On October 21, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the combination of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, OCT 21, 2020, View Source [SID1234568722]).

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Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL. The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that we announced earlier this year had met its primary endpoint of progression free survival. This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL." Mr. Weiss continued, "We look forward to presenting data from the UNITY-CLL Phase 3 trial later this year, which we plan to use as the basis of a U2 regulatory submission for CLL."

ABOUT FAST TRACK
Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.

A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologic License Application or New Drug Application.

ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the combination of ublituximab plus umbralisib, or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, umbralisib single agent, ublituximab plus umbralisib and an active control arm of obinutuzumab plus chlorambucil. A prespecified analysis was conducted to assess the contribution of ublituximab and umbralisib in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Full enrollment into the UNITY-CLL Phase 3 trial completed in October of 2017 with approximately 420 subjects enrolled to the two combinations arms. This trial enrolled approximately 60% treatment-naïve CLL patients and 40% relapsed or refractory CLL patients. The primary endpoint for this study was superior Progression Free Survival (PFS) for the U2 combination compared to the control arm to support the submission for full approval of the U2 combination in CLL. Positive topline results from this trial were announced in May 2020. The UNITY-CLL Phase 3 trial is being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia, and in 2020 it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States1. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.

On October 21, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, reported results from an independent laboratory validating internal animal studies showing the ability of Annamycin to target lung localized tumors (Press release, Moleculin, OCT 21, 2020, View Source [SID1234568721]).

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Walter Klemp, Chairman and CEO of Moleculin, stated, "This is some of the most compelling data we have seen yet to support our plans for a clinical trial evaluating the potential for Annamycin to treat lung metastatic tumors. There is an extreme unmet need for a more effective treatment of sarcomas that have metastasized to the lungs, and we intend for this to be a primary focus of our next IND for Annamycin. The timing of this new information is particularly encouraging, considering the progress we reported from our recent Pre-IND meeting with the FDA. We are hopeful we can submit this IND before year-end."

The relevance of targeting lung localized tumors is that it could provide a means to address a significant unmet need in cancer therapy. Specifically, there are limited treatment options for lung metastases resulting from a primary tumor, even though the primary tumor may have been treatable. For example, a primary soft tissue sarcoma can often be initially successfully treated (most often by removal), but if it has spread to the lungs, the anthracycline Adriamycin (doxorubicin), the approved treatment for patients whose lung-localized metastases cannot be surgically removed, has only limited efficacy. Research sponsored by Moleculin and recently presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held from June 22nd-24th, 2020 suggested a possible reason for this limited efficacy may be the inability of doxorubicin to sufficiently accumulate in the lungs in concentrations required to kill tumor cells. That presentation included findings from preliminary animal studies demonstrating that Moleculin’s drug candidate Annamycin, a more potent and non-cardiotoxic anthracycline, was capable of accumulating in the lungs of mice at up to 6-fold higher concentrations than doxorubicin.

The latest studies conducted in rats validated the previous animal studies presented at AACR (Free AACR Whitepaper). Additionally, these experiments compared both Free Annamycin (F-Anna) and Liposomal Annamycin (L-Anna) with doxorubicin (Dox), which is the current standard of care for sarcomas and other human malignancies including some that have metastasized to the lungs. The purpose of testing F-Anna (the non-liposomal form of Annamycin) was to determine whether the observed uniquely high accumulation of Annamycin in the lungs was due to its liposomal formulation (L-Anna) or whether it is an inherent property of Annamycin itself. The preliminary results show that F-Anna accumulates in the lungs of rats to a concentration 9-fold higher than Dox, demonstrating that the differences in molecular structure of Annamycin when compared to doxorubicin are responsible for Annamycin’s comparatively high accumulation in lungs and, we believe, consequently should enable an ability to target tumor cells in the lungs. In addition to the unique properties of the free drug Annamycin, the liposomal formulation further increased accumulation in the lungs and the noted concentration was more than 30-fold higher than Dox. In summary, we believe the apparent ability of the liposomal formulation of Annamycin to further enhance the natural ability of free Annamycin to accumulate in lungs without any observed toxic side effects creates a highly promising anticancer agent that may be uniquely capable of targeting lung localized tumors.

