On July 14, 2021 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported the pricing of an underwritten public offering of 5,952,381 shares of its common stock at a public offering price of $42.00 per share (Press release, Celldex Therapeutics, JUL 14, 2021, View Source [SID1234584852]). In connection with the offering, Celldex has granted the underwriters a 30-day option to purchase up to an additional 892,857 shares of common stock at the public offering price, less underwriting discounts and commissions.

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Jefferies, SVB Leerink, Guggenheim Securities and Cantor are acting as the joint book-running managers for the offering. LifeSci Capital LLC and H.C. Wainwright & Co. are acting as co-lead managers for the offering.

The Company expects to receive gross proceeds from the offering, excluding the exercise of the underwriters’ option, if any, of approximately $250 million, excluding underwriting discounts and commissions and other offering-related expenses.

Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates, including current and future development of CDX-0159, growing its bispecific antibody platform and clinical candidates, funding ongoing efforts to develop additional clinical pipeline products and for general corporate purposes.

The offering is expected to close on July 16, 2021, subject to customary closing conditions.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying base prospectus forming part of a shelf registration statement on Form S-3 (File No. 333-249917), which was previously filed with the Securities and Exchange Commission ("SEC") and deemed effective on November 6, 2020. A final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the final prospectus supplement and the accompanying base prospectus may be obtained for free by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105, or by e-mail at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at [email protected].

The offering will be made only by means of a prospectus. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 July 14, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported a payment-in-kind and a debt conversion structured as a directed issue of 24,112,523 new share Units to the guarantors and to the global coordinator and bookrunner, Aalto Capital AB, of the rights issue completed on 11 June 2021 (the "Rights Issue") (Press release, Allarity Therapeutics, JUL 14, 2021, View Source [SID1234584884]).

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The fee structure and payment-in-kind to be paid in Units to guarantors was described in the prospectus published on 19 May 2021 (the "Prospectus"): each Unit in the directed issue consists of one (1) new share of nominal DKK 0.05 with one (1) warrant attached which grants the right to subscribe one (1) share of nominal DKK 0.05 share in the Company at an exercise price of SEK 1.7. New shares are subscribed against by either receiving shares as payment-in-kind or by debt conversion. The warrants are subscribed without payment. Thereby, the Units in the directed issue are similar to the TO 3 warrants, issued as a part of the Rights Issue, and they will be issued under the same short-name (ALLR TO 3).

The Company carries out the directed issue of the 24,112,523 Units based on a Board resolution from 13 July 2021, pursuant to the authorization granted by the annual general meeting on 15 April 2021.

Of the total 24,112,523 Units, 14,349,536 Units are issued to the guarantors of the Rights Issue at a price of SEK 0.85 per Unit as described in the Prospectus. The guarantors receiving the largest numbers of Units are John Faalstrom (3,529,411 Units) and Crafoord Asset Management AB (1,411,764 Units). Moreover, 9,762,987 Units are issued to Aalto Capital AB as a debt conversion of approximately SEK 8.3 million, at a price of SEK 0.85 per Unit, for various services rendered to the Company before and during the Rights Issue.

The new shares, with a nominal per share value of DKK 0.05, hold no special rights. Following the directed issue, the share capital of the Company is a total of DKK 19,339,299.70 divided into 386,785,994 shares of nominal value DKK 0.05.

In the event that all warrants in the directed issue are fully exercised for subscription of new shares in the Company, the number of shares in the Company will increase with an additional maximum of 24,112,523 shares, from 386,785,994 shares to 410,898,517 shares, and the share capital will increase with an additional maximum DKK 1,205,626 from DKK 19,339,299.70 to DKK 20,544,925.85. These projections does not take into account possible exercise of other issued warrants in series TO 2 and TO 3.

On July 13, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that dosing of the first patient in the Company’s multi-cohort Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors (Press release, Cyclacel, JUL 13, 2021, View Source [SID1234584817]).

