Agendia Announces First Patient Enrolled in PROOFS Registry Trial to Determine Optimal Treatment and Ability to Forgo Chemotherapy for Premenopausal Women with Early HR+ Breast Cancer

On March 16, 2023 Agendia, Inc., a leader in gene expression profiling for early-stage breast cancer, reported the first patient has been enrolled in the PROOFS Registry trial (Press release, Agendia, MAR 16, 2023, View Source [SID1234628968]). In partnership with the West German Study Group (WSG), the study aims to determine whether premenopausal women with early HR+ breast cancer, originally defined as clinically high-risk and classified as MammaPrint Low Risk, can avoid chemotherapy, and maintain strong outcomes by opting instead for temporary ovarian function suppression (OFS) in combination with endocrine therapy. By determining the drivers behind a young woman’s response to chemotherapy, the trial’s results could empower young women with the ability to safely forgo chemotherapy toxicities and preserve their fertility and quality of life.

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Breast cancer uses estrogen to grow, and chemotherapy suppresses the ovaries’ production of estrogen to cut off the cancer’s fuel source. While MINDACT study data found a small 3-5% chemotherapy benefit in premenopausal women with MammaPrint Low Risk tumors, the authors later concluded it is likely due to the chemotherapy-induced ovarian function suppression (OFS), rather than the effect of chemotherapy on the cancer itself. The PROOFS Registry trial intends to show this perceived benefit is merely a side effect of chemotherapy-induced OFS, deeming chemotherapy unnecessary and replaceable by temporarily suppressing the ovaries. Every young woman with early-stage breast cancer deserves the right to make truly informed treatment decisions tailored to her unique biology.

"Several studies have shown chemotherapy can have an irreversible impact on fertility, therefore the right treatment decision is critical in a woman’s potential family planning," said PD Dr. Oleg Gluz, Scientific Director of the WSG and leader of the Breast Center Niederrhein, Ev. Hospital Bethesda, Mönchengladbach and PD at the University of Cologne. "This study could potentially show that young women with breast cancer could be treated with endocrine therapy and OFS without compromising outcomes and without the risk of permanently affecting their fertility – all based on insights from her tumor’s unique gene expression profile."

"While chemotherapy is often assumed to be necessary for all young women with hormone receptor positive breast cancer, we have been able to harness the power of gene expression profiling to understand the biology of each breast cancer beyond the effects of age and standard pathology, and better define the true benefit of treatment. These insights could allow some young women with breast cancer to forgo chemotherapy and avoid unnecessary toxicity," said William Audeh, MD, Chief Medical Officer at Agendia. "If their small chemotherapy benefit indeed stems from OFS as the PROOF Registry trial seeks to prove, more young women can forgo the potentially serious and sometimes life-threatening effects of chemotherapy. We’re proud to partner with WSG on this important step to advance personalized treatment planning, reduce overtreatment, and help more women with breast cancer maintain their quality of life."

The PROOFS Registry trial intends to enroll 1,500 patients via 100 sites in Germany by January 2025. Right now, it is critical young women with early breast cancer be afforded the opportunity for shared decision-making when weighing the small perceived chemotherapy benefit against its impact on their future fertility and quality of life. By the close of the PROOFS Registry study, providers may be in a position to confidently recommend OFS as an alternative to toxic chemotherapy and preserve a woman’s fertility while maintaining the best chance at survival. Together with WSG, Agendia continues to enable more personalized treatments in breast cancer care.

Novocure Announces 5th Annual AACR-Novocure Grants for Tumor Treating Fields Research Program

On March 16, 2023 Novocure (NASDAQ: NVCR) reported the 5th Annual AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research Program (Press release, NovoCure, MAR 16, 2023, View Source [SID1234628967]). The program represents a joint effort with the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields (TTFields) as well as to encourage investigators to enter the TTFields research field.

