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.

On July 13, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported an update on the ongoing development of its product candidates, eftilagimod alpha ("efti") and IMP761 for the quarter ended 30 June 2021 (Press release, Immutep, JUL 13, 2021, View Source [SID1234584834]).

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"In the past quarter Immutep has entered a new phase as a biotech company at the forefront of the LAG-3 immunotherapeutic landscape. We are now advancing the development of efti in multiple different cancers and have the ongoing support of large pharma collaboration partners, including MSD and Merck Germany, for many of our trials. We have begun planning for our new Phase III study in metastatic breast cancer which, if positive, could provide us with registration data and have a number of new and ongoing other trials progressing at pace. Manufacturing scale up of efti to potential commercial quantities is progressing well," said Marc Voigt, CEO of Immutep.

"All of this company activity is taking place in an exciting LAG-3 landscape where the interaction between MHC class II and LAG-3 has just recently been validated as a therapeutic mechanism for regulating the body’s immune system to fight cancer. With more LAG-3 related programs under development than any other biotech or pharma in the space, we are very excited about the future," he concluded.

Efti Development Program

AIPAC – Phase IIb clinical trial – ongoing

The trial is on track to report final overall survival (OS) data in H2 of calendar year 2021. Immutep previously reported OS data from approximately 60% of events in Dec 2020.

TACTI-003 – Phase IIb clinical trial – new

Immutep received Fast Track designation in 1st line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) from the United States Food and Drug Administration (FDA) in April 2021. This opens the potential for expedited development and review of efti in 1st line HNSCC with the FDA.

Following the close of the quarter, Immutep completed the necessary regulatory steps with the US FDA and obtained institutional review board approval in the US to commence the TACTI-003 trial. Patient recruitment is expected to begin in this quarter.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

LOGO

TACTI-002 (also designated KEYNOTE-798) – Phase II clinical trial – ongoing

At ASCO (Free ASCO Whitepaper) 2021, Immutep reported updated interim results from TACTI-002 showing the combination therapy of efti and pembrolizumab demonstrates a very favourable overall response rate (ORR) together with very encouraging duration and depth of response in 1st line non-small cell lung cancer (NSCLC) (Part A) and 2nd line HNSCC (Part C). Tumor responses were seen in all PD-L1 subgroups, including in low PD-L1 expressing patients which are typically less responsive to anti-PD-1 therapy. Importantly, the combination therapy continues to be safe and well tolerated.

Recruitment continues for the additional 74 1st NSCLC patients for the expansion of Part A, with 33 patients already enrolled and for Stage 2 of Part B, which has 8 patients now enrolled. Recruitment is tracking better than projected for the expansion cohort of Part A and as originally projected for Stage 2 of Part B. Immutep expects to report further interim data for TACTI-002 in calendar year 2021 or early calendar year 2022.

INSIGHT

INSIGHT is an investigator-initiated phase I trial investigating different combination treatments with efti and a different route of administration for efti. INSIGHT consists of 5 different arms from stratums A to E.

INSIGHT-005 – combination with bintrafusp-alpha – new

Immutep signed a collaboration and supply agreement with Merck KGaA, Darmstadt, Germany for a new stratum in 12 patients with solid tumours, known as Stratum E or INSIGHT-005. The trial will be run as an amendment to the protocol of the ongoing INSIGHT trial as the fifth arm and will evaluate efti in combination with Merck KGaA’s and GlaxoSmithKline’s bintrafusp alfa. The first patient is expected to be enrolled in H2 of calendar year 2021.

INSIGHT-004 – combination with avelumab – final data

At ASCO (Free ASCO Whitepaper) 2021, Immutep also reported encouraging final data from its INSIGHT-004 arm (stratum D). Promising activity signals were demonstrated from the combination of efti and avelumab, with a response rate of 41.7% in patients with different solid tumours. In addition, deep and durable responses were seen in patients with low or no PD-L1 expression and in indications such as gastroesophageal and cervical cancer which typically do not respond to immune checkpoint therapy. Importantly, the combination therapy showed a good safety profile.

