stable compared to 2019 and amounted to €2.5M. €0.05M corresponded to the license and collaboration agreement signed with PharmaEngine, a former partner. €1.9M corresponded to the Research Tax Credit (CIR). There we €0.5M in subsidies from the government of France, of which €0.3M was in the context of partial unemployment and €0.2M went to Curadigm SAS from BPI.
Research and development expenses decreased from €30.4M in 2019to €24.3M. This decrease is primarily a result of the Company’s cost-control efforts relating to R&D subcontracting and consulting fees, as well as a reduction in the number of Group employees assigned to research and development.
Selling, general and administrative expenses in 2020 were €14.6M compared to €18.9M in 2019. This decrease is due mainly to the decrease in external costs mainly related to savings due to the COVID-19 pandemic (especially consulting fees) and to the 2019 reclass of the Nasdaq IPO costs.
Net loss for the year ended December 31, 2020 was €33.6M, or €1.4 per share (basic and diluted), compared to net loss of €50.9 million, or €2.3 per share for the same period in 2019.
Cash, cash equivalents, and short-term investments were €119.2 million on December 31, 2020.
Clinical activities and achievements advancing NBTXR3 toward global phase III registration trial in head & neck cancer:

Clinical registration plan for global phase III head and neck cancer study for elderly patients ineligible for platinum-based chemotherapy announced following feedback from the US Food and Drug Administration (FDA) in January 2020. The FDA also agreed to the chemistry, manufacturing, and controls (CMC) development plan for NBTXR3, to support the future New Drug Application (NDA) for the product candidate and its use in the phase III clinical study.
Fast track designation granted by FDA for the patient population in the global phase III head and neck cancer study in February 2020.
Preliminary safety and efficacy data from the dose expansion part of phase I study in head and neck cancer reinforcing NBTXR3 as a potential new option for patients presented in October 2020 at the annual meeting of the American Society for Radiation Oncology ("ASTRO"). Among 31 evaluable patients, overall response rate according to RECIST 1.1 was 83.9% of the evaluable patients, 67.7% had achieved a complete response of the injected lesion.
Clinical activities and achievements advancing I/O combination strategy:

First clinical data suggesting NBTXR3 could convert anti-PD-1 non-responders to responders presented at the 35th Anniversary Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2020. Data from company-sponsored study 1100 provided a strong signal that NBTXR3 activated by radiation therapy in combination with pembrolizumab or nivolumab (anti-PD-1 checkpoint inhibitors) could convert anti-PD-1 non-responders to responders. Eight of nine patients treated on study showed tumor regression, including six of seven prior anti-PD-1 non-responders. Four of the anti-PD-1 non-responders had multiple lesions, and three of the four experienced tumor regression in the non-injected local and/or distant lesions. One patient with prior anti-PD-1 resistance experienced delayed tumor regression, suggesting an adaptive immune response aided by NBTXR3 activated by radiation therapy. The early data also demonstrated that administration of NBTXR3 via intra-tumoral injection had been feasible and well tolerated in all patients (head and neck cancer, lung metastasis, and liver metastasis). One patient in the head and neck cancer cohort experienced 4 severe adverse events related to anti-PD-1, of which 2 events were also reported as possibly related to NBTXR3.
Positive new preclinical data from two studies suggesting that NBTX3 could have a significant impact in immunotherapy presented at SITC (Free SITC Whitepaper) in November 2020. The first study demonstrated that NBTXR3 activated by radiotherapy produced a strong abscopal effect without checkpoint inhibitor combination, stimulated adaptive antitumor immunity and increased TCR repertoire diversity in treated tumors compared to radiation therapy alone. The second study suggested that NBTXR3 plus high dose and low dose radiation (RadScopal) combined with anti-PD-1 and anti-CTLA-4 could significantly improve the control of both the primary and secondary tumors, extended survival, and reduced lung metastases in an anti-PD-1 resistant lung cancer model. The NBTXR3 combination also promoted anti-tumor response both at molecular and cellular levels and produced long-term anti-tumor memory.
Clinical activities and achievements advancing clinical collaboration with The University of Texas MD Anderson Cancer Center and expanding the evaluation of NBTXR3:

