On April 6, 2021 Global contract development and manufacturing organisation (CDMO), Sterling Pharma Solutions, reported the acquisition of ADC Biotechnology (ADC Bio), a UK based bioconjugation development services business specialising in antibody drug conjugates (ADCs) (Press release, ADC BIO, APR 6, 2021, View Source [SID1234635817]).

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This follows an announcement by Sterling in December of a strategic investment into the ADC Bio business, with a view to acquisition in 2021.

The Deeside, Wales, UK facility will rebrand to become part of the Sterling Pharma Solutions international network. Together the teams will establish a centre of excellence for bioconjugation and ADC development and manufacturing services, which combine Sterling’s 50 years of experience in cGMP manufacturing, quality processes and compliance, with the expertise of the ADC Bio team and the state of the art facilities available at Deeside.

A multi-million pound investment will support the growth of the company’s ADC capabilities, which will include growing and developing the existing bioconjugation technical services team and expanding the analytical services team particularly in the cGMP area. As well as this, the team will develop and establish cGMP bioconjugation/ADC manufacturing at Deeside in 2022.

Kevin Cook, CEO at Sterling Pharma Solutions, said: "We are delighted to confirm the acquisition of the ADC Bio business, this investment provides us with the opportunity to offer a wider portfolio of services to our customers in the fast growing ADC and bioconjugation market, as well as providing additional services to existing ADC Bio customers.

"Integrating our HPAPI capabilities with the expertise already found at Deeside mean that we will also be able to offer the development and manufacture of toxin linkers. This is an exciting time for both businesses as we embark on a period of growth and diversification to ensure we always stay ahead of the next innovation. I’d like to welcome all ADC Bio employees to the Sterling family."

Alan Raymond, Executive Chairman of ADC Bio, added: "This is fantastic news for our employees and our customers; targeted investment in both people and processes will allow the team to continue supporting important advances in drug development with additional services, and importantly with the additional support and experience from the Sterling team.

This announcement follows Sterling’s acquisition of a second US API development and manufacturing facility in Wisconsin in September last year. The UK headquartered CDMO now employs over 750 people across the UK and the US.

On April 6, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the European Biotech Investor Days 2021, a US based online event taking place April 7-8, 2021 and hosted by Goodwin, Solebury Trout, Deutsche Bank and Nasdaq (Press release, PCI Biotech, APR 6, 2021, View Source [SID1234585154]).

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On Thursday, April 8, 2021 at 15:00 (CEST), Dr. Per Walday, CEO, will present an overview of PCI Biotech’s proprietary platform technology via a general company presentation.

The presentation can be accessed live through this link View Source

The presentation slides will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Other presentations" after the event.

On April 6, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported that an abstract for SBP-101, a proprietary polyamine analogue, reported that it has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held virtually from June 4-8, 2021 (Press release, Panbela Therapeutics, APR 6, 2021, View Source [SID1234583756]).

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Details of the presentation are as follows:
Poster Presentation

Title: SBP-101, a polyamine metabolic inhibitor, administered in combination with gemcitabine and nab-paclitaxel, shows signals of efficacy as first-line treatment for subjects with metastatic pancreatic ductal adenocarcinoma.

Session Name: Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website at View Source After presenting at ASCO (Free ASCO Whitepaper), the poster will be available on the Company’s website.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse evets are being evaluated and the FDA has issued a partial clinical hold for the impacted study, pending Panbela’s evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial generally provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold. For more information, please visit View Source .

On April 6, 2021 Evaxion Biotech A/S (Nasdaq: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, reported the fourth quarter and full year 2020 financial results and provided an operational update (Press release, Evaxion Biotech, APR 6, 2021, View Source [SID1234578287]).

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Lars Wegner, CEO of Evaxion, said: "Evaxion made outstanding progress in 2020 in redefining the immunotherapy discovery process through our AI platform technologies, despite the complications caused by the COVID-19 pandemic. We are very pleased with the successful initial public offering on U.S. Nasdaq, concluded in February 2021, which raised gross proceeds of $30 million and positions Evaxion for further progress with our patient-specific cancer immunotherapies."

"In 2020, we initiated a Phase 1/2a clinical trial of the adjuvant immunotherapy EVX-02, in combination with checkpoint inhibitors in patients with advanced melanoma. Both this study and our Phase 1/2a trial with EVX-01 remain on track and our other product candidates – EVX-03 for multiple cancer indications and EVX-B1, a vaccine for prevention of S. aureus – are progressing well through preclinical development."

"Financially, Evaxion is in a strong position with cash and cash equivalents of $5.8 million at December 31, 2020, to which we have now added the proceeds from our IPO. This provides funding to advance our four product candidates into 2022, covering a number of key expected milestones. These include Phase 1/2a data on EVX-01 and EVX-02 expected in late Q2 2021 and filing for approval of a clinical trial of EVX-03 in multiple cancers in the second half of the year."