INSIGHT-003 – triple combination – new

INSIGHT-003 is a new stratum in up to 20 patients with various solid tumours, also referred to as Stratum C. This is Immutep’s first evaluation of efti in a triple combination therapy of efti, chemotherapy and anti-PD-1 therapy. All regulatory and ethical approvals have already been received, enabling patient recruitment to commence. The first patient is expected to be enrolled in Q3 of calendar year 2021, with first interim results expected in 2022.

The results of INSIGHT-003 are expected to inform a potential Phase II evaluating efti as part of a triple combination therapy along with an anti-PD-1 therapy and a chemotherapy, potentially in NSCLC.

EAT COVID – Phase II clinical trial – ongoing

The randomised portion of the investigator-initiated EAT COVID study is progressing at the University Hospital Pilsen in the Czech Republic. It is evaluating efti in up to 110 hospitalised patients with COVID-19.

Preclinical Pipeline

Immutep continues to work on GMP manufacturing preparations for IMP761 and is planning for toxicology studies and other pre-clinical evaluations.

In addition, under a collaboration project commenced in 2019 with Cardiff University, Immutep has advanced the discovery and development of a potential new generation of small molecule anti-LAG-3 therapies. The project aims to make an oral treatment available to cancer patients and at a lower cost compared with the current anti-LAG-3 antibodies being developed by several other companies.

Partnerships

Immutep’s licensing and collaboration partnerships with Labcorp, GSK, Novartis, EOC Pharma and CYTLIMIC continue to progress.

Intellectual Property

Immutep was granted three new patents during the quarter, further expanding the company’s global patent estate. The European Patent Office granted a patent directed to combination therapy with leramilimab (LAG525), Immutep’s IMP701 antibody which is out-licensed to Novartis AG, and also a new divisional patent for efti in combination with a PD-1 or PD-L1 inhibitor. In addition, the Chinese Patent Office granted a new patent for efti in combination with chemotherapy, building on corresponding Australian, European, Japanese and United States patents.

Financial Summary – Q4 FY21

Cash receipts from customers for the quarter was $10k, compared to $59k in Q3 of FY 2021 (i.e. the quarter ended 31 March 2021).

The net cash used in G&A activities in the quarter was $409k compared to $242k in Q3. The increase compared with last quarter is mainly related to capital raising related activities. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $128k in payment of Non-Executive Director’s fees and Executive Director’s salary.

The net cash used in Research and Development activities in the quarter was $5.45 million, compared to $1.74 million in Q3. The significant increase is mainly due to the payment of upfront costs for the TACTI-003 clinical trial in Q4. Cash flow used in R&D activities for FY2021 was $12.47 million compared to $19.87 million for FY 2020. The decline of cash used in R&D activities in FY 2021 compared with FY 2020 is mainly due to the declining AIPAC expenses since patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase and due to more material expenses related to the Phase IIb TACTI-003 clinical trial only starting to become payable during Q4 FY 2021. Total net cash outflows used in operating activities in the quarter was $5.71 million. In comparison, total net cash outflows from operating activities in Q3 was $3.05 million.

Immutep received a A$1,155,055 cash rebate from the Australian Federal Government’s R&D tax incentive program during the quarter.

In June 2021, Immutep secured commitments for $60 million via a two-tranche institutional placement which was supported by multiple institutional investors in Australia and offshore.

The Company’s cash and cash equivalent balance as at 30 June 2021 was $60.59 million compared to a balance of $51.7 million as at 31 March 2021. This includes $13.7m from the first tranche of the institutional placement and $605k from the exercise of US warrants over American Depository Shares.

A further $46.3 million will be raised from the second tranche of the placement conditional on shareholder approval at the Company’s Extraordinary General Meeting on 26 July 2021.

In addition, Immutep is seeking to raise a further ~$5 million from eligible shareholders via a Share Purchase Plan (SPP), which closes on Monday, 19th July 2021 at 5pm (Sydney, Australia time).