Activation of first study in the collaboration and first patient injected in pancreatic cancer, in May 2020 and September 2020, respectively.
Regulatory ‘safe to proceed’ granted for a phase I esophageal cancer study in October 2020 and was activated in November 2020. The first patient was subsequently injected in January 2021.
Regulatory ‘safe to proceed’ granted for two phase II head and neck cancer studies evaluating NBTXR3 in combination with anti-PD-1 in November 2020. The first clinical study (Study 2020-0541) targets patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression, or that are refractory to PD-1 blockade. The second clinical study (Study 2020-0354) targets patients with inoperable locoregional recurrent head and neck squamous cell carcinoma amenable to re-irradiation.
Regulatory ‘safe to proceed’ granted for a phase I study in lung cancer amenable to re-irradiation in October 2020.
Corporate activities and achievements enhancing Nanobiotix balance sheet and advancing subsidiary Curadigm:

Successful IPO on Nasdaq Global Select Market in December 2020. The offering, including the full exercise of the underwriters’ over-allotment option, included a capital increase of 8,395,000 new shares consisting of 6,540,000 ordinary shares in the form of American Depositary Shares (ADSs), each representing one ordinary share, and 1,855,000 ordinary shares placed in certain jurisdictions outside of the United States. The total gross proceeds of the global offering amounted to €93.5 million ($113.3 million), or net proceeds of €82.8 million ($100.4 million) after deducting underwriting commissions and other estimated offering expenses.
Successful raise of €20 million in placement of ordinary shares with US and EU investors in July 2020. Nanobiotix placed 3,300,000 new ordinary shares for total gross proceeds of approximately €20.1 million by means of an accelerated bookbuild offering reserved for a specific class of investors in the US and EU.
€10M in non-dilutive financing secured in June 2020. Nanobiotix a total of €10 million from HSBC and Bpifrance for in the form of state-guaranteed loans (Prêts Garantis par l’Etat, or PGE in France).
Validation of novel nanoprimer technology from subsidiary Curadigm in RNA therapeutics with preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in June 2020. The data showed that the Curadigm nanoprimer could increase the efficacy of RNA-based therapeutics up to 50% by decreasing rapid liver clearance.
Expected 2021 Milestones

2021 – Expect first patient injected in phase III trial for elderly head and neck cancer patients (NANORAY-312).
Q2 2021 – Presentation of updated phase I dose expansion results in head and neck cancer (Study 102 Expansion)
Q2 2021- Updated results with new patients and additional follow up in phase I I/O basket study (Study 1100)
H1 2021 – Expect first patient injected in phase II study of NBTXR3 in combination with anti-PD-1 for patients with recurrent/metastatic head and neck cancer
H1 2021- Expect first patient injected in phase II study of NBTXR3 in combination with anti-PD-1/L1 for patients with inoperable head and neck cancer
H1 2021 – Expect first patient irradiated in phase I lung reirradiation study (first patient injected H2)
H2 2021 – Expect launch of post-registration study in soft tissue sarcoma to launch in EU
Additional news on other clinical trials and preclinical programs
Next financial press release: revenue for Q1 2021 on April 30, 2021

Annual General Meeting will be held on April 28, 2021.

On March 17, 2021 Genetron Holdings Limited ("Genetron Health" or the "Company", Nasdaq: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, reported that management will host virtual investor meetings at the 24th Credit Suisse Asian Investment Conference on Mar. 26th, 2021 (Press release, Genetron Health Technologies, MAR 17, 2021, View Source [SID1234576822]).

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Sizhen Wang, co-founder and Chief Executive Officer, will also attend a fireside chat at 3:00 pm Beijing time (3:00 am ET).

Interested parties may request more information by contacting their sales representative at Credit Suisse.

On March 17, 2021 PerkinElmer, Inc., a global leader committed to innovating for a healthier world, reported its industry-leading documentation, workflow and decision making Signals informatics platform is being expanded to build on existing capabilities in the biologics drug discovery space (Press release, PerkinElmer, MAR 17, 2021, View Source [SID1234576892]). This comes through a collaboration with Insightful Science, a software company serving the global life sciences community.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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With the collaboration, pharmaceutical and academic research teams can bring together the power of the PerkinElmer Signals platform with leading solutions from Insightful Science’s Bioinformatics division. This includes the popular SnapGene and Geneious Prime software offerings that help molecular biologists design and execute DNA construct design, molecular cloning and other kinds of molecular biology research. The integration will give scientists the ability to access and compare data across experiments and instruments and collaborate more intuitively. They can also replicate assays and experiments instantly, leading to faster time-to-result and more informed decision making on drug and vaccine targets.