Mr. Klemp concluded, "Although our focus has been on the potential to treat sarcoma lung metastases with Annamycin, we should also point out that the indications for Annamycin might be expanded and could include lung metastatic breast cancer, colon cancer, prostate cancer, bladder cancer, and neuroblastoma. Our animal studies have already demonstrated the ability of Annamycin to significantly increase survival of mice in lung localized triple negative breast cancer and colon cancer models.

As a part of our general approach to anticancer drug design, we are currently also exploring the possibility of targeting other organs that can be considered ‘sanctuary sites of cancer’. In our opinion, our additional data continues to point to the potential for Annamycin to become an important drug in a wide range of cancers, especially in light of its lack of cardiotoxicity, which is being demonstrated in our ongoing clinical trials for AML."

On October 21, 2020 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported positive top-line results from the Company’s ongoing Phase 1 CARBON trial evaluating the safety and efficacy of CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies (Press release, CRISPR Therapeutics, OCT 21, 2020, View Source [SID1234568720]).

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"We are highly encouraged by today’s data, which demonstrate the promise of allogeneic therapies in treating hematological malignancies," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "Over time, we believe CRISPR-edited allogeneic CAR-T has the potential to leapfrog autologous CAR-T and benefit much broader patient populations. We continue to enroll patients and look forward to additional data read-outs for this program as well as our other allogeneic CAR-T programs, CTX120 and CTX130, next year. We are grateful to the patients and investigators who have made this important research possible."

"From this early data read-out, CTX110 has shown dose-dependent efficacy and response rates that are comparable to the early autologous CAR-T trials. Furthermore, CTX110 had an acceptable safety profile, which could make CAR-Ts more widely accessible," said Joseph McGuirk, D.O., Professor of Medicine and Division Director of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center and investigator in the Phase 1 CARBON trial of CTX110. "While longer follow-up is required, these early data support the potential for CTX110 to become an effective off-the-shelf CAR-T therapy for patients with relapsed or refractory B-cell malignancies."

CARBON Trial Overview
The Phase 1 CARBON trial is an open-label, multicenter study evaluating the safety and efficacy of CTX110 in adult patients with relapsed or refractory non-Hodgkin lymphoma, who have received at least two prior lines of therapy. As of the September 28, 2020, data cutoff, 12 patients were enrolled and infused with CTX110. Data are reported for the 11 patients who had at least completed their one-month assessment as of the data cutoff date.

Patients were infused with CTX110 following three days of lymphodepletion using fludarabine (30mg/m2/day) and cyclophosphamide (500mg/m2/day). The primary endpoints include safety as measured by the incidence of dose limiting toxicities (DLTs) and overall response rate. Key secondary endpoints include duration of response, progression-free survival and overall survival.

Additional details may be found at clinicaltrials.gov, using identifier: NCT04035434.

Safety Data Overview
Dose Levels 1 – 3 (n=10)
No DLTs were observed. There were no cases of Graft-vs-Host Disease (GvHD) despite high HLA-mismatch between allogeneic CAR-T donors and patients. No infusion reactions to either lymphodepleting chemotherapy or CTX110 were observed. Cytokine Release Syndrome (CRS) occurred in three patients (30%) and in each case was Grade 2 or below and resolved with tocilizumab administration. One patient (10%) had Grade 2 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) that improved within 24 hours with standard interventions. Two additional serious adverse events (periorbital cellulitis and febrile neutropenia) occurred after CTX110 infusion, both of which resolved and were determined to be unrelated to disease progression or CTX110.

