On July 1, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the quarter ended March 31, 2021, and provided an update on clinical and corporate progress (Press release, Affimed, JUL 1, 2021, View Source [SID1234584549]).

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"As we continue to build momentum with our clinical programs, we see growing interest in the important work that we are doing in the emerging field of innate immuno-oncology. We published clinical data for AFM13 that is supporting our three-pronged development strategy of our ICE as monotherapy, in combination with NK cells and in combination with a checkpoint inhibitor," said Dr. Adi Hoess, CEO of Affimed. "Over the next several months, we have a number of value-creating events on AFM13, AFM24, where we expect to initiate several clinical studies, and AFM28, and are allocating capital across our portfolio to develop multiple opportunities for shareholder value creation."

Clinical Stage Program Updates
AFM13 (CD30/CD16A)

Affimed is continuing to recruit patients in the REDIRECT study (AFM13-202) after reporting positive results from the preplanned interim futility analysis in March 2021; the trial combined the high- and low-CD30 expressing cohorts into one. Affimed expects to complete enrollment in the study in the first half of 2022. REDIRECT is a phase 2, registration-directed study of AFM13 as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
Affimed reported all three dose escalation cohorts in the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center of AFM13 precomplexed with natural killer (NK) cells (AFM13-104) are now fully enrolled. The study is evaluating increasing doses of cord-blood derived NK cells pre-complexed with AFM13 followed by three weekly infusions of AFM13 monotherapy in patients with recurrent or refractory CD30-positive lymphomas.
Preclinical data published in Clinical Cancer Research support the therapeutic potential of AFM13, demonstrating that AFM13 in combination with NK cells improved tumor recognition and enhanced tumor cell killing in vitro and in vivo compared to NK cells alone. This data supported the Investigational New Drug (IND) application for the ongoing phase 1 clinical study of AFM13 pre-complexed with NK cells.
AFM24 (EGFR/CD16A)

AFM24-101, the phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE for patients with EGFR-expressing solid tumors, completed dose cohort 5 (320 mg) and patients are currently being enrolled and treated in dose cohort 6 (480 mg). Affimed expects to determine the recommended phase 2 dose and initiate dose expansion cohorts in the second half of 2021.
The phase 1/2a combination study of AFM24 with NKGen Biotech’s autologous NK cell therapy, SNK01, a first-in-human proof of concept trial with EGFR-expressing solid tumors is on track to start in the second half of 2021.
The phase 1/2a combination study of AFM24 with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) with EGFR-expressing solid tumors is on track to start in the second half of 2021.
Preclinical and Partnered Programs
Affimed expects to disclose the target of its preclinical asset AFM28 and publish initial preclinical data in the second half of 2021. The company remains on track to file an IND application for AFM28 in the first half of 2022.
Genentech has completed the dose escalation portion of the phase 1 study of RO7297089 (anti-BCMA/CD16A). No dose limiting toxicities were observed during the study. However, due to broader portfolio considerations, Genentech decided to stop the phase 1 study of RO7297089. The decision does not impact the development of other targets pursuant to the collaboration agreement with Genentech.
First Quarter 2021 Financial Highlights
As of March 31, 2021, cash and cash equivalents totaled €240.7 million compared to €146.9 million on December 31, 2020. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the second half of 2023.
Net cash used in operating activities for the quarter ended March 31, 2021, was €16.0 million compared to €16.5 million for the quarter ended March 31, 2020.
Total revenue for the quarter ended March 31, 2021, was €11.7 million compared with €5.1 million for the quarter ended March 31, 2020. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses for the quarter ended March 31, 2021, remained flat at €11.4 million compared to the quarter ended March 31, 2020.
General and administrative expenses increased 27.3% from €3.5 million in the quarter ended March 31, 2020, to €4.5 million in the quarter ended March 31, 2021. The increase relates largely to higher personnel expenses, higher premiums for our Directors and Officers liability insurance and higher legal and consulting expenses.
Net finance income for the quarter ended March 31, 2021, increased by 242% from €1.6 million in the quarter ended March 31, 2020, to €5.5 million. This increase is largely due to foreign exchange gains related to assets denominated in U.S. dollars as a result of the strengthening of the U.S. dollar against the Euro during the quarter.
Net income for the quarter ended March 31, 2021, was €1.4 million, or €0.01 per common share compared with a net loss of €8.3 million, or loss €0.11 per common share, for the quarter ended March 31, 2020.
The weighted number of common shares outstanding for the quarter ended March 31, 2021, was 116.2 million.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of March 31, 2021, of Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, July 1, 2021, at 8:30 a.m. EDT to discuss first quarter 2021 financial results and recent corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 4485380 approximately 15 minutes prior to the call. A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