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The program includes research grants and career development awards totaling more than $1.5 million over the next three years. The grants are intended to provide a deeper understanding of the mechanisms of action of TTFields therapy and to accelerate the development of new treatment strategies to advance therapeutic options for cancer.

The research grants will include three AACR (Free AACR Whitepaper)-Novocure Cancer Research Grants for independent investigators, each totaling $350,000 over three years, and one AACR (Free AACR Whitepaper)-Novocure Career Development Award for Cancer Research for junior faculty members, totaling $300,000 over three years.

"We are proud to continue the AACR (Free AACR Whitepaper)-Novocure partnership," said Mitch Stoller, the AACR (Free AACR Whitepaper)’s Chief Philanthropic Officer. "These grant mechanisms support talented investigators and catalyze advances in TTFields research in a unique way. We look forward to welcoming another class of grantees into the program this fall."

Novocure and the AACR (Free AACR Whitepaper) encourage applicants to focus their proposals on studies promoting the transition of in vitro work into in vivo systems, combination therapies involving TTFields, or translational projects bringing treatments involving TTFields into the clinic. The deadline to submit a letter of intent is May 30, 2023.

"We value the opportunity to collaborate with the AACR (Free AACR Whitepaper), the world’s first and largest cancer research organization, to support research on TTFields," said Moshe Giladi, Novocure’s Chief Science Officer. "As we aspire to make a difference in cancer, we believe TTFields therapy is a platform with game-changing potential. By deepening our understanding of the mechanisms of action behind TTFields, we hope to accelerate discovery that will allow us to help more patients around the world."

To apply for the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research, visit www.aacr.org/funding.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

Sensorion Reports Full-Year 2022 Financial Results and Business Update

On March 16, 2023 Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in gene therapies in the inner ear, reported its full-year 2022 financial results and provides a business update (Press release, Sensorion, MAR 16, 2023, View Source [SID1234628966]).

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Nawal Ouzren, Chief Executive Officer commented: "During the year, Sensorion has put the foundations in place for a pioneering franchise in gene therapy for hearing loss disorders which we believe will support clinical development plans later this year and beyond. We’re incredibly excited about the potential of our gene therapy franchise and programs, which builds on our ongoing collaboration with Institut Pasteur, to provide solutions for people with genetic hearing loss disorders.

"Our lead gene therapy candidate OTOF-GT has promising preclinical data and we are on track to submit a Clinical Trial Application in Q2 2023. We are also making encouraging progress with the identification of our GJB2-GT therapeutic candidate.

"We are now on the threshold of advancing our gene therapy programs into clinical development and have a unique opportunity to help redefine the treatment landscape for people with hearing loss disorders. We also anticipate reporting preliminary data from our Phase 2a SENS-401 studies in mid-2023. Our focus is now on execution and capital discipline to deliver on our key catalysts."

Pipeline Highlights and Upcoming Milestones

Gene Therapies for Hereditary Monogenic Hearing Loss

OTOF-GT: continued progress with positive regulatory support
OTOF-GT is Sensorion’s lead gene therapy program for the treatment of children born with hearing loss caused by otoferlin deficiency.

Sensorion presented preclinical data that indicated the potential for safe and efficient clinical translation of gene therapy for otoferlin delivered by a dual AAV vector at the Association for Research in Otolaryngology (ARO) conference, held in February 2022. Otoferlin de novo expression in inner hair cells (IHCs) in a DFNB9 mouse model (OTOF-KO) demonstrates long-term expression and hearing restoration for at least one year post injection. Sensorion has also developed, in non-human primates, an optimal surgical procedure close to the one used for cochlear implantation and demonstrated an effective transduction rate of the targeted IHCs.

Sensorion announced in January 2023 that it is designing and developing the injection system to administer gene therapy into the cochlea. This injection system used in the Non-Human Primate (NHP) GLP (Good Laboratory Practices) toxicology study is compliant with the defined specifications, notably those related to performance. Verification and validations steps are ongoing to allow the injection system’s use in clinics. Sensorion is collaborating with Eveon, a company specialized in designing and manufacturing custom medical devices for the preparation and delivery of drugs to optimise this approach.