Dose Level 4 (n=1)
One patient received Dose Level 4 of CTX110. On Day 5, the patient experienced Grade 2 CRS which resolved in 5 days. The PET/CT assessment at Day 25 showed the patient had achieved a complete response. The following day, the patient was hospitalized with febrile neutropenia and developed symptoms of short-term memory loss and confusion. The symptoms eventually progressed to significant obtundation that required intubation. He was initially treated for ICANS with steroids, anakinra and intrathecal chemotherapy without improvement. The patient was later found to have reactivation of HHV-6 and HHV-6 encephalitis and treated with antiviral therapy. The decision was made to withdraw supportive care and the patient died 52 days after CTX110 infusion.

Clinical Activity (n=11)
Early evidence of dose-dependent anti-tumor activity was seen with CTX110. Disease assessment was performed by centralized independent radiological review according to the 2014 Lugano response criteria.

Cell dose
(CAR+ T cells) DL1
30×106
N=3 DL2
100×106
N=3 DL3
300×106
N=4 DL4
600×106
N=1
Overall response rate (ORR), N (%) 0 (0%) 1 (33%) 2 (50%) 1 (100%)
Complete response
(CR) rate, N (%) 0 (0%) 1 (33%) 2 (50%) 1 (100%)
Complete response (CR) was achieved at Dose Levels 2, 3, and 4. At DL3, two out of four patients had a complete response. These two patients remain in CR.
The four patients with CR had deep responses including the complete resolution of extranodal disease, normalization of all nodal disease to 1.5 cm or smaller, and a Deauville score of 2 or lower. Additionally, one of these patients who had 30% lymphoblasts in the bone marrow achieved complete clearance after CTX110 infusion.
CR was achieved both in patients with diffuse large B-cell lymphoma and with transformed follicular lymphoma, as well as in patients who were primary refractory and who had relapsed after autologous stem cell transplant.
At DL2 and above, CTX110 was detected at multiple time points in all patients, with peak expansion occurring at 1-2 weeks and cells detected as late as 180 days post-infusion​.
Conference Call and Webcast
CRISPR Therapeutics will host a conference call and webcast today at 8:30 a.m. ET. The webcast will be made available on the CRISPR Therapeutics website at View Source in the Investors section under Events and Presentations. Following the live audio webcast, the presentation and replay will be available on the Company’s website for approximately 30 days.

Dial-In Information
Live (U.S. / Canada): +1 (866) 342‑8588
Live (International): +1 (203) 518‑9865
Conference ID: 80521

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigative therapy targeting cluster of differentiation 19, or CD19. CTX110 is being investigated in the CARBON trial.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies. CRISPR Therapeutics is the sponsor of the CARBON trial.

On October 21, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the third quarter ended September 26, 2020 (Press release, Thermo Fisher Scientific, OCT 21, 2020, View Source [SID1234568719]).

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Third Quarter 2020 Highlights

Third quarter revenue increased 36% to $8.52 billion.
Third quarter GAAP diluted earnings per share (EPS) increased 157% to $4.84.
Third quarter adjusted EPS increased 91% to $5.63.

Generated $2.0 billion of COVID-19 related revenue in the quarter and returned the base business to growth.

Further expanded our global pandemic response, including launching the Amplitude Solution to automate high-throughput PCR-based testing, adding significant capacity for viral transport media production in Europe and introducing two new COVID-19 antibody tests that are available in the U.S. and Europe.

Continued to increase our capacity to help governments and biopharma customers globally meet future demand for new therapies and vaccines, most recently partnering with the Economic Development Board of Singapore to build our first pharma services facility there, which will include the only high-speed live virus filling line in Singapore.

Launched the Just Project to benefit historically black colleges and universities by donating more than $25 million of COVID-19 diagnostic test kits, instruments, supplies and technical assistance to enable the safe return of students and staff, and also established a $20 million Foundation for Science supporting STEM education in underserved communities.