On July 13, 2021 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported the closing of a $105 million private financing round (Press release, Nimbus Therapeutics, JUL 13, 2021, View Source [SID1234584800]). The round was led by BVF Partners L.P. (BVF), with participation from existing investors including RA Capital Management and Atlas Venture. Access Biotechnology, Commodore Capital, Logos Capital, Surveyor Capital (a Citadel company), and a large alternative asset manager joined as new investors in this financing.

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"This financing from some of the world’s leading investors is validation of the exciting potential within Nimbus’ product pipeline and the singular expertise Nimbus brings in advancing these products forward. Spurred by compelling data from studies of our novel allosteric TYK2 inhibitor, we will be embarking upon multiple Phase 2 clinical studies in 2021 and 2022 to elucidate the full range of potential patient benefit from this novel therapeutic," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "Our clinical expertise with this molecule to date combined with our strong capital position make Nimbus uniquely well-resourced to advance this important medicine through the clinic in the years to come."

In addition to the Phase 2 studies of Nimbus’ allosteric TYK2 inhibitor, the financing will support a first-in-human study of the company’s HPK1 inhibitor candidate in cancer patients with solid tumors, which will begin later this year, and will accelerate preclinical programs against multiple targets in oncology and immunology. The company expects to initiate IND-enabling studies on two novel agents in 2022.

"Nimbus’ pipeline is positioned to deliver multiple clinical readouts over the next 18 months that have the promise to help transform patients’ lives," said Bruce Booth, D.Phil., co-founder and Chairman of the Board of Nimbus. "We are fortunate to have the support of many new investors joining Nimbus, and we welcome Sam Huang from BVF to the Board."

"We’re proud to lead this most recent financing round, and we see the tremendous potential of Nimbus’ vision, pipeline, and team," said Mark Lampert, founder and CEO of BVF.

On July 13, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported that it has entered into a securities purchase agreement (the "Purchase Agreement") with a single healthcare-focused institutional investor (the "Investor") for aggregate gross proceeds of approximately $10 million (Press release, CytRx, JUL 13, 2021, View Source [SID1234584819]). Under the terms of the Purchase Agreement, CytRx has agreed to sell 2,000,000 shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering and 8,240 shares of Series C 10.00% Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share for total gross proceeds of approximately $8.24 million, in a concurrent private placement. The shares of the Preferred Stock will be convertible, upon shareholder approval as described below, into an aggregate of up to 9,363,637 shares of common stock at a conversion price of $0.88 per share. The Preferred Stock includes beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock.

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CytRx will also issue to the Investor an unregistered preferred investment option (the "Investment Option") that allows for the purchase of up to 11,363,637 shares of common stock for additional gross proceeds of approximately $10 million if the Investment Option is exercised in full. The exercise price for the Investment Option is $0.88 per share. The Investment Option shall have a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval (the "Authorized Share Increase").

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

CytRx intends to use the net proceeds received from the offering for working capital purposes.

The registered direct offering and concurrent private placement are expected to close on or about July 15, 2021, subject to the satisfaction of customary closing conditions. The issuance of the shares of common stock underlying the Preferred Stock and the Investment Option sold in the private placement is subject to the Authorized Share Increase.

The shares of common stock sold in the registered direct offering are being offered and sold in the registered direct offering by CytRx pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255431), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on July 12, 2021. The registered direct offering is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, from H.C. Wainwright & Co., 430 Park Avenue, New York, NY 10022 or via telephone at (212) 856-5711 or email at [email protected].

The Series C Preferred Stock and Investment Options sold in the private placement and the shares of common stock issuable thereunder are being offered pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and have not been registered under the Act, or applicable state securities laws, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale, would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 13, 2021 Amaroq Therapeutics Ltd., a spinout out of the University of Otago in Dunedin, New Zealand, reported that it has launched after securing NZ$14 million (US$9.7 million) in seed funding to develop long non-coding RNAs to treat breast, colorectal and liver cancer (Press release, Amaroq Therapeutics, JUL 13, 2021, View Source [SID1234584960]).

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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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