Sensorion achieved a development milestone in mid-2022, by successfully producing dual AAV OTOF-GT batches at 200L clinical scale to conduct the GLP (Good Laboratory Practice) toxicology study in NHPs. The in-life part of the study has been completed and analyses are ongoing.

Sensorion has also achieved significant regulatory milestones in H2 2022 which support the medical plausibility and the development plan of OTOF-GT. On September 12, 2022, the Company announced that the European Medicine Agency (EMA) had adopted a positive opinion on Sensorion’s application for Orphan Drug Designation (ODD) for OTOF-GT, which was approved 30 days later by the European Commission. On November 7, 2022, the Company announced that the US Food and Drug Administration (FDA) granted, Rare Pediatric Disease Designation (RPDD) and on November 30, 2022, Orphan Drug Designation to Sensorion’s lead gene therapy candidate, OTOF-GT. Sensorion has received scientific advice from regulatory agencies on preclinical, CMC and clinical development plans for OTOF-GT in Q3 2021 and in Q2 2022. The company submitted a follow-up scientific advice to the EMA in H1 2023 and expects feedback in the following weeks.

The European Medicines Agency’s advisors welcomed the ongoing Natural History Study, Audioferline (NCT04202185), a component of the AUDINNOVE project coordinated by Hôpital Necker-Enfants Malades (Necker Hospital) in partnership with Sensorion (Project ANR-18-RHUS-0007). Sensorion is expanding the study across Europe to document the natural course of disease progression in otoferlin deficiency patients and to select the most relevant and clinically meaningful endpoints. The company is on track to file a Clinical Trial Application for OTOF-GT in Q2 2023.

GJB2-GT program progressing with promising pre-clinical results
On February 15, 2021, Sensorion announced its largest gene therapy program to date, a collaboration with Institut Pasteur, targeting the GJB2 gene in pediatric and adult deafness. Research by Institut Pasteur demonstrated that anomalies in GJB2 gene, known to be the most common cause of congenital deafness, are also a broad contributor to severe age-related hearing loss in adults. Although the types of GJB2 mutation in children and adults may differ, gene therapy could potentially provide solutions for both.

Sensorion’s GJB2 gene therapy programs have the potential to address three pathologies related to GJB2 mutations: early onset of presbycusis in adults, progressive forms of hearing loss in children, and pediatric congenital deafness.

Proof-of-Concept (POC) studies have confirmed the potential of Sensorion’s promising product candidate to improve congenital and progressive hearing loss forms related to GJB2 mutations in a mouse model recapitulating both human conditions. Sensorion plans to confirm the candidate selection based on the POC results in H1 2023.

SENS-401, our small molecule for the prevention of hearing loss

SENS-401 to prevent Cisplatin Induced Ototoxicity (CIO) study ongoing
Cisplatin and other platinum compounds are essential chemotherapeutic agents for many malignancies. Unfortunately, platinum-based therapies cause ototoxicity and hearing loss, which are permanent, irreversible and particularly harmful in up to 50-60% of adult patients and 90% of pediatric patients who survive cancer. This indication represents a very significant unmet need for patients and is an attractive market with more than 500,000 patients forecast in 2025 in the G7 countries.

In late 2021, Sensorion filed a POC clinical trial application in CIO to evaluate the potential of SENS-401 treatment. The NOTOXIS clinical trial application (CTA) has been approved earlier in 2022. Following extensive analysis of the AUDIBLE-S study data beginning of 2022, Sensorion has adapted the design of this trial to focus on the prevention of hearing loss. The amended Phase 2a POC Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity was approved in France on October 24, 2022.

