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Entry into a Material Definitive Agreement

On October 21, 2022 Zymeworks reported that it entered into the Sales Agreement, dated as of October 21, 2022, with Jefferies. The Sales Agreement provides for the offer and sale of Zymeworks’ common stock from time to time through Jefferies as its sales agent, subject to the maximum aggregate dollar amount registered pursuant to the applicable prospectus supplement. Sales of shares of common stock through Jefferies, if any, will be made by any method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including without limitation sales made directly on the New York Stock Exchange or any other existing trading market for the shares of common stock (Filing, 8-K, Zymeworks, OCT 21, 2022, View Source [SID1234622261]). Zymeworks will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any shares of common stock sold through Jefferies under the Sales Agreement. Zymeworks has also provided Jefferies with customary indemnification and contribution rights.

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In accordance with the Sales Agreement, Jefferies will use commercially reasonable efforts to sell Zymeworks’ common stock from time to time, based upon instructions from Zymeworks (including any price, time or size limits or other customary parameters or conditions the Company may impose). Zymeworks is not obligated to make any sales of its common stock under the Sales Agreement. The Sales Agreement may be terminated by Zymeworks or Jefferies upon the written notice to the other party in accordance with the terms of the Sales Agreement. The offering of the shares of common stock pursuant to the Sales Agreement will terminate upon the termination of the Sales Agreement in accordance with its terms.

The shares of common stock are being offered and sold pursuant to the Registration Statement on Form S-3ASR (File No. 333-259970) ("Registration Statement"), including the prospectus, dated October 1, 2021, filed by the Company and the prospectus supplement, dated October 21, 2022, filed by Zymeworks. The Registration Statement was adopted by Zymeworks pursuant to Rule 414 under the Securities Act of 1933, as amended.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 hereto and incorporated herein by reference. The Sales Agreement is also incorporated by reference into the Registration Statement.

A copy of the opinion of Wilson Sonsini Goodrich & Rosati, P.C. relating to the legality of the shares of common stock issuable under the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K and is also incorporated by reference into the Registration Statement.

This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any sale of such 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.

Alpha Tau Announces Multiple Corporate Updates Ahead of 2022 Annual Meeting of the American Society for Radiation Oncology

On October 21, 2022 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported its participation in the upcoming 2022 Annual Meeting of the American Society for Radiation Oncology ("ASTRO"), being held October 23 – 25, 2022 in San Antonio, TX, where the Company will be at Booth #3719 (Press release, Alpha Tau Medical, OCT 21, 2022, View Source [SID1234622260]). Participants interested in meeting with the Alpha Tau team at the conference can do so by booking a slot via the following link: https://calendly.com/michaelt-alpha-dart/. Ahead of the conference, the Company is pleased to announce a number of recent developments:

The Medicines and Healthcare products Regulatory Agency ("MHRA") of the United Kingdom has approved the Company’s request to initiate a clinical trial for the treatment of primary and recurrent Squamous Cell Carcinoma of the vulva using the Alpha DaRT. The trial is expected to be conducted with 10 patients, and will be led by Dr. Li Tee Tan of Addenbrooke’s Hospital of the Cambridge University Hospitals NHS Trust. The trial seeks to measure the feasibility, safety, efficacy and immunological response associated with treatment with the Alpha DaRT.
Health Canada has approved the Company’s request to revise its Investigational Testing Authorization for the Company’s clinical trial testing the feasibility and safety of the Alpha DaRT treatment in patients with advanced pancreatic cancer. The revision allows the Company to add Jewish General Hospital in Montreal, Canada as a second site to the trial, alongside Centre Hospitalier de l’Université de Montréal (CHUM).
Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center in New York will deliver a presentation at the ASTRO 2022 Annual Meeting, on Wednesday, October 26, 2022 at 8:20am in the Henry B. Gonzalez Convention Center, Room 303, entitled "A Multicenter Prospective Trial of Diffusing Alpha-Emitter Radiation Therapy for Recurrent or Unresectable Cutaneous Cancers: Early Results from a Pilot Feasibility Study in the United States," providing further detail on the results of the Company’s U.S. pilot feasibility study that was conducted in 2021, the initial results of which were reported earlier in 2022, including a 100% complete response rate observed at 12 and 24 weeks after treatment with the Alpha DaRT.
Following the Company’s announcement in January 2022 that it had signed a sponsored research agreement with investigators at The University of Texas MD Anderson Cancer Center, the investigators presented a poster at the Radiation Research Society’s 2022 Annual Meeting, held October 16 – 19, 2022 in Waikoloa Village, Hawaii. The poster detailed results of the investigators’ pre-clinical study using the Alpha DaRT to treat mice with 4T1 triple-negative breast cancer tumors, demonstrating significantly smaller tumor volume as well as a significant two-fold increase in CD8+ cell populations in the spleens of mice when treated with the Alpha DaRT vs. those treated with inert sources. The investigators concluded that, "[Alpha] DaRT seeds were effective in delaying tumor growth with activation of the immune system…The magnitude of increase in CD8+ populations in the irradiated spleens of mice suggests systemic activation of the immune system."
Alpha Tau CEO Uzi Sofer commented, "Following the completion of our U.S. pilot study earlier this year, we are laser-focused on initiating our U.S. multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma using the Alpha DaRT, which we expect to occur before the end of the year, as we are currently progressing on the associated preparatory logistics such as IRB approvals and site initiations. At the same time, we continue to forge ahead in our strategy to broaden the application of the Alpha DaRT to other indications, and are very excited to see continued meaningful progress across three different indications: cancer of the vulva, pancreas and breast. We look forward to further advances in these and other indications, as we continue to explore ways that the Alpha DaRT can help patients around the world."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Entry into a Material Definitive Agreement