"There is a limited availability of IT tools in the biologics space," said Kevin Willoe, VP and GM of PerkinElmer, Informatics. "Through our collaboration with Insightful Science, we’re able to provide enhanced informatics capabilities to scientists doing vital biologics and vaccine research. This will help significantly reduce cycle times for researchers and aid them in making data-driven decisions faster and more accurately – important capabilities when fighting foes like cancer, cardio, neurological and viral diseases."

"The integration of best-in-class scientific software with cloud-based data platforms is increasingly essential for modern pharmaceutical and biotech enterprises to streamline research and ensure the integrity of valuable data," added Brett Ammundsen, CEO Bioinformatics at Insightful Science. "The combination of SnapGene and Geneious Prime software with the PerkinElmer Signals platform powerfully enhances research workflows and enriches collaboration. Ultimately this will better connect scientists to their ideas and data, so they can focus on producing life-changing outcomes."

On March 17, 2021 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported that, following a vote in favor of the transaction by the Armata shareholders, the Company has completed the closing of the second and final tranche of the Company’s $20 million private placement of its common stock with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Inc. (NASDAQ: INVA) (together, "Innoviva") (Press release, AmpliPhi Biosciences, MAR 17, 2021, View Source [SID1234576786]). In connection with the second closing, Armata issued 4,285,935 common shares and 4,285,935 warrants with an exercise price of $3.25 per share, at a per unit price of $3.25 per unit, in exchange for gross proceeds of approximately $13.9 million. Approximately 99% of the Armata shares represented and voting at the special meeting of shareholders voted in favor of the transaction.

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The Company and Innoviva closed an initial tranche of the investment on January 26, 2021, which raised gross proceeds of approximately $6.1 million through the issuance of 1,867,912 common shares and warrants to purchase an additional 1,867,912 common shares at a strike price of $3.25 per share.

As of March 17, 2021, and following the second closing, Armata has 24,940,442 shares outstanding and warrants exercisable for 16,649,465 shares of common stock.

Armata was represented in the transaction by Thompson Hine LLP, and Ladenburg Thalmann & Co. Inc. acted as Armata’s financial advisor.

Willkie Farr & Gallagher LLP represented Innoviva in the transaction.

This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration requirements.

On March 17, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for 2020 and provided a business update (Press release, Diffusion Pharmaceuticals, MAR 17, 2021, View Source [SID1234576806]).

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Business and financial highlights during 2020 and 2021 year-to-date include:

Strengthened management team: Appointed Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer and Director, Christopher Galloway, M.D., Chief Medical Officer, and William Elder, General Counsel. Also added Jane H. Hollingsworth to the Company’s Board of Directors

Advanced development of trans sodium crocetinate ("TSC"): During 2020, the Company initiated its Phase 1b lead-in trial of 24 hospitalized COVID-19 patients. The trial was designed to evaluate the safety and tolerability of TSC when administered every six hours for up to 15 days, a previously untested dosing regimen. The company completed dosing and reported topline results from the study in February 2021. Results indicated that no dose-limiting toxicities or serious adverse events were observed in the trial
• The Phase 1b represents the first major step towards solidifying a redefined TSC development strategy that the company announced in November 2020
• In 2021, the company will execute three oxygenation studies, described below

Enhanced Financial Stability: As of December 31, 2020, the Company had $18.5 million in cash and cash equivalents. As of March 16, 2021, approximately $36.7 million in additional, aggregate gross proceeds have been received by the Company during the first quarter of 2021 through a common stock offering in February 2021 and the cash exercise of certain previously outstanding warrants

"There is no doubt that 2020 was a challenging year, but it was also a transformational year for Diffusion. We formed a new executive team, initiated and advanced our Phase 1b study of TSC in hospitalized COVID-19 patients, and concurrently redefined the clinical development pathway for TSC in an effort to maximize the probability of clinical and regulatory success," said Robert Cobuzzi, President and Chief Executive Officer of Diffusion. "The momentum we gained exiting 2020 has continued into 2021. We have completed the study of TSC in hospitalized COVID-19 patients, designed a series of three clinical trials to be conducted during 2021 to evaluate the effects of TSC on oxygenation, and secured the company’s financial position by completing our $34.5 million equity raise."

Near Term Strategy

In an effort to support further, robust clinical development of TSC, the Company intends to undertake a prospective exploration of the relationship between the level of TSC exposure (dose) and response (change in oxygenation) by conducting three short-term clinical trials in the United States during 2021, all of which the Company expects to be able to fund with cash-on-hand.