The exploratory Phase 2a, multicenter, randomized, controlled, open-label study, NOTOXIS, aims at evaluating the efficacy of SENS-401 to prevent ototoxicity induced by cisplatin in adult patients with a neoplastic disease. The trial also assesses a number of outcome measures, including the rate and severity of ototoxicity, the change in Pure Tone Audiometry (PTA) (dB) throughout the study and the tolerance.

The first patient was enrolled in December 2022 and Sensorion anticipates preliminary results in Q2 2023.

SENS-401 to prevent residual hearing loss after cochlear implantation study ongoing
At the beginning of 2021, Sensorion released positive preclinical data demonstrating that the combination of its SENS-401 molecule and a cochlear implantation helped reduce loss of residual hearing at a frequency located beyond the electrode array. Preservation of ‘natural’ hearing is particularly important in speech recognition.

Following this initial success, Sensorion and its partner Cochlear Limited (Cochlear) announced on September 8, 2021, the initiation of a POC clinical trial of SENS-401 (Arazasetron) in patients scheduled for cochlear implantation. Regulatory authorities in Australia and France have respectively approved the initiation of the trial on July 1, 2022, and on October 24, 2022.

The Phase 2a trial is a multicentric, randomized, controlled, open-label trial aimed at evaluating the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult participants prior to cochlear implantation due to moderately severe to profound hearing impairment. Following implantation, patients will continue to receive SENS-401 for 42 days. The study also assesses a number of secondary endpoints, including the change of hearing threshold from baseline to the end of the study in the implanted ear at several frequencies.

The first patient was enrolled in September 2022 and the Company expects to release preliminary data in mid-2023.

Expansion of technology platform

In 2022, to further strengthen its technology base, Sensorion has expanded its CMC (Chemistry, Manufacturing and Control) gene therapy platform. The Company has acquired bioreactors (2L, 10L and 50L scale) to develop the AAV process in suspension and automates to increase the throughput analysis for process and product characterization.

This great achievement strengthens Sensorion’s autonomy in process and analytical development and eases technology transfer to CDMOs.

Corporate Highlights:

Strengthening the Board of Directors and senior leadership

On January 4, 2022, Sensorion appointed Dr. Aniz Girach as Independent Board Member. He brings over 22 years’ experience in the industry. He is currently serving as Chief Medical Officer at ProQR Therapeutics NV, where he is leading the development of genetic therapies for inherited retinal diseases.

On March 1st, 2023, after the period end, Sensorion appointed David Lawrence as Chief Financial Officer. Mr Lawrence has over 30 years’ experience of leadership roles in life sciences, ranging from large biopharma companies such as GSK to start-ups and earlier stage companies. He brings extensive industry experience including strategy, business development and M&A, and currently sits on the Boards of Enterobiotix Limited and is an advisor to ACM Biolabs Pty.

2023 Outlook

As of December 31, 2022, the Company had €26.2 million in cash. Based on its cash position and its forecasted expenses, the Company believes it will be able to fund its operations up to the end of 2023.

Sensorion is on track to file a Clinical Trial Application for OTOF-GT in Q2 2023 and to select a gene therapy candidate to treat hearing loss related to mutations in GJB2 gene in collaboration with the Hearing Institute (Institut de l‘Audition), a center of the Institut Pasteur. The company expects the publication of its ongoing clinical trials’ interim results of SENS-401 in association with cochlear implants to prevent residual hearing loss, with partner Cochlear, and to prevent Cisplatin-Induced Ototoxicity in 1H 2023.

Expected future milestones and estimated timelines:

April 6, 2023 – Sensorion to host a Gene Therapy R&D day
Q2 2023 – SENS-401 in combination with cochlear implants: Interim results
Q2 2023 – SENS-401 CIO: Interim results
Q2 2023 – OTOF-GT: Submission of the Clinical Trial Application (CTA)
Q2 2023 – GJB2-GT: Candidate selection
2022 financial results

The annual accounts at December 31st, 2022, drawn up according to IFRS standards and approved by the Board of Directors on March 15th, 20231.