Expanded our well-established center of excellence in Suzhou, China, by opening a new bioproduction factory for manufacturing single-use technologies to meet demand for biologics in the Asia-Pacific region.

Launched innovative Thermo Scientific products across our businesses, highlighted by two Selectris imaging filters for cryo-electron microscopes that accelerate research in structural analysis of proteins, and the POROS Oligo (dT)25 Affinity Resin to advance mRNA-based therapies and vaccines.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"We further accelerated our exceptional growth momentum in the third quarter," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Our teams executed very well to build on our leadership in supporting the global pandemic response and also captured opportunities to grow our base business.

"We’ve continued to meet COVID-related customer demand by launching new products across our company, such as tests and automated workflows to accurately diagnose the virus and enable society’s return to work and school. At the same time, we’re adding new capabilities, including scaling up production of sample collection products and essential laboratory supplies as well as increasing our pharma services capacity to support new therapies and vaccines. The combination of all these activities is creating a strong foundation for future growth."

Casper added, "The past nine months have been nothing short of incredible for our company, and I’m truly humbled by our colleagues around the world who are making a meaningful and positive impact on society through their work. We’re on track to deliver a record year, and importantly, positioning our company for an even brighter future."

Third Quarter 2020

Revenue for the quarter grew 36% to $8.52 billion in 2020, versus $6.27 billion in 2019. Organic revenue growth was 34%, currency translation increased revenue by 1% and acquisitions increased revenue by 1%.

GAAP Earnings Results

GAAP diluted EPS in the third quarter of 2020 increased 157% to $4.84, versus $1.88 in the same quarter last year. GAAP operating income for the third quarter of 2020 increased to $2.43 billion, compared with $0.95 billion in the year-ago quarter. GAAP operating margin increased to 28.5%, compared with 15.1% in the third quarter of 2019.

Non-GAAP Earnings Results

Adjusted EPS in the third quarter of 2020 increased 91% to $5.63, versus $2.94 in the third quarter of 2019. Adjusted operating income for the third quarter of 2020 grew 97% compared with the year-ago quarter. Adjusted operating margin increased to 32.9%, compared with 22.7% in the third quarter of 2019.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

In the third quarter of 2020, Life Sciences Solutions Segment revenue grew to $3.42 billion, compared with revenue of $1.70 billion in the third quarter of 2019. Segment adjusted operating margin increased to 54.9%, versus 34.5% in the 2019 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue was $1.34 billion in the third quarter of 2020, compared with revenue of $1.36 billion in the third quarter of 2019. Segment adjusted operating margin was 12.8%, versus 23.0% in the 2019 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew to $1.43 billion in the third quarter of 2020, compared with revenue of $0.88 billion in the third quarter of 2019. Segment adjusted operating margin increased to 27.9%, versus 25.3% in the 2019 quarter.

Laboratory Products and Services Segment

In the third quarter of 2020, Laboratory Products and Services Segment revenue increased to $3.11 billion, compared with revenue of $2.62 billion in the third quarter of 2019. Segment adjusted operating margin was 11.4%, versus 11.6% in the 2019 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, and the impact of significant tax audits or events. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 3 to 20 years. Based on acquisitions closed through the end of the third quarter of 2020, adjusted EPS for full-year 2020 will exclude approximately $3.25 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes or the estimated initial impacts of U.S. tax reform legislation), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans and the early retirement of debt.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, October 21, 2020, at 8:30 a.m. Eastern time. To listen, dial (833) 714-0931 within the U.S. or (778) 560-2662 outside the U.S. The passcode is 1570827. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, November 6, 2020.

On October 21, 2020 ERYTECH Pharma (Euronext Paris : ERYP – Nasdaq : ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances in red blood cells (the "Company"), reported the implementation of an at-the-market program allowing the Company to issue and sell ordinary shares in the form of American Depositary Shares ("ADSs"), to eligible investors at market prices, with aggregate gross sales proceeds of up to $30,000,000 (subject to a regulatory limit of 20% dilution), from time to time, pursuant to the terms of a sales agreement with Cowen acting as sales agent (Press release, ERYtech Pharma, OCT 21, 2020, View Source [SID1234568715]).