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"Advancing oral fadraciclib, our lead candidate, into this Phase 1/2 trial, represents a key clinical milestone and corporate objective for our team," said Spiro Rombotis, Cyclacel’s President and Chief Executive Officer. "This is the first of four streamlined Phase 1/2 studies we plan to open over the coming months as we expand our clinical programs to evaluate the potential of fadraciclib and CYC140, our oral PLK1 inhibitor, first in solid tumors and lymphomas and then in leukemias. We look forward to providing periodic updates on our clinical progress and data from these open-label studies."

"We are pleased to have dosed the first patient in this study and are delighted by the enthusiasm and strong interest from current and prospective investigators," said Mark Kirschbaum M.D., Senior Vice President & Chief Medical Officer of Cyclacel. "The study has initially opened at City of Hope and MD Anderson Cancer Center with more sites to join later on. We are building an excellent network of participating institutions both in terms of clinical and scientific expertise. In previous studies with single agent, intravenous fadraciclib we have observed durable suppression of MCL1 and other mechanistically-related proteins, including cyclin E and MYC, at tolerated doses. In addition, a patient with MCL1 amplified, advanced endometrial cancer experienced deep PR and 100% shrinkage of her target tumor lesions on single agent fadraciclib treatment. We are excited to begin mid-stage development of fadraciclib with the objective of registration-enabling outcomes and offering a new treatment option for patients with advanced solid tumors or lymphomas."

"Based upon prior clinical activity shown to date, further exploration of this novel CDK2/9 inhibitor is warranted across a number of solid tumor histologies," said Miguel Villalona-Calero, M.D., co-leader of the Developmental Cancer Therapeutics Program and Professor, Department of Medical Oncology & Therapeutics Research at the City of Hope, a world-renowned, independent research and treatment center for cancer, diabetes and other life-threatening diseases. "We look forward to enrolling patients in this trial and evaluating the potential treatment benefit of this experimental therapy both as a single agent and in combinations."

The Phase 1/2 registration-directed trial (CYC065-101) uses a streamlined design and will first determine the recommended Phase 2 dose (RP2D) for single-agent, oral fadraciclib. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design, where single agent fadraciclib will be administered to patients in up to eight cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in previous studies. The cohorts will include patients with breast cancer (selected for metastatic, hormone receptor positive, HER-2 negative, post-CDK4/6 inhibitor; HER-2 refractory; or triple negative), colorectal (including KRAS mutant), endometrial, hepatocellular and ovarian cancers, as well as certain lymphomas. An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MCL1, MYC and cyclin E, regardless of histology. The protocol allows for expansion of a cohort based on response which may allow acceleration of the clinical development and registration plan for fadraciclib.

About Cyclin-Dependent Kinases and Fadraciclib

Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib, a next generation CDK inhibitor, is a highly selective, potent, orally and intravenously available, inhibitor of CDK2 and CDK9. CDK2 drives cell cycle transitions and CDK9 regulates transcription of genes through phosphorylation of the carboxy-terminal domain (CTD) of RNA polymerase II (RNAP II). By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death of cancer cells at sub-micromolar concentrations.

Preclinical data suggest that fadraciclib may benefit patients with certain cyclin E-addicted or MYC-amplified solid tumors, including certain forms of breast cancer, neuroblastoma, ovarian cancer, uterine serous carcinoma and adult and pediatric hematological malignancies, such as ALL, AML, B-cell lymphoma, CLL, and multiple myeloma. Similarly to FDA-approved CDK4/6 inhibitors, fadraciclib may be useful in combination with other anticancer drugs, including HER2 inhibitors, such as trastuzumab, or BCL2 inhibitors, such as venetoclax.

In a prior Phase 1 open-label trial (CYC065-01), patients with high copy CCNE (cyclin E), MYC or MCL1 showed sensitivity to intravenously-administered, single-agent fadraciclib. A heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib. This patient continues on therapy for almost two years and reduction in her target tumor lesions has reached 100%. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% shrinkage in her target tumor lesions.