The simplified income statement as of 31 December 2022 is as follows:

In Euros – IFRS standards


31.12.2022


31.12.2021

Operating income


5.005.515


4.348.647

Research & Development expenses


-22.924.960


-14.623.652

General & Administrative expenses


-5.217.203


-4.749.593

Total operating expenses


-28.142.143


-19.373.245

Operating loss


-23.136.648


-15,024,597

Financial result


-72.442


-112.192

Net loss


-23.209.090


-15.136.789

For the year ended 31st December 2022, Sensorion reported operating income of €5.0 million, which included €3.9 million in research tax credit (including €3.7m in France and €0.2m in Australia) and €1.0 million in grants from the Audinnove2 (RHU), and Patriot3 (PSPC) collaborations.

Operating expenses increased by 45% from €19.4 million in 2021 to €28.1 million for fiscal year 2022. In 2022, our R&D expenses and General & Administrative expenses account approximately for 81% and 19% respectively of our operating expenses, against 75% and 25% respectively in 2021.

R&D expenses increased by 57% from €14.6 million in 2021 to €22.9m in 2022. The increase was primarily due to increased efforts in OTOF-GT CTA-enabling studies including increased costs in preclinical and in manufacturing.
G&A expenses are up 10% from €4.8m in 2021 to €5.2 million in 2022, due mostly to an increase in headcount in order to support the growth of R&D activities.
Operating loss at 31 December 2022 was -€23.1 million compared with -€15.0 million at 31 December 2021.

The net financial loss decreased by €0.04 million compared to 2021, mainly due to an increase in financial income.

Net loss was -€23.2 million at 31 December 2022 compared with -€15.1 million at 31 December 2021.

As of 31 December 2022, the company employed 46 people.

Financial structure

The simplified balance sheet at December 31st, 2022 is as follows:

In Euros – IFRS standards


31.12.2022


31.12.2021

Non-current Assets


3.175.915


2.142.885

Other Current Assets


9.565.307


6.946.055

Cash & cash equivalent


26.203.905


50.001.110

Total Assets


38.945.127


59.090.050

Equity


21.885.121


44.055.803

Non-current Liabilities


3.467.116


4.504.691

Current Liabilities


13.592.890


10.529.556

Total Liabilities


38.145.127


59.090.550

Non-current assets increased by €1.0 million mainly due to investments in equipment for manufacturing.

Other current assets increased by €2.6 million mainly due to the increase of research tax credit expected for 2022 which amounts €3.9 million and a decrease in prepaid expenses.

Cash and cash equivalents amounted to €26.2 million at 31 December 2022 compared to €50.0 million at December 31st, 2021.

Total equity amounted to €21.9 million as of December 31st, 2022 compared to €44.1 million at December 31st, 2021; this decrease of -€22.2 million is mainly related to the net loss of -€23.2 million for the period.

Current liabilities increased by €3.1 million mainly explained by an increase in R&D expenses.

Leucid Bio and Great Ormond Street Hospital enter commercial agreement at new gene therapy manufacturing centre

On March 16, 2023 Leucid Bio ("Leucid" or the "Company"), a biotech company pursuing a differentiated approach to develop next generation Chimeric Antigen Receptor T-cell (CAR-T) therapies using the Company’s proprietary Lateral CAR Platform to improve treatment outcomes and save the lives of patients with refractory cancers, reported a first-of-its-kind commercial manufacturing master services agreement with Great Ormond Street Hospital NHS Foundation Trust (GOSH) to manufacture lead asset, LEU011 a lateral CAR targeting NKG2D ligands, for use in human clinical studies (Press release, Leucid Bio, MAR 16, 2023, View Source [SID1234628965]). Leucid Bio expects to file its Clinical Trial Application (CTA) to initiate the clinical trial in H1 2023 and to be dosing patients suffering from solid tumours and haematological malignancies, by H2 2023, subject to regulatory approval.