The Company believes positive data from any one or more of these three Oxygenation Trials will provide evidence of a definitive effect of TSC on oxygenation, whether through increased uptake in the lungs, enhanced delivery, increased utilization at the tissue level, or some combination thereof.

TCOM Trial: The first of the three Oxygenation Trials, which we expect to initiate imminently, will evaluate the effects of TSC on peripheral tissue oxygenation using a transcutaneous oxygen monitoring ("TCOM") device. The TCOM device directly measures the release of oxygen from the blood vessels through the skin and is commonly used to predict the likelihood of wound healing, the potential for success with hyperbaric therapy, and to map the appropriate location for limb amputation.

The TCOM Trial is designed to evaluate single, ascending, randomized doses of TSC to establish the exposure-response relationship between TSC and enhanced oxygen delivery. We anticipate this study will be completed in the second quarter of 2021, with top line results available within two months of study completion.

Hypoxia Trial: The second planned trial is the Hypoxia Trial, which we expect to initiate in the third quarter of 2021. This trial will evaluate the effects of TSC on maximal oxygen consumption (VO2), and partial pressure of blood oxygen (PaO2), in normal healthy volunteers exposed to conditions that induce hypoxia.

Trial participants will engage in incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions. The primary endpoints will be change from baseline in VO2 and PaO2 after receiving a single intravenous dose of TSC. We anticipate this study will be completed in the second half of 2021, with topline results available within two months of study completion.

DLCO Trial: The third trial is designed to evaluate the effects of TSC on the diffusion of carbon monoxide through the lungs ("DLCO") in patients with previously diagnosed interstitial lung disease who have a baseline DLCO test result that is abnormal. We expect to initiate the DLCO Trial in the third quarter of 2021. DLCO testing is commonly performed as part of standard pulmonary function testing and aids in the diagnosis of dyspnea, also known as shortness of breath, as well as to track improvement or progression over time on prescribed treatments.

In this trial, DLCO will act as a surrogate measure of oxygen transfer efficiency, or uptake, from the alveoli of the lungs, through the plasma, and onto hemoglobin within red blood cells. The DLCO Trial will test single, ascending doses of TSC in an attempt to establish the exposure-response relationship between TSC and oxygen transfer efficiency. We anticipate this study will be completed in the second half of 2021, with top line results available within two months of study completion.

Outcomes from one or each of these Oxygenation Trials will inform the company’s go-forward TSC clinical development path, focusing on the demonstration of clinical and therapeutic benefits of TSC in relevant patient populations across the hypoxia continuum. Assuming success in one or more of the three Oxygenation Trials, the Company expects to identify and announce the specific, hypoxia-related indication it will target, in the fourth quarter of 2021. The Company then plans to initiate a Phase 2, controlled, clinical outcome study evaluating TSC in one or more appropriate hypoxia-related indications in the first half of 2022.

2020 Financial Results

As of December 31, 2020, Diffusion had cash and cash equivalents of $18.5 million as compared to $14.2 million as of December 31, 2019. Net cash used in operating activities during 2020 was $13.6 million, compared to $9.9 million used during 2019. During 2020, the Company raised $12.0 million in gross proceeds through its May 2020 offering of common stock and an additional $8.0 million in gross proceeds through the exercise of certain previously outstanding warrants.

An additional $36.7 million in aggregate gross proceeds have been received by the company thus far during the first quarter of 2021, through its common stock offering in February 2021 and the exercise of certain previously outstanding warrants. As of March 16, 2021, the Company believes it has adequate cash resources to continue operations through 2023, including expenditures related to the three Oxygenation Trials and its planned Phase 2 trial in a hypoxia-related indication.

Research and development expenses were $9.4 million for 2020, compared to $6.6 million for 2019. The increase was primarily attributable to the company’s clinical trial evaluating TSC in hospitalized COVID-19 patients, which resulted in a $1.1 million uptick in manufacturing costs and a $2.2 million increase in clinical trial and other R&D related expenses.

General and administrative expenses were $6.4 million for 2020, compared to $4.8 million for 2019. The Increase was largely driven by a $0.7 million increase in professional fees and a $0.9 million increase in salaries, wages, and stock-based compensation, including certain non-recurring expenses related to the retirement and separation of Diffusion’s former executives during 2020. Diffusion reported a net loss of $14.2 million in 2020, compared to a net loss of $11.8 million in 2019.

Additional information and financial statements can be found in the 10K filed with the SEC on March 17, 2021, which can be found on the Diffusion website at: View Source,
or on Edgar at: View Source;owner=exclude