On July 13, 2021 ISA reported the closing of a EUR 26 million funding round with participation from new investors including Invest-NL and existing investors including Regeneron (Press release, ISA Pharmaceuticals, JUL 13, 2021, View Source [SID1234584799]). The proceeds of this round will be used to advance the lead product ISA101b towards first marketing authorization as well as to broaden the clinical pipeline of immunotherapies based on the Synthetic Long Peptide (SLP) platform technology.

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Gerben Moolhuizen, CEO of ISA Pharmaceuticals, said, "We are very happy with the continued support of our existing partners and shareholders. Invest-NL’s support underlines the innovation at ISA Pharma and potential impact of our SLP immunotherapies for the treatment of serious diseases."

SLP immunotherapies act through the specific activation of the patient’s own immune system. Lead product ISA101b targets cancers caused by human papilloma virus type 16 (HPV16). It is in late stage clinical development in three trials for the treatment of advanced stages of HPV16-positive head and neck cancer and cervical cancer in combination with Libtayo (cemiplimab, anti-PD1 immunotherapy), which is being co-developed by Regeneron and Sanofi.

Leo Holwerda, Director Capital at Invest-NL, notes: "Our investment in ISA Pharmaceuticals is a good example of how our TOPSS program can help promising Dutch start-ups and innovative companies which were affected by COVID-19. Invest-NL is happy to support ISA Pharmaceuticals to accelerate its clinical studies and we are confident that the company will succeed in bringing its lead therapy for patients with HPV16-positive head & neck cancer and cervical cancer to the market. This innovative and impactful therapy will strengthen the prospects of many patients."

Persistent HPV16 infection can cause head & neck, cervical and anogenital cancers. These cancers can be severe and life-threatening with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe (source) and 46,000 new cases and 9,000 deaths in the US (source).
HPV16 is also responsible for about 50% of cervical cancer cases. Cervical cancer is the 2nd most common cancer in women aged 15 to 44 years in Europe, with over 60,000 new diagnoses and 25,000 deaths each year in Europe. Globally there are more than 500,000 new patients and 300,000 deaths (source).

The SLP technology platform is at the basis of several ISA pipeline products that are scheduled to proceed into clinical trials over the next few years. Three promising products are in the final stages of pre-clinical development. ISA104 targets the hepatitis B virus (HBV) in chronically infected patients. Chronic HBV is a major cause of liver cirrhosis and liver cancer and affects over 250 million people worldwide (source). ISA103 is aimed at tumours that express PRAME, a protein closely associated with the malignant behaviour of cells in numerous types of cancers. ISA106 is a potential treatment for high risk COVID-19 infected patients.

On July 13, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the fourth quarter and fiscal year 2021, which ended May 31, 2021 (Press release, AngioDynamics, JUL 13, 2021, View Source [SID1234584818]).

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"The AngioDynamics team demonstrated excellent performance, resilience, and strong execution in what was a uniquely challenging year. We saw the pressure from COVID-19 gradually alleviate over the course of the year, and our business is now trending close to normalized run rates. During fiscal 2021, we took significant steps forward in our transformation into a growth-oriented, technology-driven company, building on the foundation we put in place over the past several years," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "Our investments in our key technology platforms are driving our growth, as evidenced by a strong first-year contribution from Auryon and continued strength from AngioVac. I am excited about the future of AngioDynamics as we continue to develop differentiated products like AlphaVac, which we anticipate launching later this year, to serve larger and faster growing markets, pursue regulatory milestones and expand our patient base."

Fourth Quarter 2021 Financial Results

Net sales for the fourth quarter of fiscal 2021 were $76.8 million, an increase of 31.7% compared to the prior-year quarter. All year-over-year comparisons have been affected by the disruption to procedure volumes resulting from the COVID-19 global pandemic.

Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Endovascular Therapies (formerly Vascular Interventions and Therapies) net sales were $38.1 million, an increase of 72.3%, compared to $22.1 million a year ago. Growth was driven by broad strength across the business relative to the prior-year period, led by sales of the Auryon and AngioVac platforms. Auryon sales during the quarter were $4.6 million.
Oncology net sales were $14.3 million, an increase of 14.2%, compared to $12.5 million in the prior-year period. The year-over-year growth was primarily due to increased sales of NanoKnife and Microwave disposables and sales of the BioSentry Tract Sealant System, partially offset by continued softness in capital spending and our international markets.
Vascular Access net sales were $24.5 million, an increase of 3.2%, compared to $23.7 million a year ago.
U.S. net sales in the fourth quarter of fiscal 2021 were $63.6 million, an increase of 42.6% from $44.6 million a year ago. International net sales were $13.2 million, a decrease of 3.6%, compared to $13.7 million a year ago.

Gross margin for the fourth quarter of fiscal 2021 was 55.1%, an increase of 330 basis points compared to the fourth quarter of fiscal 2020, primarily due to a reduction in COVID-related costs. During the quarter, gross margin was negatively impacted by macro forces including labor shortages and increased costs for labor, raw materials, and freight. Gross margins also continued to be impacted by Auryon startup costs. During the fourth quarter, inventory was reduced by $0.4 million when compared to inventory levels on February 28, 2021. During the fiscal year, inventory levels have been reduced by $11.3 million.

The Company recorded a net loss of $19.5 million, or a loss per share of $0.51, in the fourth quarter of fiscal 2021. This compares to a net loss of $157.0 million, or a loss per share of $4.13, a year ago. The current-year net loss includes a $14.0 million write-off of the OARTrac intangible assets, while the prior-year net loss includes a goodwill impairment charge of $158.6 million.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the fourth quarter of fiscal 2021 was $0.1 million, and adjusted earnings per share was $0.00, compared to adjusted net loss in the prior-year period of $2.1 million and adjusted loss per share of $0.06.

Adjusted EBITDA in the fourth quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $4.5 million, compared to $0.6 million in the fourth quarter of fiscal 2020.

In the fourth quarter of fiscal 2021, the Company generated free cash flow of $3.1 million. As of May 31, 2021, the Company had $48.2 million in cash and cash equivalents compared to $54.5 million in cash and cash equivalents on February 28, 2021. The Company reduced its debt outstanding under its revolving credit facility at May 31, 2021, to $20.0 million compared to $30.0 million on February 28, 2021.

Full-Year 2021 Financial Results

For the twelve months ended May 31, 2021:

Net sales were $291.0 million, an increase of 10.2%, compared to $264.2 million for the same period a year ago.
The Company’s net loss from continuing operations was $31.5 million, or a loss per share of $0.82, compared to a net loss of $166.8 million, or a loss of $4.39 per share, a year ago. The current-year net loss includes a $14.0 million write-off of the OARTrac intangible assets, while the prior-year net loss includes a goodwill impairment charge of $158.6 million.
Gross margin declined 300 basis points to 53.9% from 56.9% a year ago due to the Company’s COVID-related operating plan and increased labor, material, and freight costs, as well as Auryon start-up costs.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.9 million, with adjusted earnings per share of $0.05 per share, compared to adjusted net income and adjusted earnings per share of $3.5 million, or $0.09 per share, a year ago. Adjusted net income and adjusted earnings per share in fiscal 2021 includes a $1.9 million, and $0.04 per share benefit, respectively, related to the reimbursement of certain expenses under the CARES Act.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $19.5 million, compared to $18.0 million for the same period a year ago.
Fiscal Year 2022 Financial Guidance

The Company expects its fiscal year 2022 net sales to be in the range of $305 to $310 million, gross margin to be approximately 55.0% and adjusted earnings per share in the range of $0.00 to $0.05 as the Company continues to invest in new product launches to drive future growth.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fourth quarter and fiscal year 2021 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13720741.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, July 13, 2021, until 11:59 p.m. ET on Tuesday, July 20, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13720741.

As a reminder, the Company will also be hosting its Investor and Technology Day beginning at 9:30 a.m. ET this morning. Additional information and registration instructions can be found on the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the event will be archived on the same site.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.