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The ATM program will allow the Company to issue ordinary shares in the form of ADSs, each representing one ordinary share of the Company, that may be sold through Cowen, at the Company’s discretion and instruction, at prevailing market prices on Nasdaq from time to time, without shareholders’ preferential subscription rights, for an aggregate offering amount of up to $30 million, being specified that the maximum number of new shares to be admitted on the regulated market of Euronext Paris is capped at 20% of the number of shares admitted to trading on such market, including shares admitted without prospectus during the last twelve months at the date of their issuance. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM program. The ATM program will be effective until September 21, 2023, unless terminated prior to such date in accordance with the sales agreement or the maximum number of ADSs to be sold thereunder has been reached.

The establishment of this financing facility follows the resolutions adopted at the Company’s Annual General Meeting of Shareholders on June 26, 2020. A new shelf registration statement on Form F-3 was filed by the Company with the U.S. Securities and Exchange Commission on September 21, 2020 to roll over the Company’s previously filed shelf registration and to cover the ATM program, but has not yet become effective.

The ADSs and the ordinary shares will be issued through a capital increase without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to the 25th resolution adopted by the Annual General Meeting of Shareholders held on June 26, 2020. The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at market prices of the ADSs at the time of pricing of the considered capital increase.

The ATM program may only be issued to the categories of investors defined in the 25th resolution described above including natural or legal persons, including companies, trusts or investment funds or other investment vehicles whatever their form, governed by French or foreign law and investing on a regular basis in the pharmaceutical, biotechnological or medical technology sectors and/or companies, institutions or entities, whatever their form, governed by French or foreign law, that carry out a significant part of their activities in the pharmaceutical, cosmetic or chemical sectors or in medical devices and/or technology or in research in these sectors. The new ordinary shares will be admitted to trading on the regulated market of Euronext Paris and the issued ADSs will trade on Nasdaq.

The Company expects to use the net proceeds from sales of any ADSs and ordinary shares issued under the ATM program primarily to fund the research and development of its product candidates, and for working capital and general corporate purposes.

On an illustrative basis, assuming the issue of 4,016,064 ADSs at a price of $7.47 (or €6.331) the last reported sale price of the ADSs on Nasdaq on September 17, 2020, for the maximum gross proceeds of $30,000,000 (or €25,430,194 2), a holder of 1% of the outstanding Company’s share capital as of the date of this press release, would hold 0.83% of the outstanding Company’s share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release).

During the term of the ATM program, the Company will publish a quarterly communication as part of the publication of its quarterly results, as well as an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM program from time to time.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. When available, copies of the prospectus supplement and the accompanying prospectus relating to these securities may be obtained from Cowen, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926. No prospectus will be subject to the approbation of the Autorité des Marchés Financiers ("AMF").

This press release does not constitute an offer to sell or a solicitation to buy the securities mentioned and no sale of such securities will be made in any state or province in which such offer, solicitation or sale would be unlawful until the securities are registered or their distribution is permitted under the securities laws of that state or province.

Information available to the public

No prospectus will be filed with the AMF. Detailed information concerning the Company, in particular with regard to its business, results, forecasts and corresponding risk factors, is provided in (i)] the Company’s 2019 universal registration document, filed with the AMF on March 19, 2020 and under number D. 20-0140[, and (ii) the 2020 half-year financial report published on September 21, 2020. These documents, as well as other regulated information and all of the Company’s press releases, are available on its website and on the AMF website (www.amf-france.org) and are available free of charge on request at the Company’s registered office at 60 Avenue Rockefeller, Bâtiment Adénine – 69008 Lyon, France.