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GOSH operates specialised manufacturing facilities for research and development of cell and gene therapies. This includes clean-room laboratories, storage and specialist training facilities. Under the terms of the agreement GOSH will work with Leucid at the state-of-the-art cleanroom facilities at the Zayed Centre for Research into Rare Disease in Children and provide quality assurance services required for manufacture of clinical product for the LEU011 first-in-man study, and potentially, other Leucid clinical programmes.

Each Party will retain ownership of background IP and Leucid (subject to contractual obligations) will own all Intellectual Property Rights arising from the Manufacturing Services performed.

Ian Miscampbell, Interim Executive Chairman of Leucid Bio, said: "We are extremely pleased to enter this first-of-its-kind agreement with GOSH to manufacture our lead asset, LEU011, for use in human studies. Additionally, we are pleased to have started a process with GOSH to examine the feasibility of applying our approach in the paediatric setting where there remains a great unmet need for new therapies. Working in close collaboration with leading institutes such as GOSH is fundamental to our ability to move quickly into clinical trials, using their state-of-the-art manufacturing facilities based here in London."

Stephen Mathew, Head of Innovation at GOSH said: "Gene and cell therapies are the cutting-edge in clinical research, holding promise to offer personalised cancer treatment, including for rare forms that affect children and young people. At Great Ormond Street Hospital, we see children with the most rare and complex cancers. There have been incredible strides forward in the treatments that we can offer, however, sadly for many these still don’t work. Gene and cell therapies offer hope for better, and potentially curative treatments which is why we’re excited to support innovation in gene therapies through access to these highly specialist and unique facilities."

CAR T-cell therapy is revolutionary technology in which immune cells, called T-cells, are reprogrammed so they can recognise and destroy cancer cells. This has proven to be a powerful therapy for refractory blood cancers but to date has lacked efficacy for the treatment of solid cancers.

Leucid Bio has developed two proprietary platforms that build upon Dr Maher’s novel ‘lateral’ CAR-T model which develops CAR-T molecules designed to adopt a more natural configuration within the T-cells. The technology gives properties to the CAR-Ts that enable them to consistently outperform previous generations of CAR-T therapies in pre-clinical studies; enhancing T-cell potency and generating a persistent long-term response with reduced toxicity.

LEU011 is based on a novel lateral CAR structure, in which complementary signalling domains are integrated in parallel across the cell membrane. This formation replicates the natural side-by-side position of these molecules across the cell membrane that is seen in endogenous immune receptors.

Previous pre-clinical studies have shown that LEU011 consistently outperforms previous generations of CAR T-cells in those studies, enabling better control over T-cell activation, superior anti-tumour activity, and a favourable toxicity profile.

THERMOGENESIS ANNOUNCES $3 MILLION PRIVATE PLACEMENT PRICED AT-THE-MARKET UNDER NASDAQ RULES

On March 16, 2023 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported that it has entered into definitive agreements for the purchase and sale of 1,071,429 shares of its common stock (or common stock equivalents) and warrants to purchase 1,071,429 shares of its common stock at a purchase price of $2.80 per share of common stock (or common stock equivalent) and associated warrant in a private placement priced at-the-market under Nasdaq rules (Press release, Thermogenesis, MAR 16, 2023, View Source [SID1234628964]). The warrants have an exercise price of $2.65 per share, will be exercisable immediately upon issuance and expire five and one-half years following the issuance.

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

The gross proceeds to the Company are expected to be approximately $3 million. The offering is expected to close on or about March 20, 2023, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Under an agreement with the investors, the Company agreed to file an initial registration statement with the SEC covering the resale of the securities described above no later than April 5, 2023 and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days following the date of the agreement in the event of a "full review" by the SEC.

The Company has also agreed to amend certain existing warrants to purchase up to an aggregate of 158,731 shares of the Company’s common stock that were previously issued in October 2022 and have exercise price of $6.30 per share by reducing the exercise price of the warrants to $2.65 per share.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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.