On October 21, 2022, HTG Molecular Diagnostics, Inc. (the "Company") reported that it entered into a Purchase Agreement (the "Purchase Agreement") with Ann Hanham, Ph.D., the Chair of the Company’s Board of Directors ("Purchaser"), pursuant to which the Company agreed to issue and sell one share of the Company’s newly designated Series A Preferred Stock, par value $0.001 per share (the "Series A Preferred"), to the Purchaser for a purchase price of $100.00 (Filing, 8-K, HTG Molecular Diagnostics, OCT 21, 2022, View Source [SID1234622259]). The closing of the sale and purchase of the share of Series A Preferred was completed on October 21, 2022.

Additional information regarding the rights, preferences, privileges and restrictions applicable to the Series A Preferred is set forth under Item 5.03 of this report.

Pursuant to the Purchase Agreement, the Purchaser has agreed to cast the votes represented by the share of Series A Preferred on any Reverse Stock Split Proposal (defined below) in the same proportion as shares of common stock of the Company ("Common Stock") are voted (excluding any shares of Common Stock that are not voted, whether due to abstentions, broker non-votes are otherwise) on such proposal; provided, however, that unless and until at least one-third of the outstanding shares of Common Stock on the record date established for the meeting of stockholders at which the Reverse Stock Split Proposal is presented are present in person or represented by proxy at such meeting, the Purchaser will not vote the share of Series A Preferred on such Reverse Stock Split Proposal. A "Reverse Stock Split Proposal" means any proposal approved by the Company’s Board of Directors and submitted to the stockholders of the Company to adopt an amendment, or a series of alternate amendments, to the Company’s Amended and Restated Certificate of Incorporation to combine the outstanding shares of Common Stock into a smaller number of shares of Common Stock at a ratio specified in or determined in accordance with the terms of such amendment or series of alternate amendments.

Spectrum Pharmaceuticals Announces Commercial Availability of ROLVEDON™ (eflapegrastim-xnst) Injection

On October 21, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, reported the commercial availability of ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia (Press release, Spectrum Pharmaceuticals, OCT 21, 2022, View Source [SID1234622256]). ROLVEDON received U.S. Food and Drug Administration approval in September 2022.

"We are thrilled to launch ROLVEDON into an estimated $2 billion market. Our distribution partners have stocked the product and we are ready to take advantage of this compelling market opportunity," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "This is an important milestone in Spectrum’s transition to a commercial stage company, and we are excited to deliver ROLVEDON to the patients who need it."

About ROLVEDON

ROLVEDON (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from two identically designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLVEDON demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.

Please see the Important Safety Information below and the full prescribing information for ROLVEDON at www.rolvedon.com.

Indications and Usage

ROLVEDON is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
Limitations of Use

ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Contraindications

ROLVEDON is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim or filgrastim products. Reactions may include anaphylaxis.

Warnings and Precautions

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome (ARDS)

ARDS can occur in patients receiving rhG-CSF products. Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue ROLVEDON in patients with ARDS.
Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products. Permanently discontinue ROLVEDON in patients who experience serious allergic reactions.
Sickle Cell Crisis in Patients with Sickle Cell Disorders

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products. Discontinue ROLVEDON if sickle cell crisis occurs.
Glomerulonephritis

Glomerulonephritis has occurred in patients receiving rhG-CSF products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation. Evaluate and consider dose reduction or interruption of ROLVEDON if causality is likely.
Leukocytosis

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during ROLVEDON therapy. Discontinue ROLVEDON treatment if WBC count of 100 x 109/L or greater occurs.
Thrombocytopenia

Thrombocytopenia has been reported in patients receiving rhG-CSF products. Monitor platelet counts.
Capillary Leak Syndrome

Capillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The granulocyte colony-stimulating factor (G-CSF) receptor through which ROLVEDON acts has been found on tumor cell lines. The possibility that ROLVEDON acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which ROLVEDON is not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

MDS and AML have been associated with the use of rhG-CSF products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Aortitis

Aortitis has been reported in patients receiving rhG-CSF products. It may occur as early as the first week after start of therapy. Consider aortitis in patients who develop generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) without known etiology. Discontinue ROLVEDON if aortitis is suspected.
Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
Adverse Reactions

The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received ROLVEDON. The adverse reaction requiring permanent discontinuation in 3 patients who received ROLVEDON was rash.

Invitation to presentation of Q3 and first 9 months 2022 result

On October 21, 2022 Biotec Pharmacon reported that it will host a presentation for investors, analysts and media at 08:30 CET on Thursday, 27 October 2022 at Hotel Continental, Stortingsgata 24/26, Oslo (Press release, Biotec Pharmacon, OCT 21, 2022, View Source [SID1234622255])

The presentation will be given by CEO, Jethro Holter and CFO, Børge Sørvoll

The presentation can also be followed as a live webcast from Hegnar TV on www.arcticzymes.com or https://channel.royalcast.com/landingpage/hegnarmedia/20221027_3/ . It will be possible to post questions through the webcast console.

The report for the third quarter and first 9 months 2022 will be available on www.newsweb.no and on the company’s homepage www.arcticzymes.com from 07.00 CET on Thursday, 27. October 2022.