On July 1, 2021 Sirnaomics Ltd., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that it has sealed $105 million in a Series E financing (Press release, Sirnaomics, JUL 1, 2021, View Sourcesirnaomics-secures-105-million-series-e-financing/" target="_blank" title="View Sourcesirnaomics-secures-105-million-series-e-financing/" rel="nofollow">View Source [SID1234584548]). This round of funding was led by Rotating Boulder Fund, an investor that has been supporting the company since its Series B round, with participation from existing investors and a well-recognized syndicate of new investors.

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Proceeds from the financing will be used to fund the continued development of Sirnaomics’ novel RNAi therapeutics for treating diverse human disorders, which include cancers, viral infections, fibrosis, and metabolic diseases. Sirnaomics will also further advance its delivery technology platforms and strengthen its large-scale manufacturing capacity to support the company’s fast-growing product pipeline at different clinical stages (See: View Source).

Sirnaomics’ product candidates, STP705 and STP707, are dual targeting siRNA therapeutics against TGF-β1 and COX-2 for either local or systemic administration to treat various types of cancers and fibrotic diseases. Based on successful clinical and preclinical studies, a future clinical focus will be targeted towards immune oncological evaluation, with combination design of the novel RNAi drug candidate and immune checkpoint inhibitors, such as PD-1/PD-L1 monoclonal antibodies. With further expansion of the company’s systemic RNAi drug delivery platforms, encompassing siRNA-chemodrug conjugates and proprietary GalNAc-siRNA conjugates, Sirnaomics is poised to address multiple therapeutic areas.

"We are pleased to close the Series E round of financing with oversubscription from a very diversified and strong investor base," commented Patrick Lu, Ph.D., Founder, President and Chief Executive Officer. "This is another powerful validation that the RNAi therapeutics, fuelled by innovative delivery platforms, ground-breaking CMC technologies, and fast expansion of multiple clinical programs with positive results, are attracting significant interests from the investment community. We appreciate strong trust and persistent support from our existing investors, and we are very excited with this addition of a well-regarded syndicate of investors for the Series E financing. This combination of existing and new investors will not only strengthen our financial foundation, but also bring tremendous experience and expertise to Sirnaomics as it enters the next phase of growth."

On July 1, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported that it has entered into a stock purchase agreement with Robert W. Duggan, an experienced life sciences executive and the Company’s Board Chairman, for the purchase of 3,048,780 shares of the Company’s common stock at a price of $16.40 per share, the last reported sale price of the Company’s common stock on June 30, 2021, the immediately preceding trading day (Press release, Pulse Biosciences, JUL 1, 2021, View Source [SID1234584547]). All indebtedness owed by the Company to Mr. Duggan pursuant to the loan agreement between Mr. Duggan and the Company dated as of March 11, 2021, including the principal balance of $41.0 million and accrued and unpaid interest of $0.6 million, will be paid through the cancellation and extinguishment of such indebtedness and the issuance of the common stock shares in the private placement. As part of the private placement, Mr. Duggan will invest an additional $8.4 million as new capital.

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"This capital strengthens our balance sheet and enables greater flexibility to drive our top business priorities, the CellFX System Controlled Launch Program and the ongoing product development and initiatives to expand the clinical applications for NPS technology," said Darrin Uecker, President and CEO of Pulse Biosciences. "We appreciate the continued support and leadership from the Chairman of our Board of Directors. The entire team at Pulse Biosciences is excited and committed to deliver the clinically differentiated benefits of Nano-Pulse Stimulation technology to as many patients as possible, starting in aesthetic dermatology."

Mr. Duggan, who currently owns approximately 46% of the Company’s outstanding common stock, will become the beneficial owner of approximately 51% of the Company’s outstanding common stock after giving effect to the private placement. Accordingly, after the closing of the private placement, the Company will be considered a "controlled" company under applicable Nasdaq Stock Market rules.

No warrants will be provided, or other discounts given, to Mr. Duggan in the private placement, and the private placement is being facilitated directly by the Company. As such, no investment banking or placement fees are being incurred by the Company. The private placement is expected to close on or about July 7, 2021, subject to the satisfaction of customary preclosing conditions.