Operational and Business Highlights in 2020

Dosed first patient in Phase 1/2a melanoma trial of cancer vaccine EVX-02 in combination with checkpoint inhibitors
Appointed Marianne Søgaard, previously an attorney practicing technology law, including processes to acquire technology solutions, and commercial law, as Chairwoman of the Board of Directors
Launched new AI powered platform, RAVEN, to enable faster response to emerging viral pandemics
Partnered with SB3000 for rapid scale up for commercial production of corona virus vaccines with its continuous manufacturing technology
Publication of an article in Nature Communications showing how deep data on immune complex stability could optimize immunotherapy in cancer
Events after the Reporting Period

Closed U.S. initial public offering of 3,000,000 American Depositary Shares at a public offering price of $10.00 per ADS. The gross proceeds from the offering, before deducting underwriting fees and commissions and other offering expenses, were $30 million.
The shares began trading on the Nasdaq Capital Market on February 5, 2021 under the ticker symbol "EVAX".
Opened new corporate headquarters and research laboratory facility located in the DTU Science Park in Hoersholm near Copenhagen, Denmark.
Expected milestones in 2021

Phase 1/2a data on EVX-01 in metastatic melanoma – Q2 2021
Phase 1/2a data on EVX-02 in adjuvant melanoma – Q2 2021
Regulatory filing for clinical trial of EVX-03 in multiple cancers – H2 2021
Fourth Quarter and Full Year 2020 Financial Results

Cash position: As of December 31, 2020, cash and cash equivalents were $5.8 million compared to $9.6 million as of December 31, 2019. On February 9, 2021, we closed our recent IPO raising net proceeds of $27.9 million after underwriting discounts and commissions.
Research and Development expenses were $10.9 million for the year ended December 31, 2020, compared to $8.2 million for the same period in 2019. The increase of $2.7 million was primarily related to increased spending, net of grant income, for ongoing development on our platform, pre-clinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
General and Administrative expenses were $5.7 million for the year ended December 31, 2020, compared to $2.6 million for the same period in 2019. The increase of $3.1 million was primarily related to increased employee-related costs due to increased headcount and increases in overhead and professional fees related to the expansion of our corporate function for our initial public offering.
Net loss was $15.0 million for the year ended December 31, 2020 or ($0.97) loss per basic and diluted share, compared to $11.2 million, or ($0.81) loss per basic and diluted share, for the same period in 2019.
Guidance

Evaxion’s operating plan extends its cash runway into 2022.
Webcast and Conference Call

Evaxion will host a webcast and conference call today, April 6, 2021, at 8.30 a.m. EDT.

To access dial-in details for the conference call, please use the following link:
View Source

Alternatively to access the webcast, please use the following link:
View Source

On April 6, 2021 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported that it intends to offer, subject to market conditions and other factors, $500.0 million aggregate principal amount of Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ionis Pharmaceuticals, APR 6, 2021, View Source [SID1234577950]). Ionis also intends to grant the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the first date on which the notes are issued, up to an additional $75.0 million principal amount of notes.

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The notes will be general unsecured obligations of Ionis and will accrue interest payable semiannually in arrears. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.

Ionis expects to use a portion of the net proceeds from the offering to repurchase for cash certain of its 1% Convertible Senior Notes due 2021 (the "2021 notes") in privately negotiated transactions. In addition, Ionis expects to use a portion of the net proceeds from the offering to pay the cost of the convertible note hedge transactions described below (after such cost is partially offset by the proceeds to Ionis from the sale of the warrant transactions described below). Ionis expects to use the remaining net proceeds from the offering for general corporate purposes, including expansion of manufacturing, research and development, and commercial infrastructure to support its wholly owned pipeline.

In connection with the pricing of the notes, Ionis expects to enter into convertible note hedge transactions with one or more of the initial purchasers or their affiliates and/or other financial institutions (the "Option Counterparties"). The convertible note hedge transactions are generally expected to reduce potential dilution to Ionis common stock upon any conversion of notes and/or offset any cash payments Ionis is required to make in excess of the principal amount of converted notes, as the case may be. Ionis also expects to enter into privately negotiated warrant transactions with the Option Counterparties. The warrant transactions would separately have a dilutive effect to the extent that the market price per share of Ionis common stock exceeds the strike price of the warrants. If the initial purchasers exercise their option to purchase additional notes, Ionis expects to enter into additional convertible note hedge and additional warrant transactions relating to the additional notes with the Option Counterparties.

In connection with establishing their initial hedges of the convertible note hedge and warrant transactions, Ionis expects that the Option Counterparties or their respective affiliates will purchase shares of Ionis common stock and/or enter into various derivative transactions with respect to Ionis’ common stock concurrently with or shortly after the pricing of the notes. This

activity could increase (or reduce the size of any decrease in) the market price of Ionis common stock or the notes at that time.

In addition, the Option Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Ionis common stock and/or by purchasing or selling Ionis’ common stock or other securities of Ionis in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes or in connection with any repurchase of notes by Ionis on any fundamental change repurchase date or otherwise). This activity could also cause or avoid an increase or a decrease in the market price of Ionis’ common stock or the notes, which could affect the ability of noteholders to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that noteholders will receive upon conversion of such notes.

Further, in connection with any repurchases of the 2021 notes, Ionis expects that holders of the 2021 notes who agree to have their 2021 notes repurchased and who have hedged their equity price risk with respect to such notes (the "hedged holders") will unwind all or part of their hedge positions by buying Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Ionis’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price of the notes. Ionis cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes offered hereby or Ionis’ common stock.

The notes, the warrants and any shares of common stock issuable upon conversion of the notes or exercise of the warrants have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.