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

The shares of common stock being issued in the private placement have not been registered under the Securities Act of 1933, as amended (the "Act"), or any state securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Act and applicable state laws.

On July 1, 2021 Aileron Therapeutics, Inc. (Nasdaq: ALRN) reported that it has initiated a randomized, double-blind, placebo-controlled clinical trial in the US and in Europe of ALRN-6924 as a chemoprotective agent to treat patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy (Press release, Aileron Therapeutics, JUL 1, 2021, View Source [SID1234584538]). Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors in this Phase 1b trial. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy’s attack on cancer cells, a concept known as chemoprotection.

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"We are pleased to initiate this trial, which builds on promising data we previously reported from our proof-of-concept trial of ALRN-6924 in patients with small cell lung cancer (SCLC)," said Manuel Aivado, M.D., Ph.D., President and CEO of Aileron. "This NSCLC trial represents important progress in our clinical development strategy, as it involves a p53-mutated cancer indication that affects one of the largest cancer patient populations, and it is our first randomized, double-blind, placebo-controlled trial. In addition, the trial is designed to help us further advance our ultimate goal of pursuing a tumor-agnostic indication for ALRN-6924 as a chemoprotective agent for patients with p53-mutated cancers regardless of type of cancer or chemotherapy, with the potential to help millions of patients."

1 American Cancer Society

Nashat Gabrail, M.D., founder of the Gabrail Cancer Center in Canton, Ohio, President of Innovative Community Oncology Practices (ICOP) and an investigator in the ALRN-6924 NSCLC trial, commented, "Proactively protecting patients against chemotherapy-induced toxicities that impact bone marrow cells and other cells throughout the body closely aligns with our mission to improve the health and quality of life for patients. This is a significantly unaddressed need impacting nearly every patient who undergoes chemotherapy. When devising treatment strategies for today’s cancer patients, the use of targeted therapies is certainly preferred when possible. We are proud to participate in this trial to help explore the potential of ALRN-6924 as a novel chemoprotective agent that utilizes a biomarker-driven approach, thereby potentially bringing the promise of precision medicine to the field of supportive care drugs."

Patients enrolled in Aileron’s NSCLC trial will be randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles. Primary endpoints are the proportion of treatment cycles free of severe hematological and other toxicities, including Grade ≥ 3 neutropenia, Grade ≥ 3 thrombocytopenia, Grade ≥ 3 anemia, Grade 4 neutropenia and febrile neutropenia, as well as duration of Grade 4 neutropenia. An additional primary endpoint is the proportion of completed treatment cycles without chemotherapy dose reduction or without the use of growth factors or transfusions. Other endpoints include the proportion of patients with National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) Grade 3/4 treatment-emergent adverse events (TEAEs), quality of life, overall response rate, and progression-free survival.

Aileron anticipates reporting first interim safety data from the trial late in the fourth quarter of 2021 and full results in mid-2022.

The NSCLC trial follows Aileron’s presentation in October 2020 of clinical data from its completed Phase 1b clinical trial of ALRN-6924 in SCLC demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated SCLC treated with topotecan. A link to the SCLC presentation can be found here.

About ALRN-6924
Aileron is developing ALRN-6924, a novel chemoprotective medicine, to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects.

Chemotherapy preferentially acts on cells that are cycling, i.e. undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells, hair follicle cells, skin cells, and cells lining the oral cavity and the gastrointestinal tract. As a result, chemotherapy preferentially targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, can lead to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening and fatal.

ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered prior to chemotherapy to patients with p53-mutant cancers. ALRN-6924 is designed to activate normal p53 protein in patients’ healthy cells, temporarily and reversibly pausing cell cycling to selectively shield the patients’ healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that mutated p53 has lost its function in those cells. Therefore, p53-mutated cancer cells continue to cycle uninterrupted and remain fully susceptible to being killed by chemotherapy.

On July 1, 2021 ENTEROME SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, reported that Pierre Belichard, CEO, will present an overview of the Company and take part in 1-on-1 meetings with institutional investors at the following conferences (Press release, Enterome, JUL 1, 2021, View Source;utm_medium=rss&utm_campaign=enterome-to-present-at-upcoming-investor-conferences [SID1234584